The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) model ordinance; remove the definition of terminal sale date; require “sell by date” be added to labelling requirements; update ...  

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    DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

    Division of Aquaculture

    RULE NOS.:RULE TITLES:

    5L-1.001General Requirements and Intent

    5L-1.002Definitions

    5L-1.005Shellfish ProcessingCertification

    5L-1.007Container Identification, Terminal Sale Date; Prohibitions

    5L-1.008Shellfish Handling

    5L-1.009Shellfish Relaying

    5L-1.010Buildings and Facilities

    5L-1.013Facility Operation

    5L-1.015Depuration and Wet Storage Facility Operations

    5L-1.017Water Treatment Standards

    PURPOSE AND EFFECT: The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) model ordinance; remove the definition of terminal sale date; require “sell by date” be added to labelling requirements; update Shellfish Processing Certification Application (FDACS-15007), update the time/temperature matrix for the months of April, May and October; and clarify the UV light efficiency log.

    SUMMARY: The areas that will be addressed include definitions, labelling, time and temperature requirements, responsible party for removing harvester tags and UV light log.

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

    The Agency has determined that this 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 the impacts to tagging requirements. By deleting the terminal sale date the department found this would result in product not being destroyed after the 14 day terminal sale date. Also, restricting harvesting times in the months of April, May and October has been found not to impact industry as the other cooling options allow harvesters to harvest for longer hours. Additionally, no interested party submitted additional information regarding the economic impact.

    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

    RULEMAKING AUTHORITY: 597.020 F.S.

    LAW IMPLEMENTED: 597.020 F.S.

    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jill Fleiger, Division of Aquaculture, 600 S. Calhoun Street, Suite 217, Tallahassee, Florida 32399, phone (850)617-7600.

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    5L-1.001 General Requirements and Intent.

    (1) 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.

    (a) The following parts of Title 21, Code of Federal Regulations:

    1. Part 7 – Enforcement Policy, revised as of April 1, 2018 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06987;

    2. Part 101 – Food Labeling, revised as of April 1, 2017 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06988;

    3. Part 109 – Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material, revised as of April 1, 2017 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06989;

    4. Part 110 – Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, revised as of April 1, 2017 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06990;

    5. Part 117 – Current Good Manufacturing Practice in Manufacturing, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, revised as of April 1, 2017, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX

    65. Part 123 – Fish and Fishery Products, revised as of April 1, 2017 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06991;

    76. Part 161 – Fish and Shellfish, revised as of April 1, 2017 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06992;

    87. Part 509 – Unavoidable Contaminants in Animal Food and Food-Packaging Material, revised as of April 1, 2018 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06993.

    (b) Title 40, Part 141, Section 141.2, Code of Federal Regulations, revised as of July 1, 2018 2015, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-06994.

    (c) The Purpose, the Definitions, and Chapters 1 through 13, and 15 through 16 of the “Model Ordinance” of the National Shellfish Sanitation Program (NSSP), Guide for the Control of Molluscan Shellfish,  2017 2015 Revision, herein adopted and  incorporated by reference are available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX http://www.flrules.org/Gateway/reference.asp?No=Ref-07008. Except for:

    1. Definition number (16)(d) Reshipper; and,

    2. Definition number (101) Reshipper.

    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, 3-23-17, __________.            

     

    5L-1.002 Definitions.

    (1) through (26) No change.

    (27) HACCP – Hazard Analysis and Critical Control Points – A system of inspection, control, and monitoring measures initiated by a shellfish processor certified dealer to identify and control microbiological, chemical, or physical food safety hazards which are likely to occur in shellfish products produced by the facility.

    (28) through (43) No change.

    (44) Remote Buying – a shellfish processor or designated representative taking possession of shellfish at any location different than their certified shellfish processing facility facitilty location.

    (45) through (61) No change.

    (62) 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 no more than 14 calendar days subsequent to the date shellstock was harvested.

    (62)(63) Time of Harvest – is defined as the time when shellfish are first removed from the water and placed on or in a manmade conveyance or other means of transport.

    (63)(64) Time of Refrigeration – is defined as the time when shellfish are first placed within an ambient environment of 45ºF degrees or less.

    (64)(65) Unclassified area – an area for which no recent sanitary survey exists. Harvest of shellfish is not permitted.

    (65)(66) Unwholesome – shellfish which are not in sound condition, unclean, or otherwise not suitable for human consumption.

    (66)(67) UV – Ultraviolet.

    (67)(68) 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.”

    (68)(69) Warning letter – a warning letter includes a notice of non-compliance.

