[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Notices]
[Pages 19537-19539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07534]


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NUCLEAR REGULATORY COMMISSION

[NRC-2013-0053]


SHINE Medical Technologies, Inc.; Exemption

AGENCY: Nuclear Regulatory Commission.

ACTION: Exemption.

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FOR FURTHER INFORMATION CONTACT: Steven Lynch, Project Manager, 
Research and Test Reactor Licensing Branch, Division of Policy and 
Rulemaking, 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: 

1.0 Background

    SHINE Medical Technologies, Inc. (SHINE) intends to submit an 
application to construct a medical isotope production facility pursuant 
to the requirements in part 50 of Title 10 of the Code of Federal 
Regulations (10 CFR), and in accordance with 10 CFR 2.101(a)(5) for the 
purpose of producing molybdenum-99 (Mo-99). As an applicant for a 
permit to construct such a facility, SHINE will be subject to all 
applicable rules, regulations and orders of the U.S. Nuclear Regulatory 
Commission (NRC) now or hereafter in effect. SHINE intends to construct 
its medical isotope production facility in Rock County, Wisconsin.
    By letter dated July 10, 2012 (Agencywide Documents Access and 
Management System (ADAMS) Accession No. ML12214A434), SHINE requested 
an interpretation of 10 CFR

[[Page 19538]]

2.101(a)(5), which allows an applicant for a construction permit under 
10 CFR part 50 or combined operating license under 10 CFR part 52 to 
submit the required information of applicants by 10 CFR part 50 in two 
parts. However, that rule also stipulates that only production or 
utilization facility applicants subject to 10 CFR 51.20(b) \1\ may take 
advantage of the two-part submittal provisions of 10 CFR 2.101(a)(5). 
SHINE, recognizing that not all production or utilization facilities, 
particularly research reactors, require an environmental impact 
statement or environmental impact statement supplement, requested that 
the NRC provide clarification on the intent of the rule. Specifically, 
SHINE wanted to know if 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).
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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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    NRC staff responded to SHINE's request in a letter dated December 
7, 2012 (ADAMS Accession No. ML12319A192). In this letter, staff 
concluded:

    With respect to SHINE's questions regarding 10 CFR 2.101(a)(5), 
in order for an applicant for a construction permit under part 50 of 
10 CFR to submit an application in two parts under 10 CFR 
2.101(a)(5), the proposed facility must be subject to 10 CFR 
51.20(b) * * * 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).

    Staff went on to say 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.

2.0 Request/Action

    Section 2.101(a)(5) of 10 CFR states:

    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.

    SHINE's application requested an exemption from the stipulation 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 SHINE 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 or 
not an environmental impact statement or a supplement to an 
environmental impact statement is prepared for its construction permit 
application. Specifically, in accordance with 10 CFR 2.101(a)(5), SHINE 
proposes to submit the following in part one of its construction permit 
application:
     The environmental report required by 10 CFR 50.30(f),
     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.
    Part two of SHINE's construction permit application will contain 
the remainder of the preliminary safety analysis report required by 10 
CFR 50.34(a).

3.0 Discussion

    To docket SHINE's construction permit application in two parts 
under 10 CFR 2.101(a)(5), as proposed, an exemption to the regulations 
is required. Given the dependency of docketing of an application under 
10 CFR 2.101(a) to an applicant meeting the requirements of 10 CFR 
50.30, it is appropriate to use the requirements of 10 CFR 50.12 to 
evaluate this exemption request.
    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, given the 
dependency of docketing a construction permit application in accordance 
with 10 CFR 2.101(a) in order to satisfy other requirements of 10 CFR 
Part 50, it is appropriate to evaluate this exemption using the 
criteria of 10 CFR 50.12.

Authorized by Law

    This exemption would allow SHINE 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 NRC staff has determined that granting 
of the proposed exemption will not result in a violation of the Atomic 
Energy Act of 1954, as amended, or the Commission's regulations. 
Therefore, the exemption is authorized by law.

