Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 62329 

11232(e), 11246 (b) and (c) of Pub. L. 105– 

33, 111 Stat. 251; and section 721 of Pub. L. 

105–261, 112 Stat. 2061. 

■ 2. Section 890.102 is amended by 

adding paragraphs (j) and (k) to read as 

follows: 

§ 890.102 Coverage. 

* * * * * 

(j)(1) Notwithstanding paragraphs 

(c)(1), (2), and (3) of this section, a nonPostal employee working on a 

temporary appointment, a non-Postal 

employee working on a seasonal 

schedule of less than 6 months in a year, 

or a non-Postal employee working on an 

intermittent schedule, for whom the 

employing office expects the total hours 

in pay status (including overtime hours) 

plus qualifying leave without pay hours 

to be at least 130 hours per calendar 

month, is eligible to enroll in a health 

benefits plan under this part as follows: 

(i) If the employing office expects the 

employee to work at least 90 days, the 

employee is eligible to enroll upon 

notification of the employee’s eligibility 

by the employing office, and 

(ii) If the employing office expects the 

employee to work for fewer than 90 

days and the employee actually works 

for fewer than 90 days, the employee 

will generally be ineligible to enroll in 

FEHB because the employee will not be 

employed at the end of the waiting 

period applicable to these employees. 

However, if the expectation changes and 

the employee is expected to work for 90 

days or more, that individual is eligible 

to enroll upon notification by the 

employing office, but enrollment 

(including the effective date of coverage) 

must be no later than the end of the 

waiting period ending the 91st day after 

the first day of employment. 

(2) An employee working on a 

temporary appointment, an employee 

working on a seasonal schedule of less 

than 6 months in a year, or an employee 

working on an intermittent schedule for 

whom the employing office expects the 

total hours in pay status (including 

overtime hours) plus qualifying leave 

without pay hours to be less than 130 

hours per calendar month is generally 

ineligible to enroll in a health benefits 

plan under this part. If the expectation 

of hours of employment changes to 130 

hours or more per month for a nonPostal employee, that employee is 

eligible to enroll in a health benefits 

plan under this part as described in 

paragraph (j)(1)(i) of this section. 

(3) Once an employee is enrolled 

under this paragraph (j), eligibility will 

not be revoked, regardless of his or her 

actual work schedule or employer 

expectations in subsequent years, unless 

the employee separates from Federal 

service, receives a new appointment (in 

which case eligibility will be 

determined by the rules applicable to 

the new appointment), or exceeds 365 

days in nonpay status in accordance 

with § 890.303(e) (subject to extension, 

if applicable, for qualifying leave 

without pay as defined at paragraph 

(j)(4) of this section). 

(4) For purposes of this paragraph (j), 

‘‘qualifying leave without pay hours’’ 

means hours of leave without pay for 

purposes of taking leave under the 

Family and Medical Leave Act, for 

performance of duty in the uniformed 

services under the Uniformed Services 

Employment and Reemployment Rights 

Act of 1994, 38 U.S.C. 4301 et seq., for 

receiving medical treatment under 

Executive Order 5396 (Jul. 7 1930), and 

for periods during which workers 

compensation is received under the 

Federal Employees Compensation Act, 5 

U.S.C. chapter 81. 

(5) Each temporary employee who is 

initially eligible for FEHB coverage on 

the basis of this paragraph (j) is entitled 

to enroll in accordance with 

§ 890.301(a). A temporary employee 

who is currently eligible under 5 U.S.C. 

8906a (with no Government 

contribution) but who is not enrolled on 

November 17, 2014, and who would 

also meet eligibility requirements on the 

basis of paragraph (j), is entitled to 

enroll (with a Government contribution) 

on the basis of paragraph (j) in 

accordance with § 890.301(h)(4)(ii). A 

temporary employee who is enrolled 

under 5 U.S.C. 8906a (with no 

Government contribution) on November 

17, 2014, and who would also meet 

eligibility requirements on the basis of 

paragraph (j), is entitled to change 

enrollment (with a Government 

contribution) on the basis of paragraph 

(j) in accordance with 

§ 890.301(h)(4)(ii). 

(k) The Director, upon written request 

of an employer of employees other than 

those covered by 5 U.S.C. 8901(1)(A), 

may, in his or her sole discretion, waive 

application of paragraph (j) of this 

section to its employees when the 

employer demonstrates to the Director 

that the waiver is necessary to avoid an 

adverse impact on the employer’s need 

to manage its workforce. However, a 

Tribal employer participating under 25 

U.S.C. 1647b may provide a written 

notification to the Director that it has 

chosen not to apply paragraph (j) of this 

section for its workforce. 

■ 3. Amend § 890.301 as follows: 

■ a. Revise the heading of paragraph 

(h).b. Redesignate paragraph (h)(4) as 

paragraph (h)(4)(i). 

■ c. Add paragraph (h)(4)(ii). 

The revision and addition read as 

follows: 

§ 890.301 Opportunities for employees 

who are not participants in premium 

conversion to enroll or change enrollment; 

effective dates. 

* * * * * 

(h) Change in employment status or 

entitlement to Government contribution. 

* * * 

(4) * * * 

(ii) A change in entitlement to 

Government contribution as a result of 

becoming eligible for coverage under 

§ 890.102(j). 

* * * * * 

[FR Doc. 2014–24652 Filed 10–14–14; 11:15 am] 

BILLING CODE 6325–63–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 50 

[NRC–2013–0053] 

RIN 3150–AJ18 

Definition of a Utilization Facility 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Direct final rule. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC) is amending its 

regulations to add SHINE Medical 

Technologies, Inc.’s (SHINE) proposed 

accelerator-driven subcritical operating 

assemblies to the NRC’s definition of a 

‘‘utilization facility.’’ In 2013, SHINE 

submitted a two-part construction 

permit application for a medical 

radioisotope production facility that 

SHINE proposes to build in Janesville, 

Wisconsin. The proposed acceleratordriven subcritical operating assemblies, 

to be housed in SHINE’s irradiation 

facility, would be used to produce 

molybdenum-99 (Mo-99), a radioisotope 

used in medical imaging and other 

radioisotopes used for medical 

purposes. This rule allows NRC staff to 

conduct an efficient and effective 

licensing review of the SHINE 

construction permit application and any 

subsequent operating license 

application. 

