Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-3-26 - RADIATION CONTROL
Section 420-3-26-.08 - The Registration Of Particle Accelerators
Universal Citation: AL Admin Code R 420-3-26-.08
Current through Register Vol. 42, No. 11, August 30, 2024
(1) Purpose. This Rule, 420-3-26 -.08, provides for the registration of particle accelerators.
(2) Scope. No person shall receive, possess, use, transfer, own, operate, or acquire a particle accelerator except as authorized in a Notice of Registration or as otherwise provided for in this Rule, 420-3-26-.08.
(3) Definitions. As used in this Rule, 420-3-26-.08:
(a) "Act" means Act No. 582, Alabama Law,
Regular Session, 1963, codified as 22-14-1, Code of Ala.
1975.
(b) "Agency"
means the State Board of Health.
(c) "Authorized medical physicist" means an
individual who:
1. Meets the requirements in
420-3-26-.08(10)(a)3.
and 4. or, is identified as an authorized
medical physicist on an Agreement State or Licensing State accelerator
registration that authorizes the medical use of accelerators; and
2. Is identified as an authorized medical
physicist on a medical use accelerator registration issued by the
Agency.
(d) "Authorized
user" means a physician who:
1. Meets the
requirements in
420-3-26-.08(10)(a)2.
and 4. or is identified as an authorized
user on an Agreement State or Licensing State registration that authorizes the
medical use of accelerators; and
2.
Is identified as an authorized user on a medical use accelerator registration
issued by the Agency.
(e) "Industrial Radiography" means the
examination of the macroscopic structure of materials by nondestructive methods
utilizing a particle accelerator.
(4) Registration Procedures. No registration shall be complete or valid until the person applying for registration has received a written Notice of Registration which shall be issued by the Agency in accordance with this Rule, 420-3-26-.08, or is exempted from such requirement by this Rule, 420-3-26-.08.
(5) Notice of Registration-Exemptions. A Notice of Registration is not required:
(a) To transfer, own, receive, acquire, or
possess a particle accelerator when such devices are in storage or
disassembled, or otherwise incapable of intentional or accidental operation.
Each person receiving such particle accelerator shall, within thirty (30) days
after the receipt of the particle accelerator, notify the Agency of the type of
particle accelerator and the name and address of the person supplying the
particle accelerator.
(b) For
electrical equipment that is not primarily intended to produce radiation and
does not produce a radiation level greater than 0.5 mrem per hour at any
readily accessible point 5 centimeters from the surface. Such equipment shall
not be exempt if it is used or handled in such a manner that any individual
might receive a radiation dose exceeding the limits specified in these
rules.
(6) Transfer of Particle Accelerators. Any person transferring a particle accelerator shall, within thirty (30) days after the end of the calendar quarter in which any particle accelerator is transferred, notify the Agency of the type of particle accelerator and the name and address of the person to whom the particle accelerator was supplied.
(7) Filing of Application for Notice of Registration.
(a) Application for a
Notice of Registration shall be filed on a form prescribed by the
Agency.
(b) The Agency may at any
time after the filing of the original application, and before the expiration of
the Notice of Registration, require further statements in order to enable the
Agency to determine whether the application should be granted or denied, or
whether the Notice of Registration should be modified or revoked.
(c) Each application shall be signed by the
applicant or registrant or a person duly authorized to act for and on his
behalf.
(d) An application for a
Notice of Registration may include a request for the registration of one or
more activities.
(e) Applications
and documents submitted to the Agency may be made available for public
inspection except that the Agency may withhold any document or part thereof
from public inspection if disclosure of its contents is not required in the
public interest and would adversely affect the interest of a person
concerned.
(8) Application for Amendments to Notices of Registration. In addition to the requirements specified in 420-3-26-.08(15), a registrant shall apply for, and shall receive, an amendment before:
(a) Making any change in the accelerator room
shielding;
(b) Making any change in
the location of the Particle Accelerator within the accelerator room;
(c) Using the Particle Accelerator in a
manner that could result in increased radiation levels in areas outside the
accelerator room;
(d) Relocating
the Particle Accelerator;
(e)
Allowing an individual who is not a visiting medical physicist pursuant to
420-3-26-.09(8)(h)
or is not listed on the Notice of
Registration to perform the duties of a medical physicist; or
(f) Allowing any physician who is not a
visiting authorized user pursuant to
420-3-26-.09(8)(k)
or is not listed on the Notice of
Registration to prescribe radiation treatments for humans.
