2009 California Health and Safety Code - Section 115060-115093 :: Article 4. Licensing And Regulation Of Sources Of Ionizing Radiation

HEALTH AND SAFETY CODE
SECTION 115060-115093

115060.  (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.

115061.  (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.

115065.  (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.

115070.  The frequency of inspections of radioactive materials shall
be based on priorities established by the United States Nuclear
Regulatory Commission.

115075.  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.

115080.  (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.

115085.  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.

115090.  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.

115091.  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.

115092.  (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.

115093.  (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.

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