ML24059A225

2016 Annual Report - Review of Federal Advisory Committee

ML24059A225
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Issue date:	12/31/2016
From:	NRC/SECY
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2016 Current Fiscal Year Report: Review of Federal Advisory Committee Report Run Date: 11/16/2016 3:58:02 PM

I . Department or .-\\.gency 2. Fi scal Yea r Nuclear Regulato~ -Commission 2016

3. Co mmitt ee or SubCommittee 3b. GS.-\\. Committ ee No.

Advisory Committee on Reactor Safeguards 207

4 . Is thi s Ne w During F isca l Year 0 5. C urrent C harter 6. Expected Re newa l Date 7. Expec ted Term Date No 12/4/2014 12/4/20 I 6

8a. Wa s Ter minat e d During FiscalYear? 8b. Spec ifi c Term in at io n .-\\u th o rity 8c .. -\\ctual Term in ati on Dat e No

9 . . -\\ gency Recommendation for Ne .\\t Fisca lYea r  ! Oa.Legis latio n Req to Te nninat e? I Ob.Legis lati on Pending '

Continue No Not Applicable

11 . Establi shment .-\\uthority Statuto~ -(Congress Created)

12 . Specific Es tabli s hm en t .-\\ uth ority 13. Effective Date 14 . Committe e Ty pe 14c. Pre s id enti a l' 42 U.S.C. Sect. 2039 & 2232 1/1/1957 Continuing No

15. Descr ipti on of Committee Scientific Technical Program Adviso~

• Board 16a. To ta l Number of Rep o rt s 27 16b. Report T itl es and Dates Report on the Safety Aspects of the Construction Permit Application for Shine Medical Technologies, Inc. Medical Isotope 10/15/2015 Production Facili~

• Reactor Oversight Process Enhancements 10/16/2015 ISG, "Guidance for the Evaluation of Acute Chemical Exposures and Proposed Quantitative Standards" 10/20/2015 Report on the Safe~ -Aspects of the License Renewal Application for Davis-Besse Nuclear Power Station 11/12/2015 Draft Secy Paper, "Recommendations on Issues Related to Implementation ofa Risk Management Regulatory Framework" 11/13/2015 Plans for Resolving the NRC Near-Term Task Force Open Fukushima Tier 2 and 3 Recommendations 11/16/2015 The Revised Fuel C~ *cle Oversight Process Cornerstones 11/17/2015 ACRS Assessment of the Quality of Selected NRC Research Projects - FY2015 11/17/2015 Report of the Safety Aspects of the Duke Energ~ -Carolinas, LLC, Combined License Application for Williams States Lee III 12/14/2015 Nuclear Station, Units 1 and 2 Peach Bottom Atomic Power Station Units 2 and 3 Maximum Extended Load Line Limit Anal~ *sis Plus (MELLA+) License 2/17/2016 Amendment Request Draft Final Rule 10 CRF 50.46c, "Emergency Core Cooling S~ *stem Performance During Loss-of-Coolant Accidents 2/23/2016 (LOCA)" and Associated Regulatory Guides Closure of Fukushima Tier 3 Recommendations Related to Containment Vents, Hydrogen Control, and Enhanced 3/15/20 I 6 Instrumentation Non-Power Production or Utilization Facilities Proposed License Renewal Rulemaking 3/15/2016 Exemptions to the API000 Certified Design Included in the Lev~

• Nuclear Plant Units I and 2 Combined License Application 4/18/2016 Regulatory Guide 1.229, "Risk-Informed Approach for Addressing the Effects of Debris on Post-Accident Long Term Core 4/19/2016 Cooling" NUREG-1927 , Revision I, "Standard Review Plan for Renewal of Specific Licenses and Certificates of Compliance for D~

• 4/20/2016 Storage of Spent Nuclear Fuel" Review and Evaluation of the NRC Safety Research Program 4/20/2016 NRC Staff Updated Assessment of Fukushima Tier 2 Recommendations Related to Evaluation of Natural Hazards Other 5/17/2016 than Seismic and Flooding Draft ISG JLD-ISG-2016-01, "Guidance for Activities Related to Near-Term Task Force Rec 2. 1, Flooding Hazard 5/18/2016 Reevaluation; Focused Eval & Integrated Assessment NuScale Power, LLC Licensing Topical Report, "Risk Significant Determination" 5/18/2016 Draft Fin RG 1.230, "RG on Alt Pressurized Thermal Shock Rule," & Draft Final Rpt NUREG-2163, "Tech Basis for RG on 7/18/2016 Alt Pressurized Thermal Shock Rule" Report on the Safety Aspects of the License Renewal Applicationofthe Lasalle Coun~

• Station, Units I and 2 7/18/2016 Topical Report WCAP-16996-P, Vol I, II, and III, Rev I, "Realistic Loss-of-Coolant Accident Eval Methodology Applied to 7/19/2016 Full Spectrum of Break Sizes" 9/16/2016

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Report on the Safety Aspects of the Florida Power & Light Compan)"s Combined License Application for Turkey Point Units 6 & 7 Report on the Safe~

• Aspects of the License Renewal Application of the Fermi 2 Nuclear Power Plant 9/16/2016 Response to the 7/5/16 Staff Ltr Regarding ISG JLD-ISG-2016-01 For Focused Evaluations and Integrated Assessments of 9/19/2016 Reevaluated Flooding Hazards Pacific Gas & Electric Diablo Canyon Units I & 2 Digital Process Protection System Upgrade License Amendment Request 9/22/2016

