ML24152A180

2 - Enclosure 1 - Special Nuclear Materials-362 License Renewal Safety Evaluation Report - Public

ML24152A180
Person / Time
Site:	07000398
Issue date:	04/10/2025
From:	Division of Fuel Management
To:
Shared Package
ML24152A178	List: ML24152A179 ML24152A180 ML24152A181 ML24152A184
References
EPID: L-2023-RNW-0017
Download: ML24152A180 (1)

Text

Enclosure 1 Safety Evaluation Report Special Nuclear Material License SNM-362 Renewal Application Department of Commerce, National Institute of Standards and Technology Gaithersburg, Maryland Docket No.70-398 Manuscript Completed: April 10, 2025 Division of Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

TABLE OF CONTENTS Page

1.0 INTRODUCTION

...............................................................................................................1 1.1 Background............................................................................................................1 1.2 Scope of U.S. Nuclear Regulatory Commission Staff Review...............................1 2.0 GENERAL INFORMATION ABOUT THE APPLICANT...................................................3 2.1 Purpose of Review.................................................................................................3 2.2 Staff Review and Analysis.....................................................................................3 2.2.1 Applicants Name and Contact Information................................................3 2.2.2 Location and Address of Material Use.......................................................3 2.2.3 Activities for which the Material is Requested............................................4 2.2.4 Period of time for the license......................................................................4 2.2.5 Radioactive Material for which the License is Requested..........................4 2.2.6 Facility Description and Process Overview................................................6 2.2.7 Organization and Administration................................................................8 2.3 Evaluation Findings................................................................................................9 3.0 RADIATION PROTECTION............................................................................................11 3.1 Purpose of Review...............................................................................................11 3.1.1 Regulatory Requirements........................................................................11 3.1.2 Regulatory Guidance...............................................................................11 3.2 Staff Review and Analysis...................................................................................12 3.2.1 Organizational Management and Personnel Qualifications.....................12 3.2.2 Radiation Safety Officer...........................................................................14 3.2.3 Authorized Source Custodians/Users......................................................16 3.2.4 Radiation safety training...........................................................................17 3.2.5 Radiation Protection Program..................................................................19 3.2.6 As Low As Reasonably Achievable (ALARA) Program............................20 3.2.7 Occupational doses..................................................................................21 3.2.8 Public Doses............................................................................................21 3.2.9 Minimization of contamination..................................................................21 3.2.10 Ventilation and Respiratory Protection.....................................................22 3.2.11 Waste management.................................................................................22 3.2.12 Audit Program..........................................................................................26 3.2.13 Equipment and monitoring practices........................................................27

3.2.14 Radiation monitoring instruments.............................................................27 3.2.15 Leak tests.................................................................................................28 3.2.16 Surveys....................................................................................................29 3.2.17 Environmental Monitoring........................................................................29 3.2.18 Commitment to Written Procedures.........................................................30 3.2.19 Recordkeeping.........................................................................................30 3.2.20 Operating and Emergency Procedures....................................................31 3.2.21 Transportation..........................................................................................32 3.2.22 NIST Irradiators Program.........................................................................32 3.3 Evaluation Findings.............................................................................................40 4.0 NUCLEAR CRITICALITY SAFETY.................................................................................43 4.1 Purpose of Review...............................................................................................43 4.2 Staff Review and Analysis...................................................................................43 4.2.1 Use of Industry Standards........................................................................43 4.2.2 Criticality accident alarm system requirements........................................43 4.2.3 Emergency Planning and Response........................................................44 4.2.4 Subcriticality and Double Contingency Principle......................................45 4.2.5 Organization and Administration of the NCS Program.............................45 4.2.6 Nuclear Criticality Safety Program Management Measures....................46 4.2.7 Technical Practices for NCS....................................................................46 4.2.8 Calculational Method Validation...............................................................46 4.2.9 Criticality Safety Evaluations....................................................................46 4.2.10 Evaluation and Implementation of Controlled Parameters.......................47 4.2.11 Additional NCS Program Commitments...................................................47 4.2.12 Emergency Plan.......................................................................................47 4.3 Evaluation Findings.............................................................................................47 5.0 CHEMICAL SAFETY.......................................................................................................48 5.1 Purpose of Review...............................................................................................48 5.2 Staff Review and Analysis...................................................................................48 5.2.1 Review areas...........................................................................................49 5.3 Evaluation Findings.............................................................................................51 6.0 FIRE SAFETY.................................................................................................................51 6.1 Purpose of Review...............................................................................................51 6.2 Staff Review and Analysis...................................................................................51

6.2.1 Facility design..........................................................................................52 6.2.2 Fire protection..........................................................................................52 6.2.3 Process fire safety....................................................................................53 6.2.4 Combustible Loading and Potential Fire Scenarios.................................54 6.3 Evaluation Findings.............................................................................................54 7.0 NATIONAL ENVIRONMENTAL POLICY ACT AND ENVIRONMENTAL PROTECTION

.........................................................................................................................................55 7.1 Purpose of Review...............................................................................................55 7.2 Staff Review and Analysis...................................................................................55 7.2.1 National Environmental Policy Act: Classification of Regulatory Action...55 7.2.2 Environmental Protection Program..........................................................55 7.3 Evaluation Findings.............................................................................................56 7.3.1 Classification of Regulatory Action: NEPA Requirements.......................56 7.3.2 Protection of the Environment..................................................................56 8.0 MATERIAL CONTROL AND ACCOUNTING.................................................................57 8.1 Purpose of Review...............................................................................................57 8.2 Staff Review and Analysis...................................................................................57 8.2.1 Reports of loss or theft or attempted theft................................................58 8.2.2 Material status reports..............................................................................58 8.2.3 Nuclear material transaction reports........................................................59 8.2.4 Recordkeeping.........................................................................................60 8.2.5 Written Material, Control, & Accounting Procedures................................61 8.2.6 Physical inventories.................................................................................62 8.2.7 Records Access and Storage...................................................................62 8.3 Evaluation Findings.............................................................................................63 9.0 DECOMMISSIONING FINANCIAL ASSURANCE..........................................................63 9.1 Purpose of Review...............................................................................................63 9.2 Staff Review and Analysis...................................................................................63 9.3 Evaluation Findings.............................................................................................64 10.0 DECOMMISSIONING......................................................................................................64 10.1 Purpose of Review...............................................................................................64 10.2 Staff Review and Analysis...................................................................................65 10.2.1 Decommissioning plan.............................................................................65 10.2.2 Recordkeeping.........................................................................................65 10.3 Evaluation Findings.............................................................................................65

11.0 EMERGENCY MANAGEMENT......................................................................................66 11.1 Purpose of Review...............................................................................................66 11.2 Staff Review and Analysis...................................................................................66 11.3 Evaluation Findings.............................................................................................67 12.0 PHYSICAL SECURITY...................................................................................................67 12.1 Purpose of Review...............................................................................................67 12.1.1 Applicability.............................................................................................67 12.2 Staff Review and Analysis...................................................................................68 12.2.1 Physical security of SNM at fixed sites....................................................69 12.2.2 Security of SNM during transport.............................................................70 12.2.3 Physical security for category 1 and category 2 byproduct materials......72 12.3 Evaluation Findings.............................................................................................73 12.3.1 Physical security of SNM at fixed sites....................................................73 12.3.2 Security of SNM in transport....................................................................73 12.3.3 Physical security for category 1 and category 2 byproduct materials......74

13.0 CONCLUSION

................................................................................................................75

14.0 REFERENCES

................................................................................................................75 15.0 PRINCIPAL CONTRIBUTORS.......................................................................................78

v LIST OF ACRONYMS AND ABBREVIATIONS 10 CFR

...................................Title 10 of the Code of Federal Regulations ADAMS

...................................Agencywide Documents Access and Management System AGN

...................................Aerojet-General Nucleonics ALARA

...................................As Low as Reasonably Achievable Am

...................................Americium ANSI

...................................American National Standard Institute Au

...................................Gold Bk

...................................Berkelium B.S.