DATES: This final rule is effective 

December 31, 2014, unless a significant 

adverse comment is received by 

November 17, 2014. If the rule is 

withdrawn as a result of such 

comments, timely notice of the 

withdrawal will be published in the 

Federal Register. Comments received 

after this date will be considered if it is 

practical to do so, but the NRC is able 

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62330 Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 

1Letter from Gregory Piefer, Ph.D., SHINE, to Mr. 

John Kinnemann, Office of Nuclear Material Safety 

and Safeguards (NMSS), ‘‘Notice of Intent to Submit 

License Application, Request for Regulatory 

Interpretations, and Request for Public Meetings,’’ 

dated February 14, 2011 (ADAMS Accession No. 

ML110490138); and Letter from Gregory Piefer, 

Ph.D., SHINE, to Mr. John Kinnemann, NMSS, 

‘‘Updated Request for Regulatory Interpretations,’’ 

dated May 3, 2011 (ADAMS Accession No. 

ML11138A220), respectively. 

2PSAR, Chapter 4—Irradiation Unit and 

Radioisotope Production Facility Description (May 

31, 2013) (ADAMS Accession No. ML13172A265). 

3SHINE’s preliminary safety analysis report 

describes each irradiation unit containing uranium 

solution as ‘‘. . . an accelerator-driven subcritical 

operating assembly used for the irradiation of an 

aqueous uranyl sulfate target solution, resulting in 

the production of molybdenum-99 (Mo-99) and 

other fission products.’’ (ADAMS Accession No. 

ML13172A265). 

to ensure consideration only for 

comments received on or before this 

date. 

ADDRESSES: Please refer to Docket ID 

NRC–2013–0053 when contacting the 

NRC about the availability of 

information for this direct final rule. 

You may access publicly-available 

information related to this direct final 

rule by any of the following methods: 

• Federal Rulemaking Web Site: Go to 

http://www.regulations.gov and search 

for Docket ID NRC–2013–0053. Address 

questions about NRC dockets to Carol 

Gallagher; telephone: 301–287–3422; 

email: Carol.Gallagher@nrc.gov. For 

technical questions, contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publiclyavailable documents online in the 

ADAMS Public Documents collection 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, at 301–415–4737, or 

by email to pdr.resource@nrc.gov. The 

ADAMS accession number for each 

document referenced (if it is available in 

ADAMS) is provided the first time that 

it is mentioned in the SUPPLEMENTARY

INFORMATION section. 

• 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; telephone: 301–415–1524; 

email: Steven.Lynch@nrc.gov; U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Procedural Background 

II. Background 

III. Discussion 

A. What action is the NRC taking? 

B. What is the purpose of the direct final 

rule? 

C. What is the NRC’s authority to make this 

rule change? 

D. Why are the SHINE irradiation units not 

considered production facilities? 

E. Why do the SHINE irradiation units not 

fit the current definition of a utilization 

facility? 

F. Why should the SHINE irradiation units 

be licensed as 10 CFR part 50 utilization 

facilities? 

G. Who has jurisdiction over the 

accelerator? 

H. Why is 10 CFR part 70 not appropriate 

to review or license the SHINE 

irradiation units? 

I. Who will this action affect? 

J. What is the reason for the change? 

K. Why is a direct final rule appropriate? 

L. Will the NRC issue guidance for this 

rule? 

IV. Discussion of Amendments by Section 

V. Regulatory Flexibility Certification 

VI. Regulatory Analysis 

VII. Backfitting and Issue Finality 

VIII. Plain Writing 

IX. Environmental Assessment and Finding 

of No Significant Environmental Impact 

X. Paperwork Reduction Act Statement 

XI. Congressional Review Act 

XII. Compatibility of Agreement State 

Regulations 

XIII. Voluntary Consensus Standards 

I. Procedural Background 

Because the NRC considers this action 

to be non-controversial, the NRC is 

using the ‘‘direct final rule process’’ for 

this rule. The amendment to the rule 

will become effective on December 31, 

2014. However, if the NRC receives a 

significant adverse comment on this 

direct final rule by November 17, 2014, 

then the NRC will publish a document 

that withdraws this action and will 

subsequently address the comments 

received in a final rule. A companion 

proposed rule published in the 

Proposed Rule section of this issue of 

the Federal Register will serve as the 

basis for the final rule, if it is necessary. 

Absent significant modifications to the 

proposed amendments requiring 

republication, the NRC will not initiate 

a second comment period on this action. 

A significant adverse comment is a 

comment where the commenter 

explains why the rule would be 

inappropriate, including challenges to 

the rule’s underlying premise or 

approach, or would be ineffective or 

unacceptable without a change. A 

comment is significant and adverse if it 

meets the following criteria: 

(1) The comment opposes the rule and 

provides a reason sufficient to require a 

substantive response in a notice-andcomment process. For example, a 

substantive response is required when: 

(a) The comment causes the NRC staff 

to reevaluate (or reconsider) its position 

or conduct additional analysis; 

(b) The comment raises an issue 

serious enough to warrant a substantive 

response to clarify or complete the 

record; or 

(c) The comment raises a relevant 

issue that was not previously addressed 

or considered by the NRC staff. 

(2) The comment proposes a change 

or an addition to the rule, and it is 

apparent that the rule would be 

ineffective or unacceptable without 

incorporation of the change or addition. 

(3) The comment causes the NRC staff 

to make a change (other than editorial) 

to the rule. 

For detailed instructions on 

submitting comments, please see the 

companion proposed rule published in 

the Proposed Rule section of this issue 

of the Federal Register. 

II. Background 

By letters dated February 14, 2011, 

and May 3, 2011,1 SHINE notified the 

NRC of its intent to submit applications 

to construct, and operate, a medical 

isotope production facility. SHINE’s 

medical isotope production facility 

would include an irradiation facility 

and a radioisotope production facility 

housed in a single building, and is 

proposed to be built in Wisconsin, an 

Agreement State. 

