Title of Regulation: 12VAC5-165. Regulations for the Repacking of Crab Meat (amending 12VAC5-165-10, 12VAC5-165-80, 12VAC5-165-90, 12VAC5-165-100, 12VAC5-165-120, 12VAC5-165-150, 12VAC5-165-180, 12VAC5-165-220, 12VAC5-165-230, 12VAC5-165-240, 12VAC5-165-270; repealing 12VAC5-165-70, 12VAC5-165-200, 12VAC5-165-280, 12VAC5-165-290).

Statutory Authority: § 28.2-801 of the Code of Virginia.

Effective Date: December 2, 2015.

Agency Contact: Keith Skiles, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7477, FAX (804) 864-7481, or email keith.skiles@vdh.virginia.gov.

Summary:

The amendments (i) align the regulations with the Code of Federal Regulations, (ii) eliminate the requirement that the repacker contact the Division of Shellfish Sanitation when any condition that may compromise the safety of the final product exists, (iii) loosen the sampling requirements for imported crab meat, and (iv) remove the requirement for a preprinted principal display panel declaring the country of origin on a container of imported crabmeat.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

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)" or "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 of the Virginia Department of Health.

"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 of the crab meat 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.

"Principal display panel" means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

"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 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.

12VAC5-165-70. Oversight for safety of product. (Repealed.)

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 that (i) ] is currently licensed, permitted or certified and inspected by either a state public health authority or by a foreign government public health authority [ , ] and [ (ii) ] 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. Imported crab meat shall meet the requirements for imported products set forth in 21 CFR 123.12 (60 FR 65197, December 18, 1995).

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, or other information sufficient to verify that the product was not temperature abused of crab meat. Temperature recording may be by maximum temperature recording, continuous temperature recording, or by other device approved by the Division of Shellfish Sanitation such as adequate amount of ice or adequate quantity of chemical cooling media. The processor repacker shall include the transport receiving temperature conditions as a part of the receiving CCP in its the 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: importer or repacker may take samples from each lot prior to processing to be analyzed by a certified laboratory and maintain on file a copy of the sampling results for a minimum of one 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 may 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 such ] results on file for a minimum of one 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 repacker's establishment shall be made 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.

12VAC5-165-120. 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 shall be maintained on file by the repacker 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 40°F ] or less.

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

Immediately after repacking, the repacker shall place containers of repacked crab meat shall be either placed into crushed or flaked ice or placed into refrigeration not to exceed [ 36°F 40°F ] , or both.

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

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 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. 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 by the repacker into containers which that bear a declaration of the country of origin of the repacked crab meat on the [ using a preprinted 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, (ii) maintained by the repacker, and (iii) readily accessible by shall be made available to the Division of Shellfish Sanitation staff division for inspection.

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 for a minimum of one year: (i) the original processor information, (ii) verification records of shipping temperature conditions, (iii) records required by the repacker's HACCP plan, and (iv) repacked crab meat sales records. Additional clarifying records may be required by the division to identify lot codes on containers.

12VAC5-165-280. Records to be kept separate. (Repealed.)

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

12VAC5-165-290. Decertification of certified facilities. (Repealed.)

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.

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.