TO: 

FROM: 

SUBJECT: 

RESPONSE SHEET 

Annette Vietti-Cook, Secretary 

Chairman Burns 

COMSECY-16-0011: Procedures for Mandatory 

Hearings on Construction Permit Application for 

Medical Isotope Production and Utilization Facilities 

Approved X Disapproved Abstain Not Participating -- --

COMMENTS: Below X Attached None 

I would like to thank the Office of Commission Appellate Adjudication for their thoughtful 

consideration of this matter. 

Entered in STARS 

Yes X 

No 
TO: 

FROM: 

SUBJECT: 

RESPONSE SHEET 

Annette Vietti-Cook, Secretary 

COMMISSIONER SVINICKI 

COMSECY-16-0011: Procedures for Mandatory 

Hearings on Construction Permit Application for 

Medical Isotope Production and Utilization Facilities 

Approved XX Disapproved Abstain Not Participating -- --

COMMENTS: Below XX Attached XX None 

I approve the recommended revisions to Chapter IV of the Internal Commission Procedures, as 

further edited in the attached. 

08/ ' /16 

Entered on "STARS" _J_ DATE 

Yes No _ 
CHAPTER IV - COMMISSION MEETINGS/ HEARINGS 

KLS Edits 

COMMISSION MEETINGS/HEARINGS 

GOVERNMENT IN THE SUNSHINE ACT 

The Government in the Sunshine Act (PL 94-409) (Sunshine Act) requires the collegial 

agencies of the Federal Government, including the NRC, to open meetings of their 

Commissioners to public observation except where the subject matter falls within one of 

the specific categories of exemption. The law is based on the premise that "the public is 

entitled to the fullest practicable information regarding the decision-making process of the 

Federal Government." The Sunshine Act applies to meetings of at least a quorum of 

Commissioners where deliberations determine or result in the joint conduct or disposition 

of official Commission business. This Chapter describes procedures for Commission 

meetings that are governed by the Sunshine Act, and briefly covers the scope of NonSunshine Act discussions. 

The Sunshine Act favors open meetings. An agency, however, is allowed to close a 

meeting or portions of a meeting or to withhold information about a meeting or portions of 

a meeting if the agency determines that the meeting or portions thereof, if opened, or the 

information, if released , would likely disclose exempted information protected from 

disclosure under one or more of the 10 exemptions authorized by the Sunshine Act. A 

list of these exemptions is contained in 10 CFR Part 9. Determinations to close a meeting 

require a recorded majority vote of the entire Commission membership. 

The Sunshine Act further requires NRC and similar agencies to publicly announce, at 

least 7 calendar days prior to each meeting, its time, place, and subject matter, and 

whether it is to be open or closed. The agency can provide less than 7 calendar days 

notice of a meeting, provided a majority of the Commission determines by recorded vote 

"that agency business requires" less notice. 

DEVELOPMENT OF COMMISSION SCHEDULE 

1. SECY prepares a schedule of Commission meetings from an assessment of the 

following considerations: 

a. a projection of anticipated meeting subjects from the EDO; 

b. projections and requirements known to SECY; 

c. input from Commissioners, OGC, OCA, OIP, CFO; 

d. availability of all Commissioners; 

e. readiness of affirmation items; 

March 24, 2016 Chapter IV - Page 1 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

The CA briefing request to SECY should also include a description of what is to be 

conveyed to the CAs. In addition, the staff should highlight if the briefing relates to a 

SECY paper or COMSECY that is currently before the Commission, or a paper that is 

expected in the near future. 

SECY will forward the request to the CAs after checking the availability of the times 

offered against other commitments such as conference room availability, other 

Commission meetings, or other CA briefings. The Commission CAs are expected to 

respond promptly and are encouraged to support times that are mutually-convenient to 

all offices in order to finalize the schedule. 

CONDUCT OF MANDATORY HEARINGS ON 

APPLICATIONS FOR COMBINED LICENSES AND 

CONSTRUCTION PERMITS FOR MEDICAL 150TOPB 

PRODUCTION AND UTILIZATION FACILITIES 

1. Before the hearing: 

Notice: 10 CFR § 2.104(a) requires that the Secretary issue a notice of hearing for 

publication in the Federal Register as soon as practicable after a combined license (COL) 

or construction permit application has been docketed (or, in certain cases, tendered (see 

10 CFR § 2.101 (a)(2)). The Secretary will also issue a supplemental notice of hearing -

specific to the uncontested or "mandatory," portion of the GGb-proceeding - as soon as 

practicable after the staff submits to the Commission the Information Paper described 

below under "Pre-Filed Documents." 

This supplemental notice should state: (1) the time and place of the hearing, (2) the nature 

of the hearing, (3) the authority under which the hearing is to be held, (4) the matters of 

fact and law to be considered (i.e. , whether the staff's review has been adequate to 

support the applicable findings) set forth in 10 CFR §§ 52.97(a) and 51.107(a)), (5) the 

schedule for submittal of the pre-filed documents, and (6) the designation of the 

Commission itself as the presiding officer for the hearing. 

Pre-Filed Documents: Within one week of public issuance of the Final Safety Evaluation 

Report (FSER) or Final Environmental Impact Statement (FEIS)/Environmental 

Assessment (EA), whichever comes later, the NRC staff will submit an Information Paper 

to the Commission. This Information Paper will be made publicly available and should, 

at minimum: 

(1) Address each of the findings in §§ 52.97(a) and 51 .107(a) necessary for 

issuance of a COL or construction permit, and provide an adequate basis for the 

Commission to conclude whether each of these findings can be made. The 

Information Paper should not recap all matters in the safety or environmental 

review process, particularly routine aspects of the review where there was no 

actual complication or controversy. Rather, the Information Paper should be 

March 24, 2016 Chapter IV - Page 11 
CHAPTER IV - COMMISSION MEETINGS/ HEARINGS 

focused on non-routine matters. The staff should also include a discussion of 

issues raised by the ACRS, as well as the staff's responses thereto. 

