DAR File No. 32207

Environmental Quality, Radiation Control

R313-32

Medical Use of Radioactive Material

NOTICE OF PROPOSED RULE

DAR File No.: 32207
Filed: 12/11/2008, 10:32
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to maintain compatibility with corresponding federal regulations.

Summary of the rule or change:

Currently Rule R313-32 incorporates 10 CFR Part 35, 2005 ed. by reference. Some errors in 10 CFR Part 35 have been corrected in the 2007 edition of 10 CFR Part 35. Rule R313-32 will now be updated to incorporate 10 CFR Part 35, 2007 ed.

State statutory or constitutional authorization for this rule:

Sections 19-3-104 and 19-3-108

This rule or change incorporates by reference the following material:

Update from 10 CFR Part 35, 2005 ed. to 10 CFR Part 35, 2007 ed.

Anticipated cost or savings to:

the state budget:

There are no new regulatory requirements in 10 CFR 35, 2007 ed., thus there are no anticipated costs or savings expected. The proposed changes do not add or remove significant requirements that affect the radiation control program or the Utah Radiation Control Board.

local governments:

There are no new regulatory requirements in 10 CFR 35, 2007 ed., thus there are no anticipated costs or savings expected. The proposed changes do not add or remove significant requirements that affect the radiation control program or the Utah Radiation Control Board.

small businesses and persons other than businesses:

There are no new regulatory requirements in 10 CFR 35, 2007 ed., thus there are no anticipated costs or savings expected. The proposed changes do not add or remove significant requirements that affect the radiation control program or the Utah Radiation Control Board.

Compliance costs for affected persons:

There are no new regulatory requirements in 10 CFR 35, 2007 ed., thus there are no anticipated cost or savings expected. The proposed changes do not add or remove significant requirements that affect the radiation control program or the Utah Radiation Control Board.

Comments by the department head on the fiscal impact the rule may have on businesses:

Businesses with a radioactive material license will not see a fiscal impact due to the proposed changes to Rule R313-32. The proposed changes do not add or remove significant requirements that affect the radiation control program or the Utah Radiation Control Board. Richard W. Sprott, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Radiation Control
168 N 1950 W
SALT LAKE CITY UT 84116-3085

Direct questions regarding this rule to:

David Hogge at the above address, by phone at 801-536-4250, by FAX at 801-533-4097, or by Internet E-mail at dhogge@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

02/02/2009

This rule may become effective on:

02/12/2009

Authorized by:

Dane Finerfrock, Director

R313. Environmental Quality, Radiation Control.

R313-32. Medical Use of Radioactive Material.

R313-32-2. Clarifications or Exceptions.

For the purposes of Rule R313-32, 10 CFR 35.2 through 35.7; and 35.10 through 35.3067 [(January 1, 2006)](January 1, 2007) are incorporated by reference with the following clarifications or exceptions:

(1) The exclusion of the following:

(a) In 10 CFR 35.2, exclude definitions for "Address of Use," "Agreement State," "Area of Use," "Dentist," "Pharmacist," "Physician," "Podiatrist," and "Sealed Source"; and

(b) In 10 CFR 35.3067, exclude "with a copy to the Director, Office of Nuclear Material Safety and Safeguards."

(2) The substitution of the following date references:

[(a) "October 25, 2006" for "October 25, 2005";

(b) "October 24, 2006" for "October 24, 2005";]

(a)[(c)] "May 13, 2005" for "October 24, 2002"; and

(b)[(d)] "May 10, 2006" for "April 29, 2005."

(3) The substitution of the following rule references:

(a) "Rule R313-15" for reference to "10 CFR Part 20" or for reference to "Part 20 of this chapter";

(b) "Rule R313-19" for reference to "Part 30 of this chapter" or for reference to "10 CFR Part 30" except for the reference to "Part 30 of this chapter" found in 10 CFR 35.65(d);

(c) "10 CFR 30" for reference to "Part 30 of this chapter" found in 10 CFR 35.65(d);

(d) "Rules R313-15 and R313-19" for reference to "parts 20 and 30 of this chapter";

(e) "Section R313-12-110" for reference to "Sec. 30.6 of this chapter" or for reference to "Sec. 30.6(a)" or for reference to "Sec. 30.6(a) of this chapter";

(f) "Section R313-15-101" for reference to "Sec. 20.1101 of this chapter";

(g) "Subsection R313-15-301(1)(a)" for reference to "Sec. 20.1301(a)(1) of this chapter";

(h) "Subsection R313-15-301(1)(c)" for reference to "Sec. 20.1301(c) of this chapter";

(i) "Section R313-15-501" for reference to "Sec. 20.1501 of this chapter";

(j) "Section R313-18-12" for reference to "Sec. 19.12 of this chapter";

(k) "Subsection R313-22-75(10) or equivalent U.S. Nuclear Regulatory Commission or Agreement State regulations" for reference to "Sec. 32.74 of this chapter," found in 10 CFR 35.65(b);

