Fla. Admin. Code R. 5L-1.004 (2026)
Production and Market Standards
(1) Shellfish offered for sale at the wholesale market level shall be deemed to be “adulterated” as defined in subsection 5L-1.002(1), F.A.C., and Section 500.10, F.S., and will be subject to rejection or seizure by the Department when it exceeds the following bacteriological criteria: fecal coliform density of more than 230 most probable number (MPN) per 100 grams; and a 35 ºC plate count of more than 500,000 per gram.
(2) Shucked and packed shellfish shall not contain more than 15% by volume of free liquor until the product reaches the consumer.
(3) No shucked shellfish shall be sold, offered for sale, processed, packed, or repacked after the “Sell By” date as defined in paragraph 5L-1.007(1)(a), F.A.C.
(4) No frozen shellfish products shall be thawed to be processed or sold as fresh shellfish products. Thawed frozen shellfish shall be labeled as “previously frozen” in accordance with Rule 5L-1.007, F.A.C.
(5) Shellfish having undergone a depuration process shall not be released for sale prior to laboratory analysis and approval by the facility supervisor or designated representative. Shellfish shall not be released if the geometric mean of three samples exceeds a fecal coliform MPN of 45 per 100 grams of sample, or if any sample’s fecal coliform MPN exceeds 100 per 100 grams of sample.
(6) The use of the elevated temperature coliform plate count is authorized for the bacteriological evaluation of hard clams, Mercenaria spp. only from a depuration facility.
(7) Should the Department suspect contamination of shellfish by metallic ions and compounds, pesticides, detergents, radionuclides, marine toxins, or any toxic substance or adulterant, the Department shall require that shellfish meat be analyzed for such contaminants before suspect shellfish are released for sale.
(8) Shellfish or shellfish products determined to be adulterated, or misbranded shall be subject to recall by the certified shellfish processing facility responsible for distribution of the products. For a first time offense, the Department will apply mitigation measures. Mitigation measures include on-the-spot correction and reconditioning. Reconditioning shall be a mitigation option only if the products will meet the safety standards of Rule 5L-1.004, F.A.C., and the labeling standards of Rule 5L-1.007, F.A.C. For repeat violations the Department shall issue an order to stop the sale or to condemn, and destroy, shellfish or shellfish containers found to be adulterated, misbranded, or found to be held in non-compliance with any of the provisions of this chapter. Stop sale, condemnation, or reconditioning of products or containers shall be based on individual conditions found during inspections.
Rulemaking Authority 500.09, 597.020 FS. Law Implemented 500.10, 500.172, 597.020 FS. History–New 1-4-87, Amended 8-10-88, 7-9-89, Formerly 16R-7.006, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.006, Amended 8-9-00, 5-29-02, 3-23-17, 9-5-19, 9-7-26.
Effective: 9/7/2026.