Florida Regulations 5L-1.005: Shellfish ProcessingCertification
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(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), http://www.flrules.org/Gateway/reference.asp?No=Ref-10370.
(b) Shellfish Processing Facility 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). 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 Florida Statutes § 379.362, or an aquaculture certificate of registration issued pursuant to Florida Statutes § 597.004, 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).
(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).
(5) A shellfish processing certification number will be assigned by the Department after a completed Shellfish Processing Certification Application (FDACS-15007, Revision 10/18) is received.
(6) Certification is granted only to applicants whose facility meets 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”” deficiencies cited the shellfish processor must comply with the corrective action plan outlined on 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. Following certification, unannounced inspections using the Shellfish Processing Facility Inspection Form (FDACS-15009, Revision 09/16), and Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) shall be conducted during periods of operation and at such frequency as necessary to assure that adequate operational and sanitary conditions are maintained. At the completion of each inspection, a copy of the completed inspection forms shall be issued to the facility supervisor or the designated representative.
(7) Renewal certification – A shellfish processor shall complete and submit a Shellfish Processing Certification Application (FDACS-15007, Revision 10/18) 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 21 C.F.R. § 117.4 (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.
(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.
(10) One Shellfish Processing Certificate shall be issued to a shellfish processing facility operating at a single location. No single location will be issued more than one certificate.
(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) must be completed and submitted to the Department. The firm will be required to go through the complete certification process.
(12) Possession of a mechanical refrigeration unit that is non-portable and is able to maintain an ambient temperature of 45° F or below and be of sufficient size to handle one day’s production, shall be required for certification under this chapter.
(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). 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, 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) The owner, facility supervisor, or designated representative of a certified shellfish processing facility shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include at a minimum:
(a) Reassessment of the HACCP plan on an annual basis, or when shellfish processing changes occur that could affect the hazard analysis; and,
(b) Ongoing verification including a review of any consumer complaints. The shellfish processor 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.
(15) All certified shellfish processing facilities that commercially engage in purchasing shellfish from harvesters, shucking, packing, repacking or transporting shellfish are subject to inspection, pursuant to Florida Statutes § 570.15, and shall allow inspection by the Department during normal operating hours and any time there are shellfish processing activities occuring, in 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 up to and including immediate suspension of the shellfish processing certification.
(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.
(17) Upon certification a shellfish processing facility, the 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: http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006753.htm.
(18) The Shellfish Processing Certificate shall be posted in a conspicuous location on the premises.
(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.
(20) All certified shellfish processing facilities shall maintain on the premises a current copy of this rule Fl. Admin. Code Chapter 5L-1, 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 Fl. Admin. Code R. 5L-1.001
Rulemaking Authority 597.020 FS. Law Implemented Florida Statutes § 597.020. 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, 5-7-19.
(b) Shellfish Processing Facility 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). 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 Florida Statutes § 379.362, or an aquaculture certificate of registration issued pursuant to Florida Statutes § 597.004, 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).
(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).
(5) A shellfish processing certification number will be assigned by the Department after a completed Shellfish Processing Certification Application (FDACS-15007, Revision 10/18) is received.
(6) Certification is granted only to applicants whose facility meets 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”” deficiencies cited the shellfish processor must comply with the corrective action plan outlined on 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. Following certification, unannounced inspections using the Shellfish Processing Facility Inspection Form (FDACS-15009, Revision 09/16), and Shellfish Processing Facility Inspection Form Addendum (FDACS-15012, Revision 10/16) shall be conducted during periods of operation and at such frequency as necessary to assure that adequate operational and sanitary conditions are maintained. At the completion of each inspection, a copy of the completed inspection forms shall be issued to the facility supervisor or the designated representative.
(7) Renewal certification – A shellfish processor shall complete and submit a Shellfish Processing Certification Application (FDACS-15007, Revision 10/18) 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 21 C.F.R. § 117.4 (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.
(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.
(10) One Shellfish Processing Certificate shall be issued to a shellfish processing facility operating at a single location. No single location will be issued more than one certificate.
(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) must be completed and submitted to the Department. The firm will be required to go through the complete certification process.
(12) Possession of a mechanical refrigeration unit that is non-portable and is able to maintain an ambient temperature of 45° F or below and be of sufficient size to handle one day’s production, shall be required for certification under this chapter.
(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). 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, 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) The owner, facility supervisor, or designated representative of a certified shellfish processing facility shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include at a minimum:
(a) Reassessment of the HACCP plan on an annual basis, or when shellfish processing changes occur that could affect the hazard analysis; and,
(b) Ongoing verification including a review of any consumer complaints. The shellfish processor 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.
(15) All certified shellfish processing facilities that commercially engage in purchasing shellfish from harvesters, shucking, packing, repacking or transporting shellfish are subject to inspection, pursuant to Florida Statutes § 570.15, and shall allow inspection by the Department during normal operating hours and any time there are shellfish processing activities occuring, in 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 up to and including immediate suspension of the shellfish processing certification.
(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.
(17) Upon certification a shellfish processing facility, the 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: http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006753.htm.
(18) The Shellfish Processing Certificate shall be posted in a conspicuous location on the premises.
(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.
(20) All certified shellfish processing facilities shall maintain on the premises a current copy of this rule Fl. Admin. Code Chapter 5L-1, 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 Fl. Admin. Code R. 5L-1.001
Rulemaking Authority 597.020 FS. Law Implemented Florida Statutes § 597.020. 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, 5-7-19.