(2) In focusing on non-routine matters, the areas of particular importance in 

supporting the Part 51 and 52 safety and environmental findings would be any 

unique features of the facility or novel issues that arose as part of the review 

process. The Information Paper should exclude discussion of admitted 

contentions that have been (or are being) addressed in a contested proceeding 

before the Licensing Board. HoweverAdditionally, the staff's Information Paper 

should exclude matters that were previously addressed and resolved in the context 

of other reviews undertaken as part of the Part 52 process, e.g., as part of an 

earlier Early Site Permit (ESP) review, an earlier reference COL review, or have 

been (or are being) addressed in the context of a design certification rulemaking . 

The Information Paper should also exclude discussion of admitted contentions that 

have been (or are being) addressed in a contested proceeding before the 

Licensing Board. 

(3) Include other aspects of the staff's review that are important for the Commission 

to make its final decision but are not necessarily tied to specific findings. For 

instance, if an applicable design certification rulemaking is currently ongoing, the 

staff's Information Paper should include a brief summary of any significant 

technical or policy issues that the staff believes would be of significant Commission 

interest and an estimate of the completion date of that rulemaking. 

This Information Paper shall serve as the staff's primary pre-filed testimony. In addition 

to this paper, the staff shall identify its witnesses for the hearing and answer any 

Commission pre-hearing questions. Answers to any pre-hearing questions and the 

witness list would be due 21 days prior to the scheduled hearing date, unless the 

Commission directs otherwise. 

The following documents should be referenced in the pre-filed testimony and included as 

enclosures to the SECY paper or otherwise made available, for example, by providing 

ADAMS accession numbers: 

The license application and all supplements; 

The Final Safety Evaluation Report and all supplements; 

The Final Environmental Impact Statement or Environmental Assessment and all 

supplements; 

The pertinent letter from the Advisory Committee on Reactor Safeguards; and 

The proposed license or permit. 

In addition to the Information Paper, the staff may submit pre-filed testimony of its planned 

individual witnesses as late as 5 days in advance of the hearing. 

The applicant should also submit pre-filed written testimony, which would also be due 21 

days prior to the scheduled hearing date, unless the Commission directs otherwise. This 

testimony should, at minimum, include answers to any pre-hearing questions issued by 

March 24, 2016 Chapter IV - Page 12 
CHAPTER IV - COMMISSION MEETINGS/ HEARINGS 

the Commission and identify the applicant's witnesses for the oral hearing. The applicant 

may also include in this pre-filed testimony any additional views that it wishes to provide. 

Interested States, local government bodies, and federally recognized Indian Tribes may 

also submit written statements to the Commission. Such statements should be filed 36 

days prior to the scheduled hearing date. 

No filings submitted in an uncontested (i.e. , "mandatory") COL proceeding, whether 

submitted by the staff, the applicant, or an interested State, local government body, or 

federally-recognized Indian Tribe, may address substantive issues within the scope of the 

contentions that have been admitted in a contested adjudicatory proceeding for the same 

GOh-application. Such filings would include, for instance, the staff's Information Paper, 

the applicant's pre-filed testimony, answers to pre-hearing questions, question responses 

filed subsequent to the hearing, and any statements filed by interested States, local 

government bodies, or federally recognized Indian Tribes. Presentations made at the 

oral hearing must also should not address issues within the scope of admitted 

contentions. However, key reference documents such as the license application and 

supplements, the FSER, the FEIS or EA and supplements, the Advisory Committee on 

Reactor Safeguards letter, and the proposed license or permit need not be redacted to 

remove references to contested issues before being made available to the Commission 

for the uncontested hearing. 

Commissioners have the option of issuing written questions to the applicant or the staff 

before the hearing. Pursuant to his or her authority, the Secretary shall compile each 

Commissioner's pre-hearing questions and issue them in the form of an order no later 

than 34 days before the scheduled hearing date. The order should specify the date by 

which responses to these questions must be filed (as indicated above, responses would 

generally be due 21 days prior to the scheduled hearing date and would be filed in 

conjunction with the witness list in the case of the staff and the witness list and any other 

pre-filed testimony in the case of the applicant). These questions could also serve to 

focus the parties' presentations at the oral hearing. 

All documents submitted by the staff, the applicant, and interested States, local 

government bodies, and federally recognized Indian Tribes should be filed in accordance 

with 10 CFR § 2.302, docketed by SECY in accordance with 10 CFR § 2.303, and made 

part of the hearing record. 

No later than 14 days prior to the scheduled date of the oral hearing, the Secretary will 

also issue a scheduling order and note, which will provide additional logistical details 

regarding the hearing. If the Commission intends to invite an interested State, local 

government body, or federally-recognized Indian Tribe to send a representative to the 

hearing, such an invitation will also be included in the scheduling order. Procedural 

arrangements are established by a majority of the Commission in advance to determine 

the topics for discussion and to specify time limits for each party's presentation and for 

Commissioner questions. 

March 24, 2016 Chapter IV - Page 13 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

2. The Hearing: 

Documents for the Hearing: A sufficient number of copies of slides or other relevant 

written information should be placed in the hearing room for the public 30 minutes before 

the start of the oral hearing. 

Opening Remarks: The Chairman will call the hearing to order, describe the nature of 

the proceeding, under what statutes and rules it is taking place, what findings the 

Commission would have to make before authorizing issuance of the license or permit, 

what the general order of the hearing will be, and when a Commission decision might be 

expected . 

Testimony: Witnesses for both the applicant and the NRC staff, as well as any 

representatives of interested States, local government bodies, or federally-recognized 

Indian Tribes that the Commission has invited to participate, will be identified and sworn 

in by the Chairman. Before each hearing, the Commission will approve a scheduling note 

that specifies the order and composition of the witness panels for the hearing, states the 

topics the witness panels will discuss, and identifies the appropriate witness panel for 

Commissioner questions on each section of the FSER and FEIS or EA (in responding to 

Commissioner questions, the witness panel may also invite other witnesses present at 

the hearing to answer). :The applicant's presentation will come first and should address 

any written questions directed to the applicant by the Commission. The Commissioners 

will ask questions of the applicant's witnesses before hearing from the staff. The staff's 

presentations 'Nill follow and should address any written questions directed to the staff by 

the Commission. The staff's presentation will be followed by another round of 

Commission questions. Any invited representatives of interested States, local 

government bodies, or federally recognized Indian Tribes will also participate as the 

Commission deems appropriate. Limited appearance statements will not be entertained. 

