CHAPTER 165
REGULATIONS FOR THE REPACKING OF CRAB MEAT

Part I
General Provisions

12VAC5-165-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise:

"Action level" means the limit established for a deleterious substance present in a product or the environment, above which level prescribed actions by the division may be required to protect public health.

"Agency" means the Virginia Department of Health.

"Certificate of Inspection" means a numbered certificate issued by the division to a shipper after an inspection confirms compliance with applicable regulations and standards.

"Certification number" means a unique number assigned to each shipper upon issuance of a Certificate of Inspection.

"Certified laboratory" means a laboratory certified by the U.S. Food and Drug Administration for analysis of food products.

"Critical Control Point (CCP)" means a point, step or procedure in a food process at which control can be applied, and a food safety hazard can, as a result, be prevented, eliminated or reduced to acceptable numbers.

"Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

"Decertification" means the revocation of a Certificate of Inspection.

"Department" means the Virginia Department of Health.

"Division" means the Division of Shellfish Sanitation.

"Establishment" means any vehicle, vessel, property, or premises where crustacea, finfish or shellfish are transported, held, stored, processed, packed, repacked or pasteurized in preparation for marketing.

"HACCP plan" means a written document that delineates the formal procedures that a dealer follows to implement a Hazard Analysis Critical Control Point methodology to assure food safety.

"Hazard analysis" means a process used to determine whether there are food safety hazards that are reasonably likely to occur while repacking crab meat and to identify the preventive measures that the repacker can apply to control those hazards.

 "Importer" means either the owner or consignee at the time of entry into the United States, or the agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation.  

"Lot" means repacked crab meat that bears the same repack date and source code.

"Preventive measure" means actions taken to prevent or control a food safety hazard.

"Processing" means cooking, picking, packing, repacking or pasteurizing crab meat.

"Processor" means a person who operates an establishment that cooks, picks, packs, repacks or pasteurizes crab meat. "Processor means any person engaged in commercial, custom, or institutional processing of crab meat, either in the United States or in a foreign country.  

"Repacker" means a person who operates an establishment that transfers crab meat from a container originally packed by another establishment to another container.

"Repacking operation" means a process of transferring crab meat from the original shipper's packing container to a different packing container, including all steps beginning with the removal of the original containers of meat from the repacker's refrigeration and ending with the repacked crab meat in properly identified containers placed into refrigeration.

"Shipper" means a person who operates an establishment for the cooking, picking, repacking or pasteurizing of crab meat.

"Source code" means a code designated by the repacker which represents the crab processing facility where crab meat was obtained.

12VAC5-165-30. Powers and procedures of regulations not exclusive.

The commissioner may enforce this chapter through any means lawfully available.

12VAC5-165-50. Hazard Analysis Critical Control Point (HACCP) plan.

An establishment for the repacking or relabeling of crab meat shall have and maintain an approved Hazard Analysis Critical Control Point (HACCP) plan to include, at a minimum, the following:

1. A hazard analysis;

2. The identification of preventive measures;

3. The identification of critical control points;

4. The establishment of critical limits for each critical control point;

5. The monitoring records of each critical control point;

6. The establishment of corrective action when a critical limit deviation occurs;

7. The establishment and maintenance of a recordkeeping system; and

8. The establishment of verification procedures.

12VAC5-165-60. Scope of embargo.

In the event of a recall or embargo of repacked crab meat, the entire production bearing the lot number will normally be recalled or embargoed, unless a verifiable sublot coding system has been used.

12VAC5-165-70. Oversight for safety of product.

Any condition that may compromise the safety of the final product shall be identified by the repacker and the division shall be contacted for appropriate disposition of the product.

Part II
Sources of Crab Meat for Repacking

12VAC5-165-80. Source facility requirements.

Crab meat for repacking shall be picked and packed by a crab processing establishment which is currently licensed, permitted or certified and inspected by either a state public health authority or by a foreign government public health authority, and shall operate under a HACCP plan approved by the state or a foreign government public health authority, or the U.S. Food and Drug Administration. Crab meat picked and packed in the United States shall originate from a crab processing establishment which is currently certified by a state public health authority. Imported crab meat shall meet the requirements of the Code of Federal Regulations: 21 CFR 123.12 "Special requirements for imported products".

12VAC5-165-90. Verification of shipping temperatures for imported crab meat.

When imported crab meat is used as a source for repacking, the The repacker shall provide a record of international transport temperature receiving conditions for each shipment of crab meat, or other information sufficient to verify that the product was not temperature abused. Temperature recording may be by maximum temperature recording, continuous temperature recording, or by other device approved by the Division of Shellfish Sanitation. The processor  repacker shall include the transport receiving temperature conditions as a part of the receiving CCP in its HACCP plan.

12VAC5-165-100. Sampling and analysis requirements for imported crab meat.

A. When imported crab meat is used as a source for repacking, the repacker shall take a minimum of five samples from the first two shipments prior to any processing to be analyzed by a certified laboratory. If all samples from both initial shipments meet the specified action levels, then the sampling interval may be reduced to once every three months (quarterly) for each shipper. If any quarterly samples exceed the action levels, then sampling will be required on all successive shipments until all samples from two successive shipments meet the action levels as follows:  When imported crab meat is used as a source for repacking, the importer or repacker shall take a minimum of five samples from each lot prior to processing to be analyzed by a certified laboratory and shall maintain on file a copy of the sampling results for a minimum of 1 year. The action levels for the crab meat sampled are as follows:

1. Pasteurized crab meat.

a. Aerobic plate count; action level of >3,000/g.

b. Fecal coliforms; action level of >20/100g.

