Definitions, Shellfish Harvesting Area Standards, Production and Market Standards, Shellfish Processing Plant Certification License, Compliance and Penalties, Container Identification, Terminal Sale Date; Prohibitions, Shellfish Handling, Shellfish ...
DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES
RULE NO.:RULE TITLE:
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-1.012Sanitary Operations
5L-1.013Plant Operation
5L-1.014Heat Shock Method
5L-1.015Depuration Plant Operations
5L-1.019Laboratory Procedures and Sample Testing
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 42 No. 226, November 21, 2016 issue of the Florida Administrative Register.
5L-1.002 Definitions.
(1) No change.
(2) Alternative Processing – any processing done to shellfish which does not follow the time-temperature matrix as stated in subparagraphs subsection 5L-1.008(7)(a)1.-3.(1-3) and paragraph 5L-1.008(7)(b), F.A.C.
(3) through (6) No change.
(7) Closed area (closed waters) – an growing area where the harvesting of shellfish is not permitted. Closed areas include prohibited and unclassified harvest areas as well as temporarily closed approved, conditionally approved, restricted, and conditionally restricted harvest areas.
(8) through (17) No change.
(18) Depuration facility (controlled purification plant) (DP) – a shellfish processor who obtains shellstock from approved, conditionally approved, restricted or conditionally restricted harvest growing area(s) and submits such shellstock to a Department approved controlled purification process. 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) through (26) No change.
(27) Growing area – an area in which market or seed shellfish are growing
(28) through (50) renumbered (27) through (49) No change.
(50)(51) Restricted Use Shellstock – shellstock that is harvested from harvest 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) through (63) renumbered (51) through (62) No change.
(63)(64) Time of Harvest – is defined as the time when shellfish are first removed from the water growing waters and placed on or in a manmade conveyance or other means of transport.
(65) through (63) renumbered (51) through (62) No change.
(66) Unwholesome – shellfish which are not in sound condition, unclean, or otherwise not suitable for human consumption.
(67) through (69) No change.
(70) Wet storage – the temporary storage of shellfish harvested from an approved or in the open status conditionally approved harvest growing area and placed in tanks containing water that meets approved or open status conditionally approved shellfish harvesting area water quality standards.
(71) No change.
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, 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 Model Ordinance. Copies of the Shellfish Harvesting Area Classification Maps (FDACS-P-01773, Revised 1206/16), and the Shellfish Harvesting Area Classification Boundaries and Management Plans, (FDACS-P-01593, Revised 1208/16), 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, Tallahassee, Florida 32399, or online as indicated.
(a) Shellfish Harvesting Area Classification Maps, (FDACS-P-01773, Revised 1206/16) http://www.flrules.org/Gateway/reference.asp?No=Ref-07755 07007
(b) Shellfish Harvesting Area Classification Boundaries and Management Plans (FDACS-P-01593, Revised 1208/16) http://www.flrules.org/Gateway/reference.asp?No=Ref-07003
(2) Approved harvest areas – An growing area shall be classified as approved when a sanitary survey, conducted in accordance with Chapter IV of the NSSP 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 – An 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 harvest areas shall be unlawful.
(4) Restricted harvest areas – An 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 – An 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 – An 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 areas shall be unlawful. The waters of all man-made canals and marinas are classified prohibited regardless of their location.
(7) Unclassified Area – An growing area for which no recent sanitary survey exists, and it has not been classified as any area described in subsections (2), (3), (4), (5), or (6) above. Harvest of shellfish from such areas shall be unlawful.
(9) through (11) renumbered (8) through (10) No change.
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, the Department will apply mitigation measures. Mitigation measures include on-the-spot correction and reconditioning. For repeat violations, the Department shall issue an order to stop the sale or to condemn, and destroy, shellfish or shellfish containers found to be adulterated, misbranded, or found to be held in non-compliance with any of the provisions of this chapter. 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 15001, Revision 1210/16), 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, Tallahassee, Florida 32399.
