The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) Model Ordinance; remove unnecessary license requirements; remove redundant reapplication requirements; remove confusing language ...
Notice of Proposed Rule
FLORIDA DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES
Division of Aquaculture
RULE NOS:RULE TITLES:
5L-1.001General Requirements and Intent
5L-1.002Definitions
5L-1.003Shellfish Harvesting Area Standards
5L-1.004Production and Market Standards
5L-1.005Shellfish Processing Plant Certification License
5L-1.006Compliance and Penalties
5L-1.007Container Identification, Terminal Sale Date; Prohibitions
5L-1.008Shellfish Handling
5L-1.009Shellfish Relaying
5L-1.010Buildings and Facilities
5L-1.011Equipment for Shellfish Processing
5L-1.012Sanitary Operations
5L-1.013Plant Operations
5L-1.014Heat Shock Method
5L-1.015Depuration Plant Operations
5L-1.016Depuration Shellfish Sampling Procedures
5L-1.017Depuration – Process Water Treatment Standards
5L-1.018Depuration – Ultraviolet (UV) Unit
5L-1.019Laboratory Procedures and Sample Testing
PURPOSE AND EFFECT: The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) Model Ordinance; remove unnecessary license requirements; remove redundant reapplication requirements; remove confusing language regarding draining of shellfish treatment tanks; introduce and describe different styles of wet storage systems for shellfish; and clarify definitions and language associated with the penalty/fine matrix, relaying procedures, and harvester responsibilities.
Additionally, the proposed rule amendments will reclassify shellfish harvesting areas and update associated maps to ensure Florida remains in compliance with NSSP standards and Rule 5L-1.003, F.A.C., to protect the health of shellfish consumers and to provide access to renewable shellfish resources. The purpose of these amendments is to maximize the amount of shellfish harvesting waters available and to maximize the times those waters will be in the open status while continuing to protect the public health.
SUMMARY: The proposed amendments apply to commercial oyster harvesting and processing in Florida in order to protect the health of shellfish consumers. Specifically, the proposed amendments update forms, addresses and telephone numbers, implement licensing and application requirements, clearly explain harvester and processor responsibilities, separate wet storage and depuration requirements, implement relay procedures for aquacultured shellfish during red tide blooms, clarify corrective actions for failing oyster time and temperature requirements, define deficiencies and repeat deficiencies and the associated fines.
Shellfish harvesting areas and management plans will also be amended, specifically the reclassification of the Choctawhatchee Bay (#06) , Wakulla (#22), Cedar Key (#30) and Waccasassa Bay (#32) shellfish harvesting areas, removal of the St. Marks (#23) shellfish harvesting area, and updating the Pine Island (#62) management plan. Seven workshops were held for interested parties across the state of Florida, in the principal areas of oyster industry activity.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS (SERC) AND LEGISLATIVE RATIFICATION: The Agency has determined that this rule will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or, if no SERC is required, the information expressly relied upon and described herein: The Department’s economic analysis of the adverse impact or potential regulatory costs of the proposed rule did not exceed any of the criteria established in Section 120.541(2)(a), Florida Statutes. As part of this analysis, the Department relied upon adverse impacts to the proposed classification changes and predicted days closed for each shellfish area resurveyed and found no adverse financial impacts to the industry. In instances where the predicted number of days closed increased it was found that this will not impact the industry as those shellfish will be available for harvest on an open harvest day. Industry saw all proposed classification/management as positive changes. The proposed rule changes do not require additional fees. Additionally, no interested party submitted additional information regarding the economic impact
Any person who wishes to provide information regarding the statement of estimated regulatory costs or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 500.09, 500.121(1), 500.172, 597.020 FS.
LAW IMPLEMENTED: 500.10, 500.121(1), 500.172, 597.010(15), 597.010(19), 597.020 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FLORIDA ADMINISTRATIVE REGISTER.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jillian Fleiger, Division of Aquaculture, 600 S Calhoun Street, Suite 217, Tallahassee, FL, 32301, Phone: (850)617-7600
THE FULL TEXT OF THE PROPOSED RULE IS:
5L-1.001 General Requirements and Intent.
(1) A shellfish processing plant certification is required to operate any shellfish processing facility.
(2) through (5) No change.
(6) Adoption of Federal Regulations and Standards – To the extent not inconsistent with the rules herein, the following are hereby incorporated and adopted. The documents are available online as indicated. as rules under Section 597.020, F.S.:
(a) The following parts of Title 21, Code of Federal Regulations:
1. Part 7 – Enforcement Policy, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06987 2000;
2. Part 101 – Food Labeling, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06988 2000;
3. Part 109 – Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06989 2000;
4. Part 110 – Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06990 2000;
5. Part 123 – Fish and Fishery Products, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06991 2000;
6. Part 161 – Fish and Shellfish, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06992 2000 ;
7. Part 509 – Unavoidable Contaminants in Animal Food and Food-Packaging Material, revised as of April 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06993 2000.
(b) Title 40, Part 141, Section 141.2, Code of Federal Regulations, revised as of July 1, 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-06994.
(c)(b) The Purpose, the Definitions, and Chapters 1 through 13, and 15 through 16 of the “Model Ordinance 2007” of the National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish, 2015 Revision, herein adopted and incorporated by reference are available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-07008. and published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration 2007 except for:
1. Definition number (16)(14)(d) Reshipper; and
2. Definition number (101)(90) Reshipper.
Interested persons may obtain copies of the pertinent sections of the Codes of Federal Regulations referenced in paragraph (a) above by contacting the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402; www.gpo.gov. Copies of the Pertinent sections of the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Guide For The Control Of Molluscan Shellfish referenced in paragraph (b) above may be obtained by contacting the U.S. Government Printing Office or at the website: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/ FederalStatePrograms/NationalShellfishSanitationProgram/ucm046353.htm. Copies of all referenced documents are available for examination at the Florida Department of Agriculture and Consumer Services, Division of Aquaculture, 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32301, www.FloridaAquaculture.com.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, 7-9-89, 11-5-92, Formerly 16R-7.001, Amended 7-3-95, 2-6-97, 6-23-99, Formerly 62R-7.001, Amended 8-9-00, 5-29-02, 4-26-10, .
5L-1.002 Definitions.
(1) Adulterated – any shellfish harvested from closed waters; any shellfish shucked, packed, or otherwise processed in a facility plant which has not been certified and licensed by the Department in accordance with the requirements of these rules; any shellfish contaminated as determined by microbiological or other analysis; any shellfish consisting in whole or in part of any filthy, putrid or decomposed substance, or otherwise unfit for food; any shellfish prepared, packed, or held under unsanitary conditions where it may have become contaminated with filth, or whereby it may have been rendered injurious to health.;
(2) Alternative Processing – any processing done to shellfish which does not follow the time-temperature matrix as stated in subsection 5L-1.008(7)(a)(1-3) and 5L-1.008(7)(b) 5L-1.008(5), F.A.C.
(3) Approved harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that fecal material, pathogenic microorganisms, radio nuclides, harmful chemicals, and marine biotoxins are not present in dangerous concentrations.
(4) Aquaculture Use Zones – legally-defined parcels that are surveyed, describing and indicating corners and boundaries, that have been subdivided into individual aquaculture leases issued pursuant to Section 253.68, F.S., and Rule 18-21.004(2)(m), F.A.C.
(5)(4) Certification period – the period of time between July 1 and June 30 of a year.
(6)(5) Certified shellfish facility dealer – the location, structures and equipment that has been certified pursuant to Rule Chapter 5L-1.005, F.A.C., as a shellstock shipper, shucker-packer, or repacker., or depuration processor who possesses a shellfish processing plant certification license from the Department. The certified shellfish facility dealer shall comply be held accountable for compliance with all laws, rules, and permits applicable to the shellfish business operation.
(7)(6) Closed area (closed waters) – a growing area where the harvesting of shellfish is not permitted. Closed areas include prohibited and unclassified areas as well as temporarily closed approved, conditionally approved, restricted, and conditionally restricted harvest areas.
(8)(7) Code – the Comprehensive Shellfish Control Code, Rule Chapter 5L-1, F.A.C.
(9)(8) Commercial harvester – a person that harvests with the intent to sell.
(10)(9) Conditionally approved harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that the area is subjected to intermittent microbiological pollution and, under such conditions, is temporarily unsuitable as a source of shellfish for direct marketing. Such an area shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting approved area criteria.
(11)(10) Conditionally restricted harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that the area is subjected to intermittent microbiological pollution and, under such conditions, is temporarily unsuitable as a source of shellfish for relaying or depuration. Such an area shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting restricted area criteria.
(12)(11) Corrective action plan – is a brief outline of the deficiency(ies) found during an inspection of a certified licensed facility with the corresponding rule deficiencies cited and the time frame in which the deficiency(ies) must be corrected.
(13)(12) Critical control point – a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.
(14)(13) Critical deficiency – a condition or practice which may results in the production of a product that which is adulterated. A critical deficiency presents a threat to the health or safety of the consumer. is not a minor violation
(15)(14) Critical limit – the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
(16)(15) Deficiency – a condition or practice that is not in compliance with the rules governing the operation of the facility as outlined in Rule Chapter 5L-1, F.A.C., “The Comprehensive Shellfish Control Code”. a violation.
(17)(16) Department – the Department of Agriculture and Consumer Services.
(18)(17) Depuration facility processor (depuration plant; controlled purification plant) (DP) – a certified shellfish processor dealer who obtains shellstock from approved, conditionally approved, restricted or conditionally restricted growing area(s) and submits such shellstock to a Department approved controlled purification process. as described in Chapter XV of the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish Model Ordinance 2013 1999 as incorporated herein under paragraph 5L-1.001(6)(b), F.A.C. The treatment process is designed to purge shellfish of bacterial and viral contamination to the extent that such shellfish are rendered safe for human consumption.
(19)(18) Designated representative – in the absence of the plant supervisor or certified shellfish, is dealer the individual who supervises all activities associated with the operation of the certified shellfish facilty in the absence of the facility owner or facility supervisor. dealer’s plant. The designated representative shall be held accountable for compliance with all laws, rules, and permits applicable to the shellfish business operation.
(20)(19) Emergency – any unusual incident resulting from natural or unnatural causes which endangers the health, safety, or resources of the state, including, but not limited to, a hurricane, storm, or red tide; petroleum spill; toxic substance discharge; inability of a sewage treatment plant to comply with permit conditions due to a breakdown of equipment, power outage, destruction by fire, wind, or by other cause.
(21)(20) Facility supervisor – an individual who supervises all activities associated with the operation of the certified shellfish processing facility. Firm – a certified shellfish dealer who is a shellstock shipper, shucker-packer, repacker, or depuration processor who possesses a shellfish processing plant certification license from the Department.
(22)(21) Food – any raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption. Shellfish in the shell are considered food.
(23)(22) Food contact surface – a surface of equipment or utensil which food normally comes into contact; or a surface of equipment or utensil from which food may drain, drip, or splash into food or onto a surface normally in contact with food.
(24)(23) Food packaging materials – any material or container which food normally comes into contact.
(25)(24) Food safety hazard – any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
(26)(25) Free liquor – that liquid portion of a container that passes through a porous straining device when the contents (oyster or clam meats) of the container are drained.
(27)(26) Growing area – an area in which market or seed shellfish are growing either naturally or artificially.
(28)(27) HACCP – Hazard Analysis and Critical Control Points – A system of inspection, control, and monitoring measures initiated by a certified dealer to identify and control microbiological, chemical, or physical food safety hazards which are likely to occur in shellfish products produced by the firm.
(29)(28) Harvester – a person engaged in the harvesting of shellfish.
(30)(29) Health authority – the Department or its authorized representative.
(31)(30) Heat shock – the process of subjecting molluscan shellstock to any form of heat treatment prior to shucking, including steam, hot water or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the molluscan shellfish.
(31) High density aquaculture lease areas – legally-defined parcels that are surveyed and properly marked, describing and indicating corners and boundaries, that have been subdivided into individual aquaculture leases issued pursuant to Section 253.68, F.S., and paragraph 18-21.004(2)(l), F.A.C.
(32) No change.
(33) Key deficiency – a condition or practice which may result in adulterated, or misbranded, or unwholesome product. A Key deficiency is not a minor violation.
(34) through (36) No change.
(37) Mechanical refrigeration – refrigeration provided by a an electric compressor in a system where temperature can be adjusted with a thermostat and the unit will maintain a temperature of 45 degrees F or less.
(38) No change.
(39) No change.
(40) Other deficiency – a condition or practice that is not in accordance with rule requirements and is considered a minor deficiency but is not determined to be a key or critical deficiency.
(41) No change.
(42) Plant supervisor – an individual, so designated in writing to the Department, who supervises all activities associated with the operation of the shellfish depuration plant. The plant supervisor shall be held accountable for compliance with all laws, rules, and permits applicable to the shellfish business operation.
(42)(43) Processing – is the handling, unloading, storing, transporting, shucking, freezing, preparing, changing into different market form, manufacturing, preserving, packing, or labeling of shellfish or shellfish products.
(43)(44) Prohibited harvest area – an area from which the taking of shellfish is not permitted.
(44)(45) Public Water System – a system for the provision to the public of water for human consumption through pipes or other constructed conveyances, if such system has at least fifteen service connections or regularly serves an average of at least twenty-five individuals daily at least 60 days out of the year. Such term includes: any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system; and any collection or pretreatment storage facilities not under such control which are used primarily in connection with such system. Such term does not include any “special irrigation district.” A public water system is either a “community water system” or a “non-community water system.” See the Code of Federal Regulations (C.F.R.), Title 40, Part 141, Section 141.2, revised as of July 1, 2015 2000, incorporated in Rule 5L-1.001(6)(b), F.A.C.
(45) Remote Buying – a shellfish processor or designated representative taking possession of shellfish at any location different than their certified shellfish facitilty location.
(46) Repacker/Repacking Facility plant (RP) – a certified shellfish facility dealer, other than the original certified shucker-packer, who repacks shucked shellfish into other containers for distribution or sale. A repacker may also purchase, repack and ship shellstock. A repacker shall not shuck shellfish.
(47) Repeat Critical deficiency – is the same “critical” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days most recent consecutive inspection.
(48) Repeat Key deficiency – is the same “key” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days. the most recent consecutive inspection.
(49) Repeat Other deficiency – is the same “other” deficiency that has been listed on the corrective action plans for the same facility anytime during the preceeding 180 days. the most recent consecutive inspection.
(50) Restricted harvest area – an area in which it is indicated by a sanitary survey or other monitoring program data that fecal material, pathogenic microorganisms, radio nuclides, harmful chemicals, and marine biotoxins are not present in dangerous concentrations such that shellfish harvested from such an area and subjected to a suitable and effective purification process are safe for human consumption.
(51) Restricted Use Shellstock – shellstock that is harvested from growing areas classified as approved or conditionally approved in the open status and under conditions that do not allow the sale of shellstock for direct marketing for raw consumption. Restricted use shellstock is identified with a green tag indicating the shellstock is intended for shucking by a certified processing facility or post harvest processing only.
(52)(51) Retail sale – sale to the ultimate consumer or to a person who will not resell the product.