...................................Bachelor of Science C

...................................Carbon CAA

...................................Controlled Access Area Ce

...................................Cerium Cd

...................................Cadmium Cf

...................................Californium CFR

...................................Code of Federal Regulations Cm

...................................Curium Co

...................................Cobalt Cs

...................................Cesium CSO

...................................Chief Safety Officer DAC

...................................Dose Assessment Coordinator DEO

...................................Director of Emergency Operations DOE

...................................U.S. Department of Energy DOT

...................................U.S. Department of Transportation DP

...................................Decommissioning Plan EA

...................................Environmental Assessment EH&S

...................................Environmental Health and Safety EIS

...................................Environmental Impact Statement ENDF

...................................Evaluated Nuclear Data File EP

...................................Emergency Plan Es

...................................Einsteinium Fe

...................................Iron FR

...................................Federal Register Gd

...................................Gadolinium H

...................................Hydrogen 3H

...................................Tritium HazMat

...................................hazardous material HEPA High Efficiency Particulate Air Hf

...................................Hafnium Hg

...................................Mercury I

...................................Iodine In

...................................Indium IRSC

...................................Ionizing Radiation Safety Committee ISA

...................................integrated safety analysis Kr

...................................Krypton La

...................................Lanthanum LAR

...................................license amendment request LRA

...................................license renewal application LSS special nuclear material of Low Strategic Significance Lu

vi MC&A

...................................material control and accounting MD

...................................State of Maryland Mo

...................................Molybdenum mrem millirems MSS special nuclear material of Moderate Safety Significance mSv millisieverts NCS

...................................nuclear criticality safety NDA/NDE

...................................nondestructive assays and evaluation NFPA

...................................National Fire Protection Association NIST

...................................National Institute of Standards and Technology NMMSS

...................................Nuclear Materials Management and Safeguards System Np

...................................Neptunium NRC

...................................U.S. Nuclear Regulatory Commission NVLAP

...................................National Voluntary Laboratory Accreditation Program OSHA

...................................Occupational Safety and Health Administration Pa

...................................Palladium Pb

...................................Lead Pm

...................................Promethium Po

...................................Polonium PSG Police Services Group (PSG)

PSP

...................................Physical Security Plan 239Pu

...................................Plutonium-239 Pu

....................................Plutonium RAI

...................................request for additional information RAM

...................................radioactive material Rn

...................................Radon RPP

...................................radiation protection program RS

...................................radiation safety RSD

...................................Radiation Safety Division RSI

...................................request for supplemental information RSO

...................................radiation safety officer RTR

...................................research test reactor Ru

...................................Ruthenium RWP radiation work permit SCA

...................................subcritical assembly SER

...................................Safety Evaluation Report SH&E

...................................safety, health, and environmental Si

...................................Silicon SI

...................................System of International units Sm

...................................Samarium SNM

...................................special nuclear material Sr

...................................Strontium SRP

...................................Standard Review Plan Tc

...................................Technetium TEDE

...................................total effective dose equivalent Th

...................................Thorium Ti

...................................Titanium TR-5

...................................NRC Test Reactor license number 5 T&R

...................................Trustworthy and Reliability TSO

...................................Technical Safety Office U

...................................Uranium

vii 233U

....................................Uranium-233 235U

....................................Uranium-235 UF6

...................................Uranium hexafluoride U.S.

...................................United States Xe

...................................Xenon

viii This page intentionally left blank.

1

1.0 INTRODUCTION

1.1 Background

Special Nuclear Material (SNM) License SNM-362 was first issued in 1960 by the Atomic Energy Commission to the National Bureau of Standards (renamed as the National Institute of Standards and Technology (NIST) in 1988). NIST is a federal agency within the U.S.

Department of Commerce. NIST uses licensed materials for research, development, calibration, and testing activities. Under SNM-362, NIST develops, maintains, and disseminates national standards for ionizing radiation and radioactivity to support healthcare, industry, and homeland security at its Gaithersburg, Maryland site. The SNM-362 license was renewed in 1979, 1985, 1991, 1997, and 2013. The current license, was scheduled to expire on September 9, 2023.

By letter dated August 8, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23221A162), pursuant to the requirements in Title 10 of the Code of Federal Regulations (10 CFR) Part 70, Domestic Licensing of Special Nuclear Material, NIST submitted an application (with Enclosures) requesting renewal of SNM-362. NIST requested renewal of the SNM-362 license to continue its authorization to possess and use SNM for a period of 10 years. The U.S. Nuclear Regulatory Commission (NRC) acknowledged receipt of the application on August 29, 2023 (ML23237B469) and, after completing an acceptance review of the application package, by letter dated October 6, 2023 (ML23271A220), the NRC accepted NISTs license renewal application (LRA) for detailed technical review. On November 16, 2023, the NRC published a notice of receipt of NISTs LRA with an opportunity for the public to request a hearing and petition for leave to intervene in the Federal Register (88 FR 78798).

However, the NRC did not receive a request for a hearing or for a petition for leave to intervene.

During the conduct of its detailed technical review, the NRC staff identified additional information that was still needed before final action on the (LRA) could be taken. Therefore, by letter dated February 9, 2024 (ML23320A135), the NRC staff issued a request for additional information (the RAI). NIST provided its response to the RAI (with Enclosures) by letter dated March 11, 2024 (ML24071A177).

In its LRA, NIST noted that, in preparing the LRA, NIST followed the format described in draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, dated September 2022 (ML22335A087).

Additionally, NIST used guidance from the NUREG-1556 series, Consolidated Guidance About Materials Licenses.

NIST submitted its LRA not less than 30 days before its expiration date, in accordance with 10 CFR 70.38(a). As such, the SNM-362 license will remain in effect until the end of the day on which the Commission makes a final determination to deny the LRA or, if the determination states an expiration date, the expiration date stated in the determination.

1.2 Scope of U.S. Nuclear Regulatory Commission Staff Review The NRC staff conducted its safety and safeguards review in accordance with 10 CFR Part 20, Standards for Protection Against Radiation; 10 CFR Part 33, Specific Domestic Licenses of Broad Scope for Byproduct Material; 10 CFR Part 36, Licenses and Radiation Safety Requirements for Irradiators; 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material; 10 CFR Part 40, Domestic Licensing of Source Material;

2 10 CFR Part 70, Domestic Licensing of Special Nuclear Material; 10 CFR Part 73, Physical Protection of Plants and Materials; and 10 CFR Part 74, Material Control and Accounting of Special Nuclear Material. The NRC staff used the guidance in draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H (ML22335A087); NUREG-1520, Standard Review Plan (SRP) for Fuel Facilities License Applications, Revision 2 (ML15176A258); NUREG-1556 Volume 6, Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses, Revision 1 (ML18026A698); and NUREG-1556, Volume 11, Program-Specific Guidance About Licenses of Broad Scope, Revision 1 (ML17059D332). It should be noted that all of NISTs licenses to possess nuclear material, in accordance with the regulations referenced above, are issued by NRC Headquarters and inspected by NRC Region I. NIST has no NRC licenses issued thru the NRC Region I, nor does NIST have any materials licenses issued by the Agreement State of Maryland.

