5K-11.005. Guidelines for Imposing Administrative Penalties

(1) This rule sets forth the guidelines the Department will follow in imposing the penalties authorized under Chapter 500, F.S. relative to the production and manufacture of Edibles. The purpose of the guidelines is to give notice of the range of penalties that will be imposed for a single violation within a three-year period. The three-year period shall be based on the date of the last administrative enforcement action imposed against the violator. These guidelines list aggravating and mitigating factors that, if present, will reduce or increase penalties to be imposed. No aggravating factors will be applied to increase a fine imposed for a single violation above the statutory maximum for a Class II category of $5,000 for each violation as provided in Section 570.971, F.S., except for violations of Section 500.165, F.S., which have a statutory maximum for a Class III category of $10,000 as provided in Section 570.971, F.S. The guidelines in this rule chapter are based upon a single count violation of each provision listed. Multiple counts of the violated provision or a combination of the listed violations will be added together to determine an overall total penalty and will be grounds for enhancement of penalties.

(2) Any person violating this rule chapter shall be subject to the injunction procedures of Section 500.171, F.S., and to the penalties provided in Sections 500.121, 500.172, 500.173, 500.174, and 500.177, F.S.

(3) The Department will enforce compliance with Chapter 500, F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, stop-use order, release order, notice of non-compliance, permit suspension or revocation, or an immediate final order for violations of Chapter 500, F.S., and this rule chapter.

(4) Stop-Sale, or Stop-Use Orders. The Department shall issue a Stop-Sale, or Stop-Use Order FDACS-14215, (Rev. 04/19), as provided in Section 500.172, F.S., whenever necessary to effectuate the statutory duties of the Department in the interest of public health, safety, and welfare and as necessary to promote the safety of any food product, food-processing equipment, or areas within an entity operating as a food establishment in Florida. A Stop-Sale, or Stop-Use Order 14215, (Rev. 04/19), will be used to give notice that such a product, processing equipment or area is, or is suspected of, failing to comply with the requirements of Chapter 500, F.S., or this rule chapter, and shall prohibit the removal, use, or disposal of such item. The Stop-Sale, or Stop-Use Order is incorporated by reference in Rule 5K-4.035, F.A.C.

(5) Nothing in this rule shall limit the ability of the Department to informally dispose of administrative actions by settlement agreement, consent order, or other lawful means.

(6) Rule 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 that might be committed by any person. 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 this rule, the penalty will be determined by consideration of:

(a) The closest analogous violation, if any, that is listed in this rule; and

(b) The mitigating or aggravating factors listed in this rule.

(7) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of Chapter 500, F.S., and 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, defined as follows:

a. First Offense. A violation of any law subject to penalty under Chapter 500, F.S., when no disciplinary administrative complaints involving the same permitholder have been filed with the Agency Clerk within the three years preceding the date the current administrative complaint is issued.

b. Second Offense. A violation of any law subject to penalty under Chapter 500, F.S., after one disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

c. Third and Any Subsequent Offense. A violation of any law subject to penalty under Chapter 500, F.S., after two disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceeding the date the current administrative complaint is issued, even if the current violation is not the same as the previous violation.

4. The violation history over the past three years.

5. The violation was repeated within one year.

6. The violator impeded, or otherwise failed to cooperate with, the Department’s inspection and/or investigation.

7. Whether the violation resulted from negligence or an intentional act.

8. The cost of enforcement action.

9. The number of other violations proven in the same proceeding.

10. The benefit to the violator.

(b) Mitigating Factors:

1. Any documented efforts by the violator at rehabilitation.

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

3. Acts of God or nature that impaired the ability of the violator to comply with Chapter 500, F.S., or 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 disciplinary history of the violator.

6. The violator expeditiously took affirmative or corrective action after it received written notification of the violation to rectify any financial damage or harm to the public.

7. If a repeat violation, whether three years has passed since the prior violation.

(8) The provisions of this rule chapter shall not be construed so as to prohibit or limit any other civil action or criminal prosecution that may be brought.

(9) In addition to the penalties established in this rule, the Department reserves the right to seek to recover any other costs, penalties, attorney’s fees, court costs, service fees, collection costs, and damages allowed by law. Additionally, the Department reserves the right to seek to recover any costs, penalties, attorney’s fees, court costs, service fees, collection costs, and costs resulting from a payment that is returned for insufficient funds to the Department.

(10) Penalties.

(a) Minor Violation. Any Department investigation or inspection which reveals violations of this rule chapter in which the Department determines that the violator was unaware of the rule or unclear as to how to comply with it will result in the issuance of a Notice of Non-Compliance as the Department’s first response to the violation. For the purposes of this rule, the following violations shall be considered minor and shall result in the issuance of a notice of noncompliance:

1. Violations to paragraphs 5K-4.002(1)(c)-(e), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

2. Violations to subsection 5K-4.002(2), F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

3. Violations to Rule 5K-4.004, F.A.C., where the violation has a low potential for causing economic or physical harm to a person; adversely affecting the public health, safety, or welfare; or creating a significant threat of such harm, if left uncorrected.

4. Failure to notify the Department in writing of any changes or additions to food products to be produced or manufactured in accordance to subsection 5K-11.002(5), F.A.C.

(b) Major Violations. Any violation of Chapter 500, F.S., or this rule chapter that may result in economic or physical harm to a person or may adversely affect the public health, safety, or welfare or creates a significant threat of such harm shall be considered a major violation.