(53)(52) Sanitize – the effective bactericidal treatment of clean food contact surfaces of equipment and utensils by a process using only those safe sanitizing agents that have an available field test for strength and effectiveness, and is effective to yield a reduction of 5 logs, which is equal to a 99.999% reduction of representative disease microorganisms of public health importance. Such treatment shall not adversely affect the product and shall be safe for the consumer.
(53) Scheduled Depuration Process (SDP) – a process which places shellfish harvested from restricted or approved waters into a controlled aquatic environment selected by the processor as adequate to effectively reduce the level of bacteria and viruses in live shellfish.
(54) Scheduled Heat Shock Process (SHSP) – the process selected by the processor to heat shock a shellfish species in order to facilitate shucking without adversely affecting the microbial quality or altering the organoleptic characteristics of the species.
(55) Scheduled Wet Storage Process (SWSP) – a process which places shellfish harvested from approved waters in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater for product enhancement.
(54)(56) Shellfish – all edible species of oysters, clams, mussels, and whole or roe-on scallops either shucked or in the shell, fresh, or frozen.
(55) Shellfish Processor – a shellstock shipper, shucker-packer, or repacker who possesses a shellfish processing facility certification from the Department.
(56)(57) Shellfish Relaying – the transfer of shellfish from one water bottom to another water bottom which activity would otherwise be prohibited; or the transfer of shellfish from an aquaculture lease a restricted or conditionally restricted area or an area otherwise closed for the harvesting of shellfish to a certified depuration facility plant or another aquaculture lease open for the harvest of shellfish, pursuant to Rule 5L-1.009.
(57)(58) Shellstock – shellfish which remain in their shells.
(59) Shellstock plant – any establishment or place where shellstock are washed and packed or otherwise prepared for sale or shipment.
(58)(60) Shellstock shipper/Shellstock shipping facility plant (SS) – a certified shellfish facility which dealer who grows, harvests, buys, or repacks and sells shellstock. A shellstock shipper is not authorized to shuck shellfish nor to repack shucked shellfish but act as a shucker-packer or repacker . A shellstock shipper may also buy and sell ship sealed containers of shucked shellfish.
(59)(61) Shuck date – the date shucked shellfish are initially removed from their shells.
(60)(62) Shucked shellfish – shellfish or parts thereof which have been removed from their shells.
(61)(63) Shucker-packer/Shucker-packer facility plant (SP) – a certified shellfish facilty which dealer who shucks and packs shellfish. SPs and who may act as a shellstock shipper and/or repacker.
(62)(64) Swing deficiency – a deficiency that could either be a “critical” or a “key” deficiency, or it could be either a “key” or an “other” deficiency, depending on the location, severity and circumstances.
(63)(65) Terminal sale date – the last day freshly packed shellfish shall be offered for sale; that being no more than 14 calendar days subsequent to the date the product was shucked, or for oyster shellstock harvested from the Gulf of Mexico, no more than 14 calendar days subsequent to the date shellstock was harvested.
(64)(66) Time of Harvest – is defined as the that time when shellfish are first removed from growing waters and placed on or in a manmade conveyance or other means of transport.
(65)(67) Time of Refrigeration – is defined as the time when shellfish are first placed within an ambient environment of 45 degrees F or less.
(66)(68) Unclassified area – an area for which no recent sanitary survey exists. Harvest of shellfish is not permitted.
(67)(69) UV – Ultraviolet.
(68)(70) Violation and deficiency – are used interchangeably within these rules. The meaning of both is that a facility is not in compliance with the rules governing their operation as outlined in Rule Chapter 5L-1, F.A.C., “The Comprehensive Shellfish Control Code”.
(69)(71) Warning letter – a warning letter includes a notice of non-compliance.
(70)(72) Wet storage – the temporary storage of shellfish harvested from an received from permitted or approved or in the open status conditionally approved harvest growing area and placed sources and intended for marketing, on privately-owned or leased bottom, in tanks containing water that meets approved or open status conditionally approved shellfish harvesting area water quality standards. seawater, or on floating facilities in natural bodies of water.
(71)(73) Wholesale – any sale to any person or business other than the final consumer.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, 11-5-92, 5-20-93, Formerly 16R-7.003, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly 62R-7.003, Amended 8-9-00, 5-29-02, .
5L-1.003 Shellfish Harvesting Area Standards.
(1) The Department shall describe and/or illustrate harvesting areas and provide harvesting area classifications as approved, conditionally approved, restricted, conditionally restricted, prohibited, or unclassified as defined herein, including criteria for opening and closing shellfish harvesting areas in accordance with Chapters II and IV of the NSSP National Shellfish Sanitation Program Model Ordinance. Copies of the document Shellfish Harvesting Area Classification Maps (FDACS-P-01773, Revised 06/16) February 2012, and the document Shellfish Harvesting Area Classification Boundaries and Management Plans, (FDACS-P-01593, Revised 08/16)February 2012, containing shellfish harvesting area descriptions, references to shellfish harvesting area map numbers, and operating criteria are hereby incorporated by reference and may be obtained by writing to the Division of Aquaculture, Holland Building, 600 South Calhoun Street, Suite 217 Department at 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32399 32301, or online as indicated.
(a) Shellfish Harvesting Area Classification Maps, (FDACS-P-01773, (Revised 06/16) http://www.flrules.org/Gateway/reference.asp?No=Ref-07007 February 2012) – http://www.flrules.org/Gateway/reference.asp?No=Ref-01493.
(b) Shellfish Harvesting Area Classification Boundaries and Management Plans (FDACS-P-01593, (Revised 08/16) http://www.flrules.org/Gateway/reference.asp?No=Ref-07003February 2012 – http://www.flrules.org/Gateway/reference.asp?No=Ref-01492.
(2) Approved harvest areas Areas – A growing area Growing areas shall be classified as approved when a sanitary survey, conducted in accordance with Chapter IV of the NSSP National Shellfish Sanitation Program Model Ordinance, indicates that pathogenic microorganisms, radionuclides, and/or harmful industrial wastes do not reach the area in dangerous concentrations and this is verified by laboratory findings whenever the sanitary survey indicates the need. Shellfish may be harvested from such areas for direct marketing. This classification is based on the following criteria:
(a) through (b) No change.
(3) Conditionally approved harvest areas – A growing area shall be classified as conditionally approved when a sanitary survey, conducted in accordance with Chapter IV of the National Shellfish Sanitation Program Model Ordinance, indicates that the area is subjected to intermittent microbiological pollution. The suitability of such an area for harvesting shellfish for direct marketing may be dependent upon attainment of established performance standards by wastewater treatment facilities discharging effluent directly or indirectly into the area. In other instances, the sanitary quality of the area may be affected by seasonal populations, climatic and/ or hydrographic conditions, non-point source pollution, or sporadic use of a dock, marina, or harbor facility. Such areas shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting approved area criteria. In order to develop effective operating procedures, these intermittent pollution events shall be predictable. Harvest from temporarily closed conditionally approved areas shall be unlawful.
(4) Restricted harvest areas Areas – A growing area shall be classified as restricted when a sanitary survey, conducted in accordance with Chapter IV of the National Shellfish Sanitation Program Model Ordinance, indicates that fecal material, pathogenic microorganisms, radionuclides, harmful chemicals, and marine biotoxins are not present in dangerous concentrations after shellfish from such an area are subjected to a suitable and effective purification process. The bacteriological quality of every sampling station in those portions of the area most probably exposed to fecal contamination shall meet the following standard: The median or geometric mean fecal coliform Most Probable Number (MPN) of water shall not exceed 88 per 100 ml. and not more than 10 percent of the samples shall exceed a fecal coliform MPN of 260 per 100 ml. (per 5-tube, 3-dilution test) or the median or geometric mean fecal coliform Membrane Filter (MF) colony forming units of water shall not exceed 88 per 100 ml., and not more than 10 percent of the samples shall exceed a fecal coliform MF colony forming unit of 163 per 100 ml. in those portions of the area most probably exposed to fecal contamination during the most unfavorable meteorological, hydrographic, seasonal, and point source pollution conditions. Harvest is permitted according to permit conditions specified in Rule 5L-1.009, F.A.C. Harvest from temporarily closed restricted areas shall be unlawful.
(5) Conditionally restricted harvest areas Restricted Area – A growing area shall be classified as conditionally restricted when a sanitary survey or other monitoring program data, conducted in accordance with Chapter IV of the National Shellfish Sanitation Program Model Ordinance, indicates that the area is subjected to intermittent microbiological pollution. The suitability of such an area for harvest of shellfish for relaying or depuration activities is dependent upon the attainment of established performance standards by wastewater treatment facilities discharging effluent, directly or indirectly, into the area. In other instances, the sanitary quality of such an area may be affected by seasonal population, non-point sources of pollution, or sporadic use of a dock, marina, or harbor facility, and these intermittent pollution events are predictable. Such areas shall be managed by an operating procedure that will assure that shellfish from the area are not harvested from waters not meeting restricted area criteria. Harvest is permitted according to permit conditions specified in Rule 5L-1.009, F.A.C. Harvest from temporarily closed conditionally restricted areas shall be unlawful.
(6) Prohibited harvest areas Area – A growing area shall be classified as prohibited if a sanitary survey indicates that the area does not meet the approved, conditionally approved, restricted, or conditionally restricted classifications. Harvest of shellfish from prohibited such areas shall be unlawful. The waters of all man-made canals and marinas are classified prohibited regardless of their location.
(7) No change.
(8) Approved, conditionally approved, restricted, or conditionally restricted waters shall be temporarily closed to the harvesting of shellfish when counts of the red tide organism Karenia brevis exceed 5000 cells per liter in bays, estuaries, passes or inlets adjacent to shellfish harvesting areas. Areas closed to harvesting because of presence of the red tide organism shall not be reopened until counts are less than or equal to 5000 cells per liter inshore and offshore of the affected shellfish harvesting area, and shellfish meats have been shown to be free of toxin by laboratory analysis.
(9) through (10) No change.
(11) Shellfish harvesting area numbers are as follows:
AREA NUMBER
HARVEST AREA NAME
0212
Pensacola Bay Conditionally Approved Escambia Bay Shellfish Aquaculture Lease Areas managed during the Summer months of Jul – Sep
0222
Pensacola Bay Conditionally Approved Escambia Bay
0232
Pensacola Bay Conditionally Approved East Bay
0216
Pensacola Bay Conditionally Restricted Escambia Bay
0226
Pensacola Bay Conditionally Restricted East Bay
0622
Choctawhatchee Bay Conditionally Approved Central Section
0632
Choctawhatchee Bay Conditionally Approved Eastern Section
0822
1006
1012
West Bay Conditionally Approved
North Bay Conditionally Restricted Eastern
North Bay Conditionally Approved Western Section
1022
North Bay Conditionally Approved Eastern Section
1006
North Bay Conditionally Restricted Eastern
1206
East Bay Conditionally Restricted Section
1212
East Bay Conditionally Approved Section 1
1222
East Bay Conditionally Approved Section 2
1401
St. Joseph Joe Bay Approved
1506
Indian Lagoon Conditionally Restricted Winter Nov - Feb
1512
Indian Lagoon Conditionally Approved Spring/Fall Mar – Jun, Oct
1542
Indian Lagoon Conditionally Approved Zone A Winter Nov – Feb
1552
Indian Lagoon Conditionally Approved Zone B Winter Nov – Feb
1572
Indian Lagoon Conditionally Approved Summer Jul – Sep
1601
1611
Apalachicola Bay System Approved Jan – May, Sept – Dec
Apalachicola Bay System Approved Jan – May, Sept – Dec
1601
Apalachicola Bay Approved Jan – May, Sept – Dec
1605
1621
Apalachicola Bay System Zone A , Zone B, Zone C Jan - May, Sept - Dec
Apalachicola Bay System Approved June – Aug
1631
Apalachicola Bay Approved, Shellfish lease numbers 525, 551, 551B, 580, 582, 609, 672, and 981 Summer June – Aug
1612
Apalachicola Bay System Conditionally Approved Jan – May, Sept – Dec
1622
Apalachicola Bay System Conditionally Approved Jan – May, Sept – Dec
1632
Apalachicola Bay System Conditionally Approved Jan – May, Sept – Dec
1671
Apalachicola Bay System Approved Jun – Aug
1642
Apalachicola Bay System Conditionally Approved Jan – May, Sept – Dec
1652
Apalachicola Bay System Conditionally Approved June – Aug
1662
Apalachicola Bay System Conditionally Approved June – Aug
1605
Apalachicola Bay Restricted Zone A, Zone B and Zone C
1801
Alligator Harbor Approved
2002
Ochlockonee Bay Conditionally Approved
2006
Ochlockonee Bay Conditionally Restricted
2206
Wakulla County Conditionally Restricted
2212
Wakulla County Conditionally Approved Zone 1 Winter
2222
Wakulla County Conditionally Approved Zone 2 Winter
2232
Wakulla County Conditionally Approved Zone 1 Spring
2242
Wakulla County Conditionally Approved Zone 2 Spring
2302
St. Marks Conditionally Approved
2303
St. Marks Prohibited
2501
Horseshoe Beach Approved Summer Apr – Sep
2502
Horseshoe Beach Conditionally Approved Winter Oct – Mar
2506
Horseshoe Beach Conditionally Restricted Winter Oct – Mar
2802
Suwannee Sound Spring Summer Conditionally Approved Spring Summer Feb – May and Sept or Suwannee Sound Winter Conditionally Approved Winter Oct – Jan
2806
Suwannee Sound Spring Summer Conditionally Restricted Spring Summer Feb – May and Sept or Suwannee Sound Winter Conditionally Restricted Winter Oct – Jan
3001
Cedar Key Approved
3012
Cedar Key Conditionally Approved Zone A
3022
Cedar Key Conditionally Approved Zone B
3006
Cedar Key Conditionally Restricted
3202
Waccasassa Bay Conditionally Approved
3206
Waccasassa Bay Conditionally Restricted
3402
Withlacoochee Bay Conditionally Approved
3406
Withlacoochee Bay Conditionally Restricted
3701
Citrus County Approved Spring/Fall Mar. – June and Oct.
3702
Citrus County Conditionally Approved Winter Nov. – Feb.
3703
3705
Citrus County Prohibited
Citrus County Restricted Spring/Fall Mar. – June and Oct.
3706
Citrus County Conditionally Restricted Winter Nov. – Feb.
