[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63501-63504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24882]
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NUCLEAR REGULATORY COMMISSION
[Project No. 0803; NRC-2013-0235]
Request To Submit a Two-Part Application--Northwest Medical
Isotopes, LLC
AGENCY: Nuclear Regulatory Commission.
ACTION: Exemption.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an
exemption in response to an August 9, 2013, letter from Northwest
Medical Isotopes, LLC (NWMI). In this letter, NWMI requested an
exemption from certain regulatory requirements, which, if granted,
would allow the submittal of a construction permit application for a
[[Page 63502]]
medical radioisotope production facility in two parts. The NRC staff
has reviewed this request and determined that it is appropriate to
grant the exemption, as requested.
ADDRESSES: Please refer to Docket ID NRC-2013-0235 when contacting the
NRC about the availability of information regarding this document. You
may access publicly-available information related to this action by the
following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0235. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. For technical questions, contact
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section
of this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. The ADAMS accession number
for each document referenced in this document (if that document is
available in ADAMS) is provided the first time that the document is
referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Steven Lynch, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone: 301-415-1524; email: [email protected].
SUPPLEMENTARY INFORMATION: The following sections include the text of
the exemption in its entirety as it will be issued to NWMI.
1.0 Background
Currently, the United States receives all of its supply of
molybdenum-99 (Mo-99) from international sources. In recent years,
outages at these international facilities have disrupted global supply
and created a need to establish domestic Mo-99 production within the
United States. In response to this need, NWMI stated in a letter dated
August 9, 2013 (ADAMS Accession No. ML13227A295), that it intends to
``design and construct a [radioisotope production facility] and intends
to produce Mo-99'' in order to meet the emerging domestic demands for
Mo-99 and its decay product, technetium-99m, in nuclear medicine
procedures. Northwest Medical Isotopes, LLC, has proposed to submit an
application to construct a radioisotope production facility pursuant to
the requirements of part 50 of Title 10 of the Code of Federal
Regulations (10 CFR), ``Domestic Licensing of Production and
Utilization Facilities,'' and in accordance with 10 CFR 2.101(a)(5) for
the purpose of producing Mo-99. As an applicant for a permit to
construct such a facility, NWMI will be subject to all applicable
rules, regulations, and orders of the NRC now or hereafter in effect.
Generally speaking, production and utilization facility applicants
subject to 10 CFR 51.20(b) \1\ may submit the information required for
a construction permit, under 10 CFR part 50, in two parts, in
accordance with the provisions of 10 CFR 2.101(a)(5). These provisions
state that one part of the submittal must include the environmental
report required by 10 CFR 50.30(f), while the other part must include
the preliminary safety analysis report required by 10 CFR 50.34(a).
Either part of the construction permit application may be submitted
first as long as the submission of each part of the application does
not precede or follow the other by longer than six months. However, the
first part submitted must also contain the following:
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\1\ 10 CFR 51.20(b) enumerates the types of licensing and
regulatory actions requiring an environmental impact statement or a
supplement to an environmental impact statement.
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The description and safety assessment of the site required
by 10 CFR 50.34(a)(1),
the filing fee required by 10 CFR 50.30(e) and 10 CFR
170.21,
the general information required by 10 CFR 50.33, and
the agreement limiting access to Classified Information
required by 10 CFR 50.37.
Thus, 10 CFR 2.101(a)(5) provides that applicable preliminary
safety analysis report information required by 10 CFR 50.34(a)(2)-
(a)(13) need not accompany the first part of the submittal. In order to
facilitate the review of its application, NWMI would like to submit its
application in two parts, as described above; however, based on the
current language of 10 CFR 51.20, it cannot do so unless granted an
exemption from certain provisions of 10 CFR 2.101(a)(5) by the
Commission.
The NRC staff previously addressed an exemption request from SHINE
Medical Technologies, Inc. (SHINE) to submit is construction permit
application in two parts. The NRC staff responded to a letter from
SHINE, dated July 10, 2012 (ADAMS Accession No. ML12214A434), that
asked whether production or utilization facility applicants could
submit a construction permit application in two parts even if an
environmental impact statement is not explicitly required for the
application by 10 CFR 51.20(b).