The SHINE preliminary safety 

analysis report (PSAR) 2 states that the 

irradiation facility consists of eight 

irradiation units. Each irradiation unit is 

an accelerator-driven subcritical 

operating assembly and, would be used 

for the irradiation of a uranium 

solution.3 The irradiation would result 

in the production of Mo-99 and other 

fission products. Based on initial 

discussions with SHINE prior to the 

submission of its application, the NRC 

staff understood that the proposed 

irradiation units were not nuclear 

reactors as defined in § 50.2 of Title 10 

of the Code of Federal Regulations (10 

CFR). The NRC staff believed that the 

irradiation units, including the 

accelerators, were an integral part of the 

radioisotope production facility. 

Therefore, the NRC staff believed that 

the SHINE irradiation units and 

radioisotope production facility could 

be jointly licensed under the third part 

of the production facility definition 

found in 10 CFR 50.2. Based on these 

assumptions, the NRC staff relayed to 

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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 62331 

4Transcript of NRC Briefing on Potential Medical 

Isotope Production Licensing Actions, pages 55–56, 

61–62 (May 11, 2012) (ADAMS Accession No. 

ML121370084). 

5NUREG–1537, ‘‘Final Interim Staff Guidance 

Augmenting NUREG–1537, Part 1, ‘Guidelines for 

Preparing and Reviewing Applications for the 

Licensing of Non-Power Reactors: Format and 

Content,’ for Licensing Radioisotope Production 

Facilities and Aqueous Homogeneous Reactors,’’ 

October 17, 2012 (ADAMS Accession No. 

ML12156A069). 

6The ISG noted that a ‘‘subcritical multiplier 

reaction vessel containing SNM by definition is not 

a nuclear reactor because it cannot sustain a chain 

reaction. It may be included in a 10 CFR part 50 

production facility license as an assembly 

containing SNM that is authorized for use in 

conjunction with the production facility.’’ ISG page 

iv. 

7See Letter from R. Vann Bynum, Ph.D., SHINE, 

to NRC dated March 26, 2013 (ADAMS Accession 

No. ML13088A192). This transmittal letter is in a 

document package (ADAMS Accession No. 

ML130880226), which includes part one of SHINE’s 

application, consisting of portions of the PSAR, 

specifically Chapter 2, Site Characteristics and 

Chapter 19, Environmental Report (ER). 

See also Letter from R. Vann Bynum, Ph.D., 

SHINE, to NRC dated May 31, 2013 (ADAMS 

Accession No. ML13172A361). A document 

package consisting of a public version of all 19 

chapters of SHINE’s PSAR (with proprietary 

information redacted) is also available in ADAMS, 

Accession No. ML13172A324. 

8See 10 CFR 50.1, ‘‘Basis, purpose, and 

procedures applicable’’ (defining scope of 10 CFR 

part 50 to include only the licensing of production 

and utilization facilities). 

the Commission on May 11, 2012, that 

no rulemaking was required to license 

SHINE’s proposed medical isotope 

production facility.4

In 2012, the NRC staff published 

interim staff guidance (ISG) 5 to augment 

NUREG–1537, ‘‘Guidelines for 

Preparing and Reviewing Applications 

for the Licensing of Non-Power 

Reactors.’’ The ISG noted that a 

subcritical multiplier reaction vessel 

containing special nuclear material 

(SNM), similar to the irradiation units 

proposed by SHINE, could be licensed 

as a production facility pursuant to 10 

CFR part 50.6 Based on the guidance 

provided in the ISG, on March 26, 2013, 

and May 31, 2013, SHINE submitted a 

two-part construction permit 

application for a production facility as 

defined in 10 CFR 50.2.7 SHINE’s 

application describes its proposed 

medical isotope production facility as 

including two distinct operations: (1) 

The irradiation of SNM in eight 

irradiation units in the irradiation 

facility and (2) the extraction of 

radioisotopes in the radioisotope 

production facility. From this 

description, the NRC staff recognized 

that the irradiation units could be 

distinct and separate from the 

radioisotope production facility. 

Therefore, the NRC staff no longer 

believes that the irradiation units can be 

licensed pursuant to 10 CFR 50.2 as 

production facilities since the 

irradiation units are neither integral to 

the operation of the radioisotope 

production facility nor functionally 

independent as production facilities. 

Moreover, the irradiation units cannot 

be licensed as utilization facilities 

because they do not meet the current 

definition in 10 CFR 50.2. As currently 

defined in 10 CFR 50.2, a utilization 

facility is a nuclear reactor, and 

irradiation units are not nuclear reactors 

because they are not designed or used 

to sustain nuclear fission in a selfsupporting chain reaction. Therefore, 

the current 10 CFR part 50 regulations 

governing licensing of production and 

utilization facilities do not apply to 

SHINE’s irradiation facility or 

irradiation units.8

However, the NRC staff maintains its 

initial position that SHINE’s 

radioisotope production facility is 

analogous to a ‘‘production facility’’ and 

therefore should be licensed under 10 

CFR part 50. Specifically, the 

radioisotope production facility is a 

facility designed or used for the 

processing of irradiated materials 

containing SNM and does not meet any 

of the exceptions found in the definition 

of production facility in 10 CFR 50.2. 

III. Discussion 

A. What action is the NRC taking? 

The NRC is amending its regulations 

to add SHINE’s accelerator-driven 

subcritical operating assemblies 

described in the application assigned 

docket number 50–608 to the definition 

of utilization facility in 10 CFR 50.2. 

B. What is the purpose of the direct final 

rule? 

The purpose of the direct final rule is 

to add SHINE’s accelerator-driven 

subcritical operating assemblies to the 

definition of utilization facility in 10 

CFR 50.2. This change will allow the 

NRC staff to review and, if approved, 

license the irradiation units housed in 

SHINE’s irradiation facility under the 

regulations in 10 CFR part 50. 

C. What is the NRC’s authority to make 

this rule change? 

