Section 563.153 - Enforcement(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).26 Tex. Admin. Code § 563.153
Transferred from 25 TAC § 229.153 Texas Register, Volume 49, Number 45, November 8, 2024, TexReg 9026 eff. 11/29/2024