Current through Reg. 49, No. 38; September 20, 2024
(a) Denial, Suspension or Revocation of
Permit. Except for Emergency Orders under the Health and Safety Code, §
466.041, after
notice to an applicant or a permit holder and after the opportunity for a
hearing, the department may:
(1) deny an
application of the person if the person fails to comply with this chapter or
the rules establishing minimum standards for the issuance of a permit adopted
under this chapter; or
(2) suspend
or revoke the permit of a person who has committed a Level I, II, or III
violation as defined in subsection (d) of this section.
(b) Administrative Penalty. When a person
violates this chapter, a rule adopted under this chapter, or an order or permit
issued under this chapter, the commissioner may assess an administrative
penalty against the person.
(c)
Criteria for the assessment of administrative penalties. Administrative
penalties will be assessed in accordance with the following criteria:
(1) history of previous violations;
(2) seriousness of the violation;
(3) hazard to the health and safety of the
public; and
(4) demonstrated good
faith.
(d) Severity
levels.
(1) Severity Level I, penalty of
$7,500-10,000, covers violations that are most significant and have a direct
negative impact on the public health and safety including, but not limited to,
adulteration, misbranding, or false advertising that results in
fraud.
(2) Severity Level II,
penalty of $5,000-7,500, covers violations that are very significant and have
an impact on the public health and safety including, but not limited to,
adulteration, misbranding, or false advertising that results in
fraud.
(3) Severity Level III,
penalty of $2,500-5,000, covers violations that are significant and which, if
not corrected, could threaten the public and have an adverse impact on the
public health and safety including, but not limited to, adulteration,
misbranding, or false advertising that results in fraud.
(4) Severity Level IV, penalty of
$1,250-2,500, covers violations that are of more than minor significance, and
if left uncorrected, would lead to more serious circumstances.
(5) Severity Level V, penalty of $500-1,250,
covers violations that are of minor safety or fraudulent
significance.
(e)
Severity of a violation. The severity of a violation may be increased if the
violation involves deception, fraud, or other indication of willfulness. In
determining the severity of a violation, there shall be taken into account the
economic benefit gained through noncompliance.
(f) Adjustments to penalties. The department
may make adjustments to the penalties listed in subsections (e), (f), or (g) of
this section for any one of the following factors.
(1) Previous violations. The department may
consider previous violations. The penalty may be reduced or increased within
the specified range of each severity level for past performance. Past
performance involves the consideration of the following factors: whether the
previous violation was identical or similar to the current violation; how
recent the previous violation was; the number of previous violations; and the
violator's response to previous violation(s) in regard to correction of the
problem.
(2) Demonstrated good
faith. The department may consider good faith effort(s) of the violator to
correct the violations and demonstrate compliance with the department's rules
and regulations as a basis to reduce the proposed penalty. The penalty may be
reduced within the specified range of each severity level if good faith efforts
to correct a violation have been, or are being made. The department on a
case-by-case basis will determine good faith effort. All good faith effort(s)
to comply with the department's rules and regulations must be fully documented
by the violator to merit consideration from the department as to whether to
reduce the proposed penalty.
(3)
Hazard to the health and safety of the public. The department may consider the
hazard to the health and safety of the public. The penalty may be increased
within the specified range of each severity level when a direct hazard to the
health and safety of the public is involved. It shall take into account, but
need not be limited to, the following factors:
(A) whether any death(s), disease or injuries
have occurred from the violation;
(B) whether any existing conditions
contribute to a situation that could expose humans to a health
hazard;
(C) the impact that the
hazard has on various segments of the population such as children, surgical
patients, and the elderly; and
(D)
whether the consequences would be of an immediate or long-range
hazard.
(g)
Hearings, appeals from, and judicial review of final administrative decisions
under this section shall be conducted according to the contested case
provisions of the Government Code, Chapter 2001. Any hearings under this
section are governed by §§
1.21,
1.23,
1.25 and
1.27 of
this title (relating to Formal Hearings Procedures).
