20-001 Code Vt. R. 20-023-001-X

Current through August, 2024

Section 20 023 001 - INSPECTION OF MEAT AND POULTRY PRODUCTS

Part 301 MEANING OF TERMS AND DEFINITIONS

Section 301.1 Meaning of terms

As used in this subchapter, unless otherwise required by the context, the singular form shall also import the plural and the masculine form shall also import the feminine, and vice versa.

Section 301.2 Definitions

As used in these regulations, except as otherwise specified, the following terms shall have the meaning stated below:

(A) The Act. The Vermont Meat and Poultry Inspection Act, 6 V.S.A., Chapter 204.

(B) Adulterated shall apply to any livestock product or poultry product under one or more of the following circumstances:

(1) if it contains any poisonous or harmful substance which may render it injurious to health, the product shall not be considered adulterated under this definition if the quantity of the substance in or on the product does not ordinarily render it injurious to health;

(2) if it contains any poisonous or harmful substance which may, in the judgment of the commissioner, make the product injurious to health;

(3) if it is a raw agricultural commodity and the commodity contains a pesticide chemical which is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;

(4) if it contains any food additive which is unsafe within the meaning of section 409 of the Federal food, Drug, and Cosmetic Act;

(5) if it contains any color additive which is unsafe within the meaning of section 706 of the Federal Food, Drug, and Cosmetic Act. A product which is not otherwise deemed adulterated under subdivisions (3), (4), and (5) shall be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on the product is prohibited by rules of the commissioner in official, or licensed establishments;

(6) if it consists of any filthy, putrid or decomposed substance or is unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(7) if it has been prepared, packed, or held under unsanitary conditions where it may have become contaminated with filth, or where it may have been rendered injurious to health;

(8) if it is the product of an animal, including poultry, which has died in a manner other than by slaughter;

(9) if its container is composed of any poisonous or harmful substance which may render the contents injurious to health.

(10) if it has been subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act;

(11) if any valuable constituent has been omitted or abstracted; or if any substance has been substituted, wholly or in part; or if damage or inferiority has been concealed in any manner; or if any substance has been added or mixed or packed so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is; or

(12) if it is margarine containing animal fat and any of the raw material used consisted of any filthy, putrid, or decomposed substance.

(C) Anesthesia. The loss of sensation or feeling.

(D) Animal food. Any article intended for use as food for poultry, dogs, cats, or other animals derived wholly, or in part, from the carcass or parts of products of the carcass of any livestock.

(E) Animal food manufacturer. Means any person engaged in the business of preparing animal, including poultry, food derived wholly or in part from livestock or poultry carcasses or parts or products of carcasses.

(F) Artificial coloring. A coloring containing any dye or pigment, which dye or pigment was manufactured by a process of synthesis or other similar artifice, or a coloring which was manufactured by extracting a natural dye or natural pigment from a plant or other material in which such dye or pigment was naturally produced.

(G) Artificial flavoring. A flavoring containing any sapid or aromatic constituent, which constituent was manufactured by a process of synthesis or other similar artifice.

(H) Biological residue. Any substance, including metabolites, remaining in livestock at time of slaughter or in any of its tissues after slaughter as the result of treatment or exposure of the livestock to a pesticide, organic or inorganic compound hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other therapeutic or prophylactic agent.

(I) Broker. Means any person engaged in the business of buying or selling livestock products or poultry products for other persons on commission, or otherwise negotiating purchases or sales of these products other than for his or her own account or as an employee of another person.

(J) Capable of use as human food. Shall apply to any livestock or poultry carcass, or part or product of any livestock or poultry carcass, unless it is denatured or otherwise identified as required by rules prescribed by the commissioner to deter its use as human food, or which is naturally inedible by humans.

(K) Captive bolt. A stunning instrument which when activated drives a bolt out of a barrel for a limited distance.

(L) Carbon dioxide. A gaseous form of the chemical formula CO2.

(M) Carbon dioxide concentration. Ratio of carbon dioxide gas and atmospheric air.

(N) Carcass. All parts, including viscera, of any slaughtered livestock.

(O) Chemical preservative. Any chemical that, when added to a meat or meat food product, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices or substances added to meat and meat food products by exposure to wood smoke.

(P) Commerce. To carry or trade.

(Q) Commercial processor. Means any person who maintains an establishment under these regulations for the purpose of processing livestock, meat, meat food product, poultry, or poultry product other than for the exclusive use in the household of the owner of the commodity, by him or her and members of his or her household and his or her nonpaying guests and employees.

(R) Commercial slaughterhouse. Means any person engaged in the business of slaughtering livestock or poultry other than as a custom slaughterer.

(S) Commissioner. Means the commissioner of the Vermont department of agriculture or his or her designee.

(T) Consciousness. Responsiveness of the brain to the impressions made to the senses.

(U) Consumer. One who acquires goods or services; a buyer.

(V) Container-Package. Means any box, can, tin, cloth, plastic, or other receptacle, wrapper, or cover.

(W) Custom processor. Means any person who maintains an establishment under these regulations for the purpose of processing livestock, meat, meat food product, poultry, or poultry product exclusively for use, in the household of the owner of the commodity, by him or her and members of his or her household and his or her nonpaying guests and employees.

(X) Custom slaughterhouse or custom slaughterer. Means a person who maintains a slaughter establishment under these regulations for the purpose of slaughtering livestock or poultry for another persons exclusive use by him or her and members of his or household and his or her nonpaying guests and employees and who is not engaged in the business of buying or selling carcasses, parts of carcasses, meat or meat food products of any cattle, sheep, swine, goats, equines, or poultry, capable of use as human food.

(Y) Cutting up. Any division of any carcass or part thereof, except that the trimming of carcasses or parts thereof to remove surface contaminants is not considered as cutting up.

(Z) Dead livestock. The body (cadaver) of livestock which has died otherwise than by slaughter.

(AA) The Department. The Vermont Department of Agriculture.

(BB) Dying, diseased, or disabled livestock. Livestock which has or displays symptoms of having any of the following:

(1) Central nervous system disorder;

(2) Abnormal temperature (high or low);

(3) Difficult breathing;

(4) Abnormal swellings;

(5) Lack of muscular coordination;

(6) Inability to walk normally or stand;

(7) Any of the conditions for which livestock is required to be condemned on ante-mortem inspection in accordance with the regulations in Part 309 of these regulations.

(CC) Edible. Intended for use as human food.

(DD) Experimental animal. Any animal used in any research investigation involving the feeding or other administration of, or subjection to, an experimental biological product, drug, or chemical or any nonexperimental biological product, drug, or chemical used in a manner for which it was not intended.

(EE) Exposure time. The period of time an animal is exposed to an anesthesia-producing carbon dioxide concentration.

(FF) Federal Food, Drug, and Cosmetic Act. Means the Act so entitled, approved June 25, 1938 (52Stat. 1040), and amendatory or supplementary acts. It shall include as part of its meaning the "Vermont Food, Drug, Cosmetic and Hazardous Substance Labeling Act" 18 V.S.A. chapter 82, rules promulgated under that chapter and amendatory or supplementary acts, where not inconsistent with the "Federal Food, Drug, and Cosmetic Act."

(GG) Federal Meat Inspection Act. Means the Act so entitled approved March 4, 1907 (34 Stat. 1260), as amended by the Wholesome Meat Act (81 Stat.584); the term "Federal Poultry Products Inspection Act" means the Act so entitled approved August 28, 1957 (71 Stat.441), as amended by the Wholesome Poultry Products Act (82 Stat.791); and the term "Federal Acts" means these two federal laws.

(HH) Further processing. Smoking, cooking, canning, curing, refining, or rendering in an official establishment of product previously in official establishments.

(II) Handler of dead, dying, disabled, or diseased animals. Means any person who buys, sells, transports, or otherwise handles any animal which died other than by slaughter, or any animal which displays symptoms defined in section 301.2(BB) of these regulations.

(JJ) Head of service. Means the person designated by the commissioner to be in charge of the day-to-day operations of the Vermont meat and poultry inspection and licensing program established by the "Act".

(KK) Immediate container. Means any consumer package, or any other container in which livestock products or poultry products, not consumer packaged, are packed.

(LL) Inedible. Adulterated, uninspected, or not intended for use as human food.

(MM) Inhumane slaughter or handling in connection with slaughter. Slaughter or handling in connection with slaughter not in accordance with the Act of August 27, 1958 (72 Stat. 862; 7 U.S.C. 1901 - 1906, as amended by the Humane Methods of Slaughter Act of 1978, 92 Stat. 1069) and Part 313 of these regulations.

(NN) Inspector. Means an employee or official of the state of Vermont authorized by the commissioner or any employee or official of the federal government or of any other governmental entity of this state, authorized by the commissioner to perform any inspection functions under the Act under an agreement between the commissioner and the governmental entity.

(OO) Inspector in Charge. Inspector in Charge is an inspector of the Vermont Meat and Poultry Inspection Service on duty in any licensed meat or poultry plant or the inspector assigned to training or supervising duties if more than one inspector is on duty in a plant.

(PP) Intrastate commerce. Means any commerce within this state.

(QQ) Label. Means a display of written, printed, or graphic matter upon any product or the immediate container not including package liners, of any product.

(RR) Labeling. Means all labels and other written, printed, or graphic matter:

(1) upon any product or any of its containers or wrappers; or

(2) accompanying the product.

(SS) Licensed establishment. Means any person required to hold a license under section 3306 of the Act.

(TT) Livestock. Means any cattle, sheep, swine, goats, horses, mules or other equines, whether live or dead.

(UU) Livestock product. Means any carcass, or part of a carcass, meat or meat food product of any livestock.

(VV) Meat. Means the part of the muscle of any cattle, sheep, swine, goats, horses, mules or other equine which is skeletal or which is found in the tongue, in the diaphragm in the heart, or in the esophagus, with or without the accompanying and overlying fat, and the portions of bone, skin, sinew, nerve, blood vessels which normally accompany the muscle tissue and which does not include the muscle found in the lips, snout, or ears.

(WW) Meat byproduct. Any part capable of use as human food, other than meat, which has been derived from one or more cattle, sheep, swine, or goats. This term, as applied to products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.

(XX) Meat food product and meat product. Means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which are exempted from definition as a meat food product by the commissioner under conditions which he or she may prescribe to assure that the meat or other portions of carcass contained in products are unadulterated and that products are not represented as meat food products. This term as applied to food products of equines shall have a meaning comparable to that provided in this subdivision with respect to cattle, sheep, swine, and goats.

(YY) Meat and Poultry Inspection Service. The Vermont Department of Agriculture Meat and Poultry Inspection Service.

(ZZ) Misbranded. Shall apply to any livestock product or poultry product under one or more of the following circumstances:

(1) if its labeling is false or misleading in any way;

(2) if it is offered for sale under the name of another food;

(3) if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and immediately thereafter, the name of the food imitated;

(4) if its container is made, formed, or filled as to be misleading;

(5) unless it bears a label showing (1) the name and place of business of the manufacturer, packer, or distributor; and (ii) an accurate statement of the quantity of the product in terms of weight, measure, or numerical count; provided, that under this subdivision quantity of the product in terms of weight, measure, or numerical count; provided, that under this subdivision (5), exemptions as to livestock products not in containers may be established by rules prescribed by the commissioner and provided, further that under subdivision (ii) of this subdivision (5), reasonable variations may be permitted, and exemptions as to small packages may be established for livestock products or poultry products by rule prescribed by the commissioner;

(6) if any word, statement, or other information required by or under authority of the Act to appear on the label or other labeling is not prominently placed with such conspicuousness as compared with other words, statements, designs, or devices, in the labeling and in the terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) if it is represented as a food for which a definition and standard of identity or composition has been prescribed by the rules of the commissioner under section 3305 of the Act unless:

(i) it conforms to the definition and standard; and

(ii) its label bears the name of the food specified in the definition and standard and, insofar as may be required by rules, the common names of optional ingredients other than spices, flavorings, and coloring present in the food;

(8) if it is represented as a food for which a standard or standards of fill of container have been prescribed by rules of the commissioner under section 3305 of the Act and it falls below the standard of fill of container, unless its label bears, in such manner and form as the rules specify, a statement that it falls below the standard;

(9) if it is not subject to the provisions of subdivision (8), unless its label bears:

(i) the common or usual name of the food, if any; and

(ii) in case it is fabricated from two or more ingredients, the common name of each ingredient, except that spices, flavorings, and colorings may, when authorized by the commissioner, be designated as spices, flavorings, and colorings without naming each; provided, that to the extent that compliance with the requirements of subdivision (ii) of this subdivision

(9) is impracticable, or results in deception or unfair competition, exemptions shall be established by rules promulgated by the commissioner;

(10) if it is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the commissioner determines to be, and by rules prescribe as, necessary in order to fully inform purchasers as to its value for these uses;

(11) if it contains any artificial flavorings, artificial coloring or chemical preservative, unless it has a label stating that fact; provided, that to the extent that compliance with the requirements of this subdivision (11) is impracticable, exemptions shall be established by rules promulgated by the commissioner;

(12) if it fails to have, directly on its containers, as the commissioner may by rules prescribe, the official inspection legend and establishment number of the establishment where the product was prepared, and unrestricted by any of the foregoing, such other information as the commissioner may require in rules to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the product in a wholesome condition.

(AAA) Nonfood compound. Any substance proposed for use in official establishments, the intended use of which will not result, directly or indirectly in the substance becoming a component or otherwise affecting the characteristics of meat and meat food products, excluding labeling and packaging materials as covered by Part 317 of these regulations.

(BBB) Official certificate. Means any certificate prescribed by rules of the commissioner for issuance by an inspector or other person performing official functions under the Act.

(CCC) Official device. Means any device prescribed or authorized by the commissioner for use in applying any official mark.

(DDD) Official establishment. Means any establishment as determined by the commissioner at which inspection of the slaughter of livestock or poultry or the preparation of livestock products or poultry products is maintained under the authority of the Act.

(EEE) Official inspection legend. Means any symbol prescribed by rules of the commissioner showing that a product was inspected and passed in accordance with the Act.

(FFF) Official mark. Means the official inspection legend or any other symbol prescribed by rules of the commissioner to identify the status of any product of livestock or poultry under the Act.

(GGG) Packaging material. Any cloth, paper, plastic, metal or other material used to form a container, wrapper, label, or cover for meat or poultry products.

(HHH) Person. Includes any individual, partnership, corporation, association, or other business unit, and any officer, agent or employee.

(III) Pesticide chemical, food additive, color additive and raw agricultural commodity. Shall have the same meanings for purposes of these regulations as under the Federal Food, Drug, and Cosmetic Act.

(JJJ) Poultry. Means any domesticated bird, whether live or dead.

(KKK) Poultry products. Means any poultry carcass or part of a carcass; or any product which is made wholly or in part from any poultry carcass or part of a carcass, excepting products which are exempted by the commissioner from definition as a poultry product under conditions which he or she may prescribe to assure that the poultry ingredients in products are not adulterated and that these products are not represented as poultry products.

(LLL) Prepared. Means slaughtered, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed.

(MMM) Product. Any carcass, meat, meat by product, or meat food product, capable of use as human food.

(NNN) Protective covering. Means wrapping intended solely to protect the product against soiling or excessive drying during transportation of storage; the protective covering shall bear no information except company brand names, trade marks, or code numbers which do not include any information required by section 317.2.

(OOO) Public warehouseman. Means any person who acts as a temporary custodian of meat, meat food products, or poultry products stored in that person's warehouse for a fee.

(PPP) Reinspection. Includes inspection of the preparation of livestock products and poultry products, as well as re-examination of products previously inspected.

(QQQ) Renderer. Means any person engaged in the business of rendering livestock or poultry carcasses, or parts of products of carcasses, except rendering conducted under inspection or exemption under these regulations.

(RRR) Retail vendor. Means any person who sells, displays, advertises for sale, offers for sale, or has available for sale meat, meat food products and/or poultry products for purchase by consumers. Retail vendors include persons who operate stores, sell or attempt to sell to consumers at their homes, or otherwise sell, display, advertise, offer or have available for sale, meat food products and/or poultry products at retail for purchase by consumers.

(SSS) Service. The Meat and Poultry Inspection Service established by the Act.

(TTT) Service employee. Any inspector or other individual employed by the department or any cooperating agency who is authorized by the commissioner to do any work or perform any duty in connection with the Service.

(UUU) Shipping container. Means any container used or intended for use in packaging the product packed in an immediate container.

(VVV) Supervising veterinarian. The supervising veterinarian of the Meat and Poultry Inspection Service. A veterinarian who is a graduate of a school of veterinary medicine, which is approved by the American Veterinary Medical Association, and who has been appointed by the Commissioner of Agriculture to supervise inspections.

(WWW) Supervision. The controls, as prescribed in instructions to service employees, to be exercised by them over particular operations to insure that such operations are conducted in compliance with the Act and the regulations.

(XXX) Surgical anesthesia. A state of unconsciousness measured in conformity with accepted surgical practices.

(YYY) Vt. Detained. Refers to any product detained pursuant to 6 V.S.A., section 3315 or by notification of appropriate federal authorities.

(ZZZ) Vt. Condemned. Means that livestock so identified has been inspected and found to be in a dying condition, or to be affected with any other condition or disease that would require condemnation of its carcass.

(AAAA) Vt. Inspected and Condemned (or any authorized abbreviation thereof). Means that the carcass, viscera, part carcass, or other product so identified has been inspected, found to be adulterated, and condemned under these regulations.

(BBBB) Vt. Inspected and Passed or Vt. Inspected and Passed by the Department of Agriculture (or any authorized abbreviation thereof. Means that product so identified has been inspected and passed under these regulations, and at the time it was inspected, passed, and identified, it was found to be not adulterated.

(CCCC) Vt. Passed for Cooking. Means that meat or meat byproducts so identified has been inspected and passed on condition that it be cooked or rendered as prescribed by these regulations.

(DDDD) Vt. Passed for Refrigeration. Means that meat or meat byproduct so identified has been inspected and passed on condition that it be refrigerated or otherwise handled as prescribed by these regulations.

(EEEE) Vt. Retained. Means that the carcass, viscera, part carcass, other product, or article so identified is held for further examination by an inspector to determine its disposal.

(FFFF) Vt. Suspect. Means that livestock so identified is suspected of being affected with a disease or condition which may require its condemnation, in whole or in part, when slaughtered, and is subject to further examination by an inspector to determine its disposal.

(GGGG) Wholesale distributor. Means any person who sells meat to retail vendors, other merchants, or to industrial, institutional and commercial users mainly for resale or business use.

Part 302 APPLICATION OF INSPECTION AND OTHER REQUIREMENTS

Section 302.1 Establishments requiring inspection

Inspection under these regulations in this subchapter is required at:

(A) Every establishment, except as provided in Part 303.1 (A) of these regulations, in which livestock are slaughtered for transportation or sale, or in which any product of, or derived from, carcasses of livestock are, wholly or in part, prepared for transportation or sale, which are intended for use as human food;

(B) Every establishment, except as provided in Part 303.1 (A), (B), (C) of these regulations, at which any livestock are slaughtered or any products of any livestock are prepared, for use as human food for distribution; and

(C) Every establishment, except as provided in Part 303 of these regulations, that is designated by the Commissioner as one producing adulterated products which would clearly endanger the public health.

Section 302.2 Livestock and products entering official establishments

All livestock and all products entering any official establishments and all products prepared, in whole or in part, therein, shall be inspected, handled, stored, prepared, packaged, marked, and labeled as required by these regulations.

Section 302.3 Prohibited acts in general

(A) No person shall, with respect to any livestock or poultry or any livestock products or poultry products:

(1) slaughter any livestock or poultry or prepare any products which are capable of use as human food, at any establishment preparing the products solely for intrastate commerce, except in compliance with the requirements of these rules;

(2) sell, transport, offer for sale or transportation, or receive for transportation, in intrastate commerce, any products which:

(a) are capable for use as human food; and

(b) are adulterated or misbranded at the time of the sale, transportation, offer for sale or transportation, or receipt for transportation, or

(c) have not been inspected and passed by the Vermont Depart of Agriculture or the USDA unless they are exempt from inspection by these regulations; or

(3) do, with respect to any of these products which are capable of use as human food, any act while they are being transported in intrastate commerce or held for sale after transportation, which is intended to cause or has the effect of causing the products to be adulterated or misbranded.

(B) No person shall sell, transport, offer for sale or transportation, or receive for transportation, in intrastate commerce, or from an official establishment, any slaughtered poultry from which the blood, feathers, feet, head or viscera have not been removed in accordance with these rules.

(C) No person shall violate the orders of the commissioner or of his/her inspectors, provided the orders come within the authority of the commissioner and his agents stated in 6 V.S.A. chapter 204.

(D) No person shall sell or offer for sale any product unless it has been inspected and passed by the Vermont Department of Agriculture or U.S.D.A.

Part 303 EXEMPTIONS

Section 303.1 Exemptions

(A) The requirement of the Act and these regulations for of the preparation of products do not apply to:

(1) The slaughtering by any individual of livestock of his own raising, and the preparation by him and transportation of the carcasses, parts thereof, meat and meat food products of such livestock exclusively for use by him and members of his household and his nonpaying guests and employees; and

(2) The custom slaughter by any person of cattle, sheep, swine or goats delivered by the owner thereof for such slaughter, and the preparation by such slaughterer and transportation of the carcasses, parts thereof, meat and meat food products of such livestock, exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees; nor to the custom preparation by any person of carcasses, parts thereof, meat and meat food products derived from the slaughter by any individual of cattle, sheep, swine, or goats of his own raising or from game animals, delivered by the owner thereof for such custom preparation, and transportation of such custom prepared articles, exclusively for use in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, that the following requirements are met by such custom operator:

(i) The establishment in which the custom operations are conducted is maintained and operated in accordance with the provisions of Sections 308.4 through 308.11, 308.13, 308.14, and 308.3 (except 308(D) (2) and (3), of these regulations); Provided, that the provisions of said sections relating to inspection or supervision of specified activities or other action by a Service employee shall not apply to the preparation and handling of such exempted products: Provided, further, that the requirements of Section 308.4 for separate facilities for men and women workers shall not apply to such establishments when the majority of the workers in the establishment are related by blood or marriage and this arrangement will not conflict with municipal requirements, and the requirement of Section 308.4 for separation of toilet soil lines from house drainage lines to a point outside the buildings will not apply to such establishments when positive acting backflow devices are installed: and Provided, further, that the requirements of 308.13 for paved driveways, approaches, yards, pens, and alleys shall not apply to such establishments.

(ii) No custom slaughterer may engage in the business of buying or selling carcasses, parts of carcasses, meat or meat food products of any cattle, sheep, swine, goats, equines, or poultry, capable of use as human food;

(iii) The custom prepared products are plainly marked NOT FOR SALE as provided in Section 316.16 of these regulations, immediately after being prepared and are kept so identified until delivered to the owners; and

(iv) If exempted custom processing of products is conducted in an official establishment, all facilities and equipment in the official establishment used for such custom operations shall be thoroughly cleaned and sanitized before they are used for preparing any products for sale.

(B) When a commercial processing establishment does custom processing the provisions of these regulations shall apply to the custom processing.

(1) The exempted custom prepared products shall be prepared and handled in accordance with the provisions of Sections 318.5, 318.6, 318.7, 318.10, and 318.11 of these regulations and shall not be adulterated as defined in Section 301.2(B): Provided, that the provisions of Sections 318.5, 318.6, 318.10, and 318.11 relating to inspection and supervision of specified activities or other action by a Service inspector, and the provisions of Sections 318.6(B)(9) and (10), shall not apply to the preparation and handling of such exempted products.

(2) The exempted custom prepared products shall comply with the requirements of Section 316.16 of these regulations.

(3) The custom operators claiming exemptions under paragraph (A) (2) of this Section shall keep records, in addition to records otherwise required by PART 320 of these regulations, showing the number and kinds of livestock slaughtered on the custom basis, the quantities and types of products prepared on a custom basis, and the name and addresses of the owners of the livestock and products.

(4) Articles capable of use as human food, resulting from the exempted custom slaughter or other preparation of products shall be promptly denatured or otherwise identified in accordance with Section 325.13 of these regulations and not removed from the establishments where the custom operations are conducted until so identified, unless they are delivered to the owner or the articles are for use in accordance with paragraph (A)(2) of this Section.

(C) The requirements of the Act and these regulations for inspection of the preparation of products do not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment, for sale in normal retail quantities of service of such articles to consumers at such establishments.

(1) For purposes of this paragraph operations of types traditionally and usually conducted at retail stores and restaurants are the following:

(i) Cutting up, slicing, and trimming carcasses, halves, quarters, or wholesale cuts into retail cuts such as steaks, chops, and roasts, and freezing such cuts;

(ii) Grinding and freezing products made from meat;

(iii) Cooking, re-smoking, or other preparation of products, except slaughtering or the retort processing of canned products;

(iv) Breaking bulk shipment of product; and

(v) Wrapping or rewrapping products.

(2) Any quantity of product purchased by a consumer from a particular retail supplier shall be deemed to be a normal retail quantity if the quantity so purchased does not in the aggregate exceed one-half carcass and if the quantity exceeds one primal part it must meet the requirements of Section 308A.5(C). The following amounts of product will be accepted as representing one-half carcass of the species identified:

Cattle	300 lbs.
Calves	37.5 lbs.
Sheep	27.5 lbs.
Swine	100 lbs.
Goats	25 lbs.

(3) A retail store is any place of business where;

(i) The sale of products are made to consumers only;

(ii) At least 75 percent, in terms of dollar value, of total sales of product represents sales to household consumers and the total dollar value of sales of product to consumers other than household consumers does not exceed the dollar limitation per calendar year set by the Head of Service. This dollar limitation is a figure which will automatically be adjusted during the first quarter of each calendar year, upward or downward, whenever the Consumer Price Index, published by the Bureau of Labor Statistics, Department of Labor, indicates a change in the price of this same volume of product which exceeds $ 500. The adjusted dollar value is available from the Head of Service.

(iii) Only federally or state inspected and passed product is handled or used in the preparation of any product offered for sale except that product resulting from the custom slaughter or custom preparation of product may be handled or used in accordance with paragraph (A)(2) and (B) of this Section, but NOT FOR SALE;

(iv) No sale of product is made in excess of a normal retail quantity as defined in subdivision (C)(2) of this Section;

(v) The preparation of products for sale to household consumers is limited to traditional and usual operations as defined in subparagraph (C)(1) of this Section; and

(vi) The preparation of product for sale to other than household consumers is limited to traditional and usual operations as defined in subparagraph (C)(1)(i)(ii)(iv) and (v) of this Section (a retail store at which custom preparation of products is conducted is not thereby disqualified from exemption as a retail store under this paragraph (iv).) Provided, that the volume (gross weight) of product handled for custom preparation does not exceed the volume (gross weight) of meat product handled for direct sales to household consumers.

(4) A restaurant is any establishment where product is prepared only for sale or service, in meals, or as entrees, directly to individual consumers at such establishments; only federally or state inspected and passed product or such product prepared at a retail store exempted under subdivision (C)(3) of this Section is handled or used in the preparation of any product; no sale of product is made in excess of a normal retail quantity as defined in subdivision (C)(2) of this Section; and the preparation of product is limited to traditional and usual operations as defined in subdivision (C)(1) of this Section. This definition includes a caterer which delivers or serves product in meals, or as entrees, only to individual consumers and otherwise meet the requirements of this paragraph.

(5) Similar retail-type establishments: Any establishment which is a combination retail store and restaurant; any delicatessen which meets the requirements for a retail store or restaurant as described in subdivisions (C)(3) and (4) of this Section; or other establishment as determined by the Head of Service in specific cases.

(6) Consumer: Any household consumer, hotel, restaurant, or similar institution as determined by the Head of Service in specific cases.

(7) Whenever any complaint is received by the Head of Service from any person alleging that any retail store claiming exemption under subparagraph (C)(3), (as one that does not have or is not exercising adequate authority with respect to recordkeeping requirements) has been operated in violation of the conditions prescribed in this Section for exemption, and the Head of Service, upon investigation of the complaint, has reason to believe that any such violation has occurred, he shall so notify the operator of the retail store and afford him reasonable opportunity to present his views informally with respect to the matter. Thereafter, if the Head of Service still has reason to believe that such a violation has occurred, and that a requirement concerning the operations of the retail store would effectuate the purposes of the Act, the Head of Service shall order the operator to maintain complete, accurate, and legible records of total monthly purchases and of total monthly sales of meat, meat byproducts, and meat food products, in terms of dollar values of the product involved. Such records shall separately show total sales to household consumers and total sales to other consumers and shall be maintained for the period prescribed in Section 320.3 of these regulations. If the operator maintains copies of bills of lading, receiving and shipping invoices, warehouse receipts, or similar documents which give the information required herein, additional records are not required by this paragraph.

(D) The adulteration and misbranding provisions of the Act and these regulations, other than the requirements of the official inspection legend, apply to articles which are exempted from inspection or are not required to be inspected under this Section. This includes the requirement that any pork and any product containing pork be prepared only in compliance with any applicable requirements for the destruction of trichina as provided in Section 318.10 of these regulations.

Section 303.2 Denial of Exemption

(A) Any person claiming an exemption under this PART who is denied such exemption by the Head of Service, shall be given an opportunity to present his views informally and may request a formal hearing with the Commissioner.

(B) Such person shall be informed of the reasons for denial and of his right to a hearing.

Part 304 APPLICATION FOR LICENSE, FARMERS, CUSTOM SLAUGHTER, DRAWINGS INFORMATION TO BE FURNISHED, GRANT OR REFUSAL OF LICENSE

Section 304.1 Application for license

The proprietor or operator of each establishment of the kind specified in Section 3306 of the Meat and Poultry Inspection Act shall make application to the commissioner for a license on forms prescribed by him, prior to January first of each year. In case of change of ownership or change of location, a new application shall be made.

Section 304.2 Exemption; farmers, transporting

Only sound, healthy and wholesome carcasses and part carcasses slaughtered on his own farm may be transported by a farmer for processing for his own use Provided;

(A) Such carcasses and part carcasses have affixed, by the owner, a permit or printed statement, issued by the commissioner, containing the following information:

(1) Date.

(2) Name and address of owner.

(3) Kind and amount transported.

(4) Date of slaughter.

(5) Name and address of the processing establishment.

(B) Such statement shall be numbered and one copy filled, for at least one year at the processing establishment.

(C) Only Clean, Sound, Healthy and Wholesome carcasses and part carcasses properly identified may enter establishments.

(D) Carcasses and part carcasses described in this section shall be kept separate and distinct, at all times, from inspected product.

(E) On arrival at the processing establishment each carcass and part carcass shall be legibly stamped NOT FOR SALE with edible ink in letters at least three-eights inch in height and tagged or labeled for identification. The stamp, tag, or label shall contain the following information:

(1) Farm dressed-NOT FOR SALE.

(2) Establishment name.

(3) Corresponding number of farmers statement on file.

(F) Meat or product stamped and tagged or labeled in accordance with subparagraph (E) of this section shall not be sold, offered, or exposed for sale.

(G) Livestock described in this section, slaughtered by a farmer on his premises may not be sold, as provided in PART 303 Section 303.1(A)(1) and (2).

Section 304.3 Exemption; custom slaughtering establishment

Meat, meat byproducts, meat food products slaughtered and processed at custom slaughtering establishments are subject to all requirements of PART 301 through 329 of these regulations except as follows:

(A) The carcass shall be legibly stamped NOT FOR SALE:

(B) Livestock slaughtered and processed for the owner at custom slaughtering establishments need not have ante-mortem inspection.

Section 304.4 Application for license; tenants, subsidiaries

Before the license is granted, the operator of each establishment of the kind required by Section 302.1 of these regulations to have a license shall make application therefor to the commissioner as follows:

(A) Every application under this section shall be made on a form furnished by the commissioner, and shall include all information called for by that form, including the name, address, and type of legal entity of any tenant, and the name and principal office address of any subsidiary corporation that will prepare product or conduct any other operation at the establishment for which a license is requested. The license shall be prominently displayed. Trade names of the applicant for labeling purposes shall be inserted in the appropriate blank in the application. The applicant for license will be held responsible for compliance by all such tenants or subsidiaries with the Act and these regulations at such establishment if license is granted. Such tenants and subsidiaries will also be held responsible for compliance with the Act and these regulations. Preparation of product and other operations at the establishment for which license is granted may be conducted only by the applicant and any of its tenants and subsidiary corporations named in the application.

(B) In cases of change of ownership, location, tenants or subsidiaries a new application shall be made.

Section 304.5 Drawings, information to be furnished; grant or refusal of license

(A) Each applicant for license shall submit to the Service four copies of:

(1) Complete drawings with specifications of the floor plans of the establishment for which license is requested, showing the locations of principal pieces of equipment, floor drains, principal drainage lines, handwashing basins, and hose connections for cleanup purposes;

(2) A plot plan showing the limits of the establishments premises, locations in outline of buildings on the premises, cardinal points of the compass, and roadways and railways serving the establishment; and

(3) A room schedule showing the finish of walls, floors and ceilings of all rooms in the establishment.

(i) The specifications shall include statements describing the water supply, plumbing, drainage, refrigeration, equipment, lighting and operations of the establishment related to sanitation and proper performance of inspection. Applicants for licensing may request information from the Head of Service concerning the requirements before submitting drawings and other documents required by this subparagraph.

(B) Notice shall be given, in writing, to each applicant granted a license, specifying the establishment to which the grant applies.

(C) The commissioner is authorized to grant a license upon determination that the applicant and his establishment are eligible therefore and to refuse to grant a license to any establishment if he determines that it does not meet the requirements of the Act or these regulations in this PART, PARTS 305, 307 and 308 or that the applicant has not received approval of labeling and containers to be used at the establishment as required by these regulations in PARTS 316 and 317.

(D) When license is refused, for any reason, the applicant shall be informed of the action and the reasons therefore and afforded an opportunity to present his views.

(E) Any applicant for license at an establishment where the operations thereof may result in any discharge into the navigable waters in the state is required to provide the commissioner with a permit as prescribed in said subsection that there is reasonable assurance that such activity will be conducted in a manner which will not violate the applicable water quality standards.

(F) A license may be refused in accordance with humane slaughter, and handling provisions of (6 V.S.A. Chapter 205).

Section 304.6 Revocation or suspension of license

The commissioner may suspend (for such period or indefinitely as he deems necessary to effectuate the purposes of the Act) or revoke a license for the failure of a licensee to comply with the terms of his license or the provisions of the Act or these regulations.

(A) The licensee shall be notified, in writing, of the revocation or suspension and the reasons thereof. Notice of revocation or suspension shall be sent to all persons named in the license. The licensee shall be afforded an opportunity to present his views informally prior to the effective date of such revocation or suspension. Upon request, the licensee shall be afforded a hearing with regard to the merits of such revocation or suspension, but such revocation or suspension shall continue in effect pending the outcome of such hearing, unless otherwise ordered by the Commissioner.

(B) The provisions of 3 V.S.A., Chapter 25, shall apply to the conduct of such hearings, including provisions as to notice, record, and taking of evidence.

Part 305 OFFICIAL NUMBERS; INAUGURATION OF INSPECTION; WITHDRAWAL OF INSPECTION; REPORTS OF VIOLATIONS

Section 305.1 Official numbers

An official number shall be assigned to each establishment granted a license under the Act.

Section 305.2 Separation of official establishments

(A) Each official establishment that conducts more than one processing operation (commercial, custom or retail) will separate those activities by either partition or hours of operation approved, in advance, by the Head of Service.

(B) Each official establishment shall be separate and distinct from any unofficial establishment except a poultry products processing establishment operated under federal inspection under the Poultry Products Inspection Act or state inspection.

(C) The slaughter or other preparation of products of horses, mules, or other equines required to be conducted under inspection pursuant to these regulations shall be done in establishments separate from any establishment in which cattle, sheep, swine, or goats are slaughtered or their products prepared.

(D) Inspection shall not be inaugurated in any building, any part of which is used as living quarters, unless the part for which inspection is requested is separated from such quarters by floors, walls, and ceilings of solid concrete, brick, wood, or similar material and the floors, walls, and ceilings are without openings that directly or indirectly communicate with any part of the building used as living quarters.

Section 305.3 Sanitation and adequate facilities

Inspection shall not be inaugurated if an establishment is not in a sanitary condition nor unless the establishment agrees to maintain a sanitary condition and provides adequate facilities for conducting such inspection.

Section 305.4 Inauguration of inspection

(A) The operator of each establishment required to have inspection shall make application to the commissioner for inspection service. In case of change of name, ownership, or location a new application shall be made. Such operator shall be duly licensed or may consolidate applications.

(B) When inspection is granted, the Supervising Veterinarian shall at or prior to the inauguration of inspection inform the operator of the establishment of the requirements of these regulations. If the establishment, at the time inspection is inaugurated, contains any product which has not therefore been inspected, passed, and marked in compliance with these regulations, the identity of the same shall be maintained, and it shall not be distributed, or otherwise subject to the requirements of these regulations, or dealt with as inspected and passed under these regulations. The establishment shall adopt and enforce all necessary measures and shall comply with all such directions as the Supervising Veterinarian may prescribe, for carrying out the purposes of this section.

Section 305.5 Withdrawal of inspection; statement of policy

(A)

(1) The Commissioner may suspend (for such period or indefinitely as he deems necessary to effectuate the purpose of the Act) or withdraw inspection service for the failure of an operator of an establishment to comply with the Act or these regulations, including but not limited to, failure to destroy condemned products or maintaining unsanitary conditions, endangering public health, rendering products adulterated or unauthorized operations.

(2) The operator shall be notified in writing of the withdrawal or suspension and the reasons therefore and shall be afforded an opportunity to present his views informally prior to the effective date of such withdrawal or suspension. Upon request, the operator shall be afforded a hearing with respect to the merits of the validity of the withdrawal or suspension, but such withdrawal or suspension shall continue in effect pending the outcome of such hearing, unless otherwise ordered by the Commissioner.

(3) The provisions of 3 V.S.A., Chapter 25, shall apply to the conduct of such hearings, including provisions as to notice, record, and taking of evidence.

(B)

(1) The assignment of inspectors may be temporarily suspended, in whole or in part, by the Head of Service to the extent it is determined necessary to avoid impairment of the effective conduct of the service when the operator of any official establishment or any subsidiary therein, or any officer, employee, or agent of any such operator or any subsidiary therein, acting within the scope of his office, employment, or agency, threatens to forcibly assault or forcibly assaults, resists, intimidates, or interfere with any service employee in or on account of the performance of his official duties under the Act, unless promptly upon the incident being brought by an authorized supervisor of the program employee to the attention of the operator of the establishment the operator (1) satisfactorily justifies the incident, (2) takes effective steps to prevent a recurrence, or (3) provides acceptable assurance that there will not be any recurrences. Such suspension shall remain in effect until one of such actions is taken by the operator: Provided, that upon request of the operator he shall be afforded an opportunity for an expedited hearing to show cause why the suspension should be terminated.

(2) During a period of withdrawal or suspension, no processing of product shall be carried on in the establishment; except, that any product which was inspected and passed prior to the withdrawal or suspension may be shipped from the establishment, provided its identity is maintained, and it was not adulterated or misbranded.

(C) Inspection service may be temporarily suspended in whole or in part, at an official establishment, by the Head of Service, to the extent that it is determined necessary to prevent inhumane slaughtering or handling in connection with the slaughter of livestock. The Head of. Service shall notify the operator of an establishment orally or in writing, as promptly as circumstances permit, of such suspension and the reasons therefor. Such suspension shall remain in effect until the operator of the establishment takes effective steps to prevent a recurrence, or provide other satisfactory assurances that there will not be any recurrences. Upon request, the operator shall be afforded an opportunity for a hearing to show cause why the suspension should be terminated.

(D)

(1) An operator may temporarily suspend operations without reapplying for inspection for a period of up to one hundred and twenty (120) days, Provided, that the operator notify the Head of Service in writing at least one week prior to suspension. Such notice shall state the date he intends to resume operations.

(2) Prior to resumption of inspection, a service employee will thoroughly examine the premises and the operator will correct any and all deficiencies.

(3) If operations are suspended for more than one hundred and twenty days, the operator shall reapply for inspection.

Section 305.6 Reports of violations

Service employees shall report, in a manner prescribed by the Head of Service, any and all violations of the Act and of these regulations of which they have information.

Section 305.7 Petitions for rule changes or declaratory rulings

(A) Petitions for the adoption, amendment, or repeal of any rule may be filed with the Commissioner. Petitions will be considered and disposed of pursuant to the procedures specified in 3 V.S.A. Sections 803 and 806.

(B) Petitions for declaratory rulings as to the applicability of any statutory provisions or any of these regulations may be submitted to the Commissioner. Petitions shall be considered to be either a petition for adoption or a contested case as may be proper under the circumstances.

Part 306 ASSIGNMENT AND AUTHORITIES OF PROGRAM EMPLOYEES

Section 306.1 Designation of Supervising Veterinarian and assistants

The Head of Service shall designate a Supervising Veterinarian of the inspection service, and assign inspectors as may be necessary.

Section 306.2 Service employees to have access to establishments

For purpose of any examination or inspection necessary to prevent the use of any adulterated product, service employees shall have access at all times, by day or night, whether the establishment is operated or not, to every part of any official establishment to which they are assigned. Access to establishments is also authorized in accordance with 6 V.S.A. Section 3313 of the Act and PART 320 of these regulations.

Section 306.3 Badge as identification of inspectors

Each inspector will be furnished with a numbered official badge, which he shall not allow to leave his possession, and which he shall wear in such manner and at such times as the Head of Service may prescribe. This badge shall be sufficient identification to entitle him to admittance at all regular entrances and to all parts of the establishment and premises to which he is assigned. Upon termination of employment the badge and all other issued equipment will be returned to the Head of Service.

Section 306.4 Assignment of service employees where members of family are employed; soliciting employment: procuring product from official establishments

(A) Except as specifically authorized by the Head of Service, no service employee shall be detailed for duty at an establishment where any member of his family is employed by the operator of the establishment, or any tenant or subsidiary of such operator nor shall any supervisor or other employee acting in a supervisory capacity be continued on duty where any member of his family is so employed at any establishment under his jurisdiction. Service employees are forbidden to solicit, for any person, employment at any official establishment, or by any officer, manager, or employee thereof.

(B) Service employees shall not procure product from any official establishment or any other establishment if its operations or products are inspected or regulated under the Act unless the store or outlet from which the purchase is made is open to the general public and the price paid by such employee is the same as the price paid by the general public. Service employees must pay, and obtain receipts for money paid to such establishments for all such product and keep such receipts subject to inspection by supervisory employees or other authorized department employees.

Section 306.5 Appeals of inspection

Any person receiving inspection service may appeal any decision of an inspector relating to any inspection. Provided, that such appeal is filled within 48 hours from the time the decision was made. Any such appeal from a decision of an inspector shall be made to his immediate superior having jurisdiction over the subject matter of the appeal, and such superior shall determine whether the inspector's decision was correct. Should the Commissioner determine that the appeal was frivolous, he may require that the appellant bear the cost of the appeal. Products involved in any appeal shall be identified by Vt. Retained tags and segregated. Provided, that denial of a labeling application shall not constitute a basis for appeal under this section.

Part 307 FACILITIES FOR INSPECTION

Section 307.1 Facilities for Service employees

Office space, including necessary furnishings, light, heat, and janitor service shall be provided by official establishments, rent free, for the exclusive use for official purposes of the inspector in charge and other service employees assigned thereto. The space set aside for this purpose shall meet with the approval of the Commissioner and shall be conveniently located, properly ventilated and provided with lockers suitable for the protection and storage of service employees supplies and with facilities suitable for service employees to change clothing if such clothes changing facilities are deemed necessary by the supervisor. At the discretion of the Head of Service, small plants requiring the services of less than one full time inspector need not furnish facilities for service employees are prescribed in this section, where adequate facilities exist in a nearby convenient location. Laundry service for inspectors outer work clothing shall, when required by the Commissioner, be provided by each establishment.

Section 307.2 Schedule of operations

(A) No operations requiring inspection shall be conducted except under the supervision of a service employee. All slaughtering of livestock and preparation of products shall be done with reasonable speed, considering the official establishments facilities.

(B) A shift is a regularly scheduled operating period, exclusive of mealtime. One lunch period is the only official authorized interruption in the inspectors tour of duty once it begins. Lunch periods may be 30 minutes, 45 minutes, or, in any case may not exceed one hour in duration. Once established, the lunch period must remain relatively constant as to time and duration. Lunch periods for inspectors shall not, except as provided, herein, occur prior to four hours after the beginning of scheduled operations nor later than five hours after operations begin. In plants where a company rest break of not less than 30 minutes is regularly observed, approximately midpoint between start of work and the lunch period, and the inspector is allowed this time to meet his personal needs, the lunch period may be scheduled as long as 5 1/2 hours after the beginning of scheduled operations.

(C) Official establishments shall be provided inspection service, without charge, up to 8 consecutive hours per shift during the basic workweek subject to the provisions of Section 307.7: Provided, that any additional shifts meet requirements as determined by the Head of Service or his designee. The basic workweek shall consist of five consecutive 8-hour days Monday through Friday, excluding the lunch period; the Department may depart from the Monday to Friday workweek in those cases where it would seriously handicap the Department in carrying out its functions.

(D)

(1) Each official establishment shall submit a work schedule to the Head of Service for approval. In consideration of whether the approval of an establishment work schedule shall be given, the Head of Service shall take into account the efficient and effective use of inspection personnel. The work schedule must specify daily clock hours of operation and lunch periods for all departments of the establishment requiring inspection.

(2) Establishments shall maintain consistent work schedules. Any request by an establishment for a change in its work schedule involving an addition or elimination of shifts shall be submitted to the Head of Service at least 2 weeks in advance of the proposed change. Frequent requests for change shall not be approved; Provided, however, that minor deviations from a daily operating schedule may be approved by the inspector in charge, if such request is received on the day preceding the day of change.

(3) Request for inspection service outside an approved work schedule shall be made as early in the day as possible for overtime work to be performed within that same workday; or made prior to the end of the days operation when such a request will result in overtime service at the start of the following day: Provided, that an inspector may be recalled to his assignment after completion of his daily tour under the provisions of Section 307.7(B).

Section 307.3 Designation of days and hours of operations by Commissioner

When one inspector is detailed to conduct the work at two or more official establishments where few animals are slaughtered or where but a small quantity of any product is prepared, the Commissioner may, for the purpose of efficient and effective utilization of personnel, designate the hours of the day and the days of the week during which such establishments may operate.

Section 307.4 Overtime and holiday inspection

(A) The management of an official establishment shall pay to the service an amount sufficient to reimburse the Service for the cost of the inspection service, at a rate to be determined by the Commissioner, furnished on any holiday as specified in paragraph (3) of this section; or for more than 8 hours on any day, or more than 40 hours in any administrative workweek Sunday through Saturday.

(B) Holidays shall be New Years Day, January 1; Martin Luther King, 3rd Monday in January; Lincoln's Birthday, February 12; Washington's Birthday, 3rd Monday in February; Town Meeting Day, First Tuesday in March; Memorial Day; July 4; Bennington Battle Day, August 16; Labor Day, 1st Monday in September; Columbus Day, 2nd Monday in October; Veterans Day, November 11; Thanks giving Day, 4th Thursday in November; Christmas Day, December 25. When any of the above listed holidays falls outside the basic workweek, the nearest workday within that week shall become a holiday.

Section 307.5 Other facilities and conditions to be provided by establishments

When required by the Commissioner, the following facilities and conditions and such others as may be found to be essential to efficient conduct of inspection and maintenance of sanitary conditions, shall be provided by each official establishment:

(A) Satisfactory pens, equipment, and assistants for conducting ante-mortem inspection and for separating, marking and holding apart from passed livestock those marked Vt. Suspect and those marked Vt. Condemned (pens, alleys, and runways shall be paved, drained, and supplied with adequate hose connections for cleanup purposes);

(B) Sufficient light to be adequate for proper conduct of inspection, the rooms shall be kept sufficiently free of steam vapors for inspection to be properly made. Equipment of substances which generate gasses or odors shall not be used except as specifically permitted by the Commissioner.

(C) Racks, receptacles, or other suitable devices for retaining such parts as the head, tongue, tail, thymus gland, and viscera, and all parts and blood to be used in the preparation of meat food products or medical products, until after the post-mortem inspection is completed, in order that they may be identified in case of condemnation of the carcass; equipment, trucks, and receptacles for the handling of viscera of slaughtered livestock so as to prevent contact with the floor; and trucks, rack, marked receptacles, tables, and other necessary equipment for the separate and sanitary handling of carcasses of parts passed for cooking;

(D) Tables, benches, and other equipment on which inspection is to be performed, of such design, material, and construction as to enable service employees to conduct their inspection in a ready, efficient and clean manner;

(E) Watertight metal trucks or receptacles for handling and holding diseased carcasses and parts, so constructed as to be readily cleaned; such trucks or receptacles to be marked in a conspicuous manner with the phrase Vt. DA Condemned in letters not less than 2 inches high, and, when required by the Commissioner, to be equipped with facilities for locking or sealing;

(F) Adequate arrangements, including liquid soap and cleansers, for cleansing and disinfecting hands, for sterilizing all implements used in dressing diseased carcasses, floors, and such other articles and places as may be contaminated by diseased carcasses or otherwise;

(G) In establishments in which slaughtering is done, rooms, compartments, or specially prepared open places, to be known as "final inspection places," at which the final inspection of retained carcasses may be conducted (competent assistants for handling retained carcasses and parts shall be provided by establishment); final inspection places shall be adequate in size and their rail arrangement and other equipment shall be sufficient to prevent carcasses and parts passed for food or cooking, from being contaminated by contact with condemned carcasses or parts; they shall be equipped with hot water, lavatory, sterilizer, tables, and other equipment required for ready, efficient, and sanitary conduct of the inspection; the floors shall be of such construction as to facilitate the maintenance of sanitary conditions and shall have proper drainage connections and when final inspection places are part of a larger floor, it shall be separated from the rest of the floor by a curb, railing, or otherwise;

(H) Retention rooms, cages, or other compartments, and receptacles in which carcasses and product may be held for further inspection (these shall be in such number and in such locations as the needs of the inspection in the establishment may require; they shall be equipped for secure locking and sealing and shall be held under locks or official seals furnished by the Department; the keys of such locks shall not leave the custody of service employees. Every such room, compartment, or receptacle shall be marked conspicuously with the phrase Vt. DA Retained in letters not less than 2 inches high; rooms or compartments for these purposes shall be secure and susceptible to being kept clean, including a sanitary disposal of the floor liquids; establishment employees shall not enter any retention receptacles unless authorized by service employees);

(I) Adequate facilities, including denaturing materials, for the proper disposal of condemned articles in accordance with the regulations (tanks or other rendering equipment which, under these regulations, must be sealed, shall be properly equipped for sealing as specified in PART 314 of these regulations or by the Commissioner in specific cases);

(J) Docks and receiving rooms, to be designated by the operator of the official establishment, with the approval of the Commissioner, for the receipt and inspection of all products as provided in Section 318.3 of these regulations;

(K) Suitable lockers in which brands bearing the official inspection legend and other official devices (excluding labels) and official certificates shall be kept when not in use (all such lockers shall be equipped for sealing or locking with locks or seals to be supplied by the Department; the keys of such locks shall not leave the custody of service employees);

(L) Sanitary facilities and accommodations as prescribed by Section 308.4 of these regulations.

(M) In addition any facilities required to accomplish sanitary dressing procedures, the following inspection station facilities for cattle and swine slaughter lines are required:

(1) An inspection station consisting of 5 feet of unobstructed line space for each head or carcass inspector and, for viscera table kills, 8 feet for each viscera inspector on the inspectors side of the table.

(2) A minimum of 50 foot-candles of shadow-free lighting at the inspection surfaces of the head, viscera, and carcass.

(3) For each inspector a handwash lavatory (other than one which is hand operated), furnished with soap, towels, and hot and cold water, and located adjacent to the inspectors work area. In addition, for each head and viscera inspector, a sterilizer located adjacent to the inspectors work area.

(4) For mechanized operations, a switch located adjacent to each inspection station, which can stop the chain or conveyor.

(5) Facilities to position tally sheets or other recording devices, such as digital counters, and facilities to contain condemned brands.

(6) For swine slaughter lines requiring three or more inspectors and on which the swine heads are inspected while still attached to the carcass: at the carcass inspection stations, one glass, distortion-free mirror, at least 5 feet X 5 feet, mounted far enough away from the vertical axis of the moving line to allow the carcass to be turned, but not over 3 feet away and so mounted that any inspector standing at the carcass inspection station can readily view the back of the carcass.

Section 307.6 Inspectors to furnish implements and maintain hands and implements in sanitary condition

Inspectors shall be furnished through the service, implements, such as knives, steels, scabbards, flashlights and triers, for conducting inspection and shall cleanse their hands and implements as prescribed by Section 308.8 of these regulations.

Section 307.7 Basis of billing for overtime and holiday services

(A) Each recipient of overtime or holiday inspection service, both, shall be billed, at the rate established in Section 307.4(A), in increments of full quarter hours. For billing purposes, 8 or more minutes shall be considered a full quarter hour. Billing will be for each quarter hour service rendered by each service employee.

(B) Official establishments requesting and receiving the service of a service employee after he has completed his day's assignment and left the premises, or called back to duty during any overtime or holiday period, shall be billed for a minimum of 2 hours overtime or holiday inspection service at the established rate.

