5L-1.006. Compliance and Penalties

(1) The Department shall initiate enforcement action as follows:

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

(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 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 Inspection Form (FDACS-15009, Revision 01/16), as incorporated in Rule 5L-1.005, F.A.C., 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, F.A.C., 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 processor, 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 1/16), 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 any product that may have been adulterated, 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 any 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 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) A warning letter will be sent to the shellfish processor when the establishment has:

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

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

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

(e) Willful Violations Not All-Inclusive. This rule contains illustrative violations. It does not, and is not intended to, encompass all possible violations of statute or Department rule by a Shellfish Processor that may adversely affect public health, safety, or welfare or that creates a significant threat of such harm. The absence of any violation from this rule shall in no way be construed to indicate that the violation does not cause harm to the public or is not subject to a penalty. In any instance where the violation is not listed in Chapter 5L-1, F.A.C., the penalty will be determined by consideration of:

1. The closest analogous violation, if any, that is listed in this rule; and

2. The mitigating or aggravating factors listed in this rule.

(f) Willful violations shall result in the imposition of an administrative fine of $1,000 per violation, the suspension of Shellfish Processor certification, revocation of Shellfish Processor certification, or any combination thereof. The following shall constitute a willful violation by the shellfish processor:

1. The falsification of any records, tags or labels required under this rule or Chapter 5L-3, F.A.C.

2. The sale or distribution, or offering for sale or distribution, of any shellstock under recall order pursuant to subsection 5L-1.004(8), F.A.C.

3. Introducing adulterated or misbranded shellfish products into commerce.

4. The failure to oversee the receiving of shellstock from harvesters.

5. Deterring or preventing an employee of the Department from performing any duties authorized by law.

(g) 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 days of the certificate holder receiving 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 day period to the Department.

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

(2) The Department shall suspend the facility’s shellfish processing certification 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 120.60, F.S.

(3) Upon suspension or revocation of the facility’s shellfish processing certification, 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.

(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.

(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 120.57(4), F.S., or 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.

(6) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of this rule chapter. The factors shall be applied against each single count of the listed violation.

(a) Aggravating Factors:

1. The violation caused, or has the potential to cause, harm to the public and the degree or extent of such harm.

2. The violation endangered the public safety or welfare.

3. Previous violations for the same or a similar offense that resulted in enforcement action, including civil warning letters, notices of noncompliance or administrative complaints or any criminal action taken by law enforement agencies.

4. The Shellfish Processor impeded, or otherwise failed to cooperate with, the Department’s inspection and/or investigation.

5. The number and severity of other violations documented in the same proceeding.

6. The benefit to the Shellfish Processor.

(b) Mitigating Factors:

1. Any documented efforts by the violator at rehabilitation.

2. Whether actions of another party prevented the Shellfish Processor from complying with the applicable laws or rules.

3. Acts of God or nature that impaired the ability of the Shellfish Processor to comply with this rule chapter.

4. The violation has a low risk of, or did not result in, harm to the public health, safety, or welfare.

5. The violation history of the Shellfish Processor.

Rulemaking Authority 500.09, 597.020 FS. Law Implemented 500.09, 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, 3-23-17, 1-18-23.