1. (1) No person shall fail to maintain complete and accurate records of all shellfish transactions sufficient to include all required information.
2. (2) No person shall fail to make records of all shellfish transactions available for inspection for a period of at least two years for frozen shellfish and one year fresh shellfish from the date of the last entry.

3. (3) No processor shall fail to assign and include lot numbers in records for specific batches of shellfish processed as a permit condition, when deemed necessary by the department.

   (b) Harvesters (diggers).

   No harvester (digger) shall fail to make daily dated entries in a ledger or using other methods approved by the department indicating quantities (net weights or numerical counts or standard measures) of shellfish harvested, the harvest date, an identification of the areas from which the shellfish were harvested, and the names and permit numbers of all purchases of shellfish.

   (c) Dealers.

4. (1) HACCP (hazard analysis critical control point); hazard analysis and hazard control plan.

   1. (i) No shellfish dealer shall fail to conduct, or have conducted for their facility and operations, a hazard analysis to determine whether a food safety hazard is reasonably likely to exist for each shellfish product that they shuck, process, pack, repack, ship or reship and maintain a written record of the date and findings of such hazard analysis. The analysis shall identify the preventive measures that shall be implemented at critical control points to reduce or eliminate the food safety hazards. Such hazards may be introduced within or outside the permit holder's facility and include food safety hazards that can occur before, during and after harvest.
   2. (ii) No shellfish dealer shall fail to have and implement a written hazard control plan when a hazard analysis determines that one or more food safety hazards are reasonably likely to occur. The written hazard analysis and control plan shall be specific to the permit holder's facility, operations and all shellfish products handled at that facility, any off-site storage area, or any means of conveyance used by the permit holder to transport shellfish. The hazard control plan shall identify the food safety hazards, critical control points, critical limits and preventive measures the permit holder or the most responsible person at the facility shall take to control, reduce or eliminate those hazards. The hazard analysis and hazard control plan shall be dated and signed by one of the following individuals: the most responsible person at the permit holder's facility, a higher level official of the firm, or by the permit holder. That person's signature shall signify that the hazard analysis and written hazard control plan have been accepted by the permit holder for implementation at the permit holder's facility, any off-site storage area(s) or any means of conveyance used by the permit holder to transport shellfish.
   3. (iii) No shellfish dealer shall fail to provide and accurately maintain orderly dated records that document routine monitoring of the critical control points and critical limits identified in the hazard analysis and written hazard control plan. The records shall include the actual values obtained and observations made during the monitoring of critical control points and critical limits.

5. (2) Sanitation monitoring.

   1. (i) No shellfish dealer shall fail to maintain orderly dated sanitation records. Such records shall accurately document the frequency of sanitation control practices and the correction of any insanitary conditions to ensure that the permit holder's facility or off-site storage area(s) or any means of conveyance used by the permit holder to transport shellfish is kept in an orderly, non-hazardous condition and that all the shellfish products in the permit holder's facility, off-site storage area(s) or any means of conveyance used by the permit holder, are shucked, processed, packed, repacked, shipped or reshipped in a safe and sanitary manner. Such sanitation practices and sanitation records shall, at a minimum, address the following:

      1. (a) safety of water that comes in contract with food or food contact surfaces;
      2. (b) condition and cleanliness of food contact surfaces, utensils, gloves and outer garments;
      3. (c) prevention of cross-contamination from insanitary objects or materials to shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments;
      4. (d) maintenance of hand washing, hand sanitizing and toilet facilities;
      5. (e) protection of shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments from adulteration with cleaning compounds, sanitizing agents, lubricants, condensate, pesticides, and other physical, chemical and biological contaminants;
      6. (f) proper labeling, storage and use of cleaning compounds, sanitizing agents or other toxic materials;
      7. (g) monitoring and control of employees' health conditions that could result in microbiological contamination of shellfish, shellfish packing materials, food contact surfaces, utensils, gloves and outer garments; and
      8. (h) exclusion of vermin, insects, other pests and domestic animals from the permit holder's facility, any off-site storage area(s) and any means of conveyance used by the permit holder to transport shellfish.

6. (3) Receiving records.

   1. (i) No shellfish dealer shall fail to maintain receiving records that include the following:

      1. (a) the names, addresses and permit numbers of all shellfish dealers from whom shellfish were received;
      2. (b) the name and State permit numbers of harvesters if shellfish are received from harvesters;
      3. (c) the date received;
      4. (d) the date of harvest;
      5. (e) the quantities (net weights or numerical counts or standard measures) of shellfish received;
      6. (f) the common name of the shellfish received;
      7. (g) area of harvest;
      8. (h) wild or farm-raised;
      9. (i) the on/off-bottom culture permit number for farm-raised shellfish; and
      10. (j) the original shipper's permit number.
   2. (ii) No shellfish dealer shall receive a shipment of shellfish unless it is accurately identified by an invoice or bill of lading nor fail to make any such invoice or bill of lading received with shellfish readily available for inspection by the department for at least one year after the receipt of such shellfish. Such invoices or bills of lading shall include the name, address and State shellfish permit number of the dealer, the date the shipment was received, quantity an common name of all shellfish in the shipment. If such invoices or bills of lading are maintained by the dealer as the receiving record, the area of harvest, original shipper permit number and harvest date must be included. No dealer shall fail to file such invoices or bills of lading in an orderly manner by dare or by other methods acceptable to the department.

7. (4) Shipping records.

   1. (i) No shellfish dealer shall fail to maintain shipping records that include the following:

      1. (a) the recipient's name;
      2. (b) the quantities (net weights or numerical counts or standard measures) of shellfish shipped;
      3. (c) the common name of the shellfish shipped;
      4. (d) wild or farm-raised;
      5. (e) the on/off-bottom culture permit number for farm-raised shellfish; and
      6. (f) date shipped;
      7. (g) area of harvest;
      8. (h) harvest date; and
      9. (i) the original shipper permit number; such permit numbers shall be prefixed with the initials of the state or foreign country issuing such permit.
   2. (ii) No shellfish dealer shall ship shellfish unless it is accompanied by an invoice or bill of lading, nor fail to make one copy of any invoice or bill of lading for shipped shellfish readily available for inspection by the department for at least one year after the sale of such shellfish. Such invoices or bills of lading shall be preprinted or stamped with the seller's name, business address and State shellfish permit number and must clearly indicate the name and permit number, if applicable, of the receiver of the shellfish, the quantity (net weight or numerical count or standard measure) and common name of the shellfish shipped, the date shipped and the area of harvest. If such invoices or bills of lading are maintained by the dealer as the shipping record, the original shipper permit number and harvest date must be included. No dealer shall fail to file such invoices or bills of lading in an orderly manner by date or by other methods acceptable to the department.
   3. (iii) No shellfish dealer possessing a valid class A, B, D or E permit shall fail to maintain records of quantities (net weights or numerical counts or standard measures), common names and the harvest areas of all shellfish received from harvesters, nor fail to report such monthly totals to the Shellfisheries Section, Division of Fish, Wildlife and Marine Resources, New York State Department of Environmental Conservation by the 10th day of each succeeding month.

(a) General prohibitions.