(C) Bills are payable upon receipt and become delinquent 30 days from the date of the bill. Overtime or holiday inspection will not be performed for anyone having a delinquent account.

Part 308 SANITATION

Section 308.1 Examination and specifications for equipment and sanitation prior to granting inspection

Sanitation

308.1 Prior to the inauguration of inspection, an examination of the establishment and premises shall be made by a Program employee and the requirements for sanitation and the necessary facilities for inspection shall be specified by him in accordance with the regulations in this part and Part 307 of this subchapter.

Section 308.2 Drawings and specifications to be furnished in advance of construction

Sanitation

308.2 Drawings and specifications as prescribed in section 304.2 of this subchapter for remodeling any official establishment, or part thereof, and for any new structures to be used in an official establishment, or part thereof, shall be submitted to the Administrator and approval obtained for the plans in advance of construction.

(41 FR 4889, Feb. 3, 1976)

Section 308.3 Establishments: sanitary conditions, requirements

(A) Official establishments shall be maintained in a sanitary condition, and to this end the requirements of this section shall be complied with.

(B) There shall be abundant light, of good quality and well distributed, and sufficient ventilation for all rooms and compartments to insure sanitary conditions.

(C) There shall be an efficient drainage and plumbing system for the establishment and premises, and all drains and gutters shall be properly installed with traps and vents approved by the Head of Service.

(D)

(1) The water supply shall be ample, clean, and potable, with adequate facilities for its distribution in the plant and its protection against contamination and pollution. Every establishment shall make known and, whoever required by the Head of Service, shall afford opportunity for inspection of the source of its water supply, the storage facilities and the distribution system. Equipment using potable water shall be so installed as to prevent back-siphonage into the potable water system. Nonpotable water is permitted only in those parts of official establishments where no edible product is handled or prepared, and then only for limited purposes such as on ammonia condensers not connected with potable water supply, in vapor lines serving inedible product rendering tanks, in connection with equipment used for hashing and washing inedible products preparatory to tanking, and in sewer lines for moving heavy solids in the sewage. Nonpotable water is not permitted for washing floors, areas or equipment involved in trucking materials to and from edible product departments nor is it permitted in hog scalding vats, dehairing machines, or vapor lines serving edible product rendering equipment, or for cleanup of shackling pens, bleeding areas, or runways within the slaughtering department. In all cases, nonpotable water lines shall be clearly identified and shall not be cross-connected with the potable water supply unless this is necessary for fire protection and such connection is of a type with an adequate break to assure against accidental contamination, and is approved by local authorities and by the Head of Service.

(2) The Head of Service may permit the reuse of water in vapor lines leading from deodorizers used in the preparation of lard and similar edible product and in equipment used for the chilling of canned product after retorting, provided the reuse is for the identical original purpose and the following precautions are taken to protect the water that is reused:

(i) All pipelines, reservoirs, tanks, cooling towers, and like equipment employed in handling the reused water are so constructed and installed as to facilitate their cleaning and inspection.

(ii) Complete drainage and disposal of the reused water, effective cleaning of the equipment, the renewal with fresh potable water is accomplished at such intervals as may be necessary to assure an acceptable supply of water for the purpose intended.

(iii) Effective chlorination (not less than approximately 1 part per million of residual chlorine at any point within the cooling system) of the reused water utilized for cooling canned product is maintained but with the understanding that chlorination alone is not to be relied upon entirely or to be accepted in lieu of the requirements listed in subdivision (i) and (ii) of this subparagraph.

(3) Approval for the reuse of water other than as specified in subparagraph (2) of this paragraph shall be obtained from the Head of Service in specific cases.

(4) An ample supply of water at not less than 180 degrees F. shall be furnished and used for the cleaning of inspection equipment and other equipment, floors, and walls which are subject to contamination by the dressing or handling of diseased carcasses, their viscera, and other parts. Whenever necessary to determine compliance with this requirement, conveniently located thermometers shall be installed by the operator of the official establishment to show the temperature of the water at the point of use.

(5) Hot water for cleaning rooms and equipment other than those mentioned in subparagraph (4) of this paragraph shall be delivered under pressure to sufficient convenient outlets and shall be of such temperature as to accomplish thorough cleanup.

(E) The floors, walls, ceilings, partitions, posts, doors, and other parts of all structures shall be of such materials, construction, and finish as will make them susceptible of being readily and thoroughly cleaned. The floors shall be watertight. The rooms and compartments used for edible product shall be separate and distinct from those used for inedible product.

(F) Rails should be located and passageway space provided so that exposed product does not come in contact with posts, walls, and other fixed parts of the building, with barrels, boxes, and other containers trafficked through holding and operating areas. Exposed product shall not be placed or stored beneath carcasses in coolers or holding areas.

(G) The rooms and compartments in which any product is prepared or handled shall be free from dust and from odors from dressing and toilet rooms, catch basins, hide cellars, casing rooms, inedible tanking and fertilizer rooms, and livestook pens.

(H) Every practicable precaution shall be taken to exclude flies, rats, mice and other vermin from official establishments. The use of poisons for any purpose in rooms or compartments where any unpacked product is stored or handled is forbidden, except under such restrictions and precautions as are prescribed by these regulations or by the Head of Service. The use of insecticides, rodenticides, and similar pest control substances in hide cellars, inedible product departments, outbuildings, or similar places, or in storerooms containing canned or tierced products is not forbidden but only those approved by the Head of Service may be used. So-called "rat viruses" shall not be used in any part of an establishment or the premises thereof.

(1) Dogs and cats shall be excluded from the interior of official establishments; however, dogs may be permitted on the outer premises for guard purposes.

Section 308.4 Sanitary facilities and accommodations; specific requirements

Adequate sanitary facilities and accommodations shall be furnished by every official establishment. Of these, the following are specifically required:

(A) Dressing rooms, toilet rooms, and urinals shall be sufficient in number, ample in size, and conveniently located. The rooms shall be provided with facilities to provide abundant light of good quality and well distributed. They shall be properly ventilated and meet all requirements of the regulations in this PART as to sanitary construction and equipment. They shall be separate from the rooms and compartments in which products are prepared, stored, or handled. Where both sexes are employed, separate facilities shall be provided.

(B) Acceptable lavatories, including running hot and cold water, soap, and towels, shall be placed in or near toilet and urinal rooms and also at such other places in the establishment as may be essential to assure cleanliness of all persons handling any product.

(C) Toilet soil lines shall be separate from house drainage lines to a point outside the building and drainage from toilet bowls and urinals shall not be discharged into a grease catch basin.

(D) Properly located facilities shall be provided for cleansing and disinfecting utensils and hands of all persons handling any product.

Section 308.5 Equipment and utensils to be easily cleaned; those for inedible products to be so marked; evaluation of equipment and utensils

(A) Equipment and utensils used for preparing of or otherwise handling any edible product or ingredient thereof in any official establishment shall be of such material and construction as, in the judgment of the Head of Service, will facilitate their thorough cleaning and insure cleanliness in the preparation and handling of all edible products and otherwise avoid adulteration and misbranding of such product. In addition to these requirements, equipment and utensils shall not in any way interfere with or impede inspection procedures. Receptacles used for handling inedible material shall be of such material and construction that, in the judgment of the Head of Service, their use will not result in adulteration of any edible product or in insanitary conditions at the establishment, and they shall bear conspicuous and distinctive marking to identify them as only for such use and shall not be used for handling any edible product.

(B) When equipment or utensils for use in preparing or handling product are proposed for use in an official establishment, the operator of the establishment shall so notify the Head of Service, and thereafter shall submit to the Head of Service such information as the Head of Service specifies in each case as necessary to determine whether the equipment or utensils meet the criteria specified in paragraph (A) of this section. The required information shall include, but may not be limited to, assembly type drawings and a list showing the material of which parts are made. The Head of Service will evaluate the model of equipment or utensil and determine whether it is acceptable for its proposed use under the criteria set forth in paragraph (A) of this section.

(C) Equipment or utensils listed by the USDA as acceptable for use in official establishments will also be acceptable to the Vermont Inspection Service.

(D) The Head of Service may disapprove for use in official establishments particular models of equipment or utensils that he finds do not meet the requirements of paragraph (A) of this section or that he cannot evaluate because of lack of sufficient information. Further, he may prescribe such conditions for the use of particular models of equipment or utensils, either on a trial or permanent basis, as he finds necessary to prevent adulteration or misbranding of product.

(E) Nothing in this section shall affect the authority of Service inspectors to reject specific equipment or utensils under Section 308.15 of these regulations in this PART. Further:

(1) All equipment and utensils must be cleaned frequently or at least daily and, if necessary, before each use or between shifts to prevent organic matter accumulation;

(i) When temperature of processing areas is not maintained at or below 50 degrees F. a midshift cleanup of equipment surfaces contacting product shall be required within 5 hours from start of operations and at least every 5 hours thereafter.

(ii) Regardless of room temperature ALL used equipment and utensils shall be cleaned and sanitized at least every 24 hours.

(iii) A sanitizer maintained at 180 degrees must be in use at all times when edible product is being handled.

(F) Before approval of any model or specific item of equipment or utensil if finally denied, or is granted only with conditions, the applicant shall be given notice and opportunity to present his views to the Head of Service. If the applicant does not accept the Head of Service's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. This shall not preclude rejection of the equipment or utensils under Section 308.15 or this section pending the outcome of the presentation of views or hearing.

Section 308.5 Equipment and utensils to be easily cleaned; those for inedible products to be so marked; evaluation of equipment and utensils

(A) Equipment and utensils used for preparing of or otherwise handling any edible product or ingredient thereof in any official establishment shall be of such material and construction as, in the judgment of the Head of Service, will facilitate their thorough cleaning and insure cleanliness in the preparation and handling of all edible products and otherwise avoid adulteration and misbranding of such product. In addition to these requirements, equipment and utensils shall not in any way interfere with or impede inspection procedures. Receptacles used for handling inedible material shall be of such material and construction that, in the judgment of the Head of Service, their use will not result in adulteration of any edible product or in insanitary conditions at the establishment, and they shall bear conspicuous and distinctive marking to identify them as only for such use and shall not be used for handling any edible product.

(B) When equipment or utensils for use in preparing or handling product are proposed for use in an official establishment, the operator of the establishment shall so notify the Head of Service, and thereafter shall submit to the Head of Service such information as the Head of Service specifies in each case as necessary to determine whether the equipment or utensils meet the criteria specified in paragraph (A) of this section. The required information shall include, but may not be limited to, assembly type drawings and a list showing the material of which parts are made. The Head of Service will evaluate the model of equipment or utensil and determine whether it is acceptable for its proposed use under the criteria set forth in paragraph (A) of this section.

(C) Equipment or utensils listed by the USDA as acceptable for use in official establishments will also be acceptable to the Vermont Inspection Service.

(D) The Head of Service may disapprove for use in official establishments particular models of equipment or utensils that he finds do not meet the requirements of paragraph (A) of this section or that he cannot evaluate because of lack of sufficient information. Further, he may prescribe such conditions for the use of particular models of equipment or utensils, either on a trial or permanent basis, as he finds necessary to prevent adulteration or misbranding of product.

(E) Nothing in this section shall affect the authority of Service inspectors to reject specific equipment or utensils under Section 308.15 of these regulations in this PART. Further:

(1) All equipment and utensils must be cleaned frequently or at least daily and, if necessary, before each use or between shifts to prevent organic matter accumulation;

(i) When temperature of processing areas is not maintained at or below 50 degrees F. a midshift cleanup of equipment surfaces contacting product shall be required within 5 hours from start of operations and at least every 5 hours thereafter.

(ii) Regardless of room temperature ALL used equipment and utensils shall be cleaned and sanitized at least every 24 hours.

(iii) A sanitizer maintained at 180 degrees must be in use at all times when edible product is being handled.

(F) Before approval of any model or specific item of equipment or utensil if finally denied, or is granted only with conditions, the applicant shall be given notice and opportunity to present his views to the Head of Service. If the applicant does not accept the Head of Service's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. This shall not preclude rejection of the equipment or utensils under Section 308.15 or this section pending the outcome of the presentation of views or hearing.

Section 308.6 Scabbards for knives

Sanitation

308.6 Scabbards and similar devices for the temporary retention of knives, steels, triers, etc., by workers and others at official establishments shall be constructed of rust-resisting metal or other impervious material, shall be of a type that may be readily cleaned, and shall be kept clean.

Section 308.7 Rooms, compartments, etc., to be clean and sanitary

Sanitation

308.7 Rooms, compartments, places, equipment, and utensils used for preparing, storing, or otherwise handling any product, and all other parts of the establishment, shall be kept clean and in sanitary condition. There shall be no handling or storing of materials which create an objectionable condition in rooms, compartments, or places where any product is prepared, stored, or otherwise handled.

Section 308.8 Operations, procedures, rooms, clothing, utensils, etc., to be clean and sanitary

Sanitation

308.8

(a) Operations and procedures involving the preparation, storing, or handling of any product shall be strictly in accord with clean and sanitary methods.

308.8

(b) Rooms and compartments in which inspections are made and those in which livestock are slaughtered or any product is prepared shall be kept sufficiently free of steam and vapors to enable Program employees to make inspections and to insure clean operations. The walls, ceilings, and overhead structure of rooms and compartments in which product is prepared, handled, or stored shall be kept reasonably free from moisture to prevent iripping and contamination of product.

308.8

(c) Eutchers and others who dress or handle diseased carcasses or parts shall, before handling or dressing other carcasses or parts, cleanse their hands with liquid soap and hot water, and rinse them in clean water. Emplements used in dressing diseased carcasses shall be thoroughly cleansed with hot water having a minimum temperature of 180 degrees F. or in a iisinfectant

FOOTNOTE 1: A list of approved disinfectants is available upon request to the Scientific Services, Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, D.C. 20250.

Approved by the Administrator, followed by rinsing in clean water. The employees of the establishment who handle any product shall keep their hands clean, and in all cases after visiting the toilet rooms or urinals shall wash heir hands before handling any product or implements used in the preparation of product.

308.8

(d) Aprons, frocks, and other outer clothing worn by persons who handle any product shall be of material that is readily cleansed. Clean garments shall be worn at the start of each working day and the garments shall be changed during the day when required by the inspector in charge.

308.8

(e) Such practices as spitting on whetstones; spitting on the floor; placing skewers, tags, or knives in the mouth; inflating lungs or casings with air from the mouth; or testing with air from the mouth such receptacles as tierces, kegs, or casks, containing or intended as containers of any product, are prohibited. Only mechanical means may be used for such testing. Care shall be taken to prevent the contamination of product with perspiration, hair, cosmetics, medications, and similar substances.

308.8

(f) Equipment or substances which generate gases or odors shall not be used in official establishments except as permitted by the regulations in this part or by the circuit supervisor in specific cases in which he determines that such use will not result in adulteration of any product.

Section308.9 Protective handling of products

Products shall be protected from contamination from any source such as dust, dirt, or insects during storage, loading, or unloading at, and transportation from official establishments.

(A) All products shall be stored at temperatures under 40 degrees F.

(B) The temperature of all fresh product shall not be allowed to rise above 50 degrees F. during processing.

(C) All carcasses shall be placed under refrigeration as soon after slaughter as possible.

Section 308.10 Slack barrels and similar containers and means of conveyance used for product; paper in contact with product

Sanitation

308.10

(a) When necessary to avoid contamination of product with wood splinters or similar contaminants, slack barrels and similar containers and the cargo space of trucks, railroad cars, or other means of conveyance shall be lined with suitable material of good quality before packing.

308.10

(b) Slack barrels and similar containers and trucks, railroad cars, and other means of conveyance in which any product is transported shall be kept in a clean and sanitary condition.

308.10

(c) Paper used for covering or lining slack barrels and similar containers and the cargo space of trucks, railroad cars, or other means of conveyance shall be of a kind which does not tear during use but remains intact when moistened by the product and does not disintegrate.

Section 308.11 Burlap wrapping for meat

Sanitation

308.11 Since burlap used without any other material as a wrapping for meat deposits lint on the meat and does not sufficiently protect it from outside contamination, the use of burlap as a wrapping for meat will not be permitted unless the meat is first wrapped with a good grade of paper or cloth of a kind which will prevent contamination with lint or other foreign matter.

Section 308.12 Secondhand tubs, barrels, tankcars and other containers

(A) Secondhand tubs, barrels, and boxes intended for use as containers of any product shall be inspected when received at the official establishment and before they are cleaned. Those showing evidence of misuse rendering them unfit to serve as containers for food products shall be rejected. The use of those showing no evidence of previous misuse may be allowed after they have been thoroughly and properly cleaned. Steaming, after thorough scrubbing and rinsing, is essential to cleaning tubs and barrels.

(B) Interiors of tank cars and tank trailers about to be used for the transportation of any product from an official establishment shall be carefully inspected by a service employee for cleanliness even though the last previous content was edible. Lye and sode solutions used in cleaning cars and trailers must be thoroughly removed by rinsing with clean water. Whenever possible, service employees shall enter tank cars and tank trailers with a light and examine all parts of the interior.

Section 308.13 Inedible operating and storage rooms; outer premises, docks, driveways, approaches, pens, alleys, etc.; flybreeding material; other conditions

Sanitation

308.13 All operating and storage rooms and departments of official establishments used for inedible materials shall be maintained in acceptably clean condition. The outer premises of every official establishment, including docks and areas where cars and vehicles are loaded, and the driveways, approaches, yards, pens, and alleys, shall be properly paved and drained and kept in clean and orderly condition. All catch basins on the premises shall be of such construction and location and shall be given such attention as will insure their being kept in acceptable condition as regards odors and cleanliness. Catch basins shall not be located in departments where any product is prepared, handled, or stored. The accumulation on the premises of official establishments of any material in which flies may breed, such as hog hair, bones, paunch contents, or manure, is forbidden. No other conditions that may result in adulteration of product or interfere with inspection shall be allowed in any official establishment or on its premises.

Section 308.14 Employment of diseased persons

SANITATION

308.14 No operator of an official establishment or other person preparing product in an official establishment shall employ, in any department where any product is handled or prepared, any person showing evidence of a communicable disease in a transmissible stage, or known to be a carrier of such a disease, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiclogical contaminants.

Section 308.15 Tagging insanitary equipment, utensils, rooms or compartments

Sanitation

308.15 When, in the opinion of a Program employee, any equipment, utensil, room, or compartment at an official establishment is unclean or its use would be in violation of any of the regulations in this subchapter, he will attach a "U.S. Rejected" tag thereto. No equipment, utensil, room, or compartment so tagged shall again be used until made acceptable. Such tag so attached shall not be removed by anyone other than a Program employee.

Part 308A PROPER HANDLING IN OFFICIAL ESTABLISHMENTS, INCLUDING ALL RETAIL AND CUSTOM ESTABLISHMENTS, OF MEAT AND MEAT PRODUCTS

Section 308A.1 Proper handling in official establishments, including all retail and custom establishments, of meat and meat products; contamination; definitions, presence of in meat handling areas

(A) Each official establishment, including all retail and custom establishments, is responsible for producing wholesome products in a clean facility using hygienic procedures.

(B) Since meat and meat products are highly susceptible to contamination through contact, aerosol or exposure to adulterants, meat handling areas shall be so located and constructed and the meat handling practices must be such as to minimize exposure to contaminants, including rust and other overhead hazards, and further including improperly protected light bulbs.

(1) Meat handling areas shall not be located beneath overhead sewer lines. The drainage of sewer systems must be adequate so that liquid wastes are properly removed and does not accumulate in work areas, around premises, or over floors and cause sanitation hazards;

(2) Temperatures of coolers in which meat and meat products, are stored or displayed shall not exceed 40 degrees F.

(3) Hangers and the like, used for suspension of meat or meat product, shall be so located as to minimize contact of product with cooler walls or other meat product and shall be maintained in a clean and sanitary manner at all times. Sufficient separation, by space or impervious material, of inspected and uninspected product, of carcasses of different species, and products of carcasses of different species, must be maintained to prevent cross-contamination.

(4) Meat or meat product shall not be stored on cooler or freezer floors, whether wrapped, or otherwise covered, unless separated from the floor by a rack or similar device at least 4 inches high. Racks in cooler must be of material which is impervious to moisture.

(5) Smoking or the use of tobacco shall be prohibited in meat handling areas and where equipment and utensils are washed.

(6) Food and beverages must not be consumed or carried into product handling areas. Disposable food and beverage containers must be discarded in waste containers. Suitable rubbish containers must be conveniently located throughout the plant or store and be emptied frequently to control vermin and odors and to prevent rubbish from becoming a nuisance.

(7) When handling edible product, employees shall make an effort to refrain from scratching the head, placing the fingers in or around the nose or mouth, sneezing or coughing on product.

(8) Persons handling exposed product shall keep their fingernails clean and neatly trimmed.

(9) Hand creams and lotions shall not be used by product handlers. However, they may be used in dressing rooms and toilet rooms by persons leaving the plant or store.

(10) Employees known to be afflicted with or harboring an infectious or contagious disease are prohibited from handling meat or meat product.

(11) Sawdust may not be used in official establishments.

(C) Where more than one area in an establishment is maintained for handling, cutting, packaging or storing meat and meat product, except as provided in section 308A.3, all passageways and areas through which meat or meat product is moved from one meat handling area to the other shall be maintained in a clean and sanitary manner and shall be free of contaminants.

Section 308A.2 Sanitation in official establishments, including all retail and custom establishments

(A) Coolers in which meat or meat product is stored or displayed shall be maintained in a clean and sanitary manner at all times.

(B) Washing facilities shall be provided and be appropriately located to the meat handling area for the purpose of cleaning and sanitizing equipment and utensils used in handling or the preparation of meat product.

(1) Ample amounts of hot and cold running water shall be made available under sufficient pressure, to provide proper washing and sanitizing.

(2) The water supply in meat or meat product handling establishments shall be potable and, unless from a municipal supply approved by the Vermont Department of Health, arrangements shall be made by the proprietor or owner of the meat handling establishment to have the water supply tested by the Vermont Department of Health as frequently as necessary to assure a potable water supply.

(C) Sanitizers containing chemicals, substances, or compounds capable of leaving residues harmful to human health are not permitted under these regulations, as for example, sulfites.

(D) Equipment and utensils used in handling or preparation of meat or meat product, shall be maintained in a clean and sanitary manner at all times.

(1) All equipment and utensils must be cleaned frequently or at least daily and, if necessary, before each use or between shifts to prevent organic matter accumulation.

(2) Cutting blocks, boards and tables that are pitted, cracked, or otherwise capable of retaining meat particles, blood and the like and are incapable of being properly cleaned and sanitized shall be repaired or replaced.

(3) Utensils used in handling or preparation of meat or meat product shall be constructed of non-toxic, non-chipping, and rust-resistant material. Utensils showing evidence of rusting shall not be used for cutting, or otherwise in preparing meat or meat product.

(E) Scabbards shall be provided for the retention of knives and shall be constructed of impervious material, capable of being readily dismantled for cleaning and sanitizing.

(F) Lubricants of petroleum origin shall not be used on parts of power equipment, used for cutting or preparing meat or meat product.

(G) All garment (coats, frocks, etc.) shall be clean, in good repair and of readily washable material. Street clothes shall be covered while handling exposed product. Clothing that becomes soiled or contaminated during the workday shall be changed as often as necessary. White or light colored garments are desirable. All persons working where exposed product is handled must wear suitable head coverings to prevent hair falling into product. Cotton gloves worn by persons handling edible product should not have dyed cuffs that may contaminate product and should be replaced when contaminated. Adequate and appropriately located receptacles must be provided for dirty clothing.

(H) Cloth or twine wrappings or implement handles are not permitted.

(I) Existing toilet facilities in establishments shall be maintained in a clean and sanitary manner and in good repair. Toilets and urinals must be clean and functional. Handwashing facilities must be provided with hot and cold running water, an acceptable liquid soap and single service towels. All employees shall remove their smocks or aprons, scabbards, steels, knives, guards, etc., before entering toilet and urinal rooms. Employees shall properly wash and sanitize their hands upon entering or re-entering meat processing product areas, and after contacting possible contaminated materials (mechanical equipment debris, etc.). The room shall be kept sufficiently free of steam vapors for inspection to be properly made. Equipment or substances which generate gases or odors shall not be used except as specifically permitted by the Head of Service.

(J) Outer premises shall be maintained in a clean manner and shall be free of debris and trash and conditions conducive to attracting insects, rodents, or other vermin.

Section 308A.3 Prepackaged meat products; display of;

Only fresh or frozen meat products prepackaged in consumer size packages, by a commercial processing plant under the supervision of a State or Federal meat inspector may be displayed with other food product; Provided, that the prepackaged units of meat products are in a sealed container and remain in such container until purchased by the consumer; Provided, further, that the temperature of the display case be maintained not higher than 40 degrees F. and in the case of frozen products the temperature be maintained under 15 degrees F.

Section 308A.4 Carcasses of game animals; handling

(A) Carcasses of game animals with head, hide, or feet attached shall not be held in any area of an establishment, licensed under the Meat Inspection Act, where meat or meat product is handled, packaged, stored or otherwise prepared.

(B) Game animals with feet, heads, and hide removed may be handled in establishments required to be licensed under the Act, Provided, such carcasses have been washed and handled in a manner to prevent contact with or contamination of other meat or meat products.

Section 308A.5 Custom cutting and wrapping at official establishments or retail establishments not under inspection as a processing establishment

(A) Any official establishment may accept farm or custom slaughtered carcass or part carcass for cutting, wrapping or freezing in compliance with PART 304 provided, that the carcass is immediately stamped NOT FOR SALE, and that each package of such meat or meat product is stamped with the words NOT FOR SALE. The letter size of such stamp shall not be less than 3/8 inches in height. Provided further that, carcasses and part carcasses described in this section shall be kept separate and distinct, at all times, from inspected product.

(B) Carcasses or part carcasses from farm or custom slaughtered animals shall be retained by the establishment until such time as the entire carcass or part thereof has been cut and wrapped before releasing any portion of such wrapped carcass to the owner.

(C) Carcasses or part carcasses bearing the official stamp of inspection when cut and wrapped without inspection are to be stamped NOT FOR SALE on each package as required in paragraph (A) for farm and custom slaughtered animals.

(D) Retail establishments doing custom processing shall keep such records as required by the Commissioner and such records shall be made available to the Head of Service.

Section 308A.6 Handling of meat and poultry products during transportation

Carcasses or part carcasses when transported in intrastate commerce between official establishments or transported into the State to an official establishment shall be fully protected by a suitable covering to insure against contamination.

Section 308A.7 Deception; practice of

Practices that lend to consumer deception shall not be employed. Examples of practices considered to be deception, however, not limited to the following are:

(A) The use of any device or type of artificial lighting that reflects an appearance or condition other than the actual appearance or condition of meat or meat product when viewed under natural light.

(B) Covering of inferior cuts of meat or meat products with more desirable ones, such as in family packs of pork chops, lamb combination packs, and the like.

(C) The use of colored film wrapping materials.

(D) Advertising or picture displays that do not reflect the actual appearance or condition of meat or meat products.

Section 308A.8 Labeling and advertising

No person shall produce, prepare, package, advertise, sell or offer for sale at retail, any meat unless it is clearly and conspicuously labeled or advertised, as the case may be, as to its true name.

Section 308A.9 Supply of meat advertised

No person shall advertise meat for sale at retail unless such person shall have available at all outlets listed in the advertisement a sufficient quantity of the advertised meat to meet reasonable anticipation of demand, unless the advertisement clearly and adequately discloses that supply is limited and/or the product is available only at designated outlets.

Section 308A.10 Frozen Meats

All meats other than that used in hamburger, ground beef, ground pork, ground veal or ground lamb which has been frozen at anytime prior to such meat being offered or exposed for sale shall be clearly and conspicuously labeled or advertised as "Frozen" or "Frozen and thawed", whichever is appropriate and such term shall be contiguous to and in the same size and style lettering and on the same background as the product name. In the case where frozen meat is used in the grinding of fresh hamburger, ground beef, ground pork, ground veal or ground lamb, this section shall apply only if the volume of frozen meat used exceeds 25% of the total volume of meat ground by weight.

Section 308A.11 Meat and Poultry Dating Policy

(A) Retail vendors who affix labels with a date (including any other code which is used to date the product) to meat, meat food products and/or poultry products shall clearly and conspicuously post a written statement of their dating policy behind the meat case in places where the policy may be easily read by consumers. The lettering of the policy shall be at least 3/8 inches in height, or larger if necessary for consumers to easily read the document.

(B) The retail vendor shall attach the dating policy to sign boards which will be provided by the Department.

(C) Any retail store which has more than 60 feet of meat and/or poultry retail sales cases shall post at least one sign board and dating policy for every feet of retail cases.

(D) In the event a retail vendor uses a dating code, the dating policy statement shall also explain how to interpret the code into a calendar date.

Section 308A.12 Fat and Lean Claims

(A) Statements describing the fat or lean content of a meat or poultry product such as "lean" and "low fat" may only be used in the labeling and advertising of meat and poultry products if the label also contains a prominently displayed statement accurately stating the percentage of fat or lean in the product.

(B) The words "extra lean" may only be used in the labeling or advertising a meat or poultry product that contains no more than 10 percent fat and the label must also contain a prominently displayed qualifying statement accurately stating the percentage of fat or lean in the product.

(C) No retail vendor shall use the terms "lean", "extra lean", or "low fat" in the labeling and advertising of meat and poultry products unless the fat percentage determination is based upon an in-store testing procedure approved by the Commissioner.

Part 309 ANTE-MORTEM INSPECTION

Section 309.1 Antemortem inspection in pens of official establishments

(A) All livestock offered for slaughter in an official establishment shall be examined and inspected on the day of and before slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Head of Service have been made in specific cases by the inspector for such examination and inspection to be made on a different day before slaughter.

(B) Such ante-mortem inspection shall be made in pens on the premises of the establishment at which the livestock are offered for slaughter before the livestock shall be allowed to enter into any department of the establishment where they are to be slaughtered or dressed or in which edible product are handled. When the holding pens of an official establishment are located in a public stockyard and are reserved for the exclusive use of the establishment, such pens shall be regarded as part of the premises of that establishment and the operator of the establishment shall be responsible for compliance with all requirements of the regulations in this subchapter with respect to such pens.

Section 309.2 Livestock suspected of being diseased or affected with certain conditions; identifying suspects: disposition on post-mortem inspection or otherwise

(A) Any livestock which, on ante-mortem inspection, do not clearly show, but are suspected of being affected with any disease or condition that, under PART 311 of these regulations, may cause condemnation of the carcass on post-mortem inspection, and any livestock which show, on ante-mortem inspection, any disease or condition that, under PART 311 of these regulations would cause condemnation of only part of the carcass on post-mortem inspection, shall be so handled as to retain its identity as a suspect until it is given final post-mortem inspection, when the carcass shall be marked and disposed of as provided in PARTS 310 and 311 of these regulations, or until it is disposed of as otherwise provided in this PART.

(B) All seriously crippled animals and animals commonly termed "downers" shall be identified as VT. Suspects and disposed of as provided in 311.1 of these regulations unless they are required to be classed as condemned under 309.3.

(C) Livestock which have reacted to a test for leptospirosis or anaplasmosis, but which show no symptoms of the disease, shall be identified as VT. Suspects and disposed of as provided in 311.10 of these regulations.

(D) Livestock which are known to have reacted to the tuberculin test shall be identified as VT. Suspects and disposed of as provided in 311.2 of these regulations, except that livestock bearing an official VT. Reactor tag shall not be tagged as VT. Suspects.

(E) Any cattle found on ante-mortem inspection to be affected with epithelioma of the eye or of the orbital region to a lesser extent than as described in 309.6 shall be identified as a VT. Suspect and disposed of as provided in 311.12 of these regulations.

(F) Cattle found on ante-mortem inspection to be affected with anasarca to a lesser extent than as described in 309.8 shall be identified as VT. Suspects and disposed of as provided in 311.8 of these regulations or paragraph (G) of this section.

(G) Any livestock suspected of being affected with anasarca may be set apart and held for treatment under service or other responsible official supervision approved by the Head of Service. If at the expiration of the treatment period the livestock upon examination is found to be free of disease, it may be released for any purpose. Otherwise, it shall be identified as VT. Suspect and disposed of as provided in 311.8 of these regulations or condemned and disposed of as provided in 309.8, whichever is appropriate.

(H) All hogs suspected on ante-mortem inspection of being affected with swine erysipelas shall be identified as VT. Suspects and disposed of as provided in 311.5 of these regulations or paragraph (I) of this section.

(I) A hog suspected of being affected with swine erysipelas may be set apart and held for treatment under service or other responsible official supervision. If at the expiration of the treatment period the animal upon examination is found to be free from disease, it may be released for any purpose. Otherwise, it shall be identified as VT. Suspect and disposed of as provided in 311.5 of these regulations, or condemned and disposed of as provided in 309.13, whichever is appropriate.

(J) Any livestock which is affected with vesicular exanthema or vesicular stomatitis, but which has recovered to the extent that the lesions are in process of healing, the temperature is within normal range and the livestock shows a return to normal appetite and activity, shall be identified as VT. Suspect and disposed of as provided in 311.32 of these regulations, except that if desired, such livestock may be set apart and held under supervision of a service employee or other official designated by the Head of Service for treatment. If the livestock is set aside for treatment, the VT. Suspect identification device will be removed by a service employee, following such treatment, if the livestock is found to be free from any such disease may be released for slaughter or for purposes other than slaughter, provided that in the latter instance, the operator of the official establishment or the owner of the animal shall first obtain permission from the local or State livestock sanitary official having jurisdiction over movement of such livestock.

(K) Livestock which are offered for ante-mortem inspection under this PART, and which are regarded by the inspector as immature shall be identified as VT. Suspect and, if slaughtered, the disposition of their carcasses shall be determined by the post-mortem findings in connection with the ante-mortem conditions. If not slaughtered as suspects, such livestock shall be held under supervision of a service employee or other official designated by the Head of Service, and after sufficient development may be released for slaughter or may be released for any other purpose, provided they have not been exposed to any infectious or contagious disease. If such exposure occurs, permission should be obtained from the State livestock authorities prior to release of such livestock.

(L) Livestock previously condemned for listeriosis, if released for slaughter under 309.13(B) shall be identified as VT Suspect in accordance with 309.13(C).

(M) Each animal required by this PART to be treated as a VT. Suspect shall be identified as such by or under the supervision of a service employee with an official device in accordance with 309.18. No such device shall be removed except by a service employee.

(N) Each animal identified as a VT. Suspect on ante-mortem inspection shall be set apart and shall be slaughtered separately from other livestock at that establishment unless disposed of as otherwise provided in this PART.

(O) Each animal identified as a VT. Suspect on ante-mortem inspection when presented for slaughter shall be accompanied with a form on which the inspector at the establishment shall record the identification tag number and any other identifying tag numbers present and a brief description of the animal and of the disease or condition for which the animal was classed as a suspect, including its temperature when the temperature of such animal might have a bearing on the disposition of the carcass on post-mortem inspection.

(P) When any animal identified as a VT. Suspect is released for any purpose or reason, as provided in this PART, the official identification device shall be removed only by a service employee and he shall report his action to the Head of Service. When a suspect is to be released under the provisions of this PART for a purpose other than slaughter, the operator of the official establishment or the owner of the animal shall first obtain permission for the removal of such animal from the State livestock sanitary official having jurisdiction.

Section 309.3 Dead Dying, Disabled, or Diseased and similar livestock

(A) Livestock found to be dead or in a dying condition on the premises of an official establishment shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

(B) Livestock plainly showing on ante-mortem inspection any disease or condition that, under PART 311 of these regulations, would cause condemnation of their carcasses on post-mortem inspection shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

(C) Any swine having a temperature of 106 degrees F. or higher and any cattle, sheep, goat, horse, mule, or other equine having a temperature of 105 degrees F. or higher shall be identified as VT. Condemned. In case of doubt as to the cause of the high temperature, or when for other reasons a service employee deems such action warranted, any such livestock may be held for a reasonable time under the supervision of a service employee for further observation and taking of temperature before final disposition of such livestock is determined. Any livestock so held shall be reinspected on the day it is slaughtered. If, upon such reinspection, or when not held for further observation and taking of temperature, then on the original inspection, the animal has a temperature of 106 degrees F. or higher in the case of swine, or 105 degrees F. or higher in the case of other livestook it shall be condemned and disposed of in accordance with section 309.13.

(D) Any livestock found in a comatose or semicomatose condition or affected with any condition not otherwise covered in this part, which would preclude release of the animal for slaughter for human food, shall be identified VT. Condemned and disposed of in accordance with section 309.13, except that such animal may be set apart and held for further observation or treatment under supervision of a service employee or other official designated by the Head of Service and for final disposition in accordance with this PART.

Section 309.4 Livestock showing symptoms of certain metabolic, toxic, nervous, or circulatory disturbances, nutritional imbalance, or infectious or parasitic diseases

(A) All livestock showing, on ante-mortem inspection symptoms of anaplasmosis, keratosis, leptospirosis, listeriosis, parturient paresis, pseudorabies, rabies, scrapie, tetanus, grass tetany, transport tetany, strangles, purpura hemorrhagica, azoturia, infectious equine encephalomyelitis, toxic encephalomyelitis (forage poisoning), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness or extensive fistula shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

(B) If any equine is suspected on ante-mortem inspection of being infected with glanders or dourine, the State livestock official shall be so informed by a service employee. Tests shall be performed by that division to determine whether the animal is, in fact, infected with such disease. If it is found on such tests to be infected, the animal shall be disposed of in accordance with paragraph (A) of this section. Otherwise, the animal shall be identified as a VT Suspect and disposed of as provided in section 311.10 of these regulations.

Section 309.5 Swine: disposal because of hog cholera

(A) All swine found by an inspector to be affected with hog cholera shall be identified as VT. Condemned and disposed of in accordance with section 309.13. Immediate notification shall be given by the inspector to the State livestock official who has responsibility for the control of swine diseases.

(B) All swine, even though not themselves identified as VT. Suspect which are of lots in which one or more animals have been condemned or identified as VT. Suspects for hog cholera, shall, as far as possible, be slaughtered separately and apart from all other livestock passed on ante-mortem inspection.

(C) Swine, other than hyperimmune swine, shall be condemned on ante-mortem inspection if offered for slaughter within 28 days after injection with virulent hog cholera virus, and within 21 days after injection with modified live hog cholera virus, and 14 days after injection with inactivated hog cholera virus.

(D) Swine, other than hyperimmune swine, offered for slaughter after 28 days following injection with virulent hog cholera virus, 21 days after injection with modified live hog cholera virus, shall be given ante-mortem inspection in conformity with this part without reference to the injected virus.

(E) Hyperimmune swine shall be condemned on ante-mortem inspection if offered for slaughter within 10 days after hyperimmunization.

(F) Hyperimmune swine offered for slaughter after 10 days following hyperimmunization shall be given ante-mortem inspection in conformity with this part without regard to the injected virus.

Section 309.6 Epithelioma of the eye

Any animal found on ante-mortem inspection to be affected with epithelioma of the eye and the orbital region in which the eye has been destroyed or obscured by neoplastic tissue and which shows extensive infection, suppuration, and necrosis, usually accompanied with foul odor, or any animal affected with epithelioma of the eye or the orbital region which, regardless of extent, is accompanied with cachexia shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

Section 309.7 Livestock affected with anthrax: cleaning and disinfection of infected livestock pens and driveways

(A) Any livestock found on ante-mortem inspection to be affected with anthrax shall be identified as VT Condemned and disposed of in accordance with section 309.13.

(B) No other livestock of a lot in which anthrax is found on ante-mortem inspection shall be slaughtered and presented for post-mortem inspection until it has been determined by a careful ante-mortem inspection that no anthrax infected livestock remains in the lot.

(C) Apparently healthy livestock (other than hogs) from a lot in which anthrax is detected, and any apparently healthy livestock which have been treated with anthrax biologicals which do not contain living anthrax organisms, may be slaughtered and presented for post-mortem inspection if they have been held not less than 21 days following the last treatment or the last death of any livestock in the lot. Alternatively, if desired, all apparently healthy livestock of the lot may be segregated and held for treatment by a State licensed veterinarian under supervision of a service employee or other official designated by the Head of Service. No anthrax vaccine (live organisms) shall be used on the premises of the official establishment.

(D) Livestock which have been injected with anthrax vaccines (live organisms) within 6 weeks, and those bearing evidence of reaction to such treatment, such as inflammation, tumefaction, or edema at the site of the injection, shall be condemned on ante-mortem inspection, or such animals may be held under supervision of a service employee or other official designated by the Head of Service until the expiration of the 6 week period and the disappearance of any evidence of reaction to the treatment.

(E) When livestock are found on ante-mortem inspection to be affected with anthrax, all exposed livestock pens and driveways of the official establishment shall be cleaned and disinfected by promptly and thoroughly removing and burning all straw, litter, and manure. This shall be followed immediately by a thorough disinfection of the exposed premises by soaking the ground, fences, gates, and all exposed material with a 5 percent solution of sodium hydroxide or commercial lye prepared as outlined in section 310.9(E)(1) of these regulations, or other disinfectant that may be approved in specific cases by the Head of Service for this purpose.

Section 309.8 Cattle affected with anasarca and generalized edema

All cattle found on ante-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive and generalized edema shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

Section 309.9 Swine erysipelas

All hogs plainly showing on ante-mortem inspection that they are affected with acute swine erysipelas shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

Section 309.10 Onset of parturition

Any livestock showing signs of the onset of parturition shall be withheld from slaughter until after parturition and passage of the placenta. Slaughter or other disposition may then be permitted if the animal is otherwise acceptable.

Section 309.11 Vaccine livestock

Vaccine livestock with unhealed lesions of vaccinia, accompanied with fever, which have not been exposed to any other infectious or contagious disease, are not required to be slaughtered and may be released for removal from the premises.

Section 309.12 Emergency slaughter: inspection prior to

In all cases of emergency slaughter, except as provided in section 311.27 of these regulations, the animals shall be inspected immediately before slaughter, whether theretofore inspected or not. When the necessity for emergency slaughter exists, the establishment shall notify the Head of Service so that such inspection may be made.

Section 309.13 Disposition of condemned livestock

(A) Except as otherwise provided in this part, livestock identified as VT. Condemned shall be killed by the official establishment, if not already dead. Such animals shall not be taken into the official establishment to be slaughtered or dressed; nor shall they be conveyed into any department of the establishment used for edible product; but they shall be disposed of in the manner provided for condemned carcasses in part 314 of these regulations. The official VT. Condemned tag shall not be removed from, but shall remain on the carcass until it goes into the tank, or is otherwise disposed of as prescribed in PART 314 of these regulations, at which time such tag may be removed by a service employee only. The number of such tag shall be reported to the veterinary medical officer by the inspector who affixed it, and also by the inspector who supervised the tanking of the carcass.

(B) Any livestock condemned on account of ketosis, swine, erysipelas, vesicular diseases, grass tetany, transport tetany, parturient paresis, anasarca, anaplasmosis, leptospirosis, listeriosis, or inflammatory condition including pneumonia, enteritis, and peritonitis may be set apart and held for treatment under supervision of a service employee or official designated by the Head of Service. The VT. Condemned identification tag will be removed by a service employee following treatment under such supervision if the animal is found to be free from any such disease.

(C) Livestock previously affected with listeriosis, including those released for slaughter after treatment under paragraph (B) of this section, shall be identified as VT. Suspect.

(D) When livestock under the provisions of this section are to be released for a purpose other than slaughter, the operator of the official establishment or the owner of the livestock shall first obtain from the State livestock sanitary official having jurisdiction, permission for the movement of such livestock.

Section 309.14 Brucellosisreactor goats

Goats which have reacted to a test for brucellosis shall not be slaughtered in any official establishment.

Section 309.15 Vesicular diseases

(A) Immediate notification shall be given by the inspector to the State livestock sanitary officials having jurisdiction when any livestock is found to be affected with a vesicular disease.

(B) No livestock under quarantine by State livestock sanitary officials on account of a vesicular disease will be given ante-mortem inspection. If no quarantine is invoked, or if quarantine is invoked and later removed, upon ante-mortem inspection, any animal found to be affected with vesicular exanthema or vesicular stomatitis in the acute stages, as evidenced by acute and active lesions or an elevated temperature, shall be identified as VT. Condemned and disposed of in accordance with section 309.13.

Section 309.16 Livestock suspected of having biological residues

(A) Except as provided by paragraph (C) below, livestock suspected of having been treated with or exposed to any substance that may impart a biological residue which would make the edible tissues unfit for human food or otherwise adulterated, shall be identified at official establishments as VT. Condemned. These livestock may be held under the custody of a service employee, or other official designated by the Head of Service, until metabolic processes have reduced the residue sufficiently to make the tissues fit for human food and otherwise not adulterated. When the required time has elapsed, the livestock if returned for slaughter, must be re-examined on ante-mortem inspection. To aid in determining the amount of residue present in the tissues, officials of the Service may permit the slaughter of any such livestock to collect tissues for analysis of the residue.

(B) All carcasses and edible organs and other parts thereof, in which are found any biological residues which render such articles adulterated, shall be marked as VT. Condemned and disposed of in accordance with section 314.1 or section 314.3 of these regulations.

(C) Cattle that have been held on or after November, 1979, or any feedlot identified by FDA as having, or suspected as having, implanted cattle with DES on or after November 1, 1979, shall be slaughtered in any official establishment except as provided below.

(1) Cattle which have not received DES on or after November 1, 1979.

Cattle that have been held on or after November 1, 1979, at any FDA-identified feedlot which were not implanted with DES on or after November 1, 1979 may be slaughtered at an official establishment: Provided: That the official presenting the animal for slaughter executed and presents, to the inspector in charge of the official establishment, sworn statement certifying, based upon his/her personal knowledge and written records, that the animals covered by the sworn statement have received no DES in any form on or after November 1, 1979.

(2) Cattle which have received DES on or after November 1, 1979.

Cattle that have been held on or after November 1, 1979, at any FDA-identified feedlot were implanted with DES on or after November 1, 1979, may be slaughtered at an official establishment Provided, that;

(i) The implant, or its remains, are surgically removed by or under the direct supervision of a USDA or State supervising veterinarian. In the event that the implant or its remains cannot be located after careful physical examination of any animal identified by the feedlot's records as having been implanted with DES on or after November 1, 1979, the holder's customary implant site or sites must be surgically removed or opened, examined, and scraped free of any implant material and contaminated tissue. If the implant site cannot be determined and there is no customary implant site to be explored, cattle identified by the feedlot's records as having been implanted on or after November 1, 1979, cannot be reconditioned under this program:

(ii) Each animal subject to paragraph (C) of this section is individually identified by a serially numbered metal ear tag:

(iii) The USDA or State supervising veterinarian execute a sworn statement certifying that the appropriate procedures required by paragraph (C) has been performed:

(iv) The official presenting the animal for slaughter executes and presents to the inspector in charge at the official establishment a sworn statement based upon his/her personal knowledge and written records. In the sworn statement, the certifying official must acknowledge that the animals covered by the statement (a) have been implanted with DES on or after November 1, 1979; (b) have been explanted (identifying the USDA or State supervising veterinarian performing the explanting and the date on which it occurred); (C) have been withheld under his/her personal supervision from any additional implants of DES for a period of at least 41 days immediately prior to slaughter since explanting; and

(v) A copy of the USDA or State supervising veterinarian sworn statement is attached to the sworn statement of the official presenting the animal for slaughter.

Section 309.17 Livestock used for research

(A) No livestock used in any research investigation involving an experimental biological product, drug, or chemical shall be eligible for slaughter at an official establishment unless:

(1) The operator of such establishment, the sponsor of the investigation, or the investigator has submitted to the service, or the Livestock Division of the Department of Agriculture or to the Environmental Protection Agency or to the Food and Drug Administration of the Department of Health, Education and Welfare data or a summary evaluation of the data which demonstrated that the use of such biological product, drug, or chemical will not result in the products of such livestock being adulterated, and a service employee has approved such slaughter;

(2) Written approval by the Head of Service must be furnished to the supervising veterinarian prior to the time of slaughter;

(B) The Head of Service may deny or withdraw the approval for slaughter of any livestock subject to the provisions of this section when he deems it necessary to assure that all products prepared at the official establishment are free from adulteration.

Section 309.18 Official marks and devices for purposes of ante-mortem inspection

(A) All livestock required by this PART to be identified as VT. Suspects shall be tagged with a serially numbered metal ear tag bearing the term VT. Suspect, except as provided in Section 309.2(D) and except that cattle affected with epithelioma of the eye, actinomycosis, or actinobacillosis to such an extent that the lesions would be readily detected on post-mortem inspection, need not be individually tagged on ante-mortem inspection with the VT. Suspect tag provided that such cattle are segregated and otherwise handled as VT. Suspects.

(B) In addition, identification of VT. Suspect swine must include the use of tattoos specified by the inspector to maintain the identity of the animals through the dehairing equipment when such equipment is used.

(C) All livestock required by this PART to be identified as VT. Condemned shall be tagged with a serially numbered metal ear tag bearing the term VT. Condemned.

(D) The devices described in paragraphs (A), (B) and (C) of this section shall be the official devices for identification of livestock required to be identified as VT. Suspect or VT. Condemned as provided in this PART.

Part 310 POST MORTEM INSPECTION

Section 310.1 Extent and time of post-mortem inspection; post mortem inspection staffing standards

A careful post-mortem examination and inspection shall be made of the carcasses and parts thereof of all livestock slaughtered at official establishments. Such inspection and examination shall be made at the time of slaughter unless, because of unusual circumstances, prior arrangements acceptable to the Head of Service have been made in specific cases by the Service veterinarian for making such inspection and examination at a later time.

Section 310.2 Identification of carcass with certain severed parts thereof and with animal from which derived

(A) The head, tail, tongue, thymus gland, and all viscera of each slaughtered animal, and all blood and other parts of such animals to be used in the preparation of meat food products or medical products, shall be handled in such a manner as to identify them with the rest of the carcass and as being derived from the particular animal involved, until the post-mortem inspection of the carcass and parts thereof has been completed. Such handling shall include the retention of ear tags, back tags, implants, and other identifying devices affixed to the animal, in such a way to relate them to the carcass until the post-mortem examination has been completed.

(B) The official State-Federal department backtag on any carcass shall:

(1)

(i) Be removed from the hide of the animal by an establishment employee and placed in a clear plastic bag. The bag containing the tag shall be affixed to the corresponding carcass.

(ii) The bag containing the tag shall be removed from the carcass by an establishment employee and presented with the viscera to the service inspector at the point where such inspector conducts the viscera inspection.

(2)

(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales tags, ear bangles, and similar identification devices shall be removed from the animals hide or ear by an establishment employee and shall be placed in a clear plastic bag and affixed to the corresponding carcass.

(ii) The bag containing the tag shall be removed from the carcass by an establishment employee and presented with the viscera to the service inspector at the point where such inspector conducts the viscera inspection.

(3) In cases where both types of devices described in subparagraphs (1) and (2) of this paragraph are present on the same animal, both types may be placed in the same plastic bag or in two separate bags.

(4) The supervising veterinarian may allow the use of any alternate method proposed by the operator of an official establishment for handling the type of devices described in subparagraph (2) of this paragraph if such alternate method would provide a ready means of identifying a specific carcass with the corresponding devices by a service inspector during the post-mortem inspection.

(5) Disposition and use of identifying devices.

(i) The official State-Federal department backtags will be collected by a service inspector and used to obtain traceback information necessary for proper disposition of the animal or carcass and otherwise handled according to instructions issued to the inspector.

(ii) The devices described in subparagraph (2) of this paragraph shall be collected by the service inspector when required to obtain traceback information necessary for proper disposition of the animal or carcass and for controlling the slaughter of reactor animals. Devices not collected for these purposes shall be discarded after the postmortem examination is complete.

(6) Plastic bags used by the establishment for collecting identifying devices will be furnished by the Department.

Section 310.3 Carcasses and parts in certain instances to be retained

Each carcass, including all detached organs and other parts, in which any lesion or other condition is found that might render the meat or any part unfit for food purposes, or otherwise adulterated, and which for that reason would require a subsequent inspection, shall be retained by the service employee at the time of inspection. The identity of every such retained carcass, detached organ, or other part shall be maintained until the final inspection has been completed. Retained carcasses shall not be washed or trimmed unless authorized by the service employee.

Section 310.4 Identification of carcasses and parts; tagging

Such devices and methods as may be approved by the Head of Service may be used for the temporary identification of retained carcasses, organs, and other parts. In all cases, the identification shall be further established by affixing VT. Retained tags as soon as practicable and before final inspection. These tags shall not be removed except by a service employee.

Section 310.5 Condemned carcasses and parts to be so marked, tanking, separation

Each carcass or part which is found on final inspection to be unsound, unhealthy, unwholesome, or otherwise adulterated shall be conspicuously marked, on the surface tissues thereof, by a service employee at the time of inspection, as VT. Inspected and Condemned. Condemned detached organs and other parts of such character that they cannot be so marked shall be placed immediately in trucks or receptacles which shall be kept plainly marked VT. Condemned in letters not less than 2 inches high. All condemned carcasses and parts shall remain in the custody of a service employee and shall be disposed of as required in these regulations in PART 314 at or before the close of the day on which they are condemned.

