Kan. Admin. Regs. § 28-35-264

Current through Register Vol. 44, No. 2, January 9, 2025

Section 28-35-264 - General requirements

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";

(C)"authorized user";

(D)"medical event";

(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

(4)"NRC."

(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.

Kan. Admin. Regs. § 28-35-264

Authorized by and implementing K.S.A. 48-1607; effective Dec. 30, 2005; amended March 18, 2011; amended May 4, 2018; amended by Kansas Register Volume 41, No. 11; effective 4/1/2022.