    (69)(70) Wet storage – the temporary storage of shellfish harvested from an approved sources or in the open status conditionally approved harvest area and placed in tanks containing water that meets approved or open status conditionally approved shellfish harvesting area water quality standards.

    (70)(71) Wholesale – any sale to any person or business other than the final consumer.

    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, 3-23-17,                    .

     

    5L-1.005 Shellfish Processing Certification.

    (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 10/18 09/16), http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX 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) Upon request, the Department shall provide an application form entitled Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16). This completed application form is required for certification or recertification of the shellfish processing facility.

    (3) Possession of a current saltwater wholesale dealer license issued pursuant to Section 379.362, F.S., or an aquaculture certificate of registration issued pursuant to Section 597.004, F.S., shall be required to obtain a shellfish processing certification. A copy of the license or certificate or registration shall be submitted with the Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16).

    (4) If the applicant’s water supply is not from a public water system, the applicant shall submit satisfactory bacteriological water analysis results for certification pursuant to this chapter. Satisfactory bacterial water analysis results 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. Analysis shall be from the source water and an outlet location within the facility, 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 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 10/18 09/16).

    (5) A shellfish processing certification number will be assigned by the Department after a completed Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16) is received.

    (6) No change.

    (7) Renewal certification – A shellfish processor shall complete and submit a Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16) for certification renewal annually; applications must be received no later than April 30 to prevent lapse in certification. The certification year starts on July 1 and ends on June 30. The certification shall not be renewed for any facility until the shellfish processing facility has: no “Critical” deficiencies; more than two (2) “Key” item deficiencies; and no 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.

    (8) The shellfish processor, facility superivisor, or designated representative must ensure that all employees who receive, handle, and process shellfish obtain training according to subparagraph 5L-1.001(6)(a)5., F.A.C., within 30 days of their initial hiring. Proof of training for all employees shall be maintained at the certified processing facility and provided to the Department upon request. 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 training.

    (9) through (10) No change.

    (11) In the event that a licensed certified shellfish processing facility changes its name, changes owners, changes location, changes address, or changes classifications, a new Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16) must be completed and submitted to the Department. The firm will be required to go through the complete certification process.

    (12) No change.

    (13) Each applicant shall have conducted a Hazard Analysis to determine the critical control points for any food safety hazards that are reasonably likely to occur for shellfish products produced at the location listed on the Shellfish Processing Certification Application (FDACS-15007, Revision 10/18 09/16). Each certified shellfish facility shall have someone with 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 shall have 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 are taken. The HACCP plan shall include the procedures, and frequency 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 at the time of its implementation, and after any modification. Each facility shall develop or adopt sanitation monitoring records to meet the requirements in subsection 5L-1.013(17), F.A.C.

    (14) 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, 3-23-17,               .

     

    5L-1.007 Container Identification, Terminal Sale Date; Prohibitions.

    (1) Shucked shellfish container – The packer’s or repacker’s shellfish processing certification 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 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). Bulk storage containers shall be identified with state of origin, harvest date, and shuck date. Containers of frozen or previously frozen shellfish shall 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 labeled “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, the shucked shellfish container may be identified with the language “FOR POST HARVEST PROCESSING ONLY.”

    (a) Each container of fresh, fresh frozen, or previously frozen shellfish, with a capacity of less than 64 ounces, shall clearly and permanently display the words “Sell By” followed by the date when the product would be expected to reach the end of its shelf life. The date shall consist of the numerical month, and day. For fresh frozen or previously frozen shellfish, the last digit of the year shall be added to the date.

    (b) Each container of fresh, fresh frozen, or previously frozen shellfish with a capacity of 64 ounces or more, shall clearly and permanently display “Date Shucked” followed by the shuck date. The date shall consist of the numerical month, day, and year.

    (c) Bulk storage containers shall be identified with state of origin, harvest date, and shuck date.

    (d) Previously frozen shucked shellfish shall also be labeled “previously frozen” and display the freeze date and the thaw date by numerical month, day, and year.

    (e) Repacked shellfish containers shall also bear an appropriate code identifying the original packer. For restricted use shellstock, the shucked shellfish container may be identified with the language “FOR POST HARVEST PROCESSING ONLY.”

    (2) Shellstock containers. Each commercial harvester or each shellfish processor 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 harvest location, regardless of capacity of container; for certified shellfish processors dealers this shall be done after final packing. The harvester’s tag must be removed from each container and replaced with a processor’s tag prior to being shipped. The removed harvester’s tag must be kept in processor’s file for 90 days. In the case where a certified shellfish processor dealer is also the harvester, that processor’s dealer’s tag may also be used as the harvester’s tag. In these cases, the processor must ensure all harvester’s tag information is included on the tag.