The maximum allotted time for each Commissioner to ask questions and receive answers 

to questions at the hearing should be established by a majority of the Commission prior 

to the hearing. Each Commissioner will decide how to divide his or her time for questions 

and answers among the witness panels not to exceed the allotted time. Any requests to 

extend this time may be granted by a majority of the Commissioners present. The 

Commission does not anticipate, even with many complex issues, that a hearing would 

last more than three business days. 

Post-hearing Responses to Follow-up Questions: If Commissioners, at the hearing, 

ask any follow-up questions that cannot be fully answered at the hearing itself, the staff, 

the applicant, and/or participating interested States, local government bodies, or federally 

recognized Indian Tribes, as appropriate, may file supplemental responses to such 

questions no later than 14 days after the hearing concludes (unless the Commission sets 

a different deadline for such responses). 

Record: The oral hearing 1

11ould will be transcribed , and the transcription reviewed for 

errors, corrected , and made part of the hearing record. See 10 CFR § 2.327. The 

March 24, 2016 Chapter IV - Page 14 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

Commissioners, applicant, staff, or any participating government or Tribal representative 

may submit transcript corrections within 7 days after the availability of the transcript. Also 

to be made part of the record will be any presentation materials used by the applicant, 

the staff, or representatives of interested States, local government bodies, or federally 

recognized Indian Tribes at the hearing and any written responses from the applicant and 

staff to orders or questions presented by the Commission. Except for the limited purpose 

of making any necessary transcript corrections, the record will close once the deadline 

for filing and post-hearing responses to questions posed at the hearing has passed or at 

the conclusion of the hearing if no such responses are filed . 

3. Commission Decision after the Hearing: 

The Commission adjudicatory decision after the oral hearing should address whether the 

staff's review has been adequate to support the findings set forth in 10 CFR §§ 52.97(a) 

and 51 .107(a)Parts 50, 51. and 52, or imposed by Commission order. as appropriate. or 

if inadequate identify which findings were insufficient, provide the basis for the 

Commission's determinations, list the documents that comprise the entire record 

considered by the Commission and upon which it relied , and authorize the Director of the 

Office of New Reactorsappropriate Office Director to issue. deny, or appropriately 

condition. or deny the combined license or construction permit, deny issuance of the 

license, or appropriately condition the license or order further actions, as appropriate. 

See 10 CFR § 2.344. 

In the event that a contested adjudicatory proceeding regarding the GGb-application is 

taking placeongoing or has already taken place, at the time the Commission issues its 

decision in the uncontested proceeding, the Commission will condition its uncontested 

hearing decision as appropriate to ensure no prejudice is done to the contested 

proceeding. 

4. Schedule for Uncontested Hearings: 

The Commission intends to issue adjudicatory decisions in mandatory hearings no later 

than 4 months after the FSER and FEIS or EA are both publicly issued, except that in the 

case of a COL proceeding, if an associated design certification rulemaking is still pending 

as of that date, the Commission will issue a decision immediately after affirming the final 

rule for the referenced design. 

The Commission also intends, to the extent practicable, to adhere to the target dates 

listed below for the key milestones leading up to the Commission decision. The 

Commission recognizes, however, that circumstances may warrant occasional deviations 

from these target dates. It is not anticipated, however, that, absent extraordinary 

circumstances, such deviations would alter the Commission's overall objective of issuing 

its mandatory hearing decisions no later than 4 months from the public issuance of the 

later of the FSERJ. e-F-FEIS, or EA. 

I Milestone I Target Date 

March 24, 2016 Chapter IV - Page 15 
CHAPTER IV - COMMISSION MEETINGS/ HEARINGS 

Staff submits Information Paper to Within one week of public issuance of 

Commission FSER & FEIS or EA 

Notice of mandatory hearing sent to As soon as practicable after staff's 

Federal Register Information Paper is submitted to the 

Commission 

Interested States, local government 36 days before the hearing 

bodies, or federally-recognized Indian 

Tribes file any written statements 

Commission issues any pre-hearing 34 days before the hearing 

questions 

Applicant files pre-filed testimony, 21 days before the hearing 

including witness list and answers to any 

pre-hearing questions 

Staff files witness list and answers to any 21 days before the hearing 

pre-hearing questions 

Secretary issues scheduling order and 14 days before the hearing 

note 

Mandatory hearing commences 51 days after staff's Information Paper is 

submitted to the Commission 

Staff and applicant file responses to any 14 days after hearing is complete 

follow-up questions 

Commission affirms adjudicatory decision 4 months after FSER & FEIS or EA are 

fl A tl:ie sase ef a GGb pFeseeEliA§, both publicly issued 

a#iFFAatieA at tl:iis sta§e takes plase if (In the case of a COL proceeding, mfumAseEI ElesigA sertifisatieA FuleFAakiAg affirmation at this stage takes place if the 

almaEly seFAplete} referenced design certification rulemaking 

is al read}'. complete. If the referenced 

design certification rulemaking is still 

pending as of 4 months after FSER & FEIS 

for COL are both public!}'. issued, 

affirmation takes place immediate!}'. after 

Commission affirms the final design 

certification rulemaking for the referenced 

design.} 

IA a GGb pFeseeEliA§, GeFAFAissieA a#iFFAS IFAFAeEliately aftm GeFAFAissieA a#iFFAS fiAal 

aEljuElisatei=y ElesisieA if FefeFeAseEI ElesigA ElesigA sertifisatieA FuleFAakiAg foF 

sertifisatieA FuleFAakiAg still peAEliAg as ef FefeFeAseEI ElesigA 

March 24, 2016 Chapter IV - Page 16 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

14 months after FSER & FEIS fer GGb aFO I 

both publicly issued 

TEMPLATE 

Notice of Hearing 

A template for drafting a mandatory hearing notice for a COL proceeding is provided 

below. This notice is to be used to provide specific information on the uncontested 

("mandatory'} portion of the hearing and will be issued by SECY after receipt of the Staff's 

SECY paper supporting the mandatory hearing for each COL application. Appropriate 

adjustments will be made to accommodate any case-specific circumstances (e.g. , if the 

COL application contains an ITAAC closure request pursuant to 10 CFR 52.97@1(2) or a 

limited work authorization request). Notices of hearing for construction permit 

proceedings will follow the same format but will be tailored to the specific application at 

issue. 

