Naturally-Occurring and Accelerator-Produced Radioactive Materials, 75959-75963 [2020-24872]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Proposed Rules]
[Pages 75959-75963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24872]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 30

[Docket No. PRM-30-66; NRC-2017-0159; NRC-2017-0031]


Naturally-Occurring and Accelerator-Produced Radioactive 
Materials

AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider in 
its rulemaking process issues raised in a petition for rulemaking 
submitted by Matthew McKinley on behalf of the Organization of 
Agreement States (OAS, the petitioner. The petitioner requests that the 
NRC amend its decommissioning financial assurance regulations for 
sealed and unsealed byproduct material not listed in a table that sets 
out radionuclide possession values for calculating these financial 
assurance requirements. The NRC will also examine ways to make the 
table's values and other NRC decommissioning funding requirements more 
risk-informed.

DATES: The docket for the petition for rulemaking, PRM-30-66, is closed 
on November 27, 2020.

ADDRESSES: Please refer to Docket ID NRC-2017-0031 when contacting the 
NRC about the availability of information related to the future 
rulemaking. Please refer to Docket ID NRC-2017-0159 when contacting the 
NRC about the availability of information for this petition closure. 
You may obtain publicly-available information related to this action by 
any of the following methods:
     Federal Rulemaking Website: Public comments and supporting 
materials related to this petition can be found at https://www.regulations.gov by searching on the petition Docket ID NRC-2017-
0159. Address questions about NRC dockets to Dawn Forder; telephone: 
301-415-3407; email: [email protected]. For technical questions, 
contact the individual listed in the FOR FURTHER INFORMATION CONTACT 
section of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, 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, at 301-415-4737, 
or by email to [email protected]. For the reader's convenience, 
instructions about obtaining materials referenced in this document are 
provided in Section VI, ``Availability of Documents.''
     Attention: The PDR, where you may examine and order copies 
of public documents, is currently closed. You may submit your request 
to the PDR via email at [email protected] or call 1-800-397-4209 
between 8:00 a.m. and 4:00 p.m. (EST), Monday through Friday, except 
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Torre Taylor, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone: 301-415-7900, email: 
[email protected].

SUPPLEMENTARY INFORMATION:
I. Summary of the Petition
II. Background
III. Discussion
IV. Public Comments on the Petition
V. Reasons for Consideration
VI. Availability of Documents
VII. Conclusion

I. Summary of the Petition

    The NRC received a petition for rulemaking dated April 14, 2017, 
filed by Matthew McKinley on behalf of the Organization of Agreement 
States. On August 23, 2017, the NRC published a notification of 
docketing and request for comment on the petition (82 FR 39971).
    The petitioner requests that the NRC amend its existing regulations 
in appendix B, ``Quantities of Licensed Material Requiring Labeling,'' 
in part 30 of title 10 of the Code of Federal Regulations, ``Rules of 
General Applicability to Domestic Licensing of Byproduct Material,'' to 
add appropriate unlisted radionuclides and their corresponding values. 
Section 30.35, ``Financial Assurance and Recordkeeping for 
Decommissioning,'' uses multiples of the applicable quantities of 
material listed in appendix B to determine the need for decommissioning 
financial assurance for sealed and unsealed radioactive materials. 
Licensees using radionuclides not specifically listed in this appendix 
must use generic default values that the petitioner believes result in 
overly burdensome requirements.
    Without this rulemaking, the petitioner asserts, ``regulators are 
forced to evaluate new products against these [default appendix B] 
criteria and apply overly burdensome financial assurance obligations or 
to evaluate case-by-case special exemptions . . . . Rather than issuing 
exemptions on a case by case basis, the more appropriate way to address 
the inconsistency in Appendix B['s treatment of listed and unlisted 
radionuclides] is to amend it to add appropriate nuclides and their 
corresponding activities, as determined by a rulemaking working 
group.''
    The petitioner also notes that the NRC did not update appendix B 
when the Energy Policy Act of 2005 amended the Atomic Energy Act of 
1954 to give the NRC regulatory authority over discrete sources of 
naturally-occurring and accelerator-produced radioactive material 
(NARM). A significant number of medical radionuclides are accelerator-
produced. Although the NRC did update schedule B of part 30, which 
lists possession values of byproduct material exempt from the 
requirements for a license, to add some NARM, it did not do the same 
for appendix B, the petitioner points out, even though appendix B is 
``the driver'' for decommissioning financial assurance.
    The petition is available in ADAMS under Accession No. ML17173A063.

