La. Admin. Code tit. 51 § IX-317

Current through Register Vol. 50, No. 9, September 20, 2024

Section IX-317 - Seafood Plant Operation [formerly paragraph 9:027 and 9:027-1]

A. The operation of plants engaged in shucking, cleaning, picking, peeling or packing marine or fresh water animal food products shall meet the requirements listed in §317 B-O.

1. Hazard Analysis. Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of shellfish product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of shellfish product being processed in the absence of those controls.

2. HACCP Plan. Every dealer shall have and implement a written HACCP plan. A HACCP plan shall be specific to:

a. each location where shellfish products are processed by that dealer; and

b. each kind of shellfish product processed by the dealer. The plan may group kinds of shellfish products together, or group kinds of production methods together, if the food safety hazard, critical control points, critical limits, and procedures required to be identified and performed in Paragraph 3. are identical for all shellfish products so grouped or for all production methods so grouped.

3. Contents of the HACCP Plan. The HACCP plan shall, at a minimum:

a. list the food safety hazards that are reasonably likely to occur, as identified in accordance with Paragraph 1 and that thus must be controlled for each shellfish product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

i. natural toxins;

ii. microbiological contamination;

iii. chemical contamination;

iv. pesticides;

v. drug residues;

vi. unapproved use of direct or indirect food or color additives; and

vii. physical hazards;

b. list the critical control points for each of the identified food safety hazards, including as appropriate:

i. critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. As an alternative, the dealer may establish other critical control points which the dealer can demonstrate that provides equivalent public health protection. If the dealer can demonstrate through a hazard analysis that the food safety hazard is not reasonably likely to occur, the critical control point is not required with the exception of receiving which shall always be considered as a critical control point;

ii. critical control points designed to control food safety hazards that could be introduced in the processing plant environment. As an alternative, the dealer may establish other critical control points which provide equivalent public health protection. If the dealer can demonstrate to the Authority through a hazard analysis that the food safety hazard is not reasonably like to occur, the critical control point is not required;

c. list the critical limits that must be met at each of the critical control points. As an alternative the dealer may establish other critical limits which the dealer has demonstrated provide equivalent public health protection with the exception of receiving which shall always be considered as a critical control point;

d. list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

e. include any corrective action plans that have been developed in accordance with Subparagraph 6.b to be followed in response to deviations from critical limits at critical control points;

f. provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring;

g. list the verification procedures, and frequency thereof, that the dealer will use in accordance with Subparagraph 7.a.

4. Signing and Dating the HACCP Plan

a. The HACCP plan shall be signed and dated, either by the most responsible individual on site at the processing facility or by a higher level official of the dealer. This signature shall signify that the HACCP plan has been accepted for implementation by the dealer.

b. The HACCP plan shall be signed and dated:

i. upon initial acceptance;

ii. upon any modification; and

iii. upon verification of the plan in accordance with Clause 7.a.i.

5. Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with Paragraphs 10, 11, and 12. They need not be included in the HACCP plan, and vice versa.

6. Corrective Actions

a. Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:

i. following a corrective action plan that is appropriate for the particular deviation; or

ii. following the procedures in Subparagraph 6.c.

b. Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with Subparagraph 3.e, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

i. no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

ii. the cause of the deviation is corrected.

c. When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:

i. segregate and hold the affected product, at least until the requirements of Clauses 6.c.ii and iii are met;

ii. perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review. Adequate training may or may not include training in accordance with Paragraph 9;

iii. take corrective action, when necessary, with respect to the affected product to ensure that no product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

iv. take corrective action, when necessary, to correct the cause of the deviation;

v. perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with Paragraph 9, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

d. All corrective actions taken in accordance with this Section shall be fully documented in records that are subject to verification in accordance with Paragraph 7 and the record keeping requirements of Paragraph 8.

7. Verification

a. Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:

i. a reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. These changes may include: Raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The reassessment shall be performed by an individual or individuals who have been trained in accordance with Paragraph 9. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of Paragraph 3;

ii. ongoing verification of activities including:

(a) a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(b) the calibration of process-monitoring instruments; and

(c) At the option of the dealer, the performing of periodic end-product or in-process testing;

iii. a review, including signing and dating, by an individual who has been trained in accordance with Paragraph 9, of the records that document:

(a). the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(b). the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with Paragraph 6. This review shall occur within one week of the day that the records are made;

(c). the calibrating of any process monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the processor's written procedures. These reviews shall occur within a reasonable time after the records are made.

b. Dealers shall immediately follow the procedures in Paragraph 6. Whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

c. The calibration of process-monitoring instruments, and the performing of any periodic end product and in-process testing, in accordance with Subclauses 7.a.ii.(b) and (c) shall be documented in records that are subject to the record keeping requirements of Paragraph 8.

