Additional Requirements for Handlers of Shellfish

All wholesale dealers and wholesale trucks that handle shellfish shall comply with 105 CMR 500.021. (A) Requirements for wholesale dealers and wholesale trucks that handle shellfish shall be established as administrative guidelines by the Department, based on the National Shellfish Sanitation Program (NSSP) Model Ordinance (NSSP Model Ordinance), published by the United States Department of Health and Human Services and the Interstate Shellfish Sanitation Conference. All wholesale dealers and wholesale trucks that handle shellfish shall comply with the administrative guidelines. (B) Shellfish Transactions. (1) A harvester may sell shellfish only to a Massachusetts wholesale dealer holding a permit endorsed for shellfish issued by the Division of Marine Fisheries and the Department. A harvester is prohibited from selling shellfish directly to a retail dealer, wholesale truck, restaurant, or consumer. The direct sale of shellfish to a consumer from a vehicle is prohibited, except as authorized by written policy of the Department. (3) Each transaction between a harvester and a wholesale dealer shall be recorded on a serialized transaction slip approved by the Department. Information recorded on the transaction slip shall include the wholesale dealer's name and permit number, the type and amount of shellfish purchased, date of purchase, and the area from which the shellfish were harvested. Also, the transaction slip documenting the purchase of shellfish shall be imprinted by the wholesale dealer to show the number from the harvester's Shellfish Transaction Card issued by the Division of Marine Fisheries. The wholesale dealer, master digger, and harvester shall retain their copies of the transaction slip for at least 90 days. (5) A wholesale dealer shall purchase shellfish only from another wholesale dealer or from a harvester or master digger who presents a Shellfish Transaction Card and who is either known to the wholesale dealer or who presents photo identification. (6) Sales of shellfish by a harvester to a wholesale dealer shall only be conducted by: (a) The harvester transporting his or her product directly from the landing site to the wholesale dealer's physical facility for sale; or (b) The harvester selling the product to an employee of a wholesale dealer at the landing site, provided that the employee transports the product to the wholesale dealer's facility. Shellfish purchased at the landing site must be transported to the wholesale dealer's facility for washing, grading, and tagging prior to its entering the marketplace. (7) It is prohibited to land shellfish without an approved tag attached to the container as described in the Department's administrative guidelines based on the NSSP Model Ordinance. Containers with improper tags or no tags are misbranded and subject to embargo. (8) Wholesale dealers shall retain tags for a minimum of 90 days. Tags shall be maintained in an orderly manner, e.g. chronologically, by harvester/dealer, or in some other appropriate manner, which facilitates the tracking of dealer purchases. (9) Any commingling of different lots of shellfish shall be conducted in conformance with written Department policy. (10) Dealers who receive shellstock from harvesters whose commercial shellfishing permits are subject to conditions imposed by the Division of Marine Fisheries or the Department, including but not limited to the requirement of a Vibrio management plan, or requirements related to participation in the Massachusetts Program for Onboard Screening and Dockside Testing for PSP Toxins in Molluscan Shellfish in Federally Closed Waters, shall comply with requirements of all plans or memoranda of understanding related to such conditions. Failure to comply may result in enforcement action, including coordination with the Division of Marine Fisheries on appropriate enforcement. (C) Clam Juice. (1) Clam juice intended for human consumption shall not be sold or offered for sale without first being pasteurized in a manner and with equipment approved by the Department. (2) A timer and thermometer shall be used to insure that the product has been heated sufficiently to destroy pathogens. Records of timer and thermometer calibration shall be maintained for one year. (D) Wet Storage. (1) Wet storage activities shall be conducted in accordance with the Department's administrative guidelines based on the NSSP Model Ordinance. (2) Wholesale dealers shall receive written approval from the Department prior to conducting a wet storage activity. (E) Shucked Shellfish. (1) Packing operations shall be conducted in a room separated from other rooms in the facility by suitable full partitions or walls. (2) Doors to the packing room shall be self-closing and tight-fitting. (3) A shucked shellfish delivery window shall be installed in the partition or wall to the packing room and shall be equipped with a corrosion-resistant shelf that tilts away from the packing room. (4) The packing room shall be equipped with a hand-wash sink, adequate hot and cold running water, and a three-compartment sink for ware washing. (5) The packing room shall be large enough to permit the thorough cleaning of all equipment. (F) Sanitary Standard for Shellfish Sold in Massachusetts. (1) Sanitary Standard. Any shellfish, fresh or frozen, shall be deemed to meet the sanitary standard for shellfish sold in Massachusetts if: (a) It was harvested from an area approved by the appropriate shellfish control agency, or it was harvested from a restricted area and was subjected to a process of controlled purification ("depuration") approved by the Department; and (b) It meets the Department's administrative guidelines based on the NSSP Model Ordinance standards for fecal and pathogenic contamination. (2) Procedure when Shellfish Do Not Comply with Sanitary Standard. (a) When a sample of shellfish is not in compliance with the sanitary standard specified in 105 CMR 500.021(F)(1), the Department may re-sample or cause to be re-sampled shellfish from the same source in order to verify the test result and attempt to ascertain the cause of the problem. (b) If upon re-sampling and retesting, the shellfish again do not comply with the sanitary standard, the Department may undertake one or more of the following: 1. Issue a warning notice to the person or persons responsible for harvesting, handling, processing, or transporting the shellfish and/or notify the responsible permitting authority; 2. Seize or embargo all shellfish from the same lot as those that have been found not to comply with the sanitary standard; and/or 3. Notify the person or persons responsible for harvesting, handling, processing, or transporting the shellfish that all future lots of shellfish from such person or persons shall be subject to embargo. (c) The embargo against all shipments specified in 105 CMR 500.021(F)(2)(b)3. shall remain in effect until: 1. Test results obtained from sampling by the Department from two consecutive lots of shellfish, harvested on different days, indicate compliance with the sanitary standard; or 2. Test results obtained from sampling by the responsible out of state shellfish control agency from two consecutive lots of shellfish, harvested on different days, under time and temperature conditions which duplicate transportation and delivery to Massachusetts, indicate compliance with the sanitary standard. 