II. Background

    To determine the amount of decommissioning financial assurance 
required to possess a given radionuclide with a half-life greater than 
120 days, a licensee must multiply the appendix B value for that 
radionuclide by the applicable number in Sec. Sec.  30.35 or 70.25. 
Sections 30.35(a) and 70.25(a) require a license-specific 
decommissioning funding plan (DFP) to possess a quantity of 
radionuclides greater than provided in the corresponding tables set 
forth in Sec. Sec.  30.35(d) and 70.25(d). These tables require 
specific amounts of funding for specified ranges in the quantity of the 
radionuclide possessed. Both tables' funding amounts and quantity 
ranges are identical, but Sec.  30.35 applies to byproduct material and 
Sec.  70.25 applies to special nuclear material. Although the petition 
addressed only byproduct material licensed under part 30, appendix B 
has an identical use for special nuclear material licensed under part 
70.
    Section 30.35 sets a series of thresholds for decommissioning 
funding for possession and use of byproduct material. If the license 
authorizes

[[Page 75960]]

possession of an unsealed radionuclide in a quantity more than 1,000 
times its appendix B value, the licensee must provide $225,000 in 
financial assurance for decommissioning. If authorized to possess more 
than 10,000 times the appendix B value of that radionuclide, the 
licensee must provide $1,125,000. To possess more than 100,000 times 
the appendix B value, the licensee must provide a DFP for an amount 
based on the license's possession limit for the radionuclide. For 
radionuclides in the form of plated foils or sealed sources, a licensee 
must provide $113,000 in financial assurance for decommissioning to 
possess more than 10 billion times the appendix B value for the 
radionuclide, and a DFP to possess more than a trillion times the 
appendix B value.
    Appendix B also includes possession values for radionuclides not 
specifically listed. Known as the ``default'' possession values, these 
are equal to the lowest values listed in Appendix B for specific alpha-
emitting and non-alpha-emitting radionuclides, respectively, and 
restrict the quantity a licensee may possess without having to meet the 
applicable financial assurance requirements. For unlisted radionuclides 
that are in unsealed form and do not emit alpha radiation, the default 
possession value is 0.1 microcuries ([mu]Ci, one millionth of a curie), 
and for unsealed unlisted alpha-emitters, the default value is 0.01 
[mu]Ci. Thus, using the table in Sec.  30.35(d), a licensee would need 
to provide financial assurance for decommissioning funding of $225,000 
to possess more than 0.1 millicurie (mCi, one thousandth of a curie) of 
an unsealed non-alpha-emitting radionuclide not listed in appendix B. 
To possess more than 1 mCi of such a radionuclide, the licensee would 
need to have financial assurance for decommissioning of $1,125,000. A 
DFP is required to possess more than 10 mCi. For unsealed alpha-
emitting radionuclides not listed in appendix B, the corresponding 
threshold quantities are 0.01 mCi for $225,000 in financial assurance, 
0.1 mCi for $1,125,000, and 1 mCi for a DFP.
    These default values for unlisted radionuclides did not originate 
with a decommissioning funding purpose in mind. The default values, 
like the other values now in appendix B, were originally established to 
conform possession thresholds for the labeling of radioactive materials 
with the thresholds requiring a license, so that a label would only be 
required to possess an isotope in a quantity that required a license. 
The labeling values, issued in 1970 in appendix C to part 20 (35 FR 
6425; April 22, 1970), were redesignated in 1993 for decommissioning 
funding purposes as appendix B to part 30 (58 FR 67659; December 22, 
1993).
    Appendix B values were not based on an explicit consideration of 
risk, which involves an evaluation of the probability as well as the 
consequence of a postulated event. Appendix B values were based on a 
deterministic approach to regulation, which was widely used to develop 
early radiation protection requirements (60 FR 42622; August 16, 1995). 