17a O pen : 44 I 7b . C lose d : 13 17c. Partially C lose d : 20 Oth e r .-\\ c tivitie s 0 17d . To tal 77

~ lee tin g Purposes a nd Dates Fukushima 10/6/2015 10/6/2015 628th Full Committee 10/7/2015 10/I0/2015 Future Plant Designs 10/7/2015 10/7/2015 Planning and Procedures 10/7/2015 10/7/2015 Reliabili~

• and Probabilistic Risk Assessment (AM/Closed) 10/19/2015 I0/19/2015 Reliabili~

• and Probabilistic Risk Assessment (PM/Open) 10/19/2015 I0/19/2015 Thermal Hydraulic Phenomena 10/20/2015 10/20/2015 Reliabili~

• and Probabilistic Risk Assessment 10/21/2015 10/22/2015 APIOOO 10/21/2015 10/22/2015 Structural Anal) *sis 10/23/2015 10/23/2015 Metallurgy and Reactor Fuels 11/3/2015 11/3/2015 Planning and Procedures 11/4/2015 11/4/2015 629th Full Committee 11/5/2015 11/7/2015 Plant License Renewal 11/17/2015 11/17/2015 Regulator~

• Policies and Practices 11/18/2015 11/18/2015 Reliability and Probabilistic Risk Assessment 12/1/2015 12/1/2015 Planning and Procedures 12/2/2015 12/2/2015 Power Uprates 12/2/2015 12/2/2015 630th Full Committee 12/3/2015 12/5/2015 Regulato~

• Policies and Practices 2/2/2016 2/2/2016 Plant License Renewal 2/3/2016 2/3/2016 Planning and Procedures 2/3/2016 2/3/2016 631st Full Committee 2/4/2016 2/6/2016 Plant License Renewal 2/17/2016 2/17/2016 Fukushima 2/18/2016 2/18/2016 Future Plant Designs 3/1/2016 3/1/2016 Reliability and Probabilistic Risk Assessment

• http s: //database . faca.gov /rpt/rptannualreport _ sms.a s p?cid = l 94&uid = I 00 11 /16/2016 Page 3 of6

3/1/2016 3/1/2016 Planning and Procedures 3/2/2016 3/2/2016 Plant License Renewal 3/2/2016 3/2/2016 Radiation Protection and Nuclear Materials 3/2/2016 3/3/2016 632nd Full Committee 3/3/2016 3/5/2016 ACRS Meeting with the Commission 3/4/2016 3/4/2016 ReliabilitJ and Probabilistic Risk Assessment 3/22/2016 3/22/2016 Metallurgy and Reactor Fuels 3/22/2016 3/22/2016 Metallurgy and Reactor Fuels 3/23/2016 3/24/2016 Digital l&C S)*stems 4/4/2016 4/4/2016 AP 1000 4/5/2016 4/5/2016 Planning and Procedures 4/6/2016 4/6/2016 Reliability and Probabilistic Risk Assessment 4/6/2016 4/6/2016 633rd Full Committee 4/7/2016 4/9/2016 Planning and Procedures 4/16/2016 4/16/2016 Thermal H) *draulic Phenomena 4/19/2016 4/29/2016 Plant License Renewal 4/19/2016 4/19/2016 APR 1400 4/20/2016 4/21/2016 Fukushima 4/21/2016 4/21/2016 Fukushima 4/22/2016 4/22/2016 Metallurgy and Reactor Fuels 5/3/2016 5/3/2016 Reliabili~

• and Probabilistic Risk Assessment 5/4/2016 5/4/2016 Plant License Renewal 5/4/2016 5/4/2016 Planning and Procedures 5/4/2016 5/4/2016 634th Full Committee 5/5/2016 5/7/2016 T-H Phenomena 5/17/2016 5/17/2016 Metallurgy and Reactor Fuels 5/18/2016 5/18/2016 ReliabilitJ and Probabilistic Risk Assessment 5/18/2016 5/18/2016 Regulator)

• Policies and Practices 5/19/2016 5/19/2016 Metallurg) ' and Reactor Fuels 6/22/2016 6/24/2016 Future Plant Designs 6/24/2016 6/24/2016

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635th Full Committee 7/6/2016 7/8/2016 Planning and Procedures 7/6/2016 7/6/2016 Plant Operations and Fire Protection 7/28/2016 7/28/2016 ReliabilitJ and Probabilistic Risk Assessment (AM/Open) 8/15/2016 8/15/2016 ReliabilitJ and Probabilistic Risk Assessment (PM/Closed) 8/15/2016 8/15/2016 NuScale 8/16/2016 8/16/2016 Plant Operations and Fire Protection 8/16/2016 8/16/2016 Fukushima 8/17/2016 8/17/2016 Plant Operations and Fire Protection 8/17/2016 8/17/2016 AP 1000 8/18/2016 8/19/2016 Digital I&C 9/7/2016 9/7/2016 Reliability and Probabilistic Risk Assessment 9/7/2016 9/7/2016 Reliability and Probabilistic Risk Assessment 9/7/2016 9/7/2016 636th Full Committee 9/8/2016 9/10/2016 Planning and Procedures 9/9/2016 9/9/2016 T-H Phenomena 9/19/2016 9/19/2016 Metallurg~

