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.
"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" 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.
"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 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.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-20. Compliance with the Administrative Process Act.
The provisions of the Virginia Administrative Process Act (§ 9-6.14:1 et seq. of the Code of Virginia) shall govern the promulgation and administration of these regulations and shall be applicable to the appeal of any case decision based upon this chapter.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-30. Powers and procedures of regulations not exclusive.
The commissioner may enforce this chapter through any means lawfully available.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-40. Certificate of Inspection required.
No person, firm or corporation shall operate an establishment for the repacking or relabeling of crab meat until the establishment first obtains the approval of the State Health Commissioner in the form of a Certificate of Inspection. Application for a Certificate of Inspection shall be submitted to the appropriate field office or central office.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-70. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
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 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).
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-90. Verification of shipping temperatures for crab meat.
The repacker shall provide a record of transport temperature receiving conditions for each shipment of crab meat. Temperature recording may be by maximum temperature recording, continuous temperature recording, or by other device such as adequate amount of ice or adequate quantity of chemical cooling media. The repacker shall include the transport receiving temperature conditions as a part of the receiving CCP in the HACCP plan.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-100. Sampling and analysis requirements for imported crab meat.
A. When imported crab meat is used as a source for repacking, the 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 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 such results on file for a minimum of one year.
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 determine the disposition of that lot.
D. All records of sample analyses kept on file at the 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.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; Errata, 16:19 VA.R. 2399 June 5, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
Part III
Operational Requirements
Article 1
Processing
12VAC5-165-130. Separation of operations.
Article 1
Processing
All crab meat repacking operations shall be conducted separately in time or space from other packing operations.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-140. Cleaning and sanitizing of tables.
The repacking tables shall be cleaned and sanitized prior to and after each crab meat repacking operation.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-150. Pasteurized crab meat storage temperature.
Containers of pasteurized crab meat shall be stored in a refrigerated room at a temperature of 40°F or less.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-160. Blending of crab meat.
Foreign crab meat from one processor shall not be blended or combined with crab meat from another processor.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-170. Temperature of crab meat during repacking.
No portion of the crab meat shall exceed 50°F during the repacking process.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-180. Cooling of crab meat after repacking.
Immediately after repacking, the repacker shall place containers of repacked crab meat into ice or into refrigeration not to exceed 40°F.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-190. Disposal of used containers.
Empty containers from which crab meat has been repacked shall not be kept on premises for any type of reuse. After removing the crab meat, the empty containers shall be placed immediately into waste disposal receptacles.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-200. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
Article 2
Labeling
12VAC5-165-210. Certification number to be on containers.
Article 2
Labeling
Crab meat shall be repacked only into containers bearing the repacker's Virginia certification number.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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 processor. Records shall be maintained by the repacker for a minimum of one year with an explanation of the code.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-230. Country of origin for imported crab meat.
Imported crab meat shall be packed by the repacker into containers that bear a declaration of the country of origin of the repacked crab meat.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
Article 3
Records and Recordkeeping
12VAC5-165-240. Accessibility of records.
Article 3
Records and Recordkeeping
All required records shall be maintained by the repacker and shall be made available to the division for inspection.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
12VAC5-165-270. Minimum records to be kept.
The repacker shall maintain the following information on each lot of repacked crab meat 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.
Statutory Authority
§ 28.2-801 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; amended, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
12VAC5-165-280. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
Article 4
Penalties
12VAC5-165-290. (Repealed.)
Article 4
Penalties
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000; repealed, Virginia Register Volume 32, Issue 5, eff. December 2, 2015.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.
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.
Statutory Authority
§§ 28.2-801, 28.2-803 and 28.2-806 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 16, Issue 16, eff. May 24, 2000.