DAR File No. 39274

This rule was published in the May 1, 2015, issue (Vol. 2015, No. 9) of the Utah State Bulletin.


Environmental Quality, Radiation Control

Section R313-19-34

Terms and Conditions of Licenses

Notice of Proposed Rule

(Amendment)

DAR File No.: 39274
Filed: 04/14/2015 03:41:52 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This filing changes the requirements of general applicability to licensing of radioactive material.

Summary of the rule or change:

Subsection R313-19-34(5)(b) is revised to remove the reference "11 U.S.C. 101(14)" and add, in its place, the reference "11 U.S.C 101(15)."

State statutory or constitutional authorization for this rule:

  • Section 19-3-104
  • Section 19-3-108

Anticipated cost or savings to:

the state budget:

There is no anticipated cost or savings to the state budget. The proposed changes do not add or remove significant requirements that affect radiation. The proposed rule changes are adopting required federal regulations to maintain compatibility as an agreement state. These changes do not add new requirements that would cause the state budget to incur any changes in compliance costs beyond those identified by the Nuclear Regulatory Commission.

local governments:

There is no anticipated cost or savings to the local government. The proposed changes do not add or remove significant requirements that affect radiation. The proposed rule changes are adopting required federal regulations to maintain compatibility as an agreement state. These changes do not add new requirements that would cause local government to incur any changes in compliance costs beyond those identified by the Nuclear Regulatory Commission.

small businesses:

Small businesses may hold a radioactive material license, but there is no anticipated cost or savings for small businesses. The proposed rule changes are adopting required federal regulations to maintain compatibility as an agreement state. These changes do not add new requirements that would cause small businesses to incur any changes in compliance costs beyond those identified by the Nuclear Regulatory Commission.

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

Small businesses and persons other than businesses may hold a radioactive material license, but there is no anticipated cost or savings for small businesses and persons other than businesses. The proposed rule changes are adopting required federal regulations to maintain compatibility as an agreement state. These changes do not add new requirements that would cause local government to incur any changes in compliance costs beyond those identified by the Nuclear Regulatory Commission.

Compliance costs for affected persons:

There are no anticipated costs for affected persons since the proposed rule changes are adopting required federal regulations to maintain compatibility as an agreement state. These changes do not add new requirements that would cause affected persons to incur any changes in compliance costs beyond those identified by the Nuclear Regulatory Commission.

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

The proposed changes to the rule are 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 ControlRoom Third Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-3085

Direct questions regarding this rule to:

  • Spencer Wickham at the above address, by phone at 801-536-0082, 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:

06/01/2015

This rule may become effective on:

06/16/2015

Authorized by:

Rusty Lundberg, Director

RULE TEXT

R313. Environmental Quality, Radiation Control.

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

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 Director.

(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 Director 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 Director, and shall give his consent in writing.

(3) Persons licensed by the Director 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 Director 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 Director 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 USC 101[(14)](15),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 USC 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 Director. The licensee may change the approved plan without the Director's approval only if the changes do not decrease the effectiveness of the plan. The licensee shall furnish the change to the Director 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 Director.

(8) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, 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.

(9) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(10) (a) Authorization under Subsection R313-22-32(9) to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs.

(b) A licensee authorized under Subsection R313-22-32(9) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall:

(i) Satisfy the labeling requirements in Subsection R313-22-75(9)(a)(iv) for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in Subsection R313-22-75(9)(c).

(c) A licensee that is a pharmacy authorized under Subsection R313-22-32(9) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radioactive drugs shall be:

(i) an authorized nuclear pharmacist that meets the requirements in Subsection R313-22-75(9)(b)(ii); or

(ii) an individual under the supervision of an authorized nuclear pharmacist as specified in Rule R313-32 (incorporating 10 CFR 35.27 by reference).

(d) A pharmacy authorized under Subsection R313-22-32(9) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of Subsection R313-22-75(9)(b)(v).

 

KEY: license, reciprocity, transportation, exemptions

Date of Enactment or Last Substantive Amendment: [February 17, ]2015

Notice of Continuation: September 23, 2011

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

 


Additional Information

More information about a Notice of Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull-pdf/2015/b20150501.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

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For questions regarding the content or application of this rule, please contact Spencer Wickham at the above address, by phone at 801-536-0082, by FAX at 801-533-4097, or by Internet E-mail at [email protected].  For questions about the rulemaking process, please contact the Division of Administrative Rules.