83_FR_54753 83 FR 54543 - Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings

83 FR 54543 - Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 210 (October 30, 2018)

Page Range54543-54546
FR Document2018-23583

The U.S. Environmental Protection Agency (EPA) is withdrawing its January 19, 2017, proposed rule addressing health and environmental protection standards under the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) that would have applied to byproduct materials produced by uranium in-situ recovery (ISR) and would have subsequently been implemented by the U.S. Nuclear Regulatory Commission and its Agreement States. The EPA is withdrawing the proposed rule for three reasons. First, the EPA, informed in part by feedback received on the proposal, has serious questions as to whether the proposed rule as written is within EPA's authority under UMTRCA. Second, the EPA no longer believes that a national rulemaking to promulgate standards is necessary at this time, as the EPA believes the existing regulatory structures are sufficient to ensure the targeted protection of public health and the environment at existing ISR facilities. Third, present market circumstances suggest that the influx of new ISR license applications that was once anticipated and that was an underlying motive for the proposal is not likely to materialize.

Federal Register, Volume 83 Issue 210 (Tuesday, October 30, 2018)
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Proposed Rules]
[Pages 54543-54546]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23583]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 192

[EPA-HQ-OAR-2012-0788; FRL-9985-79-OAR]
RIN 2060-AP43


Health and Environmental Protection Standards for Uranium and 
Thorium Mill Tailings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; withdrawal.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is withdrawing 
its January 19, 2017, proposed rule addressing health and environmental 
protection standards under the Uranium Mill Tailings Radiation Control 
Act of 1978 (UMTRCA) that would have applied to byproduct materials 
produced by uranium in-situ recovery (ISR) and would have subsequently 
been implemented by the U.S. Nuclear Regulatory Commission and its 
Agreement States. The EPA is withdrawing the proposed rule for three 
reasons. First, the EPA, informed in part by feedback received on the 
proposal, has serious questions as to whether the proposed rule as 
written is within EPA's authority under UMTRCA. Second, the EPA no 
longer believes that a national rulemaking to promulgate standards is 
necessary at this time, as the EPA believes the existing regulatory 
structures are sufficient to ensure the targeted protection of public 
health and the environment at existing ISR facilities. Third, present 
market circumstances suggest that the influx of new ISR license 
applications that was once anticipated and that was an underlying 
motive for the proposal is not likely to materialize.

DATES: The proposed rule published on January 19, 2017 (82 FR 7400), 
entitled ``Health and Environmental Protection Standards for Uranium 
and Thorium Mill Tailings,'', is withdrawn as of October 30, 2018.

FOR FURTHER INFORMATION CONTACT: Ingrid Rosencrantz, Office of 
Radiation and Indoor Air, Radiation Protection Division, Mail Code 
6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460; telephone number: 202-343-9290; fax number: 202-
343-2304; email address: radiation.questions@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On January 19, 2017, the U.S. Environmental Protection Agency (EPA) 
proposed new health and environmental protection standards under the 
Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) (2017 
Proposal).\1\ The standards proposed in that action would have applied 
to byproduct materials produced by uranium in-situ recovery (ISR) 
facilities and would have subsequently been implemented by the U.S. 
Nuclear Regulatory Commission (NRC) and NRC Agreement States. The EPA 
initially proposed new health and environmental protection standards 
for ISR facilities on January 26, 2015 (2015 Proposal).\2\ However, the 
EPA decided to re-propose the rule on January 19, 2017, and seek 
additional public comment on changes to the original proposal, 
including changes in the regulatory framework and approach, based on 
public comment and new information received from stakeholders. The EPA 
has not finalized either of these proposals and is not doing so today. 
Instead, the EPA is withdrawing the 2017 Proposal, which superseded the 
2015 Proposal.
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    \1\ 82 FR 7400.
    \2\ 80 FR 4156.
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II. Why is the EPA withdrawing the 2017 Proposal?

    The EPA has decided to withdraw the 2017 Proposal for three 
reasons. First, stakeholders, including the NRC, raised significant 
concerns regarding the EPA's legal authority under UMTRCA to propose 
these standards. Based on those significant concerns, we now have 
serious questions concerning whether the EPA has the legal authority 
under UMTRCA to issue the regulations as developed in the 2017 
Proposal.
    Second, the EPA no longer believes that a national rulemaking to 
promulgate standards is currently necessary as the Agency believes the 
existing regulatory structures are sufficient to ensure the targeted 
protection of public health and the environment at existing ISR 
facilities. The NRC stated in its public comments that its ``current 
regulations, at 10 CFR part 40, Appendix A, and those of the various 
Agreement States, as supplemented by site-specific license conditions, 
guidance documents . . . and the operational experience and technical 
expertise of the regulatory agency staff, constitute a comprehensive 
and effective regulatory program for uranium in situ recovery 
operations (ISR) facilities.'' (emphasis added).
    Third, present market circumstances suggest that the influx of new 
ISR license applications that was once anticipated, and that was 
motivation for the proposal, is not likely to materialize. Therefore, 
there is less need for the rule, which was intended to provide a more 
workable and efficient approach for addressing these expected new 
applications, compared to existing mechanisms.

A. The EPA's Legal Authority

    In the 2015 Proposal, the EPA explained that it was ``proposing 
these new standards'' under its authority in section 206 of UMTRCA 
which ``authorizes EPA to promulgate general standards for the 
protection of public health, safety, and the environment from 
radiological and non-radiological hazards associated with . . . the 
processing and the possession, transfer, and disposal of byproduct 
material at sites at which ores are processed primarily for their 
uranium and thorium source material content or which are used for the 
disposal of such byproduct material.'' \3\ Many commenters stated that 
this provision does not provide authority for the type of standards 
that the EPA proposed. Other commenters agreed with the EPA's view that 
UMTRCA provides authority for proposing these standards. The EPA 
evaluated and responded to these comments in the 2017 Proposal.\4\ Many 
of these same commenters subsequently submitted comments on the 2017 
Proposal, arguing again that the proposed standards exceeded the EPA's 
authority to establish ``generally applicable standards.'' \5\ The NRC 
also submitted comments stating that it does not believe EPA has the 
authority to develop standards of the type contained in the 2017 
Proposal. Some of these commenters raised new arguments to support 
their position that the proposed standards exceed the EPA's authority 
under UMTRCA. In light of the comments provided on the various 
proposals, including by the NRC, the

[[Page 54544]]

