1. (a) Proposals for assessment of administrative or civil penalties. The department shall propose to assess administrative or civil penalties in accordance with the requirements of the Health and Safety Code, Chapter 145 concerning Tanning Facility Regulation Act; Chapter 146 concerning Tattoo Studio Act; Chapter 431 concerning Texas Food, Drug, and Cosmetic Act; Chapter 432 concerning Texas Food, Drug, Device, and Cosmetic Salvage Act; Chapter 437 concerning Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors; and Chapter 466 concerning Regulation of Narcotic Drug Treatment Programs.
2. (b) Assessment of administrative or civil penalties and conduct of hearings. The department shall assess administrative or civil 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 §§2001.001-2001.92; and the department's formal hearing procedures in §§1.21-1.34 of this title (relating to Formal Hearing Procedures).

3. (c) Criteria for the assessment of administrative or civil penalties. The department shall assess administrative or civil penalties in accordance with the following criteria:

   1. (1) history of previous violations;
   2. (2) seriousness of the violation;
   3. (3) hazard to the health and safety of the public; and
   4. (4) demonstrated good faith.

4. (d) Severity levels.

   1. (1) Violations. The violations shall be categorized by one of the following severity levels.

      1. (A) Severity Level I 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. (B) Severity Level II 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. (C) Severity Level III 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. (D) Severity Level IV covers violations that are of more than minor significance, and if left uncorrected, would lead to more serious circumstances.
      5. (E) Severity Level V covers violations that are of minor safety or fraudulent significance.
   2. (2) 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.
   3. (3) Examples of severity levels. Several examples are set out in subsection (i) of this section.

5. (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. (1) Level I--$15,000-25,000;
   2. (2) Level II--$10,000-15,000;
   3. (3) Level III--$5,000-10,000;
   4. (4) Level IV--$2,500-5,000; and
   5. (5) Level V--$1,000-2,500.

6. (f) Levels of penalties for retail food establishments. As to retail food establishments, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

   1. (1) Level I--$7,500-10,000;
   2. (2) Level II--$5,000-7,500;
   3. (3) Level III--$2,500-5,000;
   4. (4) Level IV--$1,250-2,500; and
   5. (5) Level V--$500-1,250.

7. (g) Levels of penalties for tattoo studios. As to tattoo studios, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

   1. (1) Level I--$4,000-5,000;
   2. (2) Level II--$3,000-4,000;
   3. (3) Level III--$2,000-3,000;
   4. (4) Level IV--$1,000-2,000; and
   5. (5) Level V--$250-1,000.

8. (h) 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. (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. (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. Good faith effort will be determined by the department on a case-by-case basis. 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. (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:

      1. (A) whether any death(s), disease or injuries have occurred from the violation;
      2. (B) whether any existing conditions contribute to a situation that could expose humans to a health hazard;
      3. (C) the impact that the hazard has on various segments of the population such as children, surgical patients, and the elderly; and
      4. (D) whether the consequences would be of an immediate or long-range hazard.

   4. (4) Implementation of a voluntary Hazard Analysis Critical Control Point (HACCP) Plan.

      1. (A) The department may consider implementation of a voluntary Hazard Analysis and Critical Control Point (HACCP) plan. The penalty may be reduced within the specified range of each severity level if the person, firm, or corporation implements a voluntary HACCP plan which is effective in correcting the violation(s) within 60 days of receiving notice of the violation(s). The HACCP plan is a written document based on the principles of HACCP, a food safety control system, which delineates the procedures to be followed to assure the control of a specific process or procedure. The HACCP plan shall include:

         1. (i) an analysis of biological, chemical, or physical hazards that may cause a food to be unsafe for consumption and a list of steps in the process where significant hazards occur with descriptions of the preventive measures;
         2. (ii) identification of the critical control points (CCPs) in the process at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels;
         3. (iii) critical limits or specifications which must be met for each preventive measure associated with each identified CCP;
         4. (iv) CCP monitoring requirements and procedures for using the results to adjust the process and maintain control;
         5. (v) corrective actions to be taken when monitoring indicates there is a deviation from established critical limit;
         6. (vi) effective record-keeping procedures that document the HACCP system; and
         7. (vii) procedures for verification that the HACCP system is working correctly.
      2. (B) Correction of violations through implementation of the HACCP plan will be determined by the department on a case-by-case basis. The HACCP plan and all required HACCP records shall be provided for review and copying upon request of an authorized agent of the commissioner. All required HACCP records shall be maintained at the plant for two years or longer if the product remains in distribution.
   5. (5) Requirement of food manager training. The penalty may be reduced within the range specified for each severity level upon successful completion of a Food Protection Manager Certification course accredited by the department by all managers of a food service establishment or retail food store operation.
   6. (6) Adjustments. Adjustments to the penalty amounts enumerated in paragraphs (1)-(5) of this subsection may not exceed or fall below the limitations described in subsections (e), (f), and (g) of this section.