(9) General Requirements for the Issuance of a Notice of Registration. A registration application will be approved if the Agency determines that:
(a)
The applicant is qualified by reason of training and experience to use the
particle accelerator and any associated radioactive
material23 for the purpose requested, in accordance
with these rules, in such a manner as to minimize danger to public health and
safety or property;
(b) The
applicant's proposed equipment, facilities, and procedures are adequate to
minimize danger to public health and safety or property;
(c) The issuance of the Notice of
Registration will not be harmful to the health and safety of the
public;
(d) The applicant has
appointed a radiation safety officer who will advise and assist on radiological
safety problems;
(e) The applicant
and the applicant's staff have substantial experience in the use of particle
accelerators;
(f) The applicant has
an adequate training program for operators of particle accelerators;
(g) The applicant has established and submits
to the Agency satisfactory written operating and emergency procedures;
and
(h) The applicant satisfies any
applicable special requirements in this Rule,
420-3-26-.08.
(10) Special Requirements for Issuance of a Notice of Registration for Particle Accelerators.
(a) Human Use. In addition to the
requirements set forth in
420-3-26-.08(9)
above, a Notice of Registration for human use of a particle accelerator in the
practice of medicine will be issued only if:
1. The applicant has access to adequate
facilities for the clinical care of patients.
2. The registrant requires the authorized
user to be a physician who:
(i) Is certified
in:
(I) Radiation oncology or therapeutic
radiology by the American Board of Radiology or Radiology (combined diagnostic
and therapeutic radiology program) by the American Board of Radiology prior to
1976; or
(II) Radiation oncology by
the American Osteopathic Board of Radiology; or
(III) Radiology, with specialization in
radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of
the Royal College of Radiology;" or
(IV) Therapeutic radiology by the Canadian
Royal College of Physicians and Surgeons; or
(ii) Is in the active practice of therapeutic
radiology, and has completed 200 hours of instruction in basic radiation
techniques applicable to the use of an external beam radiation therapy unit,
five-hundred (500) hours of supervised work experience, and a minimum of three
(3) years of supervised clinical experience.
(I) To satisfy the requirement for
instruction, the classroom and laboratory training shall include:
I. Radiation physics and
instrumentation;
II. Radiation
protection;
III. Mathematics
pertaining to the use and measurement of ionization radiation; and
IV. Radiation biology.
(II) To satisfy the requirement for
supervised work experience, training shall be under the supervision of an
authorized user and shall include:
I. Review
of the full calibration measurements and periodic quality assurance
checks;
II. Evaluation of prepared
treatment plans and calculation of treatment times/patient treatment
settings;
III. Using administrative
controls to prevent misadministrations;
IV. Implementing emergency procedures to be
followed in the event of the abnormal operation of an external beam radiation
therapy unit or console; and
V.
Checking and using radiation survey meters.
(III) To satisfy the requirement for a period
of supervised clinical experience, training shall include one (1) year in a
formal training program approved by the Residency Review Committee for
Radiology of the Accreditation Council for Graduate Medical Education or the
Committee on Postdoctoral Training of the American Osteopathic Association and
an additional two (2) years of clinical experience in therapeutic radiology
under the supervision of an authorized user. The supervised clinical experience
shall include:
I. Examining individuals and
reviewing their case histories to determine their suitability for external beam
radiation therapy treatment, and any limitations/contraindications;
II. Selecting proper dose and how it is to be
administered;
III. Calculating the
therapeutic radiation machine doses and collaborating with the authorized user
in the review of patients' progress and consideration of the need to modify
originally prescribed doses and/or treatment plans as warranted by patients'
reaction to radiation; and
IV.
Post-administration follow-up and review of case histories.
(iii) A physician shall
not act as an authorized user for any therapeutic radiation machine until such
time as said physician's training has been reviewed and approved by the
Agency.
3. The applicant
has designated a medical physicist on the application. The registrant for any
therapeutic radiation machine subject to
420-3-26-.08(10)
shall require the Medical Physicist to:
(i) Be certified by the American Board of
Radiology in:
(I) Therapeutic radiological
physics; or
(II) Roentgen-ray and
gamma-ray physics; or
(III) X-ray
and radium physics; or
(IV)
Radiological physics; or
(ii) Be certified by the American Board of
Medical Physics in Radiation Oncology Physics; or
(iii) Be certified by the Canadian College of
Medical Physics; or
(iv) Hold a
master's or doctor's degree in physics, medical physics, other physical
science, engineering, or applied mathematics from an accredited college or
university, and have completed one (1) year of full time training in medical
physics and an additional year of full-time work experience under the
supervision of an Authorized Medical Physicist. This training and work
experience shall be conducted in clinical radiation facilities that provide
high-energy external beam radiation therapy (photons and electrons with
energies greater than or equal to one MV/one MeV). To meet this requirement,
the individual shall have performed the tasks listed in
420-3-26-.09(8)(d)(g) and
(i) under the supervision of an Authorized
Medical Physicist during the year of work experience.