Rulemaking Authority 500.09, 597.020 FS. Law Implemented 500.10, 500.172, 597.020 FS. History–New 1-4-87, Amended 8-10-88, 7-9-89, Formerly 16R-7.006, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.006, Amended 8-9-00, 5-29-02.__________
5L-1.005 Shellfish Processing Certification.
(1) through (7) No change.
(8) 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. A certificate is issued by the Department upon completion of the training.
(9) through (20) No change.
Rulemaking 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) No change.
(b) At the completion of an inspection, if a deficiency is cited the Department will provide a corrective action plan. The Department will solicit input from the shellfish processor, facility supervisor or the designated representative. The consent and cooperation of the fthe shellfish processor, facility supervisor or the designated representative is not necessary. Lack of cooperation from the shellfish processor, facility supervisor or the designated representative will not affect the validity of the corrective action or requirement that the plan be implemented. A copy of the Shellfish Processing Facility Iinspection Form (FDACS-15009, Revision 01/16), 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), as incorporated in Rule 5L-1.005, will be provided to the shellfish processor, facility supervisor, or the designated representative present at the conclusion of the inspection. The shellfish processor, facility supervisor, and the designated representative shall ensure that the facility is in full compliance with the corrective action plan as outlined on Shellfish Inspection Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) The shellfish prcoessor , facility 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) will lead to administrative actions, suspension, and/or revocation of the Shellfish Processing Certification..
(c) If, upon inspection, the Department cites the facility for a “Critical”, “Key”, or “Other” deficiency(ies), 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, processing operations at the certified facility will be suspended as a public health threat and the deficiency must be corrected immediately or the certified facility’s certification to operate will be suspended. If the certification to operate is suspended, it will remain suspended until corrections are made and verified by the Department. Product affected by the “Critical” deficiency will be controlled to prevent contaminated or adulterated product from reaching consumers. When necessary, the Department shall detain or seize sieze any product that may have been adultered, initiate a recall of any distributed product and notify necessary officials of a recall.
In addition to these actions the sanction to be imposed on the certified shellfish processing facility upon the finding of repeat deficiency(ies), as defined in Rule 5L-1.002, F.A.C., 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, whichever 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
(d) No change.
(e) In cases involving the imposition of a fine the Department will forward an administrative complaint to the shellfish processor, a proposed settlement offer, and a statement of rights. In cases involving the imposition of a suspension or revocation of a facility’s shellfish processing certification the Department will forward an administrative complaint, a statement of rights, and a proposed settlement agreement to the shellfish processor 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 21 22 days of the certificate holder receiving of the notice imposing the fine unless the shellfish processor has sent a written request for a hearing on the matter pursuant to Chapter 120, F.S., within the 21 22 day period to the Department.
(f) No change.
(2) through (5) No change.
Rulemaking Authority 500.09 500.121(1), 500.172, 597.020 FS. Law Implemented 500.09 500.121(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) through (2) No change.
(3) The commercial harvester’s tags shall be white in color except as required in paragraph subsection 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 paragraphs subsections 5L-1.007(3)(a)-(i) F.A.C. arranged in the specific order as follows:
(a) 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 Florida Fish and Wildlife Commission (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 on-board cooling option (subsection 5L-1.008(9), F.A.C.), or rapid cooling option (subsection 5L-1.008(10), F.A.C.) for oysters harvested during the months of May through October.
(i) If shellstock exceeds the requirements in subsections 5L-1.008 (7), (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” 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 a. A bulk tag, containing the information required in paragraphs subsections 5L-1.007(3)(a)-(h), where applicable, along with the name of the certified shellfish facility which the product is consigned to, shall be completed at each harvest location.
(5) Bulk tagging, by a certified shellfish facility, 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 is tagged as follows:
(a) The statement “All Shellfish containers in this lot have the same date and area of harvest”
(b) through (e) No change.
(f) The identification of the cooling option if used, detailed in subsection 5L-1.008(9) and 5L-1.008(10), F.A.C., for oysters harvested during the months of May through October.
