82 FR 39971 - Naturally-Occurring and Accelerator-Produced Radioactive Materials

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 82, Issue 162 (August 23, 2017)

The U.S. Nuclear Regulatory Commission (NRC) has received a petition for rulemaking from Matthew McKinley on behalf of the Organization of Agreement States (OAS) (the Petitioner) dated April 14, 2017, requesting that the NRC revise its regulations to add radionuclides and their corresponding activities to the list of ``Quantities of Licensed Material Requiring Labeling.'' The petition was docketed by the NRC on June 21, 2017, and has been assigned Docket No. PRM-30-66. The NRC is examining the issues raised in PRM-30-66 to determine whether they should be considered in rulemaking. The NRC is requesting public comment on this petition.

[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Proposed Rules]
[Pages 39971-39972]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17690]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / 
Proposed Rules

[[Page 39971]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 30

[Docket No. PRM-30-66; NRC-2017-0159]


Naturally-Occurring and Accelerator-Produced Radioactive 
Materials

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; notice of docketing and request for 
comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a 
petition for rulemaking from Matthew McKinley on behalf of the 
Organization of Agreement States (OAS) (the Petitioner) dated April 14, 
2017, requesting that the NRC revise its regulations to add 
radionuclides and their corresponding activities to the list of 
``Quantities of Licensed Material Requiring Labeling.'' The petition 
was docketed by the NRC on June 21, 2017, and has been assigned Docket 
No. PRM-30-66. The NRC is examining the issues raised in PRM-30-66 to 
determine whether they should be considered in rulemaking. The NRC is 
requesting public comment on this petition.

DATES: Submit comments by November 6, 2017. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is able to assure consideration only for comments received on or before 
this date.

ADDRESSES: You may submit comments by any of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0159. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Email comments to: [email protected]. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
     Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal 
workdays; telephone: 301-415-1677.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Robert MacDougall, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-5175, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2017-0159 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 Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0159.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS, 
please contact the NRC's Public Document Room (PDR) reference staff at 
1-800-397-4209, 301-415-4737, or by email to [email protected]. The 
ADAMS accession number for each document referenced (if it is available 
in ADAMS) is provided the first time that it is mentioned in this 
document.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2017-0159 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 http://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. The Petitioner

    The membership of OAS consists of state radiation control directors 
and staff from the 37 Agreement States who are responsible for the 
implementation of their respective Agreement State programs. The 
purpose of the OAS is to provide a mechanism for the Agreement States 
to work with each other and with the NRC on regulatory issues 
associated with their respective agreements.

III. The Petition

    The petitioner request that the NRC amend its existing regulations 
in appendix B to part 30 of title 10 of the Code of Federal Regulations 
(10 CFR), to specifically add the appropriate radionuclides and their 
corresponding activities to the list of ``Quantities of Licensed 
Material Requiring Labeling.'' The requirements in 10 CFR 30.35, 
``Financial Assurance and Recordkeeping for Decommissioning,'' refer to 
the list in appendix B to 10 CFR part 30 to determine the need for a 
decommissioning funding plan and the amount of financial assurance 
required for sealed and unsealed sources. The petition states that the 
list in appendix B to 10 CFR part 30 is outdated and does not include 
conforming updates

[[Page 39972]]

resulting from the 2005 amendment of the Energy Policy Act. The OAS 
petition is available in ADAMS under Accession No. ML17173A063.

IV. Discussion of the Petition

    The petitioner believe that patient health and safety is being 
compromised due to licensing delays of important diagnostic and 
therapeutic products that utilize radioisotopes that are not listed in 
the appendix B table in 10 CFR part 30. The petitioner assert that when 
the Energy Policy Act was amended in 2005 to include discrete 
naturally-occurring and accelerator-produced radioactive materials 
(NARM) into the definition of byproduct material, that 10 CFR part 30, 
schedule B, exempt quantities for licensing was updated to include 
certain NARM isotopes. They note however that 10 CFR part 30, appendix 
B, ``Quantities of Licensed Material Requiring Labeling,'' which is the 
driver for the decommissioning funding plan and financial assurance, 
was not updated. As a result, the OAS believes that state regulators 
are forced to apply overly burdensome financial assurance obligations 
or evaluate on a case-by-case basis special exemptions for new 
products. They feel that this results in delays in using these improved 
products or discourages their development.
    The petitioner point out that the NRC's Advisory Committee on the 
Medical Uses of Isotopes evaluated the financial assurance requirements 
for germanium-68 generators and concluded that these requirements were 
too restrictive and would prevent or deter the use of promising 
gallium-68 diagnostic imaging agents for patients. Authorization for 
granting specific exemption from the decommissioning funding plan 
requirement for Ge-68/Ga-68 generators was developed. A rulemaking 
action to provide a permanent regulatory solution has been initiated; 
however, the petition notes that the OAS is disappointed that the rule 
would address only this one isotope.
    Rather than issue exemptions on a case-by-case basis, the 
petitioner assert the more appropriate way to address the inconsistency 
is to amend appendix B to 10 CFR part 30 to add appropriate 
radionuclides and their corresponding activities. The petition states 
that the failure to address this inconsistency puts an undue hardship 
on certain licensees with little or no radiation safety benefit, 
discourages the development of new beneficial products, and negatively 
impacts patient care.

V. Request for Comment

    The NRC staff is requesting public comment on the following 
specific questions:
    1. What products or technologies, other than the germanium-68 
generators cited in the petition, are being or could be negatively 
affected because the radioactive materials required for these products 
or technologies are not currently listed on the table in appendix B of 
10 CFR part 30?
    2. Please provide specific examples of how the current NRC 
regulatory framework for decommissioning financial assurance has put an 
undue hardship on potential license applicants. Explain how this 
hardship has discouraged the development of beneficial new products, or 
otherwise imposed unnecessarily burdensome requirements on licensees or 
members of the public (e.g., users of medical diagnostic or therapeutic 
technologies) that depend on naturally-occurring or accelerator-
produced radioactive materials (NARM).
    3. Given NRC's current regulatory authority over the radiological 
safety and security of NARM, what factors should the NRC take into 
account in establishing possession limits for any of these materials 
that should be listed in appendix B of 10 CFR part 30?
    4. Does this petition raise other issues not addressed by the 
questions above about labelling or decommissioning financial assurance 
for radioactive materials? Must these issues be addressed by a 
rulemaking, or are there other regulatory solutions that NRC should 
consider?

    Dated at Rockville, Maryland, this 16th day of August, 2017.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary for the Commission.
[FR Doc. 2017-17690 Filed 8-22-17; 8:45 am]
BILLING CODE 7590-01-P