5L-1.005. Shellfish ProcessingCertification  

Effective on Tuesday, May 7, 2019
  • 1(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:

    38(a) Shellfish Processing Certification Application (FDACS-15007, Revision 10/18), 46http://www.flrules.org/Gateway/reference.asp?No=Ref-1037048.

    49(b) Shellfish Processing Facility Inspection Form (FDACS-15009, Revision 09/16), 58http://www.flrules.org/Gateway/reference.asp?No=Ref-0699860.

    61(c) Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16), 71http://www.flrules.org/Gateway/reference.asp?No=Ref-0699973.

    74(2) Upon request, the Department shall provide an application form entitled Shellfish Processing Certification Application (FDACS-15007, Revision 10/18). This completed application form is required for certification or recertification of the shellfish 105processing facility107.

    108(3) Possession of a 112current saltwater 114wholesale dealer license issued 118pursuant to 120section 121379.362, F.S., 123or an aquaculture certificate of registration issued pursuant to section 133597.004, F.S., 135shall be required 138to obtain a shellfish processing 143certification. 144A copy of the license or certificate or registration 153shall be submitted with the 158Shellfish Processing Certification Application (FDACS-15007, Revision 10/18)165.

    166(4) If the 169applicant170171s 172water supply is not from a public water system, 181the applicant shall submit 185satisfactory bacteriological water analysis results 190for certification pursuant to this chapter. Satisfactory bacterial water analysis results 201shall 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 356Shellfish Processing Certification Application (FDACS-15007, Revision 10/18)363.

    364(5) A shellfish processing certification number will be assigned by the Department after a completed 379Shellfish Processing Certification Application (FDACS-15007, Revision 10/18) is received388.

    389(6) Certification is granted only to 395applicants whose facility 398meets the following inspection requirements: the facility has no “Critical” item deficiencies, has no more than two (2) “Key” item deficiencies or has no more than three (3) “Other” item deficiencies. However, if there are any “Key” or “Other” 437deficiencies cited 439the shellfish processor 442must comply with the corrective action plan outlined on 451Shellfish Processing Facility Inspection Form Addendum (F458DACS-15012, Revision 10/16), that is given to the 466shellfish processor, facility 469supervisor or the designated representative at the end of the inspection. 480Following 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. 527At the completion of each inspection, a copy of the completed inspection forms shall be issued to the facility supervisor or the designated representative.

    551(7) Renewal certification – A 556shellfish processor 558shall 559complete and submit a 563Shellfish Processing Certification Application 567(FDACS-15007, Revision 10/18) 570for certification renewal annually; 574applications must be received no later than April 30 to prevent lapse in certification. 588The 589certification 590year starts on July 1 and ends on June 30. The certification shall not be renewed for any facility until the 611shellfish processing facility 614has: no “Critical” deficiencies; more than two (2) “Key” item deficiencies; and no more than three (3) “Other” item deficiencies. 634Upon 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.

    710(8) The shellfish processor, facility superivisor, or designated representative must ensure that all employees who receive, handle, and process shellfish obtain training according to 73421 C.F.R. §117.4 737(2017) 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.

    766(9) The Shellfish Processing Certification will be issued to a specific location. The legal entity will be the applicant at that specific location as listed on the Shellfish Processing Certification.

    796(10) One 798Shellfish Processing Certificate 801shall be issued to a shellfish processing facility operating at a single location. No single location 817will be issued more than one certificate824.

    825(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 850Shellfish Processing Certification 853Application 854(FDACS-15007, Revision 10/18) 857must be completed and submitted to the Department. The firm will be required to go through the complete certification process.

    877(12) 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.

    918(13) Each applicant shall have conducted a Hazard Analysis to determine 929the critical control points for any 935food safety hazards that are reasonably likely to occur for shellfish products produced at the location listed on the Shellfish Processing Certification Application 958(FDACS-15007, Revision 10/18)961. 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 1001on premises1003. 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, 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, 1115facility supervisor, or designated representative 1120at the time of its implementation, and after any modification. Each facility shall develop or adopt sanitation monitoring records to meet the requirements in subsection 11455L-1.013(17), 1146F.A.C.

    1147(14) The owner, 1150facility supervisor, or designated representative of a certified shellfish processing facility 1161shall 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:

    1194(a) Reassessment of the HACCP plan on an annual basis, or when 1206shellfish processing 1208changes occur that could affect the hazard analysis; and,

    1217(b) Ongoing verification including a review of any consumer complaints. 1227The shellfish 1229processor shall determine whether the complaints relate to the performance of critical control points or reveal the existence of unidentified critical control points, or the calibration of process-monitoring instruments.

    1258(15) All 1260certified shellfish processing facilities that 1265commercially engage in purchasing shellfish from harvesters, shucking, packing, repacking or transporting shellfish are subject to inspection, 1282pursuant to section 1285570.15, 1286F.S., and shall allow inspection by the Department during normal operating hours and any time there 1302are shellfish processing activities occuring, 1307in order to determine compliance with sections of this rule. Department shall inspect all certified shellfish processing facilities. Denial of access for such inspection will automatically institute agency administrative action 1337up to and including 1341immediate suspension of the shellfish processing certification.

    1348(16) 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 certification from the Department.

    1384(17) Upon certification a 1388shellfish processing facility, 1391the Department shall notify the U.S. Food and Drug Administration of the certified shellfish processing facility’s business name and certification number to be published in the FDA website Interstate Certified Shellfish Shippers List: 1424http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006753.htm.

    1425(18) The Shellfish Processing Certificate shall be posted in a conspicuous location on the premises.

    1440(19) No person shall attempt, by means of any threat or violence, to deter or prevent an employee of the Department from performing any duties imposed by law.

    1468(20) All certified shellfish processing facilities shall maintain on the premises a current copy of this 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 15375L-1.001, 1538F.A.C.

    1539Rulemaking Authority 1541597.020 FS. 1543Law Implemented 1545597.020 FS. 1547History–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, 5-7-19.