4. The training and experience specified in
this rule must have been obtained within the seven (7) years preceding the date
of application or the individual must have had related continuing education and
experience since the required training and experience was completed.
5. Visiting Authorized User.
(i) A registrant may permit a physician to
act as a visiting authorized user of a particle accelerator in the practice of
medicine under the terms and conditions of the registrant's registration for 60
days each calendar year if:
(I) The visiting
authorized user has the prior written permission of the registrant's
management, and the Radiation Safety Committee if a committee is
required;
(II) The registrant has a
copy of an Agency registration that identifies the visiting authorized user, by
name, as an authorized user of a particle accelerator in the practice of
medicine; and
(III) The visiting
authorized user performs only those procedures:
I. For which they are specifically authorized
to perform on an Agency registration; and,
II. Which are specifically approved on the
registrant's registration.
(ii) A registrant need not apply for a
registration amendment in order to permit a visiting authorized user to use a
particle accelerator in the practice of medicine.
(iii) A registrant shall retain copies of the
records specified in
420-3-26-.08(10)(a)5.(i)
for 3 years from the date of the last
visit.
6. Visiting
Authorized Medical Physicist.
(i) A
registrant may permit a medical physicist to act as a visiting authorized
medical physicist and perform the duties of a medical physicist under the terms
and conditions of the registrant's registration for 60 days each calendar year
if:
(I) The visiting authorized medical
physicist has the prior written permission of the registrant's management, and
the radiation safety committee if a committee is required; and,
(II) The registrant has a copy of an Agency
registration that identifies the visiting authorized medical physicist, by
name, as an authorized medical physicist.
(ii) A registrant need not apply for a
registration amendment in order to permit a visiting authorized medical
physicist to perform registered duties as described in
420-3-26-.09.
(iii) A registrant shall retain copies of the
records specified in
420-3-26-.08(10)(a)6.(i)
for 3 years from the date of the last
visit.
(b)
Research and Development. In addition to the requirements of
420-3-26-.08(9)
above, a Notice of Registration for the use of a particle accelerator in
research and development will be issued only if:
1. The applicant's staff has substantial
experience in the use of particle accelerators for a variety of research and
development uses;
2. The applicant
has established a radiation safety committee (composed of such persons as a
radiation safety officer, one or more persons trained or experienced in the
safe use of particle accelerators, and a representative of management or the
administration) which will review and approve, in advance, proposals for
research, diagnostic, and therapeutic uses.
(c) Industrial Radiography. In addition to
the requirements set forth in
420-3-26-.08(9)
above, a Notice of Registration for use of a particle accelerator in industrial
radiography will be issued only if;
1. The
licensee or registrant does not permit any individual to act as a radiographer
using a particle accelerator until the individual has received at least 40
hours of training in the subjects outlined in
420-3-26-.08(10)(e)7.
, in addition to on the job training consisting of hands-on
experience under the supervision of a radiographer, is certified through a
radiographer certification program by a certifying entity in accordance with
the criteria specified in Appendix A of Rule
420-3-26-.04, and has on their
person a valid certification ID card issued by a certifying entity. The on the
job training shall include a minimum of 160 hours of active participation in
the performance of industrial radiography utilizing radiation
machines.
2. In addition, the
registrant may not permit any individual to act as a radiographer until the
individual:
(i) Has received copies of and
instruction in the requirements described in the applicable sections of Rules
420-3-26-.01,
420-3-26-.02,
420-3-26-.03,
420-3-26-.04,
420-3-26-.08,
420-3-26-.09 and
420-3-26-.10, in the registration
under which the radiographer will perform industrial radiography, and the
registrant's operating and emergency procedures;
(ii) Has demonstrated an understanding of
items in 420-3-26-.08(10)(e)2.(i)
by successful completion of a written or
oral examination;
(iii) Has
received training in the use of the registrant's radiation machines, in the
daily inspection of devices and associated equipment, and in the use of
radiation survey instruments; and
(iv) Has demonstrated understanding of the
use of the equipment described in
420-3-26-.08(10)(e)2.(iii)
by successful completion of a practical
examination.