NUCLEAR REGULATORY COMMISSION 

Docket No. [Insert Docket Number] 

TITLE: In the Matter of [Insert name of Applicant]; Combined License for [Insert site 

name and number of units] Notice of Hearing 

L. BACKGROUND 

The Commission hereby gives notice that, pursuant to section 189a of the Atomic Energy 

Act it will convene an evidentiary session to receive testimony and exhibits in the 

uncontested portion of this proceeding regarding the [Insert Date of Application], 

application of [Insert Name of Applicant] for a 10 CFR Part 52 combined license (COL), 

seeking approval to construct and operate a new nuclear power generation facility at 

[Insert Description of the Site]. This mandatory hearing will concern safety and 

environmental matters relating to the proposed issuance of the requested COL, as more 

fully described below. Participants in the hearing are not to address any contested issues 

in their written filings or oral presentations. 

DATE, TIME, AND LOCATION OF THE lL._EVIDENTIARY UNCONTESTED HEARING 

The Commission will conduct this hearing at the specified location and time: 

1. Date [Insert Date] Time: [Insert Time] Location: [Insert Location] 

The hearing on these issues will continue on subsequent days, if necessary. 

!lLPRESIDING OFFICER 

March 24, 2016 Chapter IV - Page 17 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

The Commission is the presiding officer for this proceeding. 

IV. MATTERS TO BE CONSIDERED 

The matter at issue in this proceeding is whether the review of the application by the 

Commission's staff has been adequate to support the findings found in 1 O CFR § 52.97 

and 10 CFR § 51.107. Those findings are as follows: 

Issues Pursuant to the Atomic Energy Act of 1954, as Amended 

(1) whether the applicable standards and requirements of the Act and the 

Commission's regulations have been met; (2) whether any required notifications to other 

agencies or bodies have been duly made; (3) whether there is reasonable assurance that 

the facility will be constructed and will operate in conformity with the license, the 

provisions of the Act, and the Commission's regulations; (4) whether the applicant is 

technically and financially qualified to engage in the activities authorized; (5) whether 

issuance of the license will not be inimical to the common defense and security or the 

health and safety of the public. 

Issues Pursuant to the National Environmental Policy Act (NEPA) of 1969, as 

Amended 

(1) Determine whether the requirements of Sections 102(2) (A), (C), and (E) of 

NEPA and the applicable regulations in 10 CFR Part 51 have been met; (2) independently 

consider the final balance among conflicting factors contained in the record of the 

proceeding with a view to determining the appropriate action to be taken; (3) determine, 

after weighing the environmental, economic, technical, and other benefits against 

environmental and other costs, and considering reasonable alternatives, whether the 

combined license should be issued, denied, or appropriately conditioned to protect 

environmental values; (4) determine whether the NEPA review conducted by the NRC 

staff has been adequate. 

SCHEDULE FOR SUBMITTAL OF PRE-FILED DOCUMENTS 

No later than [replace with date that is 21 days prior to the scheduled hearing date], 

unless the Commission directs otherwise, the staff and the applicant shall submit a list of 

its anticipated witnesses for the hearing. 

No later than [replace with date that is 21 days prior to the scheduled hearing date], 

unless the Commission directs otherwise, the applicant shall submit its pre-filed written 

testimony. The staff previously submitted its testimony on [replace with date of staff 

testimony]. 

The Commission may issue written questions to the applicant or the staff before the 

hearing. If such questions are issued, an order containing such questions will be issued 

no later than [replace with date 34 days before the scheduled hearing date]. 

March 24, 2016 Chapter IV - Page 18 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

Responses to such questions are due [replace with date that is 21 days prior to the 

scheduled hearing date], unless the Commission directs otherwise. 

VI. INTERESTED GOVERNMENT PARTICIPANTS 

No later than [replace with date that is 36 days prior to the oral evidentiary hearing], 

any interested State, local government body, or affected, federally-recognized Indian 

Tribe may file with the Commission a statement of any issues or questions that the State, 

local government body, or Indian Tribe wishes the Commission to give particular attention 

to as part of the uncontested hearing process. Such statement may be accompanied by 

any supporting documentation that the State, local government body, or Indian Tribe sees 

fit to provide. Any statements and supporting documentation (if any) received by the 

Commission using the agency's E-filing system25 by the deadline indicated above will be 

made part of the record of the proceeding. The Commission will use such statements 

and documents as appropriate to inform its pre-hearing questions to the Staff and 

applicant, its inquiries at the oral hearing, and its decision following the hearing. The 

Commission may also request, prior to [replace with date that is no later than 14 days 

prior to the oral hearing], that one or more particular States, local government bodies, 

or Indian Tribes send one representative each to the evidentiary hearing to answer 

Commission questions and/or make a statement for the purpose of assisting the 

Commission's exploration of one or more of the issues raised by the State, local 

government body, or Indian Tribe in the pre-hearing filings described above. The decision 

of whether to request the presence of a representative of a State, local government body, 

or Indian Tribe at the evidentiary hearing to make a statement and/or answer Commission 

questions is solely at the Commission's discretion. The Commission's request will specify 

the issue or issues that the representative should be prepared to address. 

States, local governments, or Indian Tribes should be aware that this evidentiary hearing 

is separate and distinct from the NRC's contested hearing process. Issues within the 

scope of contentions that have been admitted in a contested proceeding for a COL 

application are outside the scope of the uncontested proceeding for that COL application. 

In addition, while States, local governments, or Indian Tribes participating as described 

above may take any position they wish, or no position at all, with respect to issues 

regarding the COL application or the NRC Staff's associated environmental review that 

do fall within the scope of the uncontested proceeding (i.e., issues that are not within the 

scope of admitted contentions), they should be aware that many of the procedures and 

rights applicable to the NRC's contested hearing process due to the inherently adversarial 

nature of such proceedings are not available with respect to this uncontested hearing. 

