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 and 28.2-806 of the Code of Virginia.

Public Hearing Information:

December 18, 2013 - 9 a.m. - James Madison Building, 109 Governor Street, Mezzanine Conference Room, Richmond, VA 23219

Public Comment Deadline: February 14, 2014.

Agency Contact: Bob Croonenberghs, PhD, Director, Division of Shellfish Sanitation, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7477, FAX (804) 864-7481, or email bob.croonenberghs@vdh.virginia.gov.

Basis: Section 28.2-801 of the Code of Virginia authorizes the State Board of Health to promulgate regulations necessary to carry out the provisions of Chapter 8 (§ 32.1-800 et seq.) of Title 32.1 of the Code of Virginia. Section 28.2-806 of the Code of Virginia provides that the State Health Commissioner may establish and change standards, examinations, analyses, and inspections that control the taking and marketing of crustacea, finfish, or shellfish from a health standpoint.

Purpose: Some of the provisions of 12VAC5-165 either cannot be met by certified Virginia repacking establishments because of changes in the way that crab meat is being imported from foreign countries and shipped into the United States or are unnecessary and have no relevance to public health. The amended regulations provide requirements that Virginia processors can reasonably meet and will address the existing risks of the importation of crab meat from unapproved sources and the repacking of foreign crab meat and labeling it as domestic crab meat. The proposed regulations will serve to protect the public's health by clarifying requirements for repacking crab meat.

Substance: The proposed amendments:

1. Repeal 12VAC5-165-70, which states that the Division of Shellfish Sanitation should be contacted when any condition that may compromise the safety of the product exists. This provision is unnecessary and burdensome to both industry and the division. The repacker must be able to decide the appropriate disposition of product it is processing without the approval or disapproval of the division.

2. Modify 12VAC5-165-90, which addresses the verification of shipping temperatures of imported crab meat, to include all crab meat and to clarify the verification.

3. Modify 12VAC5-165-100 A, which addresses sampling requirements for imported crab meat to be repacked. The current U.S. Food and Drug Administration import requirements in the Code of Federal Regulations located at 21 CFR 123.12 (Special requirements for imported products) have specific requirements for fish and fishery products that preclude the end product sampling requirement currently in place.

4. Modify 12VAC5-165-100 B, which addresses organoleptic sensing. There is a lack of local capacity to train persons in organoleptic sensing to the level of being certified in seafood decomposition, which has made this regulation impractical. In its place, repacking establishments may organoleptically sense, to the best of the individual's capability, each container when opened and keep records attesting to this practice. Unsatisfactory containers would be discarded and a record kept of this process.

5. Modify 12VAC5-165-220 B, which requires that the lot number indicate the original source firm that picked the crab meat. Since a reliable indication of the establishment that picked the meat may be unrealistic, some other means of identifying lot numbers may be used by the repacker.

6. Repeal 12VAC5-165-280, which requires that records must be kept separate from other production records. This requirement is unnecessary since the method and type of records being kept are dictated by the repacker's Hazard Analysis Critical Control Point plan.

Other sections of this regulation may be addressed during this process.

Issues: The proposed regulations eliminate or modify certain regulatory requirements that are unnecessary, burdensome, or no longer practical. For example, the proposed amendment to 12VAC5-165-100 will eliminate burdensome and unnecessary sampling requirements. In addition, the repeal of 12VAC5-165-280 will eliminate unnecessary recordkeeping requirements. There are no disadvantages to the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. These regulations pertain to the practice of transferring crab meat from one processor's container into the container of a different processor, primarily for marketing purposes. Specifically these regulations address the sanitation, product traceability, and labeling concerns associated with the situation where one processor would purchase crab meat packed by another certified crab meat processor, whether of a domestic or foreign origin, and repack the meat into the new processor's container. The Board of Health (Board) proposes amendments to these regulations that either align these regulations with federal regulations or reduce the regulatory burden for crab meat processing firms without negatively affecting public safety.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The Board proposes several amendments which will align these regulations with federal regulations. Most of these changes will not affect requirements in practice for crab meat processors since the current Virginia regulations are not more restrictive than the federal regulations. Other proposed changes will have some impact as described in the following paragraphs.