Section 11cc. of the Atomic Energy 

Act of 1954, as amended (AEA), 

specifies that the Commission may 

determine by rule what constitutes a 

utilization facility. The licensing 

requirements for utilization facilities are 

in 10 CFR part 50. This rulemaking will 

resolve any licensing uncertainty 

concerning the applicable regulations 

for licensing the construction and 

potential operation of the SHINE 

irradiation units, as well as expedite the 

NRC staff’s technical review of the 

SHINE construction permit application. 

D. Why are the SHINE irradiation units 

not considered production facilities? 

The NRC has determined that 

SHINE’s irradiation units are not 

integral to the operation of the 

radioisotope production facility. In 

addition, the irradiation units do not 

meet any of the existing definitions of 

production facility in the AEA or in 10 

CFR 50.2; therefore, they cannot be 

licensed as production facilities. 

Pursuant to Section 11v. of the AEA, 

the Commission has determined by rule 

in 10 CFR 50.2 that three types of 

facilities constitute production facilities. 

First, ‘‘production facility’’ is defined as 

any nuclear reactor designed or used 

primarily for the formation of 

plutonium or uranium-233. The 

proposed irradiation units do not meet 

this definition because they are not 

nuclear reactors designed or used 

primarily for the formation of 

plutonium or uranium-233. Rather, the 

irradiation units are designed and used 

primarily to fission uranium for the 

production of fission products. 

Additionally, in contrast to nuclear 

reactors, the proposed irradiation units 

are designed to operate in the subcritical 

regime, and are not designed or used to 

sustain a self-supporting chain reaction. 

Second, ‘‘production facility’’ is 

defined as any facility designed or used 

for the separation of the isotopes of 

plutonium. SHINE’s proposed 

irradiation units do not meet this 

definition because they are designed to 

irradiate a uranium solution, not 

separate the isotopes of plutonium. 

Third, ‘‘production facility’’ is 

defined as any facility designed or used 

for the processing of irradiated materials 

containing SNM. While ‘‘processing,’’ as 

used in the definition of production 

facility, is not defined in the 

regulations, the NRC staff does not 

consider processing to include the 

irradiation and fission of materials, 

whether the material was irradiated 

previously or not, containing SNM. 

Given the similarities between the 

treatment of SHINE’s target solution and 

the fuel in existing power and nonpower reactors, the NRC staff does not 

consider the irradiation units’ function 

to constitute the processing of irradiated 

materials. For example, all fuel in 

existing utilization facilities, including 

both power and non-power reactors, 

undergoes irradiation and fission, 

beginning with its first use to start-up a 

reactor. Furthermore, it is common 

practice in existing utilization facilities 

to offload irradiated fuel from the 

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62332 Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 

9Non-power reactors currently licensed to 

operate by the NRC range in thermal power from 

5 watts to 20 megawatts. In the past, the NRC has 

licensed 12 aqueous homogeneous reactors (AHRs) 

with thermal power levels ranging from 5 watts to 

50 kilowatts. An AHR is similar to the SHINE target 

solution vessel in that both contain fissile material 

in an aqueous solution; the difference is that the 

target solution vessel has insufficient fissile 

material to support a sustained chain reaction. 

10Likewise, the Commission may by rule define 

what constitutes a production facility, AEA Section 

11v. The Commission has previously used the 

rulemaking process to amend its definition of 

production facility. See Licensing of Production 

and Utilization Facilities (21 FR 355; January 19, 

1956), Definition of Production Facility (26 FR 

4989, 4990; June 6, 1961), and Exemption for 

Facilities Processing Irradiated Materials 

Containing Limited Quantities of Special Nuclear 

Material (39 FR 4871; February 8, 1974). 

reactor core for refueling outages and 

maintenance. When it is time to refuel 

the reactor following an outage or 

maintenance, much of the irradiated 

fuel is returned to the reactor core for 

continued irradiation and fission. This 

treatment of reactor fuel is analogous to 

SHINE’s treatment of its target solution. 

Following irradiation, SHINE offloads 

the target solution from the irradiation 

units. The target solution is then 

transferred to SHINE’s radioisotope 

production facility for a period of time 

before it is returned to the irradiation 

units for continued irradiation and 

fission. 

Since all existing power and nonpower reactors are regulated as 

utilization facilities, it is clear that 

continuing to irradiate and fission 

previously irradiated reactor fuel does 

not constitute the processing of 

irradiated materials containing SNM, 

otherwise all existing reactors would be 

classified as production facilities per 10 

CFR 50.2. Consequently, based on the 

NRC staff’s assessment, SHINE’s 

proposed irradiation units cannot be 

considered production facilities. 

E. Why do the SHINE irradiation units 

not fit the current definition of a 

utilization facility? 

SHINE’s proposed irradiation units do 

not meet the current definition of a 

utilization facility because the units do 

not, singly or collectively sustain 

nuclear fission in a self-supporting 

chain reaction. As a result, the NRC staff 

concluded that the current regulatory 

definition of utilization facility does not 

apply to the irradiation units, and they 

cannot currently be licensed as 

utilization facilities as defined in 10 

CFR 50.2. 

F. Why should the SHINE irradiation 

units be licensed as 10 CFR part 50 

utilization facilities? 

The premise of the SHINE technology 

is that the irradiation units will not be 

operated such that the effective neutron 

multiplication factor (keff) is greater than 

or equal to 1.0, a range for which 

nuclear reactors are designed, analyzed, 

and licensed to operate safely. Instead, 

the irradiation units will only operate in 

a minimally subcritical range of keff. To 

operate safely within this margin of 

subcriticality, the irradiation units are 

designed with several features of a 

nuclear reactor except that, by design, 

the target solution vessels have 

insufficient reactivity to sustain a chain 

reaction. 

In addition, the accelerator and 

neutron multiplier add sufficient 

external neutrons to the target solution 

vessel to achieve a fission rate with a 

thermal power level comparable to nonpower reactors typically licensed under 

10 CFR part 50 as utilization facilities.9

Given this fission power, the irradiation 

units also have many safety 

considerations similar to those of nonpower reactors, including the following: 

• Provisions for removal of fission 

heat during operation. 