8. Records

a. All records required by Paragraphs 1-12 shall include:

i. the name and location of the dealer;

ii. the date and time of the activity that the record reflects;

iii. the signature or initials of the person performing the operation; and

iv. where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

b. All records required by Paragraphs 1-12 shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.

c. Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years after their applicability to the product being produced at the facility.

d. If the processing facility is closed for a prolonged period between seasonal operations, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations but shall be immediately returned for official review upon request.

e. All records required by Paragraphs 1-12 and HACCP plans required by Paragraphs 2 and 3 shall be available for official review and copying at reasonable times.

f. The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.

9. Training

a. At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to shellfish processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA or who is otherwise qualified through job experience to perform these functions:

i. developing a HACCP plan, which could include adapting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of Paragraph 3;

ii. reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in Clause 6.c.v, and the HACCP plan in accordance with the verification activities specified in Clause 7.a.i; and

iii. performing the record review required by Clause 7.a.iii.

b. Job experience will quality an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum.

c. The trained individual need not be an employee of the dealer.

10. Sanitation Monitoring. Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency. The requirements relate to the following sanitation items:

a. safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice, hereinafter referred to as: safety of water for processing and ice production;

b. condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, hereinafter referred to as: Condition and cleanliness of food contact surfaces;

c. prevention of cross contamination from insanitary objects to food, food packaging materials, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product, hereinafter referred to as: prevention of cross contamination;

d. maintenance of hand washing and toilet facilities, hereinafter referred to as: maintenance of hand washing and toilet facilities;

e. protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants, hereinafter referred to as: protection from adulterants;

f. proper labeling, storage, and use of toxic compounds, hereinafter referred to as: proper labeling storage, use of toxic compounds;

g. control of employee health conditions that could result in the microbiological contamination of food packaging materials, and food contact surfaces, hereinafter referred to as: control of employees with adverse health conditions; and

h. exclusion of pests from the food plant, hereinafter referred to as: Exclusion of pests. While monitoring of those specified conditions and practices that are not appropriate to the plant and the food being processed is not required, compliance with such conditions and practices remains mandatory.

11. Sanitation Monitoring Records. Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by Paragraph 10. These records are subject to the requirements of Paragraph 8.

12. Relationship to HACCP Plan. Sanitation controls may be included in the HACCP plan, required by Paragraph 2. However, to the extend that they are monitored in accordance with Paragraph 10. they need not be included in the HACCP plan, and vice versa.

B. [formerly paragraph 9:028] Employee Health. The requirements of Part I, §117 and Part II, §501-503 C of this Code shall be met.

C. [formerly paragraph 9:029] During the operating season, the plant shall be used for no purpose other than the handling of shellfish or other marine or fresh water animal foods. Materials and equipment not used in the processing of seafood shall not be stored within the operating part of the plant. All abandoned equipment shall be removed from the plant and the floors shall be kept clear for thorough cleaning. The unoccupied portion of the storage bins, the shucking benches, work tables and all the floors shall be swept and flushed until they are thoroughly cleaned, at least once every day, at the completion of the day's run, with water from a source approved by the state health officer. Refrigeration rooms or ice boxes shall be washed out and thoroughly cleaned once a week or more often if necessary. At least once a week the cleansing shall include the washing of walls.

D. [formerly paragraph 9:030] All employees shall wash their hands thoroughly with running water and soap on beginning work and after each visit to the toilet. Signs to this effect shall be posted by the proprietor in conspicuous places in the plant and in each toilet.

1. The outer clothing worn by persons engaged in handling these food products shall be of such material as to be readily cleaned, and shall be kept clean. Persons engaged in cleaning, shucking, peeling, picking or packing marine or fresh water animal food products to be consumed without further cooking or processing shall be required to wear outer garments that are clean at the start of each day's employment. If finger cots or shields for protecting the palm of the hand are worn, they shall be of waterproof, nonabsorbent material, preferably of rubber (when available).

E. [formerly paragraph 9:031] Spitting and smoking in a marine or fresh water animal food product establishment is strictly prohibited.