(g) If shellstock exceeds the requirements in subsections 5L-1.008 (7), (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” or “FOR POST HARVEST PROCESSING ONLY” in bold, 14 point font and the tag shall be green in color.
(6) The certified facility’s tag shall contain legible, waterproof, indelible information arranged in the specific order as follows:
(a) 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 paragraph subsection (3)(e) above;
(e) through (g) – No change.
(h) If shellstock exceeds the requirements in subsections 5L-1.008(5), (7), or (8) 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” or “FOR POST HARVEST PROCESSING ONLY” in bold, 14 point font and the tag shall be green in color.
(i) For depuration shellstock, subsections (6) (a), (d), (e), and (f), above, 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.
(8) through (12) No change.
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 certificate 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, 5L-1.015 and subsection 5L-1.017(2) and, 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 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. Paragraphs Subsections 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) through (6) No change.
(7) 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. through 3. No change.
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 subparagraphs subsection 5L-1.008 (7)(a)1.-3.(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. through d. No change.
(b) Oysters:
1. through 7. No change.
(8) Once received by a certified shellfish processing facility, 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 such as loading docks or in the facility during processing except for the process described in subparagraph 5L-1.008(7)(a)4.(4) F.A.C. All certified shellfish processing facilities handling oysters must have a cooling system capable of reducing the internal temperature of shellstock oysters to 55oF or less within 8-hours.
(9) 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 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 delivery to the certified shellfish processing 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) No change.
(b) Shellfish processors 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 cooling system provide a safety level equivalent to product meeting paragraph subsection 5L-1.008(7)(b), F.A.C., in order to be labeled in compliance with subsection 5L-1.007(6), F.A.C. Shellfish processors 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 shellfish processor must have written approval from the Department.
(c) through (d) No change.
(10) Rapid Cooling Option – Rapid cooling equipment includes systems using ice, mechanical refrigeration, or vacuum cooling. If a shellfish processor elects to rapidly cool oysters, the maximum cool down time to 55oF or less must not exceed two hours.
(a) through (c) No change.
(d) Shellfish processors 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 paragraph subsection 5L-1.008(7)(b), F.A.C., in order to be labeled in compliance with subsection 5L-1.007(6), F.A.C. Shellfish processors 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 shellfish processor must have written approval from the Department.
(e) through (f) No change.
(11) through (12) No change.
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) through (2) No change.
(3) Any certified shellfish aquaculturist wishing to conduct aquacultured shellfish relaying operations shall submit to the Division a completed application form entitled “Application for a Special Activity License to Relay Aquaculture Shellfish to Aquaculture Lease or Certified Licensed Depuration Facility”(FDACS-15109, Revision 1210/16), hereby incorporated by reference and is available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-07000 or may be obtained by contacting the Division of Aquaculture, Holland Building Buidling, 600 South Calhoun Street, Suite 217 Tallahassee, Florida 32399. 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) Aquaculture lease parcel number(s) or address of certified depuration facility from which aquacultured shellfish will be moved;
(e)Aquaculture lease parcel number(s) to which aquacultured shellfish will be moved;
(f) Method of transportation;
(g) Laboratory secured for collection and laboratory analysis according to subsections 5L-1.009(4) (d) -(e), F.A.C., for 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 issue a Special Activity License to Relay Aquacultured Shellfish within the general conditions set forth below:
(a) through (c) No change.
(d) If aquacultured shellfish are relayed to a lease in Approved or Conditionally Approved Harvest 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 Department staff verifies that all aqacultured shellfish in that particular day’s harvest have been relayed. The fifteen day period does not include days that shellfish harvesting areas have been temporarily closed to harvest.
(e) through (f) No change.
(g) Special conditions shall apply to aquaculture use zones (AUZ) 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.
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), F.A.C., shall incorporate the following additional information:
a. through b. No change.
2. through 4. No change.
5. Aquacultured shellfish relayed to an AUZ in an Approved or Conditionally Approved Harvest area shall not be harvested without written permission from the Department.