Section 310.6 Carcasses and parts passed for cooking; marking

Carcasses and parts passed for cooking shall be marked conspicuously on the surface tissues thereof by a service employee at the time of inspection, VT. Passes for Cooking. All such carcasses and parts shall be cooked in accordance with PART 315 of these regulations, and until so cooked shall remain in the custody of a service employee.

Section 310.7 Removal of spermatic cords, Dizzles, and preputial diverticuli

Spermatic cords and pizzles shall be removed from all carcasses. Preputial diverticuli shall be removed from hog carcasses.

Section 310.8 Passing and marking of carcasses and parts

Carcasses and parts found to be sound, healthful, wholesome, and otherwise not adulterated shall be passed and marked as provided in PART 316 of these regulations. In all cases where carcasses showing localized lesions are passed for food or for cocking and VT. Retained tags are attached to the carcasses, the affected tissues shall be removed and condemned before the tags are removed. VT. Retained tags shall be removed only by a service employee.

Section 310.9 Anthrax; carcasses not to be eviscerated; disposition of affected carcasses; hides, hoofs, horns, hair, viscera and contents, and fat; handling of blood and scalding vat water; general cleanup and disinfection

(A) Carcasses found before evisceration to be affected with anthrax shall not be eviscerated, but shall be retained, condemned, and immediately tanked or otherwise disposed of as provided in PART 314 of these regulations.

(B) All carcasses and all parts, including hides, hoofs, horns, hair, viscera and contents, blood and fat of any livestock found to be affected with anthrax shall be condemned and immediately disposed of as provided in PART 314 of these regulations, except that the blood may be handled through the usual blood cooking and drying equipment.

(C) Any part of any carcass that is contaminated with anthrax-infected material through contact with soiled instruments or otherwise shall be immediately condemned and disposed of as provided in PART 314 of these regulations.

(D) The scalding vat water through which hog carcasses affected with anthrax have passed shall be immediately drained into the sewer and all parts of the scalding vat shall be cleaned and disinfected as provided in paragraph (E) of this section.

(E)

(1) That portion of the slaughtering department, including the bleeding area, scalding vat, gambrelling bench, walls, posts, platforms, saws, cleavers, knives, and hooks, as well as employees boots and aprons, contaminated through contact with anthrax-infected material, shall, except as provided in subparagraph (2) of this paragraph, be cleaned immediately and disinfected with one of the following disinfectants or other disinfectant approved specifically for this purpose by the Head of Service.

(i) A 5 percent solution of sodium hydroxide or commercial lye containing at least 94 percent of sodium hydroxide. The solution shall be freshly prepared immediately before use by dissolving 2 1/2 pounds of sodium hydroxide or lye in a 5 1/2 gallons of hot water and shall be applied as near scalding hot as possible to be most effective. (Owing to the extremely caustic nature of sodium hydroxide solution, precautionary measures such as the wearing of rubber gloves and boots to protect the hands and feet, and goggles to protect the eyes, should be taken by those engaged in the disinfection process. It is also advisable to have an acid solution, such as vinegar, in readiness in case any of the sodium hydroxide solution should come in contact with any part of the body.)

(ii) A solution of sodium hypochlorite containing approximately one-half of 1 percent (5,000 part per million) of available chlorine. The solution shall be freshly prepared.

(iii) When disinfectant solution has been applied to equipment which will afterwards contact product, the equipment shall be rinsed with clean water before such contact.

(2) In case anthrax infection is found in the hog slaughtering department, an immediate preliminary disinfection shall be made from the head-droppers station to the point where the disease is detected and the affected carcasses shall be cut down from the rail and removed from the room. Upon completion of the slaughtering of the lot of hogs of which the anthrax-infected animals were a part, slaughtering operations shall cease, and a thorough cleanup and disinfection shall be made as provided in subparagraph (1) of this paragraph. If the slaughter of the lot has not been completed by the close of the day on which anthrax was detected, the cleanup and disinfection shall not be deferred beyond the close of that day.

(3) The first and indispensable precautionary step for persons who have handled anthrax material is thorough cleansing of the hands and arms with liquid soap and running hot water. It is important that this step be taken immediately after exposure, before vegetative anthrax organisms have had time to form spores. In the cleansing, a brush or other appropriate appliance shall be used to insure the removal of all contamination material from under and about the fingernails. This process of cleansing is most effective when performed in repeated cycles of lathering and rinsing rather than in spending the same amount of time in scrubbing with a single lathering. After the hands have been cleansed thoroughly and rinsed free of soap, they may, if desired, be immersed for about 1 minute in a 1:1,000 solution of bichloride of mercury, followed by thorough rinsing in clear running water. Supplies of bichloride of mercury for the purpose must be held in the custody of the inspector. (As a precautionary measure, all persons exposed to anthrax-infected material should report promptly any suspicious condition (sore or carbuncle) or symptoms to a physician, in order that anti-anthrax serum or other treatment may be administered as indicated.)

Section 310.10 Carcasses with skin or hide on; cleaning before evisceration; removal of larvae of Hypodermae, external parasites and other pathological skin conditions

When a carcass is to be dressed with the skin or hide left on, the skin or hide shall be thoroughly washed and cleaned before incision is made for the purpose of removing any part thereof or evisceration, except that where calves are slaughtered by the kosher method, the heads shall be removed from the carcasses, before washing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass infected with the larvae of the "oxwarble" fly (Hypoderma lineata and Hypoderma bovis), or external parasites, or affected with other pathological skin conditions.

Section 310.11 Cleaning of hog carcasses before incising

All hair, scurf, dirt, hoofs and claws shall be removed from hog carcasses and the carcasses shall be thoroughly washed and cleaned before any incision is made for inspection or evisceration.

Section 310.12 Sternum to be split; abdominal and thoracic viscera to be removed

The sternum of each carcass shall be split and the abdominal and thoracic viscera shall be removed at the time of slaughter in order to allow proper inspection.

Section 310.13 Carcasses or parts thereof not to be inflated; transferring caul or other fat

Carcasses or parts of carcasses shall not be inflated with air. Transferring the caul or other fat from a fat to a lean carcass is prohibited.

Section 310.14 Handling of bruised parts

When only a portion of a carcass is to be condemned on account of slight bruises, either the bruised portion shall be removed immediately and disposed of in accordance with PART 314 of these regulations, or the carcass shall be promptly placed in a retaining room and kept until chilled and the bruised portion shall than be removed and disposed of as provided in PART 314 of these regulations.

Section 310.15 Hyperimmune swine bled before entering official establishments

Carcasses of hyperimmune swine which have been given the final bleeding at a serum plant under the supervision of an inspector may be transferred to an official establishment for dressing and post-mortem inspection in accordance with provisions of this section. The transfer of such carcasses to the official establishment shall be made as promptly as possible and their delivery to the scalding vat shall be accomplished within 1 hour from the time bleeding is completed. The identity of the carcasses of hyperimmune swine shall be maintained in such manner as to positively identify them and to indicate the time of final bleeding.

Section 310.16 Disposition of lungs

(A) Livestock lungs shall not be saved for use as human food.

(B) Lungs found to be affected with disease of pathology and lungs found to be adulterated with chemical or biological residues shall be condemned and identified as VT. Inspected and Condemned. Condemned lungs may not be saved for pet food or other nonhuman food purposes. They shall be maintained under inspectional control and disposed of in accordance with section 314.1 and section 314.3 of these regulations.

(C) Lungs not condemned under paragraph (B) of this section may be used in the preparation of pet food or for other nonhuman food purpose at the official establishment, provided they are handled in the manner prescribed in section 318.12 of these regulations, or they may be distributed from the establishment in accordance with the conditions prescribed in section 325.8 of these regulations for nonhuman food purposes or they may be so distributed to pharmaceutical manufacturers for pharmaceutical use in accordance with section 314.9 and section 325.19(B) of these regulations, if they are labeled as "Inedible (SPECIES) Lungs-for pharmaceutical use only." Otherwise, they shall be disposed of at the official establishment, in accordance with sections 314.1 and 314.3 of these regulations.

(D) Hog lungs shall not be saved as edible product.

Section 310.17 Inspection of mammary glands

(A) Lactating mammary glands and diseased mammary glands of cattle, sheep, swine, and goats shall be removed without opening the milk ducts or sinuses. If pus or other objectionable material is permitted to come in contact with the carcass, the parts of the carcass thus contaminated shall be removed and condemned.

(B) Nonlactating cow udders may be saved for food purposes provided suitable facilities for handling and inspection are provided. Examination of udders by palpation shall be done by a service employee. When necessary in the judgment of the service employee for adequate inspection, the official establishment employees shall incise udders in sections no greater than 2 inches in thickness. All udders showing disease lesions shall be condemned by a service employee. Each udder shall be properly identified with its respective carcass and kept separate and apart from other udders until its disposal has been accomplished in accordance with the provisions of PART 311 of these regulations.

(C) Lactating mammary glands of cattle, sheep, swine, and goats shall not be saved for edible purposes.

(D) The udders from cows officially designated as "Brucellosis reactors" or as "Mastitis elimination cows" shall be condemned.

Section 310.18 Contamination of carcasses, organs, or other parts

(A) Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector.

(B) Brains, cheek meat, and head trimmings from animals stunned by lead, sponge iron, of frangible bullets shall not be saved for use as human food but shall be handled as described in section 314.1 or section 314.3 of these regulations.

Section 310.19 Inspection of kidneys

An employee of the establishment shall open the kidney capsule and expose the kidneys of all livestock at the time of slaughter for the purpose of examination by a service employee.

Section 310.20 Saving of blood from livestock as an edible product

Blood may be saved for edible purposes at official establishments provided it is derived from livestock, the carcasses of which are inspected and passed, and the blood is collected, defibrinated, and handled in a manner so as not to render it adulterated under the Vermont Meat Inspection Act and regulations issued pursuant thereto. The defibrination of blood intended for human food purposes shall not be done with the hands. Anticoagulants specified in section 318.7(C)(4) may be used in lieu of defibrination.

Section 310.21 Carcasses suspected of containing sulfa and antibiotic residues; sampling frequency; disposition of affected carcasses and parts

(A) Calf carcasses from animals suspected of containing biological residues under section 309.16(D) of these regulations shall, on post-mortem inspection, be handled in accordance with the provisions of this section.

(B) For purposes of this section, the following definitions shall apply:

(1) Calf. A calf of up to 3 weeks of age or up to 150 pounds.

(2) Certified calf. A calf that the producer certifies as not having been treated with animals drugs or, if so, that the withdrawal period as prescribed on the FDA approval label has passed.

(3) Healthy carcass. A carcass that an inspector determines shows no lesions of disease or signs of disease treatment at post-mortem inspection.

(4) Producer. The owner of the calf at the time of its birth.

(5) Sick calf carcass. A calf carcass that an inspector on post-mortem inspection determines has either signs of disease treatment or lesions of disease or was from an animal identified as sick on ante-mortem.

(6) Sign of treatment. Sign of treatment of a disease is indicated by leakage around jugular veins, subcutaneous, intramuscular or intraperitoneal injection lesions, or discoloration from particles or oral treatment in any part of the digestive tract.

(7) Veterinary medical officer. An inspector of the Service that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Service.

(C) Noncertified group. The inspector shall perform a swab bioassay test on all carcasses tagged as VT. Suspect on ante-mortem inspection, on any carcass which he/she finds has lesions of disease or a sign of treatment of disease on post-mortem, and on a statistical sample of healthy carcasses, as outlined in the following table:

Number of Healthy Carcasses Number of Carcasses Sampled

1-11	All
12-16	12
17-40	15
41-250	25
251 and above	30

All carcasses and parts thereof of the group shall be retained until all of the test results are complete. The veterinary medical officer shall determine the test results. If CAST on any of the carcasses is positive, all remaining carcasses in the group will be tested as well. The veterinary medical officer shall condemn any carcass and parts thereof for which there is a positive test result and release for human consumption those carcasses and parts thereof of the group for which there are negative test results. If there is a positive test result for any calf, subsequent calves from the producer of the calf will be tested in accordance with paragraph (E) of this section.

(D) Certified group. The inspector shall sample and perform a swab bioassay test on all carcasses of animals tagged as VT. Suspect on ante-mortem inspection, on any carcass which he/she finds has lesions of disease or a sign of treatment of disease on post-mortem inspection, and up to three healthy carcasses from the certified animals. Only the carcasses and parts thereof being sampled will be retained pending the results of the test. The veterinary medical officer shall determine the test results. If the test result for a carcass is positive, the veterinary medical officer shall condemn such carcass and parts thereof, and the inspector shall statistically sample and test any remaining healthy carcasses in the group as outlined in the following table:

Number of Healthy Carcasses Number of Carcasses Sampled

1-11	All
12-16	12
17-40	15
41-250	25
251 and above	30

The veterinary medical officer shall condemn any carcass and parts thereof for which there is a positive test result and pass for human consumption those carcasses and parts thereof for which there are negative test results. If there is a positive test result for any calf, subsequent calves from the producer of the calf will be tested in accordance with paragraph (E) of this section.

(E) Calves from producers with a previous residue condemnation.

The inspector shall perform a swab bioassay test on all carcasses of all calves in the group. The veterinary medical officer shall determine the test results and shall condemn any carcass and parts thereof for which there is a positive test result and pass for human consumption any such carcass and parts thereof for which there is a negative test result. All subsequent calves from the same producer which has previously sold or delivered to official establishments any carcass that was condemned because of drug residues must be tested according to this paragraph until five consecutive animals test completely free of animal drug residues.

Part 311 DISPOSAL OF DISEASED OR OTHERWISE ADULTERATED CARCASSES AND PARTS

Section 311.1 Disposal of diseased or otherwise adulterated carcasses and parts; general

(A) The carcasses or parts of carcasses of all animals slaughtered at an official establishment and found at the time of slaughter or at any subsequent inspection to be affected with any of the diseases or conditions named in this PART shall be disposed of according to the section pertaining to the disease or condition: Provided, that no product shall be passed for human food under any such section unless it is found to be otherwise not adulterated. Products passed for cooking or refrigeration under this PART must be so handled at the official establishment where they are initially prepared unless they are moved to another official establishment for such handling or in the case of products passed for refrigeration are moved for such refrigeration to a freezing facility approved by the Head of Service in specific cases: Provided, that when so moved the products are shipped in containers sealed in accordance with section 318.10(C) of these regulations or in a sealed means of conveyance as provided in section 325.7 of these regulations. Owing to the fact that it is impracticable to formulate rules covering every case and to designate at just what stage a disease process or a condition results in adulteration of a product, the decision as to the disposal of all carcasses, organs, or other parts not specifically covered in this PART shall be left to the supervising veterinarian. The supervising veterinarian shall exercise his judgment regarding the disposition of all carcasses or parts of carcasses under this PART in a manner which will insure that only wholesome, unadulterated product is passed for human food.

(B) In cases of doubt as to a condition, a disease, or the cause of a condition, or to confirm a diagnosis, representative specimens of the affected tissues, properly prepared and packaged, shall be sent for examination to an official laboratory.

Section 311.2 Tuberculosis

The following principles shall apply to the disposition of carcasses of livestock based on the differences in the pathogenesis of tuberculosis in swine, cattle, sheep, goats and equines.

(A) Carcasses condemned. The entire carcass of swine, cattle, sheep, goats and equines shall be condemned if any of the following conditions occur:

(1) When the lesions of tuberculosis are generalized; (tuberculosis is considered to be generalized when the lesions are distributed in a manner made possible only by entry of the bacilli into the systemic circulation);

(2) When on ante-mortem inspection the animal is observed to have a fever found to be associated with an active tuberculosis lesion on post-mortem inspection.

(3) When there is an associated cachexia;

(4) When a tuberculosis lesion is found in any muscle or intermuscular tissue, or bone, or joint, or abdominal organ (excluding the gastrointestinal tract) or in any lymph node as a result of draining a muscle, bone, joint, or abdominal organ (excluding the gastrointestinal tract);

(5) When the lesions are extensive in tissues of either the thoracic or the abdominal cavity;

(6) When the lesions are multiple, acute, and actively progressive; or

(7) When the character or extent of the lesions otherwise is not indicative of a localized condition.

(B) Organs or other parts condemned. An organ or other part of a swine, cattle, sheep, goat or equine carcass affected by localized tuberculosis shall be condemned when it contains lesions of tuberculosis or when the corresponding lymph node contains lesions of tuberculosis.

(C) Carcasses of cattle passed without restriction for human food. Carcasses of cattle may be passed without restriction for human food only when the carcass of an animal not identified as a reactor to a tuberculin test administrated by an Animal and Plant Health Inspection Service, State, or accredited veterinarian is found free of tuberculosis lesions during post-mortem inspection.

(D) Portions of carcasses and carcasses of cattle passed for cooking.

(1) When a cattle carcass reveals a tuberculosis lesion or lesions not so severe or so numerous as to the lesions described in paragraph (A) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with PART 315 of these regulations; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(2) When a carcass of a cattle identified as a reactor to a tuberculin test administered by an Animal and Plant Health Inspection Service, State or accredited veterinarian is found free of lesions of tuberculosis, the carcass may be passed for cooking in accordance with PART 315 of these regulations.

(E) Portions of carcasses and carcasses of swine passed without restriction for human food.

Swine carcasses found free of tuberculosis lesions during post-mortem inspection may be passed for numan food without restriction. When tuberculosis lesions in any swine carcass are localized and confined to one primary seat of infection, such as the cervical lymph nodes, the mesenteric lymph nodes, or the mediastinal lymph nodes, the unaffected portion of the carcass may be passed for human food without restriction after the affected organ or other part is condemned.

(F) Portions of carcasses of swine passed for cooking. When the carcass of any swine reveals lesions more severe or more numerous than those described in paragraph (E) of this section, but not so severe or so numerous as the lesions described in paragraph (A) of this section, the unaffected portions of such carcass may be passed for cooking in accordance with PART 315 of these regulations; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

(G) Carcasses of sheep, goats and equines passed without restriction for human food. Carcasses of sheep, goats and equines may be passed without restriction for human food only if found free of tuberculosis lesions during post-mortem inspection.

(H) Portions of carcasses of sheep, goats, and equines passed for cooking. If a carcass of any sheep, goats, or equine reveals a tuberculosis lesion or lesions that are not as severe or so numerous as the lesions described in paragraph (A) of this section, the unaffected portion of the carcass may be passed for cooking in accordance with PART 315 of these regulations; if the character and extent of the lesions indicate a localized condition, and if the lesions are calcified or encapsulated, and provided the affected organ or other part is condemned.

Section 311.3 Hog Cholera

(A) The carcass of all hogs affected with hog cholera shall be condemned.

(B) Inconclusive but suspicious symptoms of hog cholera observed during the ante-mortem inspection of a VT. Suspect shall be duly considered in connection with post-mortem findings and when the carcass of such suspect shows lesions in the kidneys and the lymph nodes which resemble lesions of hog cholera, they shall be regarded as those of hog cholera and the carcass shall be condemned.

(C) When lesions resembling those of hog cholera occur in kidneys and lymph nodes of carcasses of hogs which appeared normal on ante-mortem inspection, further inspection of such carcasses shall be made for corroborative lesions. If on such further inspection, characteristic lesions of hog cholera are found in some organs or tissue in addition to those in the kidneys or in the lymph nodes or in both, then all lesions shall be regarded as those of hog cholera and the carcass shall be condemned. Immediate notification shall be given by the inspector to the State Veterinarian.

Section 311.4 Swine erysipelas

Carcasses affected with swine erysipelas which is acute or generalized, or show systemic change, shall be condemned.

Section 311.5 Diamondskin disease

Carcasses of hogs affected with diamond-skin disease when localized and not associated with systemic change may be passed for human food after removal and condemnation of the affected parts, provided such carcasses are otherwise healthy.

Section 311.6 Arthritis

(A) Carcasses affected with arthritis which is localized and not associated with systemic change may be passed for human food after removal and condemnation of all affected parts. Affected joints with corresponding lymph nodes shall be removed and condemned. In order to avoid contamination of the meat which is passed, a joint capsule shall not be opened until after the affected joint is removed.

(B) Carcasses affected with arthritis shall be condemned when there is evidence of system involvement.

Section 311.7 Cattle carcasses affected with anasarca or generalized edema

(A) Carcasses of cattle found on post-mortem inspection to be affected with anasarca in advanced stages and characterized by an extensive or well-marked generalized edema shall be condemned.

(B) Carcasses of cattle, including their detached organs and other parts, found on post-mortem inspection to be affected with anasarca to a lesser extent than as described in paragraph (A) of this section may be passed for human food after removal and condemnation of the affected tissues, provided the lesions are localized.

Section 311.8 Actinomvcosis and actinobacillosis

(A) The definition of generalization as outlined for tuberculosis in section 311.2(A) shall apply for actinomycosis and actinobacillosis, and carcasses of livestock with generalized lesions of either such disease shall be condemned.

(B) Carcasses of livestock in a well-nourished condition showing uncomplicated localized lesions of actinomycosis or actinobacillosis may be passed for human food after the infected organs or other infected parts have been removed and condemned except as provided in paragraphs (C) and (D) of this section.

(C) Heads affected with actinomycosis or actinobacillosis, including the tongue, shall be condemned, except when the disease of the jaw is slight, strictly localized, and without suppuration, fistulous tracts, or lymph node involvement, the tongue, if free from disease, may be passed, or, when the disease is slight and confined to the lymph nodes, the head including the tongue, may be passed for food after the affected nodes have been removed and condemned.

(D) When the disease is slight and confined to the tongue, with or without involvement of the corresponding lymph nodes, the head may be passed for human food after removal and condemnation of the tongue and corresponding lymph nodes.

Section 311.9 Anaplasmosis, anthrax, babesiosis, bacillary hemoglobinuria in cattle, blackleg, bluetongue in sheep, hemorrhagic septicemia, icterohematuria in sheep, infectious bovine rhinotracheitis, leptospirosis, malignant epizootic catarrh strangles, purpura hemorrhagica, azoturia, infectious eouine encephalomyelitis, toxic encephalomvelitis (forage poisoning), infectious anemia (swamp fever), dourine, acute influenza, generalized osteoporosis, glanders (farcy), acute inflammatory lameness, extensive fistula, and unhealed vaccine lesions

(A) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned:

(1) Anthrax.

(2) Blackleg.

(3) Strangles.

(4) Purpura hemorrhagica.

(5) Azoturia.

(6) Infectious equine encephalomyelitis.

(7) Toxic encephalomyelitis (forage poisoning).

(8) Infectious anemia (swamp fever).

(9) Dourine.

(10) Acute influenza.

(11) Generalized osteoporosis.

(12) Glanders (farcy).

(13) Acute inflammatory lameness.

(14) Extensive fistula.

(B) Carcasses of livestock affected with or showing lesions of any of the following named diseases or conditions shall be condemned, except when recovery has occurred to the extent that only localized lesions persist, in which case the carcass may be passed for human food after removal and condemnation of the affected organs or other parts.

(1) Anaplasmosis.

(2) Bacillary hemoglobinuria in cattle.

(3) Babesiosis (piroplasmosis).

(4) Bluetongue.

(5) Hemorrhagic septicemia.

(6) Icterohematuria in sheep.

(7) Infectious bovine rhinotracheitis.

(8) Leptospirosis.

(9) Malignant epizootic catarrh.

Section 311.10 Neoplasm

(A) An individual organ or other part of a carcass affected with a neoplasm shall be condemned. If there is evidence of metastasis or that the general condition of the animal has been adversely affected by the size, position, or nature of the neoplasm, the entire carcass shall be condemned.

(B) Carcasses affected with malignant lymphoma shall be condemned.

Section 311.11 Epithelioma of the eye

(A) Carcasses of animals affected with epithelioma of the eye, or the orbital region shall be condemned in their entirety if one of the following three conditions exists:

(1) The affection has involved the osseous structures of the head with extensive infection, suppuration, and necrosis;

(2) There is metastasis from the eye, or the orbital region, to any lymph node including the parotid lymph node, internal organs, muscles, skeleton, or other structures, regardless of the extent of the primary tumor; or

(3) The affection, regardless of extent, is associated with cachexia or evidence of absorption or secondary changes.

(B) Caroasses of animals affected with epithelioma of the eye, or the orbital region, to a lesser extent than as described in paragraph (A) of this section may be passed for human food after removal and condemnation of the head, including the tongue, provided the carcass is otherwise normal.

Section 311.12 Pigmentary conditions: Melanosis, Xanthosis Ochronosis

(A) Except as provided in section 311.18, carcasses of livestock showing generalized pigmentary deposits shall be condemned.

(B) The affected parts of carcasses showing localized pigmentary deposits of such character as to be unwholesome or otherwise adulterated shall be removed and condemned.

Section 311.13 Abrasions, bruises, abscesses, pus, etc

All slight, well-limited abrasions on the tongue and inner surface of the lips and mouth, when without lymph node involvement, shall be carefully excised, leaving only sound normal tissue, which may be passed for human food. Any organ or other part of a carcass which is badly bruised or which is affected by an abscess, or a suppurating sore shall be condemned; and when the lesions are of such character or extent as to affect the whole carcass, the whole carcass shall be condemned. Portions of carcasses which are contaminated by pus or other disease material shall be condemned.

Section 311.14 Brucellosis

Carcasses affected with localized lesions of brucellosis may be passed for human food after the affected parts are removed and condemned.

Section 311.15 Carcasses so infected that consumption of the meat may cause food poisoning

(A) All carcasses of animals so infected that consumption of the products thereof may give rise to food poisoning shall be condemned. This includes all carcasses showing signs of:

(1) Acute inflammation of the lungs, pleura, pericardium or meninges;

(2) Septicemia or pyemia, whether puerperal, traumatic, or without any evident cause;

(3) Gangrenous or severe hemorrhagic enteritis.

(4) Acute diffuse metritis or mammitis.

(5) Phlebitis of the umbilical veins.

(6) Septic or purulent traumatic pericarditis.

(7) Any acute inflammation, abscess, or suppurating sore, if associated with acute nephritis, fatty and degenerated liver, swollen soft spleen, marked pulmonary hyperemia, general swelling of lymph nodes, diffuse redness of the skin, cachexia, icteric discoloration of the carcass or similar condition, either singly or in combination.

(8) Salmonellosis.

(3) Implements contaminated by contact with carcasses affected with any of the diseases or conditions mentioned in this section shall be thoroughly cleaned and sanitized as prescribed in PART 308 of these regulations. The equipment used in the dressing of such carcasses, such as viscera trucks or inspection tables, shall be sanitized with hot water having a minimum temperature of 180 degrees F. Carcasses or parts of carcasses contaminated by contact with such diseased carcasses shall be condemned unless all contaminated tissues are removed within two (2) hours.

Section 311.16 Necrobacillosis, pyemia, and septicemia

From the standpoint of meat inspection, necrobacillosis may be regarded as a local infection at the beginning, and carcasses in which the lesions are localized may be passed for human food if in a good state of nutrition, after those portions affected with necrotic lesions are removed and condemned. However, when emaciation, cloudy swelling of the parenchymatous tissue of organs or enlargement of the lymph nodes is associated with the infection, it is evident that the disease has progressed beyond the condition of localization to a state of toxemia, and the entire carcass shall therefore be condemned as both unwholesome and noxious. Pyemia or septicemia may intervene as a complication of the local necrosis, and when present the carcass shall be condemned in accordance with section 311.15.

Section 311.17 Caseous lymphadenitis

(A) A thin carcass showing well-marked lesions in the viscera and the skeletal lymph nodes, or a thin carcass showing extensive lesions in any part shall be condemned.

(B) A thin carcass showing well-marked lesions in the viscera with only slight lesions elsewhere or showing well-marked lesions in the skeletal lymph nodes with only slight lesions elsewhere may be passed for cooking.

(C) A thin carcass showing only slight lesions in the skeletal lymph nodes and in the viscera may be passed for human food without restriction.

(D) A well-nourished carcass showing well-marked lesions in the viscera and with only slight lesions elsewhere or showing well-marked lesions confined to the skeletal lymph nodes with only slight lesions elsewhere, may be passed for human food without restriction.

(E) A well-nourished carcass showing well-marked lesions in the viscera and the skeletal lymph nodes may be passed for cooking; but where the lesions in a well-nourished carcass are both numerous and extensive, it shall be condemned.

(F) All affected organs and nodes of carcasses passed for human food without restriction or passed for cooking shall be removed and condemned.

(G) As used in this section, the term "thin" does not apply to a carcass which is anemic or emaciated; and the term "lesions" refers to lesions of caseous lymphadenitis.

Section 311.18 Icterus

Carcasses showing any degree of icterus shall be condemned. Yellow fat conditions caused by nutritional factors or characteristic of certain breeds of livestock and yellow fat sometimes seen in sheep shall not be confused with icterus. Such carcasses should be passed for human food, if otherwise normal.

Section 311.19 Sexual odor of swine

(A) Carcasses of swine which give off a pronounced sexual odor shall be condemned.

(B) The meat of swine carcasses which give off a sexual odor less than pronounced may be passed for use in comminuted cooked meat food product or for rendering. Otherwise it shall be condemned.

Section 311.20 Mange or scab

Carcasses of livestock affected with mange or scab in advanced stages, showing cachexia or extensive inflammation of the flesh, shall be condemned. When the disease is slight, the carcass may be passed after removal of the affected portion.

Section 311.21 Hogs affected with urticaria, tinea tonsurans, demodex folliculorum, or erythema

Carcasses of hogs affected with urticaria (nettle rash), tinea tonsurans, demodex folliculorum, or erythema may be passed for human food after detaching and condemning the affected skin, if the carcass is otherwise not adulterated.

Section 311.22 Tapeworm cysts (cysticercus bovis) in cattle

(A) Except as provided in paragraph (B) of this section, carcasses of cattle affected with lesions of cysticercus bovis shall be disposed of as follows:

(1) Carcasses of cattle displaying lesions of cysticercus bovis shall be condemned if the infestation is extensive or if the musculature is edematous or discolored. Carcasses shall be considered extensively infested if in addition to finding lesions in at least two on the usual inspection sites, namely the heart, diaphragm and its pillars, muscles of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, they are found in at least two of the sites exposed by (i) an incision made into each round exposing the musculature in cross section, and (ii) a transverse incision into each forelimb commencing 2 or 3 inches above the point of the olecranon and extending to the humerus.

(2) Carcasses of cattle showing one or more tapeworm lesions of cysticercus bovis but not so extensive as indicated in subparagraph (1) of this paragraph as determined by a careful examination, including examination of, but not limited to, the heart, diaphragm and its pillars, muscles, of mastication, esophagus, tongue, and musculature exposed during normal dressing operations, may be passed for human food after removal and condemnation of the lesions with surrounding tissues: Provided, that the carcasses appropriately identified by retained tags, are held in cold storage under positive control of a service inspector at a temperature not higher than 15 degrees F. continuously for a period of not less than 10 days, or in the case of boned meat derived from such carcasses, the meat, when in boxes, tierces, or other containers, appropriately identified by retained tags, is held under positive control of a service inspector at a temperature of not higher than 15 degrees F. continuously for a period of not less than 20 days. As an alternative to retention in cold storage as provided in this subparagraph, such carcasses and meat may be heated throughout to a temperature of at least 140 degrees F. under positive control of a service inspector.

(B) Edible viscera and offal shall be disposed of in the same manner as the rest of the carcass from which they were derived unless any lesion of cysticercus bovis is found in these byproducts, in which case they shall be condemned.

Section 311.23 Hogs affected with tapeworm cysts

Carcasses of hogs affected with tapeworm cysts (Cysticercus cellulosae) may be passed for cooking, unless the infestation is excessive, in which case the carcass shall be condemned.

Section 311.24 Parasites not transmissible to man: tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder worms

(A) In the disposal of carcasses, edible organs, and other parts of carcasses showing evidence of infestation with parasites not transmissible to man, the following general rules shall govern except as otherwise provided in this section: If the lesions are localized in such manner and are of such character that the parasites and their lesions caused by them can be completely removed, the nonaffected portion of the carcass, organ, or other part of the carcass may be passed for human food after the removal and condemnation of the affected portions. If the organ or other part of a carcass shows numerous lesions caused by parasites, or if the character of the infestation is such that complete extirpation of the parasitic infestation or invasion renders the part in any way unfit for human food, the affected part shall be condemned. If parasites are found to be distributed in a carcass in such a manner or to be of such character that their removal and the removal of the lesions caused by them is impracticable, no part of the carcass shall be passed for human food. If the infestation is moderate the carcass may be passed for cooking, but in case such carcass is not cooked as required by PART 315 of these regulations, it shall be condemned.

(B) In the case of sheep carcasses affected with tapeworm cysts (Cysticerous ovis, so-called sheep measles, not transmissible to man), such carcasses may be passed for human food after the removal and condemnation of the affected portion: Provided, however, that if, upon the final inspection of sheep carcasses retained on account of measles, the total number of cysts found imbedded in muscular tissue, or in immediate relation to muscular tissue, excluding the heart, exceeds five, the entire carcass shall be condemned, or such carcass shall be heated throughout to a temperature of at least 140 degrees F. after removal and condemnation of all affected portions.

(C) Carcasses found infested with gid bladder worms (Coenurus cerebralis), multiceps may be passed for human food after condemnation of the affected organ (brain or spinal cord).

(D) Organs or other parts of carcasses infested with hydatid cysts (echinococcus) shall be condemned.

(E) Livers infested with flukes or fringed tapeworms shall be condemned.

Section 311.25 Emaciation

Carcasses of livestock too emaciated to produce wholesome meat, and carcasses which show serious infiltration of muscle tissues, or a serous or mucoid degeneration of the fatty tissue, shall be condemned. A gelatinous change of the fat of the heart and the kidneys of well-nourished carcasses and mere leanness shall not be classed as emaciation.

Section 311.26 Injured animals slaughtered at unusual hours

When it is necessary for humane reasons to slaughter an injured animal at night or on Sunday or a holiday when the inspector cannot be obtained, the carcass and all parts shall be kept for inspection, with the head and all viscera except the stomach, bladder, and intestines, held by the natural attachments. If all parts are not so kept for inspection, the carcass shall be condemned. If, on inspection of a carcass slaughtered in the absence of an inspector any lesion or other evidence is found indicating that the animal was sick or diseased, or affected with any other condition requiring condemnation of the animal on ante-mortem inspection, or if there is lacking evidence of the condition which rendered emergency slaughter necessary, the carcass shall be condemned.

Section 311.27 Carcasses of young calves, pigs, kids, lambs and foals

Carcasses of young calves, pigs, kids, lambs and foals are unwholesome and shall be condemned if (a) the meat has the appearance of being water-soaked, is loose, flabby, tears easily, and can be perforated with the fingers; or its color is grayish red; or (b) good muscular development as a whole is lacking, especially noticeable on the upper shank of the leg, where small amounts of serous infiltrates or small edematous patches are sometimes present between the muscles; or (C) the tissue which later develops as the fat capsule of the kidney is edematous, dirty yellow, or grayish red, tough, and intermixed with islands of fat.

Section 311.28 Unborn and stillborn animals

All unborn and stillborn animals shall be condemned and no hide or skin thereof shall be removed from the carcass within a room in which edible products are handled.

Section 311.29 Livestock suffocated and hogs scalded alive

All livestock which have been suffocated in any way and hogs which have entered the scalding vat alive shall be condemned.

Section 311.30 Livers affected with carotenosis; livers designated as "telangiectatic", "sawdust", or "spotted"

(A) Livers affected with carotenosis shall be condemned.

(3) Cattle livers and calf livers showing the conditions designated as "telangiectatic", "sawdust", or "spotted" shall be disposed of as follows:

(1) When any and all of the conditions are slight in the organ, the whole organ shall be passed for human food without restriction.

(2) When any or all of the conditions are more severe than slight and involve less than one-half of the organ, while in the remainder of the organ the conditions are slight or nonexistent, the remainder shall be passed for human food without restriction and the other portion shall be condemned.

(3) When any or all of the conditions are more severe than slight and involve one-half or more of the organ, the whole organ shall be condemned.

(4) The divisions of an organ into two parts as contemplated in this paragraph for disposition, shall be accomplished by one cut through the organ. This, of course, does not prohibit incisions which are necessary for inspection.

(C) "Telangiectatic", "sawdust", or "spotted" livers and parts of livers which are condemned for human food may be shipped from an official establishment for purposes other than human food in accordance with section 314.10 of these regulations.

Section 311.31 Vesicular diseases

(A) Any carcass affected with vesicular disease shall be condemned if the condition is acute and if the extent of the condition is such it affects the entire carcass or there is evidence of absorption or secondary change.

(B) Any carcass affected with vesicular disease to a lesser extent than as described in paragraph (A) of this section may be passed for human food after removal and condemnation of the affected parts, if the carcass is otherwise healthy.

Section 311.32 Listeriosis

Carcasses of livestock identified as VT. Suspects because of a history of listeriosis shall be passed for human food after condemnation of the head if the carcass is otherwise normal.

Section 311.33 Anemia

Carcasses of livestock too anemic to produce wholesome meat shall be condemned.

Section 311.34 Muscular inflammation, degeneration, or infiltration

(A) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is impractical, the carcass shall be condemned.

(B) If muscular lesions are found to be distributed in such a manner or to be of such character that removal is practical, the following rules shall govern the disposal of the carcass, edible organs, and other parts of the carcasses showing such muscular lesions. If the lesions are localized in such a manner and are of such character that the affected tissues can be removed, the nonaffected parts of the carcass may be passed for human food after the removal and condemnation of the affected portion. If a part of the carcass shows numerous lesions, or if the character of the lesions is such that complete extirpation is difficult and uncertainly accomplished, or if the lesions render the part in any way unfit for human food, the part shall be condemned.

(C) If the lesions are slight or of such character as to be insignificant from a standpoint of wholesomeness, the carcass or parts may be passed for use in the manufacture of comminuted cooked product, after removal and condemnation of the visibly affected portions.

Section 311.35 Coccidioidal granuloma

(A) Carcasses which are affected with generalized coccidioidal granuloma or which show systemic change because of such disease shall be condemned.

(B) Carcasses affected with localized lesions of this disease may be passed for human food after the affected parts are removed and condemned.

Section 311.36 Odors, foreign and urine

(A) Carcasses which give off a pronounced odor of medicinal, chemical, or other foreign substances shall be condemned.

(B) Carcasses which give off a pronounced urine odor shall be condemned.

(C) Carcasses, organs, or parts affected by odor to a lesser degree than as described in paragraphs (A) and (B) of this section and in which the odor can be removed by trimming or chilling may be passed for human food, after removal of affected parts or dissipation of the condition.

Section 311.37 Meat and meat byproducts from livestock which have been exposed to radiation

Meat and meat byproducts from livestock, which have been administered radioactive material shall be condemned unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act.

Section 311.38 Biological residues

Carcasses, organs or other parts of carcasses of livestock shall be condemned if it is determined that they are adulterated because of the presence of any biological residues.

Part 312 OFFICIAL MARKS, DEVICES AND CERTIFICATES

Section 312.1 General

The marks, devices, and certificates prescribed or referenced in this PART shall be official marks, devices, and certificates for purposes of the ACT, and shall be used in accordance with the provisions of this PART and the regulations cited therein.

Section 312.2 Official marks and devices to identify inspected and passed products of cattle, sheep, swine, or goats

(A) The official inspection legend required by PART 316 of these regulations to be applied to inspected and passed carcasses and parts of carcasses of cattle, sheep, swine, and goats, meat food products in animal casings, and other products as approved by the Head of Service, shall be in the appropriate form as hereinafter specified:1

[See graphic or tabular material in printed version]

For application to sheep carcasses, the loins and ribs of pork, beef tails, and the smaller varieties of sausage and meat food products in animal casings.

The number "00" is given as an example only. The establishment number of the official establishment where the product is prepared shall be used in lieu thereof.

[See graphic or tabular material in printed version]

For application to calf and goat carcasses and on the larger varieties of sausage and meat food products in animal casings.

[See graphic or tabular material in printed version]

For application to beef and hog carcasses primal parts and cuts thereof, beef livers, beef tongues, beef hearts, and smoked meats not in casings.

(B)

(1) The official inspection legend required by PART 317 of these regulations to be shown on all labels for inspected and passed products of cattle, sheep, swine, and goats shall be in the following form except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated:

[See graphic or tabular material in printed version]

(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp.

(3) The official inspection legend described in subparagraph (1) of this paragraph may also be used for purposes of PART 316 of these regulations on shipping containers, band labels, artificial casings, and other articles with the prior approval of the Head of Service.

(C) Any brand, stamp, label, or other device approved by the Head of Service and bearing any official mark prescribed in paragraphs (A) or (B) of this section shall be an official device for purposes of the Act.

Section 312.3 Official marks and devices to identify inspected and passed equine products

(A) The official inspection legend required by section 316.12 and 317.2 of these regulations to identify inspected and passed horse carcasses and parts of carcasses, or horse meat food products shall be in the appropriate form as hereinafter specified:

[See graphic or tabular material in printed version]

(B) The official inspection legend required by section 316.12 and 317.2 of these regulations to identify inspected and passed mule and other (nonhorse) equine carcasses and parts of carcasses, or equine meat food products shall be in whichever of the following form, is appropriate:

[See graphic or tabular material in printed version]

The number "00" is given as an example only. The establishment number of the official establishment where the product is prepared shall be used in lieu thereof.

(C) Any brand, stamp, label, or other device approved by the Head of Service and bearing any official mark prescribed in paragraphs (A) and (B) of this section shall be an official device for purposes of the Act.

Section 312.4 Official antemortem inspection marks and devices

The official marks and devices used in connection with ante-mortem inspection are those prescribed in section 309.18 of these regulations.

Section 312.5 Official seals for transportation of products

The official mark use in sealing railroad cars or other means of conveyance as prescribed in PART 325 of these regulations shall be the inscription and serial number as hereinafter shown and any seal approved by the Head of Service for applying such mark shall be an official device for purposes of the Act. This seal shall be attached to the means of conveyance only by a service employee.

[See graphic or tabular material in printed version]

Section 312.6 Official marks and devices in connection with postmortem inspection and identification of adulterated products and insanitary equipment and facilities

(A) The official marks required by PARTS 308 and 310 of these regulations for use in post-mortem inspection and identification of adulterated products and insanitary equipment and facilities are:

(1) The tag which is used to retain carcasses and parts of carcasses in the slaughter department: it is black and white, and bears the legend VT. Retained.

(2) The VT. Retained mark which is applied to products and articles as prescribed in PART 310 of these regulations by means of a paper tag bearing the legend VT. Retained.

(3) The VT. Rejected mark which is used to identify insanitary buildings, rooms, or equipment as prescribed in PART 308 of these regulations and is applied by means of a paper tag bearing the legend VT. Rejected.

(4) The VT. Passed for Cooking mark is applied on products passed for cooking as prescribed in PART 310 of these regulations by means of a brand and is in the following form:

[See graphic or tabular material in printed version]

(5) The VT. Inspected and Condemned mark shall be applied to products condemned as prescribed in PART 310 by means of a brand and is in the following form:

[See graphic or tabular material in printed version]

(B) The VT. Retained and VT. Rejected tags and all other brands stamps, labels, and other devices approved by the Head of Service and bearing any official mark prescribed in paragraph (A) of this section, shall be official devices for purposes of the Act.

Section 312.7 Official detention marks and devices

The official mark for articles and livestock detained under PART 329 of these regulations shall be the designation of VT. Detained and the official device for applying such mark shall be official tag as prescribed in section 329.2 of these regulations.

Part 313 HUMANE SLAUGHTER OF LIVESTOCK

Section 313.1 Livestock pens, driveways and ramps

(A) Livestock pens, driveways and ramps shall be maintained in good repair. They shall be free from sharp or protruding objects which may, in the opinion of the inspector, cause injury or pain to the animals. Loose boards, splintered or broken planking, and unnecessary openings where the head, feet, or legs of an animal may be injured shall be repaired.

(B) Floors of livestock pens, ramps, and driveways shall be constructed and maintained so as to provide good footing for livestock. Slip resistant or waffled floor surfaces, cleated ramps and the use of sand, as appropriate, during winter months are examples of acceptable construction and maintenance.

(C) VT. Suspects (as defined in section 301.2 (DDDD) and dying, diseased, and disabled livestock as defined in section 301.2(AA) shall be provided with a covered pen sufficient, in the opinion of the inspector, to protect them from the adverse climatic conditions of the locale while awaiting disposition by the inspector.

(D) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized.

Section 313.2 Handling of livestock

(A) Driving of livestock from the unloading ramps to the holding pens and from the holding pens to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Livestock shall not be forced to move faster than a normal walking speed.

(B) Electric prods, canvas slappers, or other implements employed to drive animals shall be used as little as possible in order to minimize excitement and injury. Any such use of implements which, in the opinion of the inspector, is excessive, is prohibited. Electrical prods attached to AC house current shall be reduced by a transformer to the lowest effective voltage not to exceed 50 volts AC.

(C) Pipes, sharp or pointed objects, and other items which, in the opinion of the inspector, would cause injury or unnecessary pain to the animal shall not be used to drive livestock.

(D) Disabled livestock and other animals unable to move:

(1) Disabled animals and other animals unable to move shall be separated from normal ambulatory animals and placed in the covered pen provided for in section 313.1(C).

(2) The dragging of disabled animals and other animals unable to move, while conscious, is prohibited. Stunned animals may, however, be dragged.

(3) Disabled animals and other animals unable to move may be moved, while conscious, on equipment suitable for such purpose; e.g., stone boats.

(E) Animals shall have access to water in all holding pens and, if held longer than 24 hours, access to feed. There shall be sufficient room in the holding pens for animals held overnight to lie down.

(F) Stunning methods approved in section 313.6 shall be effectively applied to animals prior to their being shackled, hoisted, thrown, cast, or cut.

Section 313.3 Chemical, carbon dioxide

The slaughter of sheep, calves, and swine with the use of carbon dioxide gas and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(A) Administration of gas, required effect; handling;

(1) The carbon dioxide gas shall be administered in a chamber in accordance with this section so as to produce surgical anesthesia in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be exposed to the carbon dioxide gas in a way that will accomplish the anesthesia quickly and calmly, with a minimum of excitement and discomfort to the animals.

(2) The driving or conveying of the animals to the carbon dioxide chamber shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the anesthesia chamber is essential since the induction, or early phase, of anesthesia is less violent with docile animals. Among other things this requires that, in driving animals to the anesthesia chamber, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) On emergence from the carbon dioxide chamber the animals shall be in a state of surgical anesthesia and shall remain in this condition throughout shackling, sticking and bleeding. Asphyxia or death from any cause shall not be produced in the animals before bleeding.

(B) Facilities and procedures:

(1) General requirements for gas chambers and auxiliary equipment; operator:

(i) The carbon dioxide gas shall be administered in a chamber which accomplishes effective exposure of the animal. Two types of chambers involving the same principle are in common use for carbon dioxide anesthesia. They are the "U" type chamber and the "Straight Line" type chamber. Both are based on the principle that carbon dioxide gas has a higher specific gravity than air. The chambers open at both ends for entry and exit of animals and have a depressed central section. Anesthetizing carbon dioxide concentrations are maintained in the central section of the chamber. Effective anesthetization is produced in this section. Animals are driven from holding pens through a pathway constructed of pipe or other smooth metal onto a continuous conveyor device which moves the animals through the chamber. The animals are compartmentalized on the conveyor by impellers synchronized with the conveyor or are otherwise prevented from crowding. While impellers are used to compartmentalize the animals a mechanically or manually operated gate will be used to move the animals onto the conveyor. Surgically anesthetized animals are moved from the chamber by the same continuous conveyor that carried them into and through the carbon dioxide gas.

(ii) Flow of animals into and through the carbon dioxide chamber is dependent on one operator. The operation or stoppage of the conveyor is entirely dependent upon this operator. It is necessary that he be skilled, attentive, and aware of his responsibility. Over-dosages and death of animals can be brought about by carelessness of this individual.

(2) Special requirements for gas chamber and auxiliary equipment. The ability of anesthetizing equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, gas chambers, and all other equipment used must be designed to accommodate properly the species of animals being anesthetized. They shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces, or openings, where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or well padded rigid material. Power activated gates designed for constant flow of animals to anesthetizing equipment shall be so fabricated that they not cause injury. All equipment involved in anesthetizing animals shall be maintained in good repair.

(3) Gas. Maintenance of a uniform carbon dioxide concentration and distribution in the anesthesia chamber is vital aspect of producing surgical anesthesia. This may be assured by reasonably accurate instruments which sample and analyze carbon dioxide gas concentrations within the chamber throughout anesthetizing operations. Gas concentrations shall be maintained uniform so that the degree of anesthesia in exposed animals will be constant. Carbon dioxide gas supplied to anesthesia chambers may be from controlled reduction of solid carbon dioxide or from a controlled liquid source. In either case the carbon dioxide shall be supplied at a rate sufficient to anesthetize adequately and uniformly the number of animals passing through the chamber. Sampling of gas for analysis shall be made from a representative place or places within the chamber and on a continuing basis. Gas concentrations and exposure time shall be graphically recorded throughout each days operation. Neither carbon dioxide nor atmospheric air used in the anesthesia chambers shall contain noxious or irritating gases. Each day before equipment is used for anesthetizing animals, proper care shall be taken to mix adequately the gas and air within the chamber. All gas producing and control equipment shall be maintained in good repair and all indicators, instruments, and measuring devices must be available for inspection by service inspectors during anesthetizing operations and at other times. A suitable exhaust system must be provided to eliminate possible overdosages due to mechanical or other failure of equipment.

Section 313.4 Mechanical: captive bolt

The slaughtering of sheep, swine, goats, calves, cattle, horses, mules, and other equines by using captive bolt stunners and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(A) Application of stunners, required effect; handling.

(1) The captive bolt stunners shall be applied to the livestock in accordance with the section so as to produce immediate unconsciousness in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be stunned in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.

(2) The driving of the animals to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the stunning areas is essential since accurate placement of stunning equipment is difficult on nervous or injured animals. Among other things, this requires that, in driving animals to the stunning area, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) Immediately after the stunning blow is delivered the animal shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.

(B) Facilities and procedures:

(1) General requirements for stunning facilities; operator:

(i) Acceptable captive bolt stunning instruments may be either skull penetrating or nonpenetrating. The latter type is also described as a concussion or mushroom type stunner. Penetrating instruments on detonation deliver bolts of varying diameters and lengths through the skull and into the brain. Unconsciousness is produced immediately by physical brain destruction and a combination of changes in intracranial pressure and acceleration concussion. Nonpenetrating or mushroom stunners on detonation deliver a bolt with a flattened circular head against the external surface of the animals head over the brain. Diameter of the striking surface of the stunner may vary as conditions require. Unconsciousness is produced immediately by a combination of acceleration concussion and changes in intracranial pressures. A combination instrument utilizing both penetrating and nonpenetrating principles is acceptable. Energizing of instruments may be accomplished by detonation of measured charges of gunpowder or accurately controlled compressed air. Captive bolts shall be of such size and design that, when properly positioned and activated, immediate unconsciousness is produced.

(ii) To assure uniform unconsciousness with every blow, compressed air devices must be equipped to deliver the necessary constant air pressure and must have accurate, constantly operating air pressure gauges. Gauges must be easily read and conveniently located for use by the stunning operator and inspector. For purposes of protection, employees, inspectors, and others, it is desirable that any stunning device be equipped with safety features to prevent injuries from accidental discharge. Stunning instruments must be maintained in good repair.

(iii) The stunning area shall be so designed and constructed as to limit the free movements of animals sufficiently to allow the operator to locate the stunning blow with a high degree of accuracy. All chutes, alleys, gates and restraining mechanisms between and including holding pens and stunning areas shall be free from pain-producing features such as exposed bolt ends, loose boards, splintered or broken planking, and protruding sharp metal of any kind. There shall be no unnecessary holes, or other openings where feet or legs of animals may be injured. Overhead drop gates shall be suitably covered on the bottom edge to prevent injury on contact with animals. Roughened or cleated cement shall be used as flooring in chutes leading to stunning areas to reduce falls of animals. Chutes, alleys, and stunning areas shall be so designed that they will comfortably accommodate the kinds of animals to be stunned.

(iv) The stunning operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately place the stunning instrument to produce immediate unconsciousness. He must use the correct detonating charge with regard to kind, breed, size, age, and sex of the animals to produce the desired result.

(2) Special requirements. Choice of instruments and force required to produce immediate unconsciousness varies, depending on kind, breed, size, age, and sex of the animal. Young swine, lambs, and calves usually require less stunning force than mature animals of the same kind. Bulls, rams, and boars usually require skull penetration to produce immediate unconsciousness. Charges suitable for smaller kinds of livestock such as swine or for young animals are not acceptably interchanged for use on larger kinds of older livestock, respectively.

Section 313.5 Mechanical: gunshot

The slaughter of cattle, calves, sheep, swine, goats, horses, mules, and other equines by shooting with firearms and the handling in connection therewith, in compliance with the provisions contained in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(A) Utilization of firearms, required effect; handling:

(1) The firearms shall be employed in the delivery of a bullet or projectile into the animal in accordance with this section so as to produce immediate unconsciousness in the animal by a single shot before it is shackled, hoisted, thrown, cast, or cut. The animals shall be shot in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.

(2) The driving of the animals to the shooting areas shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the shooting area is essential since accurate placement of the bullet is difficult in case of nervous or injured animals. Among other things, this requires that, in driving animals to the shooting areas, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) Immediately after the firearm is discharged and the projectile is delivered, the animal shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking and bleeding.