4202
Boca Ciega Bay Conditionally Approved
4802
Lower Tampa Bay Conditionally Approved
5402
Sarasota Bay Conditionally Approved
5602
Lemon Bay Conditionally Approved
5802
Gasparilla Sound Conditionally Approved
6002
Myakka River Conditionally Approved
6006
Myakka River Conditionally Restricted
6212
Pine Island Sound Conditionally Approved Western Section 1
6222
Pine Island Sound Conditionally Approved Eastern Section 2
6602
Ten Thousand Islands Conditionally Approved
7001
Indian River/St. Lucie Approved
7006
Indian River/St. Lucie Restricted
7202
North Indian River Conditionally Approved
7206
North Indian River Conditionally Restricted
7412
Body F Conditionally Approved
7416
Body F Conditionally Restricted
7506
Body E Conditionally Restricted
7602
Body D Conditionally Approved
7606
Body D Conditionally Restricted
7712
Body C Conditionally Approved Zone 1 Spring/Summer/Fall Mar – Nov
7722
Body C Conditionally Approved Zone 2 Spring/Summer/Fall Mar – Nov
7732
Body C Conditionally Approved Winter Dec – Feb
7716
Body C Conditionally Restricted Winter Dec – Feb
7726
Body C Conditionally Restricted Spring/Summer/Fall Mar – Nov
7812
Body B Conditionally Approved Zone 1
7822
Body B Conditionally Approved Zone 2
7902
South Banana River Conditionally Approved
7906
South Banana River Conditionally Restricted
8001
Body A Approved
8005
Body A Restricted
8201
South Volusia Approved
8212
South Volusia Conditionally Approved Zone 1
8222
South Volusia Conditionally Approved Zone 2
8206
South Volusia Conditionally Restricted
8802
South St. Johns South Conditionally Approved
8806
South St. Johns South Conditionally Restricted
9202
North St. Johns North Conditionally Approved
9206
North St. Johns North Conditionally Restricted
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, 7-9-89, 12-23-91, Formerly 16R-7.004, Amended 7-3-95, 6-18-97, 7-1-97, 7-22-97, 10-12-97, 12-16-97, 12-28-97, 2-12-98, 2-25-98, 7-1-98, 7-20-98, 11-13-98, 12-28-98, 3-18-99, 7-1-99, Formerly 62R-7.004, Amended 6-19-00, 8-9-00, 10-14-01(1), 10-14-01(1), 8-17-04, 9-28-04, 9-5-05, 6-11-06, 3-11-07, 10-2-07, 4-14-08, 7-28-08, 5-5-09, 6-18-09, 12-28.09, 2-9-11, 8-19-12, .
5L-1.004 Production and Market Standards.
(1) through (7) No change.
(8) Shellfish or shellfish products determined to be adulterated, or misbranded shall be subject to recall by the certified shellfish dealer responsible for distribution of the products. For a first time offense offense in a certification license year , the Department will apply mitigation measures if applicable. Mitigation measures include on-the-spot correction and reconditioning. For repeat violations, and where mitigation measures are not approved by the Department, 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. 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. Stop sale, condemnation, or reconditioning of products or containers shall be based on individual conditions found during inspections and shall be conducted using a Seizure and Destruction Order, (FDACS Form 15001, Revision) 10/16) 05/01. This form is, herein incorporated by reference, and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-06995 or may be obtained by contacting the Division of Aquauculture, Holland Building, 600 South Calhoun Street, Suite 217 for inspection at the Department’s offices located at 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32399 32301.
RulemakingSpecific 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.__________
5L-1.005 Shellfish Processing Plant Certification License.
(1) The following forms are hereby adopted and incorporated by reference and may be obtained by contacting the Division of Aquaculture, Holland Building, 600 South Calhoun Street, Suite 217, Tallahassee, FL 32399 and available online as indicated:
(a) Shellfish Processing Certification Application (FDACS-15007, Revision 09/16), http://www.flrules.org/Gateway/reference.asp?No=Ref-06997.
(b) Shellfish Processing Faciltiy Inspection Form (FDACS-15009, Revision 09/16), http://www.flrules.org/Gateway/reference.asp?No=Ref-06998.
(c) Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16), http://www.flrules.org/Gateway/reference.asp?No=Ref-06999.
(2)(1) Upon request, the Department shall provide an application form entitled Shellfish Processing Plant Certification License Application, (Form Number FDACS-15007, Revision 09/16).05/01, herein incorporated by reference, and obtainable by writing the Department of Agriculture and Consumer Services, Division of Aquaculture, 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32301. This completed application form is required for certification or recertification licensing of the shellfish processing facility. establishments. The following information shall be requested on the application form:
(a) The name and address of the firm;
(b) The name and address of the legal entity that owns the estblishment in (a) above;
(c) Name of the registered agent;
(d) The name of the designated representative, person in charge, or plant supervisor that will officially represent the firm on site;
(e) The plant classification; and
(f) The type of product to be processed.
(3)(2) Possession of a current saltwater wholesale dealer license to sell saltwater products issued pursuant to under provisions of Section 379.362 370.07, F.S. or an aquaculture certificate of registration issued pursuant to Section 597.004, F.S., shall be required to obtain a for shellfish processing certification. A copy of the license or certificate or registration licensing under this chapter. A copy of the current wholesale license to sell saltwater products shall be submitted with the Shellfish Processing Certification Application (FDACS-15007, Revision 09/16). Shellfish Processing Plant Certification License Application
(4)(3) If the applicant's water supply is not from a public water system, the applicant shall submit possession of satisfactory bacteriological water analysis results for certification pursuant to this chapter., Satisfactory bacterial water analysis results which shall not equal or exceed two cfu (colony forming units) per 100 mls for total coliform bacteria on any consecutive samples, and shall not equal or exceed two cfu per 100 mls for fecal coliform or E. coli bacteria on any samples shall be required for certification under this chapter. Analysis shall be from the source water and an outlet location within the facility plant, and ice if any is used. The water shall be sampled and approved prior to use of the water supply, every six months while the water supply is in use, and immediately after the water supply has been repaired and disinfected. If the source is a public water system, only a sample from an outlet in the facility plant and ice, if used, is required prior to certification. The water sample shall be taken and acceptable results provided to the Department within 90 days prior to certification. A copy of the current acceptable water analysis shall be submitted with the Shellfish Processing Certification Application (FDACS-15007, Revision 09/16).Shellfish Processing Plant Certification License Application
(5)(4) A shellfish processing plant certification license number will be assigned by the Department after receipt of a completed Shellfish Processing Certification Application (FDACS-15007, Revision 09/16) is received. Shellfish Processing Plant Certification License Application. Upon receipt of a completed application, an inspection of the physical facility will be conducted within 30 calendar days.
(6)(5) Certification is granted only to applicants firms whose facility who meets the following inspection requirements: the facility firm has no “Critical” item deficiencies, has no the firm does not have more than two (2) “Key” item deficiencies or has no and the firm does not have more than three (3) “Other” item deficiencies. Failure of a certification inspection requires reapplication by the applicant. After successful inspection of the facility and the applicant’s meeting the requirements of Rule 5L-1.005, F.A.C., a Shellfish Processing Certification License, DACS Form 15002, Revision 02/01, will be issued. After a firm is certified, unannounced inspections using the DACS plant inspection Forms 15009, Revision 06/01, and 15012, Revision 06/01, shall be conducted during periods of operation and at such frequency as necessary to assure that adequate operational and sanitary conditions are maintained. These forms are herein incorporated by reference, and obtainable by writing the Department of Agriculture and Consumer Services, Division of Aquaculture, 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 3201. Upon completion of the inspection where the applicant has met the requirements for licensure, he/she will be given a corrective action plan by the Department, However, if there are any “Key” “key” or “Other” “other” deficiencies cited. the shellfish processor The licensee must comply with the corrective action plan outlined on Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) 06/01Form, that is given to the shellfish processor certified dealer, facility plant supervisor or the designated representative of the plant at the end of the inspection. Following certification, unannounced inspections using the Shellfish Processing Facility Inspection Form (FDACS-15009, Revision 09/16), and Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) shall be conducted during periods of operation and at such frequency as necessary to assure that adequate operational and sanitary conditions are maintained. At the completion of each inspection, a copy of the completed inspection forms shall be issued to the facility plant supervisor or the plant’s designated representative.
(7)(6) Renewal certification – A shellfish processor dealer shall complete and submit a make application by completing the Shellfish Processing Plant Certification License Application (FDACS-15007, Revision 09/16) form for certification renewal annually; applications must be received no later than April 30 to prevent lapse in certification. The certification license year starts on July 1 and ends on June 30. The certification shall not be renewed for any facility dealer until the shellfish processing facility dealer has: no eliminated any “Critical” deficiencies;, no does not have more than two (2) “Key” item deficiencies;, and no and does not have more than three (3) “Other” item deficiencies. Upon completion of the re-certification inspection where the applicant has met the requirements for certification, he/she will be given a corrective action plan by the Department if there are any “Key” or “Other” deficiencies cited. The shellfish processor must comply with the corrective action plan outlined on the Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16), that is given to the shellfish processor, facility supervisor or the designated representative at the end of the inspection. The application (Shellfish Processing Plant Certification License Application Form) for renewal must be received by the agency by April 1 to have an inspection for recertification for the next certification period of a shellfish processor prior to June 30. The application for renewal certification will be denied to any dealer not meeting the above.
(8)(7) The shellfish processor, facility superivisor or designated representative must annually complete Department approved shellfish processor training provided by the Department at the processing facility, in workshops or online.
(9)(7) The Shellfish Processing Plant Certification License will be issued to a licensee at a specific location. The legal entity will be the applicant licensee at that specific location as listed on the Shellfish Processing Plant Certification License.
(10)(8) One Shellfish Processing Certificate shellfish processing plant certification license shall be issued to a shellfish processing facility plant owner operating at a single location., No single regardless of whether the location will be issued more than one certificate may qualify for two or more licenses or permits.
(11)(9) In the event that a licensed certified shellfish processing facility plant changes its name, changes owners, changes location, changes address, or changes classifications, a new Shellfish Processing Certification Aapplication (FDACS-15007, Revision 09/16) DACS Form 15007, Revision 05/01 must be completed and submitted to the Department. The firm will be required to go through the complete certification process.
(12)(10) Possession of a mechanical refrigeration unit that is non-portable and is able to maintain an ambient temperature of 45º F or below and be of sufficient size to handle one day’s production, shall be required for certification under this chapter.
(13)(11) Each applicant for a shellfish certification license shall have conducted a Hazard Analysis to determine the critical control points for any whether there are food safety hazards that are reasonably likely to occur for shellfish products produced at the location listed on the Shellfish Processing Plant Certification License Application (FDACS-DACS Form 15007, Revision 09/16) 05/01. Each certified shellfish facility dealer shall have someone with adequate HACCP training, knowledge or experience to develop a HACCP plan, reassess and modify the HACCP plan and perform the records review. Each certified shellfish facility dealer shall have prepare a written HACCP plan on premises. The HACCP plan shall incorporate critical control points that will eliminate, prevent, or reduce to an acceptable level the hazards identified in the hazard analysis. Critical control points shall have established critical limits for parameters to ensure when exceeded the dealer takes corrective actions. The HACCP plan shall include the procedures, and frequency thereof that will be used to monitor each of the critical control points to ensure compliance with the critical limits. The HACCP plan shall provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring. The plan shall be signed and dated by the owner, facility supervisor or designated representative or corporate officers of the firm at the time of its implementation, and after any modification. Each facility establishment shall develop or adopt acceptable sanitation monitoring records to meet the requirements in subsection 5L-1.013(17)(12), F.A.C.
(14)(12) The Each owner, facility supervisor, or designated representative of a certified shellfish processing facility or corporate officer who is a certified shellfish dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include at a minimum:
(a) Reassessment of the HACCP plan on an annual basis, or when shellfish processing changes occur that could affect the hazard analysis; and
(b) Ongoing verification including a review of any consumer complaints. The shellfish received by the processor shall to determine whether the complaints they relate to the performance of critical control points or reveal the existence of unidentified critical control points, or the calibration of process-monitoring instruments.
(15)(13) All certified shellfish processing facilities that persons who commercially engage in purchasing shellfish from harvesters, shucking, packing, repacking or transporting shellfish are subject to inspection, pursuant to Section 570.15, and shall allow inspection by the Department or its duly authorized representatives during normal operating hours and any time there are shellfish processing activities occuring is shellfish processing, in order to determine compliance with sections of this rule. Department shall inspect all licensed certified shellfish processing facilities plants. Denial of access for such inspection will automatically institute agency administrative action up to and including for immediate suspension of the shellfish processing plant certification license.
(16)(14) It is unlawful for persons to commercially engage in purchasing from harvesters, shucking, packing, or repacking shellfish without having complied with these rules and applied for and obtained a shellfish processing certificate shellfish processing plant certification license from the Department.
(17)(15) Upon certification issuance of a shellfish processing facility processing plant certification license, the Department shall notify the U.S. Food and Drug Administration of the certified shellfish processing facility’s dealer’s business name and certification license number to be published in the FDA website Interstate Certified Shellfish Shippers List: http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006753.htm
(18)(16) The Shellfish Processing Certificate shellfish processing plant certification license shall be posted in a conspicuous location on the premises.
(19)(17) No person shall attempt, by means of any threat or violence, to deter or prevent an employee agent of the Department from performing any duties imposed by law.
(20)(18) All licensed certified shellfish processing facilities plants shall maintain on the premises a current copy of this Rule rule Chapter 5L-1, F.A.C., entitled “The Comprehensive Shellfish Control Code” and a current copy of the “Model Ordinance” of the National Shellfish Sanitation Program, Guide for the Control of Molluscan Shellfish, 2015, published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration as incorporated by Rule 5L-1.001, F.A.C.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.007, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly 62R-7.007, Amended 8-9-00, 5-29-02, .
5L-1.006 Compliance and Penalties.
(1) The Department shall initiate enforcement action as follows:
(a) The Department shall inspect and re-inspect all licensed certified shellfish processing facilities plants as necessary. The deficiency(ies) cited in an inspection report shall be documented regardless of is not determined by the type of inspection being conducted.
(b) At the completion of an inspection, if a deficiency is cited where the Department finds a deficiency(ies) at a facility, the Department will provide do a corrective action plan. The Department will solicit input from the certified shellfish processor dealer, facility plant supervisor or the designated representative. The consent and cooperation of fthe certified shellfish processor dealer, facility plant supervisor or the designated representative is not necessary. for the creation of a corrective action plan by the Department nor will the Llack of cooperation from the certified shellfish processor dealer, facility plant supervisor or the designated representative will not affect the plans’ validity of the corrective action or requirement that the plan be implemented. A copy of the Shellfish Processing Facility Iinspection Form report (FDACS-15009, Revision 01/16 06/01), as incorporated in Rule 5L-1.005, and the corrective action plan outlined on the the Shellfish Inspection Facility Inspection Form Addendum (FDACS-15012, Revision 10/16 06/01), as incorporated in Rule 5L-1.005, will be provided to given to one of the following individuals who is present in the facility at the time the inspection is concluded: the shellfish processor, facility plant supervisor, the certified shellfish dealer, or the designated representative present at the conclusion of the inspection. The certified shellfish processor dealer, facility plant supervisor, and the designated representative shall ensure that the facility is in full compliance comply with the corrective action plan as outlined on Shellfish Inspection Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) 06/01 that is given to the certified shellfish dealer, plant supervisor or the designated representative of the plant at the end of the inspection. The certified shellfish prcoessor dealer, facility plant supervisor, or the designated representative’s failure to comply with the corrective action plan outlined on Shellfish Inspection Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) 06/01 will lead to administrative actions a fine, suspension, and/or revocation of the Shellfish Processing Certification. certified dealer’s certificate.
