DAR File No. 28541

Environmental Quality, Radiation Control

R313-32

Medical Use of Radioactive Material

NOTICE OF PROPOSED RULE

DAR File No.: 28541
Filed: 03/08/2006, 11:03
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for this change is to modify Utah's Radiation Control Rules to be compatible with Federal requirements found in 10 CFR 35.

Summary of the rule or change:

The modifications to Rule R313-32 (incorporating 10 CFR 35 (2006) by reference) are primarily to sections regarding training and experience requirements for individuals seeking approval to become authorized users (AUs), authorized medical physicists (AMPs), authorized nuclear pharmacists (ANPs), or radiation Safety Officers (RSOs). Specifically, modifications to the requirements that must be met as part of a specialty board's certification process for the specialty board's certification to be recognized by the U.S. Nuclear Regulatory Commission or an Agreement State have been made. In addition, the number of didactic hours of specific radiation safety training for an AU, an AMP, an ANP, or an RSO have been specified for those individuals who are not certified by an approved specialty board. The definition of the term, "preceptor," was modified and the requirements for preceptor statements were changed. A new section for limited training for individual AUs seeking approval for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) was added.

State statutory or constitutional authorization for this rule:

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

10 CFR Part 35 (2006 edition)

Anticipated cost or savings to:

the state budget:

Since the change is a modification to previously existing training and experience requirements, no additional regulatory requirements will need to be implemented by the state. Therefore, changes in the rules will not result in a cost or savings to the state budget.

local governments:

The rule modification does not affect the local governments presently licensed under the rules under R313. Therefore, there will be no cost or savings for local governments.

other persons:

Because the proposed changes allow medical licensees flexibility in methods used to attain compliance with the rule, overall costs or savings to most affected persons will depend on their business practices and cannot be determined.

Compliance costs for affected persons:

Because the proposed changes allow each specific medical licensee flexibility in methods used to attain compliance with the rule, overall costs or savings to most affected persons will depend on their business practices and cannot be determined.

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

Actual costs or savings are dependant on the business practices used and therefore, cannot be determined. Dianne R. Nielson, Executive Director

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

Direct questions regarding this rule to:

Gwyn Galloway at the above address, by phone at 801-536-4258, by FAX at 801-533-4097, or by Internet E-mail at ggalloway@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:

05/01/2006

This rule may become effective on:

05/10/2006

Authorized by:

Dane Finerfrock, Director

RULE TEXT

R313. Environmental Quality, Radiation Control.

R313-32. Medical Use of Radioactive Material.

R313-32-1. Purpose and Authority.

(1) The purpose of this rule is to prescribe requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of Rule R313-32 are in addition to, and not in substitution for, other sections of Title R313.

(2) The rules set forth herein are adopted pursuant to the provisions of Subsections 19-3-104(4) and 19-3-104(8).

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 [(2004)](January 1, 2006) 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, [2004]2005";

(b) "October 24, 2006" for "October 24, [2004]2005";[ and]

(c) "[the effective date of this rule]May 13, 2005" for "October 24, 2002"; and

(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)";[ and]

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

(s) "(c)(1) or (c)(2)" for reference to "(c)(1)" in 10 CFR 35.50(d).

(4) The substitution of the following terms:

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

(b) "final" for "draft";]

[(c)](b) "original" for "original and one copy";

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

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

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

[(g)](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";

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

[(i)](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);

[(j)](i) "Executive Secretary" for reference to "NRC Operations Center" in 10 CFR 3045(c) and 10 CFR 3047(c);

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

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

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

[(n)](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);

[(o)](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);

[(p)](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

[(q)](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).

KEY: radioactive materials, radiopharmaceutical, brachytherapy, nuclear medicine

Date of Enactment or Last Substantive Amendment: [May 13, 2005]2006

Notice of Continuation: October 10, 2001

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

ADDITIONAL INFORMATION

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For questions regarding the content or application of this rule, please contact Gwyn Galloway at the above address, by phone at 801-536-4258, by FAX at 801-533-4097, or by Internet E-mail at ggalloway@utah.gov

For questions about the rulemaking process, please contact the Division of Administrative Rules (801-538-3764). Please Note: The Division of Administrative Rules is NOT able to answer questions about the content or application of these administrative rules.