(B) Facilities and procedures:

(1) General requirements for shooting facilities, operator:

(i) On discharge, acceptable firearms dispatch free projectiles or bullets of varying sizes and diameters through the skull and into the brain. Unconsciousness is produced immediately by a combination of physical brain destruction and changes in intracranial pressure. Caliber of firearms shall be such that when properly aimed and discharged, the projectile produces immediate unconsciousness.

(ii) To assure uniform unconsciousness of the animal with every discharge where small-bore firearms are employed, it is necessary to use one of the following type projectiles: Hollow pointed bullets; frangible iron plastic composition bullets; or powdered iron missiles. When powdered iron missiles are used, the firearms shall be in close proximity with the skull of the animal when fired. Firearms must be maintained in good repair. For purposes of protecting employees, inspectors, and others, it is desirable that all firearms be equipped with safety devices to prevent injuries from accidental discharge. Aiming and discharging of firearms should be directed away from operating areas.

(iii) The provisions contained in section 313.4(B)(1) (iii) with respect to the stunning area also apply to the shooting area.

(iv) The shooting operation is an exacting procedure and requires a well-trained and experienced operator. He must be able to accurately direct the projectile to produce immediate unconsciousness. He must use the correct caliber firearm, powder charge and type of ammunition to produce the desired results.

(2) Special requirements. Choices of firearms and ammunition with respect to caliber and choice of powder charge required to produce immediate unconsciousness of the animal may vary depending on age, and sex of the animal. In the case of bulls, rams, and boars, small bore firearms may be used providing they are able to produce immediate unconsciousness of the animals. Small bore firearms are usually effective for stunning other cattle, sheep, swine, and goats, and calves, horses, and mules.

Section 313.6 Electrical; stunning with electric current

The slaughtering of swine, sheep, calves, cattle, and goats with the use of electric current and the handling in connection therewith, in compliance with the provisions in this section, are hereby designated and approved as humane methods of slaughtering and handling of such animals under the Act.

(A) Administration of electric current, required effect; handling:

(1) The electric current shall be administered so as to produce surgical anesthesia in the animals before they are shackled, hoisted, thrown, cast, or cut. The animals shall be exposed to the electric current in a way that will accomplish the anesthesia quickly and calmly, with a minimum of excitement and discomfort to the animals.

(2) The driving or conveying of the animals to the place of application of electric current shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the place of application is essential to insure rapid and effective insensibility. Among other things, this requires that, in driving animals to the place of application, electrical equipment be used as little as possible and with the lowest effective voltage.

(3) The quality and location of the electrical shock shall be such as to produce immediate insensibility to pain in the exposed animal.

(4) The stunned animal shall remain in a state of surgical anesthesia throughout shackling, sticking and bleeding. However, the animal shall die from loss of blood resulting from the sticking and bleeding, and not from the electrical shock.

(B) Facilities and procedures: operator:

(1) General requirements for operators. It is necessary that the operator of electrical current application equipment be skilled, attentive, and aware of his responsibility. Overdosages and death of animals can be brought about by carelessness of this individual.

(2) Special requirements for electric current application, equipment. The ability of electric current equipment to perform with maximum efficiency is dependent on its proper design and efficient mechanical operation. Pathways, compartments, current applicators, and all other equipment used must be designed to accommodate properly the species of animals being anesthetized. They shall be free from pain-producing restraining devices. Injury of animals must be prevented by the elimination of sharp projections or exposed wheels or gears. There shall be no unnecessary holes, spaces or openings where feet or legs of animals may be injured. Impellers or other devices designed to mechanically move or drive animals or otherwise keep them in motion or compartmentalized shall be constructed of flexible or padded material. Power activated gates designed for constant flow of animals to electrical stunning equipment shall be so fabricated that they will not cause injury. All electrical stunning and auxiliary control and other equipment shall be maintained in good repair and all indicators, instruments, and measuring devices shall be available for inspection by service inspectors during stunning operations and at other times.

(3) Electric current. Each animal shall be given a sufficient application of electric current to insure unconsciousness immediately and throughout the bleeding operation. Suitable timing, voltage and current control devices shall be used to insure that each animal receives the necessary electrical charge to produce immediate unconsciousness. Moreover, the current shall be applied so as to avoid the production of hemorrhages or other tissue changes that would interfere with the inspection procedures of the Meat and Poultry Inspection Service.

Section 313.7 Tagging of equipment, alleyways, pens, or compartments to prevent inhumane slaughter or handling in connection with slaughter

When an inspector observes an incident of inhumane slaughter or handling in connection with slaughter, he/she shall inform the establishment operator of the incident and request that the operator take the necessary steps to prevent a recurrence. If the establishment operator fails to take such action or fails to promptly provide the inspector with satisfactory assurances that such action will be taken, the inspector shall follow the procedures specified in paragraph (A), (B), or (C) of this section, as appropriate.

(A) If the cause of inhumane treatment is the result of facility deficiencies, disrepair, or equipment breakdown, the inspector shall attach a VT. Rejected tag thereto. No equipment, alleyway pen or compartment so tagged shall be used until made acceptable to the inspector. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.

(B) If the cause of inhumane treatment is the result of establishment employee actions in the handling or moving of livestock, the inspector shall attach a VT. Rejected tag to the alleyways leading to the stunning area. After the tagging of the alleyway no more livestock shall be moved to the stunning area until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to the tagging may be dressed, processed or prepared under inspection.

(C) If the cause of inhumane treatment is the result of improper stunning, the inspector shall attach a VT. Rejected tag to the stunning area. Stunning procedures shall not be resumed until the inspector receives satisfactory assurances from the establishment operator that there will not be a recurrence. The tag shall not be removed by anyone other than an inspector. All livestock slaughtered prior to such tagging may be dressed, processed, or prepared under inspection.

Part 314 HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE PRODUCTS AT OFFICIAL ESTABLISHMENTS

Section 314.1 Disposition of condemned products at official establishments having tanking facilities; sealing of tanks

(A) Carcasses, parts of carcasses, and other products condemned at official establishments having facilities for tanking shall, except as provided in paragraph (C) of this section or elsewhere in this PART, be disposed of by tanking as follows:

(1) The lower opening of the tank shall first be sealed securely by a service employee, except when permanently connected with a blow line; than the condemned products shall be placed in the tank in his presence, after which the upper opening shall also be sealed securely by such employee, who shall then see that the contents of the tank are subjected to sufficient heating for sufficient time to effectively destroy the contents for human food purposes.

(2) The use of equipment such as crushers or hashers for pre-tanking preparation of condemned products in the inedible products department has been found to give inedible character and appearance to the material. Accordingly, if condemned products are so crushed or hashed, conveying systems, rendering tanks, and other equipment used in the further handling of crushed or hashed material need not be locked or sealed during the tanking operations. If the rendering tanks or other equipment contain condemned material not so crushed or hashed, the equipment shall be sealed as prescribed in subparagraph (1) of this Paragraph. If the crushed or hashed material is not rendered in the establishment where produced, it shall be denatured as provided for in section 314.3 before leaving such establishment.

(B) The seals of tanks shall be broken only by a service employee and only after the contents of the tanks have been treated as provided in paragraph (A) of this section. The rendered fat derived from condemned material shall be held until a service employee shall have had an opportunity to determine whether it conforms with the requirements of this section. Samples shall be taken by service employees as often as is necessary to determine whether the rendered fat is effectually denatured.

(C) Carcasses of animals condemned under section 309.3 of these regulations may be disposed of as provided in section 314.3, in lieu of tanking, with the approval of the inspector.

Section 314.2 Tanking and other facilities for inedible products to be separate from edible product facilities

All tanks and equipment used for rendering, otherwise preparing, or storing inedible products shall be in rooms or compartments separate from those for preparing or storing edible products. There shall be no connection between rooms or compartments containing inedible products and those containing edible products, except that there may be one connecting doorway between the slaughtering or viscera separating department and the tank charging room of the inedible products rendering department. Pipes and chutes installed in accordance with such arrangements as are permitted by PART 308 of these regulations, or as may be approved by the Head of Service in specific cases, may be used to convey inedible and condemned material from edible product departments to inedible product departments.

Section 314.3 Disposition of condemned products at official establishments having no tanking facilities

(A) Carcasses, parts of carcasses, and other products condemned at an official establishment which has no facilities for tanking shall, except as provided in paragraph (B) of this section or elsewhere in this PART, be destroyed in the presence of an inspector by incineration, or denatured with crude carbolic acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. 3 green coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella or any other proprietary material approved by the Head of Service in specific cases. When such product is to be denatured, it shall be freely slashed before the denaturing agent is applied, except that in the case of dead animals that have not been dressed, the denaturant may be applied by injection. The denaturant must be deposited in all portions of the carcass or product to the extent necessary to preclude its use for food purposes.

(B) All carcasses and parts condemned on account of anthrax, as identified in section 310.9(B) of these regulations, at official establishments which are not equipped with tanking facilities shall be disposed of by (1) complete incineration, or (2) by thorough denaturing with crude carbolic acid, or cresylic disinfectant, and then disposed of in accordance with the requirements of PART 311, particular state or municipal authorities, who shall be notified immediately by the Supervising Veterinarian.

Section 314.4 Suppression of odors in preparing inedible products

Tanks, fertilizer driers, and other equipment used in the preparation of inedible product shall be properly equipped with condensers and other appliances which will acceptably suppress odors incident to such preparation.

Section 314.5 Inedible rendered fats prepared at official establishments

Except as provided in section 325.11(C) of these regulations, rendered animal fat derived from condemned or other inedible materials at official establishments shall be denatured to effectually distinguish it from an edible product, either with low grade offal during the rendering or by adding to, and mixing thoroughly with, such fat, denaturing oil, No. 2 fuel oil, or brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, and may be shipped in commerce in accordance with section 325.11(D) of these regulations.

Section 314.6 Inedible fats from outside official establishments

Except as provided in section 325.11(C) of these regulations, inedible fats from outside the premises of any official establishment shall not be received into an official establishment except into the tank room provided for inedible products, and then only when they have been denatured in accordance with section 314.5 and are marked in accordance with section 316.15 of these regulations, and when their receipt into the tank room produces no insanitary condition on the premises; nor shall such fats be received in such volume as interferes with prompt disposal of condemned or other inedible material produced at the establishment. When received, they shall not enter any room or compartment used for edible products.

Section 314.7 Carcasses of livestock condemned on antemortem inspection not to pass through edible product areas

Carcasses of livestock which have been condemned on ante-mortem inspection shall not be taken through rooms or compartments in which an edible product is prepared, handled or stored.

Section 314.8 Dead animal carcasses

(A) With the exception of dead livestock which have died in route and are received with livestock for slaughter at an official establishment, no dead animal or part of the carcass of any livestock that died otherwise than by slaughter may be brought on the premises of an official establishment unless advance permission therefore is obtained from the Head of Service.

(B) Under no circumstances shall the carcasses of any animal which has died otherwise than by slaughter, or any part thereof, be brought into any room or compartment in which any edible product is prepared, handled or stored.

Section 314.9 Specimens for educational, research, or other nonfood purposes; permits for, required

(A) Specimens of condemned or other inedible materials, including embryos and specimens of animal parasites, may be released for educational, research, or other nonfood purposes under permit issued by the Head of Service: Provided, that the person desiring such specimens makes a written application to the Head of Service for such permit and arranges with and receives permission from the official establishment to obtain the specimens. Permits shall be issued for a period not longer than one year. The permit may be revoked by the Head of Service if the specimens are not used as stated in the application, or if the collection or handling of the specimens interferes with inspection or the maintenance of sanitary conditions in the establishment.

(B) The specimen referred to in paragraph (A) of this section shall be collected and handled only at such time and place and in such manner as not to interfere with inspection or to cause any objectionable condition and shall be identified when they leave the establishment.

Section 314.10

Livers condemned because of parasitic infestation and for other causes: conditions for disposal for purposes other than human food

(A) Livers condemned on account of hydatid cysts shall be disposed of by tanking pursuant to the provisions of section 314.1 of this PART if condemned at official establishments having facilities for tanking; otherwise they shall be destroyed pursuant to the provisions of section 314.3 of this PART.

(B) Livers condemned because of parasites other than hydatid cysts; and livers condemned because of telangiectasis, angioma, "sawdust" condition, cirrhosis, carotenosis, or other non-malignant change, benign abscesses, or contamination, when these conditions are not associated with infectious diseases in the carcasses, may be shipped from an official establishment only for purposes other than human food, and only if all tissue affected with abscesses is removed and destroyed within the establishment, and all livers are processed and denatured, with any agent prescribed in section 325.13(A) (1) or (2) or (5), and in accordance with section 325.13(A) (6) of these regulations. This provision for movement from an official establishment is made solely under the Act and is not intended to relieve or modify any other applicable requirements under any other law regarding the movement of such articles, for purposes other than use as human food.

(C) Livers condemned because of conditions described in paragraph (B) of this section shall be in containers plainly marked INEDIBLE.

Section 314.11 Handling of certain condemned products for purposes other than human food

Condemned carcasses of animals affected with one or more of the following conditions may be shipped from an official establishment only for purposes other than human food and only if permission therefor is obtained from the Head of Service: anasarca, ocular squamous cell carcinoma (after removal of neoplastic tissues), emaciation, eosinophilic myositis, immaturity, nonseptic bruises and injuries, and sarcosporidiosis. This provision also applies to unborn calves and to products such as paunches and udders when they have not been handled as required under this PART for products for human food purposes; provided, such articles have not been condemned for other pathological reasons. Such permission will be granted only if all parts to be so used will be promptly handled, freely slashed and adequately identified as required by section 325.13(A) (2) of these regulations. The slashing, identification and packing of the product shall be accomplished in an inedible product area under the supervision of an inspector. Facilities must be adequate so that the carcasses or parts saved under these provisions are not contaminated with pus, manure, septic, or toxic materials, or similar substances. The operation must not result in insanitary conditions within the establishment.

Part 315 RENDERING OR OTHER DISPOSAL OF CARCASSES AND PARTS PASSED FOR COOKING

Section 315.1 Carcasses and parts passed for cooking; rendering into lard or tallow

Carcasses and parts passed for cooking may be rendered into lard in accordance with section 319.702 of these regulations or rendered into tallow, provided such rendering is done in the following manner:

(A) When closed rendering equipment is used, the lower opening, except when permanently connected with a blowline, shall first be sealed securely by a service employee, then the carcasses or parts shall be placed in such equipment in his presence, after which the upper opening shall be securely sealed by such employee. When the product passed for cooking in the tank does not consist of a carcass or whole primal part, the requirements for sealing shall be at the discretion of the Head of Service. Such carcasses and parts shall be cooked for a time sufficient to render them effectually into lard or tallow, provided all parts of the products are heated to a temperature not lower than 170 degrees F. for a period of not less than 30 minutes.

(B) At establishments not equipped with closed rendering equipment for rendering carcasses and parts passed for cooking into lard and tallow, such carcasses and parts may be rendered in open kettles under the direct supervision of a service employee. Such rendering shall be done during regular hours or work and in compliance with the requirements as to temperature and time specified in paragraph (A) of this section.

Section 315.2 Carcasses and parts passed for cooking; utilization for food purposes after cooking

Carcasses and parts passed for cooking may be used for the preparation of meat food products, provided all such carcasses or parts are heated to a temperature not lower than 170 degrees F. for a period of not less than 30 minutes either before being used in or during the preparation of the finished product.

Section 315.3 Disposal of products passed for cooking if not handled according to this PART

Products passed for cooking if not handled and processed in accordance with the provisions of this PART, shall be disposed of in accordance with section 314.1 or 314.3 of these regulations.

Part 316 MARKING PRODUCTS AND THEIR CONTAINERS

Section 316.1 Authorization required to make devices bearing official marks

No brand manufacturer, printer or other person shall cast, print, lithograph, or otherwise make or cause to be made any device containing any official mark or simulation thereof without prior written authority therefore from the Head of Service as provided for in PART 317 of these regulations.

Section 316.2 Approval required for official marks

No device containing any official mark shall be made or caused to be made for use on any product until it has been approved by the Head of Service as provided for in PART 317 of these regulations.

Section 316.3 Use of official marks prohibited except under supervision of service employee; removal of official marks, when required

(A) No person shall affix or place, or cause to be affixed or placed, the official inspection legend or any other official mark, or any abbreviation or simulation of any official mark, to or on any product, or container thereof, except under the supervision of a service employee, or as authorized by PART 317 of these regulations in connection with the manufacture of containers.

(B) No person shall fill, or cause to be filled, in whole or in part, with any product, any container bearing or intended to bear any official mark, or any abbreviation or simulation or any official mark, except under the supervision of a service employee.

(C) Product bearing any official mark shall not be canned, cooked, cured, smoked, salted, packed, rendered, or otherwise prepared by any person for commercial purposes unless:

(1) Such preparation is performed at an official establishment;

(2) Such preparation is conducted under State or other governmental inspection and the prepared product is marked to show that fact;

(3) The official marks are removed, defaced, or otherwise destroyed before or during such preparation; or

(4) The preparation of the product consists solely of cutting up operations at any establishment exempted from inspection under section 3305(13) of the Act.

Section 316.4 Marking devices; to be furnished by official establishments; control of

(A) The operator of each official establishment shall furnish such ink brands, burning brands, and any other device for marking products with official marks as the Head of Service may determine is necessary for marking products as such establishment. The official inspection legend on such device shall be as prescribed in PART 312 of these regulations. Each such brand or device shall also be required to have a distinct serial number for each establishment.

(B) All official devices for marking products with the official inspection legend, or other official inspection marks, including self-locking seals, shall be used only under supervision of a service employee, and when not in use for marking shall be kept locked in properly equipped lockers or compartments, the keys of which shall not leave the possession of a service employee, or the locker or compartment shall be sealed with an official seal of the Service as prescribed in PART 312 of these regulations.

Section 316.5 Branding ink: to be furnished by official establishments: approval by Service; color

(A) The operator of each official establishment shall furnish all ink for marking products with the official marks at such establishment. Such ink must be made with harmless ingredients that are approved for the purpose by the Head of Service. Samples of inks shall be submitted to the service laboratory from time to time as may be deemed necessary by the Head of Service.

(B) Only ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses of cattle, sheep, swine, or goats and fresh meat cuts derived therefrom. Any ink containing F.D.&C. Violet No. 1 shall not be considered an approved ink within the meaning of this paragraph.

(C) Green ink shall not be used to apply marks to carcasses of cattle, sheep, swine or goats or fresh meat cuts derived thereof.

(D) Except as provided in paragraphs (B) and (C) of this section, branding ink of any color, approved for the purpose by the Head of Service in specific cases, may be used to apply ink brands, bearing official marks, to processed meat cuts derived from cattle, sheep, swine or goats.

(E) Only green ink approved for the purpose shall be used to apply ink brands bearing official marks to carcasses and parts of carcasses and meat cuts derived from horses, mules, and other equines.

(F) Ink used must assure legibility and permanence of markings and the color of ink shall provide acceptable contrast with the color of the product to which it is applied.

Section 316.6 Products not to be removed from official establishments unless marked in accordance with the regulations

No person shall remove or cause to be removed from an official establishment any products which the regulations in this PART required to be marked in any way unless they are clearly and legibly marked in compliance with such regulations.

Section 316.7 Marking devices not to be false or misleading; style and size of lettering; approval required

No brand or other marking device shall be false or misleading. The letters and figures thereon shall be of such style and type as will make a clear and legible impression. All markings to be applied on products, in an official establishment, shall be approved prior to use by the Head of Service as provided for in section 317.3 of these regulations.

Section 316.8 Unmarked inspected products; moved between officialestablishments

(A) Unmarked products which have been inspected and passed but do not bear the official inspection legend may be transported in compliance with PART 325 of these regulations from one official establishment, for further processing, in a railroad car, truck, or other closed container, if the railroad car, truck, or other container is sealed with an official seal of the Service (as prescribed in PART 312 of these regulations) bearing the official inspection legend.

(B) Products which have been inspected and passed but do not bear the official inspection legend may be removed from an official establishment in closed containers bearing the official inspection legend and all other information required by this PART and PART 317 of these regulations: Provided, that upon removal from such closed container the product may not be further transported unless such removal is made under the supervision of a service employee and such product is reinspected by a service employee and packed under his supervision in containers bearing the official inspection legend and all other information required by this PART and PART 317 of these regulations. And provided further, that unmarked product shall not be brought into an official establishment in an open container.

Section 316.9 Products to be marked with official marks

(A) Each carcass which has been inspected and passed in an official establishment shall be marked at the time of inspection with the official inspection legend containing the number of the official establishment.

(B) Except as provided otherwise in section 316.8 each primal part of a carcass and each liver, beef tongue, and beef heart which has been inspected and passed shall be marked with the official inspection legend containing the number of the official establishment before it leaves the establishment in which it is first inspected and passed, and such inspected and passed product shall be marked with the official inspection legend containing the number of the official establishment where it was last prepared Provided, that products need not be so marked if packed properly labeled immediate containers in accordance with the regulations in PART 317 of these regulations. Additional official marks of inspection may be applied to products as desired to meet local conditions. Primal parts are the wholesale cuts of carcasses as customarily distributed to retailers. The round, flank, loin, rib, plate, brisket, chuck, and shank are primal parts of beef carcasses. Veal, mutton and goat primal parts are the leg, flank, loin, rack, breast, and shoulder. The ham, belly, loin, shoulder and jowl are pork primal parts. Equine primal parts are the round, flank, loin, plate, brisket, chuck and shank.

(C) Beef livers shall be marked with the official inspection legend containing the number of the official establishment, at which the cattle involved were slaughtered, on the convex surface of the thickest portion of the organ.

(D) Inspected and passed parts of carcasses which are not marked with the official inspection legend under this section shall not enter any official establishment or be sold, transported, or offered for sale or transportation, in commerce, except as provided in section 316.8 of this PART.

Section 316.10 Marking of meat food products with official inspection legend and ingredient statement

(A) Inspected and passed sausages and other products in casings or in link form, of the ordinary "ring" variety or larger shall be marked with the official inspection legend and list of ingredients in accordance with PART 317 of these regulations. The official marks required by this section shall be branded near the end of each sausage or similar product prepared in casings when the product is of a size larger than that customarily sold at retail intact.

(B) Inspected and passed sausage and other products, in casings or in link form, of the smaller varieties, shall bear one or more official inspection legends and one or more list of ingredients in accordance with PART 317 of these regulations on each kilogram (2,205 lbs.) of product, except where such products leave the official establishment completely enclosed in properly labeled immediate containers having a capacity of 5 kilograms (11.025) of product or less and containing a single kind of product: Provided, that such products in properly labeled closed containers exceeding 5 kilograms (11.025 lbs.) capacity, when shipped to another official establishment for further processing or to a governmental agency, need only have the official inspection legend and list of ingredients shown twice throughout the contents of the container. When such products are shipped to another official establishment for further processing, the inspector in charge at the point of origin shall identify the shipment to the inspector in charge at the destination.

(C) The list of ingredients may be applied by stamping, printing, using paper bands, tags, or tissue strips, or other means approved by the Head of Service in specific cases.

(D) All cured products shall be marked with the list of ingredients in accordance with PART 317 of these regulations.

Section 316.11 Special markings for certain meat food products

(A) Meat food products prepared in casings or link form (whether or not thereafter subdivided), other than sausage, which possess the characteristics of or resemble sausage, shall bear on each link or piece the word "imitation" prominently displayed: Provided, that the following need not be so marked if they bear on each link or piece the name of the product in accordance with section 317.2 of these regulations: Such products as coppa, capocolla, lachschinken, bacon, pork loins, pork shoulder butts, and similar cuts of meat which are prepared without added substances other than curing materials and condiments; meat rolls, bockwurst, and similar products which do not contain cereal or vegetables, head cheese, souse, sulze, scrapple, blood pudding, and liver pudding: and other products such as loaves, chili con carne, and meat cheese products when prepared with sufficient cheese to give definite characteristics to the finished products: and provided further, that imitation sausage packed in properly labeled containers having a capacity of 3 pounds or less of a kind usually sold at retail intact, need not bear the word "imitation" on each link or piece if no other marking or labeling is applied directly to the product.

(B) When cereal, vegetable starch, starch vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, or calcium reduced dried skim milk is added to sausage in casing or in link form within the limits prescribed in PART 319 of these regulations, the products shall be marked with the name of each added ingredient, as for example, "cereal added", "potato flour added", "cereal and potato flour added", "soy flour added", "isolated soy protein added", "nonfat dry milk added", "calcium reduced dried skim milk added", or "cereal and nonfat dry milk added", as the case may be.

(C)

(1) When product is placed in a casing to which artificial coloring is thereafter applied, as prescribed in PART 318 of these regulations, the product shall be legibly and conspicuously marked by stamping or printing on the casing the words "artificially colored".

(2) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, the product from which the casing has been removed shall be marked by stamping directly thereto the words "artificially colored".

(3) The casing containing product need not be marked to show that it is colored if it is colored prior to its use as a covering for the product, and the coloring is of a kind and so applied as not to be transferable to the product and not to be misleading or deceptive in any respect.

(D) When an approved artificial smoke flavoring or an approved smoke flavoring is added to the formula of any meat food product as permitted in PART 318 of these regulations, the product shall be legibly and conspicuously marked with the words "Artificial Smoke Flavoring Added" or "Smoke Flavoring Added", whichever may be applicable.

(E) Subject to the provisions in paragraph (A) of this section, in the case of sausage of the smaller varieties, the markings prescribed in this section may be limited to links bearing the official inspection legend, and such markings shall not be required if the sausages are packed in properly labeled containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact. Further, all markings otherwise required by this section (except those required by paragraph (A) of this section) may be omitted from the casings of sausage and other meat food products when these products are to be processed in sealed metal containers properly labeled in accordance with the requirements in PART 317 of these regulations.

(F) When an approved antioxidant is added to any meat food product as permitted in PARTS 318 and 319 of these regulations, the products shall be legibly and conspicuously marked in an approved manner identifying the specific antioxidant used by its common name or approved abbreviation and the purpose for which it is added, such as, "BHA, BHT, and Propyl-gallate added to help protect flavor".

(G) Sausage of the dry varieties treated with potassium sorbate or propylparaben (p-hydroxybenzoate) as permitted by PART 318 of these regulations shall be marked as prescribed in section 317.8(B) (28) of these regulations.

Section 316.12 Marking of equine carcasses and parts thereof

(A) All inspected and passed equine carcasses and parts thereof prepared at any establishment shall be conspicuously marked at the time of inspection with the official inspection legend as prescribed in section 312.3 of these regulations and with other information prescribed for marking products in this PART.

(B) All equine carcasses and meat and other parts thereof shall be marked to show the kinds of animals from which they were derived, before the products are sold, transported, offered for sale or transportation, or received for transportation in commerce.

Section 316.13 Marking of outside containers

(A) Except as otherwise provided in PART 325 of these regulations, when any inspected and passed product for domestic commerce is moved from an official establishment, the outside container shall bear an official inspection legend as prescribed in PART 312 of these regulations.

(B) When any product is prepared in an official establishment for commerce has been inspected and passed and is enclosed in a cloth or other wrapping, such wrapping shall bear the official inspection legend and official establishment number applied by the approved 2 1/2 inch rubber brand in the form prescribed in PART 312 of these regulations: Provided, that the rubber brand may be omitted if the official inspection legend and official establishment number on the product itself are clearly legible through the wrapping or the wrapping is labeled in accordance with PART 317 of these regulations: Provided further, that plain unprinted wrappings, such as stockinettes, cheesecloth, paper, and crinkled paper bags, for properly marked products, which are used solely to protect the product against soiling or excessive drying during transportation or storage, need not bear the official inspection legend.

(C) Slack barrels used as outside containers of products shall have a cloth or paper top covering bearing the official inspection legend containing the official establishment number. At the time of removal of the covering, the official inspection legend shall be destroyed.

(D) The outside containers of any product which has been inspected and passed for cooking, pork which has been refrigerated as provided in section 318.10(C) of these regulations, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in section 325.7(B) of these regulations.

(E) The outside containers of glands and organs which are not used for human food purposes, such as those described in section 325.19 of these regulations, shall be plainly marked with the phrase "For pharmaceutical purposes", "For organotherapeutic purposes", or "For technical purposes", as appropriate, with no reference to inspection and need not bear other markings otherwise required under these regulations.

(F) Stencils, box dies, labels, and brands may be used on shipping containers, or properly labeled products and on such immediate containers, of properly marked products, as tierces, barrels, drums, boxes, crates, and large-size fiberboard containers, without approval as provided for in section 317.3 of these regulations: Provided, that the stencils, box dies, labels, and brands are not false or misleading and are approved by the inspector in charge. The official inspection legend for use with such markings shall be approved by the Head of Service as provided for in PART 317 of these regulations.

(G) The outside containers of livers prepared as described in section 314.10(B) shall be marked as prescribed in section 314.10(C) of these regulations.

(H) The outside containers of any equine product shall be marked to show the kinds of animals from which derived, when the products are sold, transported, offered for sale or transportation, or received for transportation.

Section 316.14 Marking tank cars and tank trucks used in transportation of edible products

(A) Each tank car and each tank truck carrying inspected and passed product from an official establishment shall bear a label containing the name of the product in accordance with section 317.2 of these regulations, the official inspection legend containing the number of the official establishment and the words "date of loading" followed by a suitable space in which the inspector shall insert the date when the tank car or truck was loaded. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label.

(B) Tank cars and tank trucks carrying inspected and passed product from an official establishment to another official establishment shall be equipped for sealing and securely sealed by a service employee with an official seal of the Service bearing the official inspection legend as prescribed in PART 312 of these regulations.

Section 316.15 Marking outside containers of inedible grease etc

(A) Outside containers of inedible grease, inedible tallow, or other inedible animal fat or mixture of any such articles, resulting from operations at any official establishments shall be marked conspicuously with the word "inedible" prior to removal from the point of filling. Containers, such as tierces, barrels, and half barrels shall have both ends painted white with durable paint, if necessary, to provide a contrasting background, and the word "inedible" shall be marked thereon in letters not less than 2 inches high, while on tank cars and tank trucks the letters shall be not less than 4 inches high.

(B) Inspected animal fat which is intended not to be used for human food may also be marked "inedible" if handled as provided in paragraph (A) of this section and PART 314 of these regulations.

Section 316.16 Custom prepared products to be marked NOT FOR SALE

Carcasses and parts therefrom that are prepared on a custom basis under section 303.1(A) (2) of these regulations shall be marked at the time of preparation with the term NOT FOR SALE in letters at least three-eights inch in height, except that such products need not be so marked if in immediate containers properly labeled in accordance with the regulations in section 317.16 of these regulations. Ink used for marking such products must comply with the requirements of section 316.5.

Part 317 LABELING, MARKING DEVICES, AND CONTAINERS

Section 317.1 Labels required; Supervision by service employees

(A) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in Section 317.2 except that the following do not have to bear such a label.

(1) Wrappings of dressed carcasses and primal parts in an unprocessed state, bearing the official inspection legend, if such wrappings are intended solely to protect the product against soiling or excessive drying during transportation or storage, and the wrappings bear no information except company brand names, trade marks, or code numbers which do not include any information required by Section 317.2;

(2) Uncolored transparent coverings, such as cellophane, which bear no written, printed, or graphic matter and which enclose any unpackaged or packaged product bearing all markings required by PART 316 of these regulations which are clearly legible through such coverings;

(3) Animal and transparent artificial casings bearing only the marking required by PART 316 of these regulations;

(4) Stockinettes used as "operative devices", such as those applied to cured meats in preparation for smoking, whether or not such stockinettes are removed following completion of the operations for which they were applied;

(5) Containers such as boil-in bags, trays of frozen dinners, and pie pans which bear no information except company brand names, trademarks, code numbers, directions for preparation and serving suggestions, and which are enclosed in a consumer size container that bears a label as described in Section 317.2;

(6) Containers of products passed for cooking or refrigeration and moved from an official establishment under Section 311.1 of these regulations.

(B) Folders and similar coverings made of paper or similar material, whether or not they completely enclose the product and which bear any written, printed, or graphic matter, shall bear all features required on a label for an immediate container.

(C) No coverings or other containers which bear or is to bear a label shall be filled, in whole or in part, except with product which has been inspected and passed in compliance with these regulations which is not adulterated and which is strictly in accordance with the statements on the label. No such container shall be filled, in whole or in part, and no label shall be affixed thereto, except under supervision of a service employee.

Section 317.2 Labels; definitions; required features

(A) A label within the meaning of this part shall mean a display of any printing, lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the immediate container (not including package liners) of any product.

(B) Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this PART.

(C) Labels of all products shall show the following information on the principal display panel (except as otherwise permitted in this PART), in accordance with the requirements of this PART or, if applicable, PART 319 of these regulations.

(1) The name of the product, which in the case of a product which purports to be a representation of a product for which a definition and standard of identity or composition is prescribed in PART 319 of these regulations, shall be the name of the food specified in the standard, and in the case of any other product shall be the common or usual name of the food, if there are any, and if there is none, a truthful designation, as prescribed in paragraph (E) of this section;

(2) If the product is fabricated from two or more ingredients the word "ingredients" followed by a list of the ingredients as prescribed in paragraph (F) of this section;

(3) The name and place of business of the manufacturer, packer, distributor for whom the product is prepared, as prescribed in paragraph (G) of this section;

(4) An accurate statement of the net quantity of contents, as prescribed in paragraph (H) of this section;

(5) An official inspection legend and, except as otherwise provided in paragraph (I) of this section, the number of the official establishment, in the form required by PART 312 of these regulations; and

(6) Any other information required by the regulations in this PART or PART 319 of these regulations.

(D) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this PART and PART 319 of these regulations with clarity and conspicuousness and without obscuring of such information by designs or vignettes or crowding. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of jars. The principal display panel shall be:

(1) In the case of a rectangular package, on entire side, the area of which is at least the product of the height times the width of that side.

(2) In the case of a cylindrical or nearly cylindrical container:

(i) An area that is 40 percent of the product of the height of the container times the circumference of the container, or;

(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, that if there is immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in subparagraphs (C) (2), (3), and (5) such panel shall be known as the "20 percent panel" and such information may be shown on that panel in lieu of showing it in the principal display panel.

(3) In the case of a container of any other shape, 40 percent of the total surface of the container.

(E) Any descriptive designation used as a product name for a product which has no common or usual name shall clearly and completely identify the product. Product which has been prepared by salting, smoking, drying, cooking, chopping, or otherwise shall be so described on the label unless the name of the product implies, or the manner of the packaging shows that the product was subjected to such preparation. The unqualified terms "meat", "meat byproduct", "meat food product", and terms common to the industry but not common to consumers such as "picnic", "butt", "cala", "square", "loaf", "spread", "delight", "roll", "plate", "luncheon", and "daisy" shall not be used as names of a product or with a list of ingredients, unless accompanied with terms descriptive of the product, as deemed necessary in any specific case by the Head of Service in order to assure that the label will not be false or misleading.

(F)

(1) The list of ingredients shall show the common or usual names of the ingredients arranged in the descending order or predominance, except as otherwise provided in this paragraph.

(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner:

(a) The term "spice" means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or otherr flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10 and 184.

(b) The term "natural flavor," "natural flavoring," "flavor" or "flavoring" means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product or roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portion of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the substances listed in 21 CFR 172.510. The terms natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powdered onion, powdered garlic, and powdered celery.

(ii) The term "corn syrup" may be used to designate either corn syrup or corn syrup solids.

(iii) The term "animal and vegetable fats" or "vegetable and animal fats" may be used to designate the ingredients of mixtures of such edible fats in product designated "compound" or "shortening". "Animal fats" as used herein means fat derived from inspected and passed cattle, sheep, swine, or goats.

(iv) When a product is coated with pork fat, gelatin, or other approved substance and a specified declaration of such coating appears contiguous to the name of the product, the ingredient statement need not make reference to the ingredients of such coating.

(v) When two meat ingredients comprise at least 70 percent of the meat and meat byproducts ingredients of a formula and when neither of the two meat ingredients is less than 30 percent by weight of the total meat and meat byproducts used, such meat ingredients may be interchanged in the formula without a change being made in the ingredients statement on labeling materials: Provided, that the word "and" in lieu of a coma shall be shown between the declaration of such meat ingredients in the statement of ingredients.

(2) On containers of frozen dinners, entrees, pizzas, and similar consumer packaged products in cartons, the ingredient statement may be placed on the front riser panel: Provided, that the words "see ingredients" followed immediately by an arrow is placed on the principal display panel immediately above the location of such statement without intervening print or designs.

(3) The ingredient statement may be placed on the 20 percent panel adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container.

(G)

(1) The name or trade name of the person that prepared the product may appear as the name of the manufacturer or packer without qualification on the label. Otherwise the name of the distributor of the product shall be shown with a phrase such as "Prepared for * * *." The place of business of the manufacturer, packer, or distributor shall be shown on the label by City, State, and Postal Zip Code when such business is listed in a telephone or city directory, and if not listed in such directory, the place of business shall be shown by street address, City, State, and Postal Zip Code.

(2) The name and place of business of the manufacturer, packer, or distributor may be shown:

(i) On the principal display panel or;

(ii) On the 20 percent panel and adjacent to the principal display panel and reserved for required information, in the case of a cylindrical or nearly cylindrical container, or;

(iii) On the front riser panel of frozen food cartons.

(H)

(1) The statement of net quantity of contents shall appear on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type in distinct contrast to other matter on the package and shall be declared in accordance with the provisions of subparagraphs (2) through (10) of this paragraph.

(2) The statement as it appears on the label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container exclusive of wrappers and packaging substances. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall not be unreasonably large.

(3) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel in lines generally parallel to to the base: Provided, that on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph (H). In any case, the statement may appear in more than one line. The term "net weight" or "net wt." shall be used when stating the net quantity of contents in terms of weight, and the term "net contents" or "content" when stating the net quantity of contents in terms of fluid measure.

(4) The statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semisolid, viscous or a mixture of solid and liquid. For example, a declaration of 3/4 pound avoirdupois weight shall be expressed as "Net Wt. 12 oz." except as provided for in subparagraph (5) of this paragraph for random weight packages; a declaration of 1 1/2-pounds avoirdupois weight shall be expressed as "Net Wt. 24 oz. (1 lb. 8 oz.)", "Net Wt. 24 oz. (1 1/2 lb.)", or "Net Wt. 24 oz. (1.5 lbs.)".

(5) On packages containing 1 pound or 1 pint and less than 4 pounds or 1 gallon, the statement shall be expressed as a dual declaration both in ounces and (immediately thereafter in parentheses) in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fraction of the pint or quart, except that on random weight packages the statement shall be expressed in terms of pounds and decimal fractions of the pound carried out to not more than two decimal places, for packages over 1 pound, and for packages which do not exceed 1 pound the statement may be in a decimal fraction of the pound in lieu of ounces.

(6) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:

(i) Not less than 1/16 inch in height on packages, the principal display panel of which has an area of 5 square inches or less;

(ii) Not less than 1/8 inch in height on packages, the principal display panel of which has an area of more than 5 but not more than 25 square inches;

(iii) Not less than 3/16 inch in height on packages, the principal display panel of which has an area of more than 25 but not more than 100 square inches;

(iv) Not less than 1/4 inch in height on packages, the principal display panel of which has an area of more than 100 but not more than 400 square inches; or

(v) Not less than 1/2 inch in height on packages; the principal display panel of which has an area of more than 400 square inches.

(7) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than three times as high as it is wide). Heights pertain to upper case or capital letters. When upper and lower case letters are used, it is the lower case letter "o" or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards.

(8) The statement shall appear as a distinct item on the principal display panel and shall be separated by a space at least equal to the height of the lettering used in the statement from other printed label information appearing above or below the statement and by a space at least equal to twice the letter "N" of the style of type used in the quantity of contents statement from other printed label information appearing to the left or right of the statement. It shall not include any term qualifying a unit of weight, measure, or count such as "jumbo quart", "full gallon", "giant quart", "when packed", "minimum" or words of similar import.

(9) The following exemptions from the requirements contained in this paragraph (H) are hereby established:

(i) Individually wrapped and labeled packages of less than 1/2 ounce net weight which are in a shipping container, need not bear a statement of net quantity of contents as specified in this paragraph (H) when the statement of net quantity of contents on the shipping container meet the requirements of this paragraph (H);

(ii) Random weight consumer size packages bearing labels declaring net weight, price per pound, and total price, shall be exempt from the type size, dual declaration and placement requirements of this paragraph (H), if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.

(iii) Margarine in 1 pound rectangular packages (except packages containing whipped or soft margarine or packages that contain more than four sticks) is exempt from the requirements of subparagraphs (3) and (5) of this paragraph regarding the placement of the statement of the net quantity of contents with the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds, if the statement appears as "1 pound" or "one pound" in a conspicuous manner on the principal display panel.

(iv) Sliced shingle packed bacon in rectangular packages containing 8 ounces, 1 pound, or 2 pounds are exempt from the requirements of subparagraphs (3) and (5) of this paragraph regarding the placement of the statement of net quantity of contents within the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds if the statement appears as "8 oz.", "1/2 pound", "1 pound", "one pound", "2 pounds" or "two pounds" as the case may be, in a conspicuous manner on the principal display panel.

(10) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of net quantity of each such serving.

(11) As used in this section a "random weight package" is one which is one of a lot, shipment, or delivery of packages of the same product with varying weights and with no fixed weight pattern.

(12) On a multi-unit retail package, a statement of the net quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and, in parentheses, the total net quantity of contents of the multi-unit package in terms of avoirdupois or fluid ounces, except that such declaration of total quantity need not be followed by an additional parenthetical declaration in terms of the largest whole units and subdivisions thereof, as required by subparagraph (5) of this paragraph. For the purpose of this section, "multi-unit retail package" means a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multi-unit retail packages but capable of being individually sold in full compliance with all requirements of the regulations in this PART. Open multi-unit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph if the labeling of each individual unit complies with the requirements of subparagraphs (2), (3), (6), and (8) of this paragraph.

(13) Shingle packed sliced bacon cartons containing product weighing other than 8 ounces, 1 pound, or 2 pounds shall have the statement of the net quantity of contents shown with the same prominence as the most conspicuous feature on the label and printed in a color of ink contrasting sharply with the background and such containers of sliced bacon that are rectangular are exempt from the requirements of subparagraphs (3) and (5) of this paragraph regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds.

(I) The official establishment number of the official establishment in which the product was processed under inspection be placed as follows:

(1) Within the official inspection legend in the form required by PART 312 of these regulations; or

(2) Outside the official inspection legend elsewhere on the exterior of the container or its labeling, e.g., the lid of a can, if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition and accompanied by the prefix "EST"; or

(3) Off the exterior of the container, e.g., on a metal clip used to close casings or bags, or on the back of a paper label or a canned product, or on other packaging or labeling material in the container e.g., on aluminum pans and trays placed within containers, when a statement of its location is printed contiguous to the official inspection legend, such as "EST. No. on metal clip" or "EST. No. on Pan", if shown in a prominent and legible manner in a size sufficient to insure easy visibility and recognition; or

(4) On an insert label placed under a transparent covering if clearly visible and legible and accompanied by the prefix "EST".

(J) Labels of any product within any of the following paragraphs shall show the information required by such paragraph for such product:

(1) A label for a product which is an imitation of another food shall bear the word "imitation" immediately preceding the name of the food imitated and in the same size and style of lettering as in that name and immediately thereafter the word "ingredients", and the names of the ingredients arranged in the order of their predominance.

(2) If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations ( 21 CFR Part 125) established pursuant to section 403 and 701 of the Federal Food, Drug and Cosmetic Act.

(3) When an approved artificial smoke flavoring or an approved smoke flavoring is added as an ingredient in the formula of a meat food product, as prescribed in PART 318 of these regulations, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as "Artificial Smoke Flavoring Added" or "Smoke Flavoring Added", as may be applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring so added as an ingredient in the formula of the meat food product.

(4) When other artificial flavorings is permitted under PART 318 of these regulations to be added to a product, the ingredient statement shall identify it as "Artificial Flavoring".

(5) When artificial coloring is added to edible fats as permitted under PART 318 of these regulations such substance shall be declared on the label in a prominent manner and contiguous to the name of the product by the words "Artificially colored" or "Artificial coloring added" or "With added Artificial coloring". When natural coloring such as annatto is added to edible fats as permitted under PART 318 of these regulations, such substances shall be declared on the label in the same manner by a phrase such as "Colored with annatto".

(6) When product is placed in a casing to which artificial coloring is applied as permitted under PART 318 of these regulations, there shall appear on the label, in a prominent manner and contiguous to the name of the product, the words, "Artificially colored".

(7) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, there shall appear on the label, in a prominent manner and contiguous to the name of the product, the words "Artificially colored".

(8) When a casing is colored prior to its use as a covering for product and the color is not transferred to the product enclosed in the casing, no reference to color need appear on the label but no such casing may be used if it is misleading or deceptive with respect to color, quality, or kind of product, or otherwise.

(9) Product which bears or contains any other artificial coloring as permitted under PART 318 of these regulations, shall bear a label stating that fact on the immediate container or if there is none, on the product.

(10) When an antioxidant is added to product as permitted under PART 318 of these regulations, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement identifying the officially approved specific antioxidant by its common name or abbreviation thereof and the purpose for which it is added, such as, "BHA, BHT, and Propyl-gallate added to help protect flavor".

(11) Containers of meat packed in borax or other preservative for export to a foreign country which permits the use of such preservatives shall, at the time of packing, be marked "for export", followed on the next line by the words "packed in preservatives", or such equivalent statement as may be approved for this purpose by the Head of Service and directly beneath this there shall appear the word "establishment" or abbreviation thereof, followed by the number of the establishment at which the product is packed. The complete statement shall be applied in a conspicuous location and in letters not less than 1 inch in height.

(12) Containers of other product packed in, bearing, or containing any chemical preservative shall bear a label stating that fact.

(13)

(i) On the label of any "Mechanically Separated (Species)" described in Section 319.5(A) of these regulations, the name of such product shall be followed immediately by the phrase "for processing" unless such product has a protein content of not less than 14 percent and a fat content of not more than 30 percent.

(ii) When any "Mechanically Separated (Species)" described in Section 319.5 of these regulations is used as an ingredient in the preparation of a meat food product and such "Mechanically Separated (Species)" contributes 20 mg or more of calcium to a serving of such meat food product, the label of such meat food product shall state the calcium content of such meat food product, determined and expressed as the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a serving in accordance with 21 CFR 101.9(b)(1), (c)(7)(i) and (iv) and (e), as part of any nutrition information included on such label, or if such meat food product does not bear nutrition labeling information, as part of a prominent statement in immediate conjunction with the list of ingredients, as follows: "A ___ serving contains ___% of the U.S. RDA of calcium", with the blanks to be filled in, respectively, with the quantity of such product that constitutes a serving and the amount of calcium provided by such serving: Provided, that calcium content need not be stated where (a) the percent of the U.S. RDA of calcium to be declared would not differ from the percent of the U.S. RDA of calcium that would be declared if the meat food product contained only hand deboned ingredients or (b) the calcium content of a serving of the meat food product would be 20 percent of the U.S. RDA or more if the meat food product contained only hand deboned ingredients.

(K) Packaged products which require special handling to maintain their wholesome condition shall have prominently displayed on the principal display panel of the label the statement: "Keep Refrigerated", "Keep Frozen", "Perishable Keep Under Refrigeration", or such similar statement as the Head of Service may approve in specific cases. Products that are distributed frozen during distribution and thawed prior to or during display for sale at retail shall bear the statement on the shipping container: "Keep Frozen". The consumersize containers for such product shall bear the statement "Previously Handled Frozen for Your Protection, Refreeze or Keep Refrigerated". For all Perishable canned products the statement shall be shown in upper case letters one-fourth inch in height for containers having a net weight of 3 pounds or less, and for containers having a net weight over 3 pounds, the statement shall be in upper case letters at least one-half inch in height.

Section 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited, exception

(A) The Head of Service may approve and authorize the use of abbreviations of marks of inspection under the regulations. Such abbreviations shall have the same force and effect as the respective marks for which they are abbreviations thereof.

(B) Except for the purpose of submitting a sample or samples of the same to the Head of Service for approval, no person shall procure, make, or prepare, or cause to be procured, made or prepared, labels, brands, or other marking devices bearing the inspection legend or any abbreviation thereof, for use on any product without the written authority therefore of the Head of Service. However, when any sample label, brand, or other marking device is approved by the Head of Service, new supplies of such labels and new brands and other marking devices of a character exactly similar to such approved sample may be procured, made or prepared, for use in accordance with these regulations, without further approval by the Head of Service.

Section 317.4 Labels to be approved by the Head of Service

(A) No labeling shall be used on any product until it has been approved in its final form by the Head of Service. For the convenience of the establishment, sketches or proofs of new labeling may be submitted in triplicate to the Head of Service, for approval, and the preparation of final labeling deferred until such approval is obtained. "Sketch" labeling is a printer's proof or other copy which clearly shows all labeling material, size, location, and an indication of final color. All final labeling shall be submitted in triplicate to the Head of Service for approval.

(B) In case of lithographed labels, paper takeoffs in lieu of sections of the metal containers shall be submitted for approval. Such paper takeoffs shall not be in the form of a negative but shall be a complete reproduction of the label as it will appear on the package, including any color scheme involved. In case of fiber containers, printed layers, such as the kraft paper sheet, shall be submitted for approval in lieu of the complete container.

(C) Inserts, tabs, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed within, containers and coverings of product shall be submitted for approval in the same manner as provided for labels in paragraph (A) of this section, except that the inspector in charge may permit use of such devices which contain no reference to the product and bear no misleading feature.

(D) Stencils, labels, box dies, and brands may be used on shipping containers and on such immediate containers as tierces, barrels, drums, boxes, crates, and large-size fiberboard containers provided the markings are applicable to the product, are not false or deceptive, and are used with the approval of the Head of Service. The inspection legend for use in combination with such markings shall be approved by the Head of Service.

(E) Application may be made, consistent with the requirements of this section, for a temporary approval, for the use of a label or other labeling that may otherwise be deemed deficient in some particular aspect. Temporary approvals may be granted by the Head of Service for a period not to exceed 180 calendar days. Such an approval may be granted if:

(1) The proposed labeling would not misrepresent the product;

(2) use of the labeling would not present any potential health safety, or dietary problems to the consumer;

(3) denial of the request would create undue economic hardship; and

(4) an unfair competitive advantage would not result from the granting of the temporary approval.

Temporary approvals may not be extended unless the applicant demonstrates that new circumstances, meeting the above criteria, have developed since the original temporary approval was granted.

Section 317.5 Head of Service may permit modifications of approved labels

The Head of Service may permit modification of approved labels, or markings, under the following circumstances, provided the labeling or marking as modified is so used as not to be false or misleading:

(A) When all features of the label or marking are proportionately enlarged and the color scheme remains the same;

(B) When there is substitution of such abbreviations as "lb." for "pound", or "oz." for "ounce", or the word "pound" or "ounce" is substituted for the abbreviation;

(C) When a master or stock label has been approved from which the name and address of the distributor are omitted and such name and address are applied before being used (in such case, the words "prepared for" or similar statement must be shown together with the blank space reserved for the insertion of the name and address when such labels are offered for approval);

(D) When, during the Christmas and other holiday seasons, wrappers or other covers bearing floral or foliage designs or illustrations of rabbits, chicks, fireworks, or other emblematic holiday designs are used with approved labels or markings. (The use of such designs will not make necessary the application of labeling not otherwise required);

(E) When there is a slight change in arrangement of directions pertaining to the opening of cans or the serving of the product;

(F) When there is a slight change in the quantity of an ingredient shown in the formula without a change in the order of predominance shown on the label: Provided, that the change in quantity of ingredients complies with any minimum or maximum limits for the use of such ingredients prescribed in PARTS 318 and 319 of these regulations.

Section 317.6 Approved labels to be used only on products to which they are applicable

Labels shall be used only on products for which they are approved, and only if they have been approved for such products in accordance with Section 317.3: Provided, that existing stocks of labels approved prior to the effective date of this section and the quantity of which has been identified to the supervising veterinarian as being in storage on said date at the official establishment or other identified warehouse for the account of the operator of the official establishment may be used until such stocks are exhausted, but not later than one year after the effective date of this section unless such labels conform to all requirements of this PART and PART 319 of these regulations. The Head of Service may upon the show of good cause grant individual extension of time as he deems necessary.

Section 317.7 Generically approved labeling

(A) Labeling which is generically approved under paragraph (B) of this section is approved for use without additional authorization, Provided, the labeling shows all mandatory information in a sufficiently prominent manner and is not otherwise false or misleading in any particular. Any determination by the Head of Service that labeling being used in accordance with paragraph (B) of this section is false or misleading or that labeling alleged by an establishment to be approved under paragraph (B) of this section which the Head of Service determines is not so approved, shall preclude the use of the labeling and said determination shall remain in effect unless and until an alternative decision is made by the Head of Service. A copy of any labeling to be used in accordance with paragraph (B) of this section shall be supplied to the Head of Service prior to use.