    (3) The commercial harvester’s tags shall be white in color except as required in 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 paragraphs 5L-1.007(3)(a)-(i), F.A.C., arranged in the specific order as follows:

    (a) No change.

    (b) The date of harvest harvesting;

    (c) 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 aquaculture sugmerged land lease number;

    (f) No change.

    (g) The following statement will appear in bold capitalized type “This tag is required to be attached until container is empty and thereafter kept on file for 90 days.”

    (h) The identification of the cooling option if used, including onboard 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 April May through October.

    (i) No change.

    (4) Bulk tagging by harvesters is allowed only for those aquaculturists operating with an Aquaculture Certificate of Registration. A bulk tag, shall contain containing the information required in paragraphs 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.

    (a) The name of the certified shellfish facility in which the product is consigned;

    (b) The statement “All shellfish containers in this lot have the same date and area of harvest”; and,

    (c) The number of units in the lot container.

    (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) Harvest date;

    (c) Harvest area;

    (d) Original Dealer/Shipper identification; and,

    (e) Number of units in this lot container.

    (f) The identification of the cooling option if used, detailed in subsections 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.

    (5)(6) The certified facility’s tag shall contain legible, waterproof, indelible information arranged in the specific order as follows:

    (a) through (b) No change.

    (c) The date of harvest harvesting;

    (d) The identification of the harvest area, and for Florida harvest areas four digit code or name of the harvest area found in paragraph (3)(e) above;.

    (e) The cCommon name of shellfish and quantity of shellfish; and,

    (f) All oyster shellstock tags must clearly and permanently display the words “Sell By” followed by a date when the product would be expected to reach the end of its shelf life.  The sell by date shall consist of the numerical month, day, and year; and,

    (g)(f) The following statements statement will appear in bold capitalized type “This tag is required to be attached until container is empty and thereafter kept on file in chronological order for 90 days This tag is required to be attached until container is empty and thereafter kept on file order for 90 days. and “Retailer: date when the last shellfish from this container sold or served               .”

    (g) All oyster shellstock must display 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), (7), or (8), F.A.C., the shellstock processor 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 ONLYin bold, 14 point font and the tag shall be green in color.

    (i) For depuration shellstock, paragraphs (5) (6)(a), (d), (e), and (f) and (g), above, are required as well as the date of depuration processing, and the depuration cycle or lot number.

    (j) For shellstock wet stored, paragraphs (5)(a) through (h), above, as well as the following statement: “This product was wet stored on or at (Lease # or Facility certification number) from (date) to (date).”

    (6) 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. A bulk processor tag shall contain the information required in paragraphs 5L-1.007(5)(a)-(f); along with:

    (a) The statement “All shellfish containers in this lot have the same date and area of harvest”;

    (b) The number of units in the lot container; and,

    (c) The following statement in bold capitalized type “This tag is required to be attached until container is empty and thereafter kept on file for 90 days.”

    (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.

    (7)(8) Shellfish identification, out-of-state – No shellfish from sources outside of Florida shall be brought into the state for purpose of resale or public distribution unless the product bears evidence of certification from the state or nation of origin and certification is based on requirements similar to those outlined in this chapter.

    (8)(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 paragraphs (5) (6)(a) and (b), above.

    (9) (10) Shellstock and shucked shellfish containers shall be labeled with the following statements statement:

    (a) “Consumer information there is a risk associated with consuming raw shellfish. If you have chronic illness of the liver, stomach or blood or have immune disorders, you are at greater risk of serious illness from raw shellfish and should eat shellfish fully cooked. If unsure of your risk, consult a physician.”; and,

    (b) “Keep Refrigerated”.

    (10)(11) It shall be unlawful for any person, firm, corporation, wholesale or retailer 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.

    (11)(12) Whoever knowingly or willfully alters or damages in any manner, or loans or transfers to another person any certification number or shellfish tags, or any person who uses the certification number 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 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, 3-23-17,              .

     

    5L-1.008 Shellfish Handling.

    (1) 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, same day of harvest, 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 5L-1.008(7)(a)1.-3., F.A.C. Prior to initiating tempering a certified shellfish facility dealer shall have written approval from the Department. The certified shellfish facility dealer must provide the following:

    a. through d. No change.

