Draft Regulatory Guide: Release of Patients Administered Radioactive Material
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft Regulatory Guide (DG), DG-8070, "Release of Patients Administered Radioactive Material." This ...
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft Regulatory Guide (DG), DG-8070, “Release of Patients Administered Radioactive Material.” This DG is proposed Revision 2 of Regulatory Guide (RG) 8.39 of the same name. The proposed revision provides methods that are acceptable to the NRC staff for the release of individuals, referred to as patients in this revision, after a medical procedure involving the administration of unsealed byproduct material, such as radiopharmaceuticals, or implants that contain radioactive material.
DATES:
Comments must be submitted electronically using
www.regulations.gov
by 11:59 p.m. Eastern Time on September 10, 2026.
ADDRESSES:
Submit your comments, identified by Docket ID NRC-2026-3730, at
www.regulations.gov.
If your material cannot be submitted using
www.regulations.gov,
call or
( printed page 51750)
email the individual listed in the
FOR FURTHER INFORMATION CONTACT
section of this document for alternate instructions.
Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received, and will not be deleted, modified, or redacted. Comments may be submitted anonymously.
Follow the search instructions onwww.regulations.gov
to view public comments.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in theSUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Sarah Spence, telephone: 301-415-3697; email:
Sarah.Spence@nrc.gov,
and Amir Mobasheran, telephone: 301-415-8112; email:
Amir.Mobasheran@nrc.gov.
Both are staff of the Office of Nuclear Material Safety and Safeguards, at the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2026-3730 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
Federal Rulemaking Website:
Go to
www.regulations.gov
and search for Docket ID NRC-2026-3730.
NRC's Agencywide Documents Access and Management System (ADAMS):
You may obtain publicly available documents online in the ADAMS Public Documents collection at
www.nrc.gov/reading-rm/adams.html.
To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to
PDR.Resource@nrc.gov.
The Release of Patients Administered Radioactive Material is available in ADAMS under Accession No. ML26092A365.
NRC's PDR:
The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to
PDR.Resource@nrc.gov
or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. Eastern Time (ET), Monday through Friday, except Federal holidays.
B. Submitting Comments
Comments must be submitted electronically using
www.regulations.gov
no later than 11:59 p.m. ET on September 10, 2026. Please include Docket ID NRC-2026-3730 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
www.regulations.gov
as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
II. Additional Information
The NRC is issuing for public comment a DG in the NRC's “Regulatory Guide” series. This series was developed to describe methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific issues or postulated events, and to describe information that the staff needs in its review of applications for permits and licenses.
Proposed RG 8.39 Revision 2, entitled “Release of Patients Administered Radioactive Material,” is temporarily identified by its task number, DG-8070.
The existing version of RG 8.39 (Revision 1) was published in April 2020. The NRC previously published for comment a draft update of RG 8.39 (DG-8061), in April 2024, received comments relating to the technical complexity and requests for more examples to be included, and did not thereafter finalize that update. The NRC has now refined a draft revision to RG 8.39 and has included draft revisions in DG-8070 to align with proposed revisions to section 35.75 of title 10 of the
Code of Federal Regulations
(10 CFR) as part of a proposed rule, “Reforming and Modernizing the NRC's Radiation Protection Framework” (91 FR 43456; July 15, 2026), that addresses section 5(b) of Executive Order 14300.
The proposed revision provides methods that are acceptable to the NRC staff for the release of individuals, referred to as patients in this revision, after a medical procedure involving the administration of unsealed byproduct material, such as radiopharmaceuticals, or implants that contain radioactive material. More specifically, DG-8070 provides guidance and examples for application of new definitions and dose limits related to medical uses of byproduct material that would be introduced by the referenced proposed rule, including guidance related to doses to caregivers.
Additionally, DG-8070 incorporates up-to-date methodologies based on National Council on Radiation Protection and Measurements (NCRP) Report No. 155, “Management of Radionuclide Therapy Patients,” fundamentals for calculating the radiation dose received by members of the public from a patient containing byproduct material. DG-8070 also includes updates to reflect the evolution of the medical use of byproduct material since the last revision of RG 8.39 (Revision 1) was issued. This DG is intended to enable licensees to make more accurate estimates of the timing, circumstances, and risks associated with patient release; public doses from the released patients; and when instructions or records are required.
The staff is not issuing for public comment a separate draft regulatory analysis for this draft regulatory guide. The draft regulatory analysis associated with this draft regulatory guide was issued for public comment with the proposed rule, “Reforming and Modernizing the NRC's Radiation Protection Framework” (91 FR 43456). That draft regulatory analysis assesses the value associated with issuing or revising regulatory guides as well as alternative courses of action (ADAMS Accession No. ML26180A025).
III. Backfitting, Forward Fitting, and Issue Finality
The NRC staff may use this RG as a reference in its regulatory processes, such as licensing, inspection, or enforcement. Backfitting, forward fitting, and issue finality considerations do not apply to 10 CFR part 35 licensees and applicants because 10 CFR part 35 does not include backfitting or issue finality provisions, and the forward fitting policy in Management Directive 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and
( printed page 51751)
Information Requests,” does not apply to these licensees.
IV. Submitting Suggestions for Improvement of Regulatory Guides
A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at
www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.
Suggestions will be considered in future updates and enhancements to the “Regulatory Guide” series.
V. Executive Order (E.O.) 12866
The Office of Information and Regulatory Affairs determined that this DG is not a significant regulatory action under E.O. 12866.
Chief, Guidance and Publication Branch, Division of Guidance, Rulemaking, Economic Analysis, and Technical Editing, Office of Nuclear Material Safety and Safeguards.