3. The
registrant may not permit any individual to act as a radiographer's assistant
until the individual:
(i) Has received copies
of and instruction in the applicable sections of Rules
420-3-26-.01,
420-3-26-.02,
420-3-26-.03,
420-3-26-.04,
420-3-26-.08,
420-3-26-.09 and
420-3-26-.10, in the registration
under which the radiographer's assistant will perform industrial radiography,
and the registrant's operating and emergency procedures;
(ii) Has demonstrated an understanding of
items in 420-3-26-.08(10)(e)3.(i)
by successful completion of a written or
oral examination;
(iii) Under the
personal supervision of a radiographer, has received training in the use of the
registrant's radiation machines, in the daily inspection of devices and
associated equipment, and in the use of radiation survey instruments;
and
(iv) Has demonstrated
understanding of the use of the equipment described in
420-3-26-.08(10)(e)3.(iii)
by successful completion of a practical
examination.
4. The
registrant shall provide annual refresher safety training for each radiographer
and radiographer's assistant at intervals not to exceed 12 months.
5. Except as provided in 420-3-26
-.08(10)(c)5.(iv), the radiation safety officer or designee shall conduct an
inspection program of the job performance of each radiographer and
radiographer's assistant to ensure that the Agency rules, registration
requirements, and operating and emergency procedures are followed. The
inspection program must:
(i) Include
observation of the performance of each radiographer and radiographer's
assistant during an actual industrial radiographic operation, at intervals not
to exceed 6 months; and
(ii)
Provide that, if a radiographer or a radiographer's assistant has not
participated in an industrial radiographic operation for more than 6 months
since the last inspection, the radiographer must demonstrate knowledge of the
training requirements of
420-3-26-.08(10)(e)2.(i)
and the radiographer's assistant must
demonstrate knowledge of the training requirements of
420-3-26-.08(10)(e)3.(i)
by a practical examination before these individuals can next participate in a
radiographic operation.
(iii) The
Agency may consider alternatives in those situations where the individual
serves as both radiographer and radiation safety officer.
(iv) In those operations where a single
individual serves as both radiographer and radiation safety officer, and
performs all radiography operations, an inspection program is not
required.
6. The
registrant shall maintain records of the required training to include
certification documents, written, oral and practical examinations, refresher
safety training and inspections of job performance for three (3) years
following termination of employment.
7. The registrant shall include the following
subjects in their forty (40) hour training program:
(i) Fundamentals of radiation safety
including:
(I) Characteristics of gamma and
x-radiation;
(II) Units of
radiation dose;
(III) Hazards of
exposure to radiation;
(IV) Levels
of radiation from sources of radiation; and
(V) Methods of controlling radiation dose
(time, distance, and shielding);
(ii) Radiation detection instruments
including:
(I) Use, operation, calibration,
and limitations of radiation survey instruments;
(II) Survey techniques; and
(III) Use of personnel monitoring
equipment;
(iii)
Equipment to be used including:
(I) Operation
and control of radiation machines; and
(II) Inspection and maintenance of
equipment.
(iv) The
requirements of pertinent state and federal regulations; and
(v) Case histories of accidents in
radiography.
8. The
applicant has established and submits to the Agency satisfactory written
operating and emergency procedures as described in
420-3-26-.04(17);
and,
9. The applicant submits to
the Agency a description of his overall organizational structure pertaining to
the industrial radiography program, including specified delegations of
authority and responsibility for operation of the program.
(d) Production of Radioactive
Materials.24 In addition to the requirements set
forth in 420-3-26-.08(9)
above, a Notice of Registration for the production of multiple quantities or
types of radioactive materials by a particle accelerator will be issued only
if:
1. The applicant's staff has substantial
experience in the use of particle accelerators to produce a variety of
radioactive materials;
2. The
applicant has an adequate training program for particle accelerator operators
consisting of;
(i) Initial
training;
(ii) Periodic
training;
(iii) On-the-job
training; and
(iv) A means to be
used by the applicant to determine the operator's knowledge and understanding
of and ability to comply with or use:
I.
Agency rules;
II. Applicant's
operating and emergency procedures;
III. Survey instruments as required by these
rules; and,
IV. Personnel
monitoring equipment:
3. The applicant has an adequate training
program for staff personnel for possession and use of radioactive materials
produced by the accelerator.
(e) Modification of the Structure, Chemical
Composition, or Bacterial Composition of Materials. In addition to the
requirements set forth in
420-3-26-.08(9)
above, a Notice of Registration for the modification of the structure, chemical
composition, or bacterial composition of materials by a particle accelerator
will be issued only if:
1. The applicant's
staff has substantial experience in the modification of materials;
2. The applicant has an adequate training
program for the training of the particle accelerator operators consisting of:
(i) Initial training;
(ii) Periodic training;
(iii) On-the-job training;
(iv) A means of determining the operator's
knowledge and understanding of and ability to comply with or use:
I. Agency rules;
II. The applicant's operating and emergency
procedures;
III. Survey instruments
as required by these rules; and
IV.