In a letter dated December 7, 2012 (ADAMS Accession No.
ML12319A192), the NRC staff responded:
SHINE's proposed action for licensing a medical isotope
production facility is not an action identified in 51.20(b);
therefore, 10 CFR 2.101(a)(5) is not applicable to SHINE's licensing
proposal. However, SHINE could apply for an exemption under 10 CFR
50.12 in order to submit its application for a construction permit
in two parts as described in 10 CFR 2.101(a)(5).
The NRC staff also explained that should an exemption to 10 CFR
2.101(a)(5) be sought, the request must set forth existing special
circumstances warranting the exemption, as well as provide the proposed
contents of each part of the construction permit application.
Similarly, NWMI has proposed to submit an application requesting
the issuance of a construction permit for a medical radioisotope
production facility--a licensing action not identified in 10 CFR
51.20(b). Therefore, its application for a construction permit cannot
be submitted in two parts under 10 CFR 2.101(a)(5) unless an exemption
is granted by the Commission.
2.0 Request/Action
Section 2.101(a)(5) of 10 CFR states, in part:
An applicant for a construction permit under part 50 of this
chapter . . . for a production or utilization facility which is
subject to Sec. 51.20(b) of this chapter, and is of the type
specified in Sec. 50.21(b)(2) or (b)(3) or Sec. 50.22 of this
chapter . . . may submit the information required of applicants by
part 50 . . . of this chapter in two parts.
By its letter dated August 9, 2013, NWMI requests an exemption from
the provision of 10 CFR 2.101(a)(5) that applications for a
construction permit under 10 CFR part 50 must be of the type requiring
an environmental impact statement or a supplement to an environmental
impact statement as described in 10 CFR 51.20(b). The exemption would
allow NWMI to submit a portion of its construction permit up to six
months prior to the submittal of the remainder of the application
regardless of whether an environmental impact statement or a
[[Page 63503]]
supplement to an environmental impact statement is prepared for its
construction permit application. Specifically, in accordance with the
provisions of 10 CFR 2.101(a)(5), NWMI proposes to submit the following
in part one of its construction permit application:
The description and safety assessment of the site required
by 10 CFR 50.34(a)(1),
the environmental report required by 10 CFR 50.30(f),
the filing fee required by 10 CFR 50.30(e) and 10 CFR
170.21,
the general information required by 10 CFR 50.33, and
the agreement limiting access to Classified Information
required by 10 CFR 50.37.
Part two of NWMI's construction permit application will contain the
remainder of the preliminary safety analysis report required by 10 CFR
50.34(a) and 2.101(a)(5). Northwest Medical Isotopes, LLC, has proposed
to ``design and construct a [radioisotope production facility] and
intends to produce Mo-99.'' In its request for an exemption from
certain requirements of 10 CFR 2.101(a)(5), NWMI states that the
``demand for medical isotopes is a significant national public health
and safety concern,'' and the ability to submit its construction permit
application in two parts would ``allow for an earlier determination as
to whether an [environmental impact statement] is required, allowing a
potential earlier completion of the environmental review and ultimate
issuance of the Construction Permit . . .''
3.0 Discussion
To docket NWMI's construction permit application in two parts under
10 CFR 2.101(a)(5), as proposed, an exemption to the regulations is
required. Pursuant to 10 CFR 50.12, the Commission may, upon
application by any interested person or upon its own initiative, grant
exemptions from the requirements of 10 CFR part 50 when (1) the
exemptions are authorized by law, will not present an undue risk to
public health or safety, and are consistent with the common defense and
security; and (2) when special circumstances are present. While the
action requested is not for an exemption to a 10 CFR part 50
regulation, it is appropriate to evaluate this exemption request using
the criteria of 10 CFR 50.12 because an application for a construction
permit for a radioisotope production facility cannot be accepted for
docketing in accordance with 10 CFR 2.101(a) unless it meets the
requirements of 10 CFR part 50.