2. All other crab meat.

a. Aerobic plate count; action level of >100,000/g.

b. Fecal coliforms; action level of >93/100g.

B. When imported crab meat is used as a source for repacking, the importer or repacker shall take a minimum of five samples from every shipment to be tested for decomposition by organoleptic sensing technique and shall maintain a copy of the results on file for a minimum of 1 year. These analyses shall be conducted only by a designated person trained in organoleptic sensing technique either by Virginia Polytechnic Institute and State University (Virginia Tech), the United States Food and Drug Administration (FDA), or by another source approved by the division. The repacker shall submit to the division a copy of the certificate of training or other documentation denoting successful completion of the training from the trainer for each individual conducting the analysis, and shall maintain a copy in his records.

C. If any sample is found to exceed an action level or guideline, or is found to show evidence of decomposition, the repacker shall stop processing the lot sampled and contact the division before proceeding with processing to determine the disposition of that lot.

D. All records of sample analyses shall be kept on file at the repacker and shall be available for review by the division. These records shall be maintained for a period of one year from the date of processing for products packaged for fresh distribution, and two years for products packaged for frozen or pasteurized distribution.

12VAC5-165-110. Verification of pasteurization for imported crab meat.

If the crab meat for repacking was pasteurized in an establishment outside the United States, the repacker shall obtain a letter from the foreign crab meat producer stating that the crab meat has received a pasteurization process equivalent of F¹⁶₁₈₅=31 minutes and was processed utilizing HACCP controls.

12VAC5-165-120. Verification of container integrity for imported, pasteurized crab meat.

The repacker shall evaluate the container integrity of all imported, pasteurized crab meat products. These evaluations shall also be conducted after any pasteurization by the repacker. This evaluation shall at a minimum include visual inspection of all containers for evidence of leaks. A record of inspection should be maintained on file for a minimum of one year.

12VAC5-165-150. Pasteurized crab meat storage temperature.

Containers of pasteurized crab meat destined for repacking shall be stored and transported in a refrigerated room or vehicle at a temperature of 36°F or less.

12VAC5-165-170. Temperature of crab meat during repacking.

No portion of the crab meat shall exceed 50°F during the repacking process.

12VAC5-165-180. Cooling of crab meat after repacking.

Immediately after repacking, containers of repacked crab meat shall be either placed into crushed or flaked ice or placed into refrigeration not to exceed 36°F, or both.

12VAC5-165-200. Imported crab meat to be pasteurized.

Prior to or after repacking, the repacker shall pasteurize all imported crab meat which has not been pasteurized in the country of origin. Pasteurization shall meet the National Blue Crab Industry Pasteurization and Alternative Thermal Processing Standards, revised November 8, 1993, with records Records of pasteurization to be kept as required in Article 3 (12VAC5-165-240 et seq.) of this part. The heat penetration in the crab meat during the pasteurization process for all container sizes and types shall be confirmed in writing by Virginia Tech or other authority approved by the division as meeting the aforementioned minimum requirements.

12VAC5-165-220. Lot numbers.

A. Containers of repacked crab meat shall be stamped or embossed with the lot number.

B. Lot numbers shall consist of a repack date and a code indicating the original source firm that picked the crab meat. All codes for lot numbers shall be logged in the processor records with an explanation of the code. Lot numbers shall consist of a repack date and a code indicating the original processor. Records shall be maintained by the repacker for a minimum of one year with an explanation of the code.

12VAC5-165-230. Country of origin for imported crab meat.

Imported crab meat shall be packed into containers which bear a declaration of the country of origin of the repacked crab meat on the principal display panel of the container.

Article 3
Records and Recordkeeping

12VAC5-165-240. Accessibility of records.

All required records shall be (i) kept in logical order for a minimum of one year, (ii) maintained by the repacker, and (iii) readily accessible by the Division of Shellfish Sanitation staff for inspection.

12VAC5-165-250. Crab meat sources and source coding.

The repacker shall maintain records clearly indicating the sources of crab meat used for repacking in relation to the source code identified on the containers of repacked crab meat.

12VAC5-165-260. Traceability of repacked crab meat.

The individual lots of crab meat shall be easily traceable from their source through the repacking process to the buyer and from the buyer back through the repacker to the particular lot source.

12VAC5-165-270. Minimum records to be kept.

The repacker shall, at a minimum, maintain the following information on each lot of repacked crab meat: the source plant, quantity received from source, type of meat, date of repacking, buyers, and quantities of repacked lots sold. Additional clarifying records may be required if individual lots of product cannot easily be traced.

12VAC5-165-280. Records to be kept separate.

Records for repacked imported crab meat shall be kept separate from other production records.

Article 4
Penalties

12VAC5-165-290. Decertification of certified facilities.

Any certified crab meat processor found to be packing or repacking foreign crab meat into a container without the country of origin on the principal display panel will be decertified for 30 days, effective immediately upon the finding by the Director of the Division of Shellfish Sanitation.

12VAC5-165-300. Operating without a Certificate of Inspection.

Persons processing crab meat for marketing without a valid Certificate of Inspection shall be guilty of a Class 1 misdemeanor.

12VAC5-165-310. Improper labeling of foreign crab meat.

Persons, even if operating in a facility with a valid Certificate of Inspection, shall be guilty of a Class 1 misdemeanor if found to be packing or repacking foreign crab meat into a container without the country of origin indicated on the principal display panel.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-165)

National Blue Crab Industry Pasteurization and Alternative Thermal Processing Standards, National Blue Crab Industry Association Grades and Cooking Standards Committee, revised November 8, 1993.