EPA now has serious questions as to whether we have the legal authority 
to finalize the standards that were proposed in the 2017 Proposal.
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    \3\ 80 FR at 4163; See also 42 U.S.C. 2022(b)(1).
    \4\ 82 FR at 7418-7419, 7421-7422.
    \5\ 42 U.S.C. 2022(b)(1) uses the phrase ``standards of general 
application,'' while 42 U.S.C. 2022(b)(2) uses the term ``generally 
applicable standards.'' We use these terms interchangeably 
throughout the action.
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    Most of the commenters' objections to the EPA's application of its 
authority under UMTRCA in the 2015 Proposal centered around the meaning 
of the phrase ``standards of general application'' in the statutory 
provision. Commenters opposing the proposed standards stated, ``the 
proposed rules were legally invalid and felt the EPA was overreaching 
its authority under UMTRCA by proposing standards that are too detailed 
and prescriptive.'' \6\ These commenters stated that the EPA ``was 
redefining what UMTRCA established as the EPA's role to set general 
standards'' since these commenters did not believe UMTRCA provided the 
EPA with the authority to set standards that included ``any 
prescriptive implementation requirements.'' \7\ Other commenters that 
supported the 2015 Proposal stated that ``the proposed standards were 
an appropriate application of the EPA's authority under the UMTRCA.'' 
\8\
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    \6\ 82 FR at 7418.
    \7\ Id.
    \8\ Id.
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    In its response to the many comments opposing the EPA's proposed 
application of its authority, the EPA in the 2017 Proposal indicated 
that it ``disagree[d] with those commenters who believe the EPA has 
redefined its role or overreached its authority in developing the new 
standards for ISR facilities.'' \9\ The EPA stated that ``the new 
standards proposed in this action would apply the same requirements to 
all ISR facilities and would establish general requirements . . . 
[that] the regulatory agency would be responsible for implementing. . 
.on a site-specific basis through the licensing process and would 
retain the authority to determine when an ISR license can be 
terminated.'' \10\
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    \9\ Id.
    \10\ Id.
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    Several stakeholders, including the NRC, subsequently submitted 
comments on the 2017 Proposal, again stating that the proposed 
standards could not be reasonably classified as ``generally applicable 
standards'' under UMTRCA and thus was outside EPA's authority. In the 
2017 Proposal, the EPA identified the proposed standards as falling 
into one of three different categories: (1) ``Constituent concentration 
standards;'' (2) ``initial stability standards;'' and (3) ``long-term 
stability standards.'' \11\ In its comments, the NRC asserted the 
initial and long-term stability standards ``are not generally 
applicable standards but are implementation criteria, and as such, 
encroach upon NRC's authority and impair the NRC's ability to 
effectively regulate its ISR licensees.'' \12\ The NRC also raised 
several new significant legal arguments in its comments to support its 
position that had not been previously raised with EPA.\13\ For example, 
the NRC argues that ``EPA's authority to promulgate generally 
applicable standards, at least for radiological material, is prescribed 
by what is essentially EPA's organic authority, namely, the 
Reorganization Plan No. 3 of 1970 (Reorganization Plan).'' \14\ The NRC 
asserts that ``the Reorganization Plan provided EPA with an express 
transfer of AEA authority to set generally applicable standards `for 
the protection of the general environment from radioactive material,''' 
and that the Reorganization Plan ``expressly prescribed this standard 
setting authority by defining the term `standards' to mean `limits on 
radiation exposures or levels, or concentrations or quantities of 
radioactive material'--essentially, numerical limits.'' \15\ NRC 
further asserts that UMTRCA's legislative history shows that ``Congress 
was aware of and considered [this standard-setting authority in the 
Reorganization Plan] when it enacted UMTRCA in 1978'' and that 
``Congress structured UMTRCA's grant of authority to the EPA 
Administrator upon this very provision.'' \16\ The NRC points to 
several excerpts from the legislative history to support its claim that 
Congress intended ``that EPA's generally applicable standards under 
UMTRCA, for both radiological and non-radiological materials, be in the 
form of numerical limits, namely, limits on concentrations of 
radiological and non-radiological material, quantities of such 
material, or allowable doses or levels to individuals from such 
material.'' \17\
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    \11\ 82 FR 7405.
    \12\ EPA-HQ-OAR-2012-0788-0312 (comments of the Nuclear 
Regulatory Commission) at 11.
    \13\ EPA-HQ-OAR-2012-0788-0312, pp. 8-21.
    \14\ Id. at pg. 12.
    \15\ Id.
    \16\ Id. at pg. 13.
    \17\ Id. at pg. 14.
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    Other commenters disputed the EPA's authority to adopt regulatory 
requirements that they alleged could not reasonably be considered 
``generally applicable standards.'' For example, the Uranium Producers 
of America (UPA) argued that the proposed standards ``exceed[s] EPA's 
jurisdictional authority as set forth by UMTRCA.'' \18\ UPA further 
criticized the ``new prescriptive post-operational monitoring time and 
data requirements and new prescriptive post-restoration requirements'' 
as an ``impermissible attempt by EPA to direct the compliance of ISR 
operations.'' \19\ The Texas Commission on Environmental Quality (TCEQ) 
raised the same objection, requesting that the EPA withdraw those 
particular requirements ``because they exceed EPA's authority to 
promulgate standards.'' \20\ TCEQ stated that UMTRCA ``confers the NRC 
and Agreement State programs . . . , not EPA, with authority to 
implement and enforce EPA's standards,'' and then asserted the EPA's 
``proposed rules . . . go beyond the promulgation of standards and 
address how those standards should be implemented and enforced.'' \21\
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    \18\ EPA-HQ-OAR-2012-0788-0380 (comments of Uranium Producers of 
America) at 7.
    \19\ Id.
    \20\ EPA-HQ-OAR-2012-0788-0302 (comments of the TCEQ) at 3.
    \21\ Id. at 3-4.
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    Other stakeholders submitted comments in support of the 2017 
Proposal, reiterating their position that they believe the EPA has the 
authority to propose these types of ``generally applicable standards'' 
under UMTRCA.
    Based on the discussion above, EPA now has serious questions 
concerning whether we have the legal authority to issue the regulations 
as proposed in the 2017 Proposal. In conjunction with the grounds for 
withdrawal discussed below, this uncertainty as to our authority weighs 
in favor of withdrawing the 2017 Proposal.

B. Health and Environmental Protection Justification for the Rule

    When EPA initiated this rulemaking, there was already an effective 
system in place providing environmental oversight of ISR operations. As 
we explained in the 2015 Proposal, ``in 1983, EPA originally 
promulgated regulations at 40 CFR part 192, Health and Environmental 
Protection Standards for Uranium and Thorium Mill Tailings, in response 
to the statutory requirements of the Atomic Energy Act [AEA] of 1954, 
as amended by the Uranium Mill Tailings Radiation Control Act of 1978 
(UMTRCA).'' \22\ The 2015 Proposal further stated: ``Requirements 
currently applicable to active uranium processing and disposal sites, 
including ISR sites (i.e., Title II sites) can be found in subpart D of 
40 CFR part 192 (hereafter ``subpart D''). Subpart D contains 
provisions for managing uranium byproduct materials during and 
following the processing of uranium ores, and restoration of