• Consideration of decay heat 

generation after shutdown. 

• Reactivity feedback mechanisms 

similar to non-power reactors. 

• Control of fission gas release during 

operation and subsequent gas 

management engineering safety features. 

• Control of radiolytic decomposition 

of water and generated oxygen and 

hydrogen gases. 

• Control of fission product inventory 

buildup. 

• Accident scenarios similar to nonpower reactors, such as loss of coolant, 

reactivity additions, and release of 

fission products. 

Although SHINE’s proposed 

irradiation units closely resemble nonpower reactors, which are licensed as 

utilization facilities under 10 CFR part 

50, the irradiation units cannot 

currently be licensed as utilization 

facilities because they are not nuclear 

reactors. Therefore, while 10 CFR part 

50 would be appropriate to apply from 

a technical and licensing review process 

standpoint, the irradiation units cannot 

be licensed as utilization facilities under 

the current regulations. 

The NRC staff believes, however, that 

based on the safety considerations 

associated with operation of the 

irradiation units, the NRC should define 

and license each of the irradiation units 

as a utilization facility. Section 11cc. of 

the AEA provides that the Commission 

may determine what a utilization 

facility is by rule.10 Section 11cc. of the 

AEA provides that a utilization facility 

is any equipment or device determined 

by rule of the Commission to be capable 

of making use of special nuclear 

material in a quantity that is of 

significance to the common defense and 

security or in a manner that affects the 

health and safety of the public. 

Therefore, it would be within the 

Commission’s authority to designate the 

SHINE irradiation units, by rule, as 

utilization facilities. 

G. Who has jurisdiction over the 

accelerator? 

Because the accelerator is integral to 

the operation of the irradiation unit, and 

the Commission must retain authority 

and responsibility with respect to 

regulation of the entire utilization 

facility per Section 274c.(1) of the AEA, 

the Commission has jurisdiction over 

the accelerator. 

The NRC staff has engaged with the 

state of Wisconsin regarding licensing of 

the SHINE irradiation units because an 

accelerator that is not part of an NRC 

licensed facility might be regulated 

under state law. Based on the NRC 

staff’s informal discussions with 

Agreement State counterparts, the NRC 

staff does not expect the state of 

Wisconsin to object to the rule or 

licensing review process for the SHINE 

construction permit application. 

H. Why is 10 CFR part 70 not 

appropriate to review or license the 

SHINE irradiation units? 

The NRC staff considered whether it 

should review SHINE’s irradiation units 

under 10 CFR part 70, ‘‘Domestic 

Licensing of Special Nuclear Material,’’ 

which regulates the issuance of licenses 

to receive title to, own, acquire, deliver, 

receive, possess, use, and transfer SNM. 

From a regulatory perspective, 10 CFR 

part 70 could be applied because SHINE 

will acquire, receive, possess, use, and 

transfer SNM. The requirements of 10 

CFR part 70, subpart H, ‘‘Additional 

Requirements for Certain Licensees 

Authorized To Possess a Critical Mass of 

Special Nuclear Material,’’ could also be 

applied because SHINE will possess a 

critical mass of SNM, and will engage in 

an activity that could significantly affect 

public health and safety. 

The facilities conducting the types of 

activities typically regulated under 10 

CFR part 70, generally referred to as fuel 

cycle facilities, have a common 

objective of avoiding criticality by 

maintaining a significant margin from 

criticality under normal operating and 

accident conditions. Specifically, 10 

CFR 70.61(d) calls for ‘‘. . . use of an 

approved margin of subcriticality for 

safety.’’ SHINE’s irradiation units have 

a proposed routine operating margin of 

subcriticality of less than what has been 

previously approved for other 10 CFR 

part 70 licensees. This operating state 

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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 62333 

11PSAR, Chapter 4—Irradiation Unit and 

Radioisotope Production Facility Description (May 

31, 2013) (ADAMS Accession No. ML13172A265). 

12At this time, the NRC staff does not anticipate 

receiving any other applications for medical 

radioisotope production facilities that would 

propose a technology similar to SHINE’s irradiation 

units. 

more closely resembles the effective 

neutron multiplication factor of nuclear 

reactors than fuel cycle facilities.11

SHINE states that its proposed margin of 

subcriticality is needed to carry out 

efficient production of Mo-99, and 

proposes to control reactivity through 

administrative and engineered controls, 

including careful control of the amount 

of SNM initially placed in the target 

solution vessels. Also, in order to 

operate safely at SHINE’s proposed 

margin of subcriticality, the irradiation 

units are designed with inherent 

negative reactivity feedback 

mechanisms similar to those of nuclear 

reactors. Because SHINE proposes to 

operate each irradiation unit in a 

manner similar to a nuclear reactor, the 

NRC staff has determined that it would 

be most appropriate to use the 

regulations contained in 10 CFR part 50 

to perform its technical review of the 

irradiation units. 

I. Who will this action affect? 

The direct final rule will apply only 

to the irradiation units proposed by 

SHINE under docket number 50–608. 

This rulemaking will affect SHINE by 

bringing the licensing of its proposed 

facility, including both its irradiation 

facility and radioisotope production 

facility, entirely within the regulations 

of 10 CFR part 50. As a result of this 

rulemaking, the NRC will have 

exclusive jurisdiction over the SHINE 

facility, including the licensing and 

oversight of the accelerators associated 

with the irradiation units. Since 

Agreement States typically regulate 

accelerators, the direct final rule will 

also affect the state of Wisconsin. The 

rulemaking will not impact the public’s 

opportunity to comment or participate 

in a hearing on the pending SHINE 

construction permit application or, if 

submitted, any future operating license 

application. 

J. What is the reason for the change? 

The rulemaking will allow the NRC 

staff to conduct its licensing review of 

the proposed SHINE irradiation units 

following regulations designed for 

technologies with similar radiological, 

health, and safety considerations. While 

the proposed irradiation units do not 

currently fit the 10 CFR part 50 

definitions of production or utilization 

facilities, it is within the NRC’s 

authority under the AEA to determine 

by rule that the SHINE irradiation units 

are utilization facilities. The 

Commission has found that 10 CFR part 

50 is the most appropriate regulation to 

apply to the licensing of the SHINE 

irradiation units. 