• and Reactor Fuel s 9/20/2016 9/20/2016 Radiation Protection and Nuclear Materials 9/20/2016 9/ 20/2016 APR 1400 9/21 / 2016 9/22/2016 ESBWR 9/22/2016 9/22/2016 Cu rre nt Fisca l Year Next Fisc al Year I Ba( I ) Person ne l Pmt s t o No n-Fe dera l ~ !e mb e rs $908,829 $1,125,220 18a(2) Perso nn e l Pmt s to Fe de ra l Me mb e rs $0 $0 18a(3) Pe rso nn el Pm ts t o Fe de ral Staff $5, 121,783 $4,500,133 I 8a(4) Pe rsonn e l Pm ts to Non-m e mb e r Co ns ulta nt s $64,813 $65,000 I 8b( I ) Trave l a nd Pe r D ie m t o No n- Fe de ral Me mb ers $378,667 $380,000 18b(2) Trave l a nd Pe r Die m t o Fed e ral ~ !e mb ers $0 $0

J 8b(3) T rave l a nd Pe r Die m t o Fe deral Sta ff $21 ,719 $22,000 I 8b( 4) Tra ve l a nd Pe r Diem to Non- ~ le mb er Co nsult a nts $14,439 $14,500 18c.O th er( re nt s, use r cha rges ,graphi cs, printin g, m a il e tc.) $90,954 $90,000 18d To tal $6,601,204 $6,196,853 I 9. Fe de ra l Sta ff S upp ort Years 33 .3 28.0

20 a. How d oes th e Committ ee acc ompli sh its purp ose?

The Adviso~

• Committee on Reactor Safeguards (ACRS) reports to the Nuclear Regulato~

• Commission (NRC) and provides the Commission with independent reviews of, and advice on, the safety of proposed or existing NRC-licensed reactor facilities and the adequa9

• of applicable safety standards . The ACRS was established as a s tatutory committee by a 1957 amendment to the Atomic Energy Act of 1954. With the enactment of the Energy Reorganization Act of 1974, the licensing functions of the Atomic Energy Commission (AEC) were transferred intact from the AEC to the NRC. The ACRS ha s continued in the same advisor~

• role to the NRC with its responsibilities changing with the needs of the Commission. Some ACRS tasks are mandated by statute or regulation; some are in response to direction by the Commission , or requests from the NRC staff , or other stakeholders; and some are self initiated in response to

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ACRS concerns on important regulatory and safet) *-related matters. The ACRS, upon request from the Department of Energy (DOE),

provides advice on the safety of U.S. naval reactor designs. Upon request, the ACRS also provides technical advice to the Defense Nuclear Facilities Safet)

• Board. The ACRS and its Subcommittees meet regularly in public, Federal Advisory Committee Act (FACA)-regulated meetings to review matters within the scope of its responsibilities. ACRS meeting agendas, meeting transcripts, and letter reports are available for downloading or viewing on the Internet at http://www.nrc.gov/reading-rm/doc-collections/#acrs. The ACRS and its Subcommittees held 77 meetings during FY 2016, including 9 Full Committee meetings that were attended by all ACRS members of which there were 13 closed and 20 partially closed meetings. The ACRS members are chosen for their technical expertise relevant to the safet)

• issues important to the Commission. Consultants are used on occasion to augment the expertise of the ACRS members. The Committee has a full-time staff that provides technical support and administrative services in compliance with FACA requirements. ACRS Subcommittees normally consist of three to six ACRS members with the expertise needed to review in detail the regulator)

• and safet)*

issues and to formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee. Stakeholders' participation in ACRS meetings is encouraged and routine!)

• occurs. The Committee's advice, in the form of written reports, is only produced by the Full Committee, and reports on significant regulatory matters are discussed with the Commission in public meetings. The ACRS conducts an ongoing review of its priorities and schedules to ensure that regulatory matters within its scope of responsibilities are being properly addressed and within its resources, and timely advice is provided to the Commission. Input from the Commission, the NRC staff, and affected stakeholders is used in this process. A Memorandum of Understanding with the NRC Executive Director for Operations (EDO) provides a framework for NRC staff interaction with the ACRS. The ACRS conducts self-assessments to improve its effectiveness and efficiency. In FY16, the ACRS completed licensing reviews associated with license applications, combine license applications, and license renewals; significant rulemaking activities associated with mitigation strategies for beyond-design-basis-events; power uprate applications; NRC lessons learned activities related to the accident at Fukushima; The NRC safet)* research program; digital instrumentation and control matters; metallurgy and reactor fuels issues; and probabilistic risk assessments.

2 0b. How does th e Co mmittee balanc e it s memb e rship ?