[[Page 54545]]

disposal sites following any such use of those sites.'' \23\
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    \22\ 80 FR 4161.
    \23\ 80 FR 4163.
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    In the 2015 Proposal, under the heading ``Why does EPA believe new 
standards are necessary?'' the Agency stated: ``We believe that ISR-
specific standards are necessary because uranium ISR operations are 
very different from conventional uranium mills and the existing 
standards do not adequately address their unique aspects. In 
particular, we believe it is necessary to take a longer view of 
groundwater protection than has been typical of current ISR industry 
practices. Although the presence of significant uranium deposits 
typically diminishes groundwater quality, current industry practices 
for restoration and monitoring of the affected aquifer may not be 
adequate to prevent either the further degradation of water quality or 
the more widespread contamination of groundwater that is suitable for 
human consumption.'' \24\
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    \24\ 80 FR 4164.
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    In response to both proposals, the EPA has received numerous 
comments questioning the need or benefits of the rule. For example, in 
the 2017 Proposal the EPA noted that ``Industry commenters and others 
say that there is no need for this rule because the EPA has not 
identified an instance in which an ISR operation has contaminated a 
source of drinking water.'' \25\ In the 2017 Proposal, the EPA also 
said: ``Focusing on the area of surrounding or adjacent aquifers, the 
EPA acknowledges that the Agency does not have sufficient information 
to document a specific instance of contamination of a public source of 
drinking water caused by an ISR . . . [however,] the Agency remains 
concerned that the lack of data does not demonstrate that no 
contamination is occurring . . . . The monitoring requirements in this 
proposal address the issue of lack of data.'' \26\ (emphasis added). In 
its comments on the 2017 Proposal, UPA refers to the above statement: 
``EPA acknowledges there is no evidence of harm. . . . The EPA provides 
no evidence to contradict [NRC's findings].'' By contrast, the Natural 
Resources Defense Council (NRDC) asserts that its comments 
``demonstrate impacts to ISL mined aquifers . . . such that the 
groundwater is substantially degraded and there will be long-term harm 
to crucial natural resources.'' \27\ As is evidenced by the comments, 
the debate is nuanced and complicated and reflects differing views on 
the available data.
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    \25\ 82 FR 7404.
    \26\ 82 FR 7404.
    \27\ EPA-HQ-OAR-2012-0788-0380 at 2; EPA-HQ-OAR-2012-0788-0390 
(comments of the NRDC) at 4.
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    In addition to the public stakeholder comments mentioned above, 
most importantly, the NRC, the agency tasked with implementing the 
program, weighed in on the debate, stating in its public comments that 
``the NRC staff has concluded that its application of the 10 CFR part 
40, Appendix A regulations to ISR facilities meets the AEA standard of 
`adequate protection' of public health and safety and the environment. 
. . .'' \28\
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    \28\ EPA-HQ-OAR-2012-0788-0312 at 1.
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    In considering these factors, as well as the presence of an 
existing program that the NRC (the implementing agency) believes is 
sufficient, and the lack of expected growth and status of the industry 
as described further in the next section of this withdrawal action, the 
EPA believes that the reasonably envisioned public health and 
environmental benefits of the proposed rulemaking are limited and do 
not warrant EPA proceeding with its proposed rulemaking. The existing 
regulatory structures, adequately address the current environmental 
concerns.

C. Current and Anticipated Market Conditions

    Finally, the EPA believes that market forces themselves have 
lessened the need for such a rule. Initially, several factors, 
including the expected growth in this industry, led the EPA and the NRC 
to believe that regulation of ISR activities could be more workable and 
efficient if the EPA issued standards of general application specific 
to the ISR facilities that the NRC would incorporate into its own 
regulations and implement through its licensing activities.\29\ When 
these efforts began, the NRC expected as many as 23 ISR license 
applications for new facilities, expansions, and restarts.\30\ This 
expected influx of ISR license applications is no longer anticipated.
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    \29\ EPA-HQ-OAR-2012-0788-0006 (``Regulation of Groundwater 
Protection at In Situ Leach Uranium Extraction Facilities,'' Nuclear 
Regulatory Commission Memorandum COMJSM-06-0001, January 17, 2006) 
at 2 (``. . . the recent rapid rise in uranium prices and mining 
claims would indicate a significant future potential for new ISL 
facilities.''); 80 FR at 4167 (``In recent years, NRC has recognized 
the desirability of ISR-specific regulations. . . . [T]he Commission 
determined in 2006 that the appropriate action was `initiation of a 
rulemaking effort specifically tailored to groundwater protection 
programs at in situ leach (ISL) uranium recovery facilities.' ''); 
82 FR at 7420 (``In addition, the NRC acknowledges that efficiency 
could be gained by codifying its longstanding effective regulatory 
regime into regulations specific to ISRs. As described in the 
original proposal, this rulemaking was initially prompted by the 
NRC's conclusion that ISR-specific rules are needed to create a more 
workable and sustainable regulatory framework for this activity, and 
is not based on any specific instances of identified 
contamination.'').
    \30\ EPA-HQ-OAR-2012-0788-0405 (``Uranium Recovery Licensing 
Activities,'' Presentation of the Nuclear Regulatory Commission) at 
10.
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    The NRC is currently reviewing license applications for only three 
expansions of ISR facilities and, for the next five years, the NRC 
expects only one license application for an expansion of one ISR 
facility and one license application for one new ISR facility.\31\ 
Compared to the expected influx of ISR license applications, and the 15 
ISR facilities owned by 10 companies at the time of the 2017 Proposal, 
at the end of 2017 only approximately six ISR facilities were 
operating,\32\ with production down 17% compared to late 2016.\33\ 
According to the U.S. Energy Information Administration (EIA), 
``Domestic Uranium Production Report,'' 4th Quarter 2017, there are no 
ISR facilities reported as operating in Texas, with Alta Mesa, Hobson, 
La Palangana reported as on ``standby.'' Additional ISR facilities in 
New Mexico, Texas, and Wyoming have been licensed but have not operated 
and only one has undergone development.
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    \31\ Expectations for number of future licenses based on NRC/EPA 
telephone conversation on November 28, 2017.
    \32\ U.S. Energy Information Administration: ``Domestic Uranium 
Production Report.'' 4th Quarter 2017 (February 8, 2018). The 
operating facilities are Crow Butte in Nebraska and Lost Creek, 
Nichols Ranch, Ross, Smith Ranch-Highland and Willow Creek, all in 
Wyoming. Cameco subsequently curtailed production at the Crow Butte 
and Smith-Ranch Highland facilities (see http://www.cameco.com).
    \33\ World Nuclear News, 20 November 2017.
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    The proposal of generally applicable national standards by EPA was 
driven partly by the expectation of a significant number of new 
facilities (which would have also applied to operating wellfields at 
existing facilities), making these proposed ISR-specific standards a 
more immediate prerequisite to achieving the efficiency across all 
regulatory programs that the NRC acknowledged could be gained by a 
``regulatory regime . . . specific to ISRs.'' \34\ Today, the EPA 
questions whether this expected growth in operating ISR facilities is 
likely to be realized.
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    \34\ 82 FR 7420. See footnote 29 for a more complete citation.
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    Given this change in circumstances, completion of this rule is no 
longer expected to achieve the regulatory efficiency that was sought 
when this rulemaking effort began. The NRC and the NRC Agreement States 
currently regulate, through existing licenses, the limited number of 
operating ISR facilities and such an approach has been workable in 
practice for this number of