The Board proposes repealing 12VAC5-165-70 which states that the Department of Health, Division of Shellfish Sanitation (Division) should be contacted when any condition that may compromise the safety of the product exists. The Board has determined that this provision is unnecessary and burdensome to both industry and the Division. The proposal to repeal this requirement will save staff time for both crab meat processors and the Division.

Under the current regulations (12VAC5-165-100), 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. The Board proposes eliminating this requirement. According to the Division, in ten years of regulation experience there have been no known significant illnesses and the risk of contamination is very low as long as other required procedures are followed. If the other required procedures are not followed, any potential subsequent contamination would not have been detected at this sampling stage anyway. The Division estimates that it typically takes about a week for samples to be analyzed. (Virginia Tech provides the analysis for free.¹) This delays the sale of the crab meat and firms incur storage costs. Thus, the Board's proposal to repeal this requirement will produce savings for crab meat processors through reduced time and storage costs without endangering public safety.

The current regulations (12VAC5-165-200) require that prior to or after repacking, the repacker shall pasteurize all imported crab meat which has not been pasteurized in the country of origin. The Board proposes to eliminate this requirement. The Division and Board believe that the pasteurization requirement is not necessary for public safety. According to the Division, in ten years of regulation experience there have been no typhoid or hepatitis outbreaks and only one minor health problem perhaps linked to lack of pasteurization. One contacted crab meat firm stated that the cost of pasteurizing crab meat for a processor ranges from $1.50 - $2.00/lb. A second contacted firm stated that the cost of pasteurizing crab meat for a processor depends on the container it is pasteurized in (bags and cans are used) and ranges from $1.00 - $3.00/lb. The Division believes that most firms will continue to pasteurize all or most of the imported crab meat they process due to the greatly enhanced shelf life of pasteurized meat. For those firms that choose to stop pasteurizing some of their crab meat there will be savings of from $1.00 - $3.00/lb.

The current regulations (12VAC5-165-290) state that "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." Packing or repacking foreign crab meat into a container without the country of origin on the principal display panel is also a Class 1 misdemeanor. The Board proposes to repeal this language since decertification for noncompliance of this regulation could potentially put the processor out of business and the Board and Division believe that a Class 1 misdemeanor is adequately punitive to discourage noncompliance. This should produce a net benefit.

Businesses and Entities Affected. The Department of Health Division of Shellfish Sanitation currently certifies 19 crab meat processors.

Localities Particularly Affected. Certified crab meat processors are located primarily in coastal localities, which include, but are not limited to: Accomack County, Southampton County, Gloucester County, Hampton, Newport News, Urbanna, Montross and Deltaville.

Projected Impact on Employment. The proposed amendments will not likely significantly affect total employment. The proposal to repeal the requirement to contact the Division when any condition that may compromise the safety of the product exists will enable crab meat processor employees to use their time more productively.

Effects on the Use and Value of Private Property. The proposal to repeal the requirement to contact the Division when any condition that may compromise the safety of the product exists will enable crab meat processor employees to use their time more productively. The proposal to repeal the requirement for lab analysis of samples will provide savings for crab meat processors through reduced time and storage costs. Those processors who choose to take advantage of the proposed repeal of the pasteurization requirement will save from $1.00 - $3.00/lb of imported crab meat which has not been pasteurized in the country of origin.

Small Businesses: Costs and Other Effects. None of the proposed amendments will increase costs for small businesses. The proposal to repeal the requirement to contact the Division when any condition that may compromise the safety of the product exists will enable small crab meat processor employees to use their time more productively. The proposal to repeal the requirements for lab analysis of samples will provide savings for small crab meat processors through reduced time and storage costs. Those small processors who choose to take advantage of the proposed repeal of the pasteurization requirement will save from $1.00 - $3.00/lb of imported crab meat which has not been pasteurized in the country of origin.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed regulations do not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ Source: Virginia Department of Health, Division of Shellfish Sanitation

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The proposed 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 final product exists, and (iii) loosen the sampling requirements for imported 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)" 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 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. 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 maintain a copy of the 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 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, 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.

Article 4
Penalties

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.