N.Y. Comp. Codes R. & Regs. tit. 6 § 42.8

Current through Register Vol. 46, No. 38, September 18, 2024

Section 42.8 - Recordkeeping requirements

(a) General requirements.

(1) All shellfish transaction records, and all other records required to be kept pursuant to this Part shall:

(i) be complete and accurate;

(ii) be available for inspection for a period of at least two years from the date of the last entry; and

(iii) when required as a condition to a shellfish processor permit, include lot numbers in records for specific batches of shellfish processed.

(b) Harvesters (diggers). Shellfish harvesters shall make daily dated entries in a ledger (log book) or using other methods approved by the department. All log books shall be completed prior to landing shellfish. Such ledgers shall be made available for inspection for a period of at least two years from the date of the last entry. The ledger shall include the following:

(1) quantities of shellstock harvested (net weight, numerical counts or standard measures);

(2) the harvest date;

(3) time of harvest and, if applicable, time of cooling;

(4) harvest area or location (an identification of areas from which the shellstock were harvested shall not be less descriptive than the descriptions set forth in section 42.14(c) of this Part); and

(5) the names and permit numbers of all receivers of shellstock.

(c) Dealers.

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

(i) All shellfish dealers shall 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 receive, store, 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 preventative 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 holders facility and include food safety hazards that can occur before, during and after harvest.

(ii) All shellfish dealers shall 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 include the dealers name and address, and be specific to the permit holders facility, operations and all shellfish products handled at that facility, 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 preventative measures the permit holder or the most responsible person at the facility shall take to control, reduce, or eliminate those hazards and the corrective action that will be taken to correct any deviations from the critical limits. 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 holders facility, a higher-level official of the firm, or by the permit holder. That persons signature shall signify that the hazard analysis and written hazard control plan have been accepted by the permit holder for implementation at the permit holders facility, or any means of conveyance used by the permit holder to transport shellfish. The hazard control plan shall be reviewed by the permit holder on an annual basis and when a change is made to the plan. Any review or change to the hazard control plan shall be signified by the permit holders signature and date reviewed or when a change is made to the plan.

(iii) All shellfish dealers shall provide and maintain accurate, orderly dated records that include the dealers name and address, and 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, the time the values were obtained, observations made during the monitoring of critical control points and critical limits, and the initials of the person who made the observations during monitoring of critical control points and critical limits.

(iv) All shellfish dealers shall verify that the records in subparagraph (iii) of this paragraph are accurate. Verification must be conducted by an individual who has successfully completed adequate HACCP education or who is otherwise qualified through job experience to perform this function. Verification shall be signified by a signed and dated weekly review of the records.

(2) Recall Procedures. All shellfish dealers shall have and implement written shellfish recall procedures. Such shellfish written recall procedures shall include:

(i) The shellfish dealers name and address;

(ii) a place to include the name of the recalling firm, or local, state or federal health inspection agency from whom the recall was received;

(iii) a place to include the date and time that the dealer was notified of the recall by the recalling firm, or local, state or federal health inspection agency, and a place to include the name of the person and method of contact from whom the dealer was notified;

(iv) a place to include the name of the harvester or shipper from whom shellfish were received;

(v) a place to include the types and quantities of shellfish being recalled;

(vi) a place to include the harvest area(s) and harvest date(s) affected by the recall;

(vii) a place to include the names, addresses and phone numbers of all firms to whom all shellfish affected by the recall were distributed;

(viii) a place to include the dates the shellfish were distributed; and

(ix) a place to include confirmation of the disposition of all shellfish distributed. All shellfish dealers shall notify the department as soon as possible after being notified of a shellfish recall. Implementation of the shellfish product recall must include all information listed in subparagraphs (i) through (ix) of this paragraph and shall be submitted to the department as directed.

(3) Sanitation monitoring.

(i) All shellfish dealers shall maintain orderly dated sanitation records. Such records shall accurately document the frequency of sanitation control practices, and document the correction of any unsanitary conditions observed, to ensure that the permit holders facility used to receive, store or process shellfish, or any means of conveyance used by the permit holder to transport shellfish are kept in an orderly, non-hazardous condition, and that all the shellfish products in the permit holders facility 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 include the date and time monitoring occurred, the initials of the person who made the observations and, at a minimum, address the following:

(a) safety of water that may come in contact with food or food contact surfaces;

(b) condition and cleanliness of food contact surfaces, utensils, gloves and outer garments;

(c) prevention of cross-contamination from insanitary objects or materials to shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments;

(d) maintenance of hand washing, hand sanitizing and toilet facilities;

(e) protection of shellfish products, shellfish packaging materials, food contact surfaces, utensils, gloves and outer garments from adulteration such as, but not limited to, cleaning compounds, sanitizing agents, lubricants, condensate, pesticides, and other physical, chemical and biological contaminants;

(f) proper labeling, storage and use of cleaning compounds, sanitizing agents or other toxic materials;

(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

(h) exclusion of vermin, insects, other pests, and wild or domestic animals from the permit holders facility, and any means of conveyance used by the permit holder to transport shellfish.