Participation in the NRC's contested hearing process is governed by 10 CFR § 2.309 (for 

persons or entities, including States, local governments, or Indian Tribes, seeking to file 

25 The process for accessing and using the agency's E-filing system is described in 

the [DATE] notice of hearing that was issued by the Commission for this 

proceeding. See Notice of Hearing [xx FR xx]. Participants who are unable to use 

the EIE, or who will have difficulty complying with EIE requirements in the time 

frame provided for submission of written statements, may provide their statements 

by electronic mail to hearingdocket@nrc.gov. 

March 24, 2016 Chapter IV - Page 19 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

contentions of their own) and 10 CFR § 2.315(c) (for interested States, local governments, 

and Indian Tribes] seeking to participate with respect to contentions filed by others). 

Participation in this uncontested hearing does not affect a State's, local government's, or 

Indian Tribe's right to participate in the separate contested hearing process. 

If necessary: The Commission recognizes that [a request] I [requests] to participate 

under 10 CFR § 2.315( c) in proceedings regarding this COL application [was] I [were] 

previously dismissed on mootness grounds by an NRC Atomic Safety and Licensing 

Board . Such dismissals apply solely to the contested portion of the proceeding, and do 

not affect any rights to participate in this uncontested portion of the proceeding. 

If necessary: If the COL application contains an ITAAC closure request pursuant to 

52.97.@}(2) or an LWA request, appropriate language should be inserted regarding the 

necessary findings for those items. 

March 24, 2016 Chapter IV - Page 20 
RESPONSE SHEET 

TO: Annette Vietti-Cook, Secretary 

FROM: Commissioner Baran 

SUBJECT: COMSECY-16-0011: Procedures for Mandatory 

Hearings on Construction Permit Application for 

Medical Isotope Production and Utilization Facilities 

Approved X Disapproved -- Abstain Not Participating -- --

COMMENTS: Below X Attached X None 

I agree with OCAA that the current mandatory hearing procedures served the 

Commission well for the SHINE hearing and that these procedures can be applied effectively in 

future construction permit proceedings for medical isotope production and utilization facilities. I 

approve the recommended revisions to Chapter IV of the Internal Commission Procedures, 

subject to the attached edits. 

Entered in 

STARS I 

Yes V - --

No Date 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

The CA briefing request to SECY should also include a description of what is to be 

conveyed to the CAs. In addition, the staff should highlight if the briefing relates to a 

SECY paper or COMSECY that is currently before the Commission, or a paper that is 

expected in the near future. 

SECY will forward the request to the CAs after checking the availability of the times 

offered against other commitments such as conference room availability, other 

Commission meetings, or other CA briefings. The Commission CAs are expected to 

respond promptly and are encouraged to support times that are mutually-convenient to 

all offices in order to finalize the schedule. 

CONDUCT OF MANDATORY HEARINGS ON 

APPLICATIONS FOR COMBINED LICENSES AND 

CONSTRUCTION PERMITS FOR MEDICAL ISOTOPE 

PRODUCTION AND UTILIZATION FACILITIES 

1. BefQre the hearing: 

Notice: 1 O CFR § 2.104(a) requires that the Secretary issue a notice of hearing for 

publication in the Federal Register as soon as practicable after a combined license (COL) 

or medical isotope production and utilization facility construction permit application has 

been docketed (or, in certain cases, tendered (see 10 CFR § 2.101(a)(2)). The Secretary 

will also issue a supplemental notice of hearing - specific to the uncontested or 

"mandatory," portion of the GGb-proceeding - as soon as practicable after the staff 

submits to the Commission the Information Paper described below under "Pre-Filed 

Documents." 

This supplemental notice should state: (1) the time and place of the hearing, (2) the nature 

of the hearing, (3) the authority under which the hearing is to be held, (4) the matters of 

fact and law to be considered (i.e., whether the staff's review has been adequate to 

support the applicable findings} set forth in 10 GFR §§ 52.97(a) and 51 .107(a)), (5) the 

schedule for submittal of the pre-filed documents, and (6) the designation of the 

Commission itself as the presiding officer for the hearing. 

Pre-Filed Documents: Within one week of public issuance of the Final Safety Evaluation 

Report (FSER) or Final Environmental Impact Statement (FEIS)/Environmental 

Assessment (EA), whichever comes later, the NRG staff will submit an Information Paper 

to the Commission. This Information Paper will be made publicly available and should, 

at minimum: 

(1) Address each of the findings in §§ 52.97(a) and 51.107(a) necessary for 

issuance of a COL or construction permit, and provide an adequate basis for the 

Commission to conclude whether each of these findings can be made. The 

Information Paper should not recap all matters in the safety or environmental 

review process, particularly routine aspects of the review where there was no 

actual complication or controversy. Rather, the Information Paper should be 

March 24, 2016 Chapter IV - Page 11 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

focused on non-routine matters. The staff should also include a discussion of 

issues raised by the ACRS, as well as the staff's responses thereto. 

(2) In focusing on non-routine matters, the areas of particular importance in 

supporting the Part 51 and 52 safety and environmental findings would be any 

unique features of the facility or novel issues that arose as part of the review 

process. The Information Paper should exclude discussion of admitted 

contentions that have been (or are being) addressed in a contested proceeding 

before the Licensing Board. HoweverAdditionally, the staff's Information Paper 

should exclude matters that were previously addressed and resolved in the context 

of other reviews undertaken as part of the Part 52 process, e.g. , as part of an 

earlier Early Site Permit (ESP) review, an earlier reference COL review, or have 

been (or are being) addressed in the context of a design certification rulemaking. 

The Information Paper should also exclude discussion of admitted contentions that 

have been (or are being) addressed in a contested proceeding before the 

Licensing Board. 

(3) Include other aspects of the staff's review that are important for the Commission 

to make its final decision but are not necessarily tied to specific findings. For 

instance, if an applicable design certification rulemaking is currently ongoing, the 

staff's Information Paper should include a brief summary of any significant 

technical or policy issues that the staff believes would be of significant Commission 

interest and an estimate of the completion date of that rulemaking. 