[[Page 54546]]

facilities. We do not see a need for the EPA to continue investing its 
resources to complete this rule to develop a ``more workable and 
sustainable regulatory framework'' as originally anticipated when we 
proposed these ISR-specific standards, especially where current 
production is reduced and little or no growth is expected in the near 
future. The statutory authorities providing for this ongoing regulatory 
and licensing function remain unchanged. Thus, the appropriate 
regulatory authorities may decide on a case-by-case basis to revise 
their own pre-existing regulations based on these authorities if they 
deem it necessary to assist with their management of ISR facilities in 
a particular state or local area.
    In addition, we find support for our decision to withdraw the 
proposed rule in the NRC's comments on the 2017 Proposal. As explained 
above, the EPA developed the proposed standards partly based on its 
understanding, after consultation with the NRC, that the anticipated 
growth in the number of ISR facilities highlighted a need for standards 
specific to ISR facilities, rather than continuing to apply standards 
that were originally written to address surface disposal of uranium 
mill tailings.\35\ However, the NRC expressed the following view in its 
public comments on the proposed rulemaking:
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    \35\ 82 FR at 7402-3; 80 FR 4164-7.

    The NRC's current regulations, at 10 CFR part 40, Appendix A, 
and those of the various Agreement States, as supplemented by site-
specific license conditions, guidance documents (e.g., NRC's 
``Standard Review Plan for In Situ Leach Uranium Extraction License 
Applications,'' NUREG-1569), and the operational experience and 
technical expertise of the regulatory agency staff, constitute a 
comprehensive and effective regulatory program for uranium in situ 
recovery operations (ISR) facilities.\36\
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    \36\ EPA-HQ-OAR-2012-0788-0312 at 1.

    Considering the prevailing economic conditions affecting current 
and projected production, which leads the NRC now to expect 
significantly fewer future license applications, as opposed to the 
large increase that it expected at the time the rulemaking process was 
initiated (which was motivation for the proposal), we conclude that 
withdrawing this proposal is appropriate.

III. Statutory Authority

    The statutory authority for this notice is provided by section 275 
of the Atomic Energy Act (AEA), as added by section 206 of UMTRCA (42 
U.S.C. 2022) and the Administrative Procedure Act (APA) (5 U.S.C. 551 
et seq.).

IV. Impact Analysis

    Because the EPA is not promulgating any regulatory requirements, 
there are no compliance costs or impacts associated with today's final 
action.

V. Statutory and Executive Order Reviews

    Today's action does not establish new regulatory requirements. 
Hence, the requirements of other regulatory statutes and Executive 
Orders that generally apply to rulemakings (e.g., the Unfunded Mandate 
Reform Act) do not apply to this action.

    Dated: October 18, 2018.
Andrew R. Wheeler,
Acting Administrator.
[FR Doc. 2018-23583 Filed 10-29-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                                      Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Proposed Rules                                                     54543