(B) Labeling which has been previously approved but which contains the following modifications is generically approved and may be used in conformity with the requirements of paragraph (A) of this section:

(1) All features of the labeling are proportionately enlarged or reduced: Provided, that all minimum size requirements specified in applicable regulations are met and the labeling is legible;

(2) There is substitution of such abbreviations as "lb." for "pound", or "oz." for "ounce", or the word "pound" or "ounce" is substituted for the abbreviation;

(3) A master or stock label has been approved from which the name and address of the distributor are omitted and such name and address are applied before being used (in such a case, the words "prepared for" or similar statement must be shown together with the blank space reserved for the insertion of the name and address when such labels are offered for approval);

(4) During holiday seasons, wrappers or other covers bearing floral or foliage designs or illustrations of rabbits, chicks, fireworks, or other emblematic holiday designs are used with approved labeling (the use of such designs will not make necessary the application of labeling not otherwise required.);

(5) There is a change in the language or the arrangement of directions pertaining to the opening of containers or the serving of the product;

(6) The addition, deletion, or amendment of a coupon, a cents-off statement, cooking instruction packer product code information, or UPC product code information;

(7) Any change in the name or address of the packer, manufacturer, or distributor that appears in the signature line;

(8) Any change in the net weight: Provided, that the size of the net weight complies with Section 317.2;

(9) The addition, deletion, or amendment of recipe suggestions for the product;

(10) Any change in punctuation;

(11) Newly assigned or revised establishment numbers for a particular establishment for which use of the labeling has been approved by the Head of Service;

(12) The addition or deletion of open dating information; or

(13) A change in the type of packaging material on which the label is printed.

Section 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers

(A) No product or any of its wrappers, packaging, or other containers shall bear any false or misleading marking, label or other labeling and no statement, word, picture, design, or device which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling. No product shall be wholly or partly enclosed in any wrapper, packaging, or other container that is so made, formed, or filled as to be misleading.

(B) The labels and containers of product shall comply with the following provisions, as applicable:

(1) Terms having geographical significance with reference to a locality other than that in which the product is prepared may appear on the label only when qualified by the word: "style", "type", or "brand", as the case may be, in the same size and style of lettering as in the geographical term, and accompanied with a prominent qualifying statement identifying the Country, State, Territory, or locality in which the product is prepared, using terms, appropriate to effect the qualification. When the word "style" or "type" is used, there must be a recognized style or type of product identified with and peculiar to the area represented by the geographical term and the product must possess the characteristics of such style or type, and the word "brand" shall not be used in such a way as to be false or misleading: Provided, that a geographical term which has come into general usage as a trade name and which has been approved by the Head of Service as being a generic term may be used without the qualifications provided for in this paragraph. The terms "frankfurter", "vienna", "bologna", "lebanon bologna", "holstein", "gotegorg", "milan", "polish", "Italian" and their modifications as applied to sausages, the terms "brunswich", and "irish" as applied to stews and the term "boston" as applied to pork shoulder butts need not be accompanied with the word "style", "type", or "brand" or a statement identifying the locality in which the product is prepared.

(2) Such terms as "farm" or "country" shall not be used on labels in connection with products unless such products are actually prepared on the farm or in the country: Provided, that if the product is prepared in the same manner as on the farm or in the country these terms, if qualified by the word "style in the same size and style of lettering, may be used: Provided, further that the term "farm" may be used as part of a brand designation when qualified by the word "brand" in the same size and style of lettering, and followed with a statement identifying the locality in which the product is prepared: and Provided further, that the provisions of this subparagraph shall not apply to products prepared in accordance with section 319.106 of these regulations. Sausage containing cereal shall not be labeled "farm style" or "country style" and lard not rendered in an open kettle-shall not be designated as "farm style" or "country style".

(3) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not relieve any establishment from the requirement that its label shall not be misleading in any particular.

(4) The term "spring lamb" or "genuine spring lamb" is applicable only to carcasses of new-crop lambs slaughtered during the period beginning in March and terminating not beyond the close of the week containing the first Monday in October.

(5)

(i) Coverings shall not be of such color, design, or kind as to be misleading with respect to color, quality, or kind of product to which they are applied. For example, transparent or semitransparent coverings for such articles as sliced bacon or fresh (uncooked) meat and meat food products shall not bear lines or other designs of red or other color which give a false impression of leanness of the product. Transparent or semitransparent wrappers, casings or coverings for use in packaging cured, cured and smoked, or cured and cooked sausage products, and sliced ready-to-eat meat food products may be colored tinted or bear red designs on 50 percent of such wrappers or coverings: Provided, that the transparent or semitransparent portion of the principal display panel is free of color tinting and red designs: and Provided further, that the principal display panel provides at least 20 percent unobstructed clear space, consolidated in one area so that the true nature and color of the product is visible to the consumer.

(ii) Packages for sliced bacon that have a transparent opening shall be designed to expose, for viewing, the cut surface of a representative slice. Packages for sliced bacon which meet the following specifications will be accepted as meeting the requirements of this subparagraph provided the enclosed bacon is positioned so that the cut surface of the representative slice can be visually examined:

(a) For shingle-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice, and at least 1 1/2 inches wide. The transparent window shall be located not more than five-eights inch from the top or bottom edge of a 1 pound or smaller package and not more than 3/4 inch from either the top of or bottom edge of a package larger than 1 pound.

(b) For stack-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the longest dimension (length) of the representative slice and be at least 1 1/2 inches wide.

(6) The word "fresh" shall not be used on labels to designate product which contains any sodium nitrite, sodium nitrate, potassium nitrate, or potassium nitrite, or which has been salted for preservation.

(7) No ingredient shall be designated on the label as a spice, flavoring, or coloring unless it is a spice, flavoring, or coloring, as the case may be, except that spice may be considered to be a flavoring as provided in section 317.2(F)(1)(i). An ingredient that is both a spice and a coloring, or both a flavoring and a coloring, shall be designated as "spice and coloring" or "flavoring and coloring" as the case may be, unless such ingredient is designated by its specific name.

(8) As used on labels of product, the term "gelatin" shall mean (i) the jelly prepared in official establishments by cooking pork skins, tendons, or connective tissue from inspected and passed product, and (ii) dry commercial gelatin or jelly resulting from its use.

(9) Product (other than canned product) labeled with the term "loaf" as part of its name:

(i) If distributed from the official establishment in consumer size containers may be in any shape;

(ii) If distributed in a container of a size larger than that sold intact at retail the product shall be prepared in rectangular form, or as in subdivision (iii) of this subparagraph;

(iii) If labeled as an "Old Fashioned Loaf" shall be prepared in a traditional form, such as rectangular with rounded top or circular with flat bottom and rounded top.

(10) The term "baked" shall apply only to product which has been cooked by the direct action of dry heat and for a sufficient time to permit the product to assume the characteristics of a baked article, such as the formation of a brown crust on the surface, rendering out the surface fat, and the caramelization of the sugar if applied. Baked loaves shall be heated to a temperature of at least 160 degrees F. and baked pork cuts shall be heated to an internal temperature of at least 170 degrees F.

(11) When products such as loaves are browned by dipping in hot edible oil or by a flame, the label shall state such fact. e.g., by the words "Browned in Hot Cottonseed Oil" or "Browned by a Flame", as the case may be, appearing as part of the product name.

(12) The term "meat" and the names of particular kinds of meat, such as beef, veal, mutton, lamb, and pork shall not be used in such manner as to be false or misleading.

(13) The word "ham" without any prefix indicating the species of animal from which derived, shall be used in labeling only in connection with the hind legs of swine. Ham shanks as such or ham shank meat as such or the trimmings accruing in the trimming and shaping of hams shall not be labeled "ham" or "ham meat" without qualification. When used in connection with a chopped product the term "ham" or "ham meat" shall not include the skin.

(14) The terms "shankless" and "hockless" shall apply only to hams and pork shoulders from which the shank or hock has been completely removed, thus eliminating the entire tibia and fibula, or radius and ulna, respectively, together with the overlying muscle, skin, and other tissue.

(15) Such terms as "meat extract" or "extract of beef" without qualification shall not be used on labels in connection with products prepared from organs or other parts of the carcass, other than fresh meat. Extracts prepared from any parts of the carcass other than fresh meat may be properly labeled as extracts with the true name of the parts from which prepared. In the case of extract fluid form, the word "fluid" shall also appear on the label, as, for example, "fluid extract of beef".

(16)

(i) When cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, or calcium reduced dried skim milk is added to sausage within the limits prescribed in PART 319 of these regulations, there shall appear on the label in a prominent manner, contiguous to the name of the product, the name of each such added ingredient, as, for example: "Cereal Added", "With Cereal", "Potato Flour Added", "Cereal and Potato Flour Added", "Soy Flour Added", "Soy Protein Concentrate Added", "Isolated Soy Protein Added", "Nonfat Dry Milk Added", "Calcium Reduced Dried Skim Milk Added", or "Cereal and Nonfat Dry Milk Added" as the case may be.

(ii) Nonfat Dry Milk when used singly exceeds the limits prescribed in PART 319, there shall appear on the label in a prominent manner the percentage used in addition to the requirements of subparagraph (i). In no case shall the amount of Nonfat Dry Milk exceed 10 percent.

(17) When any product is enclosed in a container along with a packing substance such as brine, vinegar, or agar jelly, a declaration of the packing substance shall be printed prominently on the label as part of the name of the product as for example, "frankfurters packed in brine", "lamb tongue packed in vinegar", or "beef tongue packed in agar jelly", as the case may be. The packing substance shall not be used in such manner as will result in the container being so filled as to be misleading.

(18) "Leaf lard" is lard prepared from fresh leaf fat.

(19) When lard or hardened lard is mixed with rendered pork fat or hardened rendered pork fat, the mixture shall be designated as "rendered pork fat" or "hardened rendered pork fat", as the case may be.

(20) Oil, stearin, or stock obtained from beef or mutton fats rendered at a temperature above 170 degrees F. shall not be designated as "oleo oil", "oleo stearin", or "oleo stock" respectively.

(21) When not more than 20 percent of beef fat, mutton fat, oleo stearin, vegetable stearin, or hardened vegetable fat is mixed with lard or with rendered pork fat, there shall appear on the label, contiguous to and in the same size and style of lettering as the name of the product, the words "beef fat added", "mutton fat added", "oleo stearin added", "vegetable stearin added", or "hardened vegetable fat added", as the case may be. If more than 20 percent is added, the product name shall refer to the particular animal fat or fats used, such as "Lard and Beef Fat". The designation "vegetable fat" is applicable to vegetable oil, vegetable stearin, or a combination of such oil and stearin, whereas the designation "vegetable oil" and "vegetable stearin" shall be applicable only to the oil and the stearin respectively, when used in meat food products.

(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar products shall be labeled to show that the bones remain in the product, if such is the case. The designation "semi-boneless" shall not be used if less than 50 percent of the total weight of bones has been removed.

(23) When monoglycerides, diglycerides, and/or polyglycerol esters of fatty acids are added to render animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and contiguous to the name of the product a statement such as, "With Monoglycerides and Diglycerides Added" or "With Diglycerides and Monoglycerides", or "With Polyglycerol Esters of Fatty Acids" as the case may be.

(24) Colored oleomargarine or colored margarine packed for retail sale shall be in containers not exceeding 1 (one) pound capacity, labeled as follows:

(i) The word "oleomargarine" or "margarine" shall appear on each principal display panel of the container in type of lettering at least as large and in at least the same prominence as any other type of lettering appearing on such container.

(ii) A full and accurate statement of all the ingredients contained in such oleomargarine shall be prominently and informatively displayed contiguous to the word "oleomargarine" or "margarine" wherever such word is featured on the container. The ingredients shall be shown by their common or usual name and be arranged in the order of their predominance. Collective terms such as "animal fat" and "vegetable fat" shall not be used but the specific fat, oil, or stearin shall be shown.

(iii) Each part of the contents of the container shall be enclosed in a wrapper bearing the word "oleomargarine" or "margarine" in type or lettering not smaller than 20-point type.

(iv) Wrapped quarter pound sticks or similar units of such oleomargarine or margarine packed together in a container may constitute units for retail sale and they shall be individually wrapped and labeled in accordance with subdivisions (i), (ii), and (iii) of this subparagraph.

(25) When approved proteolytic enzymes as permitted in PART 318 of these regulations are used on steaks or other raw meat cuts there shall appear on the label in a prominent manner, contiguous to the product name, the statement, "Tenderized with (approved enzyme)", to indicate the use of such enzyme. Any other approved substances which may be used in the solution shall also be included in the statement.

(26) When dimethylpolysiloxane is added as an antifoaming agent to rendered fats, it presence shall be declared on the label contiguous to the name of the product. Such declaration shall read "Dimethylpolysiloxane Added".

(27) When pizzas are formulated with crust containing calcium propionate or sodium propionate, there shall appear on the label contiguous to the name of the product the statement "___ added to retard spoilage of crust" preceded by the name of the preservative.

(28) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxbenzoate) as permitted by PART 318 of these regulations, shall be marked or labeled with a statement disclosing such treatment and the purpose thereof, such as "dipped in a potassium sorbate solution to retard mold growth".

(29) Meat of goats shall be identified as goat meat or chevon.

(30) The term "Chitterlings" shall apply to the large intestines of swine, or young bovine animals when preceded with the word "Calf" or "Veal". Meat food products that contain chitterlings or calf or veal chitterlings, in accordance with section 318.6(B) (8) of these regulations shall be identified with product names that refer to such ingredients, as for example, "Chitterlings Loaf", "Chitterling Pie", or "Calf Chitterlings and Gravy", and shall be packed in containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact and bearing such other information as is required by this PART.

(31) Products that contain blood from livestock as permitted by Part 318 of these regulations shall be labeled with a name that includes the term "blood" and the specific kind of blood shall be declared in the ingredient statement, e.g., "Swine blood", in the manner required by this PART.

(32) A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:

(i) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Head of Service finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading.

(ii) Immediately adjacent to the calendar date shall be a phrase explaining the meaning of such date, in terms of "packing" date, "sell by" date, or "use before" date, with or without a further qualifying phrase, e.g., "For maximum freshness or for best quality", and such phrases shall be approved by the Head of Service as prescribed in section 317.4.

(33) When bread, cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, or isolated soy protein is added in brockwurst as permitted in section 319.281 of these regulations, there shall appear on the label in a prominent manner and contiguous to the product name, the name of such added ingredient, e.g., "Bread Added", "Cereal Added", or "Soy Protein Concentrate Added", as the case may be.

(34) The terms "All", "Pure", "100%", and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient.

(35) When agar-agar is used in canned jellied meat food products as permitted in PART 318 of these regulations, there shall appear on the label in a prominent manner, contiguous to the product name, a statement to indicate the use of agar-agar.

(36) When sodium alginate, calcium carbonate, lactic acid and calcium lactate are used together in a dry binding matrix in restructured, formed meat food products, as permitted in PART 318 of these regulations, there shall appear on the label contiguous to the product name, a statement to indicate the use of sodium alignate, calcium carbonate, lactic acid, and calcium lactate.

(37) When ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and sodium citrate, singly or in combination, are added to fresh pork cuts as permitted under PART 318 of these regulations, there shall appear on the label of that product, in letters of the same style and type and not less than one-fourth the size of letters in the product name, contiguous to the name of the product, a statement identifying the specific approved substance(s) by its common name and the purpose for which it is added, such as, "sprayed with a solution of water, ascorbic acid and citric acid to maintain color".

Section 317.9 Labeling of equine products

The immediate containers of any equine products shall be labeled to show the kinds of animals from which derived, when the products are sold, transported, offered for sale or transported or received for transportation.

Section 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc

(A) No official inspection legend or other official mark which has been previously used shall be used again for the identification of any product, except as provided for in paragraph (B) of this section.

(B) All stencils, marks, labels, or other labeling on previously used containers, whether relating to any product or otherwise shall be removed or obliterated before such containers are used for any product, unless such labeling correctly indicates the product to be packed therein and such containers are refilled under the supervision of a service employee.

Section 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations

(A) No person shall in any official establishment apply or affix or cause to be applied or affixed, any label to any product prepared or received in such establishment, or to any container thereof, or fill any container at such an establishment, except in compliance with these regulations.

(B) No covering or other container shall be filled, in whole or in part, at any official establishment with any product unless it has been inspected and passed in compliance with these regulations, is not adulterated, and is strictly in accordance with the statements on the label, and such filling is done under the supervision of a service employee.

(C) No person shall remove, or cause to be removed from an official establishment any product bearing a label unless such label is in compliance with these regulations, or any product not bearing a label required by such regulations.

Section 317.12 Relabeling product; requirements

When it is claimed by an official establishment that any of its products which bore labels bearing official marks has been transported to a location other than an official establishment, and it is desired to relabel the product because the labels have become mutilated or otherwise damaged, a request for relabeling the product shall be sent to the Head of Service, accompanied with a statement of the reasons thereof. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Head of Service. The relabeling of inspected and passed product with labels bearing any official marks shall be done under the supervision of a service inspector. The official establishment shall reimburse the Service in accordance with the regulations of the Department, for any cost involved in supervising the relabeling of such product.

Section 317.13 Storage and distribution of labels and containers bearing official marks

Labels, wrappers, and containers bearing any official marks, with or without the establishment number, may be transported from one official establishment to another official establishment provided such shipments are made with the prior authorization of the inspector at point of origin, who will notify the inspector at destination concerning the date of shipment, quantity, and type of labeling material involved. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of these regulations.

Section 317.14 Reporting of obsolete labels

Once a year, or more often if necessary, the operator of each official establishment shall submit to the Head of Service in quadruplicate, a list of approved labels no longer used or a list of the document issued by the Head of Service approving the labels involved. The approved labels shall be identified by the approval number, the date of approval, and the name of the product, or other designation showing the class of labeling material.

Section 317.15 Reserved

Section 317.16 Labeling and containers of custom prepared products

Products that are custom prepared under section 302.1(A) (2) of these regulations must be packaged after preparation and labeled (in lieu) of information otherwise required by this PART 317 with the following information in accordance with section 317.2 conspicuously displayed on the principal display panel:

(1) The words "NOT FOR SALE" in lettering not less than three-eights inch in height;

(2) the name of the product;

(3) the word "ingredients" followed by a list of ingredients, if the product is made from two or more ingredients;

(4) the name and place of business of the custom operator who prepared the product;

(5) an accurate statement of the quantity of contents;

(6) handling instructions, if necessary, to insure that the public will be informed of the manner of handling required to maintain the product in a wholesome condition; and

(7) any other information required to appear on the label except the official inspection legend. Such exempted custom prepared products shall not have false or misleading labeling or containers or be otherwise misbranded.

Section 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite

(A) With respect to section 3201 of the Act and section 317.2, any substance mixed with another substance to cure a product must be identified in the ingredients statement on the label of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any product must be identified on the label of the product by listing each such ingredient in accordance with the provisions of section 317.2.

(B) Any product, such as bacon or pepperoni, which is required to be labeled by a common or usual name or descriptive name in accordance with section 317.2(C) (1) of this PART and to which nitrite or nitrate is permitted or required to be added may be prepared without nitrate or nitrite and labeled with such common or usual name or descriptive name when immediately preceded with the term "Uncured" as part of the product name in the same size and style of lettering as the product name, Provided, that the product is found by the Head of Service to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate or nitrite, or both.

(C)

(1) Products described in paragraph (B) of this section or section 319.2 of these regulations, which contain no nitrate or nitrite shall bear the statement "No Nitrite or No Nitrate Added". This statement shall be adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name.

(2) Products described in paragraph (B) of this section and section 319.2 of these regulations shall bear, adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name, the statement "Not Preserved-Keep Refrigerated Below 40 Degrees F. at All Times" unless they have been thermally processed to Fo3 or more; they have been fermented or pickled to PH of 4.6 or less; or they have been dried to a water activity of o.92 or less.

(3) Products described in paragraph (B) of this section and section 319.2 of these regulations shall not be subject to the labeling requirements of paragraph (B) and (C) of this section if they contain an amount of salt sufficient to achieve a brine concentration of 10 percent or more.

Section 317.18 Reserved

Section 317.19 Jar closures requirements

Vacuum packed containers sealed with quick-twist, screw-on, or snap-on lids (or closures) shall not have an annular space between the inner edge of the lid's rim (lip or skirt) and the container itself or shall have such space sealed in a manner that will make it inaccessible to filth and insects.

Section 317.20 Packaging materials

(A) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substance which may render the contents adulterated or injurious to health. All packaging materials must be safe for their intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).

(B) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the materials intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties ( 21 CFR 7.12 and 7.13 ) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to service inspectors or other department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.

(C) The guaranty by the packaging supplier will be accepted by service inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.

(D) The Service will monitor the use of packaging material in official establishments to assure that the requirements of paragraph (A) of this section are met, and may question the basis for any guaranty described under paragraph (B) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information to designated service officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition and use. Selection of a material for review does not in itself affect a materials acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request -- a minimum of 30 days -- any applicable guaranty shall cease to be effective, and approval to continue using the specified packaging material in official establishments may be denied. The Head of Service may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.

(E) The Head of Service may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Head of Service, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Head of Service. If the official establishment and the supplier do not accept the Head of Service's determination, a hearing in accordance with applicable rules of practice will be held to resolve the dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Head of Service determines that such use may present an imminent hazard to public health.

(F) Periodically, the Head of Service will issue to inspectors a listing by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (A) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (A), the material will be deleted from the listing.

(G) Nothing in this section shall affect the authority of service inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health.

Part 318 ENTRY INTO OFFICIAL ESTABLISHMENTS: REINSPECTION AND PREPARATION OF PRODUCTS

Section 318.1 Products and other articles entering official establishments

(A) Except as otherwise provided in paragraph (G) and (H) of this section or Section 318.12, no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a service employee, and is identified by an official inspection legend as so inspected and passed. Notwithstanding the foregoing provisions of this paragraph, products imported and not prepared in the United States outside an official establishment may enter any official establishment subject in other respects to the same restrictions as apply to domestic product. Products received in an official establishment during the service employees absence shall be identified and maintained in a manner acceptable to such employee. Product entering any official establishment shall not be used or prepared thereat until it has been reinspected in accordance with Section 318.2. Any product originally prepared at any official establishment may not be returned into any part of such establishment, except the receiving area approved under 318.3, until it has been reinspected by the inspector.

(B) No slaughtered poultry or poultry product shall be brought into an official establishment unless it has been:

(1) previously inspected and passed and is identified as such and has not been prepared other than in an establishment under inspection; or

(2) has been inspected and passed and is identified as such in accordance with the requirements of a State law.

(C) Every article for use as an ingredient in the preparation of meat food products, when entering any official establishment and at all times while it is in such establishment, shall bear a label showing the name of the article, the amount or percentage therein of any substances restricted by this PART or PART 317 of these regulations, and a list of ingredients in the article if composed of two or more ingredients: Provided, that in the case of articles received in tank car lots, only one such label shall be used to identify each lot. In addition, the label must show the name and address of the shipper.

(D) Containers of preparations which enter any official establishment for use in cooling or retort water, in hog scalding water or in denuding a tripe shall bear labels showing the chemical names of such preparation. In the case of preparations containing any chemicals which are specifically limited by Section 318.7(C)(4), as to amount permitted to be used, the container labels shall also show the percentage of such chemical in the preparation and shall provide dilution directions which prescribe the maximum allowable use concentration of the preparation.

(E) Dyes, chemicals, or other substances the use of which is restricted to certain products may be brought into or kept in an official establishment only if such products are prepared thereat. No prohibited dye, chemical, preservative, or other substance shall be brought into or kept in an official establishment.

(F) All isolated soy protein, when entering and while in any official establishment, must be labeled in accordance with, and otherwise meet the requirements of Section 318.6(B) (11).

(G) Glands and organs, such as cotyledons, ovaries, prostate glands, tonsils, spinal cords, and detached lymphatic, pineal, pituitary, parathyroid, suprarenal, pancreatic, and thyroid glands, used in preparing pharmaceutical, organotherapeutic, or technical products and which are not used as human food (whether or not prepared at official establishments) may be brought into and stored in edible product departments of inspected establishments if packed in suitable containers so that the presence of such glands and organs will in no way interfere with maintenance of sanitary conditions or constitute an interference with inspection. Glands or organs which are regarded as human food products, such as livers, testicles, and thymus glands, may be brought into official establishments for pharmaceutical, organotherapeutic, or technical purposes, only if VT. Inspected and Passed and so identified. Lungs and lung lobes derived from livestock slaughtered in any establishment may not be brought into any official establishment except as provided in Section 318.12(A).

(H) Carcasses of game animals, and carcasses derived from the slaughter by any person of livestock of his own raising in accordance with the exemption provisions of the Act, and parts of such carcasses, may be brought into an official establishment for preparation, packaging, and storing in accordance with the provisions of Section 303.1(A) (2) of these regulations.

(I) The operator of an official establishment shall furnish such information as is necessary to determine the origin of any product or other article entering the official establishment. Such information shall include, but is not limited to, the name and address of the seller or supplier, transportation company, agent, or broker involved in the sale or delivery of the product or article in question.

(J) Any product or any poultry or poultry product or other article that is brought into an official establishment contrary to any provision of this section may be required by the Head of Service to be removed immediately from such establishment by the operator thereof, and failure to comply with such requirement shall be deemed a violation of these regulations. If any slaughtered poultry or poultry products or other articles are received at an official establishment and are suspected of being adulterated or misbranded under the Poultry Products Inspection Act or the Federal Food, Drug, and Cosmetic Act, or applicable State laws, the appropriate governmental authorities will be notified.

Section 318.2 Reinspection, retention, and disposal of meat and poultry products at official establishments

(A) All products and all slaughtered poultry and poultry products brought into any official establishment shall be identified by the operator of the official establishment at the time of receipt at the official establishment and shall be subject to reinspection by a service employee at the official establishment in such manner and at such times as may be deemed necessary to assure compliance with the regulations.

(B) All products, whether fresh, cured, or otherwise prepared, even though previously inspected and passed, shall be reinspected by service employees as often as they may deem necessary in order to ascertain that they are not adulterated or misbranded at the time they enter or leave official establishments and that the requirements of these regulations are complied with.

(C) Reinspection may be accomplished through use of statistically sound sampling plans that assure a high level of confidence. The Head of Service shall determine the type of plan and the service employee shall select the specific plant to be used in accordance with instructions issued by the Head of Service.

(D) A VT. Retained tag shall be placed by a service employee at the time of reinspection at any official establishment (or at any establishment exempted under PART 303 of these regulations) on all products which are suspected on such reinspection of being adulterated or misbranded, and such products shall be held for further inspection. Such tags shall be removed only by authorized service employees. When further inspection is made, if the product is found to be adulterated, all official inspection legends or other official marks for which the product is found to be ineligible under these regulations, shall be removed or defaced and the product will be subject to condemnation and disposal in accordance with PART 314 of this subchapter, except that a determination regarding adulteration may be deferred if a product has become soiled or unclean by falling on the floor or in any other accidental way or if the product is affected with any other condition which the inspector deems capable of correction, in which case the product shall cleaned (including trimming if necessary) or otherwise handled in a manner approved by the inspector to assure that it will not be adulterated or misbranded and shall then be presented for reinspection and disposal in accordance with this section. If upon final inspection, the product is found to be neither adulterated nor misbranded, the inspector shall remove the VT. Retained tag. If a product is found upon reinspection to be misbranded, it shall be held under a VT. Retained tag or a VT. Detention tag as provided in PART 329 of these regulations, pending correction of the misbranding or withhold from use the labeling or container of the product, or other appropriate action. The inspector shall make a complete record of each transaction under this paragraph and shall report his action to the Head of Service.

Section 318.3 Designation of places of receipt of products and other articles for reinspection

Every official establishment shall designate, with the approval of the Head of Service, a dock or place at which products and other articles subject to reinspection under Section 318.2 shall be received, and such products and articles shall be received only at such dock or place.

Section 318.4 Preparation of products to be officially supervised; responsibilities of official establishments; plant operated quality control

(A) All processes used in curing, pickling, rendering, canning, or otherwise preparing any product in official establishments shall be supervised by service employees unless such preparation is conducted as a custom operation exempted from inspection under 303.1 (A) (2) of these regulations in any official establishment or consist of operations that are exempted from inspection under Section 303.1(D) of these regulations and are conducted in a retail store. No fixtures or appliances, such as tables, trucks, trays, tanks, vats, machines, implements, cans, or containers of any kind, shall be used unless they are of such materials and construction as will not contaminate or otherwise adulterate the product and are clean and sanitary. All steps in the preparation of edible products shall be conducted carefully and with strict cleanliness in rooms or compartments separate from those used for inedible products.

(B) It shall be the responsibility of the operator of every official establishment to comply with the Act and these regulations. In order to carry out this responsibility effectively, the operator of the establishment shall institute appropriate measures to ensure the maintenance of the establishment and the preparation, marking, labeling, packaging and other handling of its products strictly in accordance with the sanitary and other requirements of these regulations. The effectiveness of such measures will be subject to review by a service employee.

(C) Applying for Total Plant Quality Control. Any owner or operator of an official establishment preparing meat food product who has a total plant quality control system or plan for controlling such product, after ante-mortem and post-mortem inspection, through all stages of preparation, may request the Head of Service to evaluate it to determine whether or not that system is adequate to result in product being in compliance with the requirements of the Act and therefore qualify as a VT. Department of Agriculture (VTDA) Total Plant Quality Control Establishment. Such a request shall, as a minimum, include:

(1) A letter to the Head of Service from the establishment owner or operator stating the company's basis and purpose for seeking an approved quality control system and willingness to adhere to the requirements of the system as approved by the Department; that all the establishment's data, analysis, and information generated by its quality control system will be maintained to enable the Department to monitor compliance and available to Department personnel; that plant quality control personnel will have authority to halt production or shipping of product in cases where the submitted quality control systems require it; and that the owner or operator (or his/her designee) will be available for consultation at any time Department personnel consider it necessary.

(2) In the case of an establishment having one or more full-time persons whose primary duties are related to the quality control system, an organizational chart showing that such people ultimately report to an establishment official whose quality control responsibilities are independent of or not predominantly production responsibilities. In the case of an establishment which does not have full-time quality control personnel, information indicating the nature of the duties and responsibilities of the person who will be responsible for the quality control system.

(3) A list identifying those PARTS and Sections of the meat inspection regulations which are applicable to the operations of the establishment applying for approval of a quality control system. The list shall also identify which part of the quality control system will serve to maintain compliance with the applicable regulations.

(4) Detailed information concerning the manner in which the system will function. Such information should include, but not necessarily be limited to, questions of raw material control, the critical check or control points, the nature and frequency of tests to be made, the nature of charts and other records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the nature of deficiencies the quality control system is designed to identify and control, the parameters or limits which will be used, and the points at which corrective action -- ranging from the least to the most severe: Provided, that subsequent to approval of the total quality control system by the Head of Service, the official establishment may produce a new product for test marketing provided labeling for the product has been approved by the Head of Service, the inspector has determined that the procedures for preparing the product will assure that all requirements are met, and the production for test marketing does not exceed 6 months. Such new product shall not be produced at that establishment after the 6 month period unless approval of the quality control system for that product has been received from the Head of Service.

(D) Applying for Partial Quality Control. Any owner or operator of an official establishment preparing meat food products who has a quality control program for a product, operation, or a part of an operation, may submit it to the Head of Service and request a determination as to whether or not that program is adequate to result in product being in compliance with the requirements of the Act. Such a request shall, as a minimum, include:

(1) A letter from the establishment official responsible for quality control stating the objective of the program, and that all data and information generated by the program will be maintained to enable the Department to monitor compliance and made available to Department personnel.

(2) Detailed information concerning raw material control, the critical check or control points, the nature and frequency of tests to be made, the charts and records that will be used, the length of time such charts and records will be maintained in the custody of the official establishment, the limits which will be used and the points at which corrective action will occur, and the nature of the corrective action -- ranging from the least to the most severe.

(E) Evaluation and Approval of Total Plant Quality Control or Partial Quality Control.

(1) The Head of Service shall evaluate the material presented in accordance with the provisions of paragraph (C) or (D) of this section. If it is determined by the Head of Service on the basis of the evaluation, that the total quality control system or partial quality control program will result in finished products controlled in this manner being in full compliance with the requirements of the Act and regulations thereunder, the total quality control system or partial quality control program will be approved and plans will be made for implementation under departmental supervision.

(2) In any situation where the system or program is found by the Head of Service to be unacceptable, formal notification shall be given to the applicant of the basis for the denial. The applicant will be afforded an opportunity to modify the system or program in accordance with the notification. The applicant shall also be afforded an opportunity to submit a written statement in response to this notification of denial and a right to request a hearing with respect to the merits or validity of the denial. If the applicant requests a hearing and the Head of Service, after review of the answer, determines the initial determination to be correct, he shall file with the Hearing Clerk of the Department the notification, answer and the request for hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with Rules of Practice which shall be adopted for this proceeding.

(3) The establishment owner or operator shall be responsible for the effective operation of the approved total plant quality control or partial quality control program to assure compliance with the requirements of the Act and regulations thereunder. The Commissioner shall continue to provide the inspection necessary to carry out his responsibilities of the Act.

(F) Labeling Logo. Owners and operators of official establishments having a total plant quality control system approved under the provisions of paragraph (C) of this section, may only use, as a part of any labeling, the following logo. Any labeling bearing the logo and any wording of explanation with respect to this logo shall be approved as required by PARTS 316 and 317 of these regulations.

(G) Termination of Total Plant Quality Control or Partial Quality Control.

(1) The approval of a total plant quality control system or a partial quality control program may be terminated at any time by the owner or operator of the official establishment upon written notice to the Head of Service.

(2) The approval of a total plant quality control system or a partial quality control program may be terminated upon the establishment's receipt of a written notice from the Head of Service under the following conditions:

(i) If adulterated or misbranded meat food product is found by the Head of Service to have been prepared for or distributed in commerce by the subject establishment. In such case, opportunity will be provided to the establishment owner or operator to present views to the Head of Service within 30 days of the date of termination of approval. In those instances where there is a conflict of facts, a hearing, will be provided to the establishment owner or operator to resolve the conflict. The Head of Service's termination of approval shall remain in effect pending the final determination of the proceeding.

(ii) If the establishment fails to comply with the quality control system or program to which it has agreed after being notified by letter from the Head of Service or his designee. Prior to such termination, opportunity will be provided to the establishment owner or operator to present views to the Head of Service within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing will be provided to the establishment owner or operator to resolve the conflict. The Head of Service's termination of quality control approval shall remain in effect pending the final determination of the proceeding.

(3) If approval of the total plant quality control system or partial quality control program has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total plant quality control system will not be evaluated by the Head of Service for at least 6 months from the termination date in the case of a partial quality control program.

Section 318.5 Requirements concerning procedures

(A)

(1) Care shall be taken to assure that product is not adulterated when placed in freezers. If there is doubt as to the soundness of any frozen product, the inspector will require the defrosting and reinspection of a sufficient quantity thereof to determine its actual condition.

(2) Frozen product may be defrosted in water or pickle in a manner and with the use of facilities which are acceptable to the inspector. Before such product is defrosted, a careful examination shall be made to determine its condition. If necessary, this examination shall include defrosting of representative samples by means other than in water or pickle.

(B) Product, such as pork tenderloins, brains, sweetbreads, stew, or chop suey, shall not be packed in hermetically sealed metal or glass containers, unless subsequently heat processed or otherwise treated to preserve the product in a manner approved by the Head of Service in specific cases.

(C) Care shall be taken to remove bones and parts of bones from product which is intended for chopping.

(D) Heads for use in the preparation of meat food products shall be split and the bodies of the teeth, the turbinated and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.

(E) Kidneys for use in the preparation of meat food products shall first be freshly sectioned and then thoroughly soaked and washed. All detached kidneys, including beef kidneys with detached kidney fat, shall be inspected before being used in or shipped from the official establishment.

(F) Cattle paunches and hog stomachs for use in the preparation of meat food products shall be thoroughly cleaned on all surfaces and parts immediately after being emptied of their contents, which shall follow promptly their removal from their carcasses.

(G) Clotted blood shall be removed from hog hearts before they are shipped from the official establishment or used in the preparation of meat food products.

(H) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog bungs, hog middles, and hog stomachs which are to be used as containers of any meat food product shall be presented for inspection, turned with the fat surface exposed.

(I) Portions of casings which show infection with Oesophagostomum or other nodule-producing parasite, and weasands infected with the larvae of Hypoderma lineatum, shall be rejected, except that when the infestation is slight and the nodules and larvae are removed, the casing or weasand may be passed.

Section 318.6 Requirements concerning ingredients and other articles used in preparation of products

(A) All ingredients and other articles used in the preparation of any product shall be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated. Official establishments shall furnish inspectors accurate information on all procedures involved in product preparation including product composition and any changes in such procedures essential for inspectional control of the product.

(B)

(1) The only animal casings that may be used in containers of product are those from cattle, sheep, swine, or goats.

(2) Casings for products shall be carefully inspected by service employees. Only those casings which have been carefully washed and thoroughly flushed with clean water immediately before stuffing and are suitable for containers, are clean, and are passed on such inspection shall be used, except that preflushed animal casings packed in-salt or salt and glycerine solution or other approved medium may be used without additional flushing provided they are found to be clean and otherwise acceptable and are thoroughly rinsed before use.

(3) Hog and sheep casings intended for use as containers of product may be treated by soaking in or applying thereto sound, fresh pineapple juice or papain or bromelin or pancreatic extract to permit the enzymes contained in these substances to act upon the casings to make them less resistant. The casings shall be handled in a clean and sanitary manner throughout and the treatment shall be followed by washing and flushing the casings with water sufficiently to effectively remove the substance used and terminate the enzymatic action.

(4) On account of the invariable presence of bone splinters, detached spinal cords shall not be used in the preparation of edible product other than for rendering where they constitute a suitable raw material.

(5) Testicles, if handled as an edible product, may be shipped from the official establishment as such, but they shall not be used as an ingredient of a meat food product.

(6) Tonsils shall be removed and shall not be used as ingredients of meat food products.

(7) Blood from livestock prepared in accordance with Section 310.20 of these regulations may be used as an ingredient of a meat food product for which a standard is prescribed in PART 319 of these regulations, if permitted by such standard, and may be used in any meat food product for which no such standard is prescribed in PART 319 of these regulations if it is a common and usual ingredient of such product.

(8) Intestines shall not be used as ingredients in any meat food product for which a standard is prescribed in PART 319 of these regulations and shall not be used in other products unless the products are labeled in accordance with Section 317.8(B) (30) of these regulations.

(9) Poultry products and egg products (other than shell eggs) which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when identified as having been inspected and passed for wholesomeness and when found to be sound and otherwise acceptable when presented for use. Poultry products and egg products (other than shell eggs) which have not been so inspected and passed for wholesomeness shall not be used in the preparation of such meat food products.

(10) Dry milk products which are intended for use as ingredients of meat food products shall be considered acceptable for such use only when produced in a plant approved by the Department and when found to be sound and otherwise acceptable when presented for use. Dry milk products prepared in a plant not so approved shall not be used in the preparation of such meat food products.

(11) Ingredients for use in any product may not bear or contain any pesticide chemical or other residues in excess of levels permitted in section 318.16.

Section 318.7 Approval of substances for use in the preparation of products

(A)

(1) No chemical substances may be used in the preparation of any product unless it is approved in this PART or PART 319 of these regulations or by the Head of Service in specific cases.

(2) Approval of new substances or new uses or new levels of use of approved substances may be granted by the Head of Service if:

(i) The substance has been previously approved by the Food and Drug Administration (FDA) for use in meat or meat food products as a food additive, color additive, or as a substance generally recognized as safe and is listed in Title 21 of the Code of Federal Regulations, Parts 73, 74, 81, 172, 173, 179, 182 and 184.

(ii) Its use is in compliance with applicable FDA requirements; and

(iii) The Head of Service has determined that:

(a) The use of the substance will not render the product in which it is used adulterated or misbranded or otherwise not in compliance with the requirements of the Act; and

(b) Its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the stated technical effect as determined in specific cases.

(3) Whenever the Head of Service determines that approval of a new substance or new use or new level of use of an approved substance should be granted in accordance with paragraph (A) (2) of this section, the Head of Service shall issue a final rule amending the chart of substances in paragraph (C) (4) of this section to include the additional substance or new use of the substance, and any technical effect or change in level or use of the substance.

(4) No product shall bear or contain any substance which would render it adulterated or misbranded which is not approved in PART 318 or PART 319 of these regulations or by the Head of Service in specific cases.

(B) Requirements for the use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon.

Nitrates shall not be used in curing bacon.

(1) Pumped bacon: With respect to bacon injected with curing ingredients and massaged bacon: Sodium nitrite shall be used at 120 parts per million (ppm) ingoing or an equivalent amount of potassium nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 ppm of sodium ascorbate or sodium erythorbate.

(2) The Department shall collect samples of pumped from producing plants and analyze them for the level of nitrosamines by the thermal energy analyzer (TEA). In the event that a TEA analysis indicates that a confirmable level of nitrosamines might be present, additional samples shall be collected and analyzed by gas chromotography. Presumptive positive results must be confirmed by mass spectrometry before being considered positive. If, during the interval required for the Department to analyze the confirmatory samples by gas chromotography and mass spectrometry, changes are made in processing procedures which are expected to result in no confirmable levels of nitrosamines in pumped bacon produced by these new procedures, an establishment may submit samples to USDA for analysis upon prior notification and arrangements with USDA. If, however, an establishment furnishes USDA with laboratory results from testing five consecutive lots of pumped bacon produced under the new procedures and the testing is performed by the USDA methodology and procedures, those results will be utilized in making the determination concerning the product produced under the new procedures. Should the results of these tests reveal that confirmable levels of nitrosamines are not indicated in any of the five consecutive lots, the confirmation analysis by USDA shall be terminated and the establishment shall revert to normal monitoring status. In the event the test results continue to indicate nitrosamines, however, USDA shall proceed in its confirmation analysis on the original samples taken for confirmation. If any one of the original samples collected by USDA for confirmation is found to contain confirmable levels of nitrosamines, all pumped bacon in the producing establishment and all future production will be retained. The Department shall sample and analyze such retained pumped bacon for nitrosamines on a lot by lot basis. A production lot shall be that pumped bacon produced by the establishment in any single shift. Samples from any lot of pumped bacon under retention found to contain nitrosamines at a confirmable level shall cause the lot of pumped bacon to be disposed of in a manner to assure it will not form nitrosamines when cooked. Such disposal may include incorporation of the uncooked pumped bacon as an ingredient of another meat food product provided it is processed for eating without further preparation in a manner to preclude the formation of nitrosamines. Pumped bacon subsequently produced shall not be retained because of nitrosamines if the operator of the establishment makes adjustments in the processing of the product and laboratory results obtained by TEA analysis of samples from five consecutive normal sized lots of pumped bacon indicates that the product being produced contains no confirmable levels of nitrosamines. These tests from five consecutive normal sized lots of pumped bacon shall be conducted by the Department: Provided, however, that if the establishment furnishes the Department with the results of tests conducted under the methodology and procedures used by the Department, such test results will be utilized in making the determination concerning the nitrosamine content of the product. All tests of pumped bacon for nitrosamines under this subparagraph shall be made on pumped bacon cooked at 340 degrees F. for 3 minutes on each side. In order to determine that no confirmable levels of nitrosamines are present in the sample tested, the testing must be performed by methodology and procedures that would detect the presence of any nitrosamines at 10 ppb.

(3) Notwithstanding the provisions of paragraph (b) (1), sodium nitrite may be used at:

(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; provided that the plant has an approved partial quality control program as provided in section 318.4(d), (e), and (g) such as to result in compliance with this provision, or

(ii) a predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and additional sucrose or other similar fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the growth of botulism toxin at a level sufficient for the purpose of preventing the growth of botulism toxin; provided that the plant has an approved partial quality control program as provided in section 318.4(d), (e), and (g) such as to result in compliance with this provision.

(4) The Department shall collect samples of bacon from plants producing under paragraph (b) (3) of this section and analyze them for the level of nitrosamines. Samples shall be randomly selected throughout the production of a lot. The actual sampling plans and methods of analysis that are used will result in approximately the same likelihood as under paragraph (b) (2) of this section of having a presumptive positive result when the true mean level of nitrosamines in a production lot is 10 ppb. In the event of a presumptive positive result, the plant shall become subject to the provisions of paragraph (b) (2) of this section.

(5) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring material. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or estimated skin-free green weight of the bacon bellies.

(6) Bacon made with dry curing materials. With respect to bacon dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.

(C) Under appropriate declaration as required in PARTS 316 and 317 of these regulations, the following substances may be added to products:

(1) Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugars, honey, corn syrup solids, corn syrup, glucose syrup, wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other substances specified in the chart in subparagraph (4) of this paragraph may be used in products under conditions, if any, specified in this PART or PART 317 of these regulations.

(2) Other harmless artificial flavorings may be added to products with approval of the Head of Service in specific cases.

(3) Coloring matter and dyes other than those specified in the chart in subparagraph (4) of this paragraph, may be applied to products, mixed with rendered fat, applied to natural and artificial casings, and applied to such casings enclosing products, if approved by the Head of Service in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product. When any coloring matter or dye is added to meat fat shortening containing artificial flavoring, the product shall be packed in conventional, round shortening containers having a capacity no greater than 3 pounds.

(4) The substances specified in the following chart are acceptable for use in the preparation of products, provided they are used for the purposes indicated, within the limits of the amounts stated and under other conditions specified in this PART and PART 317 of these regulations. In addition to the substances listed in the following chart, PART 319 of these regulations specifies other substances that are acceptable in preparing specified products.

Class of Sustance Acidifiers	Substance Acetic Acid	Purpose To adjust acidity
	Citric acid	do
	Lacitc acid	do
	Phosphoric acid	do
	Tartaric acid	do
	Glucono deltalactone	do
Anticoagulants.	Citric acid,	To prevent
sodium citrate.	clotting.
Anti-foaming	Methyl	To retard
agent.	polysilicone.	foaming.
Antioxidants and	BHA (butylated	To retard
oxygen	hydroxyanisole).	rancidity.
interceptors.
BHT (butylated hydroxytoluene)	do
Propyl gallate	do
TBHQ (teriary butylhydroquinone).	do
BHA (butylated hyrdoxyanisole).	do
BHT (butylated hydroxytoluene).	do
Glycine.	do
Propyl gallate.	do
Resin gualac.	do
TBHQ (tertiary butylhydroquinone).	do
Tocopherols.	do
BHA (butylated hydroxyanlsole).	do
BHT (butylated hydroxytoluene).	do
Propyl gallate.	do
TBHQ (tertiary butylhydroquinone).	do
BHA (butylated hydroxyanisole).	do
BHT (butylated hydroxytoluene).	do
Propyl gallate.	do
TBHQ (tertiary butylhydroquinone).	do
BHA (butylated hydroxyanisole).	do
BHT (butylated hydroxytoluene).	do
Octyl gallate.	do
Propyl gallate.	do
Dodecyl gallate.	do
Ascorbyl	do
palmitate.
Ascorbyl	do
stearate
TBHQ (tertiary butylhydroquinone.)	do
Binders	Agar-agar	To
stabilize
and thicken
Algin.	To extend
and
stabilize
product.
Carrageenan.	do
Carboxymethyl	do
cellulose
(cellulose gum).
Enzyme (rennet)	To bind and
treated calcium	extend
reduced dried	product.
skim milk and
calcium lactate.
Enzyme (rennet)	do.
treated sodium
casseinate and
calcium lactate.
Gums, vegetable.	To extend
and
stabilize
product.
Methyl	To extend
cellulose.	and to
stabilize
product
(also
carrier).
Isolated soy	To bind and
protein.	extend
product.
Sodium	do
caseinate.
A mixture of	To bind
sodium alginate,	meat pieces
calcium
carbonate,
lactic acid and
calcium lactate.
Dry or dried	do
whey.
Reduced lactose	do
whey.
Reduced minerals	do
whey.
Whey protein	do
concentrate.
Dry of dried	do
whey.
Reduced lactose	do
whey.
Reduced minerals	do
whey.
Whey protein	do
concentrate
Xanthan gum.	To
maintain:
Uniform
viscosity;
suspension
of
particulate
matter;
emulsion
stability;
freeze-thaw
stability.
Bleaching agent.	Hydrogen	To remove
peroxide.	color.
Catalysts	Nickel.	To
(substances must	accelerate
be climinated	chemical
during process).	reaction.
Sodium amide.	Rearran-
gement of
fatty acid
radicals.
Sodium	do
methoxide.
Coloring agents	Alkanet,	To color
(natural).	annatto,	casings or
carotene,	rendered
cochineal, green	fats;
chiorophyl,	marking and
saffron and	branding
tumeric.	product.
Coloring agents	Color additives	do
(artificial).	listed in 21 CFR
Part 74, Subpart
A or Part 82,
Subpart B
(operator must
furnish evidence
to inspector in
charge that
color additive
has been
certified for
use in
connection with
foods by the
Food and Drug
Administration).
Titanium	do
dioxide.
Sodium	To prevent
pyrophosphate.	staining on
canned
goods.
Sodium	do
tripolyphosphate.
Zinc oxide.	do
Zinc sulfate.	do
Curing accelera-	Ascorbic acid.	To
tors; must be	accelerate
used only in	color
combination with	fixing or
curing agents.	preserve
color
during
storage.
Erythorbic acid.	do
Fumaric acid	To
accelerate
color
fixing.
Glucono delta	To
lactone.	accelarate
color
fixing.
Sodium acid	To
pyro-phosphate.	accelerate
color
fixing.
Sodium	To
ascorbate.	accelerate
color
fixing or
preserve
color
during
storage.
Sodium	do
erythorbate.
Citric acid or	do
sodium citrate.
Curing agents.	Sodium or	Source of
potassium	nitrite.
nitrate.
Sodium or	To fix
potassium	color.
nitrite.
(Supplies of
sodium nitrite
and potassium
nitrite and
mixtures
containing them
must be kept
securely under
the care of a
responsible
employee of the
establishment.
The specific
nitrite content
of such supplies
must be known
and clearly
marked
accordingly.)
Denuding agents;	Lime (calcium	To denude
may be used in	oxide, calcium	mucous
combination.	hydroxide).	membrane.
Must be removed
from tripe by
rinsing with
potable water.
Sodium carbonate.	do
Sodium gluconate.	do
Sodium hydroxide.	do
Sodium persulfate.	do
Sodium silicates (ortho, meta, and sesqul).	do
Trisodium phosphate	do
Emulsifying	Actylated monoglycerides.	To emulsify
agents.	product.
Diacetyl	do
tartaric acid
esters of mono
and
digylcerides.
Glycerol-lacto	do
stearate,
eleate, or
palmitate.
Locithin.	To emulsify
product
(also as
antioxidant).
Mono and digly-	To emulsify
cerides	product.
(glycerol palmitate, etc.).
Mono and	do
diglycerides of
fatty acids
esterified with
any of the
following acids:
acetic,
acetyltartaric,
citric, lactic,
tartaric, and
their sodium and
calcium salts;
the sodium
sulfoacetate
derivatives of
these mono and
diglycerides.
Polyglycerol	do
esters of fatty
acids (polygly-
cerol esters of
fatty acids are
restricted to
those up to and
including the
decaglycerol
esters and
otherwise
meeting the
requirements of
c 121.1120(a) of
the Food
Additive
Regulations).
1, 2-propylene	do
glycol esters of
fatty acids.
Polysorbate 80	do
(polyoxyethylene (20) sorbitan monooleate).
Propylene glycol	do
mono and
diesters of fats
and fatty acids.
Polysorbate 60	do
(polyoxyethylene (20) sorbitan monostearate).
Stearyl-2-lactylic acid.	do
Stearyl	do
monoglyceridylcitrate.
Film forming	A mixture	To reduce
agents	consisting of	cooler
water, sodium	shrinkage
alginate,	and protect
calcium	surface
chloride, sodium
carboxymothylcellulose, and
corn syrup
solids
Flavoring agents;	Program approved	To flavor
protectors and	artificial smoke	product.
developers.	flavoring. 1
Program approved	do
smoke
flavoring, 1
Autolyzed yeast	do
extract.
Harmless	To develop
bacteria	flavor.
starters of the
acidophilus
type, lactic
acid starter or
culture of
Pediococcus cere visiae.
Harmless lactic	To prevent
acid producing	growth of
bacteria	Clostridium
botulinum.
Benzoic acid	To retard
sodium,	flavor
potassium	reversion.
Calcium lactate	To protect
flavor.
Citric acid.	Flavoring
Corn syrup	To flavor.
solids, corn
syrup, glucose
syrup.
Dextrose.	To flavor
product.
Diacetyl.	do
Disodium	do
guanylate.
Disodium	do
inosinate.
Hydrolyzed plant	do
protein.
Isopropyl	To protect
citrate.	flavor.
Malt syrup.	To flavor
product.
Milk protein	do
hydrolysbte.
Monosodium	do
glutamate.
Monoammonium	do
glutamate.
Sodium	do
sulfoacetate
derivative or
mono and
diglycerides.
Sodium tripolyphosphate.	To help
protect
flavor.
Mixture of	do
sodium
tripolyphosphate
and sodium,
meta-phosphate,
insoluble; and
sodium polyphosphates, glassy.
Sorbitol.	To flavor,
to
facilitate
the removal
of casings
from
product and
to reduce
caramelization and
charring.
Starter distillate.	do
Stearyl citrate.	To protect
flavor.
Sugars (sucrose	To flavor
and dextrose).	product.
Gases.	Carbon dioxide	To cool
solid (dry ice).	product.
Nitrogen.	To exclude
oxygen.
Hog scald agents;	Caustic soda.	To remove
must be removed by subsequent cleaning operations.	hair.
Dimethylpolysiloxane.	do
Dioctyl sodium	do
sulfosuccinate.
Disodium-calcium	do
ethylenediaminetetra-acetate.
Disodium	do
phosphate.
Ethylenediamine-	do
tetraacetic acid
(sodium salts).
Lime (calcium	do
oxide, calcium
hydroxide).
Propylene	do
glycol.
Soap (prepared	do
by the reaction
of calcium,
potassium, or
sodium with
rosin or fatty
acids of natural
fats and oils).
Sodium acid	do
pyrophosphate
Sodium	do
carbonate.
Sodium dodecyl-	do
benzene
sulfonate.
Sodium	do
gluconate.
Sodium	do
hexametaphosphate.
Sodium lauryl	do
sulfate.
Sodium mono and	do
dimethyl-
naphthalene
sulfonate
(molecular
weight 245-260).
Sodium nalkylbenzene	do
sulfonate (alkyl
group
predominantly
C12 and C13 and
not less than 95
percent
C10 to C16;
Sodium	do
pyrophosphate.
Sodium silicates	do
(ortho, meta, and sesqui).
Sodium sulfate.	do
Sodium tripolyphosphate.	do
Sucrose.	do
Triethanolamine	do
dodecylbenzene
sulfonate.
Trisodium	do
phosphate.
Miscellaneous	Ascorbic acid,	To maintain
erythorbic acid,	color
citric acid,
sodium ascorbate
and sodium
citrate, singly
or in
combination,
under an
approved partial
quality control
(PQC) program ( 9 CFR 318.4(d) & (e)).
Potassium	To retard
sorbate.	mold
growth.
Sorbic acid	To preserve
(sodium,	product and
potassium, and	to retard
calcium salts).	mold
growth.
Calcium	To preserve
disodium, EDTA	product and
(calcium	to protect
disodium	flavor.
ethylene- diaminetetraacetate).
Propylparaben	To retard
(propyl phydrosy benzoate).	mold growth
Sodium	To
bicarbonate.	neutralize
excess
acidity,
cleaning
vegetables.
Calcium	To retard
propionate.	mold
growth.
d- and dl-alpha-	To inhibit
tocopherol	nitrosamine
formation
Sodium	do
propionate.
Sodium	To decrease
hydroxide.	the amount
of cooked
out juices.
Disodium	do
phosphate.
Monosodium	do
phosphate.
Sodium	do
metaphosphate,
insoluble.
Sodium	do
polyphosphate,
glassy.
Sodium tripolyphosphate.	do
Sodium pyrophosphate.	do
Sodium acid	do
pyrophosphate.
Dlpotassium	do
phosphate.
Monopotassium	do
phosphate.
Potassium	do
tripolyphosphate.
Potassium pyrophosphate.	do
Citric acid	To acidify.
(sodium andpotassium salts).
Lactic acid	do
(sodium and potassium salts).
L-Tartaric acid	do
(sodium andsodium potassium salts).
Adipic acid.	do
Phosphoric acid.	do
Hydrochloric acid.	do
Sodium	To
bicarbonate.	alkalize.
Sodium	do
carbonate.
Sodium	do
hydroxide.
Potassium	do
carbonate.
Proteolytic	Aspergillus	To soften
enzymes.	oryzae.	tissues.
Aspergillus	do
flavus oryzae
group.
Bromelin.	do
Ficin.	do
Papain.	do
Refining agents	Acetic acid.	To separate
(must be	fatty acids
climinated during	and
process of manufacturing).	glycerol.
Bicarbonate of soda.	do
Carbon (purifiedcharcoal).	To aid in
refining of
animal
fats.
Caustic soda	To refine
(sodiumhydroxide).	fats.
Diatomaceous	do
earth; Fuller's
earth.
Sodium carbonate.	do
Tannic acid.	do
Rendering agents.	Tricalcium	To aid
phosphate.	rendering.
Trisodium phosphate.	do
Sources of	Ionizing	To control
Radiation	radiation	Trichinella
limited to gamma	spiralis.
rays from
cobalt-60 or
cesium-137.
Artificial	Saccharin.	To sweeten
sweeteners.	product.
Synergists (used in in combination with antioxidants).	Citric acid.	To increase
effectiveness of
antioxidants.
Malic acid.	do
Monoisopropyl	To increase
citrate.	effectivenes of
antioxidants.
Phosphoric acid.	do
Monoglyceride citrate.	do
Tenderizing	Aspergillus oryzae.	To soften
Agents.	tissue.
Aspergillus	do
flavus oryzae
group.
Bromelin.	do
Ficin.	do
Papain.	do
Potassium chloride.	do
Magnesium chloride.	do
Calcium chloride.	do
Potassium,	do
magnesium or
calcium
chloride.

