ML20266G516
| ML20266G516 | |
| Person / Time | |
|---|---|
| Issue date: | 09/22/2020 |
| From: | Lizette Roldan-Otero Office of Nuclear Material Safety and Safeguards |
| To: | State, Agreement States |
| Sarah Lopas, NRC/NMSS | |
| Shared Package | |
| ML20266G512 | List: |
| References | |
| 85FR57148, NRC-2020-0141, PRM-35-22, STC-20-066 | |
| Download: ML20266G516 (4) | |
Text
September 22, 2020 ALL AGREEMENT STATES NOTICE OF REQUEST FOR COMMENT: PETITION FOR RULEMAKING THAT WOULD REQUIRE REPORTING OF CERTAIN NUCLEAR MEDICINE INJECTION EXTRAVASATIONS AS MEDICAL EVENTS (STC-20-066)
Purpose:
To provide notice of the publication of the U.S. Nuclear Regulatory Commissions (NRC) request for public comment on a petition for rulemaking (PRM) that would require the reporting of certain nuclear medicine injection extravasations as medical events.
Background:
Currently, the NRC does not classify radiopharmaceutical extravasations as medical events and thus does not require them to be reported to the agency. On May 18, 2020, the NRC received a PRM from Ronald K. Lattanze on behalf of Lucerno Dynamics, LLC (NRCs Agencywide Documents Access and Management System Accession Number ML20157A366). The petitioner requests that the NRC revise its regulations to require medical event reporting of extravasations that result in a localized dose equivalent exceeding 50 rem.
The NRC docketed the petition on June 5, 2020, and assigned it Docket No. PRM-35-22.
Discussion: Enclosed with this letter is the Federal Register notice (FRN) announcing docketing of the petition and a 75-day public comment period. The FRN was published on September 15, 2020, and posted on the Federal rulemaking portal http://www.regulations.gov under Docket No. NRC-2020-0141. The FRN can also be accessed at:
https://www.govinfo.gov/content/pkg/FR-2020-09-15/pdf/2020-19903.pdf. The FRN describes how to submit comments. Comments on the PRM are due by November 30, 2020.
STC-20-066 If you have any questions regarding the PRM for extravasations or this correspondence, please contact the individuals named below:
POINT OF CONTACT: Sarah Lopas E-MAIL: Sarah.Lopas@nrc.gov TELEPHONE: (301) 415-6360 POINT OF CONTACT: Pam Noto E-MAIL: Pamela.Noto@nrc.gov TELEPHONE: (301) 415-6795 Sincerely, Lizette Roldan- Digitally signed by Lizette Roldan-Otero Otero Date: 2020.09.22 14:25:04
-05'00' Lizette Roldan-Otero, Acting Chief State Agreement Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated
57148 Proposed Rules Federal Register Vol. 85, No. 179 Tuesday, September 15, 2020 This section of the FEDERAL REGISTER confirming receipt, then contact us at The NRC cautions you not to include contains notices to the public of the proposed 301-415-1677. identifying or contact information that issuance of rules and regulations. The
- Mail comments to: Secretary, U.S. you do not want to be publicly purpose of these notices is to give interested Nuclear Regulatory Commission, disclosed in your comment submission.
persons an opportunity to participate in the Washington, DC 20555-0001, ATTN: The NRC will post all comment rule making prior to the adoption of the final Rulemakings and Adjudications Staff. submissions at https://
rules.
For additional direction on obtaining www.regulations.gov as well as enter the information and submitting comments, comment submissions into ADAMS.
NUCLEAR REGULATORY see Obtaining Information and The NRC does not routinely edit COMMISSION Submitting Comments in the comment submissions to remove SUPPLEMENTARY INFORMATION section of identifying or contact information.
10 CFR Part 35 this document. If you are requesting or aggregating FOR FURTHER INFORMATION CONTACT: comments from other persons for
[Docket No. PRM-35-22; NRC-2020-0141] Pamela Noto, Office of Nuclear Material submission to the NRC, then you should Safety and Safeguards, U.S. Nuclear inform those persons not to include Reporting Nuclear Medicine Injection Regulatory Commission, Washington, identifying or contact information that Extravasations as Medical Events DC 20555-0001; telephone: 301-415- they do not want to be publicly 6795; email: Pamela.Noto@nrc.gov. disclosed in their comment submission.
AGENCY: Nuclear Regulatory SUPPLEMENTARY INFORMATION: Your request should state that the NRC Commission. does not routinely edit comment ACTION: Petition for rulemaking; I. Obtaining Information and submissions to remove such information notification of docketing and request for Submitting Comments before making the comment comment. A. Obtaining Information submissions available to the public or entering the comment into ADAMS.