The Commission appoints ACRS members with the scientific and engineering expertise needed to address the safety issues of importance to the Commission. Members are sought who can provide an independent perspective on nuclear safet) ' issues, outstanding scientific and technical abilit) *, balanced and mature judgment, and a willingness to devote the time required to the demanding work involved . Members do not have fixed terms. However, absent unusual circumstances, the)

• do not serve more than three, four year terms. Members are reappointed in excess of this period only if there is a compelling continuing need for their expertise. Vacancies in the ACRS membership are filled from the pool of applicants which exists after solicitations of interest are published in the Federal Register, trade and professional societ)

• publications, and in the press. Recommendations to the Commission as to the selection of qualified candidates from this pool are made by the ACRS Member Candidate Screening Panel. The ACRS provides input to this Panel . During FY 2016, the membership was comprised of individuals with diverse employment backgrounds and included those with expertise in the areas of nuclear power plant operations; probabilistic risk assessment; analysis of severe reactor accident phenomena; design of nuclear power plant structures, s)*stems, and components; chemical engineering; digital instrumentation and control; materials and metallurgy; and thermal h) *draulics and computational fluid dynamics. The diversity of viewpoints represented b)* current members is based on special fields of interest, emplo) *ment experience, and technical expertise. These member attributes provide the Committee with the balance of highl)

• qualified technical expertise and diverse safet) ' perspectives necessary to carry out the Committee's statuto~

• responsibilities effective!) '*

20 c. How fr eq uent and re lev ant are the Committ ee m ee tin gs?

The ACRS and its Subcommittees held 77 meetings during FY 2016, of which 9 were Full Committee meetings. The number of meetings held in a reporting period is directly related to the number of nuclear safet)

• matters to be reviewed as required by statute; the number of rules and regulato~

• guidance referred to the Committee for review and comment; the number of special reviews requested by the Commission, EDO, or other Federal Government organizations; and other safet)

• issues of particular concern to the Committee and its stakeholders. The Full Committee normally meets 10 times a year for 3 days to consider important safety-related nuclear issues, license applications, generic issues, significant regulatory matters, rules, and regulatory guidance. The ACRS Subcommittees, which are normally comprised of three to six members with the relevant expertise, meet as necessary with stakeholders to conduct in-depth reviews of particular matters for later consideration by the full membership during Full Committee meetings. Although not required by the revised FACA, Subcommittee meetings are conducted under the same FACA procedures as the Full Committee meetings to facilitate public participation and to provide a forum for stakeholders to express their views on regulatory matters being considered b)' the ACRS.

Reviews are conducted during each Full Committee meeting to assess the relevance of proposed review topics, resource needs, and the priorit)

• of each activity. These assessments have the benefit of input from the Commission, EDO, and other stakeholders. All ACRS meetings for this reporting period addressed either matters for which ACRS review was required b)' statute or regulation, specific requests from either the Commission or the EDO, or other important regulatory and safet)* -related matters self-initiated in response to ACRS concerns.

20 d. Why ca n' t th e a dvi ce o r in fo nn ati o n thi s co mmitt ee prov ides be o btain ed e lsew here?

The ACRS is an independent bod)

• of recognized experts in the field of nuclear reactor safet)* whose Congressional mandate is to provide the Commission with independent advice. Particular duties of the ACRS (e.g., review of operating reactor license renewal applications, extended power uprate amendments, new reactor designs, and rules and regulatory guidance) are dictated by statute or regulation. In addition, functional arrangements exist wherein, upon request, the ACRS provides advice to the Department of Energy and the Defense Nuclear Facilities Safet)

• Board. The Commission has its own expert staff on whom it relies in the day-to-da) ' regulation of nuclear power facilities . The ACRS provides the Commission and the NRC staff with an independent, critical review of high level regulator) ' issues under consideration by the NRC and independent technical insights as to important matters needing Commission attention. The ACRS members are part-time special government employees with other full-time interests and activities in related fields, and provide a breadth of experience, an independent perspective on issues, and technical knowledge that is not duplicated by the NRC's full-time government employees. A standing Committee such as the ACRS remains current with respect to nuclear safet)

• issues of importance to the NRC, including those related to reactor operating experience, regulatory reform, and NRC's needs for safet)

• research, and provides an independent, collegial judgment regarding these issues that other part-time consultants could not provide. The ACRS meetings provide an important forum for stakeholders to express freel) ' their concerns on safet)

• issues and the regulatory process. A number of important safet)

• initiatives have had their origins in ACRS deliberations. Through the ACRS, the public and the Congress are ensured of an independent technical review and evaluation of the safet)* of NRC-licensed facilities, proposed reactor designs, significant regulatory and safet)* issues, and of providing an opportunity for stakeholder input.

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20e. Wh y is it necessa ry t o cl ose and/or partially cl os e committee m eeting s?

According to 5 U.S.C. 552b (c), ACRS meetings can onlJ be closed for the following reasons:* Protect information classified as national securitJ information* Discuss information relating solely to internal personnel rules and/or practices* Protect unclassified safeguards information

• Protect proprietarJ information

• Protect information provided in confidence by a foreign source* Prevent invasion of personal privacy* Prevent disclosure of information the premature disclosure of which would be likely to significantlJ frustrate implementation of a proposed AgencJ action 2 1. Re mark s None

Des ignated Federal O ffice r : Jamila PerrJ DFO Committe e ~ !e mber s Sta rt End Occup a ti on Member De signati o n Ballinger , Dr. 8/4/2013 8/3/2017 Professor of Nuclear Science and Engineering at Massachusetts Institute of Special Government Ronald TechnologJ ', Cambridge, MA Employee (SGE)

Banerjee , Dr. 7/26/2014 2/6/2016 Distinguished Professor of Chemical Engineering and Director of the Special Government Sanjoy Institute for Sustainable EnergJ ' Technologies, The Grove School of Employee (SGE)

Engineering at the Ci~

• College of New York, NY Ble)*, Dr. Dennis 8/30/2015 8/29/2019 President of Buttonwood Consulting,lnc ., Albuquerque, NM Special Government C. Emplo) *ee (SGE)

Brown Jr., Mr. 4/28/2016 4/27/2020 Senior Advisor for Electrical Systems, BMT S)*ntek Technologies, Inc., Special Government Charles H. Arlington, VA Employee (SGE)

Chu, Dr. 6/12/2016 6/12/2020 Consultant to international and domestic clients on nuclear waste Special Government Margaret management, nuclear fuel cycle analJsis, nonproliferation technologies and Employee (SGE) nuclear materials management.