This Safety Evaluation Report (SER) documents the NRC staff review and findings regarding NISTs LRA, which included the review of the information submitted by NIST in its August 8, 2023, LRA, review of NISTs March 11, 2024, responses (ML24071A178 - public, ML24071A179 - public, and ML24071A180 - non-public) to the NRC staffs February 9, 2024 (ML23320A132) RAI, observations and assessments of NISTs facilities during two NRC staff visits to their site (November 14, 2023, and February 6, 2024, respectively), and NISTs compliance history.

The LRA consisted of 10 sections:

1) General Information, which discusses information about the location of the facility and its description, activities for which radioactive materials will be used, the period of time for which the license is being requested, radioactive material for which authorization to possess is requested, and NISTs radiation safety program management;

2) Radiation Protection, which generally discusses NISTs radiation safety program, including a description of its organization, personnel qualifications, facilities and equipment, and procedures;

3) Nuclear Criticality Safety;

4) Chemical Safety;

5) Fire Protection;

6) National Environmental Policy Act, which discusses why licensing of the facility does not require the development of an Environmental Impact Statement;

7) Material Control and Accounting;

8) Decommissioning and Financial Assurance;

9) Physical Security; and,

10) Emergency Management.

The LRA initially included six Enclosures providing detailed information in support of the LRA including NRC Form 313, Application for Materials License, (Enclosure 1, ML23220A400),

Requested Exemptions (Enclosure 2 ML23220A401), NISTs 10 CFR Part 36 Irradiator (Enclosure 3, ML23221A163 - non-public), Radioactive Materials for which the license is requested (Enclosure 4, ML23221A165 - non-public), Delegation of Authority to the NIST Radiation Safety Officer (RSO) memorandum (Enclosure 5,ML23220A404), and NISTs Physical Security Plan (Enclosure 6, ML23221A166 - non-public). With its response to the NRC staffs RAI, NIST provided revised Enclosure 4 (ML24071A182 - non-public), revised (ML24071A183 - non-public), and new Enclosure 7, Fire Safety Schematics

3 (ML24071A184). The RAI response also included a revised LRA (ML24071A181) incorporating all new information provided in its response to the RAI.

2.0 GENERAL INFORMATION ABOUT THE APPLICANT 2.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the information that the U.S.

Department of Commerce, National Institute of Standards and Technology (NIST) provided in section 1 of the license renewal application (LRA) against the regulatory requirements in 10 CFR Part 70 and the associated guidance presented in section 1, General Information, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087), to establish whether the license application included adequate information identifying the applicant, the applicants characteristics, and the proposed activities. The NRC staff also reviewed the information in NISTs LRA against the regulatory requirements in 10 CFR Part 33, Specific Domestic Licenses of Broad Scope for Byproduct Material, and associated guidance presented in section 8, Contents of an Application, of NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope, Final Report, Revision 1 (ML17059D332), to establish whether the license application included adequate information to determine NISTs compliance with the requirements in 10 CFR 33.13, Requirements for the Issuance of a Type A Specific License of Broad Scope.

2.2 Staff Review and Analysis 2.2.1 Applicants Name and Contact Information In section 1, General Information, of its LRA, in accordance with the requirements in 10 CFR 70.22(a)(1), NIST provided its full name and address as follows:

National Institute of Standards and Technology 100 Bureau Drive, Mail Stop 1731 Gaithersburg, MD 20899-1731 Tel: 301-975-5022 NIST is a part of the U.S. Department of Commerce, a federal agency. The Radiation Safety Officer (RSO) is NISTs contact for all inquiries about its NRC regulated activities and programs.

2.2.2 Location and Address of Material Use In accordance with the requirements in 10 CFR 70.22(a)(1) and 70.22(a)(2), in section 1.1, Location and Address of Material Use, of its LRA, NIST provided the address of its main office and the locations where the NRC-regulated materials will be used and stored, respectively. The address at which the materials will be used is the NIST campus at 100 Bureau Drive, Gaithersburg, Maryland 20899.

4 2.2.3 Activities for which the Material is Requested In accordance with the requirements in 10 CFR 70.23(a)(1) and 10 CFR 70.22(a)(2), in section 1.2, Activities for which the Material Is Requested, of its LRA, NIST discusses the activities for which RAM will be used.

NIST stated that its primary mission is as a measurement science, standards, and technology laboratory. NISTs SNM-362 license authorizes the use of radiation sources for research and development, calibration and testing, and training activities. Authorized uses are primarily activities associated with the development and maintenance of radiation measurement standards, radioactivity assessment, the provision of radiation measurement services, and the study of radiation interactions and processes in materials.

NIST also owns an irradiator, a Hopewell Designs G150. NISTs irradiator activities are regulated under 10 CFR Part 36, Licenses and Radiation Safety Requirements for Irradiators.

Activities conducted with the irradiator include irradiation of devices and dosimeters for the development and maintenance of radiation measurement standards, and for radiation measurement services.

In its LRA, NIST further stated that there shall be no authorizations for intentional administration of radiopharmaceuticals or intentional direct exposures of human or live animal subjects.

2.2.4 Period of time for the license In accordance with the requirements in 10 CFR 70.22(a)(3), in section 1.3, Period of Time for which the License Is Requested, of its LRA, NIST requested that its SNM-362 license be renewed for a period of 10 years.

2.2.5 Radioactive Material for which the License is Requested In accordance with 10 CFR 70.22(a)(4), in Enclosure 4, Radioactive Material for which the License is Requested, of its LRA, NIST identifies the forms, quantities, and specifications of the RAM it requests authorization to possess and use as follows:

6. Byproduct, Source and/or Special Nuclear Material

7. Chemical and/or Physical Form

8. Maximum that Licensee May Possess at Any One time under this License A

Uranium enriched to less than 20 wt% in the U-235 isotope Any form except UF6 B

Uranium enriched to or greater than 20 wt% in the U-235 isotope Any form except UF6 C

Uranium-233 Any form except UF6

1. Any soluble form except UF6 D

Natural uranium

2. Any insoluble form except UF6 E

Uranium Depleted in U-235 (Primarily U-238)

1. Any soluble form except UF6 Security-Related Information - Withheld Under 10 CFR 2.390

5

2. Any insoluble form except UF6 Any separated Uranium isotope other than U-233, U-235, or U 238

1. Any form except UF6 F

U-232

2. Any form except UF6 G

Uranium As UF6 H

Any Isotope of Plutonium, except Pu-238 Any form H.1 Pu-236 H.2 Pu-239 H.3 Pu-240 H.4 Pu-241 H.5 Pu-242 H.6 Pu-244 I

Plutonium Sealed sources (e.g., PuBe)

J Plutonium enriched to more than 80% in the Pu-238 isotope Any form K

Th-228 Any form L

Th-229 Any form M

Th-230 Any form N

Th-232 Any form O

Natural Thorium Any form P

Any Thorium other than Th-228, Th-229, Th-230, or Th-232 Any form Q

Radium Any form R

Radium Sealed sources (includes RaBe sources)

