No. 27745 (Amendment): R313-19. Requirements of General Applicability to Licensing of Radioactive Material

DAR File No.: 27745
Filed: 03/11/2005, 04:32
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 the federal requirements found in 10 CFR 30.34(g).

 

Summary of the rule or change:

Corrections to references to Title 19 are made. In addition, the rule change requires regulated persons to perform a test for molybdenum contamination on particular radiopharmaceuticals that they produce.

 

State statutory or constitutional authorization for this rule:

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

 

Anticipated cost or savings to:

the state budget:

No additional regulatory requirements will need to be implemented by the state. Therefore, the rule changes 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:

Since the affected persons are presently performing this test, no additional regulatory requirements will need to be implemented by affected persons due to the rule changes. Therefore, there will be no cost or savings for affected persons.

 

Compliance costs for affected persons:

Since the affected persons are presently performing this test, no additional regulatory requirements will need to be implemented by affected persons due to the rule changes. Therefore, there will be no cost or savings for affected persons.

 

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

This rule change will have no fiscal impact on businesses. 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:

Environmental Quality
Radiation Control
168 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 [e-mail]

 

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:

05/02/2005

 

This rule may become effective on:

05/13/2005

 

Authorized by:

Dane Finerfrock, Director

 

 

RULE TEXT

R313. Environmental Quality, Radiation Control.

R313-19. Requirements of General Applicability to Licensing of Radioactive Material.

R313-19-1. Purpose and Authority.

(1) The purpose of this rule is to prescribe requirements governing the licensing of radioactive material. This rule also gives notice to all persons who knowingly provide to any licensee, applicant, certificate of registration holder, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's, applicant's or certificate of registration holder's activities subject to these rules, that they may be individually subject to Executive Secretary enforcement action for violation of Section R313-19-5.

(2) The rules set forth herein are adopted pursuant to the provisions of Subs[S]ections 19-3-104([3]4) and 19-3-104([6]8).

 

R313-19-34. Terms and Conditions of Licenses.

(1) Licenses issued pursuant to Rule R313-19 shall be subject to provisions of the Act, now or hereafter in effect, and to all rules, and orders of the Executive Secretary.

(2) Licenses issued or granted under Rules R313-21 and R313-22 and rights to possess or utilize radioactive material granted by a license issued pursuant to Rules R313-21 and R313-22 shall not be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of a license to a person unless the Executive Secretary shall, after securing full information find that the transfer is in accordance with the provisions of the Act now or hereafter in effect, and to all rules, and orders of the Executive Secretary, and shall give his consent in writing.

(3) Persons licensed by the Executive Secretary pursuant to Rules R313-21 and R313-22 shall confine use and possession of the material licensed to the locations and purposes authorized in the license.

(4) Licensees shall notify the Executive Secretary in writing and request termination of the license when the licensee decides to terminate activities involving materials authorized under the license.

(5) Licensees shall notify the Executive Secretary in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11, Bankruptcy, of the United States Code by or against:

(a) the licensee;

(b) an entity, as that term is defined in 11 U.S.C.101(14), controlling the licensee or listing the license or licensee as property of the estate; or

(c) an affiliate, as that term is defined in 11 U.S.C.101(2), of the licensee.

(6) The notification specified in Subsection R313-19-34(5) shall indicate:

(a) the bankruptcy court in which the petition for bankruptcy was filed; and

(b) the date of the filing of the petition.

(7) Licensees required to submit emergency plans pursuant to Subsection R313-22-32(8) shall follow the emergency plan approved by the Executive Secretary. The licensee may change the approved plan without the Executive Secretary's approval only if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the Executive Secretary and to affected off-site response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Executive Secretary.

(8) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators shall test the generator eluates for molybdenum-99 breakthrough in accordance with Rule R313-32 (incorporating 10 CFR 35.204 by reference). The licensee shall record the results of each test and retain each record for three years after the record is made.

 

KEY: license, reciprocity, transportation, exemptions

[December 12, 2003]2005

Notice of Continuation October 10, 2001

19-3-104

19-3-108