Under this deterministic approach, the function of a safety limit is to 
ensure that the consequences of a postulated credible event would be 
acceptably small. Although the determination that an event is credible 
involves some consideration of probability, safety limits set 
deterministically are, by definition, not considered risk-informed, 
because the probability of the event is not required to be fully 
considered. Despite their derivation from values established 
deterministically for labeling purposes, however, the NRC's experience 
with appendix B's possession values over more than 30 years has shown 
that they are generally adequate to determine the level of funding 
assurance required for decommissioning.
    The DFP requirements in Sec.  30.35(e) were also established with a 
different purpose in mind. Originally set forth in the 1988 
decommissioning rule (53 FR 24018, 24035, 24043; June 27, 1988), DFPs 
were intended for major facilities possessing large quantities of 
radioactive material, not for facilities possessing the quantities of 
radionuclides typically used by medical licensees. Licensees of these 
major facilities are required to submit a DFP with a cost estimate 
specific to their facilities. Although medical and industrial licensees 
possessing smaller quantities of radioactive material may also develop 
facility-specific decommissioning cost estimates, it is not necessary 
to ensure adequate decommissioning funding, and not cost effective for 
many such licensees. When the rule was issued, it was estimated that 
very few such licensees possessing such smaller quantities would need 
DFPs.
    These DFPs are subject to detailed requirements for their original 
content and ongoing maintenance. Under Sec.  30.35(e), DFPs must 
contain, among other things, a detailed cost estimate for an 
independent contractor to decommission the site for release for 
unrestricted use, and a certification that financial assurance in the 
amount of the cost estimate has been provided. The licensee must 
resubmit the DFP every 3 years with adjustments as necessary to account 
for changes in costs and the extent of contamination. Even if a 
licensee possesses only one radionuclide in a quantity requiring a DFP, 
that DFP must also cover all other radionuclides at the site, whether 
or not the aggregated total quantity of these other radionuclides would 
have required a DFP.
    The NRC staff has determined that DFPs are not likely to be 
necessary for licensees that possess small quantities of certain 
unlisted radionuclides, particularly if it is returned in its container 
to the manufacturer/distributor (M&D) after use. This has been the case 
for germanium-68 (Ge-68) generators of the medical radionuclide 
gallium-68 (Ga-68).
    In an August 2015 report on the effect of the DFP requirement on 
Ge-68 generators, the NRC's Advisory Committee on the Medical Uses of 
Isotopes (ACMUI) concluded that ``current Part 30 regulations are 
preventing and/or deterring the use of promising . . . Ga-68 diagnostic 
imaging agents for patients due to the decommissioning funding plan 
burden for its parent Ge-68'' (ADAMS Accession No. ML15231A047).
    After analysis, the NRC staff agreed that the DFP requirement could 
impede or limit patient access to the radiopharmaceuticals developed 
from these generators and that a DFP is not necessary to ensure the 
safe decommissioning of facilities that use them. Pending rulemaking, 
the NRC staff developed guidance on the issuance of exemptions from the 
DFP requirement for licensees that have entered into written agreements 
binding them to return the generators to an M&D and binding the 
affected M&D to accept them.
    Beyond the impact on Ge-68 generator licensees, a decision to 
forego rulemaking would also be likely to elicit requests for 
exemptions from existing decommissioning funding requirements by users 
of other unlisted radionuclides. As noted in Section IV. below, 
commenters have identified several radionuclides with actual or 
potential medical applications that are or could be negatively affected 
because these radionuclides are not currently listed in appendix B.

