S.C. Code Regs. § § 61-36.I

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-36.I - DEFINITIONS

The following definitions shall apply in the interpretation and the enforcement of this regulation:

A. ADULTERATED - a MANUFACTURED GRADE DAIRY PRODUCT is deemed to be ADULTERATED if the product:

1. Bears or contains any poisonous or deleterious substance in a quantity that may render it injurious to health;

2. Bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by state or federal regulation, or in excess of such tolerance if one has been established;

3. Consists, in whole or in part, of any substance unfit for human consumption;

4. Has been produced, processed, prepared, packaged, or held under unsanitary conditions;

5. Is packaged in a container which is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

6. Has any substance added thereto or mixed or packaged therewith 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;

7. Is in violation of Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. 342); or

8. Contains any animal DRUG residues.

B. ALCOHOL INFUSED FROZEN DESSERT- any FROZEN DESSERT that contains five percent (5%) or more alcohol by volume.

C. APPROVED - acceptable to the DEPARTMENT based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

D. ASEPTICALLY PROCESSED MIX - a MANUFACTURED GRADE DAIRY PRODUCT that is hermetically sealed in a container and so thermally processed in conformance with 21 CFR Part 113 and the provisions of this regulation so as to render the product free of MICROORGANISMS capable of reproducing in the product under normal non-refrigeration conditions of storage and distribution. The product shall be free of viable MICROORGANISMS (including spores) of public health significance.

E. ASEPTIC PROCESSING - a process whereby the MANUFACTURED GRADE DAIRY PRODUCT has been subjected to sufficient heat processing, and packaged in a HERMETICALLY SEALED CONTAINER, to conform to the applicable requirements of 21 CFR Part 113 and the provisions of Section VII A.1.c. of this regulation and maintain the commercial sterility of the product under normal non-refrigerated conditions.

F. BUSINESS DAY - every official work day of the week excluding weekends and state holidays.

G. BUTTER - the FOOD product usually known as BUTTER that is made exclusively from MILK or cream, or both, with or without salt, and with or without additional coloring matter, and which contains not less than eighty percent (80%) by weight of MILK fat. BUTTER may contain:

(a) MILK solids;

(b) APPROVED bacterial culture;

(c) salt;

(d) air or inert gas; and

(e) APPROVED FOOD color. BUTTER also includes the following MANUFACTURED GRADE DAIRY PRODUCTS:

1. BUTTER WITH (NAMING THE FRUIT, VEGETABLE, OR RELISH) - BUTTER to which any fruit, vegetable, or relish, or any combination thereof, has been added. It may contain less than eighty percent (80%) MILK fat if the percentage of MILK fat is reduced by the amount of the product added, but the resulting MILK fat content must be at least seventy-five (75%).

2. BUTTER WITH (NAMING THE SEASONING OR FLAVOR) - BUTTER to which a seasoning or a flavor other than that of BUTTER, or both, has been added. It must contain at least eighty percent (80%) MILK fat.

3. CALORIE-REDUCED BUTTER - the FOOD product usually known as calorie-reduced BUTTER that is prepared from MILK or MILK products or a combination thereof, and which contains at least thirty-nine (39%) MILK fat and not more than fifty percent (50%) of the calories that would normally be present in BUTTER. CALORIE-REDUCED BUTTER may contain:

(a) MILK solids;

(b) APPROVED bacterial culture;

(c) salt;

(d) air or inert gas;

(e) APPROVED FOOD color;

(f) APPROVED emulsifying and stabilizing agents;

(g) APPROVED preservatives; and

(h) not more than one percent (1%) added edible casein, edible caseinates, or any combination thereof.

4. LIGHT BUTTER OR LITE BUTTER - FOOD product usually known as LIGHT BUTTER or LITE BUTTER, which is prepared from MILK or MILK products or a combination thereof, and which contains at least thirty-nine (39%) MILK fat and not more than sixty percent (60%) MILK fat. LIGHT BUTTER or LITE BUTTER may contain:

(a) MILK solids;

(b) APPROVED bacterial culture;

(c) salt;

(d) air or inert gas; and

(e) APPROVED FOOD color.