Class of Suslance Acidifiers	Products Various 2	Amount Sufficient for purpose
do	do
do	do
do	do
do	do
do	do
Anticoagulants.	Fresh blood of livestock.	0.2 percent with or without water. When water is used to make a solution of citric acid or sodium citrate added to blood of livestock, not more than 2 parts of water to 1 part of citric acid or sodium citrate shall be used.
Anti-foaming agent.	Soups.	10 parts per million.
Rendered fats.	do.
During pickle.	50 parts per million.
Antioxidants and	Dry sausage.	0.003	)
oxygen	percent	)	0.006 percent in
interceptors.	based on	)	combination.
total	)
weight	)
do	do			)
)
do	do			)
do	do	)	0.006 percent in
)	combination only
)	BHA and/or BHT.
Rendered animal	0.01	)
fat or a	percent	)
combination of	)
such fat and	)
vegetable fat.	)
do	do	)	0.02 percent in
)	combination.
do	do	)
do	do	)
do	do	)
do	do	)	0.02 percent in
)	combination only
)	with BHA and/or
)	BHT.
do	0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as "lard" or "rendered pork fat."
Fresh pork	0.01	)	0.02 percent in
sausage, brown	percent	)	combination based
and serve	based on	)	on fat content.
sausages, fresh	fat	)
Italian sausage	content.	)
products,	)
pregrilled beef	)
patties, and	)
fresh sausage	)
made from beef	)
or beef and	)
pork.	)
do	do	)
)
do	do	)
do	do	)	0.02 percent in
)	combination only
)	with BHA and/or
)	BHT based on fat
)	content.
Dried meats.	0.01	)	0.01 percent in
percent	)	combination.
based on	)
total	)
weight.	)
do	do			)
)
)
do	do			)
do	do	)	0.01 percent
)	in combination
)	only with BHA
)	and/or BHT.
Margarine or oleomargarine	0.02 percent (by wt. of the finished product individually or in combination with other antioxidants approved for use in margarine.
do	do	)
)
)
do	do
do	do	)
do	do.
do	do.
do	do.
do	0.02 percent in alone or in combination only with BHA and/or BHA based on fat or oil control
Binders	Thermally				0.25 percent of finished
processed canned	product.
jellied meat
food products.
Breading mix; sauces.	Sufficient for purpose.
do	do
Baked pies.	do
Sausages, as provided for in Part 319 of this subchapter.	3 1/2 percent total finished product. (Calcium lactate required at rate of 10 percent of binder.
Imitation.	Sufficient for purpose.
sausages; non-specific loaves; soups, stews.	(Calcium lactate required at rate of 10 percent of binder.
Imitation Sausages, non-specific loaves, soups, stews.	Sufficient for purpose. (Calcium lactate required at rate of 25 percent of binder.)
Egg roll.	Sufficient for purpose.
Meat and vegetable patties.	0.15 percent
Sausage, as provided for in Part 319 of this subchapter.	2 percent.
Imitation	Sufficient for purpose.
sausage; nonspecific loaves; soups; stews.
do	do
Restructured	Sodium alginate at 1.0
meat, meat food	percent; calcium carbonate
products	at 0.2 percent; and lactic
acid and calcium lactate at 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Ingredients of mixture must be added dry.
do
do	do.
do	do.
do	do.
Imitation	do.
sausage; soups; stews; non-specific loaves.
do	do.
do	do.
do	do.
Meat sauces,
gravies do. or
sauces and
meats, canned or
frozen and/or
refrigerated
meat salads,
canned or frozen
meat stews,
canned chili or
chili with
beans, pizza
topping mixes
and batter or
breading mixes.
Bleaching agent.	Tripe (substance must be removed from product by rinsing with clear water).	do.
Catalysts	Rendered animal	do.
(substances must	fats or a
be climinated	combination of
during process).	such fats
do.	do.
do	do.
Coloring agents (natural).	Sausage casings, oleomargarine, shortening, marking or branding ink on product.	Sufficient for purpose. (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar).
Coloring agents (artificial).	do	Sufficient for purpose. (may be mixed with approved natural coloring matters or harmless inert material such as common salt or sugar).
Canned ham salad spread and creamed type canned products.	0.5 percent.
do	0.5 percent.
do	do.
do	0.01 percent.
do	do.
Curing accelerators; must be used only in combination with curing agents.	Cured pork and beef cuts, cured comminuted meat food product.	75 ozs. to 100 gals. pickle at 10 percent pump level; 3/4 oz. to 100 lbs. meat or meat byproduct; 10 percent solution to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.)
do	do.
Cured comminuted meat or meat food products.	0.065 percent (or 1 oz. to 100 lb.) of the weight of the meat or meat byproducts, before processing.
Cured, comminuted meat or meat food product.	8 oz. to each 100 lbs. of meat or meat byproduct.
Genoa salami.	16 oz. to 100 lbs. of meat (1.0 percent).
Frankfurters, wieners, vienna, bologna, garlic bologna, knockwurst, and similar products.	Not to exceed, alone or in combination with other curing accelerators, the following: 8 ozs. in 100 lbs. of the meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product.
Cured pork and beef cuts, cured comminuted meat food product.	87.5 ozs. to 100 gals. pickle at 10 percent pump level; 7/8 ozs. to 100 lbs. meat or meat byproduct; 10 percent solution to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.)
do	do
do	May be used in cured products or in 10 percent solution used to spray surfaces of cured cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate or sodium erythorbate that is used.
Curing agents.	Cured products other than bacon. Nitrates may not be used in baby, junior, and toddler foods.	7 lbs. to 100 gals. pickle; 3 1/2 ozs. to 100 lbs. meat (dry cure); 2 3/4 ozs. to 100 lbs. chopped meat.
Cured products. Nitrites may not be used in baby, junior, and toddler foods.	2 lbs. to 100 gals. pickle at 10 percent pump level; 1 oz. to 100 lbs. meat (dry cure); 1/4 oz. to 100 lbs. chopped meat and/or meat byproduct. The use of nitrites, nitrates, or combination shall not result in more than 200 parts per million of nitrite, calculated as sodium nitrite, in finished product. Except that nitrites may be used in bacon only in accordance with paragraph (b) of this section.
Denuding agents; may be used in combination.	Tripe.	Sufficient for purpose.
Must be removed from tripe by rinsing with potable water.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
Emulsifying agents.	Shortening.				do.
Rendered animal fat or a combination of such fat with vegetable fat.	do.
do	do.
Oleomargarine, shortening, various meat food products.	0.5 percent in oleo- margarine; use inother products -- sufficient amount for, emulsification. 2
Rendered animal fat or a combination of such fat with vegetable fat; oleomargarine.	Sufficient for purpose in lard and shortening; 0.5 percent in oleomargarine.
Margarine or oleomargarine	0.5 percent
Rendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity or composition.	Sufficient for purpose for rendered animal fat or combination with vegetable fat; 0.5 percent for oleomargarine.
Margarine or oleomargarine.	2.0 percent
Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods.	1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 percent.
Rendered animal fat or a combination of such fat with vegetable fat.	Sufficient for purpose.
Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods.	1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 percent.
Shortening to be used for cake icings and fillings.	3.0 percent
Shortening.	Sufficient for purpose.
Film forming agents	Freshly dressed meat carcasses. Such carcasses must bear a statement "Protected with a film of water, corn syrup solids, sodium alginate, calcium chloride and sodium carboxymethylcellulose."				Formulation may not exceed 1.5% of hot carcass weight when applied. Chilled weight may not exceed hot weight.
Flavoring agents; protectors and developers.	Various, 2				do.
do	do.
do	do.
Dry sausage, pork roll, thuringer lebanon bologna, cervelat, and salami.	0.5 percent.
Bacon	Sufficient for purpose.
Margarine or oleomargarine.	0.1 percent. Individually or if used in combination with sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
Cooked semi-dry and dry products including sausage imitation sausage, and non-specific meat food sticks.	0.6 percent in product formulation.
Chili con carne.	Sufficient for purpose.
Chili con carne sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham.	2.0 percent individually or collectively, calculated on a dry basis.
Sausage, ham and cured products.	Sufficient for purpose.
Oleomargarine.	do.
Various.	do.
do	do.
do	do.
Oleomargarine.	0.02 percent.
Cured products.	2.5 percent.
Various.	Sufficient for purpose.
do	do.
do	do.
do	do.
"Fresh Beef," "Beef for Further Cooking," "Cooked Beef," Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, and veal mutton, and goat meat which are cooked or frozen after processing.	0.5 percent of total product.
do	do.
Cooked sausage labeled frank further, frank, further, wiener knockwurst.	Not more than 2 percent of the weight formula, excluding the formula weight of water or ice; not permitted in combination with corn syrup, and/or corn syrup solids.
Oleomargarine.	Sufficient for purpose.
do	do.
Various. 2	Sufficient for purpose.
Gases.	Chopping of meat, packaging of product.				do.
Sealed container.	do.
Hog scald agents; must be removed by subsequent cleaning operations.	Hog carcasses.				do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
Miscellaneous	Fresh pork cuts				Not to exceed either 500 ppm or 1.8 mg/sq inch of surface of ascorbic acid, erythorbic acid or sodium ascorbate, singly or in combination; and/or not to exceed either 250 ppm or 0.9 mg/sq inch of surface of citric acid or sodium citrite, singly or in combination.
Dry sausage.	2.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
Margarine or oleomargarine.	0.1 percent individually, or if used in combination or with benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
do	75 parts per million by weight of the finished oleomargarine or margarine.
Dry sausage.	3.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
Rendered fats, soups, curing pickle.	Sufficient for purpose.
Pizza crust.	0.32 percent alone or in combination based on weight of the flour used.
Pump-cured bacon	500 ppm; by injection or surface application.
do	do.
Meat food products containing phosphates.	May be used only in combination with phosphates in a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product.
Meat food products except where otherwise prohibited by the Federal meat inspection regulations.	5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in product (only clear solution may be injected into product.)
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
Margarine or oleomargarine.	Sufficient for purpose.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
Proteolytic enzymes.	Raw meat cuts.				Solutions consisiong of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain or more than 3 percent above the weight of the untreated product.
do	do.
do	do.
do	do.
do	do.
Refining agents	Rendered fats.				Sufficient for purpose.
(must be climinated during process of manufacturing).
do	do.
do	do.
do	do.
do	do.
do	do.
do	do.
Rendering agents.	Animal fats.				do.
do	do.
Sources of Radiation	Pork carcasses, or fresh or previously frozen cuts of pork carcasses that have not been cured or heat-processed.				Minimum absorbed dose of 0.3 kiloGray (30 kilorads) to a maximum absorbed dose of 1 kiloGray (100 kilorads).
Artificial sweeteners.	Bacon.				0.01 percent.
Synergists (used in in combination with antioxidants).	Lard and shortening.				0.1 percent alone or in combination with antioxidants in lard or shortening.
Dry sausage.	0.003 percent in dry sausage in combination with antioxidants.
Fresh pork sausage.	0.01 percent on basis of content, in combination with antioxidants.
Dried meats.	0.01 percent on basis of total weight in combination with antioxidants.
Lard and shortening.	do.
Lard, shortening, oleomargarine, fresh pork sausage, dried meats.	0.01 percent.
Lard and shortening.	0.01 percent.
Lard, shortening, fresh pork sausage, dried meats.	0.02 percent.
Tenderizing Agents.	Raw meat cuts.				Solutions consisting of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated products.
do	do.
do	do.
do	do.
do	do.
do	Not more than 3 percent of 2.0 molar solution.
do	Not more than 3 percent of a 0.8 molar solution.
do	do.
do	A solution of approved inorganic chlorides injected into or applied to raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product.

(D) No substance may be used in or on any product if it conceals damage or inferiority or makes the product appear to be better or greater value than it is. Therefore:

(1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat food products such as chopped and formed steaks or patties; or in other meat food products consisting of fresh meat (with or without seasoning), except chorizo sausage and except other meat food products in which paprika or oleoresin paprika is permitted as an ingredient in a standard of identity or composition in PART 319 of these regulations.

(2) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of sorbic acid may not be used in cooked sausage or any other product; sulfurous acid and salts of sulfurous acid may not be used in or on any product and niacin or nicotinamide may not be used in or on fresh product; except that potassium sorbate, propylparaben (propyl-p-hydroxbenzoate), calcium propionate, sodium propionate, benzoic acid, and sodium benzoate may be used in or on any product only as provided in the chart in 318.7 (C) (4) or as approved by the Head of Service in specific cases.

Section 318.8 Reserved

Section 318.9 Samples of products, water, dves, chemicals, etc, to be taken for examination

Samples of products, water dyes, chemicals, preservatives, spices, or other articles in any official establishment shall be taken, without cost to the Service, for examination, as often as may be deemed necessary for efficient conduct of the inspection.

Section 318.10 Prescribed treatment of pork and products containing pork to destroy trichinae

(A)

(1) All forms of fresh pork, including fresh unsmoked sausage containing pork muscle tissue, and pork such as bacon and jowls, other than those covered by paragraph (3) of this section, are classed as products that are customarily well cooked in the home or elsewhere before being served to the consumer. Therefore the treatment of such products for the destruction of trichinae is not required.

(2) Pork from carcasses or carcass parts that have been found free of trichinae as described under paragraph (E) or (F) of this section is not required to be treated for the destruction of trichinae.

(B) Products named in this paragraph, and products of the character hereof, containing pork muscle tissue (not including pork hearts, pork stomachs, and pork livers), or the pork muscle tissue which forms an ingredient of such products, shall be effectively heated, refrigerated, or cured to destroy any possible live trichinae, as prescribed in this section at the official establishment where such products are prepared: Bologna, frankfurter, vienna, and other cooked sausage; smoked sausage; knoblauch sausage; all forms of summer or dried sausage, including mettwurst; flavored pork sausages such as those containing wine or similar flavoring; cured pork sausage; sausage containing cured and/or smoked pork; cooked loaves; roasted, baked, boiled, or cooked hams, pork shoulders, or pork shoulder picnics; Italian-style hams; Westphalia-style hams; smoked boneless pork shoulder butts; cured meat rolls; capocollo (capicola, capacola); coppa; fresh or cured boneless pork shoulder butts, hams, loins, shoulders, shoulder picnics, and similar pork cuts, in casings or other containers in which ready-to-eat delicatessen articles are customarily enclosed (excepting Scotch-style hams); breaded pork products; cured boneless pork loins; boneless back bacon; bacon used for wrapping around patties; steaks and similar products; and smoked pork cuts such as hams, shoulders, loins, and pork shoulder picnics (excepting smoked hams, and smoked pork shoulder picnics which are specially prepared for distribution in tropical climates or smoked hams delivered to the Armed Services); ground meat mixtures containing pork and beef, veal, lamb, mutton, or goat meat and other product consisting of mixtures of pork and other ingredients, which the Head of Service determines at the time the labeling for the product is submitted for approval in accordance with PART 317 of the regulations in this subchapter or upon subsequent reevaluation of the product, would be prepared in such a manner that the product might be eaten rare or without thorough cooking because of the appearance of the finished product or otherwise. Cured boneless pork loins shall be subjected to prescribed treatment for destruction of trichinae prior to being shipped from the establishment where cured.

(C) The treatment shall consist of heating, refrigerating, or curing, as follows:

(1) Heating:

(i) All parts of the pork muscle tissue shall be heated according to one of the time and temperature combinations in the following table:

MINIMUM INTERNAL

TEMPERATURE

Degrees	Degrees	MINIMUM
Fahrenheit	Centigrade	TIME
120	49.0	21	hours
122	50.0	9.5	hours
124	51.1	4.5	hours
126	52.2	2	hours
128	53.4	1	hour
130	54.5	30	minutes
132	55.6	15	minutes
134	56.7	6	minutes
136	57.8	3	minutes
138	58.9	2	minutes
140	60.0	1	minute
142	61.1	1	minute
144	62.2	Instant

(ii) Time and temperature shall be monitored by a calibrated recording instrument that meets the requirements of paragraph (d) of this section, except for paragraph (c) (1) (iv).

(iii) The time to raise product temperature from 60 degrees F. to 120 degrees F. shall not exceed 2 hours unless the product is cured or fermented.

(iv) Time, in combination with temperatures of 138 degrees F. to 143 degrees F. need not be monitored if the product's minimum thickness exceeds 2 inches (5.1 cm) and refrigeration of the product does not begin within 5 minutes of attaining 138 degrees F. (58.9 C).

(v) The establishment shall use procedures which insure the proper heating of all parts of the product. It is important that each piece of sausage, each ham, and other product treated by heating in water be kept entirely submerged throughout the heating period; and that the largest pieces in a lot, the innermost links of bunched sausage or other massed articles, and pieces placed in the coolest part of a heating cabinet or compartment or vat be included in the temperature tests.

(2) Refrigerating. At any stage of preparation and after preparatory chilling to a temperature of not above 40 degrees F. or preparatory freezing, all parts of the muscle tissue of pork or product containing such tissue shall be subjected continuously to a temperature not higher than one of those specified in Table 1, the duration of such refrigeration at the specified temperature being dependent on the thickness of the meat or inside dimensions of the container.

Table 1 -- REQUIRED PERIOD OF FREEZING AT TEMPERATURE INDICATED-
Temperature Degrees F.	Group 1 (Days)	Group 2 (Days)
5.	20	30
-10	10	20
-20	6	12

(i) Group 1 comprises product in separate pieces not exceeding 6 inches in thickness, or arranged on separate racks with the layers not exceeding 6 inches in depth, or stored in crates or boxes not exceeding 6 inches in depth, or stored as solidly frozen blocks not exceeding 6 inches in thickness.

(ii) Group 2 comprises product in pieces, layers, or within containers, the thickness of which exceeds 6 inches but not 27 inches, and product in containers including tierces, barrels, kegs, and cartons having a thickness not exceeding 27 inches.

(iii) The product undergoing such refrigeration or the containers thereof shall be so spaced while in the freezer as will insure a free circulation of air between the pieces of meat, layers, blocks, boxes, barrels, and tierces in order that the temperature of the meat throughout will be promptly reduced to not higher than 5 degrees F., -10 F., or -20 F., as the case may be.

(iv) In lieu of the methods prescribed in Table 1, the treatment may consist of commercial freeze drying or controlled freezing, at the center of the meat pieces, in accordance with the times and temperatures specified in Table 2.

TABLE 2-ALTERNATE PERIODS OF FREEZING AT TEMPERATURES INDICATED

Maximum Internal Temperatures

Degrees Fahrenheit	Degrees Centigrade	Minimum Time
0	-17.8	106 hours
-5	-20.6	82 hours
-10	-23.3	63 hours
-15	-26.1	48 hours
-20	-28.9	35 hours
-25	-31.7	22 hours
-30	-34.5	8 hours
-35	-37.2	1/2hour

(v) During the period of refrigeration the product shall be kept separate from other products and in the custody of the Service in rooms or compartments equipped and made secure with an official Service lock or seal. The rooms or compartments containing product undergoing freezing shall be equipped with accurate thermometers placed at or above the highest level at which the product undergoing treatment is stored and away from refrigerating coils. After completion of the prescribed freezing of pork to be used in the preparation of product covered by paragraph (b) of this section the pork shall be kept under close supervision of an inspector until it is prepared in finished form as one of the products enumerated in paragraph (b) of this section or until it is transferred under Service control to another official establishment for preparation in such finished form.

(vi) Pork which has been refrigerated as specified in this subparagraph may be transferred in sealed railroad cars, sealed motortrucks, sealed trailers, or sealed closed containers to another official establishment at the same or another location, for use in the preparation of product covered by paragraph (b) of this section. Such vehicles and containers shall be sealed and transported between official establishments in accordance with Section 325.7 of this subchapter.

(3) Curing --

TRICHINA TREATMENT OF SMOKED HAMS AND PORK SHOULDERS

Table 6 - SMOKING AND DRYING SCHEDULE

MINIMUM DAYS (1 day=24 Hours) SMOKING TIME AFTER CURING (At Minimum Smokehouse Temperature)						MINIMUM DAYS DRYING TIME AFTER SMOKING (At Minimum Drying Room Temperature)
130 F.	85F.	80F.	75F.	70F.	65F.	60F.	55F.	50F.	45F.	40F.	35F.
1/2	12	17	24	27	36	44	52	60	67	84	94
1	6	9	12	14	18	21	26	30	35	42	47
1 1/2.	0	0	0	0	0	0	0	0	0	0	0
120 F.
1	12	17	24	27	36	44	52	60	67	84	94
2	6	9	12	14	18	21	26	30	35	42	47
3	0	0	0	0	0	0	0	0	0	0	0
110 F.
1	15	20	28	32	43	52	63	72	80	100	112
2	11	15	21	24	32	39	47	54	60	75	80
3	7	10	14	16	21	26	31	36	40	50	56
4	4	5	7	8	11	13	16	18	20	25	28
5	0	0	0	0	0	0	0	0	0	0	0
100 F.
1	16	22	30	35	46	56	67	77	86	107	120
2	13	18	25	29	38	47	56	65	72	90	100
3	11	15	20	23	31	38	45	52	58	72	80
4	8	11	15	18	23	28	34	39	43	54	60
5	6	8	10	12	16	19	23	26	29	36	40
6	3	4	5	6	8	10	12	13	15	18	20
7	0	0	0	0	0	0	0	0	0	0	0
90 F.
1	17	23	32	37	49	59	71	82	91	114	128
2	15	21	29	33	44	54	64	74	82	100	115
3	13	19	26	30	39	48	57	66	73	91	102
4	12	16	23	26	34	42	50	58	64	80	89
5	10	14	20	22	29	36	43	50	55	69	77
6	9	12	16	19	25	30	35	41	46	57	64
7	7	9	13	15	20	24	29	33	37	46	51
8	5	7	10	11	15	18	22	25	28	35	39
9	4	5	7	8	10	12	15	17	19	23	26
10	2	3	4	4	5	6	8	9	10	12	13
11	0	0	0	0	0	0	0	0	0	0	0
80 F.
1	17	24	34	39	51	63	75	87	96	120	135
2	17	23	33	37	49	60	72	83	92	115	129
3	16	22	31	36	47	50	69	80	88	110	124
4	16	21	30	34	45	55	66	76	84	105	118
5	15	20	28	32	43	53	63	72	80	100	112
6	14	19	27	31	41	50	60	69	76	95	107
7	13	18	26	39	39	47	57	65	72	90	101
8	13	17	24	28	36	45	54	62	68	85	96
9	12	16	23	26	34	42	50	58	64	80	90
10	11	15	21	24	32	39	47	54	69	75	84
11	10	14	20	23	30	37	44	51	56	70	79
12	10	13	19	21	28	34	41	47	52	65	73
13	9	12	17	20	26	32	38	44	48	60	68
14	8	11	16	18	24	29	35	40	44	55	62
15	8	10	14	16	22	26	32	36	40	50	56
16	7	9	13	15	19	24	28	33	36	45	51
17	6	8	12	13	17	21	25	29	32	40	45
18	5	7	10	12	15	19	22	26	28	35	40
19	5	6	9	10	13	16	19	22	24	30	34
20	4	5	7	8	11	13	16	18	20	25	28
21	3	4	6	7	9	11	13	15	16	20	23
22	3	3	5	5	7	8	10	11	12	15	17
23	2	2	3	4	5	6	7	8	9	10	12
24	1	1	2	2	3	3	4	4	4	5	6
25	0	0	0	0	0	0	0	0	0	0	0

(i) Sausage. The sausage may be stuffed in animal casings, hydrocellulose casings, or cloth bags. During any stage of treating the sausage for destruction of live trichinae, except as provided Method 5, these coverings shall not be coated with paraffin or like substance, nor shall any sausage be washed during any prescribed period of drying. In the preparation of sausage, one of the following methods may be used:

Method No. 1. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, sausage having a diameter not exceeding 3 1/2 inches, measured at the time of stuffing, shall be held in a drying room not less than 20 days at a temperature not lower than 45 degrees F., except that in sausage of the variety known as pepperoni, if in casings not exceeding 1 3/8 inches in diameter measured at the time of stuffing, the period of drying may be reduced to 15 days. In no case, however, shall the sausage be released from the drying room in less than 25 days from the time the curing materials are added, except that sausage of the variety known as pepperoni, if in casings not exceeding the size specified, may be released at the expiration of 20 days from the time the curing materials are added. Sausage in casings exceeding 3 1/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing shall be held in a drying room not less than 35 days at a temperature not lower than 45 degrees F., and in no case shall the sausage be released from the drying room in less than 40 days from the time the curing materials are added to the meat.

Method No .2. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, sausage having a diameter not exceeding 3 1/2 inches, measured at the time of stuffing, shall be smoked not less than 40 hours at a temperature not lower than 80 degrees F., and finally held in a drying room not less than 10 days at a temperature not lower than 45 degrees F. In no case, however, shall the sausage be released from the drying room in less than 18 days from the time the curing materials are added to the meat. Sausage exceeding 3 1/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing, shall be held in a drying room, following smoking as above indicated, not less than 25 days at a temperature not lower than 45 degrees F., but in no case shall the sausage be released from the drying room in less than 33 days from the time the curing materials are added to the meat.

Method No. 3. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After adding mixture with the salt and other curing materials and before stuffing, the ground or chopped meat shall be held at a temperature not lower than 34 degrees F. for not less than 36 hours. After being stuffed, the sausage shall be held at a temperature not lower than 34 degrees F. for an additional period of time sufficient to make a total of not less than 144 hours from the time the curing materials are added to the meat, or the sausage shall be held for the time specified in a pickle-curing medium of not less than 50 degrees strength (salometer reading) at a temperature not lower than 44 degrees F. Finally, sausage having a diameter not exceeding 3 1/2 inches, measured at the time of stuffing, shall be smoked for not less than 12 hours. The temperature of the smokehouse during this period at no time shall be lower than 90 degrees F.; and for 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 degrees F. Sausage exceeding 3 1/2 inches, but not exceeding 4 inches, in diameter at the time of stuffing shall be smoked, following the prescribed curing, for not less than 15 hours. The temperature of the smokehouse during the 15-hour period shall at no time be lower than 90 degrees F., and for 7 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 128 degrees F. In regulating the temperature of the smokehouse for the treatment of sausage under this method, the temperature of 128 degrees F. shall be attained gradually during a period of not less than 4 hours.

Method No. 4. The meat shall be ground or chopped into pieces not exceeding one-fourth of an inch in diameter. A dry-curing mixture containing not less than 2 1/2 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After adding mixture with the salt and other curing materials and before stuffing, the ground or chopped sausage shall be held as a compact mass, not more than 6 inches in depth, at a temperature not lower than 36 degrees F. for not less than 10 days. At the termination of the holding period, the sausage shall be stuffed in casings of cloth bags not exceeding 3 1/3 inches in diameter, measured at the time of stuffing. After being stuffed, the sausage shall be held in a drying room at a temperature not lower than 45 degrees F. for the remainder of a 35-day period, measured from the time the curing materials are added to the meat. At any time after stuffing, if the establishment operator deems it desirable, the product may be heated in a water bath for a period not to exceed 3 hours at a temperature not lower than 85 degrees F., or subjected to smoking at a temperature not lower than 80 degrees F., or the product may be both heated and smoked as specified. The time consumed in heating and smoking, however, shall be in addition to the 35-day holding period specified.

Method No. 5. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat. After being stuffed, the sausage shall be held for not less than 65 days at a temperature not lower than 45 degrees F. The coverings for sausage prepared according to this method may be coated at any stage of the preparation before or during the holding period with paraffin or other substance approved by the Administrator.

Method No. 6.

(a) Basic requirements. The meat shall be ground or chopped into pieces not exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than 3.33 pounds of salt to each hundredweight of the unstuffed sausage, excluding the weight of dry ingredients, shall be thoroughly mixed with the ground or chopped meat. After the curing mixture has been added, the sausage shall be held for two time periods, a holding period and a drying period. The holding period will be for a minimum of 48 hours at a room temperature not lower than 35 degrees F. This holding period requirement may be fulfilled totally or in part before the drying period and then the remainder, if any, after the drying period or as an extension of the drying period. During the drying period, the sausage shall be held in a drying room at a temperature not lower than 50 degrees F, (10.0 C) for a period of time determined by Tables 3A, 3B and 4. The length of the drying period, established in (c)(3)(i)(a), may be modified as provided in paragraphs (c)(3)(i) (b) and (c)(3)(i)(c) of this section.

(a) TABLE 3A - SAUSAGE DRYING ROOM TIMES BY METHOD NO. 6

Diameter of casing at Time of Stuffing n1	Davs in Drying Room n2
up to:
1 inch	14
1 1/2 inches	15
2 inches	16
2 1/2 inches	18
3 inches	20
3 1/2 inches	23
4 inches	25
4 1/2 inches	30
5 inches	35
5 1/2 inches	43
6 inches	50

n1 The drying room times for sausages that are not circular in cross section, e.g., flattened or oval, shall be determined by the largest diameter of the sausage.

n2 Drying room time may be modified as set forth in Table 3B and 4.

(b) Reduction in drying room time. During the holding period, the sausage may be smoked or fermented If the temperature is increased to 70 degrees F. (21.1 C) or higher, while the sausage is being held after adding curing materials but before the drying period, the subsequent drying room times prescribed for this method may be reduced according to the schedule in Table 3B. No interpolation of of value is permissible.

Table 3B-PERCENTAGE REDUCTION IN DRYING ROOM TIME

(TABLE 3A) PERMITTED BY HOLDING TIMES AND TEMPERATURES PRIOR TO DRYING n1

n1 In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the required total drying time. Example: Sausage stuffed in 3" diameter casing requires 20 days in the drying room (from Drying Room Times, Table 3A). If allowed to ferment, after addition of curing materials, at 80 degrees F. for 48 hours, the 20 day drying time may be reduced 18% (from Table 3B). Eighteen percent of 20 days equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room, therefore, will be 17 days.

Minimum Temperature n2

n2 Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of 2.3:1 or less. Internal temperature shall be used for all other sausages.

70 F. 75 F. 80 F. 85 F. 90 F. 95 F. 100 F 105 F 110 F 120F Minimum 11.1C 23.9C 26.7C 29.5C 32.2C 35.0C 37.8C 40.6C 43.3C 48.9

Time

24 hrs.	4%	5%	8%	10%	15%	23%	37%	57%	90%	n3 100%
48 hrs.	9%	12%	18%	25%	35%	49%	88%	n3 100%	n3 100%	100%
72 hrs.	14%	19%	28%	39%	55%	74%	n3 100%	100%	100%	100%
96 hrs.	19%	26%	38%	53%	75%	98%	100%	100%	100%	100%
120 hrs.	24%	33%	48%	67%	95%	n3 100%	100%	100%	100%	100%

n3 Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is required for products so treated.

(c) Reduced Salt Content-Drying Room Times. Salt content of less than 3.33 pounds for each hundredweight of sausage formulation, excluding dry ingredients (such as salts, sugars, and spices), may be permitted provided the drying time is increased according to the schedule contained in Table 4.

TRICHINAE TREATMENT OF SAUSAGE BY METHOD NO. 6

TABLE 4 REDUCED SALT CONTENT -- DRYING ROOM TIMES

Required Percentage Increase in Drying Room Time (Table 3A) for Added Salt of Less Than 3.33 Pounds per Hundredweight of Sausage.

Minimum Pounds of Salt Added to Sausage n1	Increase in Drying Room Time n2
3.3	1%
3.2	4%
3.1	7%
3.0	10%
2.9	13%
2.8	16%
2.7	19%
2.6	22%
2.5	25%
2.4	28%
2.3	31%
2.2	34%
2.1	37%
2.0	40%

n1 Calculate the salt content for column 1 as follows: Multiply the pounds of salt in the sausage formulation by 100. Then divide this number by the total weight of sausage formulation minus the weight of dry ingredients and round down to the next lowest 0.1%. Percents may be substituted for pounds. Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1 lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium nitrite total 127.872 lbs. 3. 56 x 100) (127.872 - 3.56 - 2 - .8 - .012) = 356/121.5 = 2.93 Therefore, the sausage drying time must be increased by 13 percent.

n2 In computing the days to be added to the required total drying time, fractions shall be rounded to the next higher whole number and added to the required total drying time. Example: Sausage stuffed in 3 1/2 inch diameter casing required 23 days in the drying room (from Drying Room Times). If the quantity of salt added per hundredweight of sausage is 2 pounds instead of 3.33 pounds, the drying room time must be increased by 40 percent (from Reduced Salt Content-Drying Room Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to the 23 days to equal 33 days. The total drying time required in the drying room, therefore, will be 33 days.

318.10(C)(3)(ii)

(ii) Capocollo (capicola, capacola). Boneless pork butts for capocollo shall be cured in a dry-curing mixture containing not less than 4 1/2 pounds of salt per hundredweight of meat for a period of not less than 25 days at a temperature not lower than 36 degrees. F. If the curing materials are applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including, the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be smoked for a period of not less than 30 hours at a temperature not lower than 80 degrees F., and shall finally be held in a drying room not less than 20 days at a temperature not lower than 45 F.

(iii) Coppa. Boneless pork butts for coppa shall be cured in a dry-curing mixture containing not less than 4 1/2 pounds of salt per hundredweight of meat for a period of not less than 18 days at a temperature not lower than 36 F. If the curing mixture is applied to the butts by the process known as churning, a small quantity of pickle may be added. During the curing period the butts may be overhauled according to any of the usual processes of overhauling, including the addition of pickle or dry salt if desired. The butts shall not be subjected during or after curing to any treatment designed to remove salt from the meat, except that superficial washing may be allowed. After being stuffed, the product shall be held in a drying room not less than 35 days at a temperature not lower than 45 F.

(iv) Hams and pork shoulder picnics. In the curing of hams and pork shoulder picnics either of the following methods may be used:

Method No. 1. The hams and pork shoulder picnics shall be cured by a dry-salt curing process not less than 40 days at a temperature not lower than 36 F. The products shall be laid down in salt, not less than 4 pounds to each hundredweight of product, the salt being applied in a thorough manner to the lean meat of each item. When placed in cure the products may be pumped with pickle if desired. At least once during the curing process the products shall be overhauled and additional salt applied, if necessary, so that the lean meat of each item is thoroughly covered. After removal from cure the products may be soaked in water at a temperature not higher than 70 F. for not more than 15 hours, during which time the water may be changed once; but they shall not be subjected to any other treatment designed to remove salt from the meat, except that superficial washing may be allowed. The products shall finally be dried or smoked not less than 10 days at a temperature not lower than 95 F.

Method No. 2. The products shall be cured by a dry-salt curing process at a temperature not lower than 36 F. for a period of not less than 3 days for each pound of weight (green) of the individual items. The time of cure of each lot of such products placed in cure shall be calculated on a basis of the weight of the heaviest item of the lot. Products cured by this method, before they are placed in cure, shall be pumped with pickle solution of not less than 100 strength (salometer), about 4 ounces of the solution being injected into the shank and a like quantity along the flank side of the body bone (femur). The products shall be laid down in salt, not less than 4 pounds of salt to each hundredweight of product, the salt being applied in a thorough manner to the lean of each item. At least once during the curing process the products shall be overhauled and additional salt applied, if necessary, so that the lean meat of each item is thoroughly covered. After removal from the cure the product may be soaked in water at a temperature not higher than 70 F. for not more than 4 hours, but shall not be subjected to any other treatment designed to remove salt from the meat, except that superficial washing may be allowed. The products shall then be dried or smoked not less than 48 hours at a temperature not lower than 80 F., and finally shall be held in a drying room not less than 20 days at a temperature not lower than 45 F.

Method No. 3. Hams and pork shoulders (whether whole shoulder or part) weighing 20 pounds or under shall be cured by a dry salt process for not less than 40 days at a temperature not lower than 35 F. (1.7 C) during which the product is covered with salt. For hams and pork shoulders weighing more than 20 pounds, the time in salt shall be not less than 40 days plus 2 additional days for each pound in excess of 20 pounds. Time in an equalization phase may substitute for time in salt; however, such substitution may not account for more than 10 days. (The term "equalization," as used here, is the process of salt diffusion through the meat after any excess salt has been removed from the surface of the product.) The hams and pork shoulders shall be placed in a quantity of salt sufficient to cover each piece. Additional salt shall be applied thoroughly to the lean meat side of each piece. At least once during the curing process, the hams and pork shoulders shall be turned over and covered with fresh salt. When placed in cure the product may be pumped with a brine solution of not less than 100 degrees strength (salometer). After completion of the salting and equalization process, the hams and pork shoulders may be washed or sprayed to remove the surface salt, but they shall not be subjected to any other treatment designed to remove salt from the meat. After curing, the hams and pork shoulders shall then be dried or smoked, or both, according to the applicable time-temperature schedule contained in Table 5 or in Table 6.

TRICHINA TREATMENT OF UNSMOKED HAMS AND PORK SHOULDERS

Table 5 - DRYING SCHEDULE

Minimum Temperature of Drying Room		Minimum Days in Drying Room After Curing
Degrees Fahrenheit	Degrees Centigrade
130	54.5	1 1/2
125	51.7	2
120	48.9	3
115	46.1	4
110	43.3	5
105	40.6	6
100	37.8	7
95	35.0	9
90	37.2	11
85	29.5	18
80	26.7	25
75	23.9	35
70	21.1	40
65	18.3	53
60	15.6	65
55	12.8	78
50	10.0	90
45	7.2	100
40	4.5	130
35	1.7	160

(v) Boneless pork loins and loin ends. In lieu of heating or refrigerating to destroy possible live trichinae in boneless loins, the loins may be cured for a period of not less than 25 days at a temperature not lower than 36 F. by the use of one of the following methods:

Method No. 1. Application of a dry-salt curing mixture containing not less than 5 pounds of salt to each hundredweight of meats.

Method No. 2. Application of a pickle solution of not less than 80 degrees strength (salometer) on the basis of not less than 60 pounds of pickle to each hundredweight of meat.

Method No. 3. Application of a pickle solution added to the dry-salt cure prescribed as Method No. 1 in this subdivision (v) provided the pickle solution is not less than 80 degrees strength (salometer).

After removal from cure, the loins may be soaked in water for not more than 1 hour at a temperature not higher than 70 degrees F. or washed under a spray but shall not be subjected, during or after the curing process, to any other treatment designed to remove salt.

Following curing, the loins shall be smoked for not less than 12 hours. The minimum temperature of the smokehouse during this period at no time shall be lower than 100 degrees F., and the 4 consecutive hours of this period the smokehouse shall be maintained at a temperature not lower than 125 degrees F.

Finally, the product shall be held in a drying room for a period of not less than 12 days at a temperature not lower than 45 degrees F.

(4) The Head of Service shall consider additional processing methods upon petition by manufacturers, and shall approve any such method upon his/her determination that it can be properly monitored by an inspector and that the safety of such methods is adequately documented by data which has been developed by following an experimental protocol previously reviewed and accepted by the Department.

(D) General instructions: When necessary to comply with the requirements of this section, the smokehouses, drying rooms, and other compartments used in the treatment of pork to destroy possible live trichinae shall be suitably equipped, by the operator of the official establishment, with accurate automatic recording thermometers. Supervisors are authorized to approve for use in sausage smokehouses, drying rooms, and other compartments, such automatic recording thermometers as are found to give satisfactory service and to disapprove and require discontinuance of use, for purposes of the regulations in this subchapter, any thermometers (including any automatic recording thermometers) of the establishment that are found to be inaccurate or unreliable.

(E) The requirements for using the pooled sample digestion technique to analyze pork for the presence of trichina cysts are:

(1) The establishment shall submit for the approval of the Head of Service its proposed procedure for identifying and pooling carcasses, collecting and pooling samples, testing samples (including the name and address of the laboratory), communicating test results, retesting individual carcasses, and maintaining positive identification and clear separation of pork found to be trichina-free from untested pork or trichina-positive pork:.

(2) The establishment shall use the services of a laboratory approved by the Head of Service for all required testing. Such approval shall be based on adequacy of facilities, reagents, and equipment, and on demonstration of continuing competency and reliability in performing the pooled sample digestion technique for trichinae.

(3) The establishment shall sample no less than 5 grams of diaphragm muscle or tongue tissue from each carcass or no less than 10 grams of other muscle tissue. Samples may be pooled but a pool shall not consist of more than 100 grams of sample. Sampling and sample preparation are subject to inspection supervision.

(4) Pork or products made from tested pork shall not be released as trichinae free from the official establishment without treatment until the inspector in charge receives a laboratory report that the tested pork is free of trichina cysts.

(F) Approval of other tests for trichinosis in pork. The Head of Service shall consider any additional analytical method for trichinosis upon petition by a manufacturer, and may approve that method upon the determination that it will detect at least 98 percent of swine bearing cysts present at a tissue density equal to or less than one cyst per gram of muscle from the diaphragm pillars at a 95 percent confidence level. Any such petition shall be supported by any data and other information that the Head of Service finds necessary. Notice of any approval shall be given by the Head of Service, and the approved method will be incorporated into this section.

Section 318.11 Canning with heat processing and hermetically sealed containers: cleaning containers; closure; code marking; heat processing; incubation

(A) Containers which are intended to be hermetically sealed shall be cleaned thoroughly immediately before filling, and precaution must be taken to avoid soiling the inner surfaces subsequently. However, cans in which lard is to be hermetically sealed may be examined immediately before filling and if found to be acceptably clean by a service employee need not be washed.

(B) Containers of metal, glass, or other material shall be washed in an inverted position with a water spray. The nozzle on the spray attachment shall be of such design and the water delivered with such pressure as will effectively rinse all of the inner surface of each container. Such containers shall not contain an accumulation of water when received at the filling station. In lieu of cleaning with water, the use of efficient jet-vacuum type equipment for cleaning containers is permitted, immediately prior to filling.

(C) Nothing less than perfect closure is acceptable for hermetically sealed containers. Heat processing shall follow promptly after closing.

(D) Careful inspection shall be made of the containers by competent establishment employees immediately after closing, and containers which are defectively filled or defectively closed or show inadequate vacuum shall not be processed until the defect has been corrected. The containers shall again be inspected by establishment employees when they have cooled sufficiently for handling after processing by heating. The contents of defective containers shall be condemned unless correction of the defect is accomplished within 6 hours following the sealing of the containers or completion of the heat processing, as the case may be, except that:

(1) If the defective condition is discovered during an afternoon run, the cans of product may be held in coolers at a temperature not exceeding 38 degrees F. under conditions that will promptly and effectively chill them until the following day when the defect may be corrected;

(2) short vacuum or overstuffed cans of product which have not been handled in accordance with subparagraph (1) of this paragraph may be incubated under service supervision, after which the cans shall be opened and the sound product passed for food; and

(3) short vacuum or overstuffed cans of product of a class required to be labeled "Perishable, Keep Under Refrigeration" and which have been kept under adequate refrigeration since processing may be opened and the sound product passed for food.

(E) Canned products shall not be passed unless after cooling to atmospheric temperature, they show the external characteristics of sound cans, that is, the cans shall not be overfilled; they shall have concave sides, excepting the seam side, and all ends shall be concave; there shall be no bulging; the sides and ends shall conform to the product; and there shall be no slack or loose tin.

(F) All canned products shall be plainly and permanently marked on the containers by code or otherwise with the identity of the contents and date of canning. The code used and its meaning shall be on record in the office of the inspector in charge. If calendar dating is used, it must be accompanied by an explanatory statement, as provided in Part 317.8(B)(32)(ii).

(G) Canned product must be processed at such temperature and for such period of time as will assure keeping without refrigeration under usual conditions of storage and transportation when heating is relied on for preservation, with the exception of those canned products which are processed without steam-pressure cooking by permission of the Head of Service in specific cases and labeled "Perishable, Keep Under Refrigeration."

(H) Lots of canned product shall be identified during their handling preparatory to heat processing by tagging the baskets, cages, or cans with a tag which will change color on going through the heat processing or by other effective means so as to positively preclude failure to heat process after closing.

(I) Facilities shall be provided by the operator of the official establishment for incubation of representative samples of fully processed canned product. The incubation shall consist of holding the canned product for the periods of time and at the temperatures prescribed in subparagraph (4) of this paragraph.

(1) Incubation test shall be made to the extent required by the inspector in charge. The extent to which incubation tests shall be required depends on conditions such as the record of the official establishment in conducting canning operations, the extent to which the establishment furnishes competent supervision and inspection in connection with the canning operations, the character of the equipment used, and the degree to which such equipment is maintained at maximum efficiency. Such factors shall be considered by the inspector in determining the extent of incubation testing at a particular establishment.

(2) In the event of failure by an official establishment to provide suitable facilities for incubation of test samples, the inspector may require holding of the entire lot under such conditions and for such period of time as may, in his discretion, be necessary to establish the stability of the product.

(3) The inspector may permit lots of canned product to be shipped from the official establishment prior to completion of sample incubation when he has no reason to suspect unsoundness in the particular lots, and under circumstances which will assure the return of the product to the establishment for reinspection should such action be indicated by the incubation results.

(4) Incubation shall consist of holding the samples at 95 F. (+/- 2 F.) for no less than 10 days; except

(i) Samples of firmly packed products such as luncheon meat, and products with high fat content, such as chorizos packed in lard, and products weighing 3 pounds or more shall be held at 95 F. (+/- 2 F.) for no less than 20 days.

(ii) Samples of products composed of chunks or patties of meat in a medium or sauce wherein the pH of the meat component and the medium or sauce are significantly different shall be incubated at 95 F. (+/- 2 F.) for no less than 30 days.

Section 318.12 Manufacture of dog food or similar uninspected article at official establishments

(A) When dog food, or similar uninspected article is manufactured in an edible product department, there shall be sufficient space allotted and adequate equipment provided so that the manufacture of the uninspected article in no way interferes with the handling or preparation of edible products. Where necessary to avoid adulteration of edible products, separate equipment shall be provided for the uninspected article. To assure the maintenance of sanitary conditions in the edible product departments, the operations incident to the manufacture of the uninspected article will be subject to the same sanitary requirements that apply to all operations in edible product departments. The manufacture of the uninspected article shall be limited to those hours during which the establishment operates under inspectional supervision; and there shall be no handling, other than receiving at the official establishment, of any of the product ingredient of the uninspected article, other than during the regular hours of inspection. The materials used in the manufacture of the uninspected article shall not be used so as to interfere with the inspection of edible product or the maintenance of sanitary conditions in the department or render any edible product adulterated. The meat, meat byproducts, and meat food product ingredients of the uninspected article may be admitted into any edible products department of an official establishment only if they are VT. or U. S. Inspected and Passed. Products within Section 314.11 of this subchapter or parts of carcasses of kinds not permitted under the regulations in this subchapter to be prepared for human food (e.g., lungs, or intestines), which are produced at any official establishment, may be brought into the inedible products department of any official establishment for use in uninspected articles under this section. The uninspected article may be stored in, and distributed from, edible product departments: Provided, that adequate facilities are furnished, there is no interference with the maintenance of sanitary conditions, and such article is properly identified.

(B) When dog food or similar uninspected article is manufactured in a part of an official establishment other than an edible product department, the area in which the article is manufactured shall be separated from edible product departments in the manner required for separation between edible product departments and inedible product departments. Sufficient space must be allotted and adequate equipment provided so that the manufacture of the uninspected article does not interfere with the proper functioning of the other operations at the establishment. Except as provided in Section 314.11 of this subchapter, nothing in this paragraph shall be construed as permitting any deviation from the requirement that dead animals, condemned products, and similar materials of whatever origin, must be placed in the inedible product rendering equipment, and without undue delay. The manufacture of the uninspected article must be such as not to interfere with the maintenance of general sanitary conditions on the premises, and it shall be subject to inspectional supervision similar to that exercised over other inedible product departments. There shall be no movement of any product from an inedible product department to any edible product department. Trucks, barrels, and other equipment shall be cleaned before being returned to edible product department from inedible product departments. Unoffensive material prepared outside edible product departments may be stored in, and distributed from, inedible product departments only if packaged in clean properly identified, sealed containers.

(C) Animal food shall be distinguished from articles of human food, so as to avoid distribution of such animal food as human food. To accomplish this, such animal food shall be labeled or otherwise identified in accordance with Part 325.11(e) of this subchapter.

Section 318.13 Mixtures containing product but not amenable to the Act

Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Service employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of section 318.1.

Section 318.14 Adulteration of product by polluted water; procedure for handling

(A) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.

(B) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein shall under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 parts per million) or other equivalent disinfectant approved by the Head of Service shall be applied to the surface of the rooms and equipment and rinsed with potable water before use.

(C) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:

(1) Separate and condemn all product in damaged or extensively rusted containers.

(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:

(i) Immerse in a solution of sodium hypochlorite containing not less than 100 parts per million of available chlorine or other equivalent disinfectant approved by the Head of Service, rinse in potable water, and dry thoroughly; or

(ii) Immerse in 212 F. water, bring temperature of the water back to 212 F. and maintain the temperature at 212 F. for 5 minutes, then remove containers from water and cool them to 95 F. and dry thoroughly.

(3) After handling as described in subparagraph (2) of this paragraph, the containers may be relacquered, if necessary and then relabeled with approved labels applicable to the product therein.