SUMMARY
- The U.S. Nuclear Regulatory Please refer to Docket ID NRC-2020-Commission (NRC) has received a 0141 when contacting the NRC about II. The Petitioner petition for rulemaking from Ronald K. the availability of information for this The petition for rulemaking (PRM)
Lattanze on behalf of Lucerno action. You may obtain publicly- was filed by Ronald K. Lattanze, on Dynamics, LLC, dated May 18, 2020. available information related to this behalf of Lucerno Dynamics, LLC.
The petitioner requests that the NRC action by any of the following methods: Ronald K. Lattanze is the Chief revise its regulations to require
- Federal Rulemaking website: Go to Executive Officer of Lucerno Dynamics, reporting of certain nuclear medicine https://www.regulations.gov and search LLC. Lucerno Dynamics, LLC, is a North injection extravasations as medical for Docket ID NRC-2020-0141. Carolina-based company that specializes events. The NRC docketed the petition
- NRCs Agencywide Documents in the design and development of on June 5, 2020, and assigned it Docket Access and Management System systems that detect the presence of No. PRM-35-22. The NRC is examining (ADAMS): You may obtain publicly- radiolabeled biomarkers in patients.
the issues raised in PRM-35-22 to available documents online in the ADAMS Public Documents collection at III. The Petition determine whether they should be considered in rulemaking. The NRC is https://www.nrc.gov/reading-rm/ The petitioner requests that the NRC requesting public comment on this adams.html. To begin the search, select amend part 35 of title 10 of the Code of petition at this time. Begin Web-based ADAMS Search. For Federal Regulations to require the problems with ADAMS, please contact reporting of certain nuclear medicine DATES: Submit comments by November the NRCs Public Document Room (PDR) injection extravasations as medical 30, 2020. Comments received after this reference staff at 1-800-397-4209, 301- events. Extravasation is the infiltration date will be considered if it is practical 415-4737, or by email to pdr.resource@ of injected fluid into the tissue to do so, but the NRC is able to assure nrc.gov. The ADAMS accession number surrounding a vein or artery. The consideration only for comments for each document referenced (if it is petition may be found in ADAMS at received on or before this date. available in ADAMS) is provided the Accession No. ML20157A266.
ADDRESSES: You may submit comments first time that it is mentioned in the by any of the following methods: IV. Discussion of the Petition SUPPLEMENTARY INFORMATION section.
- Federal Rulemaking Website: Go to
- Attention: The Public Document The petition states that, in 1980, the https://www.regulations.gov and search Room (PDR), where you may examine NRC exempted extravasations from for Docket ID NRC-2020-0141. Address and order copies of public documents, medical event reporting with the questions about NRC dockets to Carol is currently closed. You may submit understanding that extravasations are Gallagher; telephone: 301-415-3463; your request to the PDR via email at virtually impossible to avoid. The email: Carol.Gallagher@nrc.gov. For pdr.resource@nrc.gov or call 1-800- petition further states that, since that jbell on DSKJLSW7X2PROD with PROPOSALS technical questions contact the 397-4209 between 8:00 a.m. and 4:00 time, ample evidence has been individual listed in the FOR FURTHER p.m. (EST), Monday through Friday, published demonstrating that nuclear INFORMATION CONTACT section of this except Federal holidays. medicine extravasations are avoidable document. and are capable of causing considerable
- Email comments to: B. Submitting Comments harm to patients. Referencing literature Rulemaking.Comments@nrc.gov. If you Please include Docket ID NRC-2020- research and case studies, the petition do not receive an automatic email reply 0141 in your comment submission. asserts that extravasations can result in VerDate Sep<11>2014 16:25 Sep 14, 2020 Jkt 250001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Proposed Rules 57149 patient tissue doses that exceed existing 3. For medical use licensees, does For the Nuclear Regulatory Commission.
NRC medical reporting limits and can your facility currently monitor for Annette L. Vietti-Cook, harm patients in many ways. In light of radiopharmaceutical extravasation? If Secretary of the Commission.