K. Why is a direct final rule 

appropriate? 

The NRC believes that a direct final 

rule is appropriate for the following 

reasons: 

1. From a health and safety standpoint 

the requirements in 10 CFR part 50 are 

the most appropriate for the licensing 

and technical review of the proposed 

irradiation units. 

2. Designating each proposed 

irradiation unit, by rule, as a utilization 

facility is within the Commission’s 

authority under the AEA. 

3. The proposed irradiation units 

share many characteristics of non-power 

reactors, which are licensed as 

utilization facilities under 10 CFR part 

50. 

4. SHINE has submitted a 

construction permit application that 

contains the majority of regulatory 

information required of utilization 

facilities. 

5. The proposed rulemaking only 

affects the irradiation units proposed by 

SHINE under docket number 50–608. 

The NRC staff is using a direct final 

rule because it considers this 

rulemaking to be non-controversial, it 

does not expect to receive significant 

adverse comments, and using the direct 

final rule process would allow the 

rulemaking to proceed in the most 

efficient manner. The direct final rule is 

expected to be non-controversial 

because the NRC has the authority 

under the AEA to define what 

constitutes a utilization facility; 

interested parties, including SHINE, 

have not objected to discussions and 

published guidance proposing licensing 

under 10 CFR part 50. Additionally, the 

rule does not affect the ability of the 

public to comment and request a 

hearing on the application; and the 

inclusion of SHINE’s docket number as 

well as a description of the SHINE 

irradiation unit technology limits the 

applicability of the rule to SHINE’s 

proposed irradiation units, ensuring no 

impact to other existing or future 

facilities. If, in the future, any applicant 

proposes a technology similar to 

SHINE’s irradiation units,12 the 

Commission would consider that 

application on a case-by-case basis, and 

assign a distinct docket number to each 

application. Should SHINE propose a 

technology other than the irradiation 

units currently described in its PSAR, 

the rule would no longer apply to 

SHINE, and the NRC staff would pursue 

an alternative licensing approach. 

As previously explained, because the 

irradiation units are similar to nonpower reactors, the NRC staff finds the 

10 CFR part 50 regulations most 

appropriate to apply in the review of 

this proposed technology. To limit the 

scope of this rulemaking, the NRC staff 

is recommending that this rule be made 

applicable to only the SHINE facility. A 

generic rulemaking has potential for 

unintended consequences on the 

regulation of other licensees. Expansion 

of the definition of utilization facility 

generically could result in inclusion of 

technologies appropriately regulated by 

Agreement States or under 10 CFR part 

70 within the regulatory scope of 10 

CFR part 50, which would reduce the 

NRC’s regulatory efficiency. 

By identifying 10 CFR part 50 as the 

licensing framework to review and 

evaluate the irradiation units in the 

SHINE construction permit application, 

this rulemaking would clarify the 

appropriate regulatory requirements 

governing SHINE’s requested licensing 

action for the applicant; interested 

members of the public; federal, state, 

Tribal, and local government 

representatives; and other interested 

stakeholders. Additionally, in alignment 

with the objectives of the American 

Medical Isotopes Production Act of 

2012, this rulemaking will provide the 

most efficient and effective pathway to 

reviewing and, if approved, licensing 

SHINE’s proposed irradiation units and 

will support the national effort to 

establish a reliable domestic supply of 

Mo-99 utilizing low enriched uranium 

technologies. 

L. Will the NRC issue guidance for this 

rule? 

No, the NRC does not plan to issue 

guidance specific to this rule. The 

guidance provided in NUREG–1537 

(ADAMS Accession No. ML12251A353), 

NUREG–1520 (ADAMS Accession No. 

ML101390110), and the Final Interim 

Staff Guidance Augmenting NUREG– 

1537 (ADAMS Accession No. 

ML12156A069) is sufficient to support 

the review of SHINE’s construction 

permit application under the regulations 

in 10 CFR part 50. However, the NRC 

staff is preparing a revision to NUREG– 

1537, which will incorporate the 

content of the ISG, including any 

necessary corrections. 

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62334 Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 

IV. Discussion of Amendments by 

Section 

Section 50.2 Definitions 

The definition for utilization facility 

will be changed to add: An acceleratordriven subcritical operating assembly 

used for the irradiation of materials 

containing special nuclear material and 

described in the application assigned 

docket number 50–608. 

Authority Citation 

The authority citation for 10 CFR part 

50 is being revised to include Section 11 

of the AEA because Subsection 11cc. 

provides the Commission’s authority to 

add to, or otherwise alter, the definition 

of utilization facility. In addition, minor 

editorial changes were made to the 

authority citation. 

V. Regulatory Flexibility Certification 

Under the Regulatory Flexibility Act 

(5 U.S.C. 605(b)), the Commission 

certifies that this rule does not have a 

significant economic impact on a 

substantial number of small entities. 

The direct final rule will impact one 

applicant for a construction permit, who 

may subsequently apply for an 

operating license. Although this 

company falls within the scope of the 

definition of ‘‘small entities’’ set forth in 

the Regulatory Flexibility Act or the size 

standards established by the NRC (10 

CFR 2.810), the rule is intended to 

facilitate NRC staff review of the 

company’s construction permit 

application and subsequent operating 

license application. 

VI. Regulatory Analysis 

The NRC has prepared a final 

regulatory analysis (ADAMS Accession 

No. ML14052A115) on this regulation. 

The analysis examines the costs and 

benefits of the alternatives considered 

by the NRC. 

VII. Backfitting and Issue Finality 

The NRC has determined that the 

backfit rule, 10 CFR 50.109, and the 

issue finality provisions in 10 CFR part 

52, and the backfitting provisions in 10 

CFR 70.76, 72.62, or 76.76 do not apply 

to this direct final rule because the only 

affected entity, SHINE, is currently an 

applicant for a construction permit. 

