Article 4. Licensing And Regulation Of Sources Of Ionizing Radiation of California Health And Safety Code >> Division 104. >> Part 9. >> Chapter 8. >> Article 4.

(a) The department shall provide by rule or regulation for general or specific licensing of persons to receive, possess, or transfer radioactive materials, or devices or equipment utilizing these materials. That rule or regulation shall provide for amendment, suspension, or revocation of licenses.
  (b) The department may require registration and inspection of sources of ionizing radiation other than those that require a specific license, and compliance with specific safety standards to be adopted by the department.
  (c) The department may exempt certain sources of ionizing radiation or kinds of uses or users from the licensing or registration requirements set forth in this section when the department makes a finding that the exemption of these sources of ionizing radiation or kinds of uses or users will not constitute a significant risk to the health and safety of the public.
  (d) Regulations adopted pursuant to this chapter may provide for recognition of other state or federal licenses as the department may deem desirable, subject to registration requirements as the department may prescribe.
  (e) The department shall adopt registration and certification regulations for mammography equipment. These regulations shall include, but not be limited to, all of the following requirements:
  (1) An X-ray machine used for mammography shall be specifically designed for mammography and inspected by the department, or deemed satisfactory by the department based upon evidence of certification by the American College of Radiology mammography accreditation program, or an accreditation program that the department deems equivalent before it is certified.
  (2) That all persons who have a certificate for mammography equipment follow a quality assurance program to be adopted by the department to ensure the protection of the public health and safety.
  (3) That quality assurance tests, as determined by the department, are performed on all mammography equipment located in a mobile van or unit after each relocation of the mobile van or unit to a different location for the purpose of providing mammography. This equipment shall be recalibrated if images are not of diagnostic quality as determined by the department. A written record of the location of mobile vans or units with dates and times shall be maintained and available for inspection by the department.
  (4) On or after July 15, 1993, all mammography equipment shall be registered with and certified by the department. If this mammography equipment is certified by a private accreditation organization, the department shall take into consideration evidence of this private certification when deciding to issue a mammogram certification.
  (5) All licenses, permits, and certificates issued by the department pursuant to this chapter and the Radiologic Technology Act (Section 27) relating to the use of mammography equipment shall be publicly posted pursuant to this section and regulations adopted by the department.
  (f) To further ensure the quality of mammograms, the department shall require all mammogram facilities, other than mobile units or vans, to operate quickly and efficiently so as to ensure that the facilities are able to develop mammograms of diagnostic quality prior to when the patient leaves the facility.

(a) In order to better protect the public and radiation workers from unnecessary exposure to radiation and to reduce the occurrence of misdiagnosis, the Radiologic Health Branch within the State Department of Health Services shall adopt regulations that require personnel and facilities using radiation-producing equipment for medical and dental purposes to maintain and implement medical and dental quality assurance standards that protect the public health and safety by reducing unnecessary exposure to ionizing radiation while ensuring that images are of diagnostic quality. The standards shall require quality assurance tests to be performed on all radiation-producing equipment used for medical and dental purposes.
  (b) The Radiologic Health Branch shall adopt the regulations described in subdivision (a) and provide the regulations to the health committees of the Assembly and the Senate on or before January 1, 2008.
  (c) For purposes of this section, "medical and dental quality assurance" means the detection of a change in X-ray and ancillary equipment that adversely affects the quality of films or images and the radiation dose to the patients, and the correction of this change.

