DAR File No. 43810

Environmental Quality, Waste Management and Radiation Control, Radiation

Section R313-19-34

Terms and Conditions of Licenses

Notice of Proposed Rule

(Amendment)

DAR File No.: 43810
Filed: 06/14/2019 01:39:34 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule change is proposed in order to maintain compatibility with the U.S. Nuclear Regulatory Commission (NRC) requirements and to enhance patient safety. To maintain the authority to regulate the use of certain licensed radioactive materials in the state of Utah, the state must maintain rules that are compatible with NRC requirements. Recent changes to 10 CFR Part 35 and related requirements were adopted by the NRC and published in the 07/16/2018 Federal Register (83 FR 33046). This proposed rule change maintains compatibility with the changes published for the requirements in 10 CFR 30.3a(g).

Summary of the rule or change:

The proposed rule change incorporates the requirements of 10 CFR 30.34(9), and consequently the requirements of 10 CFR 35.204(a), which requires commercial radiopharmacies to test each eluate from the elution of Molybdenum-99/Technetium (Mo-99/Tc-99m) generators for breakthrough instead of testing only the first eluate from the generator. Additionally, the change requires that results of breakthrough tests that exceed permissible concentrations from all medical generators be reported to the Director of the Division of Waste Management and Radiation Control (DWMRC) and the manufacturer of the generator. The reports must be made within a specified time frame and must be made by telephone and in writing.

Statutory or constitutional authorization for this rule:

• Section 19-3-104
• Section 19-6-104

Anticipated cost or savings to:

the state budget:

In the state of Utah there are two state-owned entities that provide commercial radiopharmacy services (NAICS# 325412). Only one of these entities uses medical generators to prepare dosages for distribution to other licensees for medical use under the provisions of Rule R313-32. Until 2002, testing each eluate of a Mo-99/Tc-99m medical generator for breakthrough was required. The 2002 revisions of 10 CFR Part 35 eliminated this requirement. Presently, only the initial elution of a Mo-99/Tc-99m medical generator is required to be tested for the breakthrough concentration of a specific impurity. Subsequent elutions are not required to be tested. Even so, radiopharmacy licensees in the state of Utah continued to test every eluate for the breakthrough concentrations. Due to certain incidents that occurred after 2002, the NRC determined that the requirement was necessary for patient safety. The requirement was reinstated in the regulations and a reporting requirement was added. Because the radiopharmacies in the state of Utah continued to test each eluate from the Mo-99/Tc-99m generators, there will be no increase to the number of breakthrough tests that must be conducted. The number of tests that may exceed the permissible concentration limits is not known but is estimated by the NRC to be about seven reports per year based on reports voluntarily made by medical licensees across the nation. The reports must be made by the licensee to the Director of DWMRC and the generator's manufacturer. The licensee's presently report any breakthrough test that exceeds the permissible concentration to the generator's manufacturer, therefore the proposed rule change will only add a requirement to make the report to the Director of DWMRC. There are no fees proposed in the rule change, therefore, there are no direct or indirect fiscal impacts associated with the proposed rule change. Since no additional breakthrough testing will be required and the required reports are presently made to the generator's manufacturer, the licensee is expected to experience a direct fiscal impact related to reporting breakthrough tests that exceed the permissible concentration to the Director of DWMRC. Using the estimated personnel time required to make the report and the mean hourly wage of a pharmacist to determine the potential costs associated with seven reports for results that exceed the permissible concentration, it is expected that the licensee may experience a direct fiscal impact of about $420. The proposed rule change requires licensees to report the results of medical generator breakthrough tests that exceed permissible concentration limits to the Director of the DWMRC. There are no fees associated with the rule change; therefore, there are no expected direct or indirect fiscal impacts for the revenues or expenditures of the DWMRC. Using the number of reports that may be made to the Director each year by all affected licensees, as estimated by the NRC, the DWMRC may receive about 14 reports annually. Based on the number of reports, the estimated time for processing the reports and evaluating the incident, and estimated personnel costs, the DWMRC is expected to experience an indirect fiscal impact of about $2,520 per year. (EDITOR'S NOTE: A proposed amendment to Rule R313-32 is under Filing No. 43812 in this issue, July 1, 2019, of the Bulletin.)

local governments:

The proposed rule change is not expected to have any fiscal impact on local governments' revenues or expenditures because interactions due to the proposed rule change with government agencies all occur at the state government level. There is no interaction of local government agencies with either the licensee or the DWMRC with respect to this rule.

small businesses:

There is one small business in the state of Utah that has been issued a radioactive materials license to provide commercial radiopharmacy services (NAICS# 325412) in the state. The assumptions as stated above under the state budget answer remain the same for the analysis of the impacts to small businesses. The commercial radiopharmacy uses Mo-99/Tc-99m generators and other medical generators to prepare dosages for distribution to other licensees who use radioactive materials for medical use under the provisions of Rule R313-32. The proposed rule change will require the licensee to test each eluate from the Mo-99/Tc-99m generator to ensure that the breakthrough does not exceed the permissible concentration; however, the radiopharmacy presently performs this testing and there will be no change to the licensees operations due to this proposed rule change. Additionally, the proposed rule change requires that a breakthrough test that exceeds the permissible concentration be reported to the state and the manufacturer. Reports are currently made to the manufacturer if a permissible breakthrough concentration limit is exceeded as required by the manufacturer. Based on voluntary reports made to the NRC over the years, the NRC estimates that licensees will report approximately seven tests where the results of breakthrough tests exceed the permissible concentration each year. The licensee is expected to have a direct fiscal impact related to the reporting requirement of about $420 per year. There are no other direct fiscal impacts expected to be experienced by the licensee.

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

It is possible that the 47 medical use radioactive materials licensees could experience an indirect fiscal impact from the proposed rule change if the radiopharmacy licensees increase the prices they charge for the dosages they prepare from the Mo-99/Tc-99m eluate due to the increased indirect fiscal costs they will incur; however, the expected costs to the licensee are not significant. Therefore, it is likely that the prices charged to medical use licensees will remain the same. At this time, it is not expected that medical use licensees will experience direct or indirect fiscal impacts due to this proposed change.

Compliance costs for affected persons:

The affected licensees will experience an estimated total of $420 annually to remain compliant with this proposed rule change.

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

Although the proposed rule change will directly cost the affected licensees about $420 in personnel costs to provide the required reports to the state, the proposed rule change is necessary to enhance patient safety. There were a number of cases where a medical generator's eluate exceeded the permissible concentration limit and was found by a licensee that was voluntarily testing the eluates at a greater frequency than required. There were also a number of cases where a patient set off a monitoring portal after the medical isotope they had been administered should have decayed to undetectable levels. This was the result of the breakthrough concentration exceeding the permissible concentration at the time of administration to the patient. Since there was no reporting requirement, even though a few of these instances occurred simultaneously in different parts of the nation, the NRC and the agreement states were not able to quickly identify the issue and address corrective measures. The reporting requirement was proposed to address patient safety, and provide a mechanism for tracking and a timely response and solution to address the unnecessary patient exposure to radiation from elevated breakthrough concentrations. Given the small number of expected reports that will be made to the DWMRC, processing the reports will have a minimal impact on the work assigned to DWMRC personnel.

Alan Matheson, Executive Director

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

Environmental Quality
Waste Management and Radiation Control, RadiationRoom Second Floor
195 N 1950 W
SALT LAKE CITY, UT 84116-4880

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:

07/31/2019

This rule may become effective on:

08/09/2019

Authorized by:

Ty Howard, Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2020	FY 2021	FY 2022
State Government	$2,940	$2,940	$2,940
Local Government	$0	$0	$0
Small Businesses	$420	$420	$420
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$3 , 36 0	$3 , 36 0	$3 , 36 0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	- $3 , 360	-$3,360	-$3,360

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

This proposed rule change is not expected to have any fiscal impact on non-small businesses' revenues or expenditures, because there are only two radioactive materials licensees that are affected by the proposed rule change and neither licensee is a "Non-Small Business" entity. One licensee is considered to be a state agency and the other is a small business entity. There are also no manufacturers of the devices affected by the proposed rule change that operate in the state of Utah. Therefore, there are no non-small business entities that are affected by the proposed rule.

 

The Director of the Department of Environmental Quality, Alan Matheson, has reviewed and approved this fiscal analysis.

 

 

R313. Environmental Quality, Waste Management and Radiation Control, Radiation.

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)(a) 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.

(b) An application for transfer of license shall include:

(i) The identity, technical and financial qualifications of the proposed transferee; and

(ii) Financial assurance for decommissioning information required by R313-22-35.

(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(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. The licensee shall report the results of each test that exceeds the permissible concentration listed in R313-32 (incorporating 10 CFR 35.204(a)) at the time of generator elution, in accordance with R313-32 (incorporating 10 CFR 35.3204).

(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: licenses, reciprocity, transportation, exemptions

Date of Enactment or Last Substantive Amendment: [October 13, 2017]2019

Notice of Continuation: July 1, 2016

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-6-104