    (b) Oysters:

    1. No change.

    2. Vibrio Control months include 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 and placed under mechanical refrigeration by 5:00 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 and placed under mechanical refrigeration by 11:00 a.m. 4:00 p.m. of the same day of harvest. unless the harvester is identified in the certified shellfish processing facility’s HACCP plan for the onboard cooling option detailed in subsection 5L-1.008(9), F.A.C., or the certified shellfish processing facility is authorized for the rapid cooling option detailed in subsection 5L-1.008(10), F.A.C.

    5. During the month of May, all oysters harvested shall be delivered to a certified shellfish processing facility and placed under mechanical refrigeration by 11:00 a.m. of the same day of harvest, unless the harvester is identified in the certified shellfish processing facility’s HACCP plan for the onboard cooling option detailed in subsection 5L-1.008(9), F.A.C., or the certified shellfish processing facility is authorized for the rapid cooling option detailed in subsection 5L-1.008(10), F.A.C.

    5.6. During the months of May, June, July, August, and September, all oysters harvested shall be tagged as “FOR SHUCKING ONLY BY A CERTIFIED FACILITY DEALER” or “FOR POST HARVEST PROCESSING ONLY” and delivered to a certified shellfish processing facility 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 HACCP plan for the onboard cooling option detailed in subsection 5L-1.008(9), F.A.C., or the certified shellfish processing facility is authorized for the rapid cooling option detailed in subsection 5L-1.008(10), F.A.C.

    6.7. During the month of October, all oysters harvested shall be delivered to a certified shellfish processing facility and placed under mechanical refrigeration by 11:00 a.m. 1:00 p.m. unless the harvester is identified in the certified shellfish processing facility’s HACCP plan for the onboard cooling option detailed in subsection 5L-1.008(9), F.A.C., or the certified shellfish processing facility is authorized for the rapid cooling option detailed in subsection 5L-1.008(10), F.A.C.

    (8) through (9) 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) During the month of April May shellfish processors must place all harvested oysters under mechanical refrigeration no later than 1:00 2:00 p.m. and cooled down to 55oF or less no later than 3:00 p. m. of the harvest day.

    (b) During the months of May, June, July, August, and September shellfish processors must place all harvested oysters under mechanical refrigeration no later than 11:00 a.m. and cooled down to 55oF or less no later than 1:00 p. m. of the harvest day.

    (c) During the month of October shellfish processors must place all harvested oysters under mechanical refrigeration no later than 1:00 3:00 p.m. and cooled down to 55oF or less no later than 3:00 p. m. of the harvest day.

    (d) No changes.

    (e) Harvested oysters failing to meet the time and temperature requirements of this subsection shall be retagged by the processor as “FOR SHUCKING ONLY BY A CERTIFIED FACILITY” or “FOR POST HARVEST PROCESSING ONLY.” Processors failing to meet the rapid cool criteria more than two times during the vibrio control months of April through October shall lose the rapid cool option for the remaining vibrio control months of that year. The processor shall only process oysters for restricted use only (Green Tag) during the remaining vibrio control months.

    (f) No changes.

    (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)

    Onboard Cooling with Ice Slurry

    (<55oF at time of delivery)

    Restricted Use Only

    (Green Tag)

    Delivery to processor from time of harvest (same day of harvest)

    November

    5:00 10:00 p.m.

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    10:00 p.m.

    December

    5:00 10:00 p.m.

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    10:00 p.m.

    January

    5:00 10:00 p.m.

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    10:00 p.m.

    February

    5:00 10:00 p.m.

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    10:00 p.m.

    March

    5:00 10:00 p.m.

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    Non-Vibrio Control Month

    10:00 p.m.

    April

    11:00 a.m. 4:00 p.m.

    1:00 4:00 p.m.

    3:00 p.m.

    4:00 p.m.

    12 Hours

    May

    Not permitted 11:00 a.m.

    11:00 a.m. 2:00 p.m.

    3:00 p.m.

    4:00 p.m.

    12 Hours

    June

    Not permitted

    11:00 a.m.

    3:00 p.m.

    4:00 p.m.

    10 Hours

    July

    Not permitted

    11:00 a.m.

    3:00 p.m.

    4:00 p.m.

    10 Hours

    August

    Not permitted

    11:00 a.m.

    3:00 p.m.

    4:00 p.m.

    10 Hours

    September

    Not permitted

    11:00 a.m.

    3:00 p.m.

    4:00 p.m.

    10 Hours

    October

    11:00 a.m. 1:00 p.m.

    1:00 3:00 p.m.

    3:00 p.m.

    4:00 p.m.

    12 Hours

     

    (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, 3-23-17,               .

     

    5L-1.009 Shellfish Relaying.