(c) If, upon inspection, of a facility by an employee of the Department cites the facility for a it is determined that there are “Critical”, “Key”, or “Other” deficiency(ies) of the facility, the following schedule will be used by the Department with respect to the administrative actions to be taken:
Critical deficiency(ies)
When a “Critical” deficiency(ies) is cited a warning letter will be issued and detected, processing operations at the certified facility affected by the “Critical” deficiency will be suspended as a public health threat and the deficiency must will be corrected immediately during the inspection or the certified facility’s firm’s certification license to operate will shall be immediately suspended as a public health threat. If the certification license to operate is suspended, it will remain suspended until corrections are made and verified by the Department inspection. Product affected by the “Critical” deficiency will be controlled to prevent contaminated or adulterated product from reaching consumers. When necessary, tThe Department shall will detain or sieze any product that may have been adultered, initiate mandate a recall of any distributed the product from the market by the certified shellfish dealer and notify necessary officials of a the recall.
In addition to these actions the sanction to be imposed on the a certified shellfish processing facility dealer upon the finding of any repeat “critical” deficiency(ies), as defined in Rule 5L-1.002, F.A.C., after the initial inspection that leads to the certificate being issued, will be as follows:
Offense
Critical
Key
Other
1st
Operations or certification suspended until corrected and a warning letter issued
Correct deficiency pursuant to date on corrective action plan
Correct deficiency pursuant to date on corrective action plan
1st Repeat within proceeding 180 days
Operations or certification suspended until corrected and fine of $500 per violation
Correct deficiency pursuant to date on corrective action plan and fine of $100 per violation
Correct deficiency pursuant to date on corrective action plan and fine of $50 per violation
2nd Repeat within proceeding 180 days
Operations or certification suspended until corrected and fine of $1000 per violation
Correct deficiency pursuant to date on corrective action plan and fine of $200 per violation
Correct deficiency pursuant to date on corrective action plan and fine of $100 per violation
3rd Repeat within proceeding 180 days
Fine of $1000 per violation and 7-day suspension of certification or until corrected, which ever is later
Correct deficiency pursuant to date on corrective action plan and fine of $500 per violation and 7-day suspension of certification
Correct deficiency pursuant to date on corrective action plan and fine of $200 per violation
4th or Subsequent Repeat within proceeding 180 days
Fine of $1000 per violation and 14-day revocation of certification
Correct deficiency pursuant to date on corrective action plan and fine of $1000 per violation and 14-day suspension of certification
Correct deficiency pursuant to date on corrective action plan and fine of $400 per violation
Repeat “Critical” deficiency(ies) the certified shellfish dealer will be fined $500.00 per violation.
2nd repeat “Critical” deficiency(ies) the certified shellfish dealer will be fined $1,000.00 per violation.
3rd repeat “Critical” deficiency(ies) certified shellfish dealer will be suspended for 7 days.
4th repeat “Critical” deficiency(ies) the certified shellfish dealer will be revoked the remainder of the certification period.
Key deficiency(ies)
The sanction to be imposed on a certified shellfish dealer upon the finding of repeat “Key” deficiency(ies), after the initial inspection that leads to the certificate being issued, will be as follows:
Repeat “Key” deficiency(ies) the certified shellfish dealer will be fined $100.00 per violation
2nd repeat “Key” deficiency(ies) the certified shellfish dealer will be fined $200.00 per violation.
3rd repeat “Key” deficiency(ies): the certified shellfish dealer license will be suspended for 7 days.
4th repeat “Key” deficiency(ies) the certified shellfish dealer will be suspended for 14 days.
5 th repeat “Key” deficiency(ies) the certified
Shellfish dealer license will be
revoked for the remainder of the certification period.
Other deficiency(ies)
A warning letter will be sent to a certified shellfish dealer upon the finding of 5 or more “Other” deficiencies. The sanction to be imposed on a certified shellfish dealer upon the finding of repeat “Other” deficiency(ies), after the initial inspection that leads to the certificate being issued, will be as follows; after 5 or more “other” item deficiencies:
Repeat “Other” deficiency(ies): Tthe certified shellfish dealer will be fined $25.00 per violation
2nd repeat “Oother” deficiency(ies) the certified shellfish dealer will be fined $50 per violation.
3rd repeat “Other” defiency(ies) the certified shellfish dealer will be fined $75.00 per violation.
4th or subsequent repeat “Other” deficiency(ies): the certified shellfish dealer will be fined $100 per violation.
(d) In those cases involving no fine, suspension or revocation, Aa warning letter will be sent to the certified shellfish processor dealer along with a notice of rights, which states that a dealer may contest the warning letter by requesting an administrative hearing to be conducted in accordance with Sections 120.569 and 120.57, F.S., when the establishment has:
1. One or more critical item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C., or
2. More than two 3 or more “Key” item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C., or when an establishment has 2 “Key” item deficiencies and 3 “Other” item deficiencies cited in violation of Chapter 5L-1, F.A.C., or
3. One 1 “Key” item deficiency and four 4 “Other” item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C.
(e) In cases involving the imposition of a fine the Department will forward an administrative complaint to the certified shellfish processor dealer, a proposed settlement offer, and a statement of rights. In cases involving the imposition of a suspension or revocation of a certified shellfish facility’s shellfish processing certification dealer’s license the Department will forward an administrative complaint, a statement of rights, and a proposed settlement agreement to the certified shellfish processor dealer except when the Department has to immediately suspend a certification license because of an immediate public health threat. Payment of fines owed to the Department must be made within 22 days of the receipt by the certificate holder receiving of the notice imposing the fine unless the shellfish processor has sent a written absent a request for a hearing on the matter pursuant to Chapter 120, F.S., within the 22 day period to the Department.
(f)(e) A renewal of a shellfish facility’s processing certification firm’s certificate will not be made if there are any unpaid fines with respect to prior certification periods.
(2) The Department or its agents shall summarily suspend the facility’s shellfish processing a certification license if it is determined that there is an immediate serious danger to the public health, safety, or welfare requiring such emergency action. The Department shall, at the time the emergency action is taken, initiate proceedings as provided in Section 120.60, F.S.
(3) Upon suspension or revocation of the facility’s shellfish processing a certification license, the Department shall notify the U.S. Food and Drug Administration so that the facility’s dealer’s business name and certification license number will may be removed from the Interstate Certified Shellfish Shippers List. Upon reinstatement of the certification license, the Department shall notify the U.S. Food and Drug Administration so that the facility’s dealer’s business name and certification license number may be reinstated on the Interstate Certified Shellfish Shippers List.
(4) When an employee of the Department finds, or has reason to believe, that any equipment which is located at a certified processing licensed facility is in violation of this chapter so as to be dangerous or unsanitary within the meaning of this chapter, an employee of the Department may issue and enforce a stop-sale, stop-use, removal, or hold order, which order gives notice that such equipment is, or is suspected of being, in violation and has been detained or embargoed and which order warns all persons not to remove, use, or dispose of such equipment by sale or otherwise until permission for removal, use, or disposal is given by the Department or the court. It is unlawful for any person to remove, use, or dispose of such detained or embargoed equipment by sale or otherwise without such permission.
(5) No change.
Rulemaking Specific Authority 500.121(1), 500.172, 597.020 FS. Law Implemented 500.121(1), 500.172, 597.020 FS. History–New 1-4-87, Amended 8-10-88, 7-9-89, Formerly 16R-7.009, Amended 7-3-95, 2-6-97, Formerly 62R-7.009, Amended 8-9-00, 5-29-02, .
5L-1.007 Container Identification, Terminal Sale Date; Prohibitions.
(1) Shucked shellfish container – The packer’s or repacker’s shellfish processing plant certification license number preceded by the state abbreviation must be embossed, imprinted, lithographed, or otherwise permanently and legibly recorded on the external body of containers or on the lid if the lid becomes an integral part of the container during the sealing process (Example: FL-872-SP). Containers shall permanently indicate type of product, quantity, and name and address of packer, repacker, or distributor. Containers of fresh shellfish, with a capacity of less than 64 ounces, shall further clearly and permanently bear the terminal sale date, by the numerical month, day, and last digit of the year. Containers of fresh shellfish with a capacity of 64 ounces or more, shall bear the actual shucking date by numerical month, day, and last digit of the year, in that order (Example: 01015). Reusable Bulk bulk storage containers shall be identified with state of origin, harvest date, and shuck date. Containers of frozen or previously frozen shellfish shall further clearly and permanently bear the date of shucking by numerical month, day, and last digit of the year, in that order (Example: 02097). Previously frozen shucked shellfish shall also be labelled “previously frozen” and have the freeze date and the thaw date following the same format. The terminal sale date for previously frozen shucked shellfish will be calculated by adding the day of shucking plus amount of time under refrigeration if not frozen, and adding the days that the product has been held thawed. Repacked shellfish containers shall also bear an appropriate code identifying the original packer. For restricted use shellstock If oysters exceed the requirements found in subsection 5L-1.008(5), (6), (7), (8) or (9), F.A.C., the shucked shellfish container may be identified with the language “FOR POST HARVEST PROCESSING ONLY”.
(2) Each commercial harvester or each certified shellfish processor dealer shall affix a durable, waterproof tag of minimal size – 2 5/8 by 5 1/4 inches – to each container of shellstock; for commercial harvesters this shall be done prior to leaving the at each harvest location, regardless of capacity of container; for certified shellfish dealers this shall be done after final packing. In the case where a certified shellfish dealer is also the harvester, that dealer’s tag may also be used as the harvester’s tag.
(3) The commercial harvester’s tags shall be white in color except as required in subsection paragraph 5L-1.007(3)(i) F.A.C. Before leaving the harvest location, commercial harvester’s tags shall be attached and contain legible waterproof indelible information required by subsections 5L-1.007(3)(a)-(i) F.A.C. arranged in the specific order as follows:
(a) The harvester’s saltwater product license number or Aquaculture Certificate of Registration number aquaculture certificate number;
(b) through (d) No change.
(e) The identification of the harvest area using the four digit area number or name of the harvest area listed in subsection 5L-1.003(11), F.A.C., as well as the most precise identification within that area as practicable. Aquaculture product harvested during FWC summer resource closures must also include the sugmerged land lease number;
(f) through (g) No change.
(h) The identification of the cooling option if used, including complete on-board cooling option (subsection 5L-1.008(9)(7), F.A.C.), partial on-board cooling option (subsection 5L-1.008(78)(c), F.A.C.), or rapid cooling option (subsection 5L-1.008(10)(9), F.A.C.) for oysters harvested during the months of May through October.
(i) If shellstock exceeds the requirements in subsections 5L-1.008(5), (7), or (8) or (9) or (10), F.A.C., the commercial oyster harvester tag shall be identified with the preprinted language “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY” in bold, 14 point font and the tag shall be green in color. Containers of oysters shall not be tagged with both a green tag and a white tag at any time.
(4) Bulk tagging is allowed for those aquaculturists operating with an Aquaculture Certificate of Registration aquaculture certificate. A bulk tag, containing the information required in subsections paragraphs (3)(a)-(h)(g) and (h), where applicable, along with the name of the certified shellfish facility dealer which the product is consigned to, shall be completed at each harvest location.
(5) Bulk tagging, by a certified shellfish facility dealer, while washing, packing, during depuration, wet storing, staging and intrastate transport of shellfish is permissible up to final packaging only when the lot container (i.e., pallet), contains shellfish which are harvested on the same day, from the same harvest area, and have the same intended use (i.e., for halfshell consumption, for shucking, or for further processing), and is tagged as follows:
(a) The statement “All Shellfish containers in this lot have the same date and area of harvest, as well as the same intended use”,
(b) through (e) No change.
(f) The identification of the cooling option if used, detailed in subsections 5L-1.008(9)(7) and 5L-1.008(10), F.A.C., including complete on-board cooling option (subsection 5L-1.008(7), F.A.C.), partial on-board cooling option (subsection 5L-1.008(8), F.A.C.), or rapid cooling option (subsection 5L-1.008(9), F.A.C.) for oysters harvested during the months of May through October.
(g) If shellstock exceeds the requirements in subsections 5L-1.008(5), (6), (7), or (8) or (9), or (10), F.A.C., the shellstock bulk tag shall be identified as restricted use shellstock with the preprinted language “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY” in bold, 14 point font and the tag shall be green in color.
(6) The certified facility’s dealer’s tag shall contain legible, waterproof, indelible information arranged in the specific order as follows:
(a) The shellfish shipper, shucker-packer, repacker, depurator, or distributors name, address, processing facility plant certification number;
(b) through (c) No change.
(d) The identification of the harvest area, and for Florida harvest areas the four digit code or name of the harvest area found in subsection paragraph (3)(e) above;
(e) through (f) – No change.
(g) All For oyster shellstock must display harvested from the Gulf of Mexico, the terminal sale date as a numeric date depicting month, day, and last digit of the year, not to exceed 14 days after the harvest date, or the statement “Sell Within 14 days of the Harvest Date”.
(h) If shellstock exceeds the requirements in subsections 5L-1.008(5), (6), (7), or (8) or (9), F.A.C, the shellstock dealer tag shall be identified as restricted use shellstock with the preprinted language “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY” in bold, 14 point font and the tag shall be green in color.
(i) For depuration shellstock processors, subsections paragraphs (6) (a), (d), (e), and (f) are required as well as the date of processing, and the depuration cycle number.
(j) No change.
(7) Containers of treated shellfish from depuration facilities shall be tagged in accordance with item (6) in addition to the lot number and date shellfish were released from the treatment facility plant.
(8) No change.
(9) In addition to the identification and labeling requirements of subsections (1) and (2), containers of fresh, frozen, previously frozen or repacked shellfish or containers of shellstock must indicate the state of origin of the shellfish, e.g., LA, MS, TX. For shellstock this requirement can be by subsections paragraphs (6)(a) and (b) above.
(10) No change.
(11) It shall be unlawful for any person, firm, corporation, wholesale or retail dealer to sell or offer for sale any fresh shellfish after the terminal sale date has expired, or sell or offer for sale any fresh, frozen, or previously frozen shellfish not in compliance with any and all requirements of Rule Chapter 5L-1, F.A.C.
(12) Whoever knowingly or willfully alters or damages in any manner, or loans or transfers to another person any certification license number or shellfish tags, or any person who uses the certification number license or shellfish tags, other than the person to whom they were issued, shall be in violation of this section and shall be subject to certification license suspension or revocation in addition to any other penalty for violation of Rule Chapter 5L-1, F.A.C.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, 8-30-89, 5-6-93, 9-14-93, 8-21-94, Formerly 16R-7.010, Amended 9-1-95, 5-8-96, 2-6-97, 10-12-97, 2-12-98, 2-25-98, 7-1-98, 11-13-98, 12-28-98, 3-18-99, 7-1-99, Formerly 62R-7.010, Amended 6-19-00, 8-9-00, 10-14-01, 5-29-02, 8-17-04, 9-28-04, 7-28-08, 7-29-08, 4-26-10, 8-31-11, .
5L-1.008 Shellfish Handling.
(1) Wet storage shall be conducted upon execution of an agreement between a person, firm, or corporation possessing a shellfish processing plant certificate certification license and the Department. Each agreement shall include the following provisions:
(a) through (i) No change.
