Current through Register Vol. 43, No. 52, December 26, 2024
The provisions of 10 C.F.R. part 35, dated January 1, 2019, are
hereby adopted by reference, with the changes specified in this
regulation.
(a) For the purposes of
part 6 of these regulations, by-product material" shall mean all radioactive
material regulated by the department.
(b) All reports required by this regulation
shall be submitted to the department.
(c) The following sections shall be deleted:
(1) 35.1,"purpose and scope";
(2) 35.2,"definitions," except that the
definitions of the following terms shall be retained:
(A)"Authorized medical physicist";
(B)"authorized nuclear pharmacist";
(E)"prescribed dose"; and
(F)"radiation safety officer";
(3) 35.8,"information collection
requirements: OMB approval";
(4)
35.18,"license issuance";
(5)
35.19,"specific exemptions";
(6)
35.26(a)(1),"radiation protection program changes";
(7) 35.57(a)(4),"training for experienced
radiation safety officer, teletherapy or medical physicist, authorized medical
physicist, authorized user, nuclear pharmacist, and authorized nuclear
pharmacist";
(8)
35.4001,"violations"; and
(9)
35.4002,"criminal penalties."
(d) Wherever the following C.F.R. references
occur within 10 C.F.R. part 35, these references shall be replaced with the
specified references to regulations and parts in this article of the
department's regulations:
(1)"
10 CFR
19.12 " shall be replaced with"K.A.R.
2835-333, x20AC;x02DC;instructions to workers.' "
(2)"10 CFR part 20" shall be replaced
with"part 4, x20AC;x02DC;standards for protection against radiation.'
"
(3)"
10 CFR
20.1101 " shall be replaced with"K.A.R.
28-35-211d, x20AC;x02DC;radiation protection programs.' "
(4)"
10 CFR
20.1301(a)(1) and
20.1301(c) "
shall be replaced with"K.A.R. 28-35-214a."
(5)"
10 CFR
20.1501 " shall be replaced with"K.A.R.
2835-217b."
(6)"10 CFR part 30"
shall be replaced with"part 3, x20AC;x02DC;licensing of sources of radiation.'
"
(7)"
10 CFR
32.72 " shall be replaced with"K.A.R.
2835-181m, x20AC;x02DC;specific licenses to manufacture, prepare, or distribute
radiopharmaceuticals containing radioactive material for medical use,' and
K.A.R. 28-35-181n, x20AC;x02DC;specific licenses to manufacture and distribute
generators or reagent kits for preparation of radiopharmaceuticals containing
radioactive material.' "
(8)"
10 CFR
32.74 " shall be replaced with"K.A.R.
28-35-181o, x20AC;x02DC;specific licenses to manufacture and distribute sources
and devices for use as a calibration, transmission, or reference source or for
certain medical uses.' "
(9)"
10 CFR
33.13 " shall be replaced with"K.A.R.
2835-182b, x20AC;x02DC;qualifications for a type A specific license of broad
scope.' "
(e) Wherever
the following terms occur within 10 C.F.R. part 35, these terms shall be
replaced with department":
(1)"Commission,"
with the exception of the phrase"Commission or Agreement State";
(2)"NRC operations center";
(3)"NRC regional office"; and
(f) The following changes shall be made to
the sections specified:
(1) 35.6(b)(1) and
(c)(1) shall be replaced with the following text:
Obtain review and approval of the research as specified in
45 CFR
46.111, x20AC;x02DC;criteria for IRB approval
of research'; and ".
(2)
35.6(b)(2) and (c)(2) shall be replaced with the following text:
Obtain informed consent from the human research subject as
specified in 45 CFR
46.116, x20AC;x02DC;general requirements for
informed consent.' "
(3)
35.10(a) shall be deleted.
(4) In
35.10(d), the date"October 24, 2002" shall be replaced with"the effective date
of these regulations."
(5)
35.12(b)(1) shall be replaced with the following text: submitting a form
specified by the department that includes the facility diagram, equipment, and
training and experience qualifications of the radiation safety officer,
authorized users, authorized physicists, and authorized pharmacists."
(6) 35.12(c)(1)(i) shall be replaced with the
following text: a form specified by the department that includes the facility
diagram, equipment, and training and experience qualifications of the radiation
safety officer, authorized users, authorized physicists, and authorized
pharmacists."
(7) 35.12(c)(1)(ii)
shall be replaced with the following text: a letter containing all information
required by the form in (i); and ".
(8) In 35.57(a)(1) and (b)(1), the date
January 14, 2019" shall be replaced with the effective date of these
regulations."
(9) In 35.57(a)(2),
(a)(3), and (b)(2), the date October 24, 2005" shall be replaced with the
effective date of these regulations."
(10) In 35.432(a), the date"October 24, 2002"
shall be replaced with"the effective date of these regulations."
(11) In 35.3045, the footnote shall be
deleted, and in subsection (a) the words"or any radiation-producing device"
shall be added before the words results in."
(12) 35.3047(d) shall be replaced with the
following text: The licensee shall submit a written report to the department
within 15 days after discovery of a dose to the embryo or fetus, or nursing
child that requires a report in paragraphs (a) or (b) in this
section."
(13) In 35.3067, the
phrase"with the department" shall be inserted after the word report" in the
first sentence, and the second sentence shall be deleted.