This Information Paper shall serve as the staff's primary pre-filed testimony. In addition 

to this paper, the staff shall identify its witnesses for the hearing and answer any 

Commission pre-hearing questions. Answers to any pre-hearing questions and the 

witness list would be due 21 days prior to the scheduled hearing date, unless the 

Commission directs otherwise. 

The following documents should be referenced in the pre-filed testimony and included as 

enclosures to the SECY paper or otherwise made available, for example, by providing 

ADAMS accession numbers: 

The license application and all supplements; 

The Final Safety Evaluation Report and all supplements; 

The Final Environmental Impact Statement or Environmental Assessment and all 

supplements; 

The pertinent letter from the Advisory Committee on Reactor Safeguards; and 

The proposed license or permit. 

In addition to the Information Paper, the staff may submit pre-filed testimony of its planned 

individual witnesses as late as 5 days in advance of the hearing. 

The applicant should also submit pre-filed written testimony, which would also be due 21 

days prior to the scheduled hearing date, unless the Commission directs otherwise. This 

testimony should, at minimum, include answers to any pre-hearing questions issued by 

March 24, 2016 Chapter IV - Page 12 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

the Commission and identify the applicant's witnesses for the oral hearing. The applicant 

may also include in this pre-filed testimony any additional views that it wishes to provide. 

Interested States, local government bodies, and federally recognized Indian Tribes may 

also submit written statements to the Commission. Such statements should be filed 36 

days prior to the scheduled hearing date. 

No filings submitted in an uncontested (i.e., "mandatory") COL proceeding, whether 

submitted by the staff, the applicant, or an interested State, local government body, or 

federally-recognized Indian Tribe, may address substantive issues within the scope of the 

contentions that have been admitted in a contested adjudicatory proceeding for the same 

GGb-application. Such filings would include, for instance, the staff's Information Paper, 

the applicant's pre-filed testimony, answers to pre-hearing questions, question responses 

filed subsequent to the hearing, and any statements filed by interested States, local 

government bodies, or federally recognized Indian Tribes. Presentations made at the 

oral hearing must also should not address issues within the scope of admitted 

contentions. However, key reference documents such as the license application and 

supplements, the FSER, the FEIS or EA and supplements, the Advisory Committee on 

Reactor Safeguards letter, and the proposed license or permit need not be redacted to 

remove references to contested issues before being made available to the Commission 

for the uncontested hearing. 

Commissioners have the option of issuing written questions to the applicant or the staff 

before the hearing. Pursuant to his or her authority, the Secretary shall compile each 

Commissioner's pre-hearing questions and issue them in the form of an order no later 

than 34 days before the scheduled hearing date. The order should specify the date by 

which responses to these questions must be filed (as indicated above, responses would 

generally be due 21 days prior to the scheduled hearing date and would be filed in 

conjunction with the witness list in the case of the staff and the witness list and any other 

pre-filed testimony in the case of the applicant). These questions could also serve to 

focus the parties' presentations at the oral hearing. 

All documents submitted by the staff, the applicant, and interested States, local 

government bodies, and federally recognized Indian Tribes should be filed in accordance 

with 1 O CFR § 2.302, docketed by SECY in accordance with 1 O CFR § 2.303, and made 

part of the hearing record . 

No later than 14 days prior to the scheduled date of the oral hearing, the Secretary will 

also issue a scheduling order and note, which will provide additional logistical details 

regarding the hearing. If the Commission intends to invite an interested State, local 

government body, or federally-recognized Indian Tribe to send a representative to the 

hearing, such an invitation will also be included in the scheduling order. Procedural 

arrangements are established by a majority of the Commission in advance to determine 

the topics for discussion and to specify time limits for each party's presentation and for 

Commissioner questions. 

March 24, 2016 Chapter IV - Page 13 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

2. The Hearing: 

Documents for the Hearing: A sufficient number of copies of slides or other relevant 

written information should be placed in the hearing room for the public 30 minutes before 

the start of the oral hearing. 

Opening Remarks: The Chairman will call the hearing to order, describe the nature of 

the proceeding, under what statutes and rules it is taking place, what findings the 

Commission would have to make before authorizing issuance of the license or permit, 

what the general order of the hearing will be, and when a Commission decision might be 

expected. 

Testimony: Witnesses for both the applicant and the NRC staff, as well as any 

representatives of interested States, local government bodies, or federally-recognized 

Indian Tribes that the Commission has invited to participate, will be identified and sworn 

in by the Chairman. The applicant's presentation will come first and should address any 

written questions directed to the applicant by the Commission. The Commissioners will 

ask questions of the applicant's witnesses before hearing from the staff. The staff's 

presentations will follow and should address any written questions directed to the staff by 

the Commission. The staffs presentation will be followed by another round of 

Commission questions. Any invited representatives of interested States, local 

government bodies, or federally recognized Indian Tribes will also participate as the 

Commission deems appropriate. Limited appearance statements will not be entertained. 

The maximum allotted time for each Commissioner to ask questions and receive answers 

to questions at the hearing should be established by a majority of the Commission prior 

to the hearing. Each Commissioner will decide how to divide his or her time for questions 

and answers among the witness panels not to exceed the allotted time. Any requests to 

extend this time may be granted by a majority of the Commissioners present. The 

Commission does not anticipate, even with many complex issues, that a hearing would 

last more than three business days. 

Post-hearing Responses to Follow-up Questions: If Commissioners, at the hearing, 

ask any follow-up questions that cannot be fully answered at the hearing itself, the staff, 

the applicant, and/or participating interested States, local government bodies, or federally 

recognized Indian Tribes, as appropriate, may file supplemental responses to such 

questions no later than 14 days after the hearing concludes (unless the Commission sets 

a different deadline for such responses). 

Record: The oral hearing would will be transcribed, and the transcription reviewed for 

errors, corrected, and made part of the hearing record. See 10 CFR § 2.327. The 

applicant, staff, or any participating government or Tribal representative may submit 

transcript corrections within 7 days after the availability of the transcript. Also to be made 

part of the record will be any presentation materials used by the applicant, the staff, or 

representatives of interested States, local government bodies, or federally recognized 

Indian Tribes at the hearing and any written responses from the applicant and staff to 

March 24, 2016 Chapter IV - Page 14 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

orders or questions presented by the Commission. Except for the limited purpose of 

making any necessary transcript corrections, the record will close once the deadline for 

filing and post-hearing responses to questions posed at the hearing has passed or at the 

conclusion of the hearing if no such responses are filed . 