                                                Title V, New source performance                         FOR FURTHER INFORMATION CONTACT:                        various Agreement States, as
                                                standards, National emission standards                  Ingrid Rosencrantz, Office of Radiation                 supplemented by site-specific license
                                                for hazardous air pollutants, Maximum                   and Indoor Air, Radiation Protection                    conditions, guidance documents . . .
                                                achievable control technology,                          Division, Mail Code 6608T, U.S.                         and the operational experience and
                                                Delegation of authority.                                Environmental Protection Agency, 1200                   technical expertise of the regulatory
                                                   Authority: 42 U.S.C. 7401 et seq.                    Pennsylvania Ave. NW, Washington, DC                    agency staff, constitute a comprehensive
                                                                                                        20460; telephone number: 202–343–                       and effective regulatory program for
                                                  Dated: October 24, 2018.                              9290; fax number: 202–343–2304; email                   uranium in situ recovery operations
                                                Douglas Benevento,                                      address: radiation.questions@epa.gov.                   (ISR) facilities.’’ (emphasis added).
                                                Regional Administrator, EPA Region 8.                   SUPPLEMENTARY INFORMATION:                                 Third, present market circumstances
                                                [FR Doc. 2018–23631 Filed 10–29–18; 8:45 am]                                                                    suggest that the influx of new ISR
                                                                                                        I. Background                                           license applications that was once
                                                BILLING CODE 6560–50–P
                                                                                                           On January 19, 2017, the U.S.                        anticipated, and that was motivation for
                                                                                                        Environmental Protection Agency (EPA)                   the proposal, is not likely to materialize.
                                                ENVIRONMENTAL PROTECTION                                proposed new health and environmental                   Therefore, there is less need for the rule,
                                                AGENCY                                                  protection standards under the Uranium                  which was intended to provide a more
                                                                                                        Mill Tailings Radiation Control Act of                  workable and efficient approach for
                                                40 CFR Part 192                                         1978 (UMTRCA) (2017 Proposal).1 The                     addressing these expected new
                                                                                                        standards proposed in that action would                 applications, compared to existing
                                                [EPA–HQ–OAR–2012–0788; FRL–9985–79–
                                                OAR]                                                    have applied to byproduct materials                     mechanisms.
                                                                                                        produced by uranium in-situ recovery
                                                                                                                                                                A. The EPA’s Legal Authority
                                                RIN 2060–AP43                                           (ISR) facilities and would have
                                                                                                        subsequently been implemented by the                       In the 2015 Proposal, the EPA
                                                Health and Environmental Protection                     U.S. Nuclear Regulatory Commission                      explained that it was ‘‘proposing these
                                                Standards for Uranium and Thorium                       (NRC) and NRC Agreement States. The                     new standards’’ under its authority in
                                                Mill Tailings                                           EPA initially proposed new health and                   section 206 of UMTRCA which
                                                                                                        environmental protection standards for                  ‘‘authorizes EPA to promulgate general
                                                AGENCY:  Environmental Protection                                                                               standards for the protection of public
                                                Agency (EPA).                                           ISR facilities on January 26, 2015 (2015
                                                                                                        Proposal).2 However, the EPA decided                    health, safety, and the environment
                                                ACTION: Proposed rule; withdrawal.                                                                              from radiological and non-radiological
                                                                                                        to re-propose the rule on January 19,
                                                                                                        2017, and seek additional public                        hazards associated with . . . the
                                                SUMMARY:    The U.S. Environmental                                                                              processing and the possession, transfer,
                                                Protection Agency (EPA) is withdrawing                  comment on changes to the original
                                                                                                        proposal, including changes in the                      and disposal of byproduct material at
                                                its January 19, 2017, proposed rule                                                                             sites at which ores are processed
                                                addressing health and environmental                     regulatory framework and approach,
                                                                                                        based on public comment and new                         primarily for their uranium and thorium
                                                protection standards under the Uranium                                                                          source material content or which are
                                                Mill Tailings Radiation Control Act of                  information received from stakeholders.
                                                                                                        The EPA has not finalized either of                     used for the disposal of such byproduct
                                                1978 (UMTRCA) that would have                                                                                   material.’’ 3 Many commenters stated
                                                applied to byproduct materials                          these proposals and is not doing so
                                                                                                        today. Instead, the EPA is withdrawing                  that this provision does not provide
                                                produced by uranium in-situ recovery                                                                            authority for the type of standards that
                                                (ISR) and would have subsequently                       the 2017 Proposal, which superseded
                                                                                                        the 2015 Proposal.                                      the EPA proposed. Other commenters
                                                been implemented by the U.S. Nuclear                                                                            agreed with the EPA’s view that
                                                Regulatory Commission and its                           II. Why is the EPA withdrawing the                      UMTRCA provides authority for
                                                Agreement States. The EPA is                            2017 Proposal?                                          proposing these standards. The EPA
                                                withdrawing the proposed rule for three                    The EPA has decided to withdraw the                  evaluated and responded to these
                                                reasons. First, the EPA, informed in part               2017 Proposal for three reasons. First,                 comments in the 2017 Proposal.4 Many
                                                by feedback received on the proposal,                   stakeholders, including the NRC, raised                 of these same commenters subsequently
                                                has serious questions as to whether the                 significant concerns regarding the EPA’s                submitted comments on the 2017
                                                proposed rule as written is within EPA’s                legal authority under UMTRCA to                         Proposal, arguing again that the
                                                authority under UMTRCA. Second, the                     propose these standards. Based on those                 proposed standards exceeded the EPA’s
                                                EPA no longer believes that a national                  significant concerns, we now have                       authority to establish ‘‘generally
                                                rulemaking to promulgate standards is                   serious questions concerning whether                    applicable standards.’’ 5 The NRC also
                                                necessary at this time, as the EPA                      the EPA has the legal authority under                   submitted comments stating that it does
                                                believes the existing regulatory                        UMTRCA to issue the regulations as                      not believe EPA has the authority to
                                                structures are sufficient to ensure the                 developed in the 2017 Proposal.                         develop standards of the type contained
                                                targeted protection of public health and                   Second, the EPA no longer believes                   in the 2017 Proposal. Some of these
                                                the environment at existing ISR                         that a national rulemaking to                           commenters raised new arguments to
                                                facilities. Third, present market                       promulgate standards is currently                       support their position that the proposed
                                                circumstances suggest that the influx of                necessary as the Agency believes the                    standards exceed the EPA’s authority
                                                new ISR license applications that was                   existing regulatory structures are                      under UMTRCA. In light of the
                                                once anticipated and that was an                        sufficient to ensure the targeted                       comments provided on the various
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                                                underlying motive for the proposal is                   protection of public health and the                     proposals, including by the NRC, the
                                                not likely to materialize.                              environment at existing ISR facilities.
                                                DATES: The proposed rule published on                   The NRC stated in its public comments                     3 80 FR at 4163; See also 42 U.S.C. 2022(b)(1).
                                                January 19, 2017 (82 FR 7400), entitled                 that its ‘‘current regulations, at 10 CFR                 4 82 FR at 7418–7419, 7421–7422.
                                                                                                                                                                  5 42 U.S.C. 2022(b)(1) uses the phrase ‘‘standards
                                                ‘‘Health and Environmental Protection                   part 40, Appendix A, and those of the                   of general application,’’ while 42 U.S.C. 2022(b)(2)
                                                Standards for Uranium and Thorium                                                                               uses the term ‘‘generally applicable standards.’’ We
                                                Mill Tailings,’’, is withdrawn as of                      1 82   FR 7400.                                       use these terms interchangeably throughout the
                                                October 30, 2018.                                         2 80   FR 4156.                                       action.



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                                                54544                      Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Proposed Rules