(a) Notwithstanding Section 6103 of the Government Code, the department shall provide by regulation a schedule of the fees that shall be paid by the following persons:
  (1) Persons possessing radioactive materials under licenses issued by the department or under other state or federal licenses for the use of these radioactive materials, when these persons use these radioactive materials in the state in accordance with the regulations adopted pursuant to subdivision (d) of Section 115060.
  (2) Persons generally licensed for the use of devices and equipment utilizing radioactive materials that are designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere, if the devices are manufactured pursuant to a specific license authorizing distribution to general licensees.
  (b) The revenues derived from the fees shall be used, together with other funds made available therefor, for the purpose of the issuance of licenses or the inspection and regulation of the licensees.
  (c) The department may adopt emergency regulations pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code to establish and adjust fees for radioactive materials licenses in an amount to produce estimated revenues equal to at least 95 percent of the department's costs in carrying out these licensing requirements, if the new fees were to remain in effect throughout the fiscal year for which the fee is established or adjusted.
  (d) A local agency participating in a negotiated agreement pursuant to Section 114990 shall be fully reimbursed for direct and indirect costs based upon activities governed by Section 115070. With respect to these agreements, any salaries, benefits, and other indirect costs shall not exceed comparable costs of the department.
  (e) The fees for licenses for radioactive materials and of devices and equipment utilizing those materials shall be adjusted annually pursuant to Section 100425.
  (f) The department shall establish fees for followup inspections related to the failure to correct violations of this chapter or regulations adopted pursuant to this chapter. The fees established by the department may be charged for each inspection visit.

The frequency of inspections of radioactive materials shall be based on priorities established by the United States Nuclear Regulatory Commission.

In addition to the annual adjustment of the fees authorized by this chapter pursuant to Section 100425, on or before January 1, 1991, the director may adopt emergency regulations in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, to establish and adjust these fees, and for purposes of that chapter, including Section 11349.6 of the Government Code, an adoption of these regulations is an emergency and shall be considered by the Office of Administrative Law as necessary for the immediate preservation of the public peace, health and safety, and general welfare.

(a) Notwithstanding Section 6103 of the Government Code, the department shall provide by regulation a ranking of priority for inspection, as determined by the degree of potentially damaging exposure of persons by ionizing radiation and the requirements of Section 115085, and a schedule of fees, based upon that priority ranking, that shall be paid by persons possessing sources of ionizing radiation that are subject to registration in accordance with subdivisions (b) and (e) of Section 115060, and regulations adopted pursuant thereto. The revenues derived from the fees shall be used, together with other funds made available therefor, for the purpose of carrying out any inspections of the sources of ionizing radiation required by this chapter or regulations adopted pursuant thereto. The fees shall, together with any other funds made available to the department, be sufficient to cover the costs of administering this chapter, and shall be set in amounts intended to cover the costs of administering this chapter for each priority source of ionizing radiation. Revenues generated by the fees shall not offset any general funds appropriated for the support of the radiologic programs authorized pursuant to this chapter, and the Radiologic Technology Act (Section 27), and Chapter 7.6 (commencing with Section 114960). Persons who pay fees shall not be required to pay, directly or indirectly, for the share of the costs of administering this chapter of those persons for whom fees are waived. The department shall take into consideration any contract payment from the Health Care Financing Administration for performance of inspections for Medicare certification and shall reduce this fee accordingly.
  (b) A local agency participating in a negotiated agreement pursuant to Section 114990 shall be fully reimbursed for direct and indirect costs based upon activities governed by Section 115085. With respect to these agreements, any salaries, benefits, and other indirect costs shall not exceed comparable costs of the department. Any changes in the frequency of inspections or the level of reimbursement to local agencies made by this section or Section 115085 during the 1985-86 Regular Session shall not affect ongoing contracts.
  (c) The fees paid by persons possessing sources of ionizing radiation shall be adjusted annually pursuant to Section 100425.
  (d) The department shall establish two different registration fees for mammography equipment pursuant to this section based upon whether the equipment is accredited by an independent accrediting agency recognized under the federal Mammography Quality Standards Act (42 U.S.C. Sec. 263b).
  (e) The department shall establish fees for followup inspections related to the failure to correct violations of this chapter or regulations adopted pursuant to this chapter. The fees established by the department may be charged for each inspection visit.

The average inspection frequency for ionizing radiation machines shall be once each year for mammography X-ray units, once every three years for high-priority sources of ionizing radiation, and once every four and one-quarter years for medium-priority sources. Sources of ionizing radiation used in dentistry shall be screened for defects by mail or other offsite methodology not less frequently than once every five years, with physical inspection of the 50 percent, determined by the department to be most in need of inspection, to average at least once every six years.