III. Discussion

    The petitioner advances three main reasons for amending appendix B 
to part 30. First, although Congress gave the NRC regulatory authority 
over discrete sources of NARM in 2005, the NRC has not updated appendix 
B to add

[[Page 75961]]

possession values for any NARM, which accounts for an increasing number 
of medical uses.
    Second, the petitioner argues that the default possession values 
for radionuclides not listed in appendix B force regulators either to 
``apply overly burdensome financial assurance obligations'' or 
``evaluate case by case special exemptions.''
    The petitioner's third reason for rulemaking cites the time and 
cost impacts of needing to request and process exemptions from these 
requirements on a case-by-case basis. Because of the need for 
exemptions, ``[t]he OAS believes that patient health and safety is 
being compromised due to licensing delays of important diagnostic and 
therapeutic products that utilize radionuclides not listed in the 10 
CFR 30 appendix B table. . . . Further, development of new products 
could be discouraged due to these obstacles, diminishing the 
possibility of new innovative and beneficial options in both medical 
and industrial applications.''

IV. Public Comments on the Petition

Overview of Public Comments

    The original comment period on PRM-30-66 closed on November 6, 
2017. To allow a larger number of stakeholders to comment, the NRC 
published a Federal Register notification extending the comment period 
to December 6, 2017. The NRC received 20 comment submissions containing 
137 discrete comments. Comments came from industry, government and non-
government organizations, and members of the public. The name of the 
commenter, the commenter's affiliation (if any), and the ADAMS 
accession number for each comment submission are provided in the 
following table, listed alphabetically by affiliation.

------------------------------------------------------------------------
                                                        ADAMS accession
          Commenter                 Affiliation               No.
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Bill Diamantopoulos..........  Advanced Accelerator   ML17307A292
                                Applications.
David Walter.................  Alabama Office of      ML17276A099
                                Radiation Control.
Melissa Martin...............  American Association   ML17321A166
                                of Physicists in
                                Medicine.
James Brink..................  American College of    ML17321A167
                                Radiology.
Michael Baxter...............  American Pharmacists   ML17307A461
                                Association.
Anonymous....................  Anonymous............  ML17345A861
Angela Minden................  Arkansas Department    ML17311A614
                                of Health Radiation
                                Control Section.
Glenn Sullivan...............  Cardinal Health......  ML17311A618
Conference of Radiation        Conference of          ML17345A862
 Control Program Directors'     Radiation Control
 Committee on Nuclear           Program Directors.
 Medicine.
Michael Guastella............  Council for            ML17311A616
                                Radionuclides and
                                Radiopharmaceuticals.
Kimberly Steves..............  Kansas Department of   ML17325B724
                                Health and
                                Environment.
Glenn Sturchio...............  Mayo Clinic..........  ML17338A830
B. J. Smith..................  Mississippi            ML17279B157
                                Department of Health.
Catherine Ribaudo............  National Institutes    ML17311A612
                                of Health.
Diane D'Arrigo, Hugh           Nuclear Information    ML17341A057
 MacMillan, and Terry Lodge.    and Resource
                                Service, Food &
                                Water Watch, and the
                                Toledo Coalition for
                                Safe Energy.
Hendrik Engelbrecht and        PharmaLogic Holdings   ML17345A859
 Richard Van Sant.              Corp. and
                                subsidiaries.
Susan Langhorst..............  Private Citizen......  ML17311A619
Caitlin Kubler and Bennett     Society of Nuclear     ML17321A165
 Greenspan.                     Medicine and
                                Molecular Imaging.
Roger Macklin................  Tennessee Department   ML17296A183
                                of Environment and
                                Conservation.
Lt. Col. Scott Nemmers.......  U.S. Air Force,        ML17312B336
                                Master Materials
                                License Management
                                Staff.
------------------------------------------------------------------------

    In its Federal Register document announcing the docketing of the 
petition, the NRC posed four questions related to the petition's scope. 
The NRC analyzed the comments received in response, sorted them into 47 
categories of common concerns, and traced each category to one of the 
questions in the notification (See ``Categorization of Comments on NRC 
Questions about PRM-30-66'' (ADAMS Accession No. ML18292A481.)) Below 
are summaries of the principal categories of comments received in 
response to each of the questions. The NRC evaluated each comment in 
deciding whether to consider or deny the issues raised by the 
petitioner. The NRC will also consider the comments further during the 
development of the regulatory basis document for this rulemaking and 
any methodology for setting more risk-informed appendix B values. These 
documents will be made available for public comment.