3. In either case specified in 105 CMR 500.021(F)(2)(c)1. or 2., if the shellfish are to be shipped to Massachusetts from out of state, the out of state shellfish control agency shall certify in writing to the Department that the sources of contamination or handling problems causing the failure of the shellfish to comply with the sanitary standard have been identified and corrected. (3) Prohibition on Sale of Shellfish in Massachusetts. (a) When the Commissioner of Public Health, upon the recommendation of the Program, finds with respect to shellfish from a particular state or country, which serves as a source of shellfish sold in Massachusetts, that: 1. There is evidence of substantial and continuing noncompliance with the shellfish sanitary standard, or 2. Multiple notices of embargoes have been issued pursuant to 105 CMR 500.021(F)(2)(b), or 3. Epidemiological evidence indicates that illnesses traceable to shellfish from multiple sources within a particular state or country have occurred, or 4. There is other evidence that shellfish from that state or country may pose a danger to public health and that other regulatory initiatives have failed to control the problem, the Commissioner may notify the appropriate shellfish control agency that all shellfish originating from or handled in that state or country shall be prohibited from being sold in Massachusetts. (b) Prohibitions on the sale of shellfish under 105 CMR 500.021(F)(3)(a) shall continue until the appropriate shellfish control agency in the state or country satisfactorily certifies to the Commissioner that the shellfish distributed in Massachusetts will meet the sanitary standard in 105 CMR 500.021(F)(1). Until such certification has been reviewed and accepted by the Commissioner upon the recommendation of the Program, no shellfish originating from any person in a state or country notified pursuant to 105 CMR 500.021(F)(3)(a) shall be sold in Massachusetts. (G) Certification for Interstate Shipment. (1) In certifying wholesale dealers for listing on the Interstate Certified Shellfish Shippers List (ICSSL), the Department shall follow the procedures in administrative guidelines of the Department based on the NSSP Model Ordinance. (2) Only those wholesale dealers who voluntarily request certification, and who meet the standards specified in the Department's administrative guidelines based on the NSSP Model Ordinance for listing on the ICSSL, and who are certified for listing by the Department, shall be allowed to ship shellfish or shellfish products interstate or to another certified dealer within the Commonwealth. (3) The Department shall annually certify wholesale dealers for listing on the ICSSL. All certifications shall expire at the end of each calendar year. (4) The Department shall certify for listing on the ICSSL for the following calendar year only those wholesale dealers who meet the requirements specified in the Department's administrative guidelines based on the NSSP Model Ordinance. (5) Inspection reports and Notices of Violation/Orders to Correct shall constitute prima facie evidence of the conditions listed therein. (6) Wholesale dealers who are removed, either voluntarily or involuntarily, from the ICSSL shall promptly notify their customers and the Department in writing that they are no longer involved in the interstate shipment of shellfish. Immediate Suspension of an ICSSL Certification without a Prior Hearing. The Department may, without a prior hearing, suspend the ICSSL certification of a certified dealer for any violation or series of violations of the standards established in the Department's administrative guidelines based on the NSSP Model Ordinance, including but not limited to: (a) A deficiency or activity that presents an imminent danger to the public health; (b) Failure to immediately correct a critical deficiency; (c) Failure to submit an approved correction plan in a timely manner; (d) Failure to comply with an approved correction plan for a key or critical deficiency in a timely manner; (e) Citation for improper tagging; or (f) Citation for operation without a proper endorsement. The Department may end the suspension of the certification at any time if reasons for the suspension no longer exist. In such a case, the Department shall notify the federal program to include the dealer's name in the next available publication. (8) Refusal to Issue an ICSSL Certification. The Department may refuse to issue an ICSSL certification if the applicant fails to meet the standards for initial certification established in the Department's administrative guidelines based on the NSSP Model Ordinance. These standards include but are not limited to the facts that the applicant must have: (a) No critical deficiencies; (b) Not more than two key deficiencies; and (c) Not more than three other deficiencies. The initial certification shall include a compliance schedule to correct the deficiencies, if necessary. (9) Refusal to Renew an ICSSL Certification. The Department may refuse to renew an ICSSL certification if the applicant fails to comply with the standards for certification renewal established in the Department's administrative guidelines based on the NSSP Model Ordinance. These standards include but are not limited to requiring that the applicant: (a) Eliminate any critical deficiencies; (b) Agree to a compliance schedule which carries forward into the next certification period no more than one key and two other deficiencies identified in previous inspection; (c) Address any new key or other deficiencies in a new or revised compliance schedule; and (d) Meet the requirements of certification described in the Department's administrative guidelines based on the NSSP Model Ordinance. Following the refusal to renew the certification, a dealer must meet the requirements of initial certification prior to restoration to the ICSSL. (10) The Department may refuse to issue or renew an ICSSL certification if the applicant fails to submit an approved correction plan in a timely manner. (11) The suspension of a permit or of a specific activity of a wholesale shellfish dealer shall automatically result in the immediate suspension of such dealer's ICSSL certification, or certification for the specific activity that was suspended. (12) The Department may suspend those activities related to shellfish on the dealer’s permit whenever the dealer’s ICSSL certification is suspended, revoked, or not renewed. Supplemental Regulations for Meat and Poultry Slaughter and Processing