In making the determination of whether to grant, deny, amend, revoke, suspend, or restrict a certification, registration, or license, the department may consider those aspects of a person's background that, in its judgment, bear materially on that person's ability to fulfill her or his obligations, including but not limited to technical competency and her or his current or prior record in areas involving ionizing radiation.

The department shall require a licensee or an applicant for a license pursuant to Section 115060 to receive, possess, or transfer radioactive materials, or devices or equipment utilizing radioactive materials, to provide a financial surety to ensure performance of its obligations under this chapter. The department shall establish, by regulation, the amount and type of financial surety that is required to be provided in order to provide for maximum protection of the public health and safety and the environment. The financial surety shall be in the form of surety bonds, deposits of government securities, escrow accounts, lines of credit, trust funds, credit insurance, or any other equivalent financial surety arrangement acceptable to the department. The department shall adopt the regulations in accordance with, but not limited to, the following criteria:
  (a) Consideration of the need for, and scope of, any decontamination, decommissioning, reclamation, or disposal activities required to protect the public health and safety and the environment.
  (b) Estimates of the costs of the required decontamination, decommissioning, reclamation, or disposal.
  (c) The costs of long-term maintenance and surveillance, if required.
  (d) Consideration of the appropriateness of specific requirements imposed in the financial assurance regulations adopted by the Nuclear Regulatory Commission, including, but not limited to, the minimum levels of financial assurance required to be provided by different categories of facilities, and the categories of facilities which are exempted from the requirement to provide a financial surety.

(a) The department shall deposit all money received from a financial surety provided pursuant to Section 115091 in the Financial Surety Account, which is hereby created in the Radiation Control Fund.
  (b) Notwithstanding Section 13340 of the Government Code, the money in the Financial Surety Account is hereby continuously appropriated to the department for expenditure only for the decontamination, decommissioning, reclamation, and disposal of radioactive materials, and for long-term maintenance and surveillance for the protection of the public health and safety and the environment, in accordance with subdivision (e), with regard to the facility or operations of the licensee who provided the financial surety.
  (c) The department may not expend the money in the Financial Surety Account for normal operating expenses of the department.
  (d) The department shall, by regulation, establish a procedure whereby a licensee may be refunded the amount of the financial surety provided by the licensee in excess of any amounts expended by the department and any amounts that are required to be retained to cover the costs of long-term maintenance and surveillance pursuant to subdivision (b), with regard to that licensee's facility or operations. The regulations shall specify that the refund may be received only after the department has determined that the licensee has fully satisfied all of its obligations under its license, and all other obligations which the regulations require to be satisfied before the licensee may receive a refund.
  (e) If the department finds that a radioactive materials licensee is unable to, or is unwilling to, conduct any decontamination, decommissioning, reclamation, disposal, or long-term maintenance and surveillance that may be necessary, the department shall issue an order directing any action and corrective measures it finds necessary to protect the public health and safety and the environment. The department may undertake, or contract for the undertaking of, any actions or corrective measures which the licensee fails to satisfactorily complete, and may expend the amount of the financial surety provided by the licensee to pay the costs of those actions and corrective measures.

(a) The department shall require, as a condition of issuing a license to receive, possess, or transfer radioactive materials, or devices or equipment utilizing radioactive materials, that the licensee take corrective action with regard to all contamination that results from the handling, use, storage, or transportation of radioactive materials at the licensee's facility regardless of when the contamination commenced at the facility.
  (b) Any corrective action required pursuant to this section shall require that corrective action be taken beyond the facility boundary if necessary to protect human health and safety or the environment, unless the licensee demonstrates to the satisfaction of the department that, despite the licensee's best efforts, the licensee is unable to obtain the necessary permission to undertake the corrective action.
  (c) When corrective action cannot be completed prior to issuance of the license, the license shall contain schedules of compliance for corrective action and assurances of financial responsibility for completing the corrective action.