    (1) through (3) No change.

    (4) The Department, after reviewing the application and finding the plan in compliance with all applicable rules and regulations shall issue a Special Activity License to Relay Aquacultured Shellfish within the general conditions set forth below:

    (a) through (d) No change.

    (e) Laboratory analysis shall consist of a minimum of two samples per individual lease parcel (each sample to consist of a minimum of 20 individual shellfish). The Department will collect and analyze samples for aquacultured shellfish relaying. For aquacultured shellfish being relayed due to marine biotoxins, the laboratory analyses shall use an approved NSSP laboratory method 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, F.A.C. 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 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) through (g) No change.

    (5) No change.

    Rulemaking Authority 597.020 FS. Law Implemented 597.010(15), (18), 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, 3-23-17,___________.

     

    5L-1.010 Buildings and Facilities.

    (1) through (5) No change.

    (6) Each facility shall provide its employees with readily accessible toilet facilities. Compliance with this requirement shall be accomplished by:

    (a) through (e) No change.

    (f) Providing a covered waste receptacle.

    (7) 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, 3-23-17,                  .

     

    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 5L-1.008(7)(a)4., and paragraphs 5L-1.013(3)(a) and (b), and identified as per subsection 5L-1.007(5) or (6), F.A.C. The harvester tag must be removed from each container and replaced with a processor’s tag prior to being shipped.

    (5) 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 operating in the state. Records shall remain on file for not less than two one years year for fresh and frozen product. and two years for frozen product. Records shall be made available for the inspection and copying by the Department personnel during facility inspections. Records shall indicate:

    (a) No change.

    (b) Harvest area, and for Florida shellfish the four digit code or name of harvest area found in 5L-1.003(11), F.A.C. Aquaculture product must also include the aquaculture lease number; Areas from which shellstock were harvested.

    (c) through (h) No change.

    (11) through (19) 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-7.016, Amended 7-3-95, 5-8-96, 2-6-97, 6-23-99, Formerly 62R-7.016, Amended 8-9-00, 5-29-02, 7-29-08, 4-26-10, 3-23-17,_________.

     

    5L-1.015 Depuration and Wet Storage Facility Operations.

    (1) through (11) No change.

    (12) Ultraviolet (UV) Unit:

    (a) No change.

    (b) Cautions and maintenance.

    1. UV tubes shall either be checked for intensity on a monthly basis or the hours the tubes are used. The bulbs and shall be replaced when they reach a point of 60% efficiency or upon the manufacturer’s maintenance, which ever occurs first. A log of intensity or hours shall be kept and an orderly numbering procedure for UV units and bulbs established. A record of UV tube replacement shall be maintainted.

    2. through 5. 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, 3-23-17,                      .

     

    5L-1.017 Water Treatment Standards.

    (1) Depuration Water Treatment Standards.

    (a) through (c) No change.

    (d) 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, F.A.C.

    (e) through (l) No change.

    (2) Wet Storage Treatment Standards.

    (a) through (b) No change.

    (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 as incorporated in Rule 5L-1.001, F.A.C 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) through (e) No change.

    (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 as incorporated in Rule 5L-1.001, F.A.C.

    Rulemaking Authority 597.020 FS. Law Implemented 597.020 FS. History–New 1-4-87, Amended 8-10-88, Formerly 16R-7.024, Amended 7-3-95, 5-8-96, 2-6-97, Formerly 62R-7.024, Amended 8-9-00, 3-23-17,___________.

     

    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: December 12, 2018

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 9/28/2018

Document Information

Comments Open:
12/14/2018
Summary:
The areas that will be addressed include definitions, labelling, time and temperature requirements, responsible party for removing harvester tags and UV light log.
Purpose:
The proposed rule amendments will incorporate and adopt the revised National Shellfish Sanitation Program (NSSP) model ordinance; remove the definition of terminal sale date; require “sell by date” be added to labelling requirements; update Shellfish Processing Certification Application (FDACS-15007), update the time/temperature matrix for the months of April, May and October; and clarify the UV light efficiency log.
Rulemaking Authority:
597.020 F.S.
Law:
597.020 F.S.
Contact:
Jill Fleiger, Division of Aquaculture, 600 S. Calhoun Street, Suite 217, Tallahassee, Florida 32399, phone (850)617-7600.
Related Rules: (10)
5L-1.001. General Requirements and Intent
5L-1.002. Definitions
5L-1.005. Shellfish Processing Plant Certification License
5L-1.007. Container Identification, Terminal Sale Date; Prohibitions
5L-1.008. Shellfish Handling
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