                                                EPA now has serious questions as to                          and long-term stability standards ‘‘are               prescriptive post-operational monitoring
                                                whether we have the legal authority to                       not generally applicable standards but                time and data requirements and new
                                                finalize the standards that were                             are implementation criteria, and as                   prescriptive post-restoration
                                                proposed in the 2017 Proposal.                               such, encroach upon NRC’s authority                   requirements’’ as an ‘‘impermissible
                                                   Most of the commenters’ objections to                     and impair the NRC’s ability to                       attempt by EPA to direct the compliance
                                                the EPA’s application of its authority                       effectively regulate its ISR licensees.’’ 12          of ISR operations.’’ 19 The Texas
                                                under UMTRCA in the 2015 Proposal                            The NRC also raised several new                       Commission on Environmental Quality
                                                centered around the meaning of the                           significant legal arguments in its                    (TCEQ) raised the same objection,
                                                phrase ‘‘standards of general                                comments to support its position that                 requesting that the EPA withdraw those
                                                application’’ in the statutory provision.                    had not been previously raised with                   particular requirements ‘‘because they
                                                Commenters opposing the proposed                             EPA.13 For example, the NRC argues                    exceed EPA’s authority to promulgate
                                                standards stated, ‘‘the proposed rules                       that ‘‘EPA’s authority to promulgate                  standards.’’ 20 TCEQ stated that
                                                were legally invalid and felt the EPA                        generally applicable standards, at least              UMTRCA ‘‘confers the NRC and
                                                was overreaching its authority under                         for radiological material, is prescribed              Agreement State programs . . . , not
                                                UMTRCA by proposing standards that                           by what is essentially EPA’s organic                  EPA, with authority to implement and
                                                are too detailed and prescriptive.’’ 6                       authority, namely, the Reorganization                 enforce EPA’s standards,’’ and then
                                                These commenters stated that the EPA                         Plan No. 3 of 1970 (Reorganization                    asserted the EPA’s ‘‘proposed rules . . .
                                                ‘‘was redefining what UMTRCA                                 Plan).’’ 14 The NRC asserts that ‘‘the                go beyond the promulgation of
                                                established as the EPA’s role to set                         Reorganization Plan provided EPA with                 standards and address how those
                                                general standards’’ since these                              an express transfer of AEA authority to               standards should be implemented and
                                                commenters did not believe UMTRCA                            set generally applicable standards ‘for               enforced.’’ 21
                                                provided the EPA with the authority to                       the protection of the general                            Other stakeholders submitted
                                                set standards that included ‘‘any                            environment from radioactive                          comments in support of the 2017
                                                prescriptive implementation                                  material,’’’ and that the Reorganization              Proposal, reiterating their position that
                                                requirements.’’ 7 Other commenters that                      Plan ‘‘expressly prescribed this standard             they believe the EPA has the authority
                                                supported the 2015 Proposal stated that                      setting authority by defining the term                to propose these types of ‘‘generally
                                                ‘‘the proposed standards were an                             ‘standards’ to mean ‘limits on radiation              applicable standards’’ under UMTRCA.
                                                appropriate application of the EPA’s                         exposures or levels, or concentrations or                Based on the discussion above, EPA
                                                authority under the UMTRCA.’’ 8                              quantities of radioactive material’—                  now has serious questions concerning
                                                   In its response to the many comments                      essentially, numerical limits.’’ 15 NRC               whether we have the legal authority to
                                                opposing the EPA’s proposed                                  further asserts that UMTRCA’s                         issue the regulations as proposed in the
                                                application of its authority, the EPA in                     legislative history shows that ‘‘Congress             2017 Proposal. In conjunction with the
                                                the 2017 Proposal indicated that it                          was aware of and considered [this                     grounds for withdrawal discussed
                                                ‘‘disagree[d] with those commenters                          standard-setting authority in the                     below, this uncertainty as to our
                                                who believe the EPA has redefined its                        Reorganization Plan] when it enacted                  authority weighs in favor of
                                                role or overreached its authority in                         UMTRCA in 1978’’ and that ‘‘Congress                  withdrawing the 2017 Proposal.
                                                developing the new standards for ISR                         structured UMTRCA’s grant of authority
                                                facilities.’’ 9 The EPA stated that ‘‘the                    to the EPA Administrator upon this very               B. Health and Environmental Protection
                                                new standards proposed in this action                        provision.’’ 16 The NRC points to several             Justification for the Rule
                                                would apply the same requirements to                         excerpts from the legislative history to                 When EPA initiated this rulemaking,
                                                all ISR facilities and would establish                       support its claim that Congress intended              there was already an effective system in
                                                general requirements . . . [that] the                        ‘‘that EPA’s generally applicable                     place providing environmental
                                                regulatory agency would be responsible                       standards under UMTRCA, for both                      oversight of ISR operations. As we
                                                for implementing. . .on a site-specific                      radiological and non-radiological                     explained in the 2015 Proposal, ‘‘in
                                                basis through the licensing process and                      materials, be in the form of numerical                1983, EPA originally promulgated
                                                would retain the authority to determine                      limits, namely, limits on concentrations              regulations at 40 CFR part 192, Health
                                                when an ISR license can be                                   of radiological and non-radiological                  and Environmental Protection
                                                terminated.’’ 10                                             material, quantities of such material, or             Standards for Uranium and Thorium
                                                   Several stakeholders, including the                       allowable doses or levels to individuals              Mill Tailings, in response to the
                                                NRC, subsequently submitted comments                         from such material.’’ 17                              statutory requirements of the Atomic
                                                on the 2017 Proposal, again stating that                        Other commenters disputed the EPA’s                Energy Act [AEA] of 1954, as amended
                                                the proposed standards could not be                          authority to adopt regulatory                         by the Uranium Mill Tailings Radiation
                                                reasonably classified as ‘‘generally                         requirements that they alleged could not              Control Act of 1978 (UMTRCA).’’ 22 The
                                                applicable standards’’ under UMTRCA                          reasonably be considered ‘‘generally                  2015 Proposal further stated:
                                                and thus was outside EPA’s authority.                        applicable standards.’’ For example, the              ‘‘Requirements currently applicable to
                                                In the 2017 Proposal, the EPA identified                     Uranium Producers of America (UPA)                    active uranium processing and disposal
                                                the proposed standards as falling into                       argued that the proposed standards                    sites, including ISR sites (i.e., Title II
                                                one of three different categories: (1)                       ‘‘exceed[s] EPA’s jurisdictional                      sites) can be found in subpart D of 40
                                                ‘‘Constituent concentration standards;’’                     authority as set forth by UMTRCA.’’ 18                CFR part 192 (hereafter ‘‘subpart D’’).
                                                (2) ‘‘initial stability standards;’’ and (3)                 UPA further criticized the ‘‘new                      Subpart D contains provisions for
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                                                ‘‘long-term stability standards.’’ 11 In its                   12 EPA–HQ–OAR–2012–0788–0312 (comments of
                                                                                                                                                                   managing uranium byproduct materials
                                                comments, the NRC asserted the initial                       the Nuclear Regulatory Commission) at 11.             during and following the processing of
                                                                                                               13 EPA–HQ–OAR–2012–0788–0312, pp. 8–21.             uranium ores, and restoration of
                                                  6 82    FR at 7418.                                          14 Id. at pg. 12.
                                                  7 Id.                                                        15 Id.                                                19 Id.
                                                  8 Id.                                                        16 Id. at pg. 13.                                     20 EPA–HQ–OAR–2012–0788–0302 (comments of
                                                  9 Id.                                                        17 Id. at pg. 14.                                   the TCEQ) at 3.
                                                  10 Id.                                                       18 EPA–HQ–OAR–2012–0788–0380 (comments of             21 Id. at 3–4.
                                                  11 82    FR 7405.                                          Uranium Producers of America) at 7.                     22 80 FR 4161.




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                                                                      Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Proposed Rules                                                        54545