9. (i) Examples of severity levels. The following examples of severity levels are neither exhaustive nor controlling. They reflect only the seriousness of the violation and not the history of previous violations, the hazard to the health and safety of the public, or the demonstrated good faith.

   1. (1) Severity I--most significant violations.

      1. (A) A foodborne disease outbreak results from consumption of a processed food product. Laboratory tests confirm the product is contaminated with pathogenic bacteria associated with insanitary conditions. Investigation reveals the processor continued operating during a sewage back-up in the food processing area.
      2. (B) A retail food establishment is implicated in a foodborne disease outbreak. Epidemiologic analysis identifies the food as the source of the illness. Follow-up investigation at the establishment reveals the food is prepared or held at temperatures that pose a critical health hazard.
      3. (C) An unlicensed salvage operator removess a truck load of flood water contaminated food and drug products, which had been placed under detention, to his place of business.
      4. (D) A person, firm, or corporation manufactures an unapproved drug and/or device that is associated with death or injury to the user.
      5. (E) A person, firm, or corporation distributes an unapproved drug and/or device as a cure or treatment for a life threatening illness, such as cancer or AIDS, and is associated with death or injury to the user.
      6. (F) A narcotic treatment program's failure to comply with federal and state regulations is associated with the death or injury of a patient.
      7. (G) A tattoo studio does not use properly sterilized tattooing equipment and has consumer complaints of infection associated with the application of tattoos.
      8. (H) A tanning facility replaces ultraviolet lamps in its tanning device with higher intensity, non-equivalent lamps or installs a timer for its tanning device which causes the device to exceed the maximum allowable exposure time determined by the manufacturer. Either of these changes result in second or third degree burns to a user of a device, requiring the user to seek medical attention.
      9. (I) A tanning facility fails to provide protective eyewear to a user of its tanning device which results in the user suffering corneal burns or other injuries to the eye.

   2. (2) Severity II--very significant violations.

      1. (A) An inspection of a large volume chocolate candy manufacturer reveals very poor sanitary practices. Laboratory results reveal the presence of pathogenic microogranisms in the candy. No cases of illness that could be traced to the candy have yet been reported.
      2. (B) Inspection of a food establishment reveals food temperature violations posing a potential health hazard. Laboratory tests confirm the food is contaminated with pathogenic microorganisms. No foodborne illness outbreaks have been previously reported to the department from the owner, manager, or employee of establishment, or from the public.
      3. (C) Inspection of a food establishment reveals the presence of plumbing violations possibly causing contamination of the facility's water supply. Laboratory analysis indicates the water supply is contaminated. No foodborne outbreaks have been previously reported to the department from the owner, manager, or employee of the establishment, or from the public.
      4. (D) A grain dealer has distributed tons of corn for human consumption. Laboratory tests confirm the corn contains aflatoxin that exceeds the level for human consumption.
      5. (E) A person, firm, or corporation is distributing counterfeit drugs and/or devices to the public.
      6. (F) A person, firm, or corporation is manufacturing a drug or device determined by the department to be potentially harmful to the public or without pre-market approval.
      7. (G) A person, firm, or corporation diverts dangerous drugs and/or controlled substances outside legal distribution channels or fails to take adequate steps to prevent illegal distribution.
      8. (H) A narcotic treatment program admits a patient or patients into maintenance treatment who does not meet the minimum standards for admission.
      9. (I) Evidence is discovered that a tattoo studio is illegally tattooing minors.
      10. (J) A tanning facility replaces ultraviolet lamps in its tanning device with higher intensity, non-equivalent lamps or installs a timer on its tanning device which causes the device to exceed the maximum allowable exposure time determined by the manufacturer. No injuries due to over exposure were reported by the owner, manager, or employee of the facility, or by the public.

   3. (3) Severity III--significant violations.

