5L-1.006. Compliance and Penalties  


Effective on Thursday, March 23, 2017
  • 1(1) The Department shall initiate enforcement action as follows:

    10(a) The Department shall inspect all certified shellfish processing facilities as necessary. The deficiency(ies) cited in an inspection report 29shall be documented regardless of 34the type of inspection being conducted.

    40(b) At the completion of an inspection, 47if a deficiency is cited 52the 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 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 125Shellfish Processing Facility 128Inspection Form (FDACS-15009, Revision 01/16), 133as incorporated in Rule 1375L-1.005, 138F.A.C., 139and the corrective action plan 144outlined on the the Shellfish Inspection Facility Inspection Form Addendum 154(FDACS-15012, Revision 10/16), 157as incorporated in Rule 1615L-1.005, 162F.A.C., 163will be provided to the 168shellfish processor, facility 171supervisor or the designated representative 176present at the conclusion of the inspection183. The shellfish processor, facility supervisor, and the designated representative shall 194ensure that the facility is in full compliance 202with the corrective action plan as outlined on 210Shellfish Inspection Facility Inspection Form Addendum (F217DACS-15012, Revision 10/16). The shellfish processor, facility supervisor, or the designated representative’s failure to comply with the corrective action plan outlined on 239Shellfish Inspection Facility Inspection Form Addendum (F246DACS-15012, Revision 1/16), will lead to 252administrative actions, 254suspension, and/or revocation of the 259Shellfish Processing Certification262.

    263(c) If, upon inspection, the Department 269cites the facility for a 274“Critical,” “Key,” or “Other” deficiency(ies), the following schedule will be used by the Department with respect to the administrative actions to be taken:

    299Critical deficiency(ies)

    301When a “Critical” deficiency(ies) is 306cited a warning letter will be issued and processing 315operations 316at the certified facility 320will be suspended 323as a public health threat 328and the deficiency must be corrected 334immediately 335or the 337certified facility’s 339certification 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 388detain or seize any product that may have been adulterated, initiate 399a recall of 402any distributed 404product and notify necessary officials of a recall.

    412In addition to these actions the sanction to be imposed on the certified shellfish 426processing facility 428upon the finding of any repeat deficiency(ies), 435as defined in Rule 4395L-1.002, 440F.A.C., 441will be as follows:

    445Offense

    446Critical

    447Key

    448Other

    4491st

    450Operations or certification suspended until corrected and a warning letter issued

    461Correct deficiency pursuant to date on corrective action plan

    470Correct deficiency pursuant to date on corrective action plan

    4791st Repeat within proceeding 180 days

    485Operations or certification suspended until corrected and fine of $500 per violation

    497Correct deficiency pursuant to date on corrective action plan and fine of $100 per violation

    512Correct deficiency pursuant to date on corrective action plan and fine of $50 per violation

    5272nd Repeat within proceeding 180 days

    533Operations or certification suspended until corrected and fine of $1000 per violation

    545Correct deficiency pursuant to date on corrective action plan and fine of $200 per violation

    560Correct deficiency pursuant to date on corrective action plan and fine of $100 per violation

    5753rd Repeat within proceeding 180 days

    581Fine of $1000 per violation and 7-day suspension of certification or until corrected, whichever is later

    597Correct deficiency pursuant to date on corrective action plan and fine of $500 per violation and 7-day suspension of certification

    617Correct deficiency pursuant to date on corrective action plan and fine of $200 per violation

    6324th or Subsequent Repeat within proceeding 180 days

    640Fine of $1000 per violation and 14-day revocation of certification

    650Correct deficiency pursuant to date on corrective action plan and fine of $1000 per violation and 14-day suspension of certification

    670Correct deficiency pursuant to date on corrective action plan and fine of $400 per violation

    685(d) A warning letter will be sent to the shellfish processor when the establishment has:

    7001. One or more critical item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C., or

    7162. More than two 720“Key” item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C., or

    7323. One “Key” item deficiency and four “Other” item deficiencies cited in violation of Rule Chapter 5L-1, F.A.C.

    750(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 791facility’s shellfish processing certification 795the 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 days of the certificate holder receiving the notice imposing the fine 856unless the shellfish processor has sent a written 864request for a hearing on the matter pursuant to Chapter 120, F.S., 876within the 21 day period to the Department.

    884(f) A renewal of a 889shellfish facility’s processing certification 893will not be made if there are any unpaid fines with respect to prior certification periods.

    909(2) The Department shall suspend 914the facility’s shellfish processing 918certification if it is determined that there is an immediate serious danger to the public health, safety, or welfare requiring such emergency action. The Department shall, at the time the emergency action is taken, initiate proceedings as provided in Section 958120.60, F.S.

    960(3) Upon suspension or revocation of 966the facility’s shellfish processing 970certification, the Department shall notify the U.S. Food and Drug Administration so that the facility’s business name and certification number will be removed from the Interstate Certified Shellfish Shippers List. Upon reinstatement of the certification, the Department shall notify the U.S. Food and Drug Administration so that the facility’s business name and certification number may be reinstated on the Interstate Certified Shellfish Shippers List.

    1034(4) When the Department finds, or has reason to believe, that any equipment which is located at a certified processing facility is in violation of this chapter so as to be dangerous or unsanitary the Department may issue and enforce a stop-sale, stop-use, removal, or hold order, which order gives notice that such equipment is, or is suspected of being, in violation and has been detained or embargoed and which order warns all persons not to remove, use, or dispose of such equipment by sale or otherwise until permission for removal, use, or disposal is given by the Department or the court. It is unlawful for any person to remove, use, or dispose of such detained or embargoed equipment by sale or otherwise without such permission.

    1160(5) Settlement and Additional Enforcement Remedies. In determining the appropriate disciplinary penalty the Department will consider the compliance record of the violator. The provisions of this rule shall not be construed to limit the authority of the Department to enter into settlement with any party per Section 1207120.57(4), F.S., 1209or to prohibit additional administrative remedies or civil actions. Settlement agreements can provide for installment payments and costs for up to six months. The Department will enforce a failure to comply with a settlement agreement with the penalties and remedies provided in the settlement agreement or as authorized by law.

    1259Rulemaking Authority 1261500.09, 1262597.020 FS. 1264Law Implemented 1266500.09, 1267597.020 FS. 1269History–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, 3-23-17.

     

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