Summaries of Responses to the NRC's Questions

    Question 1: What products or technologies, other than the Ge-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?
    Most of the commenters who responded to this question stated that 
LUTATHERA[supreg] (lutetium-177 oxodotreotide), a radiopharmaceutical 
used to treat gastro-entero-pancreatic neuro-endocrine tumors, could be 
negatively affected because a contaminant in this radiopharmaceutical, 
a metastable isomer of lutetium-177 (Lu-177m), is not listed in 
appendix B to part 30.
    Commenters also identified several other radionuclides whose use 
could be unnecessarily restricted because they are not listed in 
appendix B. Actinium-227, thorium-228, and titanium-44 are being 
considered for potential radionuclide generators, commenters stated. 
Silicon-32 has potential therapeutic applications, and sodium-22 and 
aluminum-26 have potential diagnostic applications. One commenter noted 
that rhenium-184m should be listed because it is an activation product 
from certain cyclotron target windows used to produce other 
radionuclides. Other commenters identified cobalt-57 because the use of 
products based on or associated with it could be negatively affected.
    Question 2: Please provide specific examples of how the current NRC 
regulatory framework for decommissioning financial assurance has put an 
undue hardship on potential

[[Page 75962]]

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 NARM.
    Commenters provided several examples of undue hardship. Commenters 
said that the DFP requirement is a hardship for medical licensees with 
multiple locations of use, since a DFP is required for each site using 
an unlisted radionuclide. Commenters also noted that the need to seek 
case-by-case exemptions from appendix B's default requirements is an 
administrative burden, and that the regulatory delays in obtaining 
exemptions from the financial assurance hardships negatively affect 
patient care.
    Three commenters also said that the NRC should address inequities 
in applying Sec.  30.35 in different States. One commenter said that 
the increased financial assurance burden for those possessing 
accelerator-produced radionuclides ``cascades to the Agreement States, 
which look to NRC for guidance, and absent that guidance they either 
move forward on their own or temporarily stop processing [license] 
amendment requests [for exemptions].''
    Question 3: Given the 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?
    Thirteen commenters provided a total of 38 recommendations on 
factors the NRC should consider in setting any new possession limits. 
Several of these recommendations shared common themes. One was that the 
NRC should provide special regulatory consideration for 
radiopharmaceuticals. Four commenters said, for example, that the NRC 
should consider the unique purpose of radiopharmaceuticals, the 
importance of patient access to these pharmaceuticals, and the fact 
that they undergo extensive evaluation by the U.S. Food and Drug 
Administration before they are allowed to be manufactured and regulated 
for their radiological properties.
    A related theme was that generators using unlisted radionuclides to 
produce these radiopharmaceuticals also deserve special consideration. 
Five commenters said these generators should either be considered as 
sealed sources or as a separate category qualifying for more risk-
informed regulatory treatment.
    Another theme was that for appendix B to part 30, the NRC should 
consider possession values already established in other NRC tables. 
Five commenters said, for example, that the NRC should align the values 
in appendix B to part 30 with those for the same radionuclides in 
appendix C to part 20 on labeling.
    Two commenters recommended similar sets of considerations with 
respect to which other factors should be accounted for in setting new 
appendix B possession values. These included the physical and chemical 
form and half-life of the radionuclide and its progeny, and the 
disposal pathway for these radionuclides at the time of facility 
decommissioning.
    Two commenters stated that in determining the amount of financial 
assurance required for a DFP, only the area of use of the subject 