(j) If wet storage is to be practiced using a shore-based facility, the applicable provisions of Rules 5L-1.002, 5L-1.010, 5L-1.011, 5L-1.012, 5L-1.013, subsections 5L-1.015(2), (3), (4), (5), (6) and (7), and subsection Rules 5L-1.017(2) and 5L-1.018, F.A.C., shall apply. All shore-based facilities shall employ ultraviolet light treatment of all incoming and recirculated seawater. All water quality measurements required by subsection Rule 5L-1.017(2), F.A.C., shall be documented and such data retained for inspection by the Department for a minimum of one year. Subsections Paragraphs 5L-1.008(1)(a), (b), (d), (e), (f), (h) and (i), F.A.C., shall not apply to a shore-based facility.
(k) No change.
(2) through (3) No change.
(4) Use of other receptacles for sewage disposal are approved if the receptacles are constructed of impervious, cleanable materials, have tight fitting lids, and meet the requirements of subparagraphs 5L-1.008(3)(a)-(e), F.A.C.
(5) Resubmerging or Replanting
(a) Aquacultured shellfish are the only shellfish allowed to be replanted/resubmerged.
(b) Shellfish processors must maintain an oyster replant log of all replant/resubmerged activities including:
1. Date of initial removal from water at lease site;
2. Lease number;
3. Date of replant;
4. Replant lease number;
5. Replant location on lease; and
6. Replant Quantity.
(c) Shellfish processor must provide access to records upon request by the Department.
(d) All replanted/resumberged shellfish must be segregated from other shellfish and clearly identified on the lease.
(e) Replanted/resumberged aquaculture oysters larger than 25 millimeters (3/4 inch) that are removed from the water during the course of routine oyster husbandry practices for more than 4 hours during April through October must be returned to the lease and submerged on an aquaculture lease for a minimum of 14 days before they can be harvested and sold to a certified shellfish processing facility. Routine oyster husbandry practices include the use of suspended grow out containers that maybe unsubmerged during natural tidal cycles,
(6) Remote buying is prohibited
(7)(5) Throughout the year, it is harvester’s responsibility that shellfish shall be harvested between sunrise and sunset as established by the U.S. Weather Service. All shellfish shall be delivered by the harvester directly to a shellfish dealer at their certified shellfish processing facility.
(a) Clams:
1. During the months of November, December, January, February, and March, all clams harvested shall be delivered to a certified shellfish processing facility and placed under temperature control dealer by 10:00 p.m. of the same day as harvest.
2. During the months of April, May, and October, all clams harvested shall be delivered to a certified shellfish processing facility and placed under temperature control dealer within twelve (12) hours of the time of harvest, or within the same day as harvest, whichever is earlier.
3. During the months of June, July, August, and September, all clams harvested shall be delivered to a certified shellfish processing facility and placed under temperature control dealer within ten (10) hours of the time of harvest, or within the same day as harvest, whichever is earlier.
4. Tempering, as an alternative process, shall consist of those methods which have demonstrated through verification studies that the process renders hard clams which are as safe as hard clams meeting subsection 5L-1.008 (7)(a)(1-3), F.A.C. Prior to initiating tempering a certified shellfish dealer shall have written approval from the Department. The certified shellfish dealer must provide the following:
a. A description of all facilities, equipment and methods to be used in the alternative process. This process must be included in the firm’s HACCP plan.
b. The source of hard clams and the maximum capacity of hard clams to undergo the process at any one time.
c. The process to be followed shall not exceed 16 hours total time between hard clam harvest and refrigeration at 45oF or less. Product harvest, processing, tempering and food storage at 45oF or less must be scheduled to occur as a continuous procedure.
d. Upon initiation, the tempering process must have temperature control of 68oF or less and be maintained until hard clams are placed into refrigeration of 45oF or less.
(b) Oysters:
1. Non-Vibro Control months include November, December, January, February and March.
2. Vibrio Control months inlcude April, May, June, July, August, September and October.
3. During the months of November, December, January, February, and March, all oysters harvested shall be delivered to a certified shellfish processing facility dealer and placed under mechanical refrigeration by 10:00 p.m. of the same day as harvest.
4. During the month of April, all oysters harvested shall be delivered to a certified shellfish processing facility dealer and placed under mechanical refrigeration by 4:00 p.m. of the same day of harvest.
5. During the month of May, all oysters harvested shall be delivered to a certified shellfish processing facility dealer and placed under mechanical refrigeration by 11:00 a.m. of the same day of harvest, unless the harvester is identified in the a certified shellfish processing facility’s dealer’s HACCP plan for the on-board cooling option detailed in subsection 5L-1.008(9)(7), F.A.C., or the certified shellfish processing facility dealer’s is authorized for the rapid cooling option detailed in subsection 5L-1.008(10)(8), F.A.C.
6. During the months of June, July, August, and September, all oysters harvested shall be tagged as “FOR SHUCKING ONLY BY A CERTIFIED DEALER” or “FOR POST HARVEST PROCESSING ONLY” and delivered to a certified shellfish processing facility dealer and placed under mechanical refrigeration by 4:00 p.m. of the same day of harvest, unless the harvester is identified in the certified shellfish processing facility’s dealer’s HACCP plan for the on-board cooling option detailed in subsection 5L-1.008(9)(7), F.A.C., or the certified shellfish processing facility dealer is authorized for the rapid cooling option detailed in subsection 5L-1.008(10)(8), F.A.C.
7. During the month of October, all oysters harvested shall be delivered to a certified shellfish processing facility dealer and placed under mechanical refrigeration by 1:00 p.m. unless the harvester is identified in the certified shellfish processing facility’s dealer’s HACCP plan for the on-board cooling option detailed in subsection 5L-1.008(9)(7), F.A.C., or the certified shellfish processing facility dealer is authorized for the rapid cooling option detailed in subsection 5L-1.008(10)(8), F.A.C.
(8) (6) Once received by a certified shellfish processing facility dealer, the shellstock lot shall be immediately processed and placed under temperature control and until sale to final consumer, the shellstock shall be maintained at an environmental temperature of 45º F or less and not be permitted to remain outside of temperature control for more than 2 hours cumulative at points of transfer within the processing facility plant such as loading docks or in the facility plant during processing except for the process described in paragraph 5L-1.008(7)(a)(4) 5L-1.013(3)(b), F.A.C. All certified shellfish processing facilities dealers handling oysters must have a cooling system capable of reducing the internal temperature of shellstock oysters to 55oF or less within 8-hours.
(9)(7) On-Board Cooling Option – On-board cooling equipment includes systems using ice, mechanical refrigeration, or vacuum cooling. If a commercial oyster harvester is using on-board cooling with ice slurry, the maximum time oysters can remain outside the cooling system is one 1 hour from time of harvest and the on-board cooling system shall be capable of reducing the internal temperature of oysters to 55o F or less and maintaining at 55oF or less until at time of delivery to the certified shellfish processing dealer facility. Commercial Harvesters must maintain an on-board time and temperature record documenting time of harvest, time oysters placed under refrigeration, and time that oysters reach 55o F or less.
(a) Commercial harvesters using on-board cooling systems must deliver the oysters to a certified shellfish processing facility dealer and oysters must be placed under mechanical refrigeration by the certified shellfish processor dealer no later than 3:00 p.m. of the harvest day. Oysters must be at 55oF or less at time of delivery.
(b) Shellfish processors Certified shellfish dealers electing to purchase oysters from harvesters using on-board cooling systems must document in their HACCP plan that the cooling rates on-board a vessel and in the certified shellfish processing facility’s dealer cooling system provide a safety level equivalent to product meeting subsection 5L-1.008(7)(b)(5), F.A.C., in order to be labeled in compliance with subsection 5L-1.007(6), F.A.C. Shellfish processors Certified shellfish dealers electing to purchase oysters from harvesters using such on-board cooling systems must list the harvester name, harvester license number, the maximum time oysters can be unrefrigerated on-board a vessel, and the total number of hours required to reduce the internal temperature of oysters to 55oF or less in their HACCP plan. Prior to implementing the HACCP plan, the certified shellfish processor dealer must have written approval from the Department.
(c) Harvesters proposing an alternative on-board cooling option must contact and demonstrate to the Department that the system is capable of meeting time and temperature requirements of the State’s Vibrio vulnificus Control Plan and must have written approval from the Department prior to implementation.
(d) Harvested oysters failing to meet the time and temperature requirements of this subsection shall be retagged by the processor dealer as “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY”.
(10)(8) Rapid Cooling Option – Rapid cooling equipment includes systems using ice, mechanical refrigeration, or vacuum cooling. If a certified shellfish processor dealer elects to rapidly cool oysters, the maximum cool down time to 55oF or less must not exceed two 2 hours.
(a) During the month of May certified shellfish processors dealers approved to use the rapid cooling option must place all harvested oysters under mechanical refrigeration no later than 2:00 p.m. of the harvest day.
(b) During the months of June, July, August, and September certified shellfish processors dealers approved to use the rapid cooling option must place all harvested oysters under mechanical refrigeration no later than 11:00 a.m. of the harvest day.
(c) During the month of October certified shellfish processors dealers approved to use the rapid cooling option must place all harvested oysters under mechanical refrigeration no later than 3:00 p.m. of the harvest day.
(d) Shellfish processors The certified shellfish dealers must develop and demonstrate in their HACCP plan that the cooling rates in combination with extended harvest times assure a safety level equivalent to product meeting subsection 5L-1.008(7)(b)(5), F.A.C., in order to be labeled in compliance with subsection 5L-1.007(6), F.A.C. Certified Shellfish processors shellfish dealers electing this option, must list the maximum time oysters can be unrefrigerated on-board vessel and the total number of hours required to reduce the internal temperature of oysters to 55oF or less in their HACCP plan. Prior to implementing the HACCP plan the certified shellfish processor dealer must have written approval from the Department.
(e) Harvested oysters failing to meet the time and temperature requirements of this subsection shall be retagged by the processor dealer as “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY”.
(f) During the months April through October all harvested oysters tagged as “FOR SHUCKING ONLY BY A CERTIFIED FACILITY” or “FOR POST HARVEST PROCESSING ONLY” shall be delivered to a certified processing facility by 4:00 PM of the harvest day.
(11) Handling Time/Temperature table summary:
Oysters
(Times are when oysters must be placed in cooler at a certified shellfish processing facility)
Clams
Traditional Cooling (<55oF in 8 hours)
Rapid Cooling (<55oF in 2 hours)
On-Board Cooling with Ice Slurry (<55oF at time of delivery)
Restricted Use Only (Green Tag)
Delivery from time of harvest
November
10PM
Non-Vibrio Control Month
Non-Vibrio Control Month
Non-Vibrio Control Month
10PM
December
10PM
Non-Vibrio Control Month
Non-Vibrio Control Month
Non-Vibrio Control Month
10PM
January
10PM
Non-Vibrio Control Month
Non-Vibrio Control Month
Non-Vibrio Control Month
10PM
February
10PM
Non-Vibrio Control Month
Non-Vibrio Control Month
Non-Vibrio Control Month
10PM
March
10PM
Non-Vibrio Control Month
Non-Vibrio Control Month
Non-Vibrio Control Month
10PM
April
4PM
4PM
3PM
4PM
12 Hours
May
11AM
2PM
3PM
4PM
12 Hours
June
Not permitted
11AM
3PM
4PM
10 Hours
July
Not permitted
11AM
3PM
4PM
10 Hours
August
Not permitted
11AM
3PM
4PM
10 Hours
September
Not permitted
11AM
3PM
4PM
10 Hours
October
1PM
3PM
3PM
4PM
12 Hours
(12)(9) Shellfish leaving a certified shellfish facility dealer must be transported in an enclosed, mechanically refrigerated conveyance with doors closed securely. The refrigeration unit must be capable of maintaining an ambient temperature of 45o F or less at all times.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, Formerly 16R-7.011, Amended 7-3-95, 2-6-97, 3-18-99, 6-23-99, Formerly 62R-7.011, Amended 8-9-00, 5-29-02, 7-29-08, 4-26-10, 8-31-11, 5-26-15, .
5L-1.009 Shellfish Relaying.
(1) Aquacultured shellfish are the only shellfish allowed to be relayed. No person, firm, corporation, municipality, association, or other governmental body shall engage in shellfish relay operations without first obtaining a “Special Activity License to Relay Shellfish” from the Department.
(2) Only certified shellfish aquaculturists are eligible to apply for a A Special Activity License to Relay Aquacultured Shellfish. may be issued to any person, firm, corporation, municipality, or other governmental body or agency holding a shellfish lease, aquaculture lease, or owning or operating a depuration plant, and whose past record indicates that they can be bonded and are responsible to oversee and assure compliance with all rules and licenses. A Special Activity License to Relay Shellfish may be issued to an association when the Department has public funds appropriated for relaying shellfish to public areas.
(3) Anyone certified shellfish aquaculturist wishing to conduct aquacultured shellfish relaying operations shall submit to the Division a completed provide the Department, upon application form entitled “Application for aA Special Activity License to Relay Aquaculture Shellfish to Aquaculture Lease or Licensed Depuration Facility”, Form Number (FDACS-15109, Revision 10/16), hereby incorporated by reference and is 05/01 , available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-07000 or may be obtained by contacting the Division of Aquaculture, Holland Buidling, 600 South Calhoun Street, Suite 217 from the Department of Agriculture and Consumer Services, 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32399.32301, and herein incorporated by reference, with The the following information shall be included:
(a) Name, address, Aquaculture Certificate of Registration number, telephone number, and instructions for contacting person or persons responsible for relaying operations;
(b) Species of aquacultured shellfish to be moved;
(c) Anticipated amount of aquacultured shellfish to be moved;
(d) Method of harvesting, that is raking, tonging, treading, or diving;
(d)(e) Aquaculture lease parcel number(s) or address of certified depuration facility Areas from which aquacultured shellfish will be moved;
(e)(f) Aquaculture lease parcel number(s) Areas to which aquacultured shellfish will be moved;
(f)(g) Method of transportation;
(h) Number of crews to be involved in the relay operation;
(i) The colors and design of flags to be used pursuant to paragraph 5L-1.009(4)(r), F.A.C.; and
(g)(j) Laboratory secured for collection and laboratory analysis according to subsections paragraph 5L-1.009(4) (d)(p) -(e), F.A.C., for shellfish leases and aquaculture leases and according to Rules 5L-1.016 and 5L-1.017, F.A.C., for depuration facilities.
(4) The Department, after reviewing the application and finding the plan in compliance with all applicable rules and regulations, and determining that the activity will not degrade, destroy or affect marine resources, shall issue a Special Activity License to Relay Aquacultured Shellfish within the general conditions set forth below:
(a) The Department shall is authorized to establish the effective date and expiration date of the “Special Activity License to Relay Aquacultured Shellfish”. In no case shall the expiration date be greater than one year from the effective date.