(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the containers.

Section 318.15 Tagging chemicals, preservatives, cereals, spices, etc, "VT retained"

When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Service employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a "VT Retained" tag to the substance or container thereof. The substance so tagged shall be kept separate from other substances as the Veterinary Supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Service employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.

Section 318.16 Pesticide chemicals and other residues in products

(A) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compliance with the requirements under that Act.

(B) Products, and meat, meat byproduct, or other meat food product ingredients. Products and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.

(C) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Head of Service. Copies of such instructions will be made available to interested persons upon request made to the Head of Service.

Section 318.17 Requirements for the production of cooked beef, roast beef, and cooked corned beef

(A) Cooked beef and roast beef, including sectioned and formed roasts, chunked and formed roasts, and corned beef shall be prepared by one of the time and temperature combinations in the following table. The stated temperature is the minimum which shall be produced and maintained in all parts of each piece of meat for at least the stated time:

TABLE FOR TIME/TEMPERATURE COMBINATION FOR COOKED BEEF, ROAST BEEF, AND COOKED CORNED BEEF
Minimum Internal Temperature		Minimum Processing Time in minutes after minimum temperature is reached
Degrees Fahrenheit	Degrees Centigrade
130	54.4	121
131	55.0	97
132	55.6	77
133	56.1	62
134	56.7	47
135	57.2	37
136	57.8	32
137	58.4	24
138	58.9	19
139	59.5	15
140	60.0	12
141	60.6	10
142	61.1	8
143	61.7	6
144	62.2	5
145	62.8	Instantly

(B) Cooked beef, including sectioned and formed roasts and chunked and formed roasts, and cooked corned beef shall be moist cooked throughout the process or, in the case of roast beef or corned beef to be roasted, cooked as provided in paragraph (c) of this section. The moist cooking may be accomplished by (1) placing the meat in a sealed moisture impermeable bag, removing the excess air, and cooking, (2) completely immersing the meat, unbagged, in water throughout the entire cooking process, or (3) using a sealed over or steam above 90 percent throughout the cooking process.

(C) Roast beef or corned beef to be roasted shall be cooked by one of the following methods:

(1) Heating roasts of 10 pounds or more in an oven maintained at 250 F. (121 C.) or higher throughout the process:

(2) Heating roasts of any size to a minimum internal temperature of 145 F. (62.8 C.) in an oven maintained either by continuously introducing steam for 50 percent of the cooking time or by use of a sealed oven for over 50 percent of the cooking time, or if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour; or

(3) Heating roasts of any size in an oven maintained at any temperature that will satisfy the internal temperature and time requirements or paragraph (a) of this section if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour.

The relative humidity may be achieved by use of steam injection or by sealed ovens capable of producing and maintaining the required relative humidity.

(D)

(1) Except as provided in paragraph (d)(2) of this section, establishments producing cooked beef, roast beef, and cooked corned beef shall have sufficient monitoring equipment, including recording devices, to assure that (within 5 percent) limits required by these processes are being met. Data from the recording devices shall be made available to a Service employee upon request.

(2) In lieu of recording devices, establishments may propose in the written procedures prescribed in paragraph (f) of this section, an alternative means of providing inspection personnel with evidence that finished product has been prepared in compliance with the humidity requirements of paragraphs (b) and (c) of this section, and the 145 F. (62.8 C.) temperature requirements of paragraph (a) of this section.

(E) Each package of finished product shall be plainly and permanently marked on the immediate container with the date of production either in code or with the calendar date.

(F) In order to assure that cooked beef, roast beef, and cooked corned beef are handled, processed, and stored under sanitary conditions, the establishment shall submit a set of written procedures through the inspector in charge for approval by the Head of Service.

(1) The temperature to which raw frozen product is thawed and the time required.

(2) The lot identification procedure for lots of product during processing.

(3) The storage time and temperature combinations which the establishment intends to use before cooking, the cooking time and temperature the establishment intends to use, and the time, if any, the establishment intends to wait after cooking and before cooling.

(4) If a code, instead of a calendar date, is used on the immediate container of the finished product, its meaning shall also be included.

(5) Any other critical control points in the procedures which could affect the safety of the product.

(6) In lieu of recording devices, the alternate means permitted by section 318.17(d)(2) of providing evidence to inspection personnel that the finished product will be prepared in compliance with temperature or humidity requirements.

(7) Any other alternate procedure used that is permitted in this section.

(G) The establishment shall maintain records and reports which document the time, temperature, and humidity at which any cooked beef, roast beef, or cooked corned beef is cooked and cooled at the establishment. Such records shall be kept by the establishment for six months or for such further period as the Commissioner may require for purposes of any investigation or litigation under the Act by written notice to the person required to keep such records. Such records shall be made available to the inspector and any duly authorized representative of the Head of Service upon request.

(H) The handling and processing of cooked beef, roast beef, and cooked corned beef before, during and after cooking shall be such as to prevent the finished product from being adulterated. As a minimum, they shall be controlled as follows:

(1) The establishment shall notify the inspector in charge which processing procedure will be used on each lot, including time and temperature.

(2) In order to assure uniform heat penetration and consequent adequate cooking of each piece of beef, individual pieces of raw product in any one lot shall either not vary in weight by more than 2 pounds or not vary in thickness by more than 2 inches at the thickest part. Alternate methods of assuring uniform heat penetration may be submitted in writing for approval to the Head of Service.

(3) A water-based solution that is used for injecting or immersing the meat shall be refrigerated to 50 F. (10 C) or lower from the time it contacts the meat, and shall be filtered each time it is recirculated or reused.

(4) A nonmeat ingredient, including the water-based solution in (h)(3) above, which has contacted meat shall be discarded at the end of that day's production unless it is in continuous contact with one batch of product.

(5) Product prepared for cooking shall be entered into the cooking cycle within 2 hours of completion of precooking preparation or be placed immediately in a cooler at a temperature of 40 F. (4.4 C.) or lower.

(6) The time and temperature requirements shall be met before any product in the lot is removed from the cooking units. Unless otherwise specified in the written procedures approved in accordance with paragraph (f) of this section, the heat source shall not be shut off until these requirements are met.

(7) Other than incidental contact by water currents during immersion cooking or cooling, product shall be placed so that it does not touch or overlap other products. This provision does not apply to product that is stirred or agitated to assure uniform heat transfer.

(8) Temperature sensing devices shall be so placed that they monitor product in the coldest part of the cooking unit; and when oven temperature is required by paragraph (c) of this section, the oven temperature shall also be monitored in the coldest part of the cooking unit.

(9) If a humidity sensing device is required in an oven, it shall be placed so that it measures humidity in either the oven chamber or at the exit vent.

(10) Chilling shall begin within 90 minutes after the cooking cycle is completed.

(i) All product shall be chilled from 120 F. (48.8 C.) to 55 F. (12.7 C.) in no more than 6 hours.

(ii) Chilling shall continue and the product shall not be packed for shipment until it has reached 40 F. (4.4 C.)

(11) Any establishment that has experienced a cooking process deviation during preparation of product may either reprocess the product completely, continue the heating to 145 F. (62.8 C.), or contact the Head of Service for a review of the process schedule for adequacy and, if needed, for a cooking schedule to finish that one batch of product.

(12) An establishment that has experienced a cooling deviation after the product has been cooked shall contact the Head of Service to determine the disposition of that retained product.

(I) Cooked beef, roast beef, and cooked corned beef shall be so handled as to assure that the product is not recontaminated by direct contact with raw product. To prevent direct contamination of the cooked product, establishments shall:

(1) Physically separate areas where raw product is handled from areas where exposed cooked product is handled, using a solid impervious floor to ceiling wall; or

(2) Handle raw and exposed cooked product at different times, with a cleaning of the entire area after the raw material handling is completed and prior to the handling of cooked product in that area; or

(3) Submit a written procedure for approval through the inspector in charge to the Head of Service detailing the steps to be taken which would avoid recontamination of cooked product by raw product during processing.

(J) To prevent indirect contamination of cooked product:

(1) Any work surface, machine, or tool which contacts raw product shall be thoroughly cleaned and sanitized with a solution germicidally equivalent to 50 ppm chlorine whenever they enter the heat processed product area or before preparing to handle cooked product, and as frequently as necessary during operations to avoid product contamination: and

(2) Outer garments, including aprons, smocks, and gloves shall be especially identified as restricted for use in cooked product areas only, changed at least daily, and hung in a designated location when the employee leaves the area.

(K) Cooked product shall not be stored in the same room as raw product unless it is first packaged in a sealed, water-tight container or is otherwise protected by a covering that has been approved, upon written request, by the Head of Service.

Section 318.18 Handling of certain material for mechanical processing

Material to be processed into "Mechanically Separated (Species)" shall be so processed within 1 hour from the time it is cut or separated from the carcasses or parts of carcasses, except that such product may be held for no more than 72 hours at 40 F. (4 C) or less or held indefinitely at 0 F. (-18 C) or less. "Mechanically Separated (Species)" shall directly after being processed, be used as an ingredient in a meat food product except that it may be held prior to such use for no more than 72 hours at 40 F. (4 C) or less or indefinitely at 0 F. (-18 C) or less.

Section 318.19 Compliance procedure for cured pork products

(A) Definition. For the purposes of this section:

(1) A product is that cured pork article which is contained within one Group as defined in paragraph (a)(2) of this section and which purports to meet the criteria for a single product designated under the heading "Product Name and Qualifying Statements" in the chart in section 319.104 or the chart in section 319.105.

(2) A Product Group or a Group means one of the following:

Group I, consisting of cured pork products which have been cooked while imperviously encased. Any product which fits into the Group will be placed in this Group regardless of any other considerations.

Group II, consisting of cured pork products which have been water cooked. Any product which does not fit into Group I but does fit into Group II will be placed into Group II regardless of any other considerations.

Group III, consisting of boneless smokehouse heated cured pork products. Any boneless product that does not fit into Group I or Group II shall be placed in Group III.

Group IV, consisting of bone-in or semi-boneless smokehouse heated cured pork products. Any product that is not completely boneless or still contains all the bone which is traditional for bone-in product, and does not fit Group I, Group II, or Group III shall be placed in this Group.

(3) A lot is that product from one production shift.

(4) A production rate is frequency of production, expressed in days per week.

(5) Protein fat free percentage. Protein fat free content, PFF percentage. PFF content or PFF of a product means the meat protein (indigenous to the raw, unprocessed pork cut) content expressed as a percent of the non-fat portion of the finished product.

(B) Normal Compliance Procedures. The Department shall collect samples of cured pork products and analyze them for their PFF content. n1 Each analytical result shall be recorded and evaluated to determine whether future sampling of product Groups within an official establishment shall be periodic or daily under the provisions of paragraph (b)(1) of this section, and if the affected lot and subsequent production of like product shall be retained, or administratively detained, as appropriate, as provided in paragraph (b) (2) of this section. n2

n1 Analyses shall be conducted in accordance with "Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC)", 13th ed., 1980, Sections 24.002 (page 376), 24.027 (page 379), which are incorporated by reference.

n2 Rules for Rounding 1. Laboratory results for percent meat protein and fat will be reported to the second decimal place (hundredths). 2. PFF and Sample Values for charting purposes will be calculated from the reported laboratory results to the second decimal place. Rounding of calculations to reach two decimal places will be done by the following rule: All values of five-thousandths (0.005) or more will be rounded up to the next highest hundredth. All values of less than five-thousandths (0.005) will be dropped. 3. For compliance with the Absolute Minimum PFF requirements, the PFF will be rounded to the first decimal (tenths). Rounding of calculations to reach one decimal place will be done by the following rule: All PFF values of five-hundredths (0.05) or more will be rounded up to the next highest tenth. All PFF values of less than five-hundredths (0.05) will dropped. 4. For product disposition (pass-fail of a minimum PFF standard for retained product) the average PFF calculation will be rounded to the first decimal place. Individual PFF Values will be calculated to the nearest hundredth as in (2) above. The average, however, will be rounded to the nearest tenth as in (3) above.

(B)

(1) Criteria to determine sampling frequency of Product Groups.

For each official plant preparing cured pork products, Product Groups shall be sampled periodically or daily. Analytical results shall be evaluated and the sampling frequency determined as follows:

(i) Determine the difference between the individual PFF analysis and the applicable minimum PFF percentage requirements of section 319.104 or section 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(ii) Divide the resulting number by the standard deviation assigned to the Product Group represented by the sample to find the Standardized Difference. The standard deviation assigned to Groups I and II is 0.75 and to Groups III and IV is 0.91.

(iii) Add 0.25 to the Standardized Difference to find the Adjusted Standardized Difference.

(iv) Use the lesser of 1.90 and the Adjusted Standardized Difference as the Sample Value.

(v) Cumulatively total Sample Values to determine the Group Value. The first Sample Value in a Group shall be the Group Value, and each succeeding Group Value shall be determined by adding the most recent Sample Value to the existing Group Value; provided, however, that in no event shall the Group Value exceed 1.00. When calculation of a Group Value results in a figure greater than 1.00, the Group Value shall be 1.00 and all previous Sample Values shall be ignored in determining future Group Values.

(vi) The frequency of sampling of a Group shall be periodic when the Group Value is greater than -1.40 (e.g., -1.39, 11.14, 0, 0.50, etc.) and shall be daily when the Group Value is -1.40 or less (e.g., - 1.40, -1.45, -1.50, etc.); provided, however, that once daily sampling has been initiated, it shall continue until the Group Value is 0.00 or greater, and each of the last seven Sample Values is -1.65 or greater (e.g., -1.63, -1.50, etc.), and there is no other product within the affected Group being U.S. retained as produced, under provisions of paragraph (b)(2) or (c).

(2) Criteria for VT retention or administrative detention of cured pork products for further analysis. Cured pork products shall be retained, or administratively detained, as appropriate, when prescribed by (i) or (ii) below:

(i) Absolute Minimum PFF Requirement. In the event that an analysis of an individual sample indicates a PFF content below the applicable minimum requirement of section 319.104 or Section 319.105 by 2.3 or more percentage points for a Group I or II product, or 2.7 or more percentage points for a Group III or IV product, the lot from which the sample was collected shall be VT. retained if in an official establishment and shall be subject to administrative detention if not in an official establishment unless returned to an official establishment and there VT retained. Any subsequently produced lots of like product for which production dates cannot be established shall be VT. retained or subject to administrative detention. Such administratively detained product shall be handled in accordance with Part 329 of this subchapter, or shall be returned to an official establishment and subjected to the provisions of paragraph (c)(1)((i) or (ii) of this section, or shall be relabeled in compliance with the applicable standard, under the supervision of a program employee, at the expense of the product owner. Disposition of such VT. retained product shall be in accordance with paragraph (C) of this section.

(ii) Product Value requirement. The Department shall maintain, for each product prepared in an official establishment, a Product Value. Except as provided in paragraph (c)(2) of this section, calculation of the Product Value and its use to determine if a product shall be VT. retained shall be as follows:

(A) Determine the difference between the individual PFF analysis and applicable minimum PFF percentage requirement of Section 319.104 and Section 319.105. The resulting figure shall be negative when the individual sample result is less than the applicable minimum PFF percentage requirement and shall be positive when the individual sample result is greater than the applicable minimum PFF percentage requirement.

(B) Divide the difference determined in (A), above, by the standard deviation assigned to the product's Group in paragraph (b)(1) (ii) of this section to find the standardized difference.

(C) Use the lesser of 1.65 and the standardized difference as the Sample Value.

(D) Cumulatively total Sample Values to determine the Product Value. The first Sample Value of a product shall be the Product Value, and each succeeding Product Value shall be determined by adding the most recent Sample Value to the existing Product Value; provided, however, that in no event shall be Product Value exceed 1.15. When calculation of a Product Value results in a figure greater than 1.15, the Product Value shall be 1.15, and all previous Samples Values shall be ignored in determining future Product Values.

(E) Provided daily group sampling is in effect pursuant to the provisions of paragraph (b)(1) of this section, and provided further the Product Value is -1.65 or less (e.g., -1.66), the affected lot (if within the official establishment) and all subsequent lots of like product prepared by and still within the official establishment shall be VT. retained and further evaluated under paragraph (c). Except for release of individual lots pursuant to paragraph (c) (1), subsequently produced lots of like product shall continue to be VT. retained until discontinued pursuant to paragraph (c)(2).

(C) Compliance procedure during product retention. When a product lot is VT. retained under the provisions of paragraph (b)(2) of this section, the Department shall collect three randomly selected samples from each such lot and analyze them individually for PFF content. The PFF content of the three samples shall be evaluated to determine disposition of the lot as provided in paragraph (c)(1) of this section and the action to be taken on subsequently produced lots of like product as provided in paragraph (c)(2) of this section.

(1) A product lot which is VT. retained under the provisions of paragraph (b)(2) of this section may be released for entry into commerce provided one of the following conditions is met:

(i) The average PFF content of the three samples randomly selected from the lot is equal to or greater than the applicable minimum PFF percentage required by Section 319.104 or Section 319.105. Further processing to remove moisture for the purpose of meeting this provision is permissible. In lieu of further analysis to determine the effects of such processing, each 0.37 percent weight reduction due to moisture loss resulting from the processing may be considered the equivalent of a 0.1 percent PFF gain.

(ii) The lot of the product is relabeled to conform to the provision of Section 319.104 or Section 319.105, under the supervision of a program employee.

(iii) The lot is one that has been prepared subsequent to preparation of the lot which, under the provisions of paragraph (c)(2) of this section, resulted in discontinuance of VT. retention of new lots of like product. Such lot may be released for entry into commerce prior to receipt of analytical results for which sampling has been conducted. Upon receipt of such results, they shall be subjected to the provisions of paragraphs (b)(2)(i) and (c)(2) of this section.

(2) The PFF content of three randomly selected samples from each VT. retained lot shall be used to maintain the Product Value described in paragraph (b)(2)(ii).

The manner and effect of such maintenance shall be as follows:

(i) Find the average PFF content of the three samples.

(ii) Determine the difference between that average and the applicable minimum PFF percentage requirement of Section 319.104 or Section 319.105. The resulting figure shall be negative when the average of the sample results is less than the applicable minimum PFF percentage requirement and shall be positive when the average of the sample results is greater than the applicable minimum PFF requirement.

(iii) Divide the resulting figure by the standard deviation assigned to the product's Group in paragraph (b)(1)(ii) of this section, to find the standardized difference.

(iv) Use the lesser of 1.30 and the standardized difference as the Sample Value.

(v) Add the first Sample Value thus calculated to the latest Product Value calculated under the provisions of paragraph (b)(2)(ii) of this section to find the new Product Value. To find each succeeding Product Value, add the most recent Sample Value to the existing Product Value; provided, however, that in no event shall the Product Value exceed 1.15. When the addition of a Sample Value to an existing Product Value results in a figure greater than 1.15, the Product Value shall be 1.15 and all previous Sample Values shall be ignored in determining future Product Values.

(vi) New lots of like product shall continue to be retained pending disposition in accordance with paragraph (c)(1) of this section until, after 5 days of production, the Product Value is 0.00 or greater, and the PFF content of no individual sample from a VT. retained lot is less than the Absolute Minimum PFF requirement specified in paragraph (b)(2)(i) of this section.

Should an individual sample fail to meet its Absolute Minimum PFF requirement, the 5-day count shall begin anew.

(vii) When VT. retention of new lots is discontinued under the above provisions, maintenance of the Product Value shall revert to the provisions of paragraph (b)(2)(ii) of this section.

(3) For purposes of this section, the plant owner or operator shall have the option of temporarily removing from its Product Group, provided product lots are being VT. retained, as produced, and provided further that the average production rate of the product, over the 8-week period preceding the week in which the first VT. retained lot was prepared, is not greater than 20 percent of the production rate of its Group. When a product is thus removed from its Group, analytical results of product samples shall not cause daily sampling of the Group. When pursuant to paragraph (c)(2)(vi) of this section, new lots of the product are no longer being VT. retained, the product shall again be considered with its Group.

(D) Adulterated and misbranded products. Products not meeting specified PFF requirements, determined according to procedures set forth in this section, may be deemed adulterated under section 1(m)(8) of the Act ( 21 U.S.C. 601(m)(8) and misbranded under section 1(n) of the Act ( 21 U.S.C. 601(n).

(E) Quality control. Cured pork products bearing on their labeling the statement "X% of Weight is Added Ingredients" shall be prepared only under a total quality control system or partial quality control program in accordance with section 318.4 of this subchapter. With respect to any other cured pork product, official establishments may institute quality control procedures under section 318.4 of this subchapter. Cured pork products produced in such establishments may be exempt from the requirements of this section, provided inplant quality control procedures are shown to attain the same or higher degree of compliance as the procedures set forth in this section; provided, however, that all cured pork products produced shall be subject to the applicable Absolute Minimum PFF content requirement, regardless of any quality control procedures in effect.

Section 318.20 Use of animal drugs

Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by the Food and Drug Administration, unless otherwise determined by the Administrator and listed herein.

Part 319 DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

Section 319.1 Labeling and preparation of standardized products

Labels for products for which standards of identity or composition are prescribed in this part shall show the appropriate product name, and ingredient statement, and other label information in accordance with the special provisions, if any, in this part, and otherwise in accordance with the general labeling provisions in part 317 of this subchapter, and such products shall be prepared in accordance with the special provisions, if any, in this part and otherwise in accordance with the general provisions in this subchapter. Any product for which there is a common or usual name must consist of ingredients and be prepared by the use of procedures common or usual to such products insofar as specific ingredients or procedures are not prescribed or prohibited by the provisions of this subchapter.

Section 319.2 Products and nitrates and nitrites

Any product, such as frankfurters and corned beef, for which there is a standard in this Part and to which nitrate or nitrite is permitted or required to be added, may be prepared without nitrate or nitrite and labeled with such standard name when immediately preceded with the term "Uncured" in the same size and style of lettering as the rest of such standard name: Provided, that the product is found by the Head of Service to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate and nitrite: And provided further, That labeling for such product complies with the provisions of Section 317.17(c) of this subchapter.

Section 319.3 - 319.4 Reserved

Section 319.5 Mechanically Separated (Species)

(A) Mechanically Separated (Species) is any finely comminuted product resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of livestock carcasses and parts of carcasses and meeting the other provisions of this paragraph. Examples of such product are "Mechanically Separated Beef", "Mechanically Separated Veal", "Mechanically Separated Pork", and "Mechanically Separated Lamb". At least 98 percent of the bone particles present in such product shall have a maximum size no greater than 0.5 millimeter in their greatest dimension and there shall be no bone particles larger than 0.85 millimeter in their greatest dimension. The product resulting from the separating process shall not have a calcium content exceeding 0.75 percent, as a measure of a bone solids content of not more than 3 percent, and shall have a minimum PER of 2.5 (except as modified in paragraph (e)(1) of this section). Such product also shall have a protein content of not less than 14 percent and a fat content of not more than 30 percent, or it shall be deemed to be product for processing. Such product failing to meet the bone particle size, calcium, or PER requirements of this paragraph shall only be used in producing animal fats. Where such product meets the bone particle size, calcium, and PER requirements of this paragraph, it may also be used in the formulation of meat food products in accordance with Section 319.6.

(B)-(D) Reserved

(E)

(1) An essential amino acid content of at least 33 percent of the total amino acids present in "Mechanically Separated (Species)" shall be accepted as evidence of compliance with the protein quality requirement set forth in paragraph (a) of this section. For purposes of this paragraph, essential amino acid content includes isoleucine, leucine, lysine, methionine, phenylalanine, threonine, and valine content, and the total amino acids present include isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine, tyrosine, arginine, histidine, alanine, aspartic acid, glutamic acid, glycine, proline, serine, and hydroxyproline content.

(2) A prerequisite for label approval for products consisting of or containing "Mechanically Separated (Species)" is that such "Mechanically Separated (Species)" shall have been produced by an establishment under an approved plant quality control system. The Head of Service shall receive, evaluate, and approve requests for plant quality control in accordance with Section 318.4(d)(1) and (2) and (e) of this subchapter. Such a plant quality control system shall provide the controls and information necessary to assure that the product will meet the requirements described in Section 319.5(a) and to enable establishment personnel and program employees to monitor the system for effectiveness. The system shall include a written description of the methods used by the establishment to maintain uniformity of the raw ingredients used in manufacturing product, to control the handling and processing of the raw ingredients and the finished product, and shall contain provisions for chemical analyses of the product and other procedures to determine and assure compliance with standards for the product. For purposes of this paragraph, a lot shall consist of the "Mechanically Separated (Species)" designated as such by the operator of the establishment or his or her agent from the product produced from a single species of livestock in no more than one continuous shift of up to 12 hours. All units of any lot must be available for inspection by program employees. Analysis of a sample of at least 1 pound from each lot to verify contents of fat, protein, and calcium in "Mechanically Separated (Species)" shall be performed by the operator of the establishment or his or her agent to assure that finished product will meet the requirements in Section 319.5(a), except that such analyses with respect to fat, protein, and calcium content shall be required to be performed with respect to fat, protein, and calcium content shall be required to be performed with respect to only one randomly selected lot of every five lots if the preceding ten analyses and all such analyses performed by the Department during the preceding ten analyses period establish compliance with the requirements of Section 319.5(a), and that no analyses with respect to fat or protein content shall be required where the finished product is represented as product for processing. An analysis of a sample of at least 1 pound to verify contents of fat, protein, and calcium in "Mechanically Separated (Species)" shall be performed by the operator of the establishment or his/her agent at the rate of at least one per month during production to assure that finished product will meet the requirements of Section 319.5(a), except that such analyses with respect to essential amino acid content and/or protein efficiency ratio shall be required to be performed only once every 6 months if the preceding three analyses and all such analyses performed by the Department during the preceding three analyses period establish compliance with the requirements of Section 319.5(a). The method of analysis of finished product samples shall be approved by the Head of Service, who may require evidence of reliability to be submitted. The plant quality control system shall be subject to periodic review, and the approval of such system may be terminated in accordance with Section 318.4(g)(2) of this subchapter.

Section 319.6 Limitations with respect to use of Mechanically Separated (Species)

(A) Meat food products required to be prepared from one species shall not contain Mechanically Separated (Species) of any other species.

(B) Mechanically Separated (Species) described in Section 319.5 that has a protein content of not less than 14 percent and a fat content of not more than 30 percent may constitute up to 20 percent of the livestock and poultry product portion of any meat food product except those listed in paragraph (d) of this section.

(C) Mechanically Separated (Species) for processing described in Section 319.5 may constitute up to 20 percent of the livestock and poultry product portion of any meat food product that is subject to a definition and standard of identity or composition in Part 319 which establishes a maximum limit on the fat content of such meat food product except those listed in paragraph (d) of this section.

(D) Mechanically Separated (Species) and Mechanically Separated (Species) for processing described in Section 319.5 shall not be used in baby, junior or toddler foods, ground beef, hamburger, fabricated steaks ( Section 319.15(a), (b), and (d), barbecued meats ( Section 319.80), roast beef-parboiled and steam roasted ( Section 319.81), corned (cured) beef cuts ( Sections 319.100 and 319.103), certain cured pork products ( Sections 319.104(a)-(e) and 319.106), tripe with milk ( Section 319.308), lima beans with ham and similar products ( Section 319.310), beef with gravy and gravy with beef ( Section 319.313), and meat pies ( Section 319.500).

Section 319.15 Miscellaneous beef products

(A) Chopped beef, ground beef. "Chopped Beef" or "Ground Beef" shall consist of chopped fresh and/or frozen beef with or without seasoning and without the addition of beef fat as such, shall not contain more than 30 percent fat, and shall not contain added water, phosphates, binders, heart meat, or extenders. When beef cheek meat (trimmed beef cheeks) is used in the preparation of chopped or ground beef, the amount of such cheek meat shall be limited to 25 percent; and if in excess of natural proportions, its presence shall be declared on the label, in the ingredient statement required by Section 317.2 of this subchapter, if any, and otherwise contiguous to the name of the product.

(B) Hamburger. "Hamburger" shall consist of chopped fresh and/or frozen beef with or without the addition of beef fat as such and/or seasoning, shall not contain more than 30 percent fat, and shall not contain added water, phosphates, binders, heart meat, or extenders. Beef cheek meat (trimmed beef cheeks) may be used in the preparation of hamburger only in accordance with the conditions prescribed in paragraph (a) of this section. The term "burger" shall not be used with or without a prefix for any chopped or ground fresh and/or frozen beef product unless such product is in compliance with this subsection.

(C) Beef patties. "Beef Patties" shall consist of chopped fresh and/or frozen beef with or without the addition of beef fat as such and/or seasonings. Binders or extenders, Mechanically Separated (Species) used in accordance with Section 319.6, and/or partially defatted beef fatty tissue may be used without added water or with added water only in amounts such that the product's characteristics are essentially that of a meat pattie. "Beef Patties" shall not contain heart meat.

(D) Fabricated Steak. Fabricated beef steaks, veal steaks, beef and veal steaks, or veal and beef steaks, and similar products, such as those labeled "Beef Steak, Chopped, Shaped, Frozen," "Minute Steak, Formed, Wafer Sliced, Frozen," "Veal Steaks, Beef Added, Chopped-Molded-Cubed-Frozen, Hydrolyzed Plant Protein, and Flavoring" shall be prepared by comminuting and forming the product from fresh and/or frozen meat, with or without added fat, of the species indicated on the label. Such products shall not contain more than 30 percent fat and shall not contain added water, heart meat, binders or extenders. Beef cheek meat (trimmed beef cheeks) may be used in the preparation of fabricated beef steaks only in accordance with the conditions prescribed in paragraph (a) of this section.

(E) Partially defatted beef fatty tissue. "Partially Defatted Beef Fatty Tissue" is a beef byproduct derived from the low temperature rendering (not exceeding 120 F.) of fresh beef fatty tissue. Such product shall have a pinkish color and a fresh odor and appearance.

Section 319.29 Miscellaneous pork products

(A) Partially defatted pork fatty tissue. "Partially Defatted Pork Fatty Tissue" is a pork by product derived from the low temperature rendering (not exceeding 120 F.) of fresh pork fatty tissue, exclusive of skin. Such product shall have a pinkish color and a fresh odor and appearance.

Section 319.80 Barbecued meats

Barbecued meats, such as product labeled "Beef Barbecue" or "Barbecued Pork," shall be cooked by the direct action of dry heat resulting from the burning of hard wood or the hot coals therefrom for a sufficient period to assume the usual characteristics of a barbecued article, which include the formation of a brown crust on the surface and the rendering of surface fat. The product may be basted with a sauce during the cooking process. The weight of barbecued meat shall not exceed 70 percent of the weight of the fresh uncooked meat.

Section 319.81 Roast beef parboiled and steam roasted

"Roast Beef Parboiled and Steam Roasted" shall be prepared so that the weight of the finished product, excluding salt and flavoring material, shall not exceed 70 percent of the fresh beef weight. Beef cheek meat and beef head meat from which the overlying glandular and connective tissues have been removed, and beef heart meat, exclusive of the heart cap may be used individually or collectively to the extent of 5 percent of the meat ingredients in the preparation of canned product labeled "Roast Beef Parboiled and Steam Roasted." When beef cheek meat, beef head meat, or beef heart meat is used in the preparation of this product, its presence shall be reflected in the statement of ingredients required by Part 317 of this subchapter.

Section 319.100 Corned beef

"Corned Beef" shall be prepared from beef briskets, navels, clods, middle ribs, rounds, rumps, or similar cuts using one or a combination of the curing ingredients specified in Section 318.7(c)(1) and (4) of this subchapter. Canned product labeled "Corned Beef" shall be prepared so that the weight of the finished product, excluding cure, salt, and flavoring material, shall not exceed 70 percent of the fresh beef weight. Corned beef other than canned shall be cured in pieces weighing not less than 1 pound, and if cooked, its weight shall not exceed the weight of the fresh uncured beef. Beef cheek meat, beef head meat and beef heart meat may be used to the extent of 5 percent of the meat ingredient in preparation of this product when trimmed as specified in Section 319.81. When beef cheek meat, beef head meat, or beef heart meat is used in preparation of this product, its presence shall be reflected in the statement of ingredients required by Part 317 of this subchapter. The application of curing solution to beef cuts, other than briskets, which are intended for bulk corned beef shall not result in an increase in the weight of finished cured product of more than 10 percent over the weight of the fresh uncured meat.

Section 319.101 Corned beef brisket

In preparing "Corned Beef Brisket," the application of curing solution to the beef brisket shall not result in an increase in the weight of the finished cured product of more than 20 percent over the weight of the fresh uncured brisket. If the product is cooked, the weight of the finished product shall not exceed the weight of the fresh uncured brisket.

Section 319.102 Corned beef round and other corned beef cuts

In preparing "Corned Beef Round" and other corned beef cuts, except "Corned Beef Briskets," the curing solution shall be applied to pieces of beef weighing not less than one pound and such application shall not result in an increased weight of the cured beef product of more than 10 percent over the weight of the fresh uncured beef cut. If the product is cooked, the weight of the finished product shall not exceed the weight of the fresh uncured beef cut.

Section 319.103 Cured beef tongue

In preparing "Cured Beef Tongue," the application of curing solution to the fresh beef tongue shall not result in an increase in the weight of the cured beef tongue of more than 10 percent over the weight of the fresh uncured beef tongue.

Section 319.104 Cured pork products, unsmoked and smoked

(A) Cured pork products, including hams, shoulders, picnics, butts and loins shall comply with the minimum Protein Fat Free (PFF) percentage requirements set forth in the following chart.

Type of Cured Pork Product	Minimum Meat PFF	Product Name and
Percentage n1	Qualifying Statements
Cooked ham, loin n2	20.5	(common and usual)
18.5	(common and usual) With Natural Juices
17.0	(common and usual) Water Added
Less than 17.0	(common and usual) and Water Product -- X% of Weight is Added Ingredients n3
Cooked shoulder, butt, picnic n2	20.0	(common and usual)
18.0	(common and usual) With Natural Juices
16.5	(common and usual) Water Added
Less than 16.5	(common and usual) and Water Product - -X% of Weight is Added Ingredients n3
Uncooked cured ham, loin	18.0	Uncooked (common and usual)
Less than 18.0	Uncooked (common and usual) and Water Product - -X% of Weight is Added Ingredients n3
Uncooked cured shoulder, butt, picnic	17.5	Uncooked (common and usual)
Less than 17.5	Uncooked (common and unusual) and Water Product -- X% of Weight is Added Ingredients n3

n1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw, unprocessed pork expressed as a percent of the non-fat portion of the finished product; and compliance shall be determined under section 318.19 of this subchapter for domestic cured pork product and section 327.23 of this subchapter for imported cured pork product.

n2 The term "cooked" is not appropriate for use on labels of cured pork products heated only for the purpose of destruction of possible live trichinae.

n3 Processors may immediately follow this qualifying statement with a list of the ingredients in descending order of predominance rather than having the traditional ingredients statement. In any case, the maximum percent of added substances in the finished product on a total weight percentage basis would be inserted as the X value; e.g., Ham and Water Product -- 20% of Weight is Added Ingredients. A prerequisite for label approval of these products is a quality control program approved by the Administrator under section 318.4 of this subchapter.

(B) Cured pork products for which there is a qualifying statement required in paragraph (a) of this section shall bear that statement as part of the product name in lettering not less than 3/8 inch in height. However, the Administrator may approve smaller lettering for labeling of packages of 1 pound or less, provided such lettering is at least one-third the size and of the same color and style as the product name. If the cured pork product is not placed in a consumersize package and labeled in accordance with all other provisions of this part, such product shall be marked with the qualifying statement the full length of the product.

(C) Cured pork product prepared pursuant to this section shall be subject to the compliance procedures in section 318.19 of this subchapter.

Section 319.105 "Ham patties," "Chopped ham," "Pressed ham," "Spiced ham," and similar products

(A) Finely divided (chopped, ground, flaked, chipped) cured ham products such as "Ham patties," "Chopped ham," "Pressed ham," and "Spiced ham" shall comply with minimum meat Protein Fat Free (PFF) percentage requirements set forth in the following chart:

Type of Cured Pork Product	Minimum Meat PFF Percentage n1	Product Name and Qualifying Statements
"Ham Patties"	19.5	(common and usual)
"Chopped Ham"
"Pressed Ham," and
"Spiced Ham"
"Ham Patties"	17.5	(common and usual)
"Chopped Ham"	With Natural Juices
"Pressed Ham," and
"Spiced Ham"
"Ham Patties"			16.0	(common and usual)
"Chopped Ham"	Water added
"Pressed Ham," and
"Spiced Ham"
"Ham Patties"			Less than 16.0	(common and usual)
"Chopped Ham"	and Water Product --
"Pressed Ham," and	(x)% of Weight is
"Spiced Ham"	Added Ingredients n2

n1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw, unprocessed pork expressed as a percent of the nonfat portion of the finished product; and compliance shall be determined under section 318.19 of this subchapter.

n2 Processors may immediately follow this qualifying statement with a list of the ingredients in descending order of predominance rather than having the traditional ingredients statement. In any case, the maximum percent of added substances in the finished product on a total weight percentage basis would be inserted as the x value; e.g., Ham and Water Product -- 20% of Weight is Added Ingredients. A prerequisite for label approval of these products is a quality control program approved by the Head of Service under section 318.4 of this subchapter.

(B) Cured pork products prepared under this section except "Ham patties" may contain finely chopped ham shank meat to the extent of 25 percent over that normally present in boneless ham. Mechanically Separated (Species) Product may be used in accordance with section 319.6.

(C) Cured pork product prepared pursuant to this section shall be subject to the compliance procedures in section 318.19 of this subchapter, and those cured pork products prepared under this section for which there is a qualifying statement required shall comply with the requirements of section 319.104(b) of this subchapter.

(D) In addition to the other requirements of this section, "Chopped Ham" may contain up to 2 percent, on a dry basis, of sweetener solid or liquid, such a corn syrup solids or corn syrup.

(E) In addition to the other requirements of this section, "Ham Patties" may not contain more than 35 percent fat, by analysis.

Section 319.106 "Country Ham," "Country Style Ham," "Dry Cured Ham," "Country Pork Shoulder," "Country Style Pork Shoulder," and "Dry Cured Pork Shoulder"

(A) "Country Ham," "Country Style Ham," or "Dry Cured Ham," and "Country Pork Shoulder," "Country Style Pork Shoulder," or "Dry Cured Pork Shoulder," are the uncooked, cured, dried, smoked or unsmoked meat food products made respectively from a single piece of meat conforming to the definition of "ham," as specified in section 317.8(b)(13) of this subchapter, or from a single piece of meat from a pork shoulder. They are prepared in accordance with paragraph (c) of this section by the dry application of salt (NaC1), or by the dry application of salt (NaC1) and one or more of the optional ingredients as specified in paragraph (d) of this section. They may not be injected with curing solutions nor placed in curing solutions.

(B) The product must be treated for the destruction of possible live trichinae in accordance with such methods as may be approved by the Head of Service upon request in specific instances and none of the provisions of this standard can be interpreted as discharging trichinae treatment requirements.

(C)

(1) The entire exterior of the ham or pork shoulder shall be coated by the dry application of salt or by the dry application of salt combined with other ingredients as permitted in paragraph (d) of this section.

(2) Additional salt, or salt mixed with other permitted ingredients, may be reapplied to the product as necessary to insure complete penetration.

(3) When sodium or potassium nitrate, or sodium or potassium nitrite, or a combination thereof, is used, the application of salt shall be in sufficient quantity to insure that the finished product has an internal salt content of at least 4 percent.

(4) When no sodium nitrate, potassium nitrate, sodium nitrite, potassium nitrite or a combination thereof is used, the application of salt shall be in sufficient quantity to insure that the finished product has a brine concentration of not less than 10 percent or a water activity of not more than 0.92.

(5) For hams or pork shoulders labeled "country" or "country style," the combined period for curing and salt equalization shall not be less than 45 days for hams, and shall not be less than 24 days for pork shoulders; the total time for curing, salt equalization, and drying shall not be less than 70 days for hams, and shall not be less than 50 days for pork shoulders. During the drying and smoking period, the internal temperature of the product must not exceed 95 F., provided that such temperature requirement shall not apply to product dried or smoked under natural climatic conditions.

(6) For hams or pork shoulders labeled "dry cured," the combined period for curing and salt equalization, and drying shall not be less than 55 days for hams and shall not be less than 40 days for pork shoulders.

(7) The weight of the finished hams and pork shoulders covered in this section shall be at least 18 percent less than the fresh uncured weight of the article.

(d) The optional ingredients for products covered in this section are:

(1) Nutritive sweeteners, spices, seasonings and flavorings.

(2) Sodium or potassium nitrate and sodium or potassium nitrite if used as prescribed in this section and in accordance with section 318.7(c)(4) of this subchapter.

Note:

On January 6, 1981, FSIS announced that the temperature and time period provisions of Section 319.106(c)(5) and (c)(6) have not been in effect since November 17, 1980, and will not be enforced pending future Agency action in the matter. However, ham and pork shoulders must continue to be prepared in compliance with all other provisions in Section 319.106 in order to be labeled "country ham," "country style ham," or "dry cured ham," and "country pork shoulder," "country style pork shoulder," or "dry cured pork shoulder."

Section 319.107 Bacon

The weight of cured pork bellies ready for slicing and labeling as "Bacon" shall not exceed the weight of the fresh uncured pork bellies.

Section 319.140 Sausage

(a) Except as otherwise provided in this section, or under the Poultry Products Inspection Act with respect to products consisting partly of poultry, sausage is the coarse or finely comminuted meat food product prepared from one or more kinds of meat or meat and meat by products, containing various amounts of water as provided for elsewhere in this part, and usually seasoned with condimented proportions of condimental substances, and frequently cured.

(b) Certain sausage as provided for elsewhere in this part may contain binders and extenders; e.g., cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, nonfat dry milk, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, calcium reduced dried skim milk, enzyme, (rennet) treated calcium reduce dried skim milk, and calcium lactate or dried milk. The finished product shall contain no more than 3.5 percent of these additives individually or collectively. Two percent of isolated soy protein shall be deemed equivalent to 3 1/2 percent of any one or more of these binders. Sausage may not contain phosphates except that phosphates listed in Part 318.7(c)(4) of this subchapter may be used in cooked sausage. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of sausage which is not cooked in an amount not to exceed 3 percent of the total ingredients in the formula. Cooked sausages such as Polish sausage, cotto salami, braunschweiger, liver sausage, and similar cooked sausage products may contain no more than 10 percent of added water in the finished product. Sausage may contain Mechanically Separated (Species) used in accordance with Part 319.6.

Section 319.141 Fresh pork sausage

"Fresh Pork Sausage" is sausage prepared with fresh pork or frozen pork, or both, not including pork byproducts, and may contain Mechanically Separated (Species) in accordance with Section 319.6 and may be seasoned with condimental substances as permitted under Part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Section 319.142 Fresh beef sausage

"Fresh Beef Sausage" is sausage prepared with fresh beef or frozen beef, or both, but not including beef byproducts, and may contain Mechanically Separated (Species) used in accordance with Section 319.6, and may be seasoned with condimental substances as permitted under Part 318 of this subchapter. The finished product shall not contain more than 30 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Section 319.143 Breakfast sausage

"Breakfast Sausage" is sausage prepared with fresh and/or frozen meat; and meat byproducts, and may contain Mechanically Separated (Species) in accordance with Section 319.6, and may be seasoned with condimental substances as permitted in Part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used. Extenders or binders as listed in Part 318 of this subchapter may be used to the extent of 3 1/2 percent of the finished sausage as permitted in Section 319.140.

Section 319.144 Whole hog sausage

"Whole Hog Sausage" is sausage prepared with fresh and/or frozen meat from swine in such proportions as are normal to a single animal, and may include any Mechanically Separated (Species) produced from the animal and used in accordance with Section 319.6, and may be seasoned with condimental substances as permitted in Part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Section 319.145 Italian sausage products

(a) Italian sausage products are uncured, unsmoked sausages containing at least 85 percent meat, or combination of meat and fat, with the total fat content constituting not more than 35 percent of the finished product. Such products shall be prepared in accordance with the provisions of paragraphs (a)(1), (2), or (3) of this section, and shall contain salt, pepper, and either fennel or anise, or a combination of fennel and anise. Such products may contain any or all of the optional ingredients listed in paragraph (b) of this section.

(1) "Italian Sausage" shall be prepared with fresh or frozen pork, or pork and pork fat, and may contain Mechanically Separated (Species) in accordance with Section 319.6.

(2) "Italian Sausage with Beef," Italian Sausage with Veal," or "Italian Sausage with Beef and Veal" shall be prepared so that fresh or frozen pork constitutes the major portion of the meat content requirement of this paragraph. Mechanically Separated (Species) may be used in accordance with Section 319.6. When pork muscle tissue is combined with beef or veal, or both, in the preparation of bulk-packed products, or patties, it shall be treated for the destruction of possible live trichinae in accordance with Section 318.10 of this subchapter.

(3) "Italian Beef Sausage" or "Kosher Italian Beef Sausage" shall be prepared with fresh or frozen beef or beef and beef fat. "Italian Veal Sausage" or "Kosher Italian Veal Sausage" shall be prepared with fresh or frozen veal or veal and veal fat. Mechanically Separated (Species) may be used in accordance with Section 319.6.

(b) Optional ingredients permitted in Italian sausage products include:

(1) Spices (including paprika) and flavorings.

(2) Water or ice to facilitate chopping or mixing, but not to exceed 3 percent of the total weight of all ingredients including the water.

(3) Red or green peppers, or both.

(4) Dehydrated or fresh onions, garlic, and parsley.

(5) Sugar, dextrose, corn syrup, corn syrup solids, and glucose syrup.

(6) Monosodium glutamate and antioxidants in accordance with the chart of substances in Section 318.7(c)(4) of this subchapter.

(c) If Italian sausage products are cooked, determination of compliance with the provisions of paragraphs (a) and (b) of this section shall be based on the uncooked product.

Section 319.160 Smoked pork sausage

"Smoked Pork Sausage" is pork sausage that is smoked with hardwood or other approved nonresinous materials. It may be seasoned with condimental substances as permitted in Part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Section 319.180 Frankfurter, frank, further, hotdog, wiener, vienna, bologna, garlic bologna, knockwurst and similar products

(a) Frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages are comminuted, semi-solid sausages prepared from one or more kinds or raw skeletal muscle meat or raw skeletal muscle meat and raw or cooked poultry meat, and seasoned and cured, using one or more of the curing agents in accordance with Section 318.7(c) of this chapter. They may or may not be smoked. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve the curing ingredients but the sausage shall contain no more than 10 percent of added water. These sausage products may contain only phosphates approved under Part 318 of this chapter. Such products may contain raw or cooked poultry meat not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and Mechanically Separated (Species) used in accordance with Section 319.6. Such poultry meat ingredients shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of Section 381.118 of this chapter.

(b) Frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages that are labeled with the phrase "with byproducts" or "with variety meats" in the product name are comminuted, semi-solid sausages consisting of not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts, or not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts and raw or cooked poultry products; and seasoned and cured, using one or more of the curing ingredients in accordance with Section 318.7(c) of this chapter. They may or may not be smoked. Partially defatted pork fatty tissue or partially defatted beef fatty tissue, or a combination of both, may be used in an amount not exceeding 15 percent of the meat and meat by products or meat, meat byproducts, and poultry ingredients. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve the curing and seasoning ingredients, but the sausage shall contain no more than 10 percent of added water. These sausage products may contain only phosphates approved under Part 318 of this chapter. These sausage products may contain poultry products, individually or in combination, not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and may contain Mechanically Separated (Species) Product in accordance with Section 319.6. Such poultry products shall not contain kidneys or sex glands. The amount of poultry skin present in the sausage must not exceed the natural proportion of skin present on the whole carcass of the kind of poultry used in the sausage, as specified in Section 381.117(d) of this chapter. The poultry products used in the sausage shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of Section 381.118 of this chapter. Meat byproducts used in sausage shall be designated individually in the ingredient statement on the label for such sausage in accordance with Section 317.2 of this chapter.

(c) A cooked sausage as defined in paragraph (a) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst. When such sausage products are prepared with meat from a single species of cattle, sheep, swine, or goats they shall be labeled with the term designating the particular species in conjunction with the generic name; e.g., "Beef Frankfurter," and when such sausage products are prepared in part with Mechanically Separated (Species) Product in accordance with Section 319.6, they shall be labeled in accordance with Section 317.2(j)(13) of this subchapter.

(d) A cooked sausage as defined in paragraph (b) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst, in conjunction with the phrase "with by products" or "with variety meats" with such supplemental phrase shown in a prominent manner directly contiguous to the generic name and in the same color on an identical background.

(e) With appropriate labeling as required by Section 317.8(b)(16) of this chapter, e.g., Frankfurter, Calcium Reduced Dried Skim Milk Added," or "Bologna, with Byproducts (or Variety Meats), Soy Flour Added," one or more of the following binders may be used in cooked sausage otherwise complying with paragraph (a) or (b) of this section: dried milk, calcium reduced dried skim milk, enzyme (rennet) treated calcium reduced dried skim milk and calcium lactate, nonfat dry milk, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate and isolated soy protein, provided such ingredients, individually or collectively, do not exceed 3 1/2 percent of the finished product, except that 2 percent of isolated soy protein shall be deemed to be the equivalent of 3 1/2 percent of any one or more of the other binders.

(f) Cooked sausages shall not be labeled with terms such as "All Meat" or "All (Species)," otherwise to indicate they do not contain nonmeat ingredients or are prepared only from meat.

(g) For the purpose of this section: Poultry meat means deboned chicken meat, turkey meat, or both, without skin or added fat; poultry products mean chicken or turkey, or chicken meat as defined in Section 381.118 of this chapter, or poultry byproducts as defined in Section 381.1 of this chapter; and meat byproducts (or variety meats) mean pork stomachs or snouts; beef, veal, lamb or goat tripe; beef, veal, lamb, goat or pork hearts, tongues, fat, lips, weasands and spleens; and partially defatted pork fatty tissue, or partially defatted beef fatty tissue.

Section 319.181 Cheesefurters and similar products

"Cheesefurters" and similar products are products in casings which resemble frankfurters except that they contain sufficient cheese to give definite characteristics to the finished article. They may contain cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, nonfat dry milk, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, calcium reduced dried skim milk, enzyme (rennet) treated calcium reduced dried skim mild and calcium lactate, or dried milk. The finished product shall contain no more than 3.5 percent of these additives, individually and collectively, exclusive of the cheese constituent. In determining the maximum amount of the ingredients specified in this subparagraph which may be used individually and collectively, in a product, 2 percent of isolated soy protein shall be considered the equivalent of 3.5 percent of any other ingredient specified in this subparagraph. When any such additive is added to these products, there shall appear on the label in a prominent manner, contiguous to the name of the product, the name of each such added ingredient, as for example, "Cereal Added," "With Cereal," "Potato Flour Added," "Cereal and Potato Flour Added," "Soy Flour Added," "Nonfat Dry Milk Added," "Cereal and Nonfat Dry Milk Added," as the case may be. These products shall contain no more than 10 percent of added water and/or ice, 30 percent fat and shall comply with the other provisions for cooked sausages that are in this subchapter.

Section 319.182 Braunschweiger and liver sausage or liverwurst

(a) "Braunschweiger" is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal livers computed on the weight of the fresh livers. It may also contain pork and/or beef fat. Mechanically Separated (Species) may be used in accordance with Section 319.6. Binders and extenders may be used as permitted in Section 319.140. The product may have a smoked taste characteristic, which may be imparted by use of smoked meats, smoke flavoring or smoking. If prepared from components of a single species, the product name may reflect the species, e.g., "Beef Braunschweiger." Braunschweiger may also be labeled as any of the following: "Braunschweiger -- A Liver Sausage," "Braunschweiger -- A Liverwurst," or "Braunschweiger (Liver Sausage)" or "Braunschweiger (Liverwurst)."

(b) "Liver Sausage" or "Liverwurst" is cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 percent pork, beef, veal, sheep, and/or goat livers computed on the weight of the fresh livers. It may also contain pork and/or beef byproducts. Mechanically Separated (Species) may be used in accordance with 319.6. Binders and extenders may be used as permitted in Section 319.140. If prepared from components of a single species, the product name may reflect that species, e.g., "Port Liver Sausage."

Section 319.260 Luncheon meat

"Luncheon Meat" is cured, cooked meat food product made from comminuted meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of luncheon meat in an amount not to exceed 3 percent of the total ingredients.

Section 319.261 Meat loaf

"Meat Loaf" is a cooked meat food product in loaf form made from comminuted meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients.

Section 319.280 Scrapple

"Scrapple" shall contain not less than 40 percent meat and/or meat byproducts computed on the basis of the fresh weight, exclusive of bone. Mechanically Separated (Species) may be used in accordance with Section 319.6. The meal or flour used may be derived from grain and/or soybeans.

Section 319.281 Bockwurst

(a) Bockwurst is an uncured, comminuted meat food product which may or may not be cooked. It contains meats, milk or water or a combination thereof, eggs, vegetables, and any of the optional ingredients listed in paragraph (b) of this section; and is prepared in accordance with the provisions of this paragraph (a)(1), (2), (3), and (4) of this section.

(1) Meat shall constitute not less than 70 percent of the total weight of the product and shall consist of pork or a mixture of pork and veal, pork and beef, or pork, veal, and beef. Such meat shall be fresh or fresh frozen meat. Pork may be omitted when the specie or species of meat used in the product is identified in the product name (e.g., Veal Bockwurst, Beef Bockwurst, or Beef and Veal Bockwurst). Mechanically Separated (Species) may be used in accordance with Section 319.6.