radionuclide should be considered. These commenters noted that medical 
licensees use different radionuclides in different areas of their 
facilities, and that some of these radionuclides, such as technetium-99 
and iodine-125, do not require any financial assurance for 
decommissioning.
    Four other commenters shared a concern that establishing new 
possession limits in appendix B to part 30 could result in unsafe waste 
disposal practices. Three commenters submitting a single set of 
comments argued that possession values high enough to make 
decommissioning financial assurance requirements more commensurate with 
the radiological hazards of medical uses could also effectively exempt 
some industrial and commercial licensees, including those engaged in 
oil and gas fracking, from a requirement to dispose of their wastes in 
licensed facilities. These commenters also said that the NRC must 
prepare a ``programmatic'' (i.e., generic) environmental impact 
statement for any rulemaking to amend appendix B.
    Two commenters raised issues about the number of radionuclides with 
half-lives greater than 120 days--the minimum, as noted at Sec.  30.35, 
for decommissioning funding requirements--that should be added to 
appendix B. One commenter said that the appendix should list all 
radionuclides with such half-lives, ``since it is hard to predict where 
the next medically useful radionuclide will come from in the future.'' 
The other commenter noted that appendix B to part 30 contains only 45 
radionuclides (the staff counted 49) with half-lives greater than 120 
days, while appendix C to part 20 lists 150.
    One commenter on Question 3 suggested that, because the factors 
that need to be considered in setting new appendix B possession limits 
may change with time, the NRC should review part 30 decommissioning 
funding requirements every 3 to 5 years.
    Question 4: Does this petition raise other issues not addressed by 
the questions above about labeling 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?
    On the question of whether the NRC should consider solutions other 
than rulemaking, 15 of the 20 comment submissions explicitly supported 
the need for rulemaking, and one requested that Sec.  30.35 
requirements not apply to certain radiopharmaceuticals approved by the 
U.S. Food and Drug Administration--a change that can only be effected 
by rule. No commenters opposed rulemaking, although three commenters 
that submitted a single set of comments were concerned that setting new 
possession limits for medical radionuclides could effectively exempt 
from needed regulation industrial wastes containing those 
radionuclides. Of those commenters that explicitly supported 
rulemaking, seven also said it would be preferable to issuing 
exemptions, and two said that a rulemaking would improve or minimize 
negative impacts on research, medical licensees, and the availability 
of new radiopharmaceuticals to patients.
    On the question of whether the petition raised any issues not 
addressed by the other three NRC questions, responding commenters 
raised 16 additional issues. The majority of these are related to 
Question 3 on factors to be considered in setting new appendix B 
possession limits. Six commenters, for example, called on the NRC to 
address the inconsistencies in possession values between appendix B to 
part 30 and appendix C to part 20. Two of these commenters recommended 
replacing appendix B values with appendix C values, and one recommended 
that the NRC withdraw appendix B and reference appendix C instead.
    Two other commenters recommended that the NRC describe the 
methodology for deriving possession values in a footnote to appendix B 
to part 30. Providing a formula instead of the current default values 
for unlisted radionuclides, one commenter said, ``will alleviate the 
need for subsequent amendments to appendix B and minimize [the] 
negative impact (or potential impact) on medical licensees and patient 
care.''
    Four commenters raised a new issue unrelated to the issues 
associated with

[[Page 75963]]

setting possession limits. These commenters noted that the title of 
appendix B to part 30, ``Quantities of Licensed Material Requiring 
Labeling,'' does not express the actual purpose of the appendix.