Special Circumstances
The application of 10 CFR 2.101(a)(5) is limited to applications
for licensing actions that meet the criteria for environmental impact
statements as described in the provisions of 10 CFR 51.20(b) and to
facilities of the types specified in 10 CFR 50.21(b)(2) or (b)(3) or 10
CFR 50.22. Northwest Medical Isotopes, LLC, has proposed to submit an
application requesting the issuance of a construction permit for a
medical radioisotope production facility--a licensing action not
identified in 10 CFR 51.20(b). Consequently, its application for a
construction permit cannot be submitted in two parts under 10 CFR
2.101(a)(5) unless an exemption is granted by the Commission. The
Commission will not consider granting an exemption under 10 CFR 50.12
unless special circumstances are present. One of the special
circumstances listed in 10 CFR 50.12(a)(2) is ``(ii) [a]pplication of
the regulation in the particular circumstances would not serve the
underlying purpose of the rule or is not necessary to achieve the
underlying purpose of the rule.'' Therefore, should the Commission
determine that the underlying purpose of 10 CFR 2.101(a)(5) is
achieved, application of the regulation would not be necessary, and the
special circumstances would exist for granting of an exemption from
certain requirements of 10 CFR 2.101(a)(5).
The underlying purpose of the 10 CFR 2.101(a)(5) provision that
allows certain applicants to submit an application for a construction
permit in two parts is to enable the NRC review of significant portions
of the application, as they become available, without unnecessary
delay. The provision for two-part construction permit application
submittals was added as an amendment to the regulations of 10 CFR part
2, ``Agency Rules of Practice and Procedure,'' on April 24, 1974 (39 FR
14506). The intent of this final rule was to ``reduce the time required
to bring on line nuclear power plants which satisfy all environmental
and safety requirements . . . [and remove] unnecessary obstacles to the
construction of power plants needed to meet the nation's energy
needs.'' Recognizing the procedural nature of the amendment, the
Commission made the language of the final rule effective without the
customary 30-day notice. It is consistent with the procedural nature of
and rationale for the rule to allow NWMI to submit its construction
permit application in two parts to facilitate the licensing process of
this facility and NWMI's effort to respond to the nation's demand for a
domestic supply of Mo-99.
Furthermore, when the rule was originally written, there was a
``deep national concern over energy sources and supply.'' Similarly,
there currently exists a national concern over the sources and supply
of Mo-99 in the United States. Recognizing this concern, the U.S.
Department of Energy (DOE) and the National Nuclear Security
Administration (NNSA) are supporting four separate entities in the
development of low enriched uranium technologies to accelerate
commercial production of Mo-99 in the United States through the Global
Threat Reduction Initiative.\2\ By producing Mo-99 to meet emerging
domestic needs, NWMI's proposed medical radioisotope production
facility supports the efforts of DOE and NNSA and is in alignment with
the underlying purpose of 10 CFR 2.101(a)(5). Therefore, since the
underlying purpose of the rule is achieved, application of the
regulation is not necessary, and the special circumstances, required by
10 CFR 50.12(a)(2)(ii), exist for granting an exemption from certain
requirements of 10 CFR 2.101(a)(5).
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\2\ To learn more about the Global Threat Reduction Initiative
and U.S. Department of Energy's support of domestic Mo-99
production, please visit http://nnsa.energy.gov/.
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Additionally, in 2007, the rule language was modified to include
applicants seeking combined licenses under 10 CFR part 52, ``Licenses,
Certifications, and Approvals for Nuclear Power Plants'' (72 FR 49412).
The Commission determined that ``[t]here are no considerations unique
to combined licenses which would weigh against allowing a combined
license applicant to submit a two part application under paragraph
(a)(5) of Sec. 2.101.'' Similarly, the NRC staff concludes that given
the procedural nature of this rule, there are no unique considerations
for medical radioisotope production facilities that would weigh against
allowing an applicant such as NWMI to submit a two-part application
under 10 CFR 2.101(a)(5).