Corradini , Dr. 9/7/2014 9/6/2018 Professor and Chair of the Nuclear Engineering and Engineering PhJsics Special Government Michael L. Program , Universi~

• of Wisconsin, Madison, WI Employee (SGE)

Kirchner , Dr. 6/12/2016 6/11/2020 Retired Institutional Liaison Manager for Argonne National Laboratory Special Government Walter Employee (SGE)

March-Leuba, 6/12/2016 6/11/2020 Principal of MRU and Associate Professor in the nuclear engineering Special Government Dr. Jo se department of the Universi~

• of Tennessee, Knoxville Employee (SGE)

Powers, Dr. 6/6/2014 6/5/2018 Retired, Senior Scientist, Sandia National Laboratories, Alburquerque, Special Government Dana A. NM Employee (SGE)

RaJ , Mr. Harold 6/23/2012 6/22/2020 Retired Chief Executive Vice President, Southern California Edison Special Government B Company, Rosemead, CA EmploJee (SGE)

Rempe , Ms. JO)' 10/7/2014 10/6/2018 Principal of Rempe and Associates, LLC, Idaho Falls, ID Special Government Empto, *ee (SGE)

Riccardella, Dr. 9/1/2013 8/31/2017 Founding Member, Structural Integri~

• Associates, San Jose, CA Special Government Peter Employee (SGE)

Schultz, Dr. 1/9/2012 12/31/2016 Consultant, International Atomic EnergJ Agenq; Retired Engineering Special Government Steven Manager, Nuclear Design Duke Energy Corporation, Charlotte, NC Employee (SGE)

Skillman, Mr. 8/21/2015 8/20/2019 President and Principal, Skillman Technical Resources, Hershey, PA Special Government Gordon Employee (SGE)

Stetkar, Mr. 9/5/2015 9/4/2019 Principal, Stetkar & Associates, Hot Springs, AR Special Government John W. EmploJee (SGE)

Sunseri, Mr. 6/12/2016 6/11/2020 Independent nuclear indust~

• consultant in the safe operation of large Special Government Matthew commercial reactors EmploJee (SGE)

To ta l Co unt o f Co mmitt ee ~ (e mb e rs 16

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2016 Current Fiscal Year Report: Review of Federal Advisory Committee Report Run Date: 9/27/2016 11 : 23:25 AM

I . Department or .-\\gene) 2. Fisca l Year Nuclear Regulato~

• Commission 2016

3. Co mmitt ee o r S ub Committee 3b . GSA Co mmittee No.

Licensing Support S~ *stem Advisor~

• Review Panel 1104 4 . Is thi s 1ew Dur ing Fi sca l Year? 5. C urre nt C harter 6. Expected Renewa l Dal e 7. Ex pecte d Tenn Date No 1/7/2015 1/7/2017

8a . Wa s Term in a te d Du rin g F iscalYear  ? 8b. Spec ifi c Term inat io n A uth o rity 8c .. .\\ctu a l Te rm inatio n Date No 42 u.s.c. 2201

9. Agency Reco mm e ndati o n fo r Nex t Fi sca lYea r I0a.Leg is lat io n Req to Terminat e? I Ob .L eg is lat io n Pe ndin g?

Continue No Not Applicable

11. Es tabli s hm e nt Author ity Agenc~

• Authoriry *

12. Spec ific Es tab li s hm e nt Authority 13 . E ffec tiv e Da te 14 . Co mmitt ee Ty pe 14 c. Presidential?

42 u.s.c. 2201 1/19/1975 Continuing No

15. De sc ripti o n of Co mmittee Non Scientific Program Advisory Board

16a. Tota l Numb e r of Report s No Report s for thi s Fiscal Year.

17d. To ta l ~ leet in gs No Meetings for this Fiscal Year .

C urre nt Fisca l Year Nex t Fiscal Year 18a( I ) Pe rso nn e l Pmt s to ' o n-F e deral ~ !e mb e rs so so

18a(2) Per sonne l Pmt s to Federa l ~ lember s 18a(3) Perso nn e l Pmt s lo Federa l Staff ~ ~

18a(4) Per so nn e l Pmt s to No n-member Co ns ultant s so so

18b( I ) Trave l and Per Diem to Non- Federa l ~ I e mb e rs so so 18b(2) Trave l a nd Per D iem to Federa l ~!ember s so so

18b(3) Trave l a nd Per Diem to Fede ra l Staff so so 18 b(4) T rave l a nd Per Diem to No n- ~ lember Con sult ant s so so

I 8c.O ll1er(rent s, user c ha rges,g raphic s, prinlin g, mail etc .) so so 18d To tal S200 S500

19. Federal Staff S upp ort Yea r s 0.0 0.0

20a . How does th e Co mmitt ee accompli sh it s p urp ose?