S Co-60 Sealed sources (e.g.,

irradiators)

T Cs-137 Sealed sources (e.g.,

irradiators)

U Po-210 Sealed sources V

Am-241 Sealed sources (e.g., AmBe)

W Cf-252 Sealed sources X

Sr-90 Sealed sources Y

Pm-147 Sealed Sources Z

I-125 Sources sealed in titanium or stainless steel Byproduct material Any nuclide of half-life less than 30 days except for the following nuclides:

Au-198 Any form Mo-99, Tc-99m, and Xe-133 Rn-220, Rn-222 AA I-120m Security-Related Information - Withheld Under 10 CFR 2.390

6 Pa-230 I-124, I-126 Gd-149 Any nuclide of half-life more than 30 days except for the following nuclides:

H-3 Kr-85 Cs-137 C-14, Co-60 In-115 I-129 Pb-210 Ac-227 Am-241 Am-242m, Am-243 Bk-247, Es-254 Cf-248, 249, 250, 251, 252, and 254 Cm-242, 243, 244, 245, 246, 247, and 248 Np-236, Np-237 Sm-146, Sm-147 Gd-152, Pa-231, Cm-250 Any byproduct material with Atomic Number 3 to 83 except for the following nuclides:

Any form-Neutron activated materials (e.g., research sample or sample container)

I-129, Sm-146, Bi-210m BB Si-32, Ti-44, Fe-60, Sr-90, Ru-

106, Cd-113, In-115, I-120, I-120m, I-121, I-123, I-132, I-132m, I-

133, I-135, La-138, Ce-144, Sm-147, Gd-148, Gd-152, Hf-172, Lu-176, Hg-194, Pb-210, and Pb-212 CC Irradiated Fuel U-235 Pellets DD Cm-244, Cm-248 Sealed Sources Security-Related Information - Withheld Under 10 CFR 2.390 2.2.6 Facility Description and Process Overview In accordance with the requirements in 10 CFR 70.23(a)(3), an application for a license will be approved if the Commission determines that the applicants proposed equipment and facilities are adequate to protect health and minimize danger to life or property. In accordance with the requirements in 10 CFR 70.22(a)(7), in section 2.3, Facilities and Equipment, of its LRA, NIST describes the equipment and facilities it will use for protecting health and safety, minimize danger to life or property, and protecting the environment.

7 2.2.6.1 Facilities The regulations in 10 CFR 70.22(a)(7) require that each application for a license shall contain a description of the facilities that will be used by the applicant to protect health and minimize danger to life or property (such as handling devices, working areas, shields, measuring and monitoring instruments, devices for the disposal of radioactive effluents and wastes, storage facilities, criticality accident alarm systems, etc.).

The NIST campus is located in Gaithersburg, Montgomery County, MD, about 25 miles northwest of Washington, DC. The site is bordered to the east by Interstate 270 and Muddy Branch Road, to the north by Clopper Road, and to the west by Quince Orchard Road. The site is fenced and encompasses 578 acres on which there are 52 structures and facilities, including 23 laboratory buildings. The primary RAM laboratories, where of much of NISTs NRC-regulated activities and operations are conducted and where radioactive materials are stored, are in Building 245 (Radiation Physics). The majority of NISTs operations and activities involving the use of licensed materials include:

the panoramic beam and self-shielded irradiators; facilities containing primary beta/gamma standard sources for instrument and secondary source cross calibrations; californium and other neutron sources; instrument calibration facilities; radiochemistry laboratories for standard source production; and charged particle accelerators.

NIST further stated that its facilities and equipment meet two main objectives: 1) keep radioactive sources physically secured; and 2) ensure safe use of RAM. The equipment and procedures are intended to minimize, to the extent practicable, contamination of the facility and the environment; facilitate eventual decommissioning; and minimize, to the extent practicable, the generation of radioactive waste. NIST staff actively participate in the planning and design of new facilities and in the review of facilities/laboratories proposed for use in performing licensed activities. For selection of facilities, NIST staff considers the minimization of potential doses to co-located workers who are not involved with radiological work. Facility layout is integral to efficient operations and an effective ALARA program.

Other buildings within the NIST campus, including buildings 215, 217, 227, and 235, also house radiation facilities and/or laboratories. All of these facilities have been approved for RAM activities by NIST management and the Ionizing Radiation Safety Committee (IRSC). A map of NISTs campus depicting its buildings and surrounding areas can be found at https://www.nist.gov/image/astmmappng.

In Enclosure 7, Fire Safety Facility Schematics (ML24071A184 - Non-Public) of its LRA, NIST provided detailed diagrams and specific information on the construction of, and layouts of Building 245 where the majority of NISTs radiochemistry activities and operations are conducted. Each specific area where regulated activities are conducted are identified within the diagrams.

2.2.6.2 Process overview In section 1.2, Activities for which the Material Is Requested, of its LRA, NIST discusses the

8 operations and activities conducted under the SNM-362 license. These operations and activities include the following:

research and development; calibration and testing of devices; training activities; development and maintenance of radiation measurement standards; radioactivity assessments; provision of radiation measurement services; and study of radiation interactions and processes in materials.

In section 2.4, Commitment to Written Procedures, of its LRA, NIST stated that these activities are approved by the RSO or its designated alternate through radiation work permits that define the authorized activities, including the level of approval required, information requirements, period of validity, expiration and termination times, and recordkeeping requirements.

2.2.7 Organization and Administration In accordance with the requirements in 10 CFR 70.22(a)(6), in section 1.6, Organization and Administration, of its LRA, NIST discusses the members of the radiation protection program (RPP) managers and technical staff that would be involved in the conduct of the licensed activities. NIST also included a description of positions, their roles and responsibilities, technical qualifications, and experience in radiation safety. The organization includes the NIST Director, the IRSC, the Chief Safety Officer (CSO), and the RSO. The Executive Director, the IRSC, and the RSO are the main individuals responsible for NISTs RSP.

2.2.7.1 NIST Executive Director Section 1.6.1, Executive Management, of NISTs LRA discusses the NISTs Director position.

The Director is the RPPs Executive Manager and has the ultimate responsibility for ensuring the establishment and maintenance the ionizing radiation safety program at NIST and provides executive leadership on issues involving compliance with regulatory requirements and the conditions of the license. See section 3.2.1.1, NIST Director, of this report for additional information on the NIST Director.

2.2.7.2 Chief Safety Officer In section 1.6.2, NIST CSO, of its LRA, NIST discusses the responsibilities for the CSO. The CSO is responsible for developing, implementing, and maintaining a robust, integrated, and risk-based safety, health, and environmental (SH&E) management system and developing strategies to improve the agencys safety performance and maintain a positive safety culture.

Section 3.2.1.2, Chief Safety Officer, of this report discusses the CSO qualifications and additional responsibilities.

2.2.7.3 Ionizing Radiation Safety Committee Section 1.6.3.2, IRSC Membership and Organization, of NISTs LRA discusses the committees membership, which, as appointed by the NIST Director, consists of a minimum of five members, with the following voting ex officio members: 1) the CSO (Executive Management representative on the IRSC); 2) the Director of NISTs Center for Neutron Research; 3) NISTs

9 Chief, Radiation Physics Division, Physical Measurement Laboratory; and 4) NISTs RSO. NIST also stated that the IRSC meets the requirements of 10 CFR 33.13(c)(1) which requires that the IRSC members be trained and experienced in the safe use of radioactive materials. The IRSC members with full voting rights must be NIST employees. The Director of NIST appoints the IRSC Chair and Vice Chair (for indefinite terms at their discretion). Section 3.2.1.3, Ionizing Radiation Safety Committee, of this report discusses the IRSC members qualifications and responsibilities.