5. WHEY BUTTER - FOOD product usually known as WHEY BUTTER that is prepared from MILK or MILK products or a combination thereof, and which contains at least eighty percent (80%) MILK fat that is recovered from whey, by weight. WHEY BUTTER may contain:

(a) MILK solids;

(b) APPROVED bacterial culture;

(c) salt;

(d) air or inert gas; and

(e) APPROVED FOOD color.

H. CODE OF FEDERAL REGULATIONS (CFR) - a codification of the general and permanent rules and regulations (administrative LAW) published in the Federal Register by the executive departments and agencies of the federal government of the United States. Citations to the CFR in this regulation refer sequentially to the Title, Part, and Section numbers (e.g., 21 CFR 117.10 refers to Title 21, Part 117, Section 117.10).

I. CHEESE - the fresh or matured product obtained by draining after coagulation of MILK, cream, skimmed or partly skimmed MILK, or a combination of some or all of these products, including any CHEESE that conforms to the requirements of 21 CFR 133, as amended.

J. DEPARTMENT - the South Carolina Department of Health and Environmental Control and its authorized representatives.

K. DRUG - shall mean:

1. articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

2. articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

3. articles (other than FOOD) intended to affect the structure of any function of the body of man or other animals; and

4. articles intended for use as a component of any articles specified in clauses 1, 2, or 3, but does not include devices or their components, parts, or accessories.

L. EMPLOYEE - permit holder, PERSON in charge, PERSON having supervisory or managerial duties, PERSON on the payroll, family member, volunteer, PERSON performing work under a contractual agreement, or any other PERSON working in a MANUFACTURED GRADE DAIRY PRODUCTS plant or distribution station.

M. EXCLUSION - prevention of a PERSON from working as an EMPLOYEE in a MANUFACTURED GRADE DAIRY PRODUCTS plant or distribution station or entering a MANUFACTURED GRADE DAIRY PRODUCTS plant or distribution station as an EMPLOYEE.

N. FDA - United States Food and Drug Administration.

O. FD&C - United States Food, Drug, and Cosmetic Act, the federal LAWS giving authority to FDA to oversee the safety of FOOD, DRUGS, medical devices and cosmetics, as set forth in 21 U.S.C. Section 301 et seq.

P. FOOD - means FOOD as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C) and includes raw materials and ingredients.

Q. FROZEN DESSERT - as used in this regulation is defined in S.C. Code Ann. Section 39-37-10. They shall also include MIXES used for FROZEN DESSERT manufacturing and products such as gelato and sorbetto made in semblance of those products defined in Section 39-37-10.

R. HERMETICALLY SEALED CONTAINER - a container that is designed and intended to be secure against the entry of MICROORGANISMS and thereby maintain the commercial sterility of its contents after processing.

S. IMITATION MILK AND IMITATION MILK PRODUCTS, SYNTHETIC MILK AND SYNTHETIC MILK PRODUCTS, MILK DERIVATIVES, AND ANY OTHER PRODUCTS MADE IN SEMBLANCE OF MILK OR MILK PRODUCTS - Products made in semblance of MILK and MILK products are products that are made to resemble in form and are intended to be used in substitution for MILK and/or MILK products and that are determined not to be nutritionally inferior to MILK and/or MILK products.

T. IMMINENT HEALTH HAZARD - a significant threat or danger to health that is considered to exist when there is sufficient evidence to show that a product, practice, circumstance, or event creates a situation requiring immediate correction or cessation of operation to prevent illness or injury based on the number of potential illnesses or injuries, and the nature, severity, and duration of the anticipated illness or injury.

U. LAW - applicable local, state, and federal statues, regulations, and ordinances.

V. MANUFACTURED GRADE DAIRY PRODUCT(S) - refers to all types of dairy based manufactured FOOD products to include CHEESES, BUTTERS, FROZEN DESSERTS (including MIX), and IMITATION MILK and IMITATION MILK PRODUCTS, SYNTHETIC MILK AND SYNTHETIC MILK PRODUCTS, MILK DERIVATIVES, and ANY OTHER PRODUCTS MADE IN SEMBLANCE OF MILK OR MILK PRODUCTS.

W. MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATION - any place or PREMISES, except MANUFACTURED GRADE DAIRY PRODUCTS RETAILERS, where MANUFACTURED GRADE DAIRY PRODUCTS are received, stored, and dispensed to retailers (may also be referred to as "Distribution Station").

X. MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTOR - any PERSON, except a MANUFACTURED GRADE DAIRY PRODUCTS RETAILER, who receives, stores, and dispenses MANUFACTURED GRADE DAIRY PRODUCTS to retailers (may also be referred to as "Distributor").

Y. MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURER - any PERSON, except a MANUFACTURED GRADE DAIRY PRODUCTS RETAILER, who manufactures, processes, or freezes MANUFACTURED GRADE DAIRY PRODUCTS for distribution or sale.

Z. MANUFACTURED GRADE DAIRY PRODUCTS PLANT - any place or PREMISES, except MANUFACTURED GRADE DAIRY PRODUCTS RETAILERS, where MANUFACTURED GRADE DAIRY PRODUCTS are manufactured, processed, or frozen for distribution or sale.

AA. MANUFACTURED GRADE DAIRY PRODUCTS RETAILER - any PERSON who sells, serves, or dispenses MANUFACTURED GRADE DAIRY PRODUCTS at retail which have been processed in an APPROVED MANUFACTURED GRADE DAIRY PRODUCTS PLANT.

BB. MICROORGANISMS - means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are PATHOGENS. The term "undesirable MICROORGANISMS" includes those MICROORGANISMS that are PATHOGENS, that subject FOOD to decomposition, that indicate that FOOD is contaminated with filth, or that otherwise may cause FOOD to be ADULTERATED.

CC. MILK (HOOVED MAMMALS' MILK) - Hooved mammals' MILK is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy hooved mammals. Hooved mammals for the purpose of this regulation include, but are not limited to, the members of the Order Cetartiodactyla, such as: Family Bovidae (cattle, water buffalo, sheep, goats, yaks, etc.), Family Camelidae (llamas, alpacas, camels, etc.), Family Cervidae (deer, reindeer, moose, etc.), and Family Equidae (horses, donkeys, etc.).

DD. MIX - the unfrozen combination of ingredients of FROZEN DESSERTS except such fruits, nuts, flavors, color, and other ingredients as may be exempted by the DEPARTMENT. MIX shall be PASTEURIZED.

EE. NUISANCE - for purposes of this regulation, a public health NUISANCE, meaning whatever is dangerous to human life or detrimental to health; or whatever structure or PREMISES is not sufficiently ventilated, sewered, drained, cleaned, or lighted with respect to its intended occupancy.

FF. OFFICIALLY DESIGNATED LABORATORY - a commercial laboratory authorized to do official work by the DEPARTMENT, or a MILK industry laboratory officially designated by the DEPARTMENT for the examination of producer samples of Grade "A" RAW MILK for PASTEURIZATION and commingled MILK tank truck samples of RAW MILK for antibiotic residues and bacterial limits.

GG. OFFICIAL LABORATORY - a biological, chemical, or physical laboratory that is under the direct supervision of the DEPARTMENT.

HH. PASTEURIZATION - the process of heating every particle of MANUFACTURED GRADE DAIRY PRODUCT in properly designed and operated equipment to one of the temperatures given in the following table, and holding the product continuously at or above that temperature for at least the corresponding specified time:

Batch (Vat) PASTEURIZATION
Temperature	Time
145°F (63°C)*	30 minutes
Continuous Flow (HTST and HHST) PASTEURIZATION
Temperature	Time
161°F (72°C)*	15 seconds
191°F (89°C)	1.0 second
194°F (90°C)	0.5 second
201°F (94°C)	0.1 second
204°F (96°C)	0.05 second
212°F (100°C)	0.01 second

^*If the fat content of the dairy product is ten percent (10%) or greater, or a total solids of eighteen percent (18%) or greater, or if it contains added sweeteners, the specified temperature shall be increased by 5°F (3°C).

Provided, that FROZEN DESSERTS shall be heated to at least the following temperature and time specifications:

Batch (Vat) PASTEURIZATION
Temperature	Time
155°F (69°C)	30 minutes
Continuous Flow (HTST) PASTEURIZATION
Temperature	Time
175°F (80°C)	25 seconds
180°F (83°C)	15 seconds

Provided, that MILK for CHEESE making shall be heated to at least the following temperature and time specification:

Batch (Vat) PASTEURIZATION
Temperature	Time
145°F (63°C)	30 minutes
Continuous Flow (HTST) PASTEURIZATION
Temperature	Time
161°F (72°C)	15 seconds

Provided, that cream for BUTTER making shall be heated to at least the following temperature and time specifications:

Batch (Vat) PASTEURIZATION
Temperature	Time
165°F (74°C)	30 minutes
Continuous Flow (HTST) PASTEURIZATION
Temperature	Time
185°F (85°C)	15 seconds

Provided further that nothing in this definition shall be construed as barring any other process found equivalent to PASTEURIZATION for dairy products, which has been recognized by the FDA as provided in Section 403(h)(3) of the FD&C ( 21 U.S.C. Section 343(h)(3)) , as amended, and which is APPROVED by the DEPARTMENT.