The Nuclear Regulatory Commission relied on the Licensing Support Network Advisory Review Panel (LSNARP) for advice and recommendation s on the design and operation of the sear chable electronic database (Licensing Support Network (LSN)) for documents that were relevant to the licen s ing of a geologic repo s itor~* for the storage of high level nuclear waste as defined in 10 CFR 2.1003. The document collection contained electronic copies of all of the material that was use d by partie s in the N RC' s licen si ng proceeding for a high level radioactive waste repositor~ *. The LSN was loaded with more than 3 million documents begining in FY-2004 and continuing through FY-2011. Document addition continued during FY-2011, however , no committee meetings were held since December 2003. DOE had planned on s ubmitting an application to build a high level waste dispo sa l faciliry* at Yucca Mountain , Nevada in December 2004, however dela~ *s occured and in the spring of2006 DOE iss ued a revised schedule. DOE certified their LSN document collection in late 2007 and s ubmitted a License application to the NRC in June 2008. The dela~* in DOE' s program negated an~

• need for LSN meetings during this period. During FY 2010 DOE asked to withdraw the Yucca Mountain License Application pending before the NRC. In FY-2011 through FY20l6 , Congress did not appropisate any funds for DOE or NRC for the Licenseing of the Yucca Mountain Application. NRC shut down the licensing review in FY-2011 and preserved the record of the proceeding. The Atomic Safery* and Licensing Board that presided over the application hearing ordered the parties to submit their LSN document collections to the NRC Secretary for presen ,ation. The LSN sys tem was decomis sioned at the close ofFY-2011. Litigation continued before the DC Circuit Court in FY-2012 and in August 2013 the DC Circuit iss ued a Writ of Mandamus. During FY-2016 the NRC staff finished a Supplemental Environmental Impact Statement for the Yucca Mtn reposito~

• using carr~ *onr funding. Further meeting s will depend upon deci sions b~

• the Commission on a course of action and the availabiliry

• of funding .

20b . How does th e Co mmi tt ee balanc e it s m ember ship  ?

The LSNARP is a"Representational Committee" and the membership was balanced b~

• being drawn from among the full spectrum of parties to NRC's licensing proceeding for the burial of high level radioactive waste. Since the burial site under review is in Nevada , the membership includes the State of Nevada, local counry

• governments of both Nevada and California, Indian tribes (represented by the National Congress of American Indians), and an environmental group (the Nevada Nuclear Waste Task Force). It also included the nuclear indust~ *, the potential licensee (DOE) and the licensing agency (NRC) . Input b~

• these representative s was essential to the success of the LSN project. If the Committee meets in the future , the parties will be reque sted to de signate new members as their repre se ntati\\ ,es.

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20c . How frequen t and re leva nt a re th e Co mmi ttee meet in gs?

The LSNARP did not meet in FY-2016 . The need for additional meetings of the LSNARP will be determined based upon the Commission's course of action in response to the DC Circuit Courts Writ of Mandamus and the availabili~

• of funding ..

20d. Wh~ can' t th e advice o r infoI111ati o n thi s comm ittee prov id es be obtained e lsew here?

The Committee was formed as part of a negotiated rulemaking to oversee the operation of the LSN. The advice provided b)* the state, coun~

• and tribal governmental units, together with other potential users of the LSN and EHD, was unique to this particular computer application . It was not available from other existing committees or within the NRC itself. NRC considered it essential that advice on the design of the software and hardware should come from representatives of the future hands-on users of the LSN .

20e . Why is it necessa ry to clo se and /or partially cl ose comm ittee mee tin gs?

The LSNARP did not hold any closed meetings in FY 2016.

21. Remark s In FY-2016, Congress did not appropisate any funds for DOE or NRC for the Licenseing of the Yucca Mountain Application. In August 2013 the DC Circuit Court issued a Writ of Mandamus ordering the NRC to "promptly continue with the legally* mandated licensing process" for DOE's Yucca Mountain application using the car~

• o,*er funds available . During FY-2016 the Commission use d available car~ *over funding to complete a supplemental Environmental Impact Statement and to load 3.7 million documents from the LSN into a publican,- accessible electronic library as part of the NRC's ADAMS document management system to fullfil the Courts mandate. Future meetings of the Committee remain uncertain and depend upon availabili~

• of funding and any resumption of the adjudicatory proceeding.

Designated Fede ral O fficer: Dr. Andrew L Bates DFO Comm itt ee ~ )e mber s Start End Occ up ation f'demb er De sig nati o n Bate s, Dr Andrew L 6/1/2003 12/30/2017 US Nuclear Regulator~

• Commission Regular Government Employ *ee (RGE)

Tota l Co unt of Co mmitt ee ~ !e mber s

https  ://dat aba se. faca.gov /rp t/rptannualr eport _ sms.asp?cid = 970&uid = I 00 09 /27 /2016 Page I of3

2016 Current Fiscal Year Report: Review of Federal Advisory Committee Report Run Date: 11/16/2016 4:03:02 PM

I . De partm en t or . .\\gency 2. Fiscal Year Nuclear Regulatory Commission 2016

3. Co mmitt ee o r Su bCo mmitte e 3b. GS . .\\ Co mmitt ee No.

Advisory Committee on the Medical Uses of Isotopes 1102

4 . Is thi s New During Fisca l Year? 5. C urr e nt C ha rt e r 6 . Expected Renewal Date 7 . Expec ted Te nn Date No 3/10/2016 3/10/2018

8a. Was Tenninated During FiscalYear? 8b. Specific Term in ati on ..\\uthority 8c . ..\\ctual Te rmin a ti on Date No 42 u.s.c. 2201

9 . . -\\gency Recommendation fo r Next Fisca!Year I0a . Le g is la ti on Req to Terminate  ? I Ob.Leg is lati o n Pending?