No Undue Risk to Public Health and Safety

    The underlying purpose of 10 CFR 2.101(a)(5) is to provide a 
mechanism to facilitate the construction permit application process by 
allowing applicants to submit their applications for a construction 
permit in two parts. The provisions for two-part construction permit 
application submittals were added as an amendment to the regulations of 
10 CFR part 2 on April 24, 1974, in the Federal Register. 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'' 
(39 FR 14506). 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 this reasoning that the 
ability for SHINE to submit its construction permit application in two 
parts will facilitate the licensing process of this facility in its 
effort to respond to the nation's demand for a domestic supply of Mo-
99.
    The current provisions of 10 CFR 2.101(a)(5) 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). Whichever part is 
submitted first must also contain the following as part of the 
submittal:
     The filing fee required by 10 CFR 50.30(e) and 10 CFR 
170.21,
     The general information required by 10 CFR 50.33,
     The description and safety assessment of the site required 
by 10 CFR 50.34(a)(1); and
     The agreement limiting access to Classified Information 
required by 10 CFR 50.37.
    For the case where the preliminary safety analysis report required 
by 10

[[Page 19539]]

CFR 50.34(a) is submitted second, the information required by 10 CFR 
50.34(a)(2)-(a)(8) does not need to accompany the first part of the 
submittal. 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.
    While the current language of the rule limits its applicability to 
applications meeting the criteria of licensing and regulatory actions 
requiring environmental impact statements as described in the 
provisions of 10 CFR 51.20(b), over time the language of the rule has 
been expanded to include types of applications not originally 
considered at the time of the initial rulemaking. For example, in 2007 
the language of the rule was modified to include applicants seeking 
combined licenses under 10 CFR Part 52. 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'' (72 FR 49412). 
Similarly, given the procedural nature of this rule, there are no 
unique considerations for medical isotope production facilities, which 
would weigh against allowing a license applicant such as SHINE to 
submit a two-part application under 10 CFR 2.101(a)(5).
    Based on the procedural nature of this request, as described above, 
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. Also, based on 
the above, the consequences of postulated accidents are not increased. 
Therefore, there is no undue risk \2\ to public health and safety.
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    \2\ 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.
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Consistent With Common Defense and Security

    As discussed above, the proposed exemption would allow SHINE 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.

Special Circumstances

    Special circumstances, in accordance with 10 CFR 50.12, are present 
whenever application 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.\3\ The underlying 
purpose of 10 CFR 2.101(a)(5), as discussed above, is to facilitate the 
application submittal process for construction permit applicants when 
it is in the interest of the public to remove unnecessary obstacles to 
meet the needs of the nation. When the rule was originally written, 
there was a ``deep national concern over energy sources and supply'' 
(39 FR 14508). 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 and the National Nuclear 
Security Administration are currently supporting four separate 
commercial 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.\4\ In support of 
this effort and in alignment with the underlying purpose of the rule, 
SHINE's letter requesting an exemption from the requirements of 10 CFR 
2.101(a)(5) dated February 18, 2013, states that it intends to 
``construct and operate a medical isotope production facility able to 
produce molybdenum-99'' (ADAMS Accession No. ML13051A007) in order to 
meet the emerging domestic demands for the Mo-99 and its decay product, 
technetium-99m, in nuclear medicine procedures. Therefore, since the 
underlying purpose of 10 CFR 2.101(a)(5) is achieved, the special 
circumstances required by 10 CFR 50.12 for the granting of an exemption 
from 10 CFR 2.101(a)(5) exist.
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    \3\ There are several ways to demonstrate the presences of 
special circumstances. See 10 CFR 50.12(a)(2)(i)-(vi). SHINE has 
proposed that the special circumstances described in 10 CFR 
50.12(a)(2)(ii) are present in this circumstance.
    \4\ 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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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, the Commission hereby grants SHINE Medical Technologies, 
Inc. an exemption from the requirement of 10 CFR 2.101(a)(5) limiting 
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 granting of this exemption allows 
SHINE to submit the construction permit application for its medical 
isotope 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 an environmental assessment because the 
granting of this exemption: (1) Neither involves a significant 
reduction in the margin of safety nor creates a possibility of an 
accident, thus resulting in no significant hazards consideration; (2) 
would not result in the release of effluents, thus resulting in no 
significant change in the types or significant increase in the amounts 
of any effluents that may be released offsite; (3) neither introduces 
new radiological hazards nor increases existing radiological hazards, 
thus resulting in no significant increase in individual or cumulative 
public or occupational radiation exposure; (4) would not involve 
construction, thus resulting in no significant construction impact; (5) 
would occur prior to any radiological components being in place at the 
facility and would not create any new accident precursors, thus 
resulting in no significant increase in the potential for or 
consequences from radiological accidents; and (6) would allow the 
submission of a construction permit application in two parts, which is 
related to a scheduling requirement and is administrative in nature in 
accordance with 10 CFR 51.22(c)(25)(G) and (I), respectively. This 
exemption is effective upon issuance.

    Dated at Rockville, Maryland, this 20th day of March, 2013.

    For the Nuclear Regulatory Commission.
Lawrence E. Kokajko,
Director, Division of Policy and Rulemaking, Office of Nuclear Reactor 
Regulation.
[FR Doc. 2013-07534 Filed 3-29-13; 8:45 am]
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