3. Commission Decision after the Hearing: 

The Commission adjudicatory decision after the oral hearing should address whether the 

staff's review has been adequate to support the findings set forth in 1 O CFR §§ 52.97(a) 

and 51 .107(a)Parts 50, 51, and 52, or imposed by Commission order, as appropriate. If 

the Commission determines that the staff's review is inadequate to support any of these 

findings, then the Commission adjudicatory decision should identify the findings the staff's 

review did not support., or if inadequate identify which findings were insufficient, The 

Commission adjudicatory decision should provide the basis for the Commission's 

determinations, list the documents that comprise the entire record considered by the 

Commission and upon which it relied, and authorize the Director of the Office of New 

Reactorsappropriate Office Director to issue, deny, or appropriately condition, or deny the 

combined license or construction permit, deny issuance of the license, or appropriately 

condition the license or orderfurther actions, as appropriate. See 10 CFR § 2.344. 

In the event that a contested adjudicatory proceeding regarding the GGb--application is 

taking placeongoing or has already taken place, at the time the Commission issues its 

decision in the uncontested proceeding, the Commission will condition its uncontested 

hearing decision as appropriate to ensure no prejudice is done to the contested 

proceeding. 

4. Schedule for Uncontested Hearings: 

The Commission intends to issue adjudicatory decisions in mandatory hearings no later 

than 4 months after the FSER and FEIS or EA are both publicly issued, except that in the 

case of a COL proceeding, if an associated design certification rulemaking is still pending 

as of that date, the Commission will issue a decision immediately after affirming the final 

rule for the referenced design. 

The Commission also intends, to the extent practicable, to adhere to the target dates 

listed below for the key milestones leading up to the Commission decision. The 

Commission recognizes, however, that circumstances may warrant occasional deviations 

from these target dates. It is not anticipated , however, that, absent extraordinary 

circumstances, such deviations would alter the Commission's overall objective of issuing 

its mandatory hearing decisions no later than 4 months from the public issuance of the 

later of the FSER.1 ef-FEIS, or EA. 

Milestone Target Date 

Staff submits Information Paper to Within one week of public issuance of 

Commission FSER & FEIS or EA 

March 24, 2016 Chapter IV - Page 15 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

Notice of mandatory hearing sent to As soon as practicable after staffs 

Federal Register Information Paper is submitted to the 

Commission 

Interested States, local government 36 days before the hearing 

bodies, or federally-recognized Indian 

Tribes file any written statements 

Commission issues any pre-hearing 34 days before the hearing 

questions 

Applicant files pre-filed testimony, 21 days before the hearing 

including witness list and answers to any 

pre-hearing questions 

Staff files witness list and answers to any 21 days before the hearing 

pre-hearing questions 

Secretary issues scheduling order and 14 days before the hearing 

note 

Mandatory hearing commences 51 days after staff's Information Paper is 

submitted to the Commission 

Staff and applicant file responses to any 14 days after hearing is complete 

follow-up questions 

Commission affirms adjudicatory decision 4 months after FSER & FEIS or EA are 

~IA tl=le sase ef a GGb pFesee9iA§, both publicly issued 

affim:iatieA at this sta§e takes plase if (In the case of a COL proceeding, rnfernAse9 9esigA sertifisatieA Fulemaking affirmation at this stage takes place if the alreasy semplete} referenced design certification rulemaking 

is already: complete. If the referenced 

design certification rulemaking is still 

pending as of 4 months after FSER & FEIS 

for COL are both publicly: issued, 

affirmation takes place immediately: after 

Commission affirms the final design 

certification rulemaking for the referenced 

design.} 

In a GGb pFeseesin§, Gemmissien affiFms lmmesiately aftOF Gemmissien affiFms final 

a9ju9isater:y 9esisien if FefeFenseEl Elesign ElesigA sertifisatien FUlemakiAg for 

sertifisatien FUlemaking still peAEling as ef rnfernnseEl Elesign 

4 menths after: i;:~~R & i;:~1~ fer: GGb arn 

setl=l puslisly issues 

March 24, 2016 Chapter IV - Page 16 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

TEMPLATE 

Notice of Hearing 

A template for drafting a mandatory hearing notice for a COL proceeding is provided 

below. This notice is to be used to provide specific information on the uncontested 

("mandatory') portion of the hearing and will be issued by SECY after receipt of the Staff's 

SECY paper supporting the mandatory hearing for each COL application. Appropriate 

adjustments will be made to accommodate any case-specific circumstances (e.g. , if the 

COL application contains an ITAAC closure request pursuant to 10 CFR 52.97@1(2) or a 

limited work authorization request). Notices of hearing for medical isotope production 

and utilization facility construction permit proceedings will follow the same format but will 

be tailored to the specific application at issue. 

NUCLEAR REGULATORY COMMISSION 

Docket No. [Insert Docket Number] 

TITLE: In the Matter of [Insert name of Applicant]; Combined License for [Insert site 

name and number of units] Notice of Hearing 

I. BACKGROUND 

The Commission hereby gives notice that, pursuant to section 189a of the Atomic Energy 

Act it will convene an evidentiary session to receive testimony and exhibits in the 

uncontested portion of this proceeding regarding the [Insert Date of Application], 

application of [Insert Name of Applicant] for a 10 CFR Part 52 combined license (COL), 

seeking approval to construct and operate a new nuclear power generation facility at 

[Insert Description of the Site]. This mandatory hearing will concern safety and 

environmental matters relating to the proposed issuance of the requested COL, as more 

fully described below. Participants in the hearing are not to address any contested issues 

in their written filings or oral presentations. 

DATE, TIME, AND LOC/\,TION OF THE lL.._EVIDENTIARY UNCONTESTED HEARING 

The Commission will conduct this hearing at the specified location and time: 

1. Date [Insert Date] Time: [Insert Time] Location: [Insert Location] 

The hearing on these issues will continue on subsequent days, if necessary. 

Ill. PRESIDING OFFICER 

The Commission is the presiding officer for this proceeding. 