6. through 7. No change
(5) Penalty for violation of Rule 5L-1.009, F.A.C.
(a) No change.
(b) Pursuant to Section 120.60(5)(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) No change.
Rulemaking Authority 597.020 FS. Law Implemented 597.010(15),(18) (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) No change.
(2) Grounds about a processing facility 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) through (d) No change.
(3) through (9) No change.
Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 5-21-87, 8-10-88, Formerly 16R-7.013, Amended 7-3-95, 2-6-97, Formerly 62R-7.013, Amended 8-9-00, 5-29-02, .
5L-1.012 Sanitary Operations.
(1) through (11) No change.
(12)The owner, facility supervisor, or designated representative 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) through (c) No change.
(d) In any area where shellfish are processed and in any area which is used for the cleaning or storage of utensils, the owner, facility supervisor, or designated representative dealer shall not allow employees to store clothing or other personal belongings, eat or drink, spit and use tobacco in any form.
(13) The facility supervisor or designated representative shall monitor the conditions and practices during processing to ensure, conformance with those conditions and practices specified in subsection 5L-1.005(8) (7), paragraphssubsections 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 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 Operation.
(1) through (3) No change.
(4) Shellfish shall be segregated by the shellfish processor in accordance with its intended use as determined in subparagraph subsection 5L-1.008(7)(a)4.(4) and paragraphs subsections 5L-1.013 (3)(a) and (b) and identified per subsection 5L-1.007(5) or (6), F.A.C.
(5) through (13) No change.
(14) Processors shall submit to the Department a monthly report of the volume of shellfish received recieved from Florida Shellfish Harvesting Areas for each shellfish species. Quantity data shall include utilization type (raw, shucked, Post Harvest Processing PHP).
(15) No change.
(16) 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. The reviewed records shall be signed and dated by the owner, facility supervisor, or designated representative of an individual who is in a supervisory position in the facility firm and is knowledgeable of HACCP.
(17) through (18) No change.
(19) Responsibility – It shall be the duty and responsibility of the owner, facility supervisor, or designated representative each owner, manager, and operator of a shellfish facility to ensure that all regulations pertaining thereto are strictly adhered to and that only safe, wholesome, unadulterated shellfish shall be produced. It shall be his or her duty and responsibility to see that the facility is properly supervised at all times and all shellfish can be identified, whether shellstock or shucked shellfish, to ensure that they were harvested from approved or conditionally approved harvest area in the open status 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.
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 Operations.
(1) All plans for construction or remodeling of depuration or wet storage facilities shall be reviewed and approved by the Department. Approval is contigent upon the plan meeting the criteria in Rule 5L-1.005, F.A.C. and Rule 5L-1.010, F.A.C.
(2) Operating procedures for conducting depuration or wet storage shall be reviewed and approved by the Department. Approval is contigent upon the plan meeting the criteria in Rule 5L-1.008, F.A.C.
(3) through (8) No change.
(9) Shellfish treatment – All shellfish, upon receipt at the facility, shall be promptly treated or placed in controlled storage. Shellfish from approved or conditionally approved harvest area growing waters which are to undergo wet storage shall be segregated from shellfish destined for depuration from restricted or conditional restricted harvest area 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) through (11) No change.
Rulemaking 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-1.019 Laboratory Procedures and Sample Testing.
(1) No change.
(2) Bacterial examinations of shellfish and seawater shall be conducted in accordance with Recommended Procedures for the Examination of Sea Water and Shellfish Fourth Edition, 1970 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 Tallahassee, Florida 32399. 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. The material incoporated in this section is copyrighted material that This reference is available for inspection and examination at the Department of State, Administrative Code and Register Unit, The Capitol, 400 South Monroe Street, Room 701, Tallahassee, Florida, 32399 and at 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, Tallahassee, Florida 32399.
(3) No change.
(4) The laboratory must be certified by the Department in accordance with Section IV, Chapter II, section .12. of the NSSP Model Ordinance.
Rulemaking 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, .