Continue No Not Applicable

11 . Estab li shmen t ..\\ uth or ity Agency Authority 12 . Specific Es ta bli shm en t A uthorit y 13. Effective Date 14 . Co mmitt ee Type 14c . Presidential?

42 u.s.c. 2201 7/1/1958 Continuing No

15. Description of Comm itt ee Scientific Technical Program Advisor)

• Board 16a. To ta l Number of Reports 13 16 b. Report T itl es and Dates Report on the Hormesis/Linear No-Threshold Petitions, Draft 10/14/2015 Report on the Hormesis/Linear No-Threshold Petitions, Final 10/28/2015 Report on Proposed Revision of the NRC Policy Statement on Reporting Abnormal Occurrences to Congress , Final 11/6/2015 Report on the Nuclear Regulatory Commission (NRC) Draft Final Rule, 10 CFR Parts 30, 32 and 35, Draft 12/23/2015 Report on the Nuclear Regulator) ' Commission (NRC) Draft Final Rule, 10 CFR Parts 30, 32 and 35, Final 1/6/2016 Report on Training & Experience for Authorized Users of Alpha and Beta Emitters under 10 CFR 35.390 , Draft 3/10/2016 Report on Training & Experience for Authorized Users of Alpha and Beta Emitters under 10 CFR 35.390, Final 3/16/2016 Report on the Draft "Low Activity Radioactive Seeds Used for Localization of Non-palpable Lesions and Lymph Nodes 6/10/2016 Guidance," Draft Report on the Draft "Low Activity Radioactive Seeds Used for Localization of Non-palpable Lesions and Lymph Nodes 6/24/2016 Guidance," Final Report on the Draft Germanium-68/Gallium-68 Generator Licensing Guidance, Draft 7/26/2016 Report on the Draft Germanium-68/Gallium-68 Generator Licensing Guidance, Final 8/25/2016 Report on the Yttrium-90 Microsphere Brach) *therapy Sources and Devices TheraSpheres Licensing Guidance, Rev 10, 9/13/2016 Draft Standing Subcommittee on Training and Experience Requirements, Status Report 9/16/2016

17a O pen: 5 17b. C lo sed: 0 17c . Part ially C lo sed  : 2 O th e r . .\\ct iv iti e s 0 17d. Tota l 7 l\\ leet in g Purpo se s and Dates ACMUI Fall 2015 Meeting - Discuss issues related to JO CFR part 35 Medical Use of B)*product Material . 10/8/2015 10/9/2015 To discuss the Adviso~

• Committee on the Medical Uses of Isotopes (ACMUI) subcommittee report on the AC MUI review of 10/28/2015 and comments on Petitions for Rulemaking (PRM)-20-28, 20-29, 20-30, "Linear No-Threshold Model and Standards for 10/28/2015 Protection Against Radiation."

To discuss the Advisor)

• Committee on the Medical Uses of Isotopes (ACMUI) subcommittee report on the ACMUJ review of 1/6/2016 and comments on the draft final rule for Title 10 Code of Federal Regulations (CFR), Part 35, "Medical Use of Byproduct 1/6/2016 Material ."

To discuss the draft Advisory Committee on the Medical Uses of Isotopes (ACMUI) subcommittee report on the training and 3/10/2016 experience (T & E) requirements of authorized users (A Us) of alpha, beta and gamma emitters under 10 CFR 35.390. 3/10/2016 To discuss issues related to the implementation of the medical regulations in Title 10, Code of Federal Regulations (CFR), 3/17/2016 Part 35, and "Medical Use of B)*product Material." 3/18/2016 To discuss the Advisor)

• Committee on the Medical Uses of Isotopes (ACMUI) Subcommittee on Radioactive Seed Localization (RSL Subcommittee) response to the NRC working group draft "Low Activity Radioactive Seeds Used for 6/24/2016 Localization of Non-palpable Lesions and L)*mph Nodes Guidance" and the potential rulemaking to expand the financial 6/24/2016 assurance requirements to include Catego~

• I and 2 radioactive sealed sources tracked in the National Source Tracking System.

https  :/ /database . faca.gov /rp t/rptannualreport _ sms.asp?cid=969&uid= 100 11 /16/2016 Page 2 of 3

To discuss the draft AdviSOI)' Committee on the Medical Uses of Isotopes (ACMUI) Germanium-68/Gallium-68 Generators 8/10/2016 Licensing Guidance Subcommittee Report 8/10/2016