(l) "Subsection R313-22-75(10)" for reference to "10 CFR 32.74 of this chapter," or for reference to "Sec. 32.74 of this chapter" except for the reference to "Sec. 32.74 of this chapter" found in 10 CFR 35.65(b);

(m) "Rule R313-70" for reference to "Part 170 of this chapter";

(n) "Section R313-19-34(2)" for reference to "Sec. 30.34(b) of this chapter";

(o) "Rule R313-22" for reference to "Part 33 of this chapter";

(p) "Subsection R313-22-50(2)" for reference to "Sec. 33.13 of this chapter";

(q) "Subsection R313-22-75(9)(b)(iv)" for reference to "Sec. 32.72(b)(4)";

(r) "Subsection R313-22-75(9)" for reference to "Sec. 32.72 of this chapter";[ and]

(s) "Subsection R313-22-75(9)(b)(v)" for reference to "Sec. 32.72(b)(5)"

[(s)](t) "(c)(1) or (c)(2)" for reference to "(c)(1)" in 10 CFR 35.50(d)[.]; and

(u) "35.600 or 35.1000" for reference to "35.600" in 10 CFR 35.41(b)(1).

(4) The substitution of the following terms:

(a) "radioactive material" for reference to "byproduct material";

(b) "original" for "original and one copy";

(c) "(801) 536-4250 or after hours, (801) 536-4123" for "(301) 951-0550";

(d) "Form DRC-[02]01, ['Application for Medical Use of] 'Radioactive Material License Application'" for reference to "NRC Form 313, 'Application for Material License'";

(e) "State of Utah radioactive materials" for reference to "NRC" in 10 CFR 35.6(c);

(f) "the Executive Secretary, the U.S. Nuclear Regulatory Commission, or an Agreement State" for reference to "the Commission or Agreement State" or for reference to "the Commission or an Agreement State";

(g) "an Executive Secretary, the U.S. Nuclear Regulatory Commission, or an Agreement State" for reference to "a Commission or Agreement State";

(h) "Equivalent U.S. Nuclear Regulatory Commission or Agreement State" for reference to "equivalent Agreement State" as found in 10 CFR 35.63(b)(2)(i), 10 CFR 35.63(c)(3), 10 CFR 35.65(a), 10 CFR 35.100(a), 10 CFR 35.200(a), and 10 CFR 35.300(a);

(i) "Executive Secretary" for reference to "NRC Operations Center" in 10 CFR 35.3045(c) and 10 CFR 35.3047(c);

(j) "Utah Division of Radiation Control" for reference to "NRC Operations Center" in Footnote 3 to 10 CFR 35.3045;

(k) "Executive Secretary" for reference to "appropriate NRC Regional Office listed in Sec. 30.6 of this chapter";

(l) "Utah Radiation Control Board" for reference to "Commission" in 10 CFR 35.18(a)(3)(second instance) and 10 CFR 35.19;

(m) "Executive Secretary" for reference to "Commission" in 10 CFR 35.10(b), 10 CFR 35.12(d)(2), 10 CFR 35.14(a)(first instance), 10 CFR 35.14(b), 10 CFR 35.18(a), 10 CFR 35.18(a)(3)(first instance), 10 CFR 35.18(b), 10 CFR 35.24(a)(1), 10 CFR 35.24(c), 10 CFR 35.26(a), and 10 CFR 35.1000(b);

(n) "the Executive Secretary" for reference to "NRC" in 10 CFR 35.13(b)(4)(i), 10 CFR 35.3045(g)(1), and 10 CFR 35.3047(f)(1);

(o) "the U.S. Nuclear Regulatory Commission or an Agreement State" for reference to "an Agreement State" in 10 CFR 35.49(a) and 10 CFR 35.49(c);[ and]

(p) "Executive Secretary, a U.S. Nuclear Regulatory Commission, or Agreement State" for reference to "NRC or Agreement State" in 10 CFR 35.63(b)(2)(ii), 10 CFR 35.100(c), 10 CFR 35.200(c), and 10 CFR 35.300(c)[.];

(q) In 10 CFR 35.2, Definitions, "Medium dose-rate remote afterloader," substitute "remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour" for "remotely delivers a dose rate of greater than 2 gray (200 rads), but less than 12 gray (1200 rads) per hour."

(r) In 10 CFR 35.75(a) "Footnote 1", substitute "The current version of NUREG-1556, Vol. 9" for "NUREG-1556 Vol. 9,";

(s) In 10 CFR 35.92(a) substitute "less than or equal to" for "less than";

(t) In 10 CFR 35.190, paragraph (a)(1), substitute "as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section; and" for "that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section; and"

(u) In 10 CFR 35.290, paragraph (a)(1), substitute "as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of this section; and" for "that includes the topics listed in (c)(1)(i) and (c)(1)(ii) of this section."

 

KEY: radioactive materials, radiopharmaceutical, brachytherapy, nuclear medicine

Date of Enactment or Last Substantive Amendment: [May 10, 2006]2009

Notice of Continuation: October 5, 2006

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-3-108