Environmental Quality, Radiation Control

Rule R313-32

Medical Use of Radioactive Material

Notice of Proposed Rule

(Amendment)

DAR File No.: 33913
Filed: 08/10/2010 05:42:38 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The State of Utah entered into an agreement with the U.S. Nuclear Regulatory Commission (NRC) to establish and maintain a compatible program for the control of radioactive material in Utah. To maintain compatibility with NRC requirements, the State of Utah is required to modify the Utah Radiation Control Rules.

Summary of the rule or change:

The rule modifications address the adoption of appropriate requirements found in 72 FR 55864 - 55937 and 74 FR 33901 - 33906. The rulemaking clarifies which individuals need to comply with specific training requirements and clarifies that experienced individuals that meet the requirements may serve as preceptors and work experience supervisors. Specific requirements for the use of radioactive materials included under the expanded definition of byproduct material are added. The added regulations relate to the use of accelerator produced radioactive materials in medical facilities including training and experience for authorized individuals, certain tests, recordkeeping, and authorized sources for the accelerator produced materials. The rulemaking also incorporates the most recent version of 10 CFR 35. In addition to this rulemaking action, comments are being solicited regarding the applicability of Subsection 19-3-104(8), restricting the Board's ability to adopt rules more stringent than corresponding federal regulations. The Executive Secretary and the Board have made a preliminary determination that there are no corresponding federal regulations, but are soliciting comments on that issue, see www.radiationcontrol.utah.gov for the Statement of Basis. The Executive Secretary and the Board have also made a determination that, if Subsection 19-3-104(8) is applicable, corresponding federal regulations are not adequate to protect public health and the environment of the state since they do not address radioactive sources that are identical to those being addressed under federal rules except that they are from a different source.

State statutory or constitutional authorization for this rule:

• Subsection 19-3-104(8)
• Subsection 19-3-104(4)

This rule or change incorporates by reference the following material:

• Updates 10 CFR 35, published by Government Printing Office, 01/01/2010

Anticipated cost or savings to:

the state budget:

This proposed change is expected to have an minimal impact on the state budget. There may be a small cost to obtain or print updated regulations and new versions of the CFRs. Radioactive materials included in the expanded definition of byproduct material were regulated by the State of Utah prior to the modification of NRC requirements; therefore, the Division does not anticipate that additional licenses or license amendments will be required.

local governments:

This proposed change is expected to have a minimal impact on local government. There may be a small cost for regulated local government agencies to obtain or print updated regulations and new versions of the CFRs. The majority of radioactive materials included in the expanded definition of byproduct material were regulated by the State of Utah prior to the modification of NRC requirements. The Division has not identified any local government agencies licensed to use radioactive materials for medical purposes; therefore, no additional costs are expected for local government agencies.

small businesses:

This proposed change is expected to have a minimal impact on small businesses. There may be a small cost for regulated small businesses to obtain or print updated regulations and new versions of the CFRs. The majority of radioactive materials included in the expanded definition of byproduct material were regulated by the State of Utah prior to the modification of NRC requirements. It is not anticipated that small businesses with a radioactive materials license will have to modify their radiation safety program or their license.

persons other than small businesses, businesses, or local governmental entities:

Prior to the NRC's expansion of the definition for byproduct material, entities authorized to use radioactive materials for medical purposes in Utah have been regulated by the State for the use of these materials. Therefore, the anticipated costs for other persons is expected to be minimal and would be limited to costs associated with obtaining copies of revised rules and new versions of the CFRs, if desired.

Compliance costs for affected persons:

Affected persons may incur a small cost to print or obtain printed copies of the revised regulations. The revised regulations will also be available on line at no cost to affected persons.

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

The proposed change to the rule is necessary for the Utah Radiation Control Rules to be compatible with NRC requirements, and to ensure that the Division's program activities are adequate to protect the public health and safety. The Division is not aware of any business that would be impacted fiscally due to the proposed rule changes.

Amanda Smith, 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
195 N 1950 W
SALT LAKE CITY, UT 84116-3085

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 [email protected]

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:

10/04/2010

This rule may become effective on:

10/11/2010

Authorized by:

Rusty Lundberg, Director

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; 35.10(d)through 35.10(f); 35.11(a) through 35.11(b); 35.12; and [35.10]35.13(b) through 35.3067 ([January 1, 2007]2010) 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) "May 13, 2005" for "October 24, 2002"; and

(b) "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) , 10 CFR 32.72, " for reference to "Sec. 32.72 of this chapter";

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

(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) ; and

(v) "Subsection R313-22-32(9), 10 CFR 30.32(j)," for reference to "30.32(j)of this chapter".

(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-01, '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);

(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); and

[ (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]q) 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: [ February 12, 2009 ] 2010

Notice of Continuation: October 5, 2006

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