Fla. Admin. Code Ann. R. 5K-10.005 - Guidelines for Imposing Administrative Penalties
(1) This rule sets forth guidelines the
Department will follow in imposing the penalties authorized under Chapter 502,
F.S., for violations of Chapter 502, section
581.217, 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 plant 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 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, section
581.217(7),
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 Chapter 502, section
581.217(7),
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 Chapter 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, or
section 581.217(7),
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, or section
581.217(7),
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, section
581.217(7),
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, section 581.217, 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 subsections
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, as adopted by reference in paragraph
5K-10.006(6)(a),
F.A.C.
7. Out-of-State firm
operating without proper FL permit(s) as applicable.
(b) Major Violations. Any violation of
Chapter 502, section 581.217, 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. Major violations
shall result in the issuance of a stop-sale order, or stop-use order, permit
suspension. and an administrative fine of $500 up to the statutory maximum, or
any combination thereof. 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 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 major violations:
1. Producing or offering for sale
reconstituted or recombined milk or milk product.
2. 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.
3. Failure to make corrective action listed
in a notice of non-compliance within allotted time as indicated by the
Department.
4. Samples deemed
violative for residual phosphatase as outlined in Rule
5K-10.003, F.A.C.
5. 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.
6. Violations of subsection
5K-10.006(5),
F.A.C.
7. Violations of subsection
5K-10.006(6),
F.A.C.
8. Violations of labeling
requirements found in 21 CFR 101, as adopted by reference in paragraph
5K-10.006(6)(a),
F.A.C., 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.
9. Any milk and or milk product found to have
an aflatoxin limit over 0.5 ppb.
10. Equipment found to be out of compliance
or unclean in consecutive inspections.
11. Bottling or processing of animal feed
into retail containers for sale in a dairy permitted facility.
12. Repackaging of Grade "A" product in a
facility where final pasteurization does not occur.
14. 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.
15. Refusal to permit entry or inspection as
required by Section 502.014, F.S.
16. Operating as a dairy establishment or
frozen dessert plant without a valid dairy permit, as provided in Section
502.053, F.S.
17. The misbranding of species identification
in milk products.
18. The
introduction of adulterated or misbranded products into commerce.
19. Violations of subsection
5K-10.006(7),
F.A.C.
(c) Willfull
Violations. Willful violations shall result in the imposition of an
administrative fine of $5, 000 for each violation in the case of a frozen
dessert licensee, $1, 000 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:
1. The unauthorized breaking, cutting, or
removal of any seal or tag applied by the Department.
2. 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.
3. The use of any equipment under Stop-use
order unless done so within the parameters of a conditional release.
4. Failure to comply with conditions
stipulated in a release of a Stop-sale, and/or Stop-use order.
5. The intentional misbranding of species
identification in milk products.
6.
The intentional introduction of adulterated or misbranded products into
commerce.
7. The failure to comply
with either a Final Order or a Default Final Order of the Department.
8. The unathorized tampering with, removal,
or circumvention of public health controls applied by the Department.
9. The falsification of any records required
under Chapter 502, F.S., or this rule chapter.
10. Violations of Section
502.091(1),
F.S.
11. 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.
12. 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.
Notes
Rulemaking Authority 500.09, 502.014, 570.07(23), 570.971(5), 581.217(12) FS. Law Implemented 500.172, 502.014, 502.053, 502.091, 502.121, 502.231, 518.217(7) FS.
New 6-29-22, Amended 11-5-23.
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