The purpose of this rulemaking is to establish guidelines for administering penalties for violations. Additionally, the updated rule package will institute a more defined enforcement matrix for common issues found in the ....

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-10.005Guidelines for Imposing Administrative Penalties

PURPOSE AND EFFECT: The purpose of this rulemaking is to establish guidelines for administering penalties for violations. Additionally, the updated rule package will institute a more defined enforcement matrix for common issues found in the dairy industry.

SUMMARY: Chapter 502, F.S. enables the Department’s authority to regulate milk, milk products and frozen desserts as defined therein. This rulemaking will enable a new update to imposing administrative penalties. This will help maintain facilities and inspections for the Department to meet their responsibility of ensuring a safe food supply for consumers.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The department’s proposed rules do not increase fees or otherwise impose any other costs, directly or indirectly, on the regulated industry.

Based on this information, the department determined there will be no adverse impact to small businesses and the potential regulatory costs of the proposed rule chapter does not exceed any of the criteria established in Section 120.541(2)(a), F.S. Additionally, no interested party submitted additional information regarding the economic impact.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 502.014, 570.07(23), FS.

LAW IMPLEMENTED: 502.014, 502.053, 502.091, 502.121, 502.231, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jennifer Lester by email at

[e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-10.005 Guidelines for Imposing Administrative Penalties.

(1) This rule sets forth the guidelines the Department will follow in imposing the penalties authorized under

Chapter 502, F.S., for violations of Chapter 502, F.S., and this rule chapter. The purpose of these 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 increase or reduce penalties to be imposed. No aggravating factors will be applied to increase a fine imposed for a single violation above the statutory maximum as follows:

(a) In the case of a frozen dessert licensee, the fine imposed for each violation shall not exceed $5,000 as provided in section 570.971, F.S., for Class II category;

(b) In the case of failure to report the information described in section 502.053(3)(d), F.S., the fine imposed shall not exceed ten percent of the license fee or $100, whichever is greater; and

(c) In the case of any other violation, the fine imposed shall not exceed $1000 for each occurrence as provided in section 570.971, F.S., for a Class I category.

(2) The guidelines in this rule 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.

(3) The Department will enforce compliance with Chapter 502, F.S., and this rule chapter by issuing an administrative complaint, a stop-sale order, or stop-use order, notice of non-compliance, permit suspension or revocation for violations of Chapters 502, F.S., and this rule chapter.

(4) 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.

(5) 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 aggravating or mitigating factors listed in this rule.

(6) Aggravating and Mitigating Factors. The Department will consider aggravating and mitigating factors in determining penalties for violations of Chapters 502, 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 502, 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 502, F.S., after one disciplinary administrative complaint involving the same permitholder has been filed with the Agency Clerk within the three years preceding 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 502, F.S., after two disciplinary administrative complaints involving the same permitholder has been filed with the Agency Clerk within the three years preceding 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 502, 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.

(7) 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.

(8) 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.

(9) 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 sections 5K-10.003(1) and (2), F.A.C., pertaining to dating standards for milk, milk products, manufactured milk products and frozen desserts, 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. Misbranded or mislabeled Grade “A”, manufactured milk, or frozen dessert product 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 of rule 5K-10.004, F.A.C., pertaining to submitting and approval of dairy farm plans prior to beginning work, 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. Violations of Rule 5K-10.004, F.A.C., pertaining to submitting and approval of milk plant, frozen dessert plant, receiving station or transfer station plans prior to beginning work, 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.

5. Grade “A” milk plant or frozen dessert plant, whether located in the state or outside the state, offering products for sale in the state without a valid Florida permit.

6. Violations of the labeling requirements found in 21 CFR 101.

7. Out-of-State firm operating without proper FL permit(s) as applicable.

8. Repeat violations of 5K-10.006, F.A.C. as found on consecutive inspections.

(b) Major Violations. Any violation of Chapter 502, 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 major violations. Tier 1 major violations shall result in the issuance of a stop-sale order, stop-use order, permit suspension. For the purposes of this rule, the following violations shall be considered Tier I violations:

a. Producing or offering for sale reconstituted or recombined milk or milk product.

b. Grade “A” milk products found offered for sale in the State of Florida produced in a facility outside the State  of  Florida  that  is  not  included  on  the  Interstate  Milk  Shippers  list,  available  online  at https://www.fda.gov/Food/GuidanceRegulation/FederalStateFoodPrograms/ucm2007965.htm.

c. Failure to make corrective action listed in a notice of non-compliance within allotted time as indicated by the Department.

d. Samples deemed violative for residual phosphatase as outlined in Rule 5K-10.003, F.A.C.

e. Manufactured milk or frozen dessert products deemed violative for Pathogens, Listeria monocytogenes, salmonella, E. Coli (STEC) and/or Staphylococcal enterotoxin as outlined in Rule 5K-10.003, F.A.C.

f. Violations of Rule 5K-10.006(5).

g. Violations of Rule 5K-10.006(6).

h. Violations of labeling requirements found in 21 CFR 101 that could result in economic or physical harm to a person or may adversely affect public health, safety, or welfare or create a significant threat as determined by the Department.

i. Any milk and or milk product found to have an aflatoxin limit over 0.5 ppb.

j. Equipment found to be out of compliance or unclean in consecutive inspections.

k. Bottling or processing of animal feed into retail containers for sale in a dairy permitted facility.

l. Repackaging of Grade “A” product in a facility where final pasteurization does not occur.

m. Violation of Rule 5K-10.004(1) 9 and/or Rule 5K-10.004(2) 17.

2. Tier II Major Violations. Tier II violations shall result in the issuance of a stop-sale or 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 (7)(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 502, 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 minor violation for the same or similar offense within a three-year period.

b. Refusal to permit entry or inspection as required by section 502.014, F.S.

c. Operating as a dairy or frozen dessert establishment without a valid dairy permit, as provided in section 502.053, F.S.

d. The misbranding of species identification in milk products.

e. The introduction of adulterated or misbranded products into commerce.

f. Violations of Rule 5K-10.006(7).

3. Willfull Violations. Willful violations shall result in the imposition of an administrative fine of $5000 for each violation in the case of a frozen dessert licensee, $1000 for each occurrence of a willful violation by any other permit holder, permit suspension, 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 misbranding of species identification in milk products.

f. The intentional introduction of adulterated or misbranded products into commerce.

g. The failure to comply with either a Final Order or a Default Final Order of the Department.

h. The unathorized tampering with, removal, or circumvention of public health controls applied by the Department.

i. The falsification of any records required under Chapter 502, F.S., or this rule chapter.

j. Violations of section 502.091(1), F.S.

k. Operating a dairy or frozen dessert establishment that has been deemed an imminent threat to the public health, safety, and welfare by the Department for failure to comply with Chapter 502, F.S. or this rule chapter.

l. Marketing and/or sale of products labeled as animal feed for human consumption.

(10) 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 502, 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 authorized by section 502.231, F.S.

(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 502.014, 570.07(23) FS. Law Implemented 502.014, 502.053, 502.091, 502.121, 502.231, FS.

History–New.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jennifer Lester, Bureau Chief

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole "Nikki" Fried, Commissioner of Agriculture

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 1/28/2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 4/15/2021, Vol. 47 No. 73