(b) Aquacultured Shellfish relaying shall be conducted only during daylight hours, commencing at official sunrise and ending at official sunset, as established by the U.S. Weather Service, except as defined by subparagraph 5L-1.009(4)(n)5., F.A.C., under approved law enforcement, licensed security guard monitoring, or and under the direct supervision of the Department. All persons involved in harvest, transport, and relaying shall comply with these rules and license conditions. Harvesters shall remain within the immediate control and observation of a monitor at all times. A monitor shall be provided by the Department. No more than 15 watercraft shall be under the supervision of a monitor at any time. The requirement for a monitor is not necessary when an association is conducting shellfish relaying to public areas in conjunction with Department supervision using public funds.
(c) All persons operating under a “Special Activity License to Relay Shellfish”, shall comply with all applicable shellfish rules, regulations, and specific license conditions listed on the “Special Activity License to Relay Shellfish”, under which he/she is operating.
(d) The licensee and person named as being responsible, shall be lawfully responsible for all activities conducted under the conditions of the “Special Activity License to Relay Shellfish” and applicable rules and regulations.
(e) The licensee must notify the local Marine Enforcement District Office of the Florida Fish and Wildlife Conservation Commission and the Department within twelve (12) hours by telephone and in writing by certified mail or hand delivery, within three days of any changes in ownership or person named as being responsible for the activities conducted under the conditions of the “Special Activity License to Relay Shellfish”.
(f) The Licensee shall use only Department approved monitors, as specified by subsection 5L-1.009(5), F.A.C., to supervise relay harvesting, relay transport operations, placement on permitted site, and completion of required relay reports.
(g) Approved monitors must have completed the Department monitor training course and have a current “Department Approved Monitor Identification Card” showing successful completion of the course.
(h) Approved monitors shall have in their possession and available for immediate inspection, a current “Department Approved Monitor Identification Card” and a valid picture identification card during relay operations, available for immediate inspection.
(i) Approved monitors shall have in their possession a complete copy of the valid “Special Activity License to Relay Shellfish”, including complete copies of all licenses of each licensee who participates in a relay crew when the relay crew is comprised of more than one licensee, available for immediate inspection during any phase of relay operation. The copy(ies) shall be supplied by the licensee(s) or person(s) named as being responsible.
(j) Harvesters shall harvest shellfish within one hundred yards of the approved monitor, and remain under the immediate supervision and unobstructed view of the approved monitor, except as described in subparagraph 5L-1.009(4)(n)13., F.A.C.
(k) No more than fifteen (15) harvesters shall comprise one crew and not more than one crew shall be under the immediate supervision of an approved monitor, except as described in subparagraph 5L-1.009(4)(n)3., F.A.C.
(l) Relay teams that are treading or using rakes and/or tongs shall remain at a distance greater than 100 yards from any diving relay team that is in operation.
(m) Seagrasses shall not be disturbed.
(n) If relay harvesting is to be conducted by divers, the following additional conditions shall apply:
1. Any harvester who wishes to engage in a diving operation shall be required to obtain an “Underwater Shellfish Harvester Certificate” from the Florida Marine Enforcement District Office of the Florida Fish and Wildlife Conservation Commission, in which geographic area the harvester works. No certificate shall be issued to any applicant with a conviction of harvesting in a restricted, conditionally restricted, prohibited, or unclassified area within one year prior to application. No certificate shall be issued to any applicant who is not a certified diver.
2. It shall be unlawful for a diver to harvest shellfish on a relay crew without an “Underwater Shellfish Harvester Certificate” issued by the Florida Marine Enforcement District Office in which geographic area harvesting occurs.
3. A diver relay crew shall not be comprised of more than five divers, and not more than one crew shall be under the immediate supervision of an approved monitor.
4. Diving shall be the only method used by a team. Other harvesting methods, such as raking or tonging from a vessel or treading, shall not be permitted by a team employing diving.
5. The use of self contained underwater breathing apparatus (SCUBA) is not permitted.
6. The air supply shall come from the surface and consist of an apparatus which is supported by flotation, and used by no more than two harvesters at a time.
7. The air line from the apparatus to each diver shall not exceed 150 feet in length.
8. A designated diver’s apparatus must be tethered to the approved monitor’s vessel to provide a means of communication. The designated diver will provide communication for the approved monitor to the other divers.
9. Diver down flags shall be utilized as prescribed by Section 861.065, F.S. In addition, each diver shall have a diver’s down flag on any flotation device designating the diver’s approximate location.
10. Flags, as required by paragraph 5L-1.009(4)(r), F.A.C., shall be flown on the vessels and not on the flotation device used to support a compressor.
11. Each diver shall have in his possession, while in the water, a maximum of one container at any time. No other container of any type shall be allowed with the diver while in the water.
12. Harvesters shall remain within 100 yards of the approved monitor’s vessel.
13. Relay teams shall remain more than 100 yards from any other relay team.
(c)(o) Relayed aquacultured shellfish shall be delivered directly to the designated aquaculture lease or certified depuration facility license location on the same day of harvest. Diverting aquacultured shellfish to any other source or location is prohibited and will result in immediate seizure of aquacultured shellfish and permanent exclusion of the license holder from future relays.
(d)(p) If aquacultured shellfish are relayed to a lease in Approved or Conditionally Approved areas, they shall not be harvested without written permission from the Department. Permission will be granted only after a minimum of 15 days have elapsed to allow the aquacultured shellfish to cleanse themselves, and this cleansing is verified by laboratory biotoxin analysis. The fifteen days will commence when the Department staff verifies that all aqacultured shellfish in that particular day’s harvest have been relayed. receives the licensee’s “Special Activity License to Relay Shellfish” for cancellation. The fifteen day period does not include days that shellfish harvesting areas have been temporarily closed to harvest.
(e) Laboratory analysis shall consist of a minimum of two five samples per individual lease parcel (each sample to consist of a minimum of 20 12 individual shellfish)., collected by an employee of a laboratory with a current Department certification letter or staff of the Department. Four samples are to be collected from four corners of the lease and one sample collected from approximately the center of the lease. High-density aquaculture lease areas will be treated as a single entity pursuant to subparagraphs 5L-1.009(4)(s)3. and 8., F.A.C., for sampling. The Department will collect and analyze samples for aquacultured shellfish relaying. to public areas in conjunction with Department supervision using public funds. The laboratory must be certified by the Department State Laboratory Certification Officer pursuant to Guidance document A.11 of the National Shellfish Sanitation Program Model Ordinance and the Shellfish Laboratory Evaluation Checklist (1995), published by the U.S. Food and Drug Administration, which is hereby incorporated by reference and available for inspection at the Department’s offices located at 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32301. Laboratory analysis shall include approved methods for fecal coliform bacteria and standard plate count. The bacteriological quality of the relayed shellfish shall be equal to or better than shellfish of the same species harvested from nearby Approved or Conditionally Approved areas. If For aquacultured shellfish are being relayed due to marine biotoxins, the laboratory analyses shall use an approved NSSP laboratory method include mouse bioassays for the specific toxin. The toxin level must be less than the levels defined in Section II, Chapter IV, @.04(C) of the 2015 NSSP Model Ordinance, as incoporated in Rule 5L-1.001. than 20 mouse units. Aquacultured shellfish are the only shellfish allowed to be relayed due to marine biotoxins. Relaying for marine biotoxins is only allowed within the following four specific geographic regions of the state: (1) Escambia County through Jefferson County; (2) Taylor County through Levy County; (3) Citrus County through Monroe County; (4) Dade County through Nassau County. Relaying due to marine biotoxins between these specific geographic regions is prohibited unless specifically authorized by the Department. The licensee holder of the “Special Activity License to Relay Shellfish” must coordinate with the certified laboratory and other persons or agencies that these criteria are met and communicate this information to the Department. Upon verification that the criteria have been met the Department will issue the written permission in the form of a letter.
(f)(q) Aquacultured shellfish Shellfish relaying from Florida waters to another state or country, or from the waters of another state or country to Florida waters or a certified licensed depuration facility plant, is prohibited.
(r) Persons engaged in relaying operations shall fly a flag on their vessel, the color of which was applied for and approved by the Department in the “Special Activity License to Relay Shellfish”. The flag will be a rigid flag, minimum size of 12 inches high by 18 inches wide. Only one color design will be approved for each license, except as provided in sub-subparagraph 5L-1.009(4)(s)4.a.-d., F.A.C. The flags will be free standing and identifiable from the air and the water. The vessel which contains the Department approved monitor will fly a flag of the same description as before described but differentiated by two, three (3) inch wide strips, of contrasting color to the flag, extending diagonally from corner to corner, forming an X. Individual flags shall be mounted such that the entire flag extends a minimum of 2 feet higher than the highest point on the craft.
(g)(s) Special conditions shall apply to high-density aquaculture use zones (AUZ) lease areas, to relaying and transport operations, laboratory sampling, and harvesting when more than one person or licensee participates on a relay crew composed of other persons or licensees from the same AUZ high-density aquaculture lease areas.
1. The “Application for a Special Activity License to Relay Aquacultured Shellfish to Aquaculture Lease or Certified Depuration Facility” pursuant to subsection 5L-1.009(4)(3), F.A.C., shall incorporate the following additional information:
a. The description of the high-density aquaculture use zone lease area, and
b. The description of the aquaculture lease parcel in the high-density aquaculture use zone lease area.
2. The Department shall establish an expiration date pursuant to paragraph 5L-1.009(4)(a), F.A.C., which shall be the same for all applicants for Special Activity Licenses to Relay Shellfish who participate in relays to high-density aquaculture use zones. lease areas.
3. For an AUZ a high-density aquaculture lease area to be considered as a single entity for laboratory sampling and harvesting, all relaying activity must be terminated by the designated expiration date. The number of participating licensees shall be determined by the number of applicants using the same expiration date and the number of participants is limited by the number of individual aquaculture leases located in the AUZ high-density aquaculture lease areas. When an expiration date has been established for relaying to an AUZ a high-density aquaculture lease areas, all applicants shall terminate relay activities on or before the established expiration date regardless of the effective date of the Special Activity License to Relay Aquacultured Shellfish; except when a single licensee surrenders the Special Activity License to Relay Aquacultured Shellfish for cancellation and harvests shellfish pursuant to paragraph 5L-1.009(4)(d)(p) and (e), F.A.C.
4. Persons or licensees participating on relay crews composed of other persons or licensees from the same high-density aquaculture lease area shall fly a flag on their vessel pursuant to paragraph 5L-1.009(4)(r), F.A.C., except:
a. Only one color design will be approved for each high-density aquaculture lease area when relay crews are composed of more than one licensee.
b. Each vessel shall also fly a flag or banner, the color and design of which is designated and provided by the approved monitor.
c. The licensee shall maintain possession of the flag designated in the Special Activity License to Relay Shellfish.
d. The approved monitor shall maintain possession and have available the designated monitor flag and provide such flags or banners to all persons or licensees participating on relay crews under his/her immediate supervision during the days activity.
5. No more than 15 boats or licensees shall comprise a relay crew from the same high-density aquaculture lease area and not more than one crew shall be under the immediate supervision of an approved monitor, except as described in subparagraph 5L-1.009(4)(n)3., F.A.C.
46. All participating licensees shall surrender their Special Activity License to Relay Aquacultured Shellfish to the Department for cancellation when requested by the Department on the same date.
57. Aquacultured shellfish Shellfish relayed to high-density an AUZ aquaculture lease areas in an Approved or Conditionally Approved areas shall not be harvested without written permission from the Department pursuant to paragraph 5L-1.009(4)(p), F.A.C., except the 15 days will commence when the Department receives all participating licensees’ “Special Activity License to Relay Shellfish” for cancellation.
68. High-density aquaculture lease areas will be treated as a single entity pursuant to subparagraph 5L-1.009(4)(s)3., F.A.C., for laboratory sampling when all participating licensees have surrendered their Special Activity License to Relay Shellfish pursuant to subparagraph 5L-1.009(4)(s)6., F.A.C. Laboratory analysis shall consist of a minimum of two five samples (each sample to consist of a minimum of 20 12 individual shellfish) from each individual aquaculture lease parcel, collected by an employee of a laboratory with a current Department certification letter or staff of the Department. Four samples are to be collected from individual aquaculture leases located most proximate to the four corners of the high-density aquaculture lease area and one sample collected from an individual lease located near the center of the high-density aquaculture lease area.
79. Aquacultured shellfish Shellfish relayed under the provisions of Rule paragraph 5L-1.009(4)(s), F.A.C., shall not be harvested without written permission from the Department as defined in paragraph 5L-1.009(4)(p), F.A.C., and permission to harvest by individual licensees shall be denied until all participating licensees receive written permission to harvest.
(5) Requirements for Department approved monitors include the following:
(a) Department approved monitors must be current “Certified Law Enforcement Officers” or licensed “Class D Security Guards” working for a licensed “Class B Security Agency”, hired by a “Special Activity License to Relay Shellfish” licensee, or staff of the Department. Staff of the Department, who are not “Certified Law Enforcement Officers”, shall monitor only relay operations directed and supervised by the Department during cooperative shellfish resource development programs. Staff of the Department shall monitor shellfish relays to licensed leases pursuant to paragraphs 5L-1.009(4)(g)-(i), subsection 5L-1.009(5) and paragraph 5L-1.009(6)(b), F.A.C.
(b) Applicants shall not possess a current Shellfish License or upon application for training they must surrender their Shellfish License.
(c) It shall be unlawful for any approved monitor to be involved in any other activities within the commercial shellfish industry.
(d) Department approved monitor training will consist of a course developed and approved by the Florida Marine Enforcement and the Division of Aquaculture. The course shall cover the responsibilities of the approved monitor, shellfish laws, shellfish relay license rules, water classifications, health issues and other information deemed necessary by the Department. Training shall be conducted by Department personnel, as follows:
1. Initial training will consist of weekly courses for a period of two months if sufficient applicants apply to fill classes of twenty students. Applicants need to attend only one of the weekly courses.
2. A training course will be scheduled every six months.
3. Contracted licensed security agencies and licensees to relay shellfish will receive written notification of training dates and where the courses will be conducted.
4. An applicant who completes the course satisfactorily will be issued a “Department Approved Monitor Identification Card” in his or her name. The Identification Card will bear an expiration date that coincides with eligibility requirements established for a Department approved monitor. This identification card will expire on the expiration date printed on the identification card, or in no case longer than one year from the date of issue. The identification card will be renewed only after satisfactory completion of the training course.
(e) A Department approved monitor whose identification card has expired may reapply and will be issued a new identification card with a new expiration date if he or she meets the eligibility requirements established for a Department approved monitor.
(5)(6) Penalty for violation of Rule 5L-1.009, F.A.C.
(a) An approved monitor’s failure to supervise shellfish relay operations, complete required reports, and comply with the requirements of Rule 5L-1.009, F.A.C., and the “Special Activity License to Relay Shellfish”, will result in the suspension of his authorization to act as a Department approved monitor.
(b) A diver, who is permitted by the Department Florida Marine Enforcement to harvest shellfish on a relay crew, will have his “Underwater Shellfish Harvester Certificate” suspended for any conviction of violating subparagraphs 5L-1.009(4)(n)1.-13., F.A.C. The suspension will be for one year from the date of conviction.
(a)(c) A “Special Activity License to Relay Aquacultured Shellfish” will be revoked for:
1. Any conviction for violation of diverting aquacultured shellfish to any location other than specified on the license.
2. Any conviction for violation of depuration periods specified by law for relayed aquacultured shellfish or sale of relayed aquacultured shellfish prior to written authorization by the Department Division of Aquaculture.