                                                disposal sites following any such use of                complicated and reflects differing views                   expansions, and restarts.30 This
                                                those sites.’’ 23                                       on the available data.                                     expected influx of ISR license
                                                   In the 2015 Proposal, under the                        In addition to the public stakeholder                    applications is no longer anticipated.
                                                heading ‘‘Why does EPA believe new                      comments mentioned above, most                                The NRC is currently reviewing
                                                standards are necessary?’’ the Agency                   importantly, the NRC, the agency tasked                    license applications for only three
                                                stated: ‘‘We believe that ISR-specific                  with implementing the program,                             expansions of ISR facilities and, for the
                                                standards are necessary because                         weighed in on the debate, stating in its                   next five years, the NRC expects only
                                                uranium ISR operations are very                         public comments that ‘‘the NRC staff                       one license application for an expansion
                                                different from conventional uranium                     has concluded that its application of the                  of one ISR facility and one license
                                                mills and the existing standards do not                 10 CFR part 40, Appendix A regulations                     application for one new ISR facility.31
                                                adequately address their unique aspects.                to ISR facilities meets the AEA standard                   Compared to the expected influx of ISR
                                                In particular, we believe it is necessary               of ‘adequate protection’ of public health                  license applications, and the 15 ISR
                                                to take a longer view of groundwater                    and safety and the                                         facilities owned by 10 companies at the
                                                protection than has been typical of                     environment. . . .’’ 28                                    time of the 2017 Proposal, at the end of
                                                current ISR industry practices. Although                  In considering these factors, as well as                 2017 only approximately six ISR
                                                the presence of significant uranium                     the presence of an existing program that                   facilities were operating,32 with
                                                deposits typically diminishes                           the NRC (the implementing agency)                          production down 17% compared to late
                                                groundwater quality, current industry                   believes is sufficient, and the lack of                    2016.33 According to the U.S. Energy
                                                practices for restoration and monitoring                expected growth and status of the                          Information Administration (EIA),
                                                of the affected aquifer may not be                      industry as described further in the next                  ‘‘Domestic Uranium Production
                                                adequate to prevent either the further                  section of this withdrawal action, the                     Report,’’ 4th Quarter 2017, there are no
                                                degradation of water quality or the more                EPA believes that the reasonably                           ISR facilities reported as operating in
                                                widespread contamination of                             envisioned public health and                               Texas, with Alta Mesa, Hobson, La
                                                groundwater that is suitable for human                  environmental benefits of the proposed                     Palangana reported as on ‘‘standby.’’
                                                consumption.’’ 24                                       rulemaking are limited and do not                          Additional ISR facilities in New Mexico,
                                                   In response to both proposals, the                   warrant EPA proceeding with its                            Texas, and Wyoming have been licensed
                                                EPA has received numerous comments                      proposed rulemaking. The existing                          but have not operated and only one has
                                                questioning the need or benefits of the                 regulatory structures, adequately                          undergone development.
                                                rule. For example, in the 2017 Proposal                 address the current environmental                             The proposal of generally applicable
                                                the EPA noted that ‘‘Industry                           concerns.                                                  national standards by EPA was driven
                                                commenters and others say that there is                                                                            partly by the expectation of a significant
                                                no need for this rule because the EPA                   C. Current and Anticipated Market                          number of new facilities (which would
                                                has not identified an instance in which                 Conditions                                                 have also applied to operating wellfields
                                                an ISR operation has contaminated a                        Finally, the EPA believes that market                   at existing facilities), making these
                                                source of drinking water.’’ 25 In the 2017              forces themselves have lessened the                        proposed ISR-specific standards a more
                                                Proposal, the EPA also said: ‘‘Focusing                 need for such a rule. Initially, several                   immediate prerequisite to achieving the
                                                on the area of surrounding or adjacent                  factors, including the expected growth                     efficiency across all regulatory programs
                                                aquifers, the EPA acknowledges that the                 in this industry, led the EPA and the                      that the NRC acknowledged could be
                                                Agency does not have sufficient                         NRC to believe that regulation of ISR                      gained by a ‘‘regulatory regime . . .
                                                information to document a specific                      activities could be more workable and                      specific to ISRs.’’ 34 Today, the EPA
                                                instance of contamination of a public                   efficient if the EPA issued standards of                   questions whether this expected growth
                                                source of drinking water caused by an                   general application specific to the ISR                    in operating ISR facilities is likely to be
                                                ISR . . . [however,] the Agency remains                 facilities that the NRC would                              realized.
                                                concerned that the lack of data does not                incorporate into its own regulations and                      Given this change in circumstances,
                                                demonstrate that no contamination is                    implement through its licensing                            completion of this rule is no longer
                                                occurring . . . . The monitoring                        activities.29 When these efforts began,                    expected to achieve the regulatory
                                                requirements in this proposal address                   the NRC expected as many as 23 ISR                         efficiency that was sought when this
                                                the issue of lack of data.’’ 26 (emphasis               license applications for new facilities,                   rulemaking effort began. The NRC and
                                                added). In its comments on the 2017                                                                                the NRC Agreement States currently
                                                Proposal, UPA refers to the above                         28 EPA–HQ–OAR–2012–0788–0312             at 1.
                                                                                                                                                                   regulate, through existing licenses, the
                                                statement: ‘‘EPA acknowledges there is                    29 EPA–HQ–OAR–2012–0788–0006             (‘‘Regulation   limited number of operating ISR
                                                no evidence of harm. . . . The EPA                      of Groundwater Protection at In Situ Leach                 facilities and such an approach has been
                                                provides no evidence to contradict                      Uranium Extraction Facilities,’’ Nuclear Regulatory        workable in practice for this number of
                                                [NRC’s findings].’’ By contrast, the                    Commission Memorandum COMJSM–06–0001,
                                                                                                        January 17, 2006) at 2 (‘‘. . . the recent rapid rise
                                                Natural Resources Defense Council                       in uranium prices and mining claims would
                                                                                                                                                                      30 EPA–HQ–OAR–2012–0788–0405 (‘‘Uranium

                                                (NRDC) asserts that its comments                                                                                   Recovery Licensing Activities,’’ Presentation of the
                                                                                                        indicate a significant future potential for new ISL
                                                                                                                                                                   Nuclear Regulatory Commission) at 10.
                                                ‘‘demonstrate impacts to ISL mined                      facilities.’’); 80 FR at 4167 (‘‘In recent years, NRC         31 Expectations for number of future licenses
                                                aquifers . . . such that the groundwater                has recognized the desirability of ISR-specific
                                                                                                        regulations. . . . [T]he Commission determined in          based on NRC/EPA telephone conversation on
                                                is substantially degraded and there will                2006 that the appropriate action was ‘initiation of        November 28, 2017.
                                                be long-term harm to crucial natural                    a rulemaking effort specifically tailored to
                                                                                                                                                                      32 U.S. Energy Information Administration:

                                                resources.’’ 27 As is evidenced by the                  groundwater protection programs at in situ leach           ‘‘Domestic Uranium Production Report.’’ 4th
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                                                                                                        (ISL) uranium recovery facilities.’ ’’); 82 FR at 7420     Quarter 2017 (February 8, 2018). The operating
                                                comments, the debate is nuanced and                                                                                facilities are Crow Butte in Nebraska and Lost
                                                                                                        (‘‘In addition, the NRC acknowledges that efficiency
                                                                                                        could be gained by codifying its longstanding              Creek, Nichols Ranch, Ross, Smith Ranch-Highland
                                                  23 80FR 4163.                                         effective regulatory regime into regulations specific      and Willow Creek, all in Wyoming. Cameco
                                                  24 80FR 4164.                                                                                                    subsequently curtailed production at the Crow
                                                                                                        to ISRs. As described in the original proposal, this
                                                  25 82FR 7404.                                         rulemaking was initially prompted by the NRC’s             Butte and Smith-Ranch Highland facilities (see
                                                 26 82 FR 7404.                                         conclusion that ISR-specific rules are needed to           http://www.cameco.com).
                                                                                                                                                                      33 World Nuclear News, 20 November 2017.
                                                 27 EPA–HQ–OAR–2012–0788–0380 at 2; EPA–                create a more workable and sustainable regulatory
                                                HQ–OAR–2012–0788–0390 (comments of the                  framework for this activity, and is not based on any          34 82 FR 7420. See footnote 29 for a more

                                                NRDC) at 4.                                             specific instances of identified contamination.’’).        complete citation.



