A. Applicability. This regulation does not
apply to persons using the following radiation machines:
(1) Those used for dental diagnosis or
screening (machines classified in Group 6);
(2) Those used for veterinary diagnosis or
screening (machines classified in Group 7);
(3) Those used for mammography diagnostic or
screening purposes located in a mammography facility regulated under 21 CFR
Part
900 (machines classified in Group 8);
(4) Those used for veterinary dental
diagnosis or screening (machines classified in Group 9);
(5) Radiation machines exempted from the
requirements of Section B.3 of the Regulations for the Control of Ionizing
Radiation 1994, which is incorporated by reference in COMAR
26.12.01.01 a; and
(6) Radiation machines that are licensed by
the Department as provided by §C. of the incorporated document in COMAR
26.12.01.01 a.
B. Classification of Radiation Machines.
Radiation machines are classified according to the following system:
(1) Group 1-Radiation machines that can
generate radiation levels of 500 rems in one hour at one meter from the source
of radiation and are used to irradiate materials. These are the radiation
machines subject to §D.602 of the incorporated document in COMAR
26.12.01.01 a.
(2) Group 2-Radiation machines that are used
for human medical therapy. These are the radiation machines subject toSections
F.8 and F.9 of the incorporated document in COMAR
26.12.01.01 a.
(3) Group 3-Radiation machines other than
those in Group 2 that are used for healing arts purposes in hospitals certified
by the Joint Commission on Accreditation of Hospitals.
(4) Group 4-Radiation machines that are not
included in Group 3 or Group 5 but their use is prescribed by a physician,
chiropractor, or podiatrist.
(5)
Group 5-Radiation machines that are not included in Groups 1 through 4 but are
used:
(i) In industrial
applications;
(ii) For research
purposes;
(iii) For security
fluoroscopy of baggage or parcels; or
(iv) Solely for educational
purposes.
C.
State Certification Required for Radiation Machines.
(1) Exemptions from Other Regulations Not
Implied. A person is not exempted from complying with an applicable provision
of the incorporated document in COMAR
26.12.01.01 a because of
compliance with this regulation.
(2) General State Certification. Other than
during inspections for compliance with these regulations, a person may not
cause or permit the use of any radiation machine after the State certification
due date specified for that machine in §C(5) of this regulation if it has not
been State certified by the Department.
(3) Recertification After Replacement or
Rebuilding of Major Components. Except for routine X-ray tube replacement, a
person may not cause or permit the use of any radiation machine that has had
any major component replaced or substantially rebuilt until the major component
that has been affected has been reinspected and the radiation machine has again
been State certified.
(4) Interim
State Certification.
(a) The following
classes of radiation machines are State certified until the time the Department
promulgates regulations controlling the use of these radiation machines:
(i) Radiation machines that produce
non-ionizing electromagnetic radiation; and
(ii) Radiation machines that produce sonic,
ultrasonic, or infrasonic radiation.
(b) A radiation machine shall be considered
State-certified by the Department until the first State certification due date
established in §C(5) of this regulation, if:
(i) The machine has been registered by the
Department under §§B and F of the Regulations for the Control of Ionizing
Radiation (1994), which is incorporated by reference in COMAR
26.12.01.01 a; or
(ii) The person responsible for the use of
the machine has not been notified by the Department that the machine does not
meet a provision of this subtitle.
(5) Due Dates for State Certification. Due
dates for State certification of radiation machines are established according
to the Group as set forth in §B of this regulation. These dates are as follows:
Certification Due Date
|
Group 1
|
Group 2
|
Group 3
|
Group 4
|
Group 5
|
July 1, 2017
|
All1
|
Even3
|
December 31, 2017
|
All
|
Even3
|
Even3
|
July 1, 2018
|
All
|
Odd2
|
December 31, 2018
|
All
|
Odd2
|
July 1, 2019
|
All
|
Even
|
December 31, 2019
|
All
|
Even
|
Odd2
|
July 1, 2020
|
All
|
Odd
|
December 31, 2020
|
All
|
Odd
|
Even
|
July 1, 2021
|
All
|
Even
|
December 31, 2021
|
All
|
Even
|
July 1, 2022
|
All
|
Odd
|
December 31, 2022
|
All
|
Odd
|
Odd
|
July 1, 2023
|
All
|
Even
|
December 31, 2023
|
All
|
Even
|
Even
|
July 1, 2024
|
All
|
Odd
|
December 31, 2024
|
All
|
Odd
|
July 1, 2025
|
All
|
Even
|
December 31, 2025
|
All
|
Even
|
Odd
|
July 1, 2026
|
All
|
Odd
|
December 31, 2026
|
All
|
Odd
|
Even
|
July 1, 2027
|
All
|
Even
|
December 31, 2027
|
All
|
Even
|
July 1, 2028
|
All
|
Odd
|
December 31, 2028
|
All
|
Odd
|
Odd
|
July 1, 2029
|
All
|
Even
|
December 31, 2029
|
All
|
Even
|
Even
|
1 "All" means all facilities of
that group regardless of registration number. The certification due date for
Group 1 machines shall be July 1st of each year. The certification due date for
Group 2 machines shall be December 31st of each year.
2 "Odd" means facilities with a
registration number ending in an odd digit. For such facilities, the
certification due date for Group 3 machines shall be as indicated in the table
and biennially thereafter beginning December 31, 2018, the certification due
date for Group 4 machines shall be as indicated in the table and biennially
thereafter beginning July 1, 2018, and the certification due date for Group 5
machines shall be as indicated in the table and triennially thereafter
beginning December 31, 2019.
3 "Even" means facilities with a
registration number ending in an even digit. For such facilities, the
certification due date for Group 3 machines shall be as indicated in the table
and biennially thereafter beginning December 31, 2017, the certification due
date for Group 4 machines shall be as indicated in the table and biennially
thereafter beginning July 1, 2017, and the certification due date for Group 5
machines shall be as indicated in the table and triennially thereafter
beginning December 31, 2017.
D. Application for State Certification.
(1) Each person responsible for the use of a
radiation machine shall apply for State certification of the machine at least
45 days, but not more than 180 days, before the scheduled due date established
in §C(5) of this regulation.
(2)
The application shall be made on forms issued by the Department and shall
contain:
(a) All information indicated on the
forms; and
(b) A Departmental
inspection report that has been completed and signed by an inspector licensed
under Regulation .03 of this chapter.
E. Denial of Certification.
(1) The Department shall deny State
certification of a radiation machine if it determines that the use of the
machine will result in a violation of either the Maryland Radiation Act or any
regulation promulgated under this Act.
(2) A determination made by the Department
under §E(1) may be made based on information contained on the inspection
report, an independent inspection made by the Department, or any other
pertinent information known by the Department.
Notes
Md. Code Regs.
26.12.02.02
Regulations .02
adopted April 30, 1987 (14:4 Md. R. 418)
Regulation .02 amended
effective March 29, 2004 (31:6 Md. R. 510)
Regulation .02B amended
effective October 20, 1997 (24:21 Md. R. 1453)
Regulation .02C
amended effective February 15, 1993 (20:3 Md. R. 261); October 20, 1997 (24:21
Md. R. 1453); November 15, 2010 (37:23 Md. R. 1613)
Regulation .02D
amended effective May 14, 1990 (17:9 Md. R. 1092); amended effective
45:10
Md. R. 504, eff. 5/21/2018; amended effective
48:4
Md. R. 178, eff. 2/22/2021