2.2.7.4 Radiation Safety Officer The RSO, is an ex-officio member of the IRSC. The NRC staff evaluated the current RSO qualifications back in May 2017 (see ML17109A118 and ML17109A121) and found, in accordance with the requirements in 10 CFR 33.13(c)(2), that NIST had appointed an RSO with extensive experience, education, and training in the radiation field and with the necessary qualifications and resources to oversee the safe operation of NISTs NRC-licensed program activities.

In its LRA, NIST stated that the RSO, in coordination with NISTs executive management and the IRSC, serves as NISTs SNM-362 license manager and point of contact with the NRC. The RSO has overall responsibility for managing the radiation safety program and all aspects of the utilization of ionizing radiation sources. The RSO, or their designee, has the authority, as delegated by the NIST Director, necessary to meet their responsibilities and to immediately stop any operations that may compromise the health or safety of NIST employees and non-NIST personnel, have an adverse impact on the environment or public, or that result in non-compliance with the NRC, State, or local requirements. Enclosure 5 of NISTs LRA provided a copy of the delegation of authority memorandum for the RSO. See section 3.2.2, Radiation Safety Officer, of this report for additional discussion on the RSO qualifications and responsibilities).

2.2.7.5 Additional staff responsible for radiation safety NIST also lists source custodians and users as part of the staff responsible for the safe use of radioactive materials. Information and qualifications of this staff are discussed in more detail in section 3.2.3, Authorized Source Custodians/Users, of this report.

2.3 Evaluation Findings

Based on its review, in accordance with section 1.1-1.7 of draft NUREG-2212, for the general information provided by NIST in its LRA, the NRC staff finds that NIST:

provided its full name and contact information for the application, in accordance with the requirements in 10 CFR 70.22(a)(1);

provided the location of the principal office and information on its principal officers in accordance with the requirements in 10 CFR 70.22(a)(1);

adequately described the activities for which authorization for possession and use of RAM is requested, in accordance with the requirements in 10 CFR 70.22(a)(2);

provided the address and location where SNM activities will be conducted, and its general plan for conducting the regulated activities, in accordance with the requirements in 10 CFR 70.22(a)(2);

specified the period of time for which the SNM-362 license is requested, in accordance

10 with the requirements in 10 CFR 70.22(a)(3);

provided the names, amounts, and specifications of the RAM it proposes to possess and use, in accordance with the requirements in 10 CFR 70.22(a)(4);

described the facilities to be used to protect health and minimize danger to life or property, in accordance with the requirements in 10 CFR 70.22(a)(7);

provided all information regarding the positions and qualifications of the principal officers and radiological safety staff in its RPP organization, in accordance with the requirements in 10 CFR 70.22(a)(6);

has established a radiation safety committee composed of such persons as a representative of management, the radiation safety officer, and persons trained and experienced in the safe use of radioactive materials, in accordance with the requirements in 10 CFR 33.13(c)(1); and has appointed an RSO who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters, in accordance with the requirements in 10 CFR 33.13(c)(2).

Therefore, the NRC staff finds that the information provided by NIST in its LRA and supplements adequately:

stated the full name, address, location of the principal office, and the names of its principal officers in accordance with the requirements in 10 CFR 70.22(a)(1);

discussed the activity for which the SNM is requested, the place at which the activity is to be performed and the general plan for carrying out the activity in accordance with the requirements in 10 CFR 70.22(a)(2);

specified the period of time for which the license is requested in accordance with the requirements in 10 CFR 70.22(a)(3);

stated the name, amount, and specifications (including the chemical and physical form and, where applicable, isotopic content) of the SNM it proposes to use in accordance with the requirements in 10 CFR 70.22(a)(4);

discussed its staffs technical qualifications, training and experience to engage in the proposed activities in accordance with the requirements in 10 CFR 70.22(a)(6); and described the equipment and facilities to be used to protect health and minimize danger to life or property (such as handling devices, working areas, shields, measuring and monitoring instruments, devices for the disposal of radioactive effluents and wastes, storage facilities, criticality accident alarm systems, etc.) in accordance with the requirements in 10 CFR 70.22(a)(7).

The NRC staff also finds that:

in accordance with the requirements in 10 CFR 70.23(a)(1), NIST will use SNM o

for research or development activities of a type specified in section 31 of the Act, in activities licensed by the Commission under section 103 or 104 of the Act, or o

for such other uses as the Commission determines to be appropriate to carry out the purposes of the Act; NIST is qualified by reason of training and experience to use the material for the purpose requested in accordance with the regulations in 70.23(a)(2);

NISTs proposed equipment and facilities are adequate to protect public health and minimize danger to life or property in accordance with the requirement in 10 CFR 70.23(a)(3);

11 NISTs proposed procedures to protect health and to minimize danger to life or property are adequate and in accordance with the requirement sin 10 CFR 70.23(a)(4);

in accordance with the requirements in 10 CFR 33.13(c)(1), NIST has established a radiation safety committee composed of representatives from NIST management, the RSO, and other individuals trained and experienced in the safe use of radioactive materials; and in accordance with the requirements in 10 CFR 33.13(c)(2), NIST has appointed an RSO that is qualified by training and experience in radiation protection.

3.0 RADIATION PROTECTION 3.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the U.S. Department of Commerce, National Institute of Standards and Technology (NIST) license renewal application (LRA) against the applicable requirements in 10 CFR and associated guidance presented in section 2, Radiation Protection, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087), to determine if the information provided by NIST discussing its RPP meets applicable requirements. The NRC staff also reviewed the information to determine whether there is reasonable assurance that NISTs RPP, as described in the LRA, is adequate to protect workers, the public, and the environment from the radiological hazards of radioactive materials.

3.1.1 Regulatory Requirements The following 10 CFR regulatory requirements are applicable to the review of NISTs RPP:

Part 19, Notices, Instructions and Reports to Workers: Inspection and Investigations; Part 20, Standards for Protection Against Radiation; Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material; Part 33, Specific Domestic Licenses of Broad Scope for Byproduct Material; Part 36, Licenses and Radiation Safety Requirements for Irradiators; Part 70, Domestic Licensing of Special Nuclear Material; and Part 74, Material Control and Accounting for Special Nuclear Material, Subpart B, General Reporting and Recordkeeping Requirements.

3.1.2 Regulatory Guidance The NRC staff used the following regulatory guidance to evaluate NISTs RPP:

NUREG-1556 Volume 11, Revision 1, Program-Specific Guidance about Licenses of Broad Scope; NUREG-1556 Volume 12, Revision 1, Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution; NUREG-1556 Volume 6, Revision 1, Program-Specific Guidance about 10 CFR 36 Irradiator Licenses; and Draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70

12 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H - Draft Report for Comment.