1. Tier I. Tier I major violations shall result in the issuance of a stop-sale order, and/or stop-use order. For the purposes of this rule, the following violations shall be considered Tier I violations:

a. Operating a food establishment with no hot water available.

b. Operating a food establishment while hot water is available, but the source is turned off.

c. Failure to provide copies of required microbiological and/or chemical analysis for review.

d. Operating a food establishment without the required service sink or curbed cleaning facility.

e. Failure to have an adequate or accurately maintained process control system including Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other required by Rule 5K-4.002, F.A.C.

f. Failure to follow process control system such as Hazards Analysis and Critical Control Points (HACCP), scheduled process, food safety plan, or any such other required by Rule 5K-4.002, F.A.C.

g. The manufacture, sale or delivery, holding or offering for sale any Edible that is deemed adulterated as outlined in Section 500.10, F.S.

h. The manufacture, sale or delivery, holding or offering for sale any Edible that is misbranded as provided in Section 500.11, F.S, or in 21 CFR Part 101 as incorporated in Rule 5K-4.002, F.A.C.

i. Transporting food under conditions which may render the Edible to be deemed adulterated, as provided in Section 500.10, F.S.

j. The presence of a pathogenic Escherichia Coli, Salmonella Enterica, or Listeria Monocytogenes found in the environment of a Food Establishment in a location where contamination of food is likely to occur from the presence of the organism(s). In case of such violation, a stop-use order(s) shall be issued and shall not be released by the Department until the Food Establishment has cleaned and/or repaired the affected areas and all test results following  environmental sampling  are observed by the Department and reported as “negative”  from an ISO (International Organizaiton of Standardization) 17025 based accredited laboratory certified to conduct testing for the microorganism of concern. Any and all cleaning, repairs, environmental sampling and testing shall be at the expense of the facility.

k. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K-4.002, F.A.C., where sewage is not conveyed to the point of disposal through an approved sanitary sewage system or another system constructed, maintained, and operated according to law, which may result in a way that a public health hazard or nuisance is created.

l. Violation of 21 CFR Part 117.20, as incorporated in Rule 5K-4.002, F.A.C., premises are not maintained free of roaches and rodents.

2. Tier II. Tier II violations shall result in the issuance of a stop-sale, stop-use order, and an administrative fine of $500 up to the statutory maximum. Aggravating factors, as defined in paragraph (6)(a) of this rule, shall warrant the adjustment of the fine upward per violation per aggravating factor and mitigating factors, as defined in paragraph (6)(b) of this rule, shall warrant the adjustment of the fine downward per violation per mitigating factor, but no fine shall exceed the statutory maximum as outlined in Section 570.971, F.S., as applicable. If, three years after the day of the last violation under Chapter 500, F.S., or this rule chapter, no new violation has occurred, all previous fines shall be disregarded when administering a fine for the next violation. For the purposes of this rule, the following violations shall be considered Tier II violations:

a. Violations that result in a second and any subsequent notice of non-compliance or Tier 1 major violation for the same or similar offense, within a three-year period.

b. The receipt of two or more consecutive inspection reports not meeting requirements.

c. The receipt of an inspection report not meeting inspection requirements, followed by an inspection report meeting inspection requirements, followed by an inspection report not meeting inspection requirements, within a three-year period.

d. Refusal to permit entry or inspection during operating hours as required by Section 500.147, F.S.

e. Operating as a food establishment without a valid food permit, as provided in Section 500.12, F.S.

f. Any violation requiring an Immediate Final Order, as authorized by Chapter 500, F.S.

(11) Willful violations shall result in the imposition of an administrative fine of $5,000 per violation, permit suspension, or permit revocation or any combination thereof. The following shall constitute a willful violation:

(a) The unauthorized breaking, cutting, or removal of any seal or tag applied by the Department.

(b) The sale or distribution, or offering for sale or distribution, of any commodity under stop sale order unless done so within the parameters of a conditional release.

(c) The use of any equipment under stop use order unless done so within the parameters of a conditional release.

(d) Failure to comply with conditions stipulated in a release of a stop sale, and/or stop use order.

(e) The intentional introduction of adulterated or misbranded products into commerce.

(f) The failure to comply with either a Final Order, Immediate Final Order, or a Default Final Order of the Department.

(g) Operating a food establishment that has been deemed an imminent threat to the public health, safety, and welfare by the Department for failure to comply with Chapter 500, F.S., and this rule chapter.

(h) The falsification of any records required under Chapter 500, F.S., and this rule chapter.

(12) Resolution Of Violations, Settlement, And Additional Enforcement Remedies.

(a) The Department and person(s) charged with a violation may agree to resolve violations prior to an administrative hearing or enter into settlement pursuant to Section 120.57(4), F.S. The penalties addressed in this rule chapter shall not be construed to limit the authority of the Department to resolve violations prior to or after initiation of any administrative action or to settle with any party. The Department shall utilize all available remedies to ensure compliance including administrative action, civil actions, settlements, and referrals for criminal prosecution. The Department shall enforce a failure to comply with an agreement to resolve violations or a settlement agreement with the penalties and remedies provided in the agreement and as authorized by Chapter 120 or 500, F.S.

(b) Failure to respond to an administrative complaint shall result in the entry of a Default Final Order against the violator or entity responsible for the violation. The Department shall impose administrative fines in a Default Final Order equal to the maximum amount possible, not to exceed $5,000 per violation.

(c) A violator’s failure to comply with either a Final Order or a Default Final Order of the Department shall result in additional enforcement actions as authorized by law.

(d) Fines resulting from multiple violations or Final Orders shall be assessed cumulatively.

Rulemaking Authority 500.09, 500.12, 570.07(23) FS. Law Implemented 500.04, 500.09, 500.121, 500.171, 500.172, 500.173, 500.174, 500.177 FS. History–New 3-16-20.