      1. (A) Inspection of a food establishment reveals the presence of pooled sewage near the water well. There is no indication the water supply is contaminated, but there is a great potential for occurrence.
      2. (B) Inspection of a food establishment reveals food ingredients contaminated by dust, insects, rodents, unclean equipment and utensils, unnecessary handling, coughs, sneezes, flooding drainage, overhead leakage, or overhead drippage from condensation. None of the contaminated food ingredients has been used to make the finished product.
      3. (C) A bottling plant has repeatedly produced beverages that contain foreign objects such as cigarette packages, tooth brushes, metal fragments, or other foreign matter.
      4. (D) Inspection of a food establishment reveals the establishment is operating without hot water or without an adequate water supply.
      5. (E) Inspection of a food establishment reveals employees touching ready-to-eat foods with unclean hands.
      6. (F) Inspection of a food establishment reveals unclean, unsanitized food contact surfaces of equipment.
      7. (G) The operator of an establishment refuses to permit an authorized agent of the department to conduct an inspection, collect samples, or otherwise perform his/her official duties.
      8. (H) A person, firm, or corporation fails to comply with the current good manufacturing practices for finished pharmaceuticals or devices.
      9. (I) An applicant has falsified information on the license application to the department concerning a wholesale drug or device.
      10. (J) A narcotic treatment program delivers narcotic drugs to a patient without a physician's order.
      11. (K) An inspection reveals that a narcotic treatment program fails to perform required laboratory tests on program patients such as tuberculosis screens, urine analysis, or other required tests.
      12. (L) A person, firm, or corporation diverts over-the-counter drugs outside legal distribution channels or fails to take adequate steps to prevent illegal distribution.
      13. (M) A tattoo facility operator fails to report to the department an injury or illness associated with a tattoo.
      14. (N) A tanning facility operator allows a consumer to be exposed to ultraviolet radiation from its tanning device more than once in a 24-hour period.
      15. (O) A sanitizer used to sanitize the body contact surfaces of a tanning device was tested and found to have an active ingredient concentration that is lower than recommended by the manufacturer. The body contact surfaces of a tanning device are tested and found to be positive for human pathogenic bacteria. No injuries to users were reported to have occurred as a result of this incident.
      16. (P) A tanning facility fails to report injuries or illnesses associated with one of its tanning devices to the department.

   4. (4) Severity IV--violations.

      1. (A) A frozen shrimp processor has failed to declare sodium bisulfite on the labeling of his five pound and ten pound boxes of shrimp tails.
      2. (B) A cannery has dicovered a defective part on a closing machine which has resulted in the improper sealing of 360,000 cases of cut green beans. The entire lot has been shipped to five midwestern states. To date, no complaints have been received regarding any part of the lot.
      3. (C) Inspection of a food establishment reveals evidence of current rodent or insect activity, but no contaminated foods are identified.
      4. (D) A person, firm, or corporation is distributing drugs or devices that have been held outside of recommended storage temperatures.
      5. (E) A person, firm, or corporation is distributing damaged and expired drugs or devices.
      6. (F) A person, firm, or corporation is distributing drugs or devices labeled only in a foreign language.
      7. (G) An applicant has falsified information on a tattoo or tanning facility license application.
      8. (H) A physician is administering or dispensing a narcotic drug to treat opiate addiction outside a licensed narcotic treatment program or detoxification hospital, not including addiction treatment performed as an incidental adjunct to medical or surgical treatment of conditions other than addiction.
      9. (I) The work surfaces in a tattoo studio are not properly cleaned and disinfected.
      10. (J) A tanning facility falsifies or fails to maintain information required to be kept in individual consumer records such as ultraviolet radiation exposure times, frequency of ultraviolet radiation exposures, or informed consent for minors.

   5. (5) Severity V--minor violations.

      1. (A) A retail food store has installed red-tinted flourescent lighting in all meat cases to bring out the natural color in the red meat cuts thereby making the meat appear to be a higher quality.
      2. (B) A food manufacturer has used an unapproved food additive in his food product.
      3. (C) A food manufacturer fails to label or misbrands a product resulting in minor public health or fraudulent significance.
      4. (D) A person, firm, or corporation has failed to obtain a required license or permit from the department.
      5. (E) A person, firm, or corporation is distributing drugs or devices with inaccurate or misleading labeling which the department determines is not likely to cause death or injury.
      6. (F) A narcotic treatment program is not providing required counseling services for patients.
      7. (G) An inspection of a tattoo studio reveals the studio to be unsanitary or in general disrepair and there are no complaints of infection associated with the application of tattoos.
      8. (H) Warning signs in a tanning facility do not comply with size, design, or content requirements.

Source Note:The provisions of this §229.261 adopted to be effective July 17, 1987, 12 TexReg 2147; amended to be effective November 19, 1996, 21 TexReg 11373.