3.2 Staff Review and Analysis An application for a license must describe an applicants RPP pursuant to the requirements in 10 CFR 20.1101, Radiation protection programs, addressing the following:

description of the organization; commitment to maintain occupational exposures to radiation ALARA; written radiation protection procedures and radiation work permits; description of the operating and emergency procedures that include the following provisions:

instructions to keep radiation doses to workers and members of public ALARA, instructions for maintaining security during storage and transportation, instructions to maintain accountability during use, use of personnel monitoring and radiation survey equipment, instructions for packaging and transporting licensed material, instructions on whom to contact when an emergency occurs, and procedures for safe transportation of licensed material.

The regulations in 10 CFR 70.22(a)(6) require that each application for a license shall contain the technical qualifications, including training and experience of the applicant and members of its staff, to engage in the proposed activities.

3.2.1 Organizational Management and Personnel Qualifications Section 2.1, Organizational Management, of NISTs LRA provides a description of the organizational management structure of NISTs RPP. The management structure includes the NIST Director, the CSO, and the IRSC. Section 2.1, Organization and Personnel Qualifications, of NISTs LRA discusses the responsibilities of the key managers as follows:

3.2.1.1 NIST Director Section 1.6.1, Executive Management, of the NIST LRA discusses the Directors position and responsibilities. NIST, however, did not specify the technical qualifications required for the position.

Based on the information provided by NIST, the position is administrative in nature. The NRC regulations do not require administrative positions to possess background education or training in radiation safety. However, the NRC regulations do require that...a licensee's management shall appoint an RSO who agrees, in writing, to be responsible for implementing the radiation protection program [e.g., 10 CFR 35.24(b)] - see discussion on the RSO qualifications in section 3.2.2 below. Since the director of NIST is merely an administrative position, a description of the positions responsibilities is all what is needed in the LRA.

In the LRA, NIST stated that Director serves as the Under Secretary of Commerce for Standards and Technology and reports to the Secretary of Commerce. The Director has ultimate responsibility for ensuring the establishment and maintenance of the ionizing radiation safety program at NIST and provides executive leadership on issues involving compliance with regulatory requirements and the conditions of the license. Section 1.6.1 of NISTs LRA

13 discusses the Directors responsibilities which include the following:

ensuring the establishment and maintenance of an effective ionizing radiation safety program; appointment of the IRSC Chair and Vice Chair for indefinite terms at their discretion and selection of its members and their designated alternates; providing direction to CSO and IRSC as needed; leadership on issues concerning the Gaithersburg site, safety of workers, regulatory compliance, and environmental impacts; and review the IRSC recommendations and actions on these recommendations to guarantee safety and compliance with regulations.

3.2.1.2 Chief Safety Officer In its LRA, NIST did not provide the qualifications for the CSO. However, the NRC staff found, in NISTs website1, that the current CSO holds a Bachelor of Science (B.S.) degree in Chemistry, and a PhD in Nuclear Chemistry (information also confirmed by NISTs RSO). The CSO reports directly to the NIST Director.

The current CSO has held other positions related to safety at NIST, including Chair of NISTs Safety Advisory Committee and Chair of NISTs Executive Safety Committee. In these positions, the CSO has led NISTs research for developing and improving radiochemical analysis methods, development of operational policies, procedures and guidance on safety program development and improvements, conduct strategic planning, being the head of technical operations teams, and budget management. The NRC staff contacted NIST to verify this information and NIST confirmed that the information was accurate and up to date.

In section 1.6.2, NIST CSO, of its LRA, NIST lists the CSOs main responsibilities as follows:

serves as a representative of executive management on the IRSC; supervising the establishment of radiation protection at NIST in support of the SNM-362 license; submitting the licensee amendment and renewal of SNM-362; annually auditing the SNM-362 licensed program.

Based on the review of the CSO qualifications and NISTs description of the CSO responsibilities, as discussed above, the NRC staff determined that the individual currently in this position possesses extensive experience, education, and training in the radiation field adequately to oversee the safe operation of NISTs NRC-licensed program activities.

3.2.1.3 Ionizing Radiation Safety Committee Section 1.6.3.2, IRSC Membership and Organization, of NISTs LRA discusses the IRSC membership and qualifications. The IRSC shall be comprised of a minimum of five (5) appointed members (all NIST employees) or their designated alternates and four (4) positions voting ex officio members including: a) the CSO; b) the Director, NCNR; c) the Chief, Radiation Physics Division, Physical Measurement Laboratory; and 4) the RSO. Members of the IRSC shall have, at a minimum, a Bachelor of Science degree or equivalent professional training in their respective fields of expertise, and at least two years of relevant experience.

1https://www.nist.gov/people/lizmackey#:~:text=Elizabeth%20%E2%80%9CLiz%E2%80%9D%20Mackey%20is%20t he,Institute%20of%20Standards%20and%20Technology

14 Section 1.6.3.1, Duties and Responsibilities, of NISTs LRA discusses the responsibilities and duties of the IRSC. The IRSC is responsible for the oversight of the operation and activities of the NIST radiation program except for those activities conducted under the NRC test reactor license number 5 (TR-5). The IRSC duties include the following:

reviewing and approving (or rejecting) procedures (or changes to the procedures) for the use of radioactive materials to ensure workers, the public, and the environment are adequately protected from these materials hazards; ensuring that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public; providing independent advice and oversight on ionizing radiation safety to the NIST director and RSO at the NIST Gaithersburg, MD, facility; approving or rejecting source custodians and source users; approving or rejecting requests for the use of radioactive materials (RAM) specified in safety evaluation that include safe use protocols, emergency response, list of approved source users and/or custodians, and use and storage locations (i.e., radiation facilities);

reviewing and approving or rejecting proposed changes to the SNM-362 license amendments; and reviewing, approving, and recording safety evaluations of all proposed new uses of byproduct material prior to their use in accordance with 10 CFR 33.13(c).

In section 1.6.3.3, Licensing Flexibility, of its LRA, NIST stated that the RSO, together with the IRSC, may approve or reject proposed program changes and revisions to procedures previously approved by the NRC without amendment of the license provided that the changes are in accordance with regulatory requirements, will not change license conditions, will not decrease the effectiveness of the program and are documented. Documentation of the changes shall state the reason for the change and summarize the radiation safety matters that were considered prior to the changes approval. Major program and procedural changes proposed pursuant to this flexibility shall be reviewed and approved by the IRSC. The IRSC shall review and approve any major program and procedural changes proposed under license flexibility and will audit operations to verify adequacy of implementation and to audit compliance. The IRSC shall also ensure that appropriate actions are taken when noncompliance is identified, including analysis of the cause(s), and development and implementation of corrective actions to prevent recurrence.

3.2.2 Radiation Safety Officer In accordance with the requirements in 10 CFR 70.22(a)(6), in section 2.1.2, Radiation Safety Officer, of its LRA, NIST discusses the qualifications and training of the RSO. The required qualifications for this individual are the following:

at a minimum, a college degree at the bachelor level or equivalent training and experience in physical, chemical, biological sciences, or engineering; education, training and extensive experience in the radiations field; training and experience sufficient to identify and control anticipated radiation hazards associated with the use, in research and development, of RAM authorized on the license; and experience in applying knowledge of the regulatory requirements applicable to licensed activities.

The RSO reports directly to the NIST Director. The RSO qualifications were previously

15 evaluated (and approved) by the NRC during its review of NISTs May 12, 2017, license amendment request (LAR, Amendment 8 of the SNM-362 NRC license - ML17109A118), and again during the review of NISTs LAR for the commissioning of the new Part 36 Irradiator Facility (SNM-362 Amendment 11 - ML21126A113) - see also section 2.2.7.4, Radiation Safety Officer, of this document for additional discussion on NISTs RSO.

