Request To Submit a Two-Part Application-Northwest Medical Isotopes, LLC, 63501-63504 [2013-24882]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63501-63504]
From the Federal Register Online via the Government Printing 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 https://www.regulations.gov and search for Docket ID NRC-2013-0235. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: Carol.Gallagher@nrc.gov. 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 https://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 pdr.resource@nrc.gov. 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: Steven.Lynch@nrc.gov.

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 https://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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