F. [formerly paragraph 9:032] All utensils and tools in use, such as opening knives, shucking pails, measures, skimmers, colanders, tanks, tubs, and paddles, which come in contact with oysters, cooked shrimp or cooked and picked crabs, shall each day be thoroughly scoured until clean, using detergent or an alkali cleanser and then sanitized either:

1. by exposure for at least 15 minutes to a temperature of not less than 170°F, or for not less than five minutes to a temperature of at least 200°F, in a steam cabinet equipped with an indicating thermometer located in the coldest zone;

2. by exposure to a steam jet for at least one minute;

3. by immersion in or exposure to a flow of a chlorine solution of not less than 100 parts of free chlorine per million parts of water for not less than two minutes;

4. by immersion in an iodine solution concentration between 12.5 mg/L and 25 mg/L(ppm); or

5. by immersion in a quarternary ammonium compound solution concentration of 200 mg/L (ppm) or as indicated by the manufacturer's use directions included in labeling; or.

6. by immersion in hot water at a temperature of 170 degrees F or more for not less than two minutes; or

7. by exposure to hot air at a temperature of not less than 180 degrees F for not less than 20 minutes, in a properly designed oven or hot air cabinet equipped with an indicating thermometer located in the coldest zone or other method of eliminating pathogenic bacteria as approved by the state health officer.

G. [formerly paragraph 9:033] All equipment used in the shucking, picking, packing or other handling of seafoods, including shucking buckets, knives breaking blocks, finger cots and so forth, shall be stored in such a manner as not to become contaminated after cleaning and bactericidal treatment. Equipment in daily use during operating seasons shall not be removed from the plant for storage, but sufficient room or space shall be provided to store equipment that is not being used.

H. [formerly paragraph 9:034] Shucking, picking, peeling, packing, or other work operations shall be carried out on tables, counters, etc., above floor-level; such operations shall not be performed on the floor. Where marine or fresh water animal food products are stored, adequate protection shall be provided within the storage space to prevent possible contamination from fresh water, wastes, and from foot traffic. Utensils, for handling marine or fresh water animal food products that are to be consumed without further cooking or processing, shall be so placed as to prevent handling of drippings from the food by the workers.

I. [formerly paragraph 9:035] The "nesting" of empty pails shall not be permitted during the operating season. When not in use, pails shall be inverted on racks or benches provided for this purpose.

J. [formerly paragraph 9:036] The cooling to a temperature of 45°F or less of shucked shellfish, picked crabs, cooked, peeled shrimp or other seafoods which are to be consumed without further cooking or processing shall be effected as promptly as possible, and in no case shall the time exceed two hours after shucking, picking or cooking; provided that crabs or similar seafoods, which are picked after cooking, shall be cooled as rapidly as possible after cooking to a temperature of 45°F or less and held at such temperature until ready to be picked, after which the picked material shall again be cooled, as specified above.

K. [formerly paragraph 9:037] Water for washing any marine or fresh water animal used as a food, or any food products derived from them, shall be from an approved source as defined in Part XII, Water Supplies, of this Code.

L. [formerly paragraph 9:038] Shells, washings and other wastes shall be disposed of in such manner defined in Part XIII of the state sanitary code.

M. [formerly paragraph 9:039] All persons handling shucked shellfish, picked crabs, cooked, peeled shrimp, or other marine or fresh water animal food to be consumed without further cooking or processing, shall keep their hands scrupulously clean. A solution of at least 50 parts per million (ppm) of free chlorine should be provided in which such persons can frequently rinse their hands and forearms.

N. [formerly paragraph 9:040] When necessary in the interest of the public health, a duly authorized representative of the state health officer shall attach a tag to any equipment or utensil which is insanitary, or the use of which would be in violation of these regulations. Any equipment or utensil so tagged shall not be used again until made sanitary and approved by the state health officer. Tags so placed shall not be removed by anyone other than a duly authorized representative of the state health officer.

O. [formerly paragraph 9:041] A single individual shall be designated by the management to supervise the shucking and packing of shellfish, the packing of peeled and cooked shrimp and picked crabs. They shall be responsible for the cleanliness the shucking, picking, or packing rooms and shall see that the requirements with reference to washing of hands after interruption of working operations is carried out by all persons engaged in the establishment. They shall be responsible at the end of each day's operations for the thorough cleansing and sanitizing of all equipment such as pails, knives, breaking blocks, finger cots, aprons, and so forth.

La. Admin. Code tit. 51, § IX-317

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1303 (June 2002), Amended by the Department of Health, Office of Public Health, LR 481853 (7/1/2022), Amended LR 482141 (8/1/2022).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:4.A.(1) and R.S. 40:5.3.