These backfitting and issue finality 

provisions, with exceptions not 

applicable here, do not apply to 

applicants. For these reasons, the NRC 

did not prepare either a backfit analysis 

or documentation addressing issue 

finality provisions in 10 CFR part 52 for 

this direct final rule. 

VIII. Plain Writing 

The Plain Writing Act of 2010 (Pub. 

L. 111–274) requires Federal agencies to 

write documents in a clear, concise, and 

well-organized manner. The NRC has 

written this document to be consistent 

with the Plain Writing Act as well as the 

Presidential Memorandum, ‘‘Plain 

Language in Government Writing,’’ 

published June 10, 1998 (63 FR 31883). 

IX. Environmental Assessment and 

Finding of No Significant 

Environmental Impact 

The Commission has determined 

under the National Environmental 

Policy Act of 1969, as amended, and the 

Commission’s regulations in subpart A 

of 10 CFR part 51, that this rule would 

not be a major Federal action 

significantly affecting the quality of the 

human environment, and therefore, an 

environmental impact statement is not 

required. The rule changes the 

definition of utilization facility to 

include the SHINE irradiation units for 

the purposes of facilitating the licensing 

review of one proposed facility. The 

rule will not affect radiological or nonradiological releases, nor will it affect 

occupational or public exposure. The 

determination of this environmental 

assessment is that there will be no 

significant offsite impact to the public 

from this action. 

The NRC has prepared a final 

Environmental Assessment and Finding 

of No Significant Impact (ADAMS 

Accession No. ML14052A097). 

X. Paperwork Reduction Act Statement 

This direct final rule affects only one 

entity and therefore is not subject to the 

requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid Office of 

Management and Budget control 

number. 

XI. Congressional Review Act 

This is a rule of particular 

applicability and, as such, this action is 

not a rule as defined in the 

Congressional Review Act (5 U.S.C. 

801–808). Therefore, the NRC is not 

required to submit a rule report 

regarding this action under Section 801 

of the Congressional Review Act. 

XII. Compatibility of Agreement State 

Regulations 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997, and 

published in the Federal Register (62 

FR 46517; September 3, 1997), this rule 

is classified as compatibility ‘‘NRC’’. 

Compatibility is not required for 

Category ‘‘NRC’’ regulations. The NRC 

program elements in this category are 

those that relate directly to areas of 

regulation reserved to the NRC by the 

Atomic Energy Act or the provisions of 

10 CFR, and though an Agreement State 

may not adopt program elements 

reserved to the NRC, it may wish to 

inform its licensees of certain 

requirements via a mechanism that is 

consistent with a particular State’s 

administrative procedure laws, but does 

not confer regulatory authority on the 

State. 

XIII. Voluntary Consensus Standards 

The National Technology Transfer 

and Advancement Act of 1995 (Pub. L. 

104–113), requires that Federal agencies 

use technical standards that are 

developed or adopted by voluntary 

consensus standards bodies unless the 

use of such a standard is inconsistent 

with applicable law or otherwise 

impractical. In this direct final rule, the 

NRC will revise the definition of 

utilization facility found in 10 CFR 50.2 

to include the proposed SHINE 

irradiation units. This action does not 

constitute the establishment of a 

standard that establishes generally 

applicable requirements. 

List of Subjects in 10 CFR Part 50 

Antitrust, Classified information, 

Criminal penalties, Fire protection, 

Intergovernmental relations, Isotopes, 

Medical isotopes, Molybdenum-99, 

Nuclear materials, Nuclear power plants 

and reactors, Radiation protection, 

Reactor siting criteria, Reporting and 

recordkeeping requirements, Utilization 

facility. 

For the reasons set out in the 

preamble and under the authority of the 

Atomic Energy Act of 1954, as amended; 

the Energy Reorganization Act of 1974, 

as amended; and 5 U.S.C. 552 and 553, 

the NRC is adopting the following 

amendments to 10 CFR part 50. 

PART 50—DOMESTIC LICENSING OF 

PRODUCTION AND UTILIZATION 

FACILITIES 

■ 1. The authority citation for 10 CFR 

part 50 is revised to read as follows: 

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Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Rules and Regulations 62335 

Authority: Atomic Energy Act secs. 11, 

102, 103, 104, 105, 147, 149, 161, 181, 182, 

183, 186, 189, 223, 234 (42 U.S.C. 2014, 2132, 

2133, 2134, 2135, 2167, 2169, 2201, 2231, 

2232, 2233, 2236, 2239, 2273, 2282); Energy 

Reorganization Act secs. 201, 202, 206 (42 

U.S.C. 5841, 5842, 5846); Nuclear Waste 

Policy Act sec. 306 (42 U.S.C. 10226); 

Government Paperwork Elimination Act sec. 

1704 (44 U.S.C. 3504 note); Energy Policy Act 

of 2005, Pub. L. 109–58, 119 Stat. 194 (2005). 

Section 50.7 also issued under Pub. L. 95– 

601, sec. 10, as amended by Pub. L. 102–486, 

sec. 2902 (42 U.S.C. 5851). Section 50.10 also 

issued under Atomic Energy Act secs. 101, 

185 (42 U.S.C. 2131, 2235); National 

Environmental Policy Act sec. 102 (42 U.S.C. 

4332). Sections 50.13, 50.54(d), and 50.103 

also issued under Atomic Energy Act sec. 108 

(42 U.S.C. 2138). 

Sections 50.23, 50.35, 50.55, and 50.56 also 

issued under Atomic Energy Act sec. 185 (42 

U.S.C. 2235). Appendix Q also issued under 

National Environmental Policy Act sec. 102 

(42 U.S.C. 4332). Sections 50.34 and 50.54 

also issued under sec. 204 (42 U.S.C. 5844). 

Sections 50.58, 50.91, and 50.92 also issued 

under Pub. L. 97–415 (42 U.S.C. 2239). 

Section 50.78 also issued under Atomic 

Energy Act sec. 122 (42 U.S.C. 2152). 

Sections 50.80–50.81 also issued under 

Atomic Energy Act sec. 184 (42 U.S.C. 2234). 