(4) Shellfish dealer education records.

(i) All shellfish dealers shall maintain a record of all employees that have been trained as provided in section 42.5 of this Part. The record shall include:

(a) the employees name;

(b) the date the employee has completed the training;

(c) the employees signature; and

(d) for new employees, the date hired. Training for new employees must be completed within 30 days of date hired.

(5) Receiving records.

(i) All shellfish dealers shall maintain receiving records that include the following:

(a) the names, addresses and permit numbers of all shellfish dealers from whom shellfish were received;

(b) the name and State permit numbers of harvesters if shellfish were received from harvesters;

(c) the date and time received;

(d) the date and time of harvest if shellfish were received from harvesters;

(e) the temperature of the shellfish when received;

(f) the quantities (net weights, numerical counts, or standard measures) of shellfish received;

(g) the common name of the shellfish received;

(h) area (location) of harvest;

(i) wild or farm-raised;

(j) the on/off-bottom culture permit number for shellfish farm-raised within the State; and

(k) the original shippers permit number.

(ii) No shellfish dealer shall receive a shipment of shellfish unless it is accurately identified by an invoice or bill of lading, and shall not fail to make any such invoice or bill of lading received with shellfish readily available for inspection by the department for at least two years 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, and the quantity and common names 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, the harvest date, and the original shipper permit number must be included. All shellfish dealers shall file such invoices or bills of lading in an orderly manner by date or by other methods acceptable to the department.

(iii) No shellfish dealer shall receive a shipment of shellstock unless the shipment is accompanied with a shipping document indicating the temperature of the shellstock at shipping, and initials, date, and time of shipment. For shipments of shellstock shipped prior to being cooled to an internal temperature of 50°F (10°C), the shipping document must indicate the presence of a time/temperature recording device. Upon receipt of the shellstock shipment, the dealer shall record the temperature of the conveyance in which the shellstock were received, the internal temperature of the shellstock, or if the shellstock were received adequately iced, and the date and time the shellstock and other shellfish were received. Such shipping document shall be available for inspection by the department for at least two years after receipt.

(6) Shipping records.

(i) All shellfish dealers shall maintain shipping records that include the following:

(a) the recipients name and address;

(b) the quantities (net weights, numerical counts or standard measures) of shellfish shipped;

(c) the common names of the shellfish shipped;

(d) wild or farm-raised;

(e) the on/off-bottom culture permit number for shellfish farm-raised within the State;

(f) date shipped;

(g) area of harvest;

(h) harvest date; and

(i) the original shipper permit number; such permit numbers shall be prefixed with the initials of the state or foreign country issuing such permit.

(ii) No shellfish dealer shall ship shellfish unless it is accompanied by an invoice or bill of lading. All shellfish dealers shall make one copy of any invoice or bill of lading for shipped shellfish readily available for inspection by the department for at least two years. Such invoices or bills of lading shall be preprinted or stamped with the sellers name, business address and State shellfish permit number, and must clearly indicate the name, address and permit number, if applicable, of the receiver of the shellfish, the quantity (net weight, numerical count or standard measure), the common name of the shellfish shipped, the date shipped, and the area of harvest, or a method approved by the department for accurately tracing back shipments of shellfish. If such invoices or bills of lading are maintained by the dealer as the shipping record, and no other method for accurately tracing back shipments of shellfish has been approved by the department, the harvest date, and the original shipper permit number must be included. All shipping invoices or bills of lading shall be filed in an orderly manner by date or by other methods acceptable to the department.

(iii) No shellfish dealer shall ship shellstock unless it is accompanied by a shipping document indicating the time and temperature of shellstock at the time of shipping. The document must also include the date of shipment and the shellfish dealers initials. If this is a separate document as described in subparagraph (ii) of this paragraph, the name of the shipper and the receiver of the shipment must also be included. The shipping document is not required for shellstock shipments to retail or food service establishments. Shellfish dealers shall ship shellfish adequately iced or in a conveyance prechilled at or below 45°F (7.2°C).

(iv) All shellfish dealers possessing a valid class A, B, or E shellfish dealer permit shall maintain records that include monthly totals of quantities (net weights, numerical counts or standard measures), common names and the harvest areas (locations) of all shellfish received from harvesters. Such monthly totals shall also be submitted, on a form that may be prescribed by the department, to the Bureau of Shellfisheries, Division of Marine Resources, New York State Department of Environmental Conservation by the 10th day of each succeeding month. The monthly totals may also be submitted electronically.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 42.8

Amended New York State Register November 1, 2023/Volume XLIV, Issue 44, eff. 11/1/2023