Personnel monitoring equipment.
(10) Issuance of a Notification of Registration.
(a) Upon
a determination that an application meets the requirements of the Act and the
rules of the Agency, the Agency will issue a Notice of Registration authorizing
the proposed activity.
(b) The
Agency may incorporate in any Notice of Registration at the time of issuance,
or thereafter by appropriate rule, regulation, or order, such additional
requirements with respect to the registrant's particle accelerator subject to
the Rule 420-3-26-.08 as it deems
appropriate or necessary in order to:
1.
Minimize danger to public health and safety or property;
2. Require the maintenance of specific
records and the reporting of specific information to the Agency; and
3. Require necessary inspections,
calibrations and output checks.
(12) Specific Terms and Conditions of the Notice of Registration.
(a) Each
Notice of Registration issued pursuant to this Rule
420-3-26-.08 shall be subject to
all the provisions of the Act, now or hereafter in effect, and to all rules,
regulations, and orders of the Agency.
(b) Each person registered by the Agency
pursuant to this Rule
420-3-26-.08 shall confine his
use and possession of the particle accelerator registered to the locations and
purposes authorized in the Notice of Registration.
(13) Expiration of Registration. Except as provided in 420-3-26-.08(14)(b), each Notice of Registration shall expire at the end of the day, in the month and year stated therein.
(14) Renewal of Registration.
(a)
Applications for renewal of a Notice of Registration shall be filed in
accordance with
420-3-26-.08(7).
(b) In any case in which a registrant, not
less than thirty (30) days prior to expiration of his existing Notice of
Registration, has filed an application in proper form for renewal or for a new
Notice of Registration authorizing the same activities, such existing Notice of
Registration shall not expire until the application has been finally determined
by the Agency.
(15) Amendment of Notice of Registration at Request of Registrant. Applications for amendment of a Notice of Registration shall be filed in accordance with 420-3-26-.08(8) and shall specify the respects in which the registrant desires his Notice of Registration to be amended and the grounds for such amendment.
(16) Agency Action on Application to Renew or Amend. In considering an application by a registrant to renew or amend his Notice of Registration, the Agency will apply the criteria set forth in 420-3-26-.08(9), and 420-3-26-.08(10) as applicable.
(17) Inalienability of Notice of Registration. No Notice of Registration issued or granted under this Rule and no right to utilize a particle accelerator granted by any Notice of Registration issued pursuant to this Rule shall be transferred, assigned, or in any manner disposed of, either voluntarily, directly, or indirectly, through transfer of control of any Notice of Registration to any persons unless the agency shall, after securing full information find that the transfer is in accordance with the provisions of the act, and shall give its consent in writing.
(18) Modification, Revocation, and Termination of a Notice of Registration.
(a) A Notice of Registration shall be subject
to amendment, revision, or modification or the Notice of Registration may be
suspended or revoked by reason of amendments to the Act, or by reason of rule,
regulations, or orders issued by the Agency.
(b) Any Notice of Registration may be
revoked, suspended, modified in whole or part, for any material false statement
in the application, or any statement of fact required under provisions of the
Act, or because of conditions revealed by the application, or any statement of
fact, or by any report, records, or inspection or other means, such that said
conditions which would warrant the Agency to refuse to grant a Notice of
Registration on an original application, or for violation of, or failure to
observe any of, the terms and conditions of the Act, or the Notice of
Registration, or of any rule, regulation, or order of the Agency.
(c) Except in cases of willfulness, or those
in which the public health, interest or safety requires otherwise, no Notice of
Registration shall be modified, suspended, or revoked unless, prior to the
institution of proceedings, facts or conduct which may warrant such action
shall have been called to the attention of the registrant in writing and the
registrant shall have been accorded an opportunity to demonstrate or achieve
compliance with all lawful requirements.
(d) The Agency may terminate a Notice of
Registration upon request submitted by the registrant to the Agency in writing.
24 See Rule 420-3-26-.02 for the licensing requirements for the possession of such radioactive materials.
23 See Rule 420-3-26-.02 for the licensing of such radioactive material.
Filed September 1, 1982. Readopted with amendments filed October 24, 1983. Amended filed January 19, 1990.
Author: Karl David Walter
Statutory Authority: Code of Ala. 1975, §§ 22-14-4, 22-14-6, 22-14-7, 22-14-8, 22-14-9, 22-14-11, 22-14-12, 22-14-13, 22-14-14, also 22-2-1, 22-2-2, 22-2-5, 22-2-6.
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