this evidence, the petition requests that so, why and how do you monitor? If not, [FR Doc. 2020-19903 Filed 9-14-20; 8:45 am]
the NRC revisit the policy established in why not? BILLING CODE 7590-01-P 1980 and require the reporting of 4. Do you expect that monitoring for medical events of extravasations that extravasation and reviewing the results result in a localized dose equivalent would improve radiopharmaceutical exceeding 50 rem (0.5 Sv). The petition administration techniques at medical DEPARTMENT OF ENERGY asserts that the reporting of certain use licensee facilities? If so, how? If not, why not? 10 CFR Part 431 extravasations as medical events will not only alert the NRC to instances of 5. Do you believe an NRC regulatory [EERE-2017-BT-STD-0032]
serious misuse of byproduct material, action requiring monitoring and review but also will incentivize practitioners to of extravasation would improve patient RIN 1904-AE07 improve injection and infusion quality. radiological health and safety? If so, The petition states that this is intended how? If not, why not? Energy Conservation Program: Energy to ensure that diagnostic and Conservation Standards for Medical Event Classification and Evaporatively-Cooled Commercial therapeutic nuclear medicine patients Reporting Criteria are protected from avoidable irradiation Package Air Conditioners and Water-and given access to vital information to Currently, the NRC excludes Cooled Commercial Package Air understand when and how medical extravasation of radiopharmaceuticals Conditioners events impact their care. from its medical event reporting regulations. Medical events may not AGENCY: Office of Energy Efficiency and V. Request for Public Comment necessarily result in harm to the patient, Renewable Energy, Department of but they can indicate a potential Energy.
The NRCs Medical Use Policy Statement (65 FR 47654) states, in part, problem in a medical facilitys use of ACTION: Notice of proposed that the NRC will not intrude into radioactive materials or in determination and request for comment.
medical judgments affecting patients, administration as directed by the physician. Because licensees are not
SUMMARY
- The Energy Policy and except as necessary to provide for the Conservation Act (EPCA), as radiation safety of workers and the required to report extravasations to the NRC, extravasation events are not amended, prescribes energy general public. It also states that the conservation standards for various NRC will, when justified by the risk to documented in the NRCs Nuclear Material Events Database (NMED), consumer products and certain patients, regulate the radiation safety of commercial and industrial equipment, patients primarily to assure the use of which contains records of events involving nuclear material reported to including evaporatively-cooled radionuclides is in accordance with the commercial package air conditioners physicians directions. Considering the NRC.
- 1. Are there any benefits, not related and water-cooled commercial package these policy objectives and how they air conditioners (referred to as may relate to radiopharmaceutical to medical techniques, to monitoring and reporting certain extravasations as evaporatively-cooled commercial extravasations, the NRC is requesting unitary air conditioners (ECUACs) public comment on the following medical events? What would be the burden associated with monitoring for and water-cooled commercial unitary specific questions. air conditioners (WCUACs) in this and reporting certain extravasations as Injection Quality Monitoring medical events? document). EPCA also requires the U.S.
The NRC encourages licensees to use 2. If the NRC were to require that Department of Energy (DOE) to quality assurance tools and available licensees report certain extravasations periodically determine whether more technology to ensure that the licensee as medical events (recorded in NMED), stringent, amended standards would delivers the administration that the what reporting criteria should be used result in significant additional physician intended. The NRC requires to provide the NRC data that can be conservation of energy, be certain quality assurance procedures used to identify problems, monitor technologically feasible, and be such as calibrating instruments used to trends, and ensure that the licensee economically justified. In this notice of measure patient dosages and recording takes corrective action(s)? proposed determination (NOPD), DOE dosages administeredbut there are 3. If the NRC requires reporting of has tentatively determined that the other procedures that the NRC does not extravasations that meet medical event standards for small (cooling capacity require that could be relevant to reporting criteria, should a distinction less than 135,000 Btu/h), large (cooling extravasation. The NRC is seeking be made between reporting capacity greater than or equal to 135,000 information on use of quality assurance extravasations of diagnostic and and less than 240,000 Btu/h), and very tools and technologies for therapeutic radiopharmaceuticals? If so, large (cooling capacity greater than or radiopharmaceutical injection quality why? If not, why not? equal to 240,000 and less than 760,000 monitoring and extravasation. Btu/h) ECUACs and WCUACs do not VI. Conclusion need to be amended, and DOE requests
- 1. How frequently does radiopharmaceutical extravasation The NRC has determined that the comment on this proposed occur? petition meets the sufficiency determination and the associated jbell on DSKJLSW7X2PROD with PROPOSALS
- 2. Do you know of any extravasations requirements for docketing at § 2.803. analyses and results.
that have resulted in harm to patients? The NRC will examine the issues raised DATES:
If so and without including information in PRM-35-22 and any comments Meeting: DOE will hold a webinar on that could lead to the identification of received on this document to determine Thursday, October 1, 2020, from 10:00 the individual, describe the whether these issues should be a.m. to 3:00 p.m. See section V, Public circumstances, type of effect harm, and considered in rulemaking. Participation, for webinar registration the impacts. Dated: September 3, 2020. information, participant instructions, VerDate Sep<11>2014 16:25 Sep 14, 2020 Jkt 250001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\15SEP1.SGM 15SEP1