The RSO shall, in coordination with executive management and the IRSC, serve as the SNM-362 license manager and as the point of contact with the NRC. The RSO is responsible for managing the RPP and all aspects of the utilization of ionizing radiation sources. Enclosure 5 of NISTs LRA provides a copy of a letter dated April 27, 2022, signed by the NIST Director delegating to the RSO authority necessary to meet NISTs responsibilities. The letter also delegates authority to the RSO to immediately stop any operations that may compromise the health or safety of NIST employees and non-NIST personnel that have an adverse impact on the environment or public; or that may result in noncompliance with Federal (NRC), State, or local requirements. Other RSO responsibilities include the following:

establishing and maintaining an effective radiation safety program that allows for the safe and regulatorily compliant use of ionizing radiation sources in a manner that conforms with ALARA principles and applicable Federal, State, and local regulations and NIST policy; establishing and maintaining a system for hazard analysis, mitigation planning, and emergency response planning integrated into ionizing radiation source use protocols and Radiation Facility authorizations; performing, or designating a member of NISTs Radiation Safety Division (RSD) to perform, hazard assessments on requests for the acquisition and use, or for changes in use, of RAM; transmitting requests that present a significant level of risk, e.g., a potential for adverse safety and health or regulatory compliance issues to the IRSC for review; providing advice and assistance on radiological safety matters to individuals whose assigned duties involve the use of or exposure to ionizing radiation sources and working closely with the IRSC and NIST executive management in implementing the radiation safety program; identifying radiation safety issues and initiating, recommending, providing, and verifying implementation of corrective actions; assisting the IRSC in the performance of its duties, including providing timely information to the IRSC on issues and incidents with potentially significant adverse impact on radiation safety or regulatory compliance; documenting and reporting metrics indicating the status of the radiation safety program to the IRSC, NIST management, and regulators as required; establishing and updating guidance, procedures, instructions, and other requirements to promote radiation safety and regulatory compliance; maintaining records of source acquisition, utilization, transfers, and disposal; maintaining written records documenting IRSC activities; and developing and implementing a program for the protection of RAM.

In section 1.6.3.3, Licensing Flexibility, of its LRA, NIST further stated that the RSO together with the IRSC may approve or reject proposed program changes and revisions to procedures without the need to amend the SNM-362 license in the areas listed below provided that the changes are in accordance with regulatory requirements, will not change license conditions, and will not decrease the effectiveness of the program:

16 Training Program for Individuals Working in or Frequenting Restricted Areas; Audit and Review of Program; Radiation Monitoring Instruments; Material Receipt and Accountability; Occupational Dose; Safe Use of Radionuclides and Emergency Procedures; and Surveys and Leak Tests.

3.2.3 Authorized Source Custodians/Users Authorized source custodians and users at NIST are individuals whose primary responsibility is to ensure that RAM is used safely and in accordance with regulatory requirements. NIST further stated that, pursuant to the requirements in 10 CFR 33.17, Conditions of specific licenses of broad scope, (b), licensed materials may only be used by, or under the direct supervision of these individuals.

Section 2.1.3, Authorized Users, of NISTs LRA, discusses the qualifications for these individuals, in accordance with the requirements in 10 CFR 70.22(a)(6). According to NIST, these individuals must receive instruction commensurate with their duties and responsibilities, which are discussed below. Section 3.2.4.2, Authorized source custodians/users and ancillary workers training, of this report discusses the specific training requirements for these individuals.

Source custodians These individuals are responsible for the primary control and accountability of RAM. Their main responsibilities include the following:

coordinating any transfers of custodianship, changes in utilization, shipments of radiation sources to offsite entities, or disposal of waste; maintaining source inventory records of utilization, transfer, and disposal; and performing physical inventory verifications and reconciling documentary records as necessary.

Source users These individuals, as approved by the IRSC, are responsible for materially controlling, using, or otherwise, manipulating RAM. Their responsibilities include using only RAM for which they are approved according to NISTs current utilization approvals.

17 3.2.4 Radiation safety training 3.2.4.1 Radiation Safety Officer training2 By letter dated March 31, 2017, NIST submitted a request for NRCs approval of the current individual as the RSO for their facility (ML17095A956). The submittal listed the qualifications and training that the RSO must have, which include training and experience equivalent to a degree at the bachelor level or a combination of education and experience that includes, at least, 30 semester hours in health physics, engineering, radiological science, chemistry, physics, biology, mathematics, and /or calculus.

NISTs current RSO met these requirements by completing the following education and training:

Associate Degree in Science, Nuclear Engineering Technology, Three Rivers Community College, May 2005; Radiological Health Physics Courses (23 credits), University of Massachusetts at Lowell, 2005-2006; 40-hour RSO Training for Lab Safety Professionals, Harvard University 2006; Management courses, Harvard University 2008-2010; 40-hour ORAU Occupational Internal Dosimetry-June 2012; 40-hour ORAU Air Sampling for Radioactive Materials - November 2012; 40-hour ORAU MARSSIM Training-June 2014; 24-hour NMMSS Training - December 2014; 40-hour ORAU Gamma Spectroscopy-June 2015; 5+ years of training and experience at NIST commensurate with the types, forms, and quantities of radioactive material authorized on the SNM-362 license; 5+ years of training and experience at NIST sufficient to identify and control anticipated radiation hazards associated with the use of radioactive material authorized on the SNM-362 license; and 5+ years of experience at NIST in applying knowledge of the regulatory requirements applicable to SNM-362 licensed activities.

In section 2.1.2 of the LRA, NIST further states that, when a decision is made regarding a change in RSO, NIST shall provide the following to the NRC:

A description of the training and experience for the proposed RSO that demonstrates that the individual is qualified to perform the duties required under the license; and An RSO Delegation of Authority signed by the licensees executive management.

3.2.4.2 Authorized source custodians/users and ancillary workers training In accordance with the requirements in 10 CFR 70.22(a)(6), in section 2.1.4, Radiation Safety Training, of its LRA, NIST describes the training requirements for the radioactive sources custodians/users and ancillary workers (i.e., individuals which are likely to receive more than 100 millirem (mrem) of occupational exposures in a year). NIST states that training shall be done in accordance with 10 CFR 19.12, Instruction to workers, and that it shall be 2 In May 2017 the NRC staff evaluated the current RSO qualifications (ML17095A956) and found, in accordance with the requirements in 10 CFR 33.13(c)(2), that the individual possessed extensive experience, education, and training in the radiation field and with the necessary qualifications to oversee the safe operation of NISTs NRC-licensed program (see ML17109A118 and ML17109A121)

18 commensurate with their duties, responsibilities, and access to sources of ionizing radiation prior to receiving approval to work independently with RAM or any other sources of ionizing radiation. NIST further states that training requirements3 for radiation workers shall include the topics listed below and shall be commensurate with the potential radiological health protection issues associated with the specific workplaces and duties:

types of ionizing radiation sources and emissions; biological risks associated with exposure to RAM or sources of ionizing radiation; ALARA principles, tools, and practices to minimize exposure, including time, distance, shielding, and contamination control; purposes, functions, and uses of protective devices, including engineered facilities and equipment (e.g., ventilation controls, shielding, interlocks, area radiation monitors, personnel contamination monitors), and personal protective equipment; basic radiation and contamination monitoring equipment and practices; procedures and requirements for control, security, storage, transfer, disposal, and use of RAM at their workplaces; agency and other rules and regulations and conditions of licenses, and responsibilities for observing and complying with these to the extent under the workers control; duties and responsibilities of management (e.g., Group Leaders and Division Chiefs),

Source Custodians, Source Users, and RSD staff; requirements for reporting to supervisors and the RSO any condition that may lead to or cause a violation of the rules, regulations, or conditions of licenses or an unnecessary exposure to radiation or RAM; reporting rights and responsibilities per 10 CFR 19-NRC Form 3: Notice to Employees; appropriate responses to warnings given in the event of any unusual occurrence or malfunction that may result in or involve excessive radiation or RAM exposure; fire and other non-radiological safety and emergency response procedures, including emergency reporting, egress, and personnel accountability; principles and practices of personnel dosimetry, including the availability of radiation exposure reports; and hands-on use of RAM.

