(1) The facility shall operate in accordance with the HACCP plan designed and approved by the owner or corporate officers and shall be made available upon request. If facilities, equipment or methods change, the Department must be notified and a modified HACCP plan must be submitted within 14 days of change.
    (2) Prior to acceptance of shellstock from a licensed harvester, shellfish processor or aquaculturist, the shellfish processor will ensure that shellstock are properly identified as specified in subsection 5L-1.007(3), F.A.C., are clean, wholesome, and alive.
    (3) Upon acceptance of shellstock from a licensed harvester, the shellfish processor and/or aquaculturist, the receiving shellfish processor shall determine the appropriate use of the shellfish through examination of shellfish labeling as follows:
    (a) Shellfish which fails to meet the requirements of subsection 5L-1.008(7), F.A.C., or is labeled in compliance with Fl. Admin. Code R. 5L-1.007(6)(h), shall only be shucked by a certified shucker-packer facility, or post-harvest processed by a certified shellfish processing facility, or shall undergo an alternative post harvest processing method to assure a safety level equivalent to product meeting subsection 5L-1.008(7), F.A.C.
    (b) Post-Harvest Processing shall consist of those methods which have demonstrated through validation studies meeting the requirements of Section II, Chapter XVI of the National Shellfish Sanitation Program, Guide for the Control of Molluscan Shellfish, 2015, as incorprated in Fl. Admin. Code R. 5L-1.001 Prior to initiating post harvest processing, a shellfish processor shall provide validation and obtain written approval from the Department.
    (4) Shellfish shall be segregated by the shellfish processor in accordance with its intended use as determined in subparagraph 5L-1.008(7)(a)4. and paragraphs 5L-1.013(3)(a) and (b), and identified as per subsection 5L-1.007(5) or (6), F.A.C. The harvester tag must be removed from each container and replaced with a processor’s tag prior to being shipped.
    (5) Unidentified, adulterated, unwholesome, dead, or contaminated shellstock shall be discarded.
    (6) Shucking of shellfish – Shellfish shall be shucked in a manner such that they are not subjected to possible contamination. Only live shellfish shall be shucked.
    (a) Shucked meats shall be delivered to the packing room within one hour.
    (b) Shucked meats shall be thoroughly drained, cleaned as necessary, and packed promptly after delivery to the packing room. Packing operations shall be scheduled and conducted so as to chill all meats to an internal temperature of 45° F or less within two hours of delivery to the packing room. Shucked meats which are packed into containers having a capacity of more than one gallon shall be pre-chilled to 45° F or less prior to packing.
    (7) Shucked shellfish shall be held and transported at temperatures of 45° F or less.
    (8) Ice shall be manufactured from potable water in a commercial machine which has been properly installed and maintained without connections to nonpotable water sources.
    (9) Ice shall be stored so as not to come into contact with non-clean surfaces and is handled in such a manner that it will not be contaminated.
    (10) Records – Complete, legible, and accurate dated records of purchase and sale of all shellfish shall be kept by all shellfish facilities operating in the state. Records shall remain on file for not less than one year for fresh product and two years for frozen product. Records shall be made available for the inspection and copying by the Department personnel during facility inspections. Records shall indicate:
    (a) From whom shellfish were purchased;
    (b) Harvest area, and for Florida shellfish the four digit code or name of harvest area found in subsection 5L-1.003(11), F.A.C. Aquaculture product must also include the aquaculture lease number;
    (c) State from which shucked shellfish were harvested;
    (d) Harvesting date;
    (e) The date of receipt by the processor;
    (f) Names and addresses of persons to whom shellfish were sold;
    (g) Date sold; and,
    (h) Transaction record indicating:
    a. Date and time shipped.
    b. Temperature of conveyance.
    (11) Within 72 hours of any purchase or sales entries of purchases or sales of shellfish shall be made into a permanently bound ledger book, computer record, or any other method that permanently records the information in an organized manner that can be reviewed by the Department.
    (12) Production records shall be maintained for shucked meats which provide the amount of shellstock used, the harvest area, harvest date of the shellstock, and the amount of shucked meats produced.
    (13) Production records shall be maintained for shellstock which provides for the amount of shellstock used, the harvest area, harvest date, harvest state, and the units of shellstock produced.
    (14) Processors shall submit to the Department a monthly report of the volume of shellfish received from Florida Shellfish Harvesting Areas for each shellfish species. Quantity data shall include utilization type (raw, shucked, Post Harvest Processing).
    (15) Records for shellfish lots having completed a depuration or wet storage treatment process shall include:
    (a) Name or location of harvesting areas;
    (b) Relaying permit numbers, if applicable;
    (c) Date received;
    (d) Date released;
    (e) Date and time of initiation of treatment;
    (f) Date and time of termination of treatment;
    (g) Ending UV unit meter readings;
    (h) Number of hours treated; and,
    (i) All laboratory results as specified.
    (16) Monitoring records of HACCP plan critical control points shall be maintained and reviewed at least weekly as specified in the facility’s HACCP plan. Records shall be reviewed to ensure that the records are complete and to verify that they document values that are within the critical limits. The review shall occur weekly. The reviewed records shall be signed and dated by the owner, facility supervisor, or designated representative of the facility and is knowledgeable of HACCP.
    (17) Sanitation monitoring records shall be maintained for those conditions identified in Fl. Admin. Code R. 5L-1.012, per the schedule of the activity, e.g. daily, weekly, monthly.
    (18) Whenever a deviation from a critical limit occurs, a shellfish processor shall take corrective action either by following a corrective action that is appropriate for the particular deviation, or by segregating and holding the affected product until a review can determine the acceptability of the affected product for distribution. Corrective actions include, when necessary, reconditioning, seizure, or destruction of affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. Corrective action also include, when necessary, correcting the cause of the deviation. All corrective actions shall be documented in writing.
    (19) Responsibility – It shall be the duty and responsibility of the owner, facility supervisor, or designated representative of a shellfish facility to ensure that all regulations pertaining thereto are strictly adhered to and that only safe, wholesome, unadulterated shellfish shall be produced. It shall be his or her duty and responsibility to see that the facility is properly supervised at all times and all shellfish can be identified, whether shellstock or shucked shellfish, to ensure that they were harvested from approved or conditionally approved harvest area in the open status and that they have been handled and processed in a sanitary manner.
Rulemaking Authority 379.2522, 597.020 FS. Law Implemented 379.2522, 597.020 FS. History-New 1-4-87, Amended 5-21-87, 8-10-88, Formerly 16R-7.016, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly 62R-7.016, Amended 8-9-00, 5-29-02, 7-29-08, 4-26-10, 3-23-17, 4-2-19, 9-5-19.