Current through Reg. 50, No. 249, December 24, 2024
(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 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 500, F.S., after two 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.
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.
New 3-16-20.