C urrent Fi scal Yea r Ne xt Fiscal Year I Sa( I ) Pe rso nnel Pmt s to No n-Federal ~!ember s $120,188 $130,000 18a(2) Per so nn e l Pmt s to Federal Member s $0 $0 18a(3) Per so nnel Pmt s to Federal Staff $152,118 $150,000 I Sa( 4) Per so nn e l Pmt s to No n-m e mb er Co ns ultant s $0 $0 I Sb( I ) Trave l a nd Per Diem to Non-Federa l ~ !embe rs $24,696 $42,350 18b(2) Travel and Per Diem to Federal ~ !emb e rs $0 $0 18b(3) Trave l and Per Die m to Federal Staff $3,705 $4,250 I 8b(4) Trave l and Per Diem to Non- ~ lembe r Cons ultant s $9,659 $8,080 1 Sc .O th e r(re nt s, user charges ,graphic s, printing ,mail e tc. ) $0 $0 18d To tal $310,366 $334,680

19. Federa l Staff Suppor t Years 0.9 1.0

20a. How d oes th e Co mmitte e accompli s h it s purp ose?

The NRC staff believes that licensees, the general public, and medical professionals benefit when recognized experts provide advice to the staff. This advice enables staff to develop rules that will maintain public safety, while not inappropriately intruding upon the practice of medicine . The Staff provides a summary of issues to be addressed during meetings, and the ACMUI discusses the issues and gives advice and make s recommendations to the Staff. Furthermore, the ACMUI keeps staff abreast of new developments . This ongoing communication helps ensure that staff is aware of important issues during critical s tages of rule development . When issues that need s pecial emphasis arise, working groups and subcommittees are formed.

20 b. How d oes the Co mmittee balance it s memb e rship ?

Membership is balanced by placing individuals of diverse specialty on the committee. For instance, there are members who represent both diagnostic and therapeutic applications of medicine. There are members who have a regulato11

• function within their specialties. There is a member who represents medicine from an administrative standpoint, and there is a patient advocate member, who represents patients' intere sts. ACMUI members also perform regular self-evaluations, in which they give feedback on the appropriateness of the committee's composition.

20c. How fr equent and re leva nt are the Comm ittee m ee tin gs" Committee meetings are generally held semi-annuau, ,. The committee will hold more frequent meeting s when important issues emerge or when issues need timely resolution.

20d. Why ca n't th e ad v ice o r information thi s committe e prov id es be o btained e lsewhere  ?

NRC continues to strive to achieve its goal of creating risk-informed, performance-based regulations that provide for the health and safet)

• of the public while imposing no unnecessa11* burden on licensees. Furthermore, the medical profession continues to see regular advance s that create unique regulatory challenge s. The advice and recommendation s from medical professionals who are exposed to these advances is crucial to the NRC staffs abilit)

• to continue to regulate effectively.

20e . Why is it necessa ry to close and/or partiall y cl ose comm ittee meetin gs?

Meetings are closed to conduct annual ethics briefings, annual allegations training, annual information securit)

• awareness training, conduct reviews of paperwork of a personal and confidential nature, and to discuss administrative matters that are purely internal to Committee business. It would be inappropriate to conduct these types of meetings opent, *. They must be conducted privately to allow Committee members the freedom to ask and answer personal questions and to protect individuals' privac, *.

21. Remark s

Des igna ted Federa l O fficer  : Mr. Douglas Rollock DFO Committ ee ~ !e mber s Start End Occupation ~ !emb e r Des ignat io n Alderson MD , Dr. Philip 0. 3/24/2014 3/23/2018 Health Care Administrator Special Government Employee (SGE)

Costello, Mr. Francis M. 5/12/2014 5/11/2018 Agreement State Representative Special Government Employee (SGE)

Dilsizian MD, Dr. Vasken 5/12/2014 5/11/2018 Nuclear Cardiologist Special Government Employee (SGE)

Ennis MD, Dr. Ronald D. 3/18/2015 3/17/2019 Radiation Oncologist Special Government Employee (SGE)

Langhorst PhD, Dr. Susan M. 9/28/2009 9/27/2016 Radiation Safet)

• Officer Special Government Employee (SGE)

Mattmuller , Mr. Steven R. 3/30/2008 3/29/2016 Nuclear Pharmacist Special Government Employee (SGE)

Metter , Dr. Darlene 3/5/2016 3/4/2020 Diagnostic Radiologist Special Government Employee (SGE)

O'Hara PhD, Dr. Michael D. 11/1/2014 9/30/2016 Food and Drug Administration Regular Government Employee Representative (RGE)

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... ., Page 3 of3

Palestro MD, Dr. Christopher 9/22/2011 9/21/2019 Nuclear Medicine Physician Special Government Employee J. (SGE)

Suh MD, Dr. John H. 10/18/2010 10/17/2018 Radiation Oncologist Special Government Employee (SGE)

Thomadsen PhD, Dr. Bruce R. 10/15/2007 10/14/2015 Medical Ph~ *sicist - Therap~

• Special Government Emplo~ *ee (SGE)

Weil, Ms. Laura M. 8/29/2011 8/28/20.19 Patients' Rights Advocate Special Government Emplo~ *ee (SGE)

Zanzonico PhD , Dr. Pat B. 3/8/2010 3/7/2018 Nuclear Medicine Medical Phy sicist Special Government Employee (SGE)

Tota l Coun t of Committee l\\lernb ers 13

http s: //databa se . faca.gov /rpt /rptannualreport _ sm s.asp ?cid=969& uid = l 00 11/16/2016