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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER PASSESSMENT OF ADMINISTRATIVE PENALTIES
RULE §229.261Assessment of Administrative Penalties

(a) Proposals for assessment of administrative penalties. The department shall propose to assess administrative penalties in accordance with the requirements of the Texas Health and Safety Code, Chapter 146 concerning Tattoo and Certain Body Piercing Studios; Chapter 431 concerning Texas Food, Drug, and Cosmetic Act; Chapter 432 concerning Texas Food, Drug, Device, and Cosmetic Salvage Act; and Chapter 437 concerning Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors.

(b) Assessment of administrative penalties and conduct of hearings. The department shall assess administrative penalties and conduct hearings pursuant to those administrative penalties in accordance with the appropriate statute in subsection (a) of this section and rules adopted under it; the Administrative Procedure Act, Texas Government Code, Chapter 2001; and the department's formal hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).

(c) Criteria for the assessment of administrative penalties. The department shall assess administrative penalties based upon one or more of the following criteria:

  (1) history of previous violations;

  (2) seriousness of the violation;

  (3) hazard to the health and safety of the public;

  (4) demonstrated good faith efforts to correct;

  (5) economic harm to property or the environment;

  (6) amounts necessary to deter future violations;

  (7) enforcement costs relating to the violation; and

  (8) any other matter justice may require.

(d) Severity levels. The violations shall be categorized by one of the following severity levels.

  (1) Severity Level I covers violations that are most significant and may have a significant negative impact on the public health and safety.

  (2) Severity Level II covers violations that are very significant and may have a negative impact on the public health and safety.

  (3) Severity Level III covers violations that are significant and, if not corrected, could threaten the public health and safety.

  (4) Severity Level IV covers violations that are of more than minor significance, but if left uncorrected, could lead to more serious circumstances.

  (5) Severity Level V covers violations that are of minor health or safety significance.

(e) Levels of penalties. Except as provided for in subsection (f) of this section relating to retail food establishments and subsection (g) of this section relating to tattoo studios, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

  (1) Level I--Up to $25,000;

  (2) Level II--Up to $15,000;

  (3) Level III--Up to $10,000;

  (4) Level IV--Up to $5,000; and

  (5) Level V--Up to $2,500.

(f) Levels of penalties for retail food establishments. As to retail food establishments permitted under Texas Health and Safety Code, Chapter 437, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

  (1) Level I--Up to $10,000;

  (2) Level II--Up to $7,500;

  (3) Level III--Up to $5,000;

  (4) Level IV--Up to $2,500; and

  (5) Level V--Up to $1,250.

(g) Levels of penalties for tattoo and body-piercing studios. As to certain tattoo and body-piercing studios licensed under Texas Health and Safety Code, Chapter 146, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

  (1) Level I--Up to $5,000;

  (2) Level II--Up to $4,000;

  (3) Level III--Up to $3,000;

  (4) Level IV--Up to $2,000; and

  (5) Level V--Up to $1,000.

(h) Adjustments to penalties. The department may adjust 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 for past performance. Past performance involves the consideration of the following factors:

    (A) whether the previous violation was identical or similar to the current violation;

    (B) how recent was the previous violation;

    (C) the number of previous violations; and

    (D) the violator's response to previous violations in regard to correction of the problem.

  (2) Demonstrated good faith. The department may consider good faith efforts 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 if good faith efforts to correct a violation have been, or are being made. Good faith effort is determined by the department on a case-by-case basis. All good faith efforts 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 when a direct hazard to the health and safety of the public is involved. The department shall take into account, but need not be limited to, the following factors:

    (A) whether any deaths, diseases, 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.


Source Note: The provisions of this §229.261 adopted to be effective April 24, 2003, 28 TexReg 3337; amended to be effective December 26, 2021, 46 TexReg 9037

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