Authorized by Law
This exemption would allow NWMI to submit its application for a 10
CFR part 50 construction permit in two parts, as provided for in 10 CFR
2.101(a)(5). The exemption would not change the quality or content of
the environmental report or the preliminary safety analysis report. The
NRC staff has determined that special circumstances exist to
[[Page 63504]]
support the issuance of an exemption. Thus, the granting of the
proposed exemption is consistent with the Atomic Energy Act of 1954, as
amended, and the Commission's regulations. Therefore, the exemption is
authorized by law.
No Undue Risk to Public Health and Safety
As described above, the requested exemption is procedural in nature
and does not alter any substantive safety requirements regarding the
content of a construction permit application. Due to the procedural
nature of this request, no new accident precursors are created by
allowing an applicant to submit a construction permit application in
two parts; thus, the probability of postulated accidents is not
increased. Similarly, the consequences of postulated accidents are not
increased by an exemption that authorizes an application to be
submitted in two parts. Therefore, there is no undue risk \3\ to public
health and safety.
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\3\ Risk is defined as the probability of an accident multiplied
by the consequences of an accident. More information on risk as it
is applies to NRC regulatory activities can be found in the
Commission White Paper on Risk-Informed and Performance Based
Regulation, SECY-98-144 (ADAMS Accession No. ML003753601).
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Consistent With Common Defense and Security
As discussed above, the proposed exemption would allow NWMI to
submit its application for a 10 CFR part 50 construction permit
application in two parts as provided for in 10 CFR 2.101(a)(5). The
timing of submitting a construction permit application has no relation
to security issues. Therefore, the common defense and security is not
impacted by this exemption.
4.0 Conclusion
Accordingly, the Commission has determined that, pursuant to 10 CFR
50.12, the exemption is authorized by law, will not present an undue
risk to the public health and safety, and is consistent with the common
defense and security. Also, special circumstances are present.
Therefore, pursuant to 10 CFR 50.12, the Commission hereby grants NWMI
an exemption from the 10 CFR 2.101(a)(5) requirement that limits the
regulation's applicability to licensing and regulatory actions
requiring environmental impact statements, as described in the
provisions of 10 CFR 51.20(b). The exemption granted allows NWMI to
submit the construction permit application for its medical radioisotope
production facility in two parts, in accordance with the remainder of
the provisions of 10 CFR 2.101(a)(5).
Pursuant to 10 CFR 51.32, the Commission has determined that the
granting of this exemption will not have a significant effect on the
quality of the human environment as it is procedural in nature.
Furthermore, the Commission has determined that this exemption request
meets the criteria in 10 CFR 51.22(c)(25) for a licensing action that
is categorically excluded from the requirement to prepare an
environmental assessment because the granting of this exemption: (1)
Does not involve a significant increase in the probability or
consequences of an accident previously evaluated, does not create the
possibility of a new or different kind of accident from that previously
evaluated, and does not involve a significant reduction in the margin
of safety and, thus there is no significant hazards consideration; (2)
does not authorize the release of effluents, thus there is no
significant change in the types or significant increase in the amounts
of any effluents that may be released offsite; (3) neither authorizes
new radiological hazards nor increases existing radiological hazards,
thus there is no significant increase in individual or cumulative
public or occupational radiation exposure; (4) does not authorize
construction, thus there is no significant construction impact; (5)
does not authorize any placement of radiological components at a
facility or create any new accident precursors, thus there is no
significant increase in the potential for or consequences from
radiological accidents; and (6) allows the submission of a construction
permit application in two parts, and thus involves a scheduling
requirement in accordance with 10 CFR 51.22(c)(25)(vi)(G). This
exemption is effective upon issuance to NWMI.
Dated at Rockville, Maryland, this 7th day of October, 2013.
For the Nuclear Regulatory Commission.
Lawrence E. Kokajko,
Director, Division of Policy and Rulemaking, Office of Nuclear Reactor
Regulation.
[FR Doc. 2013-24882 Filed 10-23-13; 8:45 am]
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