3. Any Second conviction for violation of harvesting aquacultured shellfish from any waters not approved by the license.
4. Four separate instances involving convictions for violations, other than subparagraphs 5L-1.009(6)(d)1., 2., and 3., F.A.C., within any six month period.
(b)(d) Pursuant to Section 120.60(7), F.S., prior to the entry of a final order revoking a “Special Activity License to Relay Aquacultured Shellfish”, the Department will serve an administrative complaint which affords reasonable notice to the licensee of facts or conduct which warrant the intended action and the licensee is given an adequate opportunity to request a proceeding pursuant to Section 120.57, F.S.
(c)(e) Revocation of a A “Special Activity License to Relay Aquacultured Shellfish” is permanent will be revoked for the following periods:
1. First revocation of license will be for a minimum of thirty days.
2. Second revocation of license will be for a minimum of sixty days and continue until such time the licensee can show to the satisfaction of the Department that corrective measures have been taken to control violations.
3. Third revocation of license will be permanent. No other “Special Activity License to Relay Shellfish” will be issued to a person, firm, corporation, municipality, or other governmental body holding a shellfish lease, aquaculture lease, or owning or operating a depuration plant whose “Special Activity License to Relay Shellfish” was revoked three times. After a six month period a new lease holder or owner or operator of a depuration plant must show to the satisfaction of the Department that corrective measures to control violations will be implemented prior to having an application considered.
(f) During periods of revocation no further “Special Activity License to Relay Shellfish” will be issued to a person, firm, corporation, municipality, or other governmental body holding a shellfish lease, aquaculture lease, or owning or operating a depuration plant who had their “Special Activity License to Relay Shellfish” revoked.
RulemakingSpecific Authority 597.020 FS. Law Implemented 597.010(15), (19), 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, 7-9-89, 12-23-91, 4-21-93, 5-20-93, 6-9-94, Formerly 16R-7.012, Amended 1-1-98, Formerly 62R-7.012, Amended 8-9-00, 5-29-02, .
5L-1.010 Buildings and Facilities.
(1) Facility Plant construction and design. Plant Buildings buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food processing manufacturing purposes. At a minimum For for shellstock shipping facilities, depuration and on shore wet storage operations, the structure shall have sealed flooring and a sealed roof. and screened walls. At a minimum, For shucker-packer, and repacker and depuration operations, operators the structure shall have a sealed roof, solid walls, and sealed flooring. The facility plant and facilities shall:
(a) through (e) No change.
(f) Provide screening to ensure that pests are not present in the facility. or other protection to prevent the entrance of pests.
(2) Grounds about a processing facility food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for maintenance of grounds include, but are not limited to:
(a) Storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant building or structures that may constitute an attractant, breeding place, or harborage for pests.
(b) through (c) No change.
(d) Operating systems for waste treatment and disposal in such a manner that they do not constitute a source of contamination in areas where food is exposed. If the facility plant grounds are bordered by grounds not under the operator’s control and not maintained in the manner described in paragraphs (2)(a) through (c) of this section, care shall be exercised in the facility plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.
(3) The water supply shall be sufficient for the operations intended. Any water that contacts food or food contact surfaces shall be safe and of sanitary quality. Running water at a suitable temperature of 100 110°F or above, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. Sanitary quality shall be maintained by the following steps:
(a) In facilities plants that are not on a public water system, routine microbiological monitoring shall be conducted on water, and ice used in the facility plant, at least once every six months by the operator of the certified processing facility plant. The sample collected shall be from a tap that provides water for use in processing shellfish. When treatment includes disinfection, a source water standard bacterial sample must also be collected on the same day.
(b) Microbiological results from testing shall not equal or exceed two colony forming units (cfu) cfu (colony forming units) per 100 mls for total coliform bacteria on any consecutive samples, and shall not equal or exceed two cfu per 100 mls for fecal coliform or E. coli bacteria on any samples.
(4) Plumbing shall be of size and design and installed and maintained to:
(a) Carry sufficient quantities of water to required locations throughout the facility plant.
(b) Convey sewage and liquid disposable waste from the facility plant.
(c) through (e) No change.
(5) Sewage and all in-facility plant wastewater shall be discharged into a public sewage treatment system or other approved sewage treatment system in accordance with provisions of Rule Chapter 64E-6, F.A.C.
(6) Each facility plant shall provide its employees with readily accessible toilet facilities. Compliance with this requirement shall be accomplished by:
(a) through (e) No change.
(7) Handwashing facilities shall be furnished and easily accessible, where persons handle food, food packaging materials, or food contact surfaces, and include the following:
(a) Running water at a minimum temperature of 100o 110 degrees F.
(b) through (e) No change.
(8) Processing rooms and all other areas where employees may handle such food, materials, or surfaces. shall be furnished with readily understandable signs directing employees handling exposed food, unprotected food-packaging materials, or food-contact surfaces that eating, drinking, spitting, chewing gum or using tobacco are not permitted in the processing areas.
(9)(8) Refuse receptacles shall be constructed and maintained in a manner that protects against contamination of food. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pest, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, Formerly 16R-7.013, Amended 7-3-95, 2-6-97, Formerly 62R-7.013, Amended 8-9-00, 5-29-02, .
5L-1.011 Equipment for Shellfish Processing.
(1) All facility plant equipment and utensils shall be so designed and of such material and workmanship as to be cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with contaminants. All equipment shall be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant, made of nontoxic materials, and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source.
(2) through (3) No change.
(4) Three compartment sinks shall be properly installed, maintained and provided with hot and cold running water to all three compartments in establishments required to wash, rinse and sanitize food contact surfaces. Signs shall be posted indicating proper use of the three compartment sink. A three compartment sink shall be used for washing, rinsing and sanitizing food contact surfaces and shall not be used for hand washing. Shellstock shippers shall not be required to install or maintain three compartment sinks.
(5) through (8) No change.
(9) Depuration and wet storage tanks:
(a) Shall shall be designed to allow for good water circulation and prevent short-circuiting of the seawater. Tanks shall be designed so that scum and sludge, including shellfish feces and pseudo-feces, sand, and grit can be easily removed or flushed out. The bottom shall be sloped longitudinally at least 1/4 to 1/2 inch per foot toward the outlet end.
(b)(10) To facilitate proper cleaning and sanitation, as well as proper treatment of shellfish, tanks Shall shall be constructed from impervious, non-toxic, food safe and inert materials. Coatings, when used, may include epoxy resins, powdered polyesters, vinyl bituminous water-tank paint, and paraffin. These coatings are not only for waterproofing but should provide a smooth, hard, non-porous surface to facilitate proper cleaning and sanitation, as well as proper treatment of shellfish.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.014, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.014, Amended 8-9-00, 5-29-02, .
5L-1.012 Sanitary Operations.
(1) General maintenance. Buildings, fixtures, and other physical facilities of the facility plant shall be maintained and kept in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of this rule. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
(2) Cleaning compounds used in cleaning procedures shall be free from undesirable microorganisms and shall be safe and effective adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier’s guarantee or certification, or examination of these substances for contamination.
(3) Only sanitizing agents found in Title 21, Code of Federal Regulations, Section 178.1010, revised as of April 1, 2015 2000, hereby incorporated by reference, and available oline at http://www.flrules.org/Gateway/reference.asp?No=Ref-07009 for inspection at the Department’s offices located at 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 3239901, will be used at recommended levels in shellfish processing facilities plants.
(4) No change.
(5) No pests shall be allowed in any area of a shellfish processing facility food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions of product labeling.
(6) No change.
(7) Non-food contact surfaces of equipment used in the operation of shellfish processing facilities food plants shall be cleaned as frequently as necessary to protect against contamination of food.
(8) through (11) No change..
(12)(a) The dealer shall require all employees to wash their hands thoroughly with soap and water and sanitize their hands in an adequate handwashing facility before starting work, after each absence from the work station, after each work interruption and any time when their hands may have been soiled or contaminated.
(a)(b) Where the same employee works in both the shucking and packing activities, the employee shall wash his hands thoroughly after entering the area.
(b) Any employee handling shellfish shall wear outer garments to protect shellfish from adulteration.
(c) No change.
(d) In any area where shellfish are processed shucked or packed and in any area which is used for the cleaning or storage of utensils, the dealer shall not allow employees to store clothing or other personal belongings, eat or drink, spit and us tobacco in any form.
(13)(12) The facility supervisor or designated representative Each certified dealer shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in subsection 5L-1.005(8) (7), subsections paragraphs 5L-1.010(1)(a) and (b), subsections 5L-1.010(6) and (7), 5L-1.011(1), 5L-1.012(1)-(12) (11), 5L-1.013(6), (7), (8) and (9), and 5L-1.014(5), F.A.C.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.015, Amended 7-3-95, Amended 2-6-97, 6-23-99, Formerly 62R-7.015, Amended 8-9-00, 5-29-02, .
5L-1.013 Facility Plant Operation.
(1) The facility plant 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, certified shellfish processor dealer and/or certified aquaculturist, the certified shellfish processor dealer 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 certified aquaculturist or certified shellfish dealer, the receiving certified shellfish processor dealer 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)(5), F.A.C., or is labeled in compliance with paragraph 5L-1.007(6)(h), F.A.C., shall only be shucked used for shucking by a certified shucker-packer facility certified shellfish dealer, or post-harvest processed by a certified shellfish processing facility, labeled “For Post Harvest Processing Only” or shall undergo an alternative post harvest processing method to assure a safety level equivalent to product meeting subsection 5L-1.008(7)(5), F.A.C.
(b) Tempering, as an alternative process shall consist of those methods which have demonstrated through verification studies that the process renders hard clams which are as safe as hard clams meeting subsection 5L-1.008(5), F.A.C. Prior to initiating tempering a certified shellfish dealer shall have written approval from the Department. The certified shellfish dealer must provide the following:
1. A description of all facilities, equipment and methods to be used in the alternative process. This process must be included in the firm’s HACCP plan.
2. The source of hard clams and the maximum capacity of hard clams to undergo the process at any one time.
3. The process to be followed shall not exceed 16 hours total time between hard clam harvest and refrigeration at 45 degrees F or less. Product harvest, processing, tempering and food storage at 45 degrees F or less must be scheduled to occur as a continuous procedure.
4. Upon initiation, the tempering process must have temperature control of 68 degrees F or less and be maintained until hard clams are placed into refrigeration of 45 degrees F or less.
5. If facilities, equipment or methods change, the Department must be notified.
(b)(c) Post-Harvest Processing, including but not limited to such processes as frozen storage, hydrostatic high pressure, mild pasteurization, and irradiation, 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 Rule 5L-1.001 2007. Prior to initiating post harvest processing, a certified shellfish processor dealer shall provide validation and obtain written approval from the Department.
(4) Shellfish shall be segregated by the certified shellfish processor dealer in accordance with its intended use as determined in subsection 5L-1.008(7)(a)(4) and subsections 5L-1.013 paragraphs (3)(a) and (b) (c) above and identified per subsection 5L-1.007(5) or (6), F.A.C.
(5) through (9) No change.
(10) Records – Complete, legible, and accurate dated records of purchase and sale of all shellfish shall be kept by all shellfish facilities establishments 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. Entries of purchases or sales of shellfish shall be made into a permanently bound ledger book, computer record, or other method acceptable to and authorized by the authority within 72 hours of any purchase or sales. Records shall indicate:
(a) through (e) No change.
(f) Names and addresses of persons to whom shellfish were sold; and
(g) Date sold; and
(h) Transaction record indicating:
i. Date and time shipped.
ii. 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.
(h) Records shall remain on file for not less than one year and shall be made available for inspection and copying by Department personnel during plant inspections.
(12)(i) 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)(j) 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 produces.
(14) Processors shall submit to the Department a monthly report of the volume of shellfish recieved from Florida Shellfish Harvesting Areas for each shellfish species. Quantity data shall include utilization type (raw, shucked, PHP).
(k) Records covering purchases and sales of frozen or previously frozen shellfish shall be retained for at least two years or for a period of time that exceeds the shelf-life of the product.
(15) (l) Records for shellfish lots having completed a depuration or wet storage treatment process shall include:
1. Counties from which shellfish were harvested;
(a)2. Name or location of harvesting areas;
(b)3. Relaying permit numbers, if applicable;
(c)4. Date received in plant;
(d)5. Date released from the plant;
(e)6. Date and time of initiation of treatment;
(f)7. Date and time of termination of treatment;
(g)8. Ending UV unit meter readings
(h)9. Number of hours treated; and
(i)10. All laboratory results as specified.
(16)(11) Monitoring records of HACCP plan critical control points shall be maintained and reviewed at least weekly as specified in the firm’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. within one week of the day that the records are made. The reviewed records shall be signed and dated by an individual who is in a supervisory position in the firm and is knowledgeable of HACCP.
(17)(12) Sanitation monitoring records shall be maintained for those conditions identified in Rule subsection 5L-1.012(11), F.A.C., per the schedule of the activity, e.g. daily, weekly, monthly.
(18)(13) Whenever a deviation from a critical limit occurs, a certified shellfish processor dealer 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)(14) Responsibility – It shall be the duty and responsibility of each owner, manager, and operator of a shellfish facility plant to ensure insure 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 plant is properly supervised at all times and all shellfish can be identified, whether shellstock or shucked shellfish, to ensure insure that they were harvested from approved growing waters and that they have been handled and processed in a sanitary manner.
Rulemaking Authority 597.020 FS. Law Implemented 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, .
5L-1.014 Heat Shock Method.
(1) through (6) No change.
(7) Records of heat shock time and temperatures – Each certified shellfish processing facility plant operating the heat shock process shall maintain an accurate daily record of the time and temperature of the immersion of all lots of shellfish during each day of operation as well as recording the time of change of heat shock water. These records shall be maintained for at least one year.
(8) through (9) No change.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.017, Amended 7-3-95, 2-6-97, Formerly 62R-7.017, Amended 8-9-00, .
5L-1.015 Depuration and Wet Storage Facility Plant Operations.
(1) All plans for construction or remodeling of depuration or wet storage facilities shall be reviewed and approved by the Department.
(2) Operating procedures for conducting depuration or wet storage shall be reviewed and approved by the Department
(3) The Department shall be immediately notified in writing of any changes in equipment or operating procedures.
(4)(1) Source of shellfish – Shellfish shall be accepted for treatment at a depuration or wet storage facility shellfish treatment plant only from areas specified by the Department pursuant to Rule 5L-1.009, F.A.C. The facility plant supervisor or designated representative shall inspect all containers of untreated shellfish upon arrival at the depuration or wet storage facility plant to verify that they contain the species and quantity stated on the receiving record.monitor’s reports.
(5)(2) Shellfish containers – Shellfish shall be accepted for depuration or wet storage treatment and released after treatment in clean containers only. All containers shall be constructed of non-absorbent and rust-proof material, and kept clean and free from foreign matter. Burlap bags or similar absorbent material shall not be used in the treatment tanks for transporting shellfish to the treatment plant, nor for the transportation removal of shellfish from the facility plant.