II. PATHOGEN - a microorganism of public health significance.

JJ. PERMIT - the document issued by the DEPARTMENT that authorizes a PERSON or entity to operate a MANUFACTURED GRADE DAIRY PRODUCTS PLANT or MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATION.

KK. PERMIT HOLDER - the entity, such as the owner, the owner's agent, or other PERSON, that possesses a valid PERMIT to operate a MANUFACTURED GRADE DAIRY PRODUCTS PLANT or MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATION and is legally responsible for its operation.

LL. PERSON - any individual, plant operator, partnership, corporation, company, firm, trustee, association, or institution.

MM. PEST - any objectionable animals or insects including but not limited to birds, rodents, flies, and larvae.

NN. PASTEURIZED MILK ORDINANCE (PMO) - a set of minimum standards and requirements that are established by the FDA for regulating the production, processing, and packaging of Grade "A" MILK.

OO. PREMISES -

1. The physical facility, its contents, its land, and any adjacent or bordering contiguous land or property under the control of the PERMIT HOLDER; or

2. The physical facility, its contents, and land or property not described in (a) of this definition if the facilities and contents are under the control of the PERMIT HOLDER and may impact the MANUFACTURED GRADE DAIRY PRODUCTS PLANT or distribution station personnel, facilities, or operations, and the MANUFACTURED GRADE DAIRY PRODUCTS PLANT or distribution station is only one component of a larger operation such as a healthcare facility, hotel, motel, school, recreational camp, or prison.

PP. RAW MILK - MILK that has not been PASTEURIZED.

QQ. RESTRICTION - limitation of the activities of an EMPLOYEE so that there is no RISK of transmitting a disease that is transmissible through MANUFACTURED GRADE DAIRY PRODUCTS or ingredients and the EMPLOYEE does not work with exposed MANUFACTURED GRADE DAIRY PRODUCTS or ingredients, clean equipment, utensils, linens, or unwrapped single-service or single-use articles.

RR. RETAIL FOOD ESTABLISHMENT - an establishment that sells FOOD products directly to consumers as its primary function. RETAIL FOOD ESTABLISHMENTS include, but are not limited to, grocery stores, convenience stores, roadside stands, farmers markets, and community supported agriculture (CSA) operations. Any business making FOOD (including a farm business) with at least 50.1 percent in direct to individual consumer FOOD sales satisfies the definition of a RETAIL FOOD ESTABLISHMENT and is exempt from the Bioterrorism Act registration regulations under the 2002 Bioterrorism Act (21 CODE OF FEDERAL REGULATIONS [C.F.R.] 1.225) as a RETAIL FOOD ESTABLISHMENT. The term "consumers" does not include businesses. A RETAIL FOOD ESTABLISHMENT also includes certain farm-operated businesses selling FOOD directly to consumers as their primary function.

SS. RISK - the likelihood that an adverse health effect will occur within a population as a result of a hazard in a FOOD.

TT. SANITIZE - to adequately treat cleaned surfaces by a DEPARTMENT-accepted process that is effective in destroying vegetative cells of PATHOGENS, and in substantially reducing numbers of other undesirable MICROORGANISMS, but without adversely affecting the product or its safety for the consumer.

UU. ULTRA-PASTEURIZED - MANUFACTURED GRADE DAIRY PRODUCT that has been thermally processed at or above 280ºF (138ºC) for at least two (2) seconds, either before or after packaging, so as to produce a product that has an extended shelf life under refrigerated conditions.

VV. UNEXPOSED PACKAGED FOOD - packaged FOOD that is not exposed to the environment.

S.C. Code Regs. § 61-36.I

Replaced and amended by State Register Volume 44, Issue No. 06, eff. 6/26/2020.