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                                                54546                   Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Proposed Rules

                                                facilities. We do not see a need for the                  Energy Act (AEA), as added by section                 drug costs translated into a set payment
                                                EPA to continue investing its resources                   206 of UMTRCA (42 U.S.C. 2022) and                    amount, would lead to higher quality of
                                                to complete this rule to develop a ‘‘more                 the Administrative Procedure Act (APA)                care for beneficiaries and reduced
                                                workable and sustainable regulatory                       (5 U.S.C. 551 et seq.).                               expenditures to the Medicare program.
                                                framework’’ as originally anticipated                                                                           DATES: To be assured consideration,
                                                                                                          IV. Impact Analysis
                                                when we proposed these ISR-specific                                                                             comments must be received at one of
                                                standards, especially where current                         Because the EPA is not promulgating
                                                                                                                                                                the addresses provided below, no later
                                                production is reduced and little or no                    any regulatory requirements, there are
                                                                                                                                                                than 5 p.m. on December 31, 2018.
                                                growth is expected in the near future.                    no compliance costs or impacts
                                                The statutory authorities providing for                   associated with today’s final action.                 ADDRESSES:   In commenting, please refer
                                                this ongoing regulatory and licensing                                                                           to file code CMS–5528–ANPRM.
                                                                                                          V. Statutory and Executive Order                      Because of staff and resource
                                                function remain unchanged. Thus, the
                                                                                                          Reviews                                               limitations, we cannot accept comments
                                                appropriate regulatory authorities may
                                                decide on a case-by-case basis to revise                    Today’s action does not establish new               by facsimile (FAX) transmission.
                                                their own pre-existing regulations based                  regulatory requirements. Hence, the                     Comments, including mass comment
                                                on these authorities if they deem it                      requirements of other regulatory statutes             submissions, must be submitted in one
                                                necessary to assist with their                            and Executive Orders that generally                   of the following three ways (please
                                                management of ISR facilities in a                         apply to rulemakings (e.g., the                       choose only one of the ways listed):
                                                particular state or local area.                           Unfunded Mandate Reform Act) do not                     1. Electronically. You may submit
                                                   In addition, we find support for our                   apply to this action.                                 electronic comments on this regulation
                                                decision to withdraw the proposed rule                     Dated: October 18, 2018.                             to http://www.regulations.gov. Follow
                                                in the NRC’s comments on the 2017                         Andrew R. Wheeler,                                    the ‘‘Submit a comment’’ instructions.
                                                Proposal. As explained above, the EPA
                                                                                                          Acting Administrator.                                   2. By regular mail. You may mail
                                                developed the proposed standards
                                                partly based on its understanding, after                  [FR Doc. 2018–23583 Filed 10–29–18; 8:45 am]          written comments to the following
                                                consultation with the NRC, that the                       BILLING CODE 6560–50–P                                address ONLY: Centers for Medicare &
                                                anticipated growth in the number of ISR                                                                         Medicaid Services, Department of
                                                facilities highlighted a need for                                                                               Health and Human Services, Attention:
                                                standards specific to ISR facilities,                     DEPARTMENT OF HEALTH AND                              CMS–5528–ANPRM, P.O. Box 8013,
                                                rather than continuing to apply                           HUMAN SERVICES                                        Baltimore, MD 21244–8013.
                                                standards that were originally written to                                                                         Please allow sufficient time for mailed
                                                address surface disposal of uranium                       Centers for Medicare & Medicaid                       comments to be received before the
                                                mill tailings.35 However, the NRC                         Services                                              close of the comment period.
                                                expressed the following view in its                                                                               3. By express or overnight mail. You
                                                public comments on the proposed                           42 CFR Chapter IV                                     may send written comments to the
                                                rulemaking:                                                                                                     following address ONLY: Centers for
                                                                                                          [CMS–5528–ANPRM]
                                                  The NRC’s current regulations, at 10 CFR                                                                      Medicare & Medicaid Services,
                                                part 40, Appendix A, and those of the various             RIN 0938–AT91                                         Department of Health and Human
                                                Agreement States, as supplemented by site-                                                                      Services, Attention: CMS–5528–
                                                specific license conditions, guidance                     Medicare Program; International                       ANPRM, Mail Stop C4–26–05, 7500
                                                documents (e.g., NRC’s ‘‘Standard Review                  Pricing Index Model for Medicare Part                 Security Boulevard, Baltimore, MD
                                                Plan for In Situ Leach Uranium Extraction                 B Drugs                                               21244–1850.
                                                License Applications,’’ NUREG–1569), and
                                                                                                          AGENCY: Centers for Medicare &                          For information on viewing public
                                                the operational experience and technical
                                                expertise of the regulatory agency staff,                 Medicaid Services (CMS), HHS.                         comments, see the beginning of the
                                                constitute a comprehensive and effective                                                                        SUPPLEMENTARY INFORMATION section.
                                                                                                          ACTION: Advance notice of proposed
                                                regulatory program for uranium in situ                    rulemaking with comment.                              FOR FURTHER INFORMATION CONTACT:
                                                recovery operations (ISR) facilities.36                                                                         Hillary Cavanagh, 410–786–6574 or the
                                                  Considering the prevailing economic                     SUMMARY:   We are issuing this advance                IPI Model Team at IPIModel@
                                                conditions affecting current and                          notice of proposed rulemaking                         cms.hhs.gov.
                                                projected production, which leads the                     (ANPRM) to solicit public comments on
                                                                                                          potential options we may consider for                 SUPPLEMENTARY INFORMATION:
                                                NRC now to expect significantly fewer
                                                future license applications, as opposed                   testing changes to payment for certain                  Inspection of Public Comments: All
                                                to the large increase that it expected at                 separately payable Part B drugs and                   comments received before the close of
                                                the time the rulemaking process was                       biologicals (hereafter called ‘‘drugs’’).             the comment period are available for
                                                initiated (which was motivation for the                   Specifically, CMS intends to test                     viewing by the public, including any
                                                proposal), we conclude that                               whether phasing down the Medicare                     personally identifiable or confidential
                                                withdrawing this proposal is                              payment amount for selected Part B                    business information that is included in
                                                appropriate.                                              drugs to more closely align with                      a comment. We post all comments
                                                                                                          international prices; allowing private-               received before the close of the
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                                                III. Statutory Authority                                  sector vendors to negotiate prices for                comment period on the following
                                                   The statutory authority for this notice                drugs, take title to drugs, and compete               website as soon as possible after they
                                                is provided by section 275 of the Atomic                  for physician and hospital business; and              have been received: http://
                                                                                                          changing the 4.3 percent (post-                       www.regulations.gov. Follow the search
                                                  35 82   FR at 7402–3; 80 FR 4164–7.                     sequester) drug add-on payment in the                 instructions on that website to view
                                                  36 EPA–HQ–OAR–2012–0788–0312           at 1.            model to reflect 6 percent of historical              public comments.




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Document Created: 2018-10-30 00:43:36
Document Modified: 2018-10-30 00:43:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule; withdrawal.
DatesThe proposed rule published on January 19, 2017 (82 FR 7400), entitled ``Health and Environmental Protection Standards for Uranium and Thorium Mill Tailings,'', is withdrawn as of October 30, 2018.
ContactIngrid Rosencrantz, Office of Radiation and Indoor Air, Radiation Protection Division, Mail Code 6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-343-9290; fax number: 202-
FR Citation83 FR 54543 
RIN Number2060-AP43

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