March 24, 2016 Chapter IV - Page 1 7 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

IV. MATTERS TO BE CONSIDERED 

The matter at issue in this proceeding is whether the review of the application by the 

Commission's staff has been adequate to support the findings found in 10 CFR § 52.97 

and 10 CFR § 51 .107. Those findings are as follows: 

Issues Pursuant to the Atomic Energy Act of 1954, as Amended 

( 1) whether the applicable standards and requirements of the Act and the 

Commission's regulations have been met; (2) whether any required notifications to other 

agencies or bodies have been duly made; (3) whether there is reasonable assurance that 

the facility will be constructed and will operate in conformity with the license, the 

provisions of the Act, and the Commission's regulations; (4) whether the applicant is 

technically and financially qualified to engage in the activities authorized; (5) whether 

issuance of the license will not be inimical to the common defense and security or the 

health and safety of the public. 

Issues Pursuant to the National Environmental Policy Act (NEPA) of 1969, as 

Amended 

(1) Determine whether the requirements of Sections 102(2) (A), (C), and (E) of 

NEPA and the applicable regulations in 10 CFR Part 51 have been met; (2) independently 

consider the final balance among conflicting factors contained in the record of the 

proceeding with a view to determining the appropriate action to be taken; (3) determine, 

after weighing the environmental, economic, technical, and other benefits against 

environmental and other costs, and considering reasonable alternatives, whether the 

combined license should be issued, denied, or appropriately conditioned to protect 

environmental values; (4) determine whether the NEPA review conducted by the NRC 

staff has been adequate. 

V. SCHEDULE FOR SUBMITTAL OF PRE-FILED DOCUMENTS 

No later than [replace with date that is 21 days prior to the scheduled hearing date], 

unless the Commission directs otherwise, the staff and the applicant shall submit a list of 

its anticipated witnesses for the hearing. 

No later than [replace with date that is 21 days prior to the scheduled hearing date], 

unless the Commission directs otherwise, the applicant shall submit its pre-filed written 

testimony. The staff previously submitted its testimony on [replace with date of staff 

testimony]. 

The Commission may issue written questions to the applicant or the staff before the 

hearing. If such questions are issued, an order containing such questions will be issued 

no later than [replace with date 34 days before the scheduled hearing date]. 

Responses to such questions are due [replace with date that is 21 days prior to the 

scheduled hearing date], unless the Commission directs otherwise. 

March 24, 2016 Chapter IV - Page 18 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

VI. INTERESTED GOVERNMENT PARTICIPANTS 

No later than [replace with date that is 36 days prior to the oral evidentiary hearing], 

any interested State, local government body, or affected, federally-recognized Indian 

Tribe may file with the Commission a statement of any issues or questions that the State, 

local government body, or Indian Tribe wishes the Commission to give particular attention 

to as part of the uncontested hearing process. Such statement may be accompanied by 

any supporting documentation that the State, local government body, or Indian Tribe sees 

fit to provide. Any statements and supporting documentation (if any) received by the 

Commission using the agency's E-filing system25 by the deadline indicated above will be 

made part of the record of the proceeding. The Commission will use such statements 

and documents as appropriate to inform its pre-hearing questions to the Staff and 

applicant, its inquiries at the oral hearing, and its decision following the hearing. The 

Commission may also request, prior to [replace with date that is no later than 14 days 

prior to the oral hearing], that one or more particular States, local government bodies, 

or Indian Tribes send one representative each to the evidentiary hearing to answer 

Commission questions and/or make a statement for the purpose of assisting the 

Commission's exploration of one or more of the issues raised by the State, local 

government body, or Indian Tribe in the pre-hearing filings described above. The decision 

of whether to request the presence of a representative of a State, local government body, 

or Indian Tribe at the evidentiary hearing to make a statement and/or answer Commission 

questions is solely at the Commission's discretion. The Commission's request will specify 

the issue or issues that the representative should be prepared to address. 

States, local governments, or Indian Tribes should be aware that this evidentiary hearing 

is separate and distinct from the NRC's contested hearing process. Issues within the 

scope of contentions that have been admitted in a contested proceeding for a COL 

application are outside the scope of the uncontested proceeding for that COL application. 

In addition, while States, local governments, or Indian Tribes participating as described 

above may take any position they wish, or no position at all, with respect to issues 

regarding the COL application or the NRC Staff's associated environmental review that 

do fall within the scope of the uncontested proceeding (i.e., issues that are not within the 

scope of admitted contentions), they should be aware that many of the procedures and 

rights applicable to the NRC's contested hearing process due to the inherently adversarial 

nature of such proceedings are not available with respect to this uncontested hearing. 

Participation in the NRC's contested hearing process is governed by 10 CFR § 2.309 (for 

persons or entities, including States, local governments, or Indian Tribes, seeking to file 

contentions of their own) and 10 CFR § 2.315(c) (for interested States, local governments, 

and Indian Tribes] seeking to participate with respect to contentions filed by others). 

25 The process for accessing and using the agency's E-filing system is described in 

the [DATE] notice of hearing that was issued by the Commission for this 

proceeding. See Notice of Hearing [xx FR xx]. Participants who are unable to use 

the EIE, or who will have difficulty complying with EIE requirements in the time 

frame provided for submission of written statements, may provide their statements 

by electronic mail to hearingdocket@nrc.gov. 

March 24, 2016 Chapter IV - Page 19 
CHAPTER IV - COMMISSION MEETINGS/HEARINGS 

Participation in this uncontested hearing does not affect a State's, local government's, or 

Indian Tribe's right to participate in the separate contested hearing process. 

If necessary: The Commission recognizes that [a request] I [requests) to participate 

under 10 CFR § 2.315(c) in proceedings regarding this COL application [was] I [were] 

previously dismissed on mootness grounds by an NRC Atomic Safety and Licensing 

Board. Such dismissals apply solely to the contested portion of the proceeding, and do 

not affect any rights to participate in this uncontested portion of the proceeding. 

If necessary: If the COL application contains an IT AAC closure request pursuant to 

52.97@2(2) or an LWA request, appropriate language should be inserted regarding the 

necessary findings for those items. 

March 24, 2016 Chapter IV - Page 2 0