(6)(3) Culling – All untreated shellfish, prior to, or upon arrival at the facility plant, shall be thoroughly inspected and culled by personnel under the supervision of the facility plant supervisor or designated representative. All dead shellfish or shellfish in broken or cracked shells shall be destroyed. The facility plant supervisor or designated representative shall be responsible for the culling and the removal and disposal of dead shellfish or shellfish with broken or cracked shells both before and after treatment. depuration
(7)(4) Washing shellfish – All shellfish shall be thoroughly washed prior to and after treatment. Immersion of shellfish for washing purposes is prohibited.
(8)(5) Containers Baskets used in treatment process – All containers baskets used in the treatment process shall be of suitable size, easily cleanable, designed for easy handling, and made of impervious material. Containers Baskets shall be of such design to allow water to flow freely over the shellfish in the treatment tanks. Containers Baskets shall not be filled beyond the level which will allow free circulation of water during the treatment process. The height of the shellfish in the containers baskets shall be stacked to allow sufficient cleansing. not exceed 6 inches. Containers Baskets shall be stacked in such a manner as to allow free circulation of water provide clearance between shellstock and tank bottom as to allow free circulation of water. Containers used for treatment purposes shall not be used for any other purpose, and no containers or other equipment shall be placed in the treatment tanks.
(9)(6) Shellfish treatment – All shellfish, upon receipt at the facility treatment plant, shall be promptly treated or placed in controlled storage. Shellfish from approved growing waters which are to undergo wet storage shall be segregated from shellfish destined for depuration from restricted or conditional restricted waters. Shellfish for wet storage shall be treated by a Department approved scheduled wet storage process (SWSP). Shellfish from restricted or conditionally restricted waters shall undergo a Department approved scheduled depuration process (SDP).
(10)(7) Washing treatment tanks – All systems must be cleaned and sanitized before any lot of shellfish is placed into the treatment tanks. After each 24 hours that the shellfish are in the depuration treatment tanks, the seawater in the tanks shall be drained out and the shellfish hosed down thoroughly. Feces, pseudo-feces, and any other waste matter must be flushed out of the tank. Immediately after hosing, the tanks shall again be filled with treated seawater. Treatment tanks employing some form of refrigeration shall be drained and thoroughly washed after each depuration period or lot of shellfish depurated.
(11)Treatment tank design specifications – water flow must be maintained at a minimum of one gallon per minute per bushel of shellfish or the flow rate recommended by the disinfection systems manufacturer to attain the flow and volume necessary for maximum disinfection. System piping shall include backflow and back siphonage protective devices and be constructed for easy cleaning either directly or through gasket or compression joints.
(12) Ultraviolet (UV) Unit:
(a) Any UV unit used for the purification of water to be used in the treatment process shall provide the required treatment to non-detectable coliform bacteria level for the duration of storage. The unit shall be designed to deliver, at peak load the flow rate recommended by the disinfection systems manufactor to attain the flow and volume necessary for maximum disinfection.
(b) Cautions and maintenance.
1. UV tubes shall be checked for intensity on a monthly basis and shall be replaced when they reach a point of 60% efficiency. A log of intensity shall be kept and an orderly numbering procedure for UV units and bulbs established.
2. UV tubes and reflectors shall be kept cleaned. Cleaning shall be done with a clean damp cloth or sponge. A cleaning schedule shall be recorded on the sanitation record.
3. Signs stating “Ultraviolet Light Danger to Eyes – Do Not Look at Bulbs Without Eye Protection” shall be displayed in full view of personnel and authorized visitors. Eye, head, and skin protection, especially for the face and hands, shall be provided for personnel monitoring the bulbs.
4. An automatic shutoff switch shall be provided to break the electric circuit, thus shutting off the current to the UV bulb when the lid of the UV unit is raised.
5. In depuration facilities a tamper-proof hour meter shall be installed in line with all UV units to measure continuity of operation as well as to measure bulb life. A log which documents meter readings taken at the beginning and end of each depuration cycle shall be maintained for each UV unit.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.021, Amended 7-3-95, Formerly 62R-7.021, Amended 8-9-00, .
5L-1.016 Depuration Shellfish Sampling Procedures.
(1) Start-up phase sampling procedures – When shellfish are delivered to the facility treatment plant, the following schedule shall be followed:
(a) through (c) No change.
(2) Routine Sampling Procedures.
(a) Start-up phase sampling procedures shall be followed until such time as the Department and the facility plant supervisor, after review of start-up phase results, determine that the shellfish are responding properly to the treatment process, and that the treatment process is successfully reducing bacterial levels in the shellfish and providing process water quality pursuant to section Rule 5L-1.017(1), F.A.C. After such a determination, the routine sampling procedures shall be followed. Written permission from the Department shall be obtained before the initiation of the following routine monitoring procedures:
1. through 3. No change.
(b) In the event of the installation of a new laboratory, new laboratory equipment, employment of new laboratory personnel, initiation of new laboratory procedures, or the alteration of treatment procedures, the Department may require reinitiation of start-up phase sampling procedures until such time as the Department and the facility plant supervisor, after review of the results, determine that the laboratory and treatment procedures are providing valid results. Written permission from the Department shall be obtained before routine monitoring procedures are again followed.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.022, Formerly 62R-7.022, .
5L-1.017 Depuration - Process Water Treatment Standards
(1) Depuration Water Treatment Standards
(a)(1) All controlled processes require quality tests to determine if standards are being met and if controls are effective. The depuration treatment of shellfish is a controlled process designed to reduce bacterial contamination to an acceptable level, as defined in subsection 5L-1.004(5) (6), F.A.C., for depuration, or in the case of Wwet storage, is designed to enhance the product quality without degradation of market standards as defined in Rule 5L-1.004, F.A.C. To insure the continuing effectiveness of the shellfish depuration treatment process, the minimum sampling procedure as described below shall be followed.
(b)(2) Incoming seawater.
1. (a) Type of test – temperature, turbidity, salinity, dissolved oxygen.
2. (b) Frequency – each time seawater is withdrawn.
(c)(3) Effluent from UV light treatment unit.
1. (a) Type of test – bacteriological.
2. (b) Frequency – once per day per unit.
(d)(4) Bacteriological – All water to be used in shellfish treatment tanks shall be subjected to UV light treatment. The water discharged from the UV unit shall have no detectable levels of the coliform group as measured by the recognized multi-tube MPN test per 100 ml for potable water and acceptable for use with marine water and follow the protocol of the Decision Tree (Section IV. Guidance Documents Chapter III .05), as stated in Section II Chapter VII .04 C (1)(f), of the 2015 NSSP Model Ordinance as incorporated in Rule 5L-1.001. be of bacterial quality equal to or better than the quality of water required in the U. S. P. H. S. Drinking Water Standards, as stated in the NSSP Model Ordinance.
(e)(5) Dissolved oxygen – The amount of dissolved oxygen in the water in the treatment tanks shall be at least 5 mg/l and shall be measured daily.
(f)(6) Temperature – Treatment tank water temperature shall be measured daily during the treatment process. Temperature of seawater used in the treatment process shall be suitable for depuration.
(g)(7) Turbidity – Turbidity in the treatment process water shall not exceed 20 N.T.U. (Nephelos Turbidity Units) and shall be measured daily.
(h)(8) Salinity – Salinity of the treatment process water shall be suitable for depuration and shall be measured daily.
(i)(9) pH – pH of the treatment process water shall range from greater than or equal to 7.0 to less than or equal to 8.4 and shall be measured daily.
(j)(10) Metallic ions and compounds – Levels of metallic ions and compounds shall not exceed levels found in approved shellfish harvesting areas and shall be measured if required by the Department.
(k)(11) Pesticides, detergents, and radionuclides – Levels of pesticides, detergents, and radionuclides shall not exceed levels found in approved shellfish harvesting areas and shall be measured if required by the Department.
(l)(12) Marine toxins (Karenia brevis Gymnodinium breve) – Levels of Karenia brevis Gymnodinium breve in the incoming seawater and in the source water shall not exceed 1,000 cells/liter. Estuarine and/or marine waters adjacent to the source waters with salinities of at least 26 parts per thousand shall also be examined for the presence of Gymnodinium breve. Only Department personnel, or personnel approved by the Department, shall determine levels of Karenia brevis Gymnodinium breve.
The following table provides a summary of the depuration treatment process water standards:
Table 1. DEPURATION TREATMENT PROCESS WATER STANDARDS
Parameter
Minimum
Maximum
Bacteriological
0
Less than 1
Dissolved Oxygen (Milligrams/liter)
5.0
Saturation
Temperature
Suitable
Suitable
Turbidity (Nephelos Turbidity Units)
0
20 units
Salinity
Suitable
Suitable
pH
7.0
8.4
Metallic Ions and Compounds
Not exceeding levels found
in approved shellfish
harvesting areas.
Pesticides, Detergents and Radionuclides
Not exceeding levels found
in approved shellfish
harvesting areas.
Marine Toxins (Karenia brevis Gymnodinium breve)
0 cells/liter
1,000 cells/liter
(2) Wet Storage Treatment Standards
(a) Wet storage of shellfish is done to enhance product quality of shellfish that have been harvested from Approved or Conditionally Approved shellfish harvest areas in the open status. Inland wet storage systems are classified by the Department as continuous flow through or recirculating systems. Continuous flow through systems have a continuous flow of new water passing through and exiting the wet storage system before being permanently discharged. Recirculating systems recirculate system water for wet storage cycle. All inland wet storage requires the minimum sampling procedure as described below.
(b) Incoming seawater must be from an Approved or Conditionally Approved shellfish harvesting area in the open status.
(c) Bacteriological Standards – Source water shall be from a shellfish harvest area classified as Approved or Conditionally Approved and in the open status and any well water used as source water shall meet the requirements of Chapter XI .02 of the 2015 NSSP Model Ordinance with the exception of salt content for salt water wells. Any source water meeting above standards and used in continuous flow through systems do not require the use of additional UV sterilization. Well water from salt water wells must be sampled semi-annually at a minimum. Water used in shellfish treatment tanks for recirculating wet storage systems shall be subjected to disinfection as provided by department approved disinfection treatment. Systems using one or more UV light units must be rated for both the volume and flow used by the recirculating system. The water discharged from the disinfection treatment system shall have no detectable levels of the coliform group as measured by the recognized multi-tube MPN test per 100 ml for potable water and acceptable for use with marine water and follow the protocol of the Decision Tree (Section IV. Guidance Documents Chapter III .05).
(d) Turbidity – Water that is disinfected by UV light shall not exceed 20 N.T.U. (Nephelos Turbidity Units).
(e) Wet storage using recirculating systems requires the effluent from the disinfection treatment unit to be tested for coliform while in operation but not to exceed once per week.
(f) Other disinfection treatment such as the addition of salt shall not leave residues unless they are Generally Recognized as Safe (GRAS) and do not interfere with the shellstock’s survival, quality or activity during wet storage, as stated in Section II. Chapter VII .04 C (1)(e) of the 2015 NSSP Model Ordinance.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.024, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.024, Amended 8-9-00, .
5L-1.018 Depuration - Ultraviolet (UV) Unit.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.026, Formerly 62R-7.026. Repealed ________.
5L-1.019 Laboratory Procedures and Sample Testing.
(1) Samples of shellfish, processing water, or ice, may be taken at any reasonable time or place by the Department and examined for compliance with sections of this Chapter. Samples of shellfish shall be furnished by processors of such shellfish upon request of the Department. Samples will be collected and appropriate sample collection and receipt forms will be used by Department staff to document sample collections. Forms include Collection/Analysis Water Report (DACS-15005, revision 7/2000), Shellfish, (FDACS-15004 revision 7/2000), and Receipt for Samples (DACS-15013, revision 7/2000). These forms are herein incorporated by reference, and obtainable by writing the Department of Agriculture and Consumer Services, Division of Aquaculture, 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32301.
(2) Bacterial examinations of shellfish and seawater shall be conducted in accordance with The Recommended Procedures for Bacterial the Examination of Sea Wwater and Shellfish Fourth Edition, 1970 Fifth Edition, 1985 published by the American Public Health Association which is hereby incorporated herein by reference and is available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-07001 or may be obtained by contacting the Division of Aquaculture, Holland Building, 600 South Calhoun Street, Suite 217 for inspection at the Department’s office, located 1203 Governors Square Boulevard, Suite 501 5th Floor, Tallahassee, Florida 32399 32301. Bacteriological examinations of seawater employing the fecal coliform Membrane Filter (MF) colony forming unit procedure referenced in paragraph 5L-1.003(2)(b) and subsection 5L-1.003(4), F.A.C., shall be conducted in accordance with Enumeration of fecal coliforms and E. coli in marine and estuarine waters: an alternative to the APHA-MPN approach written by Scott R. Rippey, Willard N. Adams, and William D. Watkins and published in the Journal Water Pollution Control Federation Volume 59, Number 8, pages 795 – 798, August 1987, which is hereby incorporated herein by reference. This procedure is terminated at the fecal coliform stage. The urease step is not required. This reference is available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-07002 or may be obtained by contacting the Division of Aquaculture, Holland Building, 600 South Calhoun Street, Suite 217 available for inspection at the Department’s office, located at 1203 Governors Square Boulevard, 5th Floor, Tallahassee, Florida 32399 32301.
(3) No change.
(4) The laboratory must be certified by the Department in accordance with Section IV, Chapter II, section .12. Appendix L of the NSSP National Shellfish Sanitation Program Model Ordinance.
Rulemaking Specific Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.030, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.030, Amended 8-9-00, 8-17-04, .
NAME OF PERSON ORIGINATING PROPOSED RULE: Kal Knickerbocker
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Commissioner of Agriculture Adam H. Putnam
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 11/15/2016
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 4/15/2016
Document Information
- Comments Open:
- 11/21/2016
- Summary:
- The proposed amendments apply to commercial oyster harvesting and processing in Florida in order to protect the health of shellfish consumers. Specifically, the proposed amendments update forms, addresses and telephone numbers, implement licensing and application requirements, clearly explain harvester and processor responsibilities, separate wet storage and depuration requirements, implement relay procedures for aquacultured shellfish during red tide blooms, clarify corrective actions for ...
- Purpose:
- The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) Model Ordinance; remove unnecessary license requirements; remove redundant reapplication requirements; remove confusing language regarding draining of shellfish treatment tanks; introduce and describe different styles of wet storage systems for shellfish; and clarify definitions and language associated with the penalty/fine matrix, relaying procedures, and harvester ...
- Rulemaking Authority:
- 500.09, 500.121(1), 500.172, 597.020 F.S.
- Law:
- 500.10, 500.121(1), 500.172, 597.010(15), 597.010(19), 597.020 F.S
- Contact:
- Jillian Fleiger, Division of Aquaculture, 600 S Calhoun Street, Suite 217, Tallahassee, FL, 32301, Phone: (850) 617-7600.
- Related Rules: (15)
- 5L-1.001. General Requirements and Intent
- 5L-1.002. Definitions
- 5L-1.003. Shellfish Harvesting Area Standards
- 5L-1.004. Production and Market Standards
- 5L-1.005. Shellfish Processing Plant Certification License
- More ...