V. Reasons for Consideration

    The NRC has reviewed the petition in accordance with Sec.  
2.803(h). For several reasons, the NRC concludes that the issues raised 
by the petitioner and commenters should be considered in the rulemaking 
process. First, the Energy Policy Act of 2005 gave the NRC regulatory 
authority over discrete sources of NARM, and the NRC needs to 
incorporate appropriate NARM into its regulatory framework for 
decommissioning funding. This would also provide a clearer, more 
predictable basis for Agreement State regulation of decommissioning 
funding for these radionuclides. Second, rulemaking would also reduce, 
if not eliminate, the need to process exemption requests from licensees 
seeking a more risk-informed alternative to the generic default values 
that result in decommissioning funding requirements that are not 
commensurate with likely costs.
    Moreover, a rulemaking would also advance the NRC's commitment to 
more risk-informed regulation by better aligning NRC funding 
requirements with the risks of decommissioning the affected licensee 
facilities.
    In addition, the NRC expects that rulemaking would be more cost-
effective than maintaining applicable existing regulations. The short-
term savings to the NRC from denying this petition for rulemaking would 
likely be outweighed by the higher aggregate cost to license 
applicants, Agreement States, and the NRC for case-by-case exemption 
reviews over the long term. The higher cost of NRC inaction would 
accrue not only for Ge-68 generators and the Lu-177 
radiopharmaceuticals cited by most commenters on Question 1, but 
foreseeably for other new technologies. In addition to making costly 
exemption reviews unnecessary, a rulemaking would also provide a more 
stable, risk-informed basis for decommissioning funding requirements by 
using radionuclide-specific possession values that better reflect the 
amount of financial assurance required.
    Further, more predictable and risk-informed decommissioning funding 
requirements could remove an unnecessary barrier to making Ge-68 
generator-supported Ga-68 imaging, Lu-177 radiotherapy, and other 
emerging medical and industrial technologies that depend on unlisted 
radionuclides available to the public.
    An additional reason to undertake rulemaking on appendix B is to 
align its title with its decommissioning funding purpose.
    Lastly, adding unlisted radionuclides in a single comprehensive 
rulemaking would minimize the need for additional rulemakings in the 
future when new applications are developed for radionuclides remaining 
unlisted in appendix B.

VI. Availability of Documents

    The documents identified in the following table, listed by their 
order of reference in this proposed rule, are available to interested 
persons through one or more of the following methods, as indicated.

------------------------------------------------------------------------
                                                 ADAMS accession No. or
                   Document                         Federal Register
                                                        citation
------------------------------------------------------------------------
Petition letter of Organization of Agreement    ML17173A063
 States Board Chairman Mathew McKinley, April
 14, 2017.
Federal Register notification of docketing of   82 FR 39971
 petition for rulemaking PRM-30-66 and request
 for public comment, August 23, 2017.
Federal Register notification extending         82 FR 51363
 comment period, November 6, 2017.
Federal Register notification, Final rule,      35 FR 6425
 Part 20--Standards for Protection Against
 Radiation, Appendix C, April 16, 1970.
Federal Register notification, Final            53 FR 24018
 decommissioning rule, June 27, 1988.
Federal Register notification, Final rule,      58 FR 67659
 removal of expired material, December 22,
 1993.
``Use of Probabilistic Risk Assessment Methods  60 FR 42622
 in Nuclear Regulatory Activities; Final
 Policy Statement,'' August 16, 1995.
``Categorization of Comments on NRC Questions   ML18292A481
 about PRM-30-66''.
``Advisory Committee on the Medical Use of      ML15231A047
 Isotopes Germanium-68 (Ge-68) Decommissioning
 Funding Plan (DFP) Final Report,'' August 12,
 2015.
NRC Strategic Plan, Fiscal Years 2018-2022....  ML18032A561
------------------------------------------------------------------------

VII. Conclusion

    For the reasons cited in this document, the NRC will consider in 
the rulemaking process the issues raised in PRM-30-66 and will seek 
public input on any proposed changes to its requirements in appendix B 
to part 30, 10 CFR 30.35, and 10 CFR 70.25. The rulemaking is titled 
``Decommissioning Financial Assurance Requirements for Sealed and 
Unsealed Radioactive Materials.'' Publication of this document in the 
Federal Register closes Docket ID NRC-2017-0159 for PRM-30-66.
    The public can monitor further action on the rulemaking that will 
address this petition by searching Docket ID NRC-2017-0031 on the 
Federal rulemaking website, https://www.regulations.gov. The site 
allows members of the public to receive alerts when changes or 
additions occur in a docket folder. To subscribe: (1) Search for and 
open the docket folder (NRC-2017-0031); (2) click the ``Email Alert'' 
link; and (3) enter an email address and select the frequency for email 
receipts (daily, weekly, or monthly). The NRC also tracks the status of 
all NRC rules and PRMs on its website at https://www.nrc.gov/about-nrc/regulatory/rulemaking/rules-petitions.html.

    Dated at Rockville, Maryland, this 4th day of November, 2020.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2020-24872 Filed 11-25-20; 8:45 am]
BILLING CODE 7590-01-P