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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER DGENERAL
RULE §289.205Hearing and Enforcement Procedures

    (C) Adjustments to the percentages of base amounts in Table IB may be made for the presence or absence of the following factors:

      (i) prompt identification and reporting;

      (ii) corrective action to prevent recurrence;

      (iii) compliance history;

      (iv) prior notice of similar event;

      (v) multiple occurrences; and

      (vi) negligence that resulted in or increased adverse effects.

    (D) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Act or a rule, order, license or registration issued in accordance with the Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment.

  (4) The department may conduct settlement negotiations.

(k) Severity levels of violations for licensees, registrants, certified industrial radiographers, or other persons.

  (1) Violations for licensees, registrants, certified industrial radiographers, or other persons shall be categorized by one of the following severity levels.

    (A) Severity level I are violations that are most significant and may have a significant negative impact on occupational and/or public health and safety or on the environment. Severity level I violations are most significant and may have a significant negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety.

    (B) Severity level II are violations that are very significant and may have a negative impact on occupational and/or public health and safety or on the environment. Severity level II violations are very significant and may have a negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety.

    (C) Severity level III are violations that are significant and which, if not corrected, could threaten occupational and/or public health and safety or the environment. Severity level III are significant and, if not corrected, could increase the risk of unauthorized use of radioactive material that would be detrimental to public health and safety.

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

    (E) Severity level V are violations that are of minor safety or environmental significance.

  (2) Additional violations for mammography registrants. Violations for mammography registrants shall be categorized by one of the following severity levels.

    (A) Severity level I violations indicate a serious noncompliance that may adversely affect image quality or that may compromise the quality of mammography services.

    (B) Severity level II violations indicate key quality system requirements are being met, but there is a failure to meet one or more quality standards that may lead to a compromise of the quality of mammography services.

    (C) Severity level III violations indicate that the quality system requirements are being met, but minor corrective actions are required for compliance with the quality standards.

    (D) Severity level IV violations indicate that the quality system requirements and standards are being met, but minor corrective actions are required for compliance.

  (3) Criteria to elevate or reduce severity levels.

    (A) Severity levels may be elevated to a higher severity level for the following reasons:

      (i) more than one violation resulted from the same underlying cause;

      (ii) a violation contributed to or was the consequence of the underlying cause, such as a management breakdown or breakdown in the control of licensed or registered activities;

      (iii) a violation occurred multiple times between inspections;

      (iv) a violation was willful or grossly negligent;

      (v) compliance history; or

      (vi) other mitigating factors.

    (B) Severity levels may be reduced to a lower level for the following reasons:

      (i) the licensee/registrant identified and corrected the violation prior to the agency inspection;

      (ii) the licensee/registrant's actions corrected the violation and prevented recurrence; or

      (iii) other mitigating factors.

  (4) Examples of severity levels. Examples of severity levels are available upon request to the agency.

(l) Impoundment of sources of radiation.

  (1) In the event of an emergency, the agency shall have the authority to impound or order the impounding of sources of radiation possessed by any person not equipped to observe or failing to observe the provisions of the Act, or any rules, license or registration conditions, or orders issued by the agency. The agency shall submit notice of the action to be published in the Texas Register no later than 30 days following the end of the month in which the action was taken.

  (2) At the agency's discretion, the impounded sources of radiation may be disposed of by:

    (A) returning the source of radiation to a properly licensed or registered owner, upon proof of ownership, who did not cause the emergency;

    (B) releasing the source of radiation as evidence to police or courts;

    (C) returning the source of radiation to a licensee or registrant after the emergency is over and settlement of any compliance action; or

    (D) sale, destruction or other disposition within the agency's discretion.

  (3) If agency action is necessary to protect the public health and safety, no prior notice need be given the owner or possessor. If agency action is not necessary to protect the public health and safety, the agency will give written notice to the owner and/or the possessor of the impounded source of radiation of the intention to dispose of the source of radiation. Notice shall be the same as provided in subsection (i)(8) of this section. The owner or possessor shall have 30 days from the date of personal service or mailing to request a hearing in accordance with 1 TAC, Chapter 155, and the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title, and in accordance with subsection (i)(9) of this section, concerning the intention of the agency. If no hearing is requested within that period of time, the agency may take the contemplated action, and such action is final.

  (4) Upon agency disposition of a source of radiation, the agency may notify the owner and/or possessor of any expense the agency may have incurred during the impoundment and/or disposition and request reimbursement. If the amount is not paid within 60 days from the date of notice, the agency may request the Attorney General to file suit against the owner/possessor for the amount requested.

  (5) If the agency determines from the facts available to the agency that an impounded source of radiation is abandoned, with no reasonable evidence showing its owner or possessor, the agency may make such disposition of the source of radiation as it sees fit.

(m) Emergency orders.

  (1) When an emergency exists requiring immediate action to protect the public health or safety or the environment, the agency may, without notice or hearing, issue an order citing the existence of such emergency and require that certain actions be taken as it shall direct to meet the emergency. The agency shall, no later than 30 days following the end of the month in which the action was taken, submit notice of the action for publication in the Texas Register. The action taken will remain in full force and effect unless and until modified by subsequent action of the agency.

  (2) In addition to the requirements of paragraph (1) of this subsection, the agency shall issue an order directing any action and corrective measure needed to remedy or neutralize the following emergency situations:

    (A) when the agency determines that byproduct material as defined in the Act, §401.003(3)(B), or the operation generating the byproduct material, or that radioactive waste threatens the public health or safety or the environment; and

    (B) if the person managing the byproduct material, or the operation generating the byproduct material or the radioactive waste, is unable to correct or neutralize the threat.

  (3) An emergency order takes effect immediately upon service.

  (4) Any person receiving an emergency order shall comply immediately.

  (5) The agency shall use any security provided by a licensee in accordance with the Act to pay toward the costs of such actions and corrective measures taken. If the cost of actions and corrective measures require more funds than the security has provided, the agency shall request the Attorney General to seek reimbursement from the licensee or person causing the threat.

Cont'd...

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