■ 2. In § 50.2, revise the definition of 

‘‘utilization facility’’ to read as follows: 

§ 50.2 Definitions. 

* * * * * 

Utilization facility means: 

(1) Any nuclear reactor other than one 

designed or used primarily for the 

formation of plutonium or U–233; or 

(2) An accelerator-driven subcritical 

operating assembly used for the 

irradiation of materials containing 

special nuclear material and described 

in the application assigned docket 

number 50–608. 

Dated at Rockville, Maryland, this 9th day 

of October, 2014. 

For the Nuclear Regulatory Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. 2014–24732 Filed 10–16–14; 8:45 am] 

BILLING CODE 7590–01–P 

FEDERAL ELECTION COMMISSION 

11 CFR Part 110 

[Notice 2014–11] 

Aggregate Biennial Contribution Limits 

AGENCY: Federal Election Commission. 

ACTION: Interim final rule. 

SUMMARY: The Commission is removing 

regulatory limits on the aggregate 

amounts that an individual may 

contribute to federal candidates and 

political committees in each two-year 

election cycle. The Commission is 

taking this action in light of the 

Supreme Court’s recent decision in 

McCutcheon v. FEC, which held that the 

aggregate contribution limits are 

unconstitutional. The Commission is 

accepting comments on these revisions 

to its regulations. 

DATES: Effective October 17, 2014. 

Comments must be received on or 

before November 17, 2014. 

ADDRESSES: All comments must be in 

writing. Comments may be submitted 

electronically via the Commission’s 

Web site at sers.fec.gov, reference REG 

2014–01. Commenters are encouraged to 

submit comments electronically to 

ensure timely receipt and consideration. 

Alternatively, comments may be 

submitted in paper form. Paper 

comments must be sent to the Federal 

Election Commission, Attn.: Amy L. 

Rothstein, Assistant General Counsel, 

999 E Street NW., Washington, DC 

20463. All comments must include the 

full name and postal service address of 

a commenter, and of each commenter if 

filed jointly, or they will not be 

considered. The Commission will post 

comments on its Web site at the 

conclusion of the comment period. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Amy L. Rothstein, Assistant General 

Counsel, or Mr. Theodore M. Lutz, 

Attorney, 999 E Street NW., 

Washington, DC 20463, (202) 694–1650 

or (800) 424–9530. 

SUPPLEMENTARY INFORMATION: 

Background 

The Federal Election Campaign Act, 

52 U.S.C. 30101–46 (formerly 2 U.S.C. 

431–57) (‘‘FECA’’), imposes limits on 

the aggregate amounts that an 

individual may contribute to federal 

candidates, political parties, and other 

political committees during a two-year 

election cycle. 52 U.S.C. 30116(a)(3) 

(formerly 2 U.S.C. 441a(a)(3)). The 

Commission has implemented FECA’s 

aggregate limits in its regulations at 11 

CFR 110.5. 

On April 2, 2014, the United States 

Supreme Court held that the aggregate 

contribution limits are unconstitutional. 

McCutcheon v. FEC, 572 U.S. l, 134 S. 

Ct. 1434 (2014) (plurality op.). To 

conform its regulations to the 

McCutcheon decision, the Commission 

is deleting 11 CFR 110.5 and is making 

technical and conforming changes to 11 

CFR 110.1(c), 110.14(d) and (g), 

110.17(b), and 110.19. In an Advance 

Notice of Proposed Rulemaking 

published in today’s Federal Register, 

the Commission is separately seeking 

comment on whether to begin a 

rulemaking to revise other regulations in 

light of certain language from the 

McCutcheon decision. 

The Commission is taking this action 

without advance notice and comment 

because it falls under the ‘‘good cause’’ 

exception of the Administrative 

Procedure Act (‘‘APA’’), 5 U.S.C. 

553(b)(B). The revisions set forth herein 

are necessary to conform the 

Commission’s regulations to the 

Supreme Court’s holding that the 

statutory aggregate limits are 

unconstitutional. See McCutcheon, 134 

S. Ct. at 1442. Because this action does 

not involve any Commission discretion 

or policy judgments, notice and 

comment are unnecessary. 5 U.S.C 

553(b)(B), (d)(3). A pre-publication 

notice and comment period would also 

be contrary to the public interest 

because the 2014 election campaigns for 

federal office are ongoing, and so the 

delay that would result from such a 

period might cause confusion among the 

public as to the enforceability of the 

regulations addressed below. 

For the same reasons, these revisions 

fall within the ‘‘good cause’’ exception 

to the APA’s delayed effective date 

provision and the requirements of the 

Congressional Review Act. 5 U.S.C. 

553(d)(3), 808(2). Moreover, because 

this interim final rule is exempt from 

the APA’s notice and comment 

procedure under 5 U.S.C. 553(b), the 

Commission is not required to conduct 

a regulatory flexibility analysis under 5 

U.S.C. 603 or 604. See 5 U.S.C. 601(2), 

604(a). Nor is the Commission required 

to submit these revisions for 

congressional review under FECA. See 

52 U.S.C. 30111(d)(1), (4) (formerly 2 

U.S.C. 438(d)(1), (4)) (providing for 

congressional review when Commission 

‘‘prescribe[s]’’ a ‘‘rule of law’’). 

Accordingly, these revisions are 

effective upon publication in the 

Federal Register. 

Explanation and Justification 

FECA imposes two types of limits on 

the amount that individuals may 

contribute in connection with federal 

elections. The ‘‘base limits’’ restrict how 

much an individual may contribute to a 

particular candidate or political 

committee per election or calendar year. 

See 52 U.S.C. 30116(a)(1) (formerly 2 

U.S.C. 441a(a)(1)). The ‘‘aggregate 

limits’’ restrict the amounts that an 

individual may contribute to all 

candidate committees, political party 

committees, and other political 

committees in each two-year election 

cycle. See 52 U.S.C. 30116(a)(3) 

(formerly 2 U.S.C. 441a(a)(3)). Under the 

aggregate limits, as indexed for inflation 

in the 2013–14 election cycle, an 

individual could contribute up to 

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