(2) The "milk" may be fresh whole milk, dried milk, nonfat milk, calcium reduced dried skim milk, enzyme (rennet) treated calcium reduced dried skim milk and calcium lactate, or any combination thereof.

(3) "Eggs" refer to whole eggs that are fresh, frozen, or dried.

(4) "Vegetables" refers to onions, chives, parsley, and leeks, alone or in any combination.

(b) Bockwurst may contain one or more of the following optional ingredients:

(1) Pork fat.

(2) Celery, fresh or dehydrated.

(3) Spices, flavorings.

(4) Salt.

(5) Eggs whites, fresh, frozen, or dried.

(6) Corn syrup solids, corn syrup, or glucose syrup with a maximum limit of 2 percent individually or collectively, calculated on a dry basis. The maximum quantities of such ingredients shall be computed on the basis of the total weight of the ingredients.

(7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein hydrolysate, and monosodium glutamate.

(8) Sugars (sucrose and dextrose).

(9) Cereal, bread, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, and isolated soy protein, provided such ingredients, individually or collectively, do not exceed 3 1/2 percent of any one or more of the other ingredients permitted in this subparagraph. Bockwurst containing any of the ingredients permitted by this subparagraph shall be labeled in accordance with Section 317.8(b)(33) of this subchapter.

(c) If bockwurst is cooked or partially cooked, the composition of the raw mix from which it is prepared shall be used in determining whether it meets the requirements of this section.

Section 319.300 Chili con carne

"Chili con Carne" shall contain not less than 40 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. Head meat, cheek meat, and heart meat exclusive of the heart cap may be used to the extent of 25 percent of the meat ingredients under specific declaration on the label. The mixture may contain not more than 8 percent, individually or collectively, of cereal, vegetable starch, starchy vegetable flour, soy flour, soy protein concentrate, isolated soy protein, dried milk, nonfat dry milk, dry or dried whey, reduced lactose whey, reduced minerals whey, whey protein concentrate, or calcium reduced dried skim milk.

Section 319.301 Chili con carne with beans

"Chili con Carne with Beans" shall contain not less than 25 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. Head meat, cheek meat, or heart meat exclusive of the heart cap may be used to the extent of 25 percent of the meat ingredient, and its presence shall be reflected in the statement of ingredients required by Part 317 of this subchapter.

Section 319.302 Hash

"Hash" shall contain not less than 35 percent of meat computed on the weight of the cooked and trimmed meat. The weight of the cooked meat used in this calculation shall not exceed 70 percent of the weight of the uncooked fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.303 Corned beef hash

(a) "Corned Beef Hash" is the semisolid food product in the form of a compact mass which is prepared with beef, potatoes, curing agents, seasonings, and any of the optional ingredients listed in paragraph (b) of this section, in accordance with the provisions of subparagraphs (1), (2), (3) and (4) of this paragraph and the provisions of paragraph (c) of this section.

(1) Either fresh beef, cured beef, or canned corned beef or a mixture of two or more of these ingredients, may be used, and the finished product shall contain not less than 35 percent of beef computed on the weight of the cooked and trimmed beef. The weight of the cooked meat used in this calculation shall not exceed 70 percent of the weight of the uncooked fresh meat.

(2) "Potatoes" refers to fresh potatoes, dehydrated potatoes, cooked dehydrated potatoes, or a mixture of two or more of these ingredients.

(3) The curing agents that may be used are salt, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, or a combination of two or more of these ingredients. When sodium nitrate, or sodium nitrite, potassium nitrate, or potassium nitrite is used it shall be used in amounts not exceeding. those specified in Section 318.7(c)(4) of this subchapter.

(4) The seasonings that may be used, singly or in combination, are salt, sugar (sucrose or dextrose), spice, flavoring, including essential oils, oleoresins, and other spice extractives.

(b) Corned beef hash may contain one or more of the following optional ingredients:

(1) Beef cheek meat and beef head meat from which the overlying glandular and connective tissues have been removed, and beef heart meat, exclusive of the heart cap, may be used individually or collectively to the extent of 5 percent of the meat ingredients;

(2) Onions, including fresh onions, dehydrated onions, or onion powder;

(3) Garlic, including fresh garlic, dehydrated garlic, or garlic powder;

(4) Water;

(5) Beef broth or beef stock;

(6) Monosodium glutamate;

(7) Hydrolyzed plant protein;

(8) Beef fat;

(9) Mechanically Separated (Species) when derived from carcasses of cattle may be used in accordance with Section 319.6.

(c) The finished product shall not contain more than 15 percent fat nor more than 72 percent moisture.

(d)

(1) When any ingredient specified in paragraph (b)(1) of this section is used, the label shall bear the following applicable statement: "Beef cheek meat constitutes 5 percent of the meat ingredient," or "Beef head meat constitutes 5 percent of the meat ingredient," or "Beef heart meat constitutes 5 percent of the meat ingredient." When two or more of the ingredients are used, the words "Constitutes 5 percent of meat ingredient" need only appear once.

(2) Whenever the words "corned beef hash" are featured on the label so conspicuously as to identify the contents, paragraph shall immediately and conspicuously precede or the following such name without intervening written, printed, or other graphic matter.

Section 319.304 Meat stews

Meat stews such as "Beef Stew" or "Lamb Stew" shall contain not less than 25 percent of meat of the species named on the label, computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.305 Tamales

"Tamales" shall be prepared with at least 25 percent meat computed on the weight of the uncooked fresh meat in relation to all ingredients of the tamales. When tamales are packed in sauce or gravy, the name of the product shall include a prominent reference to the sauce or gravy; for example, "Tamales with Sauce" or "Tamales with Gravy." Product labeled "Tamales With Sauce" or "Tamales With Gravy" shall contain not less than 20 percent meat, computed on the weight of the uncooked fresh meat in relation to the total ingredients making up the tamales and sauce or the tamales and gravy. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.306 Spaghetti with meatballs and sauce, spaghetti with meat and sauce, and similar products

"Spaghetti with Meatballs and Sauce" and "Spaghetti with Meat and Sauce," and similar products shall contain not less than 12 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. The presence of the sauce or gravy constituent shall be declared prominently on the label as part of the name of the product. Meatballs may be prepared with not more than 12 percent, singly and collectively, of farinaceous material, soy flour, soy protein concentrate, isolated soy protein, nonfat dry milk, calcium reduced dried skim milk, and similar substances.

Section 319.307 Spaghetti sauce with meat

"Spaghetti Sauce with Meat" shall contain not less than 6 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.308 Tripe with milk

"Tripe with Milk" shall be prepared so that the finished canned article, exclusive of the cooked-out juices and milk, will contain at least 65 percent tripe. The product shall be prepared with not less than 10 percent milk.

Section 319.309 Beans with frankfurters in sauce, sauerkraut with wieners and juice, and similar products

"Beans with Frankfurters in Sauce," "Sauerkraut with Wieners and Juice," and similar products shall contain not less than 20 percent frankfurters or wieners computed on the weight of the smoked and cooked sausage prior to its inclusion with the beans or sauerkraut.

Section 319.310 Lima beans with ham in sauce, beans with ham in sauce, beans with bacon in sauce, and similar products

"Lima Beans with Ham in Sauce," "Beans with Ham in Sauce," "Beans with Bacon in Sauce," and similar products shall contain not less than 12 percent ham or bacon computed on the weight of the smoked ham or bacon prior to its inclusion with the beans and sauce.

Section 319.311 Chow mein vegetables with meat and chop suey vegetables with meat

"Chow Mein Vegetables with Meat" and "Chop Suey Vegetables with Meat" shall contain not less than 12 percent meat computed on the weight of the uncooked fresh meat prior to its inclusion with the other ingredients. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.312 Pork with barbecue sauce and beef with barbecue sauce

"Pork with Barbecue Sauce" and "Beef with Barbecue Sauce" shall contain not less than 50 percent meat of the species specified on the label, computed on the weight of the cooked and trimmed meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. The weight of the cooked meat used in this calculation shall not exceed 70 percent of the uncooked weight of the meat. If uncooked meat is used in formulating the products, they shall contain at least 72 percent meat computed on the weight of the fresh uncooked meat.

Section 319.313 Beef with gravy and gravy with beef

"Beef with Gravy" and "Gravy with Beef" shall not be made with beef which, in the aggregate for each lot contains more than 30 percent trimmable fat, that is, fat which can be removed by thorough, practicable trimming sorting.

Section 319.500 Meat Pies

Meat pies such as "Beef Pie", "Veal Pie", and "Pork Pie" shall contain meat of the species specified on the label, in an amount not less than 25 percent of all ingredients including crust and shall be computed on the basis of the fresh uncooked meat.

Section 319.600 Pizza

(a) "Pizza with Meat" is a bread base meat food product with tomato sauce, cheese, and meat topping. It shall contain cooked meat made from not less than 15 percent raw meat. Mechanically Separated (Species) may be used in accordance with Section 319.6.

(b) "Pizza with Sausage" is a bread base meat food product with tomato sauce, cheese, and not less than 12 percent cooked or 10 percent dry sausage; e.g., pepperoni. Mechanically Separated (Species) may be used in accordance with Section 319.6.

Section 319.700 Oleomargarine or margarine n2

n2 Insofar as the standard contains provisions relating to margarine or oleomargarine which does not contain any meat food products, such provisions merely reflect the applicable standard under the Federal Food, Drug, and Cosmetic Act.

(a) Margarine or oleomargarine is the food in plastic form or liquid emulsion, containing not less than 80 percent fat determined by the method prescribed under Section 16.206 of the "Indirect Methods," in "Official Methods of Analysis of the Association of Official Analytical Chemists (AOAC)," 13th edition 1980. n3 It is produced from one or more of the ingredients designated in subparagraph (1) of this paragraph, and one or more of the ingredients designated in subparagraph (2) of this paragraph, to which may be added one or more of the optional ingredients designated in paragraph (b) of this section. Margarine or oleomargarine contains Vitamin A as provided for in subparagraph (3) of this paragraph.

n3 Copies may be obtained from the Association of Official Analytical Chemist, P. O. Box 540, Benjamin Franklin Station, Washington, DC 20044.

(1) Edible fats and oils or mixtures of these, whose origin is vegetable or rendered animal fats from cattle, sheep, swine, or goats.

(2)

(i) Water; milk; milk products including, but not limited to, the liquid, condensed, or dry form of whey, reduced lactose whey, reduced minerals whey, or whey protein concentrate, non-lactose-containing whey components, casein, or caseinate; or other suitable edible protein including albumin, vegetable proteins, or soy protein isolate; or any mixture of two or more of the articles designated in this subparagraph, in amounts not greater than reasonably required to accomplish the desired effect.

(ii) The articles designated in this subparagraph shall be pasteurized and then may be subjected to the action of harmless bacterial starters. One or more of the articles designated in this subparagraph is intimately mixed with the edible fat or oil ingredients, or both, to form a solidified or liquid emulsion.

(3) Vitamin A in such quantity that the finished margarine or oleomargarine contains not less than 15,000 International Units (IU) of Vitamin A per pound or 33,000 IU per kilogram.

(b)

(1) Vitamin D in such quantity that the finished margarine or oleomargarine contains not less than 1,500 IU of Vitamin D per pound or 3,300 IU per kilogram.

(2) Salt (sodium chloride); or potassium chloride for dietary margarine or oleomargarine.

(3) Nutritive carbohydrate sweeteners.

(4) Emulsifiers identified in Section 318.7(c)(4) of this chapter, within these maximum amounts in percent by weight of the finished food: Mono- and diglycerides of fatty acids esterified with any or all of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts, 0.5 percent; such mono- and diglycerides in combination with sodium sulfoacetate derivatives thereof, 0.5 percent; polglycerol esters of fatty acids, 0.5 percent; 1, 2-propylene glycol esters of fatty acids, 2 percent; lecithin, 0.5 percent.

(5) Preservatives identified in Section 318.7(c)(4) of this chapter, within these maximum amounts in percent by weight of the finished food: Sorbic acid, benzoic acid and their sodium, potassium, and calcium salts, individually, 0.1 percent, or in combination, 0.2 percent, expressed as the acids; calcium disodium EDTA, 0.0075 percent; stearyl citrate, 0.15 percent; isopropyl citrate mixture, 0.02 percent.

(6) Antioxidants identified in Section 318.7(c)(4) of this chapter, within these maximum amounts in percent by weight of the finished food: propyl, octyl and dodecyl gallates, BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), ascorbyl palmitate, ascorbyl stearate, all individually or in combination, 0.02 percent. Instead of these antioxidants, TBHQ (tertiary butylhydroquinone), alone or in combination only with BHT and/or BHA, with a maximum 0.02 percent by weight of the fat and oil content.

(7) Coloring agents identified in Section 318.7(c)(4) of this chapter, in amounts sufficient for purpose. n4 For the purpose of this subparagraph, provitamin A (beta carotene) shall also be deemed to be a coloring agent.

n4 Colored margarine or oleomargarine is also subject to the provisions of section 407 of the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. 347) , as reflected in Section 317.8(h)(24) of this subchapter.

(8) Flavoring substances in amounts sufficient for purpose.

(9) Acidulants identified in Section 318.7(c)(4) of this chapter, in amounts sufficient for purpose: adipic acid; citric and lactic acids and their potassium and sodium salts; phosphoric acid; L-tartaric acid and its sodium and sodium-potassium salts; and hydrochloric acid.

(10) Alkalizers identified in Section 318.7(c)(4) of this chapter, in amounts sufficient for purpose: potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate, and sodium hydroxide.

(11) For the purposes of this section, the term "milk" unqualified means milk from cows. If any milk other than cow's milk is used in whole or in part, the animal source shall be identified in conjunction with the word "milk" in the ingredient statement.

Section 319.701 Mixed fat shortening

Shortening prepared with a mixture of meat fats and vegetable oils may be identified either as "Shortening Prepared with Meat Fats and Vegetable Oils" or "Shortening Prepared with Vegetable Oils and Meat Fats" depending on the predominance of the fat and oils used, or the product may be labeled "Shortening" when accompanied by an ingredient statement with ingredients listed in descending order of predominance.

Section 319.702 Lard, leaf lard

(a) Lard is the fat rendered from clean and sound edible tissues from swine. The tissues may be fresh, frozen, cooked, or prepared by other processes approved by the Head of Service in specific cases, upon his determination that the use of such processes will not result in the adulteration or misbranding of the lard. The tissues shall be reasonably free from blood and shall not include stomachs, livers, spleens, kidneys, and brains, or settlings and skimmings. "Leaf Lard": is lard prepared from fresh leaf (abdominal) fat.

(b) Lard (when properly labeled) may be hardened by the use of lard stear in or hydrogenated lard or both and may contain refined lard and deodorized lard, but the labels of such lard shall state such facts as applicable.

(c) Products labeled "Lard" or "Leaf Lard" must have the following identity and quality characteristics to insure good color, odor, and taste of finished product:

(1) Color White when solid. Maximum 3.0 red units in a 5 1/4 inch cell on the Lovibond scale.

(2) Odor and Taste Characteristic and free from foreign odors and flavors.

(3) Free fatty acid Maximum 0.5 percent (as oleic) or 1.0 acid value, as milligrams KOH per gram of sample.

(4) Peroxide value Maximum 5.0 (as milliequivalents of peroxide per kilogram fat).

(5) Moisture and volatile matter Maximum 0.2 percent.

(6) Insoluble impurities By appearance of liquid, fat, or maximum 0.05 percent.

(d) Product found upon inspection not to have the characteristics specified in paragraph (c) of this section but found to be otherwise sound and in compliance with paragraph (a) of this section may be further processed for the purpose of achieving such characteristics.

Section 319.703 Rendered animal fat or mixture thereof

(a) Rendered Animal Fat," or any mixture of fats containing edible rendered animal fat, shall contain no added water, except that "Puff Pastry Shortening' may contain not more than 10 percent of water.

Section 319.720 Meat extract

Meat extracts (e.g., "Beef Extract") shall contain not more than 25 percent of moisture.

Section 319.721 Fluid extract of meat

Fluid extract of meat (e.g., "Fluid Extract of Beef") shall contain not more than 50 percent of moisture.

Section 319.760 Deviled ham, deviled tongue, and similar products

(a) "Deviled Ham" is a semiplastic cured meat food product made from finely comminuted ham and containing condiments. Mechanically Processed (Species) Product may be used in accordance with Section 319.6. Deviled ham may contain added ham fat: Provided, That the total fat content moisture content of deviled ham shall not exceed that of the fresh unprocessed meat.

(b) The moisture content of "Deviled Tongue" and similar products shall not exceed that of the fresh, unprocessed meat.

Section 319.761 Potted meat food product and deviled meat food product

"Potted Meat Food Product" and "Deviled Meat Food Product" shall not contain cereal, vegetable flour, nonfat dry milk, or similar substances. The amount of water added to potted meat food product and deviled meat food product shall be limited to that necessary to replace moisture lost during processing.

Section 319.762 Ham spread, tongue spread, and similar products

"Ham Spread," "Tongue Spread," and similar products shall contain not less than 50 percent of the meat ingredient named, computed on the weight of the fresh meat. Other meat and fat may be used to give the desired spreading consistency provided it does not detract from the character of the spreads named. Mechanically Processed (Species) Product may be used in accordance with Section 319.6.

Section 319.880 Breaded products

The amount of batter and breading used as a coating for breaded product shall not exceed 30 percent of the weight of the finished breaded product.

Section 319.881 Liver meat food products

Meat food products characterized and labeled as liver products such as liver loaf, liver cheese, liver spread, liver mush, liver paste, and liver pudding shall contain not less than 30 percent of pork, beef, sheep, or goat livers computed on the fresh weight of the livers.

Part 320 RECORDS, REGISTRATION, AND REPORTS

Section 320.1 Records reouired to be kept

(a) Every person (including every firm or corporation) within any of the classes specified in subparagraph (1), (2), or (3) of this paragraph must keep records which will fully and correctly disclose all transactions involved in his or its business subject to the Act:

(1) Any person that engages in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging or labeling any carcasses, or parts, or products of carcasses, of any such animals, for use as human food or animal food;

(2) Any person that engages in the business of buying, selling, (as a meat broker, wholesaler, or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such animals;

(3) Any person that engages in business as a renderer, or engages in the business of buying, selling, or transporting, or importing, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter.

(b) The required records are:

(1) Records, such as bills of sale, invoices, bills of lading, and receiving and shipping papers, giving the following information with respect to each transaction in which any livestock or carcass, part thereof, meat or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by said person in connection with any business subject to the Act:

(i) The name or description of the livestock or article;

(ii) The net weight of the livestock or article;

(iii) The number of outside containers (if any);

(iv) The name and address of the buyer of livestock or article sold by such person, and the name and address of the seller of livestock or articles purchased by such person;

(v) The name and address of the consignee or receiver (if other than the buyer);

(vi) The method of shipment;

(vii) The date of shipment; and

(viii) The name and address of the carrier.

(2) Shipper's certificates and permits required to be kept by shippers and carriers of articles under Part 325 of this subchapter.

(3) A record of seal numbers required to be kept by consignees of inedible products shipped under unofficial seals under Section 325.11(b) or (e), and a record of new consignees of inedible products diverted under Section 325.11(e) of these regulations.

(4) Records of processing procedures for cooked beef and roast beef as required in Section 318.17(d).

(5) Guarantees provided by suppliers of packaging material under Section 317.20.

Section 320.2 Place of maintenance of records

Every person engaged in any business described in Section 320.1 and required by these regulations to keep records, shall maintain such records at the place where such business is conducted except that if such person conducts such business at multiple locations, he/she may maintain such records at his/her headquarters' office. When not in actual use, all such records shall be kept in a safe place at the prescribed location in accordance with good commercial practices.

Section 320.3 Record retention period

Every record required to be maintained under this part shall be retained for a period of 2 years after December 31 of the year in which the transaction to which the record relates has occurred and for such further period as the Head of Service may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such records.

Section 320.4 Access to and inspection of records, facilities, and inventory; copying and sampling

Every person (including every firm or corporation) within any of the classes specified in Section 320.1 shall upon the presentation of official credentials by any duly authorized representative of the Commissioner during ordinary business hours, permit such representative to enter his or its place of business and examine the records required to be kept by Section 320.1 and the facilities and inventory pertaining to the business of such person subject to the Act, and to copy all such records and to take reasonable samples of the inventory upon payment of the fair market value therefor. Any necessary facilities (other than reproduction equipment) for such examination and copying of records and for such examination and sampling of inventory shall be afforded to such authorized representative of the Commissioner.

Section 320.5 Reserved

Section 320.6 Information and reports required from official establishment operators

(a) The operator of each official establishment shall furnish to Service employees accurate information as to all matters needed by them for making their daily reports of the amount of products prepared or handled in the departments of the establishment to which they are assigned and such reports concerning sanitation and other aspects of the operations of the establishment and the conduct of inspection thereat as may be required by the Head of Service in specific cases.

(b) The operator of each official establishment shall report quarterly the number of pounds of meat and meat food product produced at that establishment. The report shall be made on a form furnished by the Head of Service and shall be submitted to an inspector at the establishment. Each report shall cover a calendar quarter and shall be filed within 15 days after the end of each quarter.

(c) The operator of each official establishment shall also make such other reports as the Head of Service may from time to time require.

Section 320.7 Reports by consignees of allegedly adulterated or misbranded products; sale or transportation as violations

Whenever the consignee of any product which bears an official inspection legend refuses to accept delivery of such product on the grounds that it is adulterated or misbranded, the consignee shall notify the Head of Service of the kind, quantity, source, and present location of the product and the respects in which it is alleged to be adulterated or misbranded, and it will be a violation of the Act for any person to sell or transport or offer for sale or transportation, or receive for transportation, any such product which is capable of use as human food and is, adulterated or misbranded at the time of such sale, transportation, offer, or receipt: Provided, however, That any such allegedly adulterated or misbranded product may be transported to the official establishment from which it has been transported, in accordance with Section 325.10 of this subchapter.

Part 325 TRANSPORTATION

Section 325.1 Transactions in commerce prohibited without official inspection legend or certificate; exceptions; and vehicle sanitation requirements

(a) No person shall sell, transport, offer for sale or transportation, or received for transportation, any product which is capable of use as human food unless the product and its container, if any, bear the official inspection legend as required under Parts 316 and 317 of this subchapter or such product is exempted from the requirement of inspection under Part 303 of this subchapter.

(b) No carrier shall transport or receive for transportation, and no person shall offer for transportation any carcass, part thereof, meat or meat food product until a certificate, if required for such transportation by this Part, is made and furnished to the carrier in one of the forms prescribed in this Part.

(c) No person engaged in the business of buying, selling, freezing, storing, or transporting meat or meat food products capable of use as human food, shall transport, offer for transportation, or receive for transportation, any such meat or meat food product which is capable of use as human food and is not wrapped, packaged, or otherwise enclosed to prevent adulteration by airborne contaminants, unless the railroad car, truck, or other means of conveyance in which the product is contained or transported is completely enclosed with tight fitting doors or other covers for all openings. In all cases, the means of conveyance shall be reasonably free of foreign matter (such as dust, dirt, rust, or other articles or residues), and free of chemical residues, so that product placed therein will not become adulterated. Any cleaning compound, lye, soda solution, or other chemical used in cleaning the means of conveyance must be thoroughly removed from the means of conveyance prior to its use. Such means of conveyance onto which product is loaded, being loaded, or intended to be loaded, shall be subject to inspection by an inspector at any official establishment. The decision whether or not to inspect a means of conveyance in a specific case, and the type and extent of such inspection shall be at the Service's discretion and shall be adequate to determine if product in such conveyance is or when moved could become, adulterated. Circumstances of transport that can be reasonably anticipated shall be considered in making said determination. These include, but are not limited to, weather conditions, duration and distance of trip, nature of product covering, and effect of restowage at stops en route. Any means of conveyance found upon such inspection to be in such condition that product placed therein could become adulterated shall not be used until such condition which could cause adulteration is corrected.

Product placed in any means of conveyance that is found by the inspector to be in such condition that the product may have become adulterated shall be removed from the means of conveyance and handled in accordance with Section 318.2(d) of this subchapter.

Section 325.2 Parcel post and ferries deemed carriers

(a) For the purposes of this subchapter, the United States parcel post shall be deemed a carrier, and the provisions of this subchapter relating to transportation by carrier shall apply, so far as they may be applicable, to transportation by parcel post.

(b) For the purposes of this subchapter, the operator of every ferry shall be deemed a carrier, and the provisions of this subchapter relating to transportation by carrier shall apply to transportation by ferry of any product loaded on a truck or other vehicle, or otherwise moved by such ferry.

Section 325.3 Reserved

Section 325.4 VT inspected, passed, and marked product; certificate

(a) When any product which has been inspected and passed and bears the official inspection legend on the outside container (or on the product if not in a container) is offered to any initial carrier for transportation, the carrier shall require, and the shipper shall make and deliver to the carrier, a certificate in the following form:

Date ___, 19__

Name of carrier ___

Shipper ___

Point of shipment ___

Consignee ___

Destination ___

I hereby certify that the following described product, which is offered for shipment has been VT inspected and passed by the VT Department of Agriculture, is so marked, and at this date is not adulterated or misbranded.

Kind of product ___

Amount and weight ___

(Signature of Shipper)

(Address of Shipper)

(b) The signature of the shipper or his agent shall be written in full. This certificate may be stamped upon or incorporated in any form ordinarily used in the transportation of product. Certificates in this form or copies thereof need not be forwarded to any official or office of the Department. A copy of the certificate required by this section shall be retained by the carrier in accordance with Part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with Part 320 of this subchapter.

Section 325.5 Unmarked inspected product transported under official seal between official establishments for further preparation; certificate

(a) Any product which has been inspected and passed may be transported from one official establishment to another for further processing without each article being marked with the official inspection legend, if it is so transported in a railroad car, motor truck, or other means of conveyance which is sealed by a Service employee with an official seal of the Department prescribed in 312.5(a) of this subchapter. Unless 25 percent or more of the contents of each car or other means of conveyance consists of product not marked with the inspection legend, transportation will not be permitted under this paragraph.

(b) When articles are offered for transportation under paragraph (a) of this section, the initial carrier shall require, and the shipper shall make in duplicate and deliver to the carrier one copy of a certificate in the following form:

Date ___ 19 __

Name of carrier ___

Establishment number of consignor ___

Point of shipment ___

Establishment number of consignee ___

Destination ___

Car number and initials ___

License number of other means of conveyance ___

I hereby certify that the following described product has been VT inspected and passed by the VT Department of Agriculture; and that it is not marked "VT Inspected and Passed," but has been placed in the means of conveyance specified above under the supervision of an employee of the Meat and Poultry Inspection Service of said Department, and the means of conveyance has been sealed by him with official VT Government seals Nos ___ and ___

Kind of product ___

Amount of weight ___

(Signature of shipper) ___

(Address of shipper) ___

(c) The signature of the shipper or his agent shall be written in full. This certificate may be stamped upon or incorporated in any form ordinarily used in the transportation of product. Certificates in this form or copies thereof need not be forwarded to any official or office of the Department. The original of the certificate required by this section shall be retained by the carrier and a copy shall be retained by the shipper in accordance with Part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with Part 320 of this subchapter.

Section 325.6 Shipment of paunches between official establishments under official seal: certificate

Cattle and sheep paunches which have been made clean and from which the mucous membrane has not been removed may be transported from one official establishment to another official establishment for further processing, only under an official seal of the Department as prescribed in Section 312.5(a) of this subchapter. When paunches are offered for transportation under this paragraph, the initial carrier shall require, and the shipper shall make in duplicate and deliver to the carrier, one copy of a certificate in duplicate in the form set out in Section 325.5(b), appropriately modified. Certificates in this form or copies thereof need not be forwarded to any official or office of the Department, but the original of the certificate shall be retained by the carrier and a copy shall be retained by the shipper in accordance with Part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with part 320 of this subchapter.

Section 325.7 Shipment of products requiring special supervision between official establishments under official seal: certificate

(a) Products passed for cooking, pork that has been refrigerated to destroy trichinae, and beef that is to be refrigerated to destroy cysticerci, may be shipped loose from one official establishment to any other official establishment, for further handling in accordance with Part 318 of this subchapter, in railroad cars, trucks, or other means of conveyance sealed with the official seal of the Department as prescribed in Section 325.16: Provided, That in the case of railroad cars, the receiving establishment has railroad facilities for unloading the products directly into the establishment.

(b) When such restricted product is shipped from one official establishment to another official establishment in the same railroad car or other means of conveyance with other product, such restricted product shall be packed in individual closed containers as herein after provided. Containers shall be sealed by firmly applying a pressure sensitive tape around each container in two directions and stamping the intersection of the tape with the marking device described in Section 312.2(a) of this subchapter for use on burlap, muslin, etc. (2 1/2-inch rubber brand). Such tape must possess the adhesive property to actually remove a portion of the container surface when the tape is removed. Alternatively, an inelastic, nonmetallic strap which will retain a legible imprint of the marking device (2 1/1-inch rubber brand) may be used. The imprint of the marking device shall be placed partially on the strap and partially on the container. Such restricted product shall be marked "VT. passed for cooking" or "pork product F. days refrigeration" or "beef passed for refrigeration," as the case may be. In addition, a "VT. retained" tag shall be securely affixed to each container of product passed for cooking and of beef passed for refrigeration. The means of conveyance shall not be sealed unless at least 25 percent of the other product in the vehicle is unmarked. For each consignment there shall be promptly issued and forwarded by the inspector to the inspector in charge at destination, a report on the form entitled "Notice of Unmarked Meats Shipped in Sealed Cars," appropriately modified to show the character of the containers, and that the contents are restricted. A duplicate copy shall be retained in the Service files.

(c) When products are offered for transportation under this section, the initial carrier shall require and the shipper shall make in duplicate and deliver to the carrier one copy of a certificate in the form set out in Section 325.5(b). Certificates in this form or copies thereof need not be forwarded to any official or office of the Department, but the original of the certificate shall be retained by the carrier and a copy shall be retained by the shipper in accordance with Part 320 of this subchapter. If the shipper is also the carrier, he shall nevertheless execute and retain the certificate in accordance with Part 320 of this subchapter.

Section 325.8 Transportation and other transactions concerning certain undenatured lungs or lung lobes from official establishments; provisions and restrictions

(a) Lungs or lung lobes, other than those condemned under Section 310.16(b) of this subchapter, that are prepared at any official establishment, may be sold, transported, offered for sale or transportation, or received for transportation from the establishment, without denaturing as prescribed in Section 314.1 or Section 314.3 of this subchapter: Provided:

(1) The lungs or lung lobes are sold, transported, or offered for sale or transportation to, or received for transportation by: An animal food manufacturer for use in manufacturing animal food; a zoo, mink farm, or other establishment for use as animal food without further processing; a warehouse in Vermont for storage and subsequent movement to such a manufacturer or establishment in Vermont, or from one warehouse to another for the account of any subsequent movement to such a manufacturer or establishment, for nonhuman food purposes.

(2) The boxes or other containers used for shipping the undenatured lungs or lung lobes are closed with nylon filament tape, metallic or nonmetallic straps, round wire, or other similar materials that securely effect closure of such containers, and the containers are permanently identified in at least 2-inch (5 cm) high lettering with the statement "(Species) Lungs - Not Intended for Human Food." In lieu of securely closing the immediate container with any of the above materials, a 1-inch (2.5 cm) wide bright orange band, imprinted around the length and width of the container may be used.

(3) The name and place of business of the packer or distributor shall be shown on the immediate container of the product. In addition, the country of origin shall be shown on the immediate container of imported lungs or lung lobes.

(b) All such lungs or lung lobes, if intended for animal food, are subject to the Federal Food, Drug, and Cosmetic Act.

Section 325.9 Reserved

Section 325.10 Handling of products which may have become adulterated or misbranded; authorization and other requirements

(a) When it is claimed that any inspected and passed product, marked with an inspection legend, has become adulterated or misbranded after it has been transported from an official establishment after oral permission is obtained from the veterinary supervisor. The transportation of the product may be to the official establishment from which it had been transported or to another official establishment designated by the person desiring to handle the product. The transportation shall be authorized only for the purpose of officially determining if the product has become adulterated or misbranded and making the appropriate disposition. The veterinary supervisor shall make a record of the authorization and such other information which will effectively identify the shipment and shall provide a copy of the record to the inspector at the establishment receiving the product. The shipper shall be furnished a copy of the authorization record upon request.

(b) Upon the arrival of the shipment at the official establishment, a careful inspection shall be made of the product by a Service Inspector, and if it is found that the article is not adulterated, the same may be received into the establishment; but if the article is found to be adulterated, it shall at once be stamped "VT. Inspected and Condemned" and disposed of in accordance with Part 314 of this subchapter, and if it is found to be misbranded, it shall be handled in accordance with Section 318.2(d) of this subchapter: Provided, That when a product is found to be affected with one of the correctable conditions specified in Section 318.2(d) of this subchapter, in respect to which rehandling is permitted, it may be transported from the official establishment to another official establishment for such rehandling as is necessary to assure that the product is not adulterated or misbranded when finally released. The transportation of such a product from an official establishment shall be done in a manner prescribed in each specific case by the Head of Service.

Section 325.11 Inedible articles: denaturing and other means of identification: exception

(a) Except as provided in Section 325.8 and Section 325.10, no carcass, part of a carcass, rendered grease, tallow, or other fat derived from the carcasses of livestock, or other meat food product, that has not been inspected and passed at an official establishment under the provisions of these regulations and is not exempted from such inspection, and no carcass, part of a carcass, fat or other meat food product that is adulterated or misbranded, shall be offered for transportation in commerce by any person unless it is handled in accordance with paragraph (b), (c), (d), or (e), of this section or is denatured or otherwise identified as prescribed in Section 325.13, Section 314.1, Section 314.3, Section 314.9, Section 314.10, or Section 314.11 of this subchapter.

(b) Inedible rendered animal fats from official or other establishments having the physical characteristics of a meat food product fit for human food may be transported without denaturing, if the following conditions are met:

(1) Such inedible rendered fat shall not be bought, sold, transported, or offered for sale or offered for transportation, or imported, except by rendering companies, dealers, brokers, or others who obtain a license for such activities from the Commissioner.

(2) Such inedible rendered animal fat may be so distributed only if consigned to a domestic manufacturer of technical articles other than for human food, and Provided, That in the case of such fat consigned to a domestic manufacturer, the product is for use solely by the consignee for manufacturing purposes of nonhuman food articles and may not be further sold or shipped without first receiving approval of the Head of Service.

(3) When transported or imported, such inedible rendered fat shall be marked conspicuously with the words "technical animal fat not intended for human food" on the ends of the shipping containers, in letters not less than 2 inches high; in the case of shipping containers such as drums, tierces, barrels, and half barrels, and not less than 4 inches high in the case of tank cars and trucks. All shipping containers shall have both ends painted with a durable paint, if necessary, to provide a contrasting background for the required marking.

(4) Such inedible rendered fat shall be transported only in sealed shipping containers bearing unofficial seals applied by the shipper, which shall include the identification number assigned by said Head of Service for the permit holder. The number shall appear on the bill of lading or other transportation documents for the shipment. The consignees must retain the seals in their records as prescribed in Part 320 of this subchapter.

(5) Any diversion or effort to divert inedible rendered fat contrary to the provisions of this paragraph (b) or other violation of the provisions of this section may result in the revocation of the permit for shipment of technical animal fat at the discretion of the Commissioner.

(c) Inedible rendered animal fat derived from condemned or other inedible materials at official or other establishments may be transported if mixed with low grade offal or other materials which render the fat readily distinguishable from an article of human food, and if the outside container bears the word "inedible."

(d)

(1) Except as provided in paragraphs (d)(2), (3), and (4) of this section, or in Section 314.10 and Section 314.11 of this subchapter, no animal food prepared, in whole or in part, from materials derived from the carcasses of livestock in an official establishment or elsewhere, shall be transported unless:

(i) It is properly identified as animal food;

(ii) It is not represented as being a human food; and

(iii) It has been denatured as prescribed in Section 325.13(a) (2) so as to be readily distinguishable from an article of human food.

(2) Notwithstanding the provisions of paragraph (d) (1) of this section, an animal food that consists of less than 5 percent of parts or products of the carcasses of livestock and that is not represented by labeling or appearance or otherwise as being a human food or as a product of the meat food industry need not be denatured in accordance with Section 325.13(a) (2).

(3) Notwithstanding the provisions of paragraph (d) (1) of this section, animal food packed in hermetically sealed, retort processed, conventional retail-size containers, and retail-size packages of semimoist animal food need not be denatured in accordance with Section 325.13(a) (2) if the name of the article, as for example, "Dog and Cat Food" or "Animal Food," appears on the label in a conspicuous manner. To be considered conspicuous, the letters in the name of the articles must be at least three times as high, wide, and thick as the letters in the words denoting the use, as ingredients in the article, of the materials derived from the carcasses of livestock. The letters in the name of such article shall contrast as markedly with their background as the letters in the words denoting the use of such ingredient materials contrast with their background.

(4) The requirements of this part do not apply to any animal food which does not consist of any parts or products of the carcasses of livestock, or to livestock or poultry feed which does not consist of any such articles other than processed livestock byproducts (such as meat meal tankage, meat and bone meal, blood meal and feed grade animal fat).

(e) Except for inedible rendered animal fats and lungs or lung lobes, inedible products (including condemned products only if condemned for causes specified in Section 314.11 of this subchapter) which were prepared at any official establishment, which have the physical characteristics of a product fit for human food, may be transported from an official establishment without denaturing as required by this subchapter, if the following conditions are met:

(1) The shipper must have obtained a license for such activity from the Commissioner as identified in Section 301.2 of this subchapter. Such license may be obtained upon written application to the Commissioner and his determination that the proposed transportation would be authorized under this paragraph (e). The application shall state the name and address of the applicant, a description of the type of his business operations, and the purpose of making such application.

(2) Such inedible products may be transported under this paragraph (e) only if consigned to a manufacturer in Vermont of articles other than for human food and if the product is for use solely by the consignee for manufacturing articles not for human food. Such products may not be transported to any consignee other than the one to which they were originally shipped unless prior notice of the diversion is given to the Head of Service and a record identifying the new consignee is maintained by the shipper as required by Section 320.1 of this subchapter.

(3) When transported from an official establishment under this paragraph (e), the outside container of such inedible products shall be marked conspicuously with the words "Inedible-Not Intended for Human Food" in letters not less than 2 inches high, in the case of containers such as cartons, drums, tierces, barrels, and half barrels, and not less than 4 inches high in the case of tank cars and trucks used to transport such products not in other containers. (4) Such inedible products shall be transported from an official establishment under this paragraph (e) only in railroad cars, trucks, or containers which bear unofficial seals applied by the shipper, which shall include the identification number assigned to the license holder and an individual seal serial number assigned by the shipper; and the product so transported shall be accompanied by an invoice or bill of lading specifying the license holder's identification number. The consignee in Vermont must retain a record of the identification and serial numbers shown on the seals in his records as prescribed in Part 320 of this subchapter.

(5) Any diversion, or effort to divert, undenatured, inedible product contrary to the provisions of this paragraph (e) or other violation of the provisions of this section may result in the revocation of the permit for shipment of inedible products under this paragraph (e), at the discretion of the Head of Service.

Section 325.12 Reserved

Section 325.13 Denaturing procedures

(a) Carcasses, parts thereof, meat and meat food products (other than rendered animal fats) that have been treated in accordance with the provisions of this paragraph shall be considered denatured for the purposes of the regulations in this part, except as otherwise provided in Part 314 of this subchapter for articles condemned at official establishments.

(1) The following agents are prescribed for denaturing carcasses, parts thereof, meat or meat food products which are affected with any condition that would result in their condemnation and disposal under Part 314 of this subchapter if they were at an official establishment: Crude carbolic acid; cresylic disinfectant; a formula consisting of 1 part FD&C green No. 3 coloring, 40 parts water, 40 parts liquid detergent, and 40 parts oil of citronella, or other proprietary substance approved by the Head of Service in specific cases.

(2) Except as provided in subparagraphs (3), (4), and (5) of this paragraph, the following agents are prescribed for denaturing other carcasses, parts thereof, meat and meat food products, for which denaturing is required by this part; FD&C green No. 3 coloring; FD&C blue No. 1 coloring; FD&C blue No. 2 coloring; finely powdered charcoal; or other proprietary substance approved by the Head of Service in specific cases.

(3) Tripe may be denatured by dipping it in a 6 percent solution of tannic acid for 1 minute followed by immersion in a water bath, then immersing it for 1 minute in a solution of 0.022 percent FD&C yellow No. 5 coloring;

(4) Meat may be denatured by dipping it in a solution of 0.0625 percent tannic acid, followed by immersion in a water bath, then dipping it in a solution of 0.0625 percent ferric acid; and

(5) When meat, meat byproducts, or meat food products are in ground form, 4 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 5 mesh in the standards issued by the U.S. Bureau of Standards or 6 percent by weight of coarsely ground hard bone, which shall be in pieces no smaller than the opening size specified for No. 8 mesh in said Standards, uniformly incorporated with the product may be used in lieu of the agents prescribed in subparagraph (2) of this paragraph.

(6) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sectioning will not be necessary.) The application of any of the denaturing agents listed in subparagraph (1) or (2) of this paragraph to the outer surface of molds or blocks of boneless meat, meat byproducts, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all of the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of food.

(7) Carcasses (other than viscera), parts thereof, cuts of meat, and unground pieces of meat darkened by charcoal or other black dyes shall be deemed to be denatured pursuant to this section only if they contain at least that degree of darkness depicted by diagram 1 of the Meat Denaturing Guide (MP Form 91).

(b) Inedible rendered animal fats shall be denatured by thoroughly mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any proprietary denaturing agency approved for the purpose by the Head of Service in specific cases. The charcoal shall be used in no less quantity than 100 parts per million and shall be of such character that it will remain suspended indefinitely in the liquid fat. Sufficient of the chosen identifying agents shall be used to give the rendered fat so distinctive a color, odor, or taste that it cannot be confused with an article of human food.

Section 325.14 Certificates, retention by carrier

All original certificates delivered to a carrier in accordance with this part shall be filed separate and apart from all its other papers and records or identified in such manner as to be readily checked by Service employees. Every certificate required to be maintained under this part shall be retained for a period of 2 years after December 31 of the year in which the transaction has occurred.

Section 325.15 Evidence of proper certification required on waybills; transfer bills, etc, for shipment by connecting carrier; forms of statement

(a) All waybills, transfer bills, running slips, conductor's cards, or other papers accompanying a shipment, in the course of importation or otherwise, of any products shall have embodied therein, stamped thereon, or attached thereto a signed statement which shall be evidence to connecting carriers that the proper shipper's certificate, as required in Section 325.5, Section 325.6, or Section 325.7 is on file with the initial carrier. No connecting carrier shall receive for transportation or transport in the course of importation or otherwise any product unless the waybill, transfer bill, running slip, conductor's card, or other papers accompanying the same includes the signed statement in the following form:

(Name of transportation company) ___

VT. or U.S. inspected and passed, as evidenced by shipper's certificate on file with initial carrier.

(Signed) ___ Agent

* * *

(b) Signatures of agents to statement required under this section shall be written in full.

* * *

Section 325.16 Official seals; forms, use, and breaking

(a) The official seals required by this part shall be those prescribed in Section 312.5(a) of this subchapter.

(b) Except as provided in Section 325.18(b), official seal affixed under this part shall be affixed or broken only by Service employees, and no person other than a Service employee shall affix, detach, break, change, or tamper with any such seal in any way whatever. Commission of any such acts contrary to this regulation is a criminal offense.

Section 325.17 Loading or unloading products in sealed railroad cars, trucks, etc, en route prohibited; exception

Unloading any product from an officially sealed railroad car, truck, or other means of conveyance containing any unmarked product or loading any product or any other commodity in the means of conveyance while en route from one official establishment to another official establishment is not permitted, except that product transported under Section 325.5 from one official establishment to another for further processing may be unloaded and stored in transit at any approved warehouse which has railroad facilities or a receiving dock for unloading the product directory into such warehouse: Provided, That the product is stored in rooms which are of such size and type as will not result in adulteration or misbranding of the product: and provided further, that the product is transported to and from such warehouse, and under official seal as provided in Section 325.5 and stored in such rooms at such warehouse.

Section 325.18 Diverting of shipments, breaking of seals, and reloading by carrier in emergency; reporting to the Head of Service

(a) Shipments of inspected and passed product that bear the inspection legend may be diverted from the original destination without a reinspection of the articles; provided the waybills, transfer bills, running slips, conductor's card, or other papers accompanying the shipments are marked, stamped, or have attached thereto signed statements in accordance with Section 325.15.

(b) In case of wreck or similar extraordinary emergency, the Service seals on a railroad car or other means of conveyance containing any inspected and passed product may be broken by the carrier, and if necessary, the articles may be reloaded into another means of conveyance, or the shipment may be diverted from the original destination, without another shipper's certificate; but in all such cases the carrier shall immediately report the facts by telephone or telegraph to the Head of the Vermont Meat Inspection Service. Such report shall include the following information:

(1) Nature of the emergency.

(2) Place where seals were broken.

(3) Original points of shipment and destination.

(4) Number and initial of the original car or truck.

(5) Number and initials of the car or truck into which the articles are reloaded.

(6) New destination of the shipment.

(7) Kind and amount of articles.

Section 325.19 Provisions inapplicable to specimens for laboratory examination, etc, or to naturally inedible articles

The provisions of this Part do not apply:

(a) To specimens of product sent to or by the Meat Inspection Service or divisions thereof in Montpelier, Vermont or elsewhere, for laboratory examination, exhibition purposes, or other official use;

(b) To material released for educational, research, and other nonfood purposes, as prescribed in Section 314.9 of this subchapter;

(c) To glands and organs for use in preparing pharmaceutical, organotherapeutic, or technical products and not used for human food, as described in Section 318.1(g) of this subchapter;

(d) To material or specimens of product for laboratory examination research, or other nonhuman food purposes, when authorized by the Head of Service and under conditions prescribed by him in specific cases; and

(e) To articles that are naturally inedible by humans, such as hoofs, horns, and hides in their natural state.

Section 325.20 Transportation and other transactions concerning dead, dying, disabled, or diseased livestock, and parts of carcasses of livestock that died otherwise than by slaughter

No person engaged in the business of buying, selling, or transporting, or importing any dead, dying, disabled, or diseased animals or parts of the carcasses of any animals that died otherwise than by slaughter shall:

(a) Buy, sell, transport, or offer for sale or transportation, or import any dead livestock if its hide or skin has been removed;

(b) Sell, transport, offer for sale or transportation, or receive for transportation, any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any livestock that died otherwise than by slaughter, unless such livestock and parts are consigned and delivered, without avoidable delay, to establishments of animal food manufacturers, renderers, or collection stations that are licensed and required, or to official establishments that operate under Federal inspection.

(c) Buy or import any dead, dying, disabled, or diseased livestock or parts of the carcasses of any livestock that died otherwise than by slaughter, unless he is an animal food manufacturer or renderer and is licensed as required, or is the operator of an establishment inspected as required by paragraph (b) of this section and such livestock or parts of carcasses are to be delivered to establishments eligible to receive them under paragraph (b) of this section;

(d) Unload en route to any establishment eligible to receive them under paragraph (b) of this section, any dead, dying, disabled, or diseased livestock or parts of the carcasses of any livestock that died otherwise than by slaughter, which are transported or imported by any such person: Provided, That any such dead, dying, disabled, or diseased livestock, or parts of carcasses may be unloaded from a means of conveyance en route where necessary in case of a wreck or otherwise extraordinary emergency, and may be reloaded into another means of conveyance; but in all such cases, the carrier shall immediately report the facts by telegraph or telephone to the Head of the Meat and Poultry Inspection Service, VT. Department of Agriculture, Montpelier, VT 05602.

(e) Load into any means of conveyance containing any dead, dying, disabled, or diseased livestock, or parts of the carcasses of any livestock that died otherwise than by slaughter, while in the course of importation or other transportation any livestock or parts of carcasses not within the foregoing description or any other products or other commodities.

Section 325.21 Means of conveyance in which dead, dying, disabled, or diseased livestock and products thereof shall be transported

All vehicles and other means of conveyance used by persons subject to Section 325.20 for transporting or importing, any dead, dying, disabled, and diseased livestock or parts of carcasses of livestock that died otherwise than by slaughter shall be leak-proof and so constructed and equipped as to permit thorough cleaning and sanitizing. The means of conveyance so used in conveying such livestock, or parts thereof, shall be cleaned and disinfected prior to use in the transportation of any product intended for use as human food. The cleaning procedure shall include the complete removal from the means of conveyance of any fluid, parts, or product of such dead, dying, disabled, or diseased livestock and the thorough application of a disinfectant to the interior surfaces of the cargo space. Substances permitted for such use are:

(a) "Liquefied phenol" (U.S.P. strength 87 percent phenol) in the proportion of at least 6 fluid ounces to 1 gallon of water.

(b) "Cresylic disinfectant" in the proportion of not less than 4 fluid ounces to 1 gallon of water; and such other disinfectants as are approved by the Head of Service in specific cases.

Part 329 DETENTION; SEIZURE AND CONDEMNATION; CRIMINAL OFFENSES

Section 329.1 Article or livestock subject to administrative detention

Any carcass, part of a carcass, meat or meat food product of livestock, or article exempted from the definition of meat food product, or any dead, dying, disabled, or diseased livestock is subject to detention for a period not to exceed 30 days upon any premises where it is held for the purposes of, or during or after distribution or it is otherwise subject to the Act, and there is reason to believe that:

(a) Any such article is adulterated or misbranded and is capable of use as human food; or

(b) Any such article has not been inspected, in violation of the provisions of the Vermont Meat Inspection Act and/or regulations promulgated thereunder; or

(c) Any such article or livestock has been or is intended to be, distributed in violation of the provisions of the Vermont or Federal Meat Inspection Acts and/or regulations promulgated thereunder.

Section 329.2 Method of detention; form of detention tag

An authorized representative of the Service shall detain any article or livestock to be detained under this part, by affixing an official "VT. Detained Tag" to such article or livestock.

Section 329.3 Notification of detention to the owner of the article or livestock detained, or his agent, or person having custody

When any article or livestock is detained under this part, an authorized representative of the Service shall give oral notification to the owner of the article or livestock detained if he can be ascertained and notified, and, if not, to his agent or the immediate custodian of the article or livestock, and promptly furnish the person so notified with a completed "Preliminary Notice of Detention". Within 48 hours after the detention of any article or livestock, an authorized representative of the Commissioner shall, if the detention is to continue, give written notification to the owner of the article or livestock detained by furnishing him a "Notice of Detention", or if such owner cannot be ascertained and notified within such period of time, furnish such notice to his agent, or the carrier or other person having custody of the article or livestock detained. The notification, with a copy of the preliminary notice shall be served by either delivering the notification to such owner or his agent, or to such other person, or by certifying and mailing the notification, addressed to such owner, agent, or other person, at his last known residence or principal office or place of business.

Section 329.4 Notification of governmental authorities having jurisdiction over article or livestock detained; form of written notification

Within 48 hours after the detention of any livestock or article pursuant to this part, an authorized representative of the Commissioner shall give oral or written notification of such detention to any Federal authorities not connected with the Service and any State or other governmental authorities, having jurisdiction over such livestock or article. In the event notification is given orally, it shall be confirmed in writing, as promptly as circumstances permit.

Section 329.5 Movement of article or livestock detained; removal of official marks

No article or livestock detained in accordance with the provisions in this part shall be moved by any person from the place at which it is located when so detained, until released by an authorized representative of the Commissioner: Provided, that any such article or livestock may be moved from the place at which it is located when so detained, for refrigeration, freezing, or storage purposes if such movement has been approved by an authorized representative of the Commissioner: and Provided further, That the article or livestock so moved will be detained by an authorized representative of the Commissioner after such movement until such time as the detention is terminated. When the detention of such article or livestock is terminated, the owner, or his agent or the carrier or other person in possession of the article or livestock who was notified when the article or livestock was detained, will receive notification of the termination. The notification "Notice of Termination of Detention" shall be served by either delivering the notice to such person, or by certifying and mailing the notification, addressed to such person at his last known residence or principal office or place of business. All official marks may be required by such representative to be removed from such article or livestock before it is released unless it appears to the satisfaction of the representative that the article or livestock is eligible to retain such marks.

Section 329.6 Articles or livestock subject to seizure and condemnation

Any carcass, part of a carcass, meat or meat food product, or any dead, dying, disabled, or diseased livestock, that is being transported or is otherwise subject to the Vermont Meat Inspection Act, or is held for sale after such transportation, is subject to seizure and condemnation, if such articles or livestock:

(a) Is or has been prepared, sold, transported, or otherwise distributed or offered or received for distribution in violation of the Act, or

(b) Is capable of use as human food and is adulterated or misbranded, or

(c) In any other way is in violation of the Act.

Part 350 EXOTIC ANIMAL, VOLUNTARY INSPECTION

Section 350.1 Definitions

20-001 Code Vt. R. 20-023-001-X

Effective Date: July 6, 1992 (Secretary of State Rule Log #92-34)
AMENDED: March 15, 1999 (Secretary of State Rule Log #99-11)

Statutory Authority: 6 V.S.A. § 3305(4), (5) and (8)