Prior work experience and training in radiological safety can be substituted for parts of the fundamental physics aspects of the training described above. Evaluation of an individuals radiological safety knowledge shall be by methods such as direct testing, performance observations, personal interviews, prior work experience, and dosimetry reviews. The RSD shall maintain documentation of the training program records. All individuals authorized to work independently with licensed RAM shall receive refresher training biennially. Irradiator workers receive facility specific annual refresher training.

3 Appendix A of NIST internal procedure number 1-4B, Source User, Source Custodian, and Supervised User Training and Approval, discusses the topics to be discussed in the initial radiation safety training. In addition to those listed here, the list includes the following additional topics: 1) radiological fundamentals (i.e., atomic structure, definitions and units of radiation measurements and quantities, basic types of ionizing radiation); 2) sources of radiation; 3) acute and chronic doses; 3) prenatal radiation exposures and declared pregnant worker dose limits; 4) radiation risks, 5) security and control of radioactive materials; 6) radioactive waste control and minimization; 7) external and internal dosimetry; 8) contamination control; 9) emergency response; 10) decontamination procedures. Other topics are included as appropriate and commensurate with the workers responsibilities.

19 3.2.4.3 Transportation training In section 2.1.4.1, Transportation Training, of its LRA, NIST states that all individuals whose normal duties may include packaging, labeling, and manifests of sources for shipment regulated by U.S. Department of Transportation shall receive appropriate biennial training. Training materials for these individuals are developed in accordance with the requirements in 49 CFR Parts 171-173, and 10 CFR Parts 20, 71, and 73.

3.2.4.4 Security Training Section 2.1.4.2, Security Training, of NISTs LRA discusses the training requirements for individuals who need unescorted access to category 1 and 2 materials or SNM of Low Strategic Significance (LSS), access to security related information, individuals who are program implementers, the Police Services Group (PSG) and Dispatchers, and Reviewing Officials for maintaining compliance with the requirements in 10 CFR 37.43, General security program requirements, (c), Training, and 10 CFR Part 73.

The content and scope of the training reflects the duties and responsibilities of the trainees.

Refresher training to these individuals is provided, at least, annually or earlier if significant changes have been made to the security program. The training for the protection of RAM covers the requirements of 10 CFR Parts 20, 37, and 73. Training content varies based upon the job requirements of the audience and shall include, but is not limited to, the following:

Federal and NIST security requirements; NISTs security procedures and SNM-362 NRC license Security Plan to secure RAM Security Zones and the general purposes and functions of the security measures employed; responsibility to report promptly to the RSO, their line management and security any condition that causes or may cause a violation of NRC requirements or security policies (e.g., escorting);

responsibility to report promptly to Office of Security, PSG, any actual or attempted theft, sabotage, or diversion of category 1 or category 2 quantities of RAM or SNM-LSS, or suspicious activities; incident and emergency response procedures for RAM Security Zones including, but not limited to, the appropriate response to security alarms; and NIST initial 10 CFR Part 37 Information Protection Training.

3.2.5 Radiation Protection Program The RPP is the means by which a licensee meets the NRC radiation protection requirements in 10 CFR. The RPP must address the occupational radiation protection measures in 10 CFR Parts 19, 20, and 70. The intent of a satisfactory RPP is to safely control the receipt, possession, use, transfer, and disposal of licensed material such that the total dose to an individual does not exceed the standards for protection against radiation prescribed in the regulations. Specifically, licensees must develop, document, and conduct an RPP in accordance with 10 CFR 20.1101.

20 3.2.6 As Low As Reasonably Achievable (ALARA) Program In section 2.2.1, ALARA Program, of its LRA, NIST discusses its commitment to maintain doses ALARA. NIST stated that it is its policy to maintain an RPP that ensures that exposures to workers from radiological activities are kept ALARA, commensurate with the beneficial application of ionizing radiation technologies. NIST also stated that it has established procedures, engineering, and administrative controls to adequately use radioactive materials and achieve occupational doses and maintain doses to the members of the public ALARA, in accordance with the requirements in 10 CFR 20.1101, Radiation protection programs, (b) and 10 CFR 33.13(c)(3). In addition, in section 1.6.3.2, IRSC Membership and Organization, NIST stated that the IRSC is responsible for assessing and authorizing new users of radioactive materials in accordance with the requirements in 10 CFR 33.13(c)(3)(ii), and for reviewing, approving, and recording safety evaluations of all proposed new uses of byproduct material prior to its use in accordance with the requirements in 10 CFR 33.13(c)(3)(iii).

NIST further stated that all radiological activities conducted under the SNM-362 license undergo assessment by the RSD staff to evaluate key ALARA concepts such as time, distance, and shielding to ensure that occupational doses and doses to members of the public are kept both below regulatory limits and ALARA and consistent with NRC regulatory requirements.

In section 2.2.4, Minimization of Contamination, of its LRA, NIST stated that its ALARA program considers work processes and dose reduction features into these processes and its facilities as those are designed and/or commissioned. In laboratory areas where radiochemistry operations warrant it, there are personnel contamination monitors and continuous air monitors as well as a robust survey protection program. Areas of operations are confined to a minimal space, when practicable, and surveillance activities are maximized, including post-experiment checks by the source users, with weekly surveys conducted by RSD personnel. There is a dedicated decontamination room and waste retention tanks in Building 245, and the labs have ventilated enclosures (e.g., chemical fume hoods) to prevent spread of material and nonporous floor and bench materials.

NIST further stated that all individuals likely to exceed ten (10) percent of the applicable occupational exposure limits shall have their doses monitored and that dosimetry results shall be reviewed by the RSD as part of the ALARA program. NIST also stated that the IRSC monitors and reports ALARA status as part of the annual report to the NIST Director and that the RSO will have primary responsibility to ensure ALARA practices are incorporated into all safety evaluations.

In section 2.1.2, Radiation Safety Officer, of its LRA, NIST stated that the RSO has been delegated to authority to manage all aspects of the ALARA Program, including implementing the radiation safety program, and to approve or reject authorizations for the utilization of ionizing radiation sources. The RSO also has the necessary authority, as delegated by the NIST Director, to immediately stop any operations that may:

compromise the health or safety of NIST employees and non-NIST personnel; have an adverse impact on the environment or public; or result in non-compliance with NRC, State, or local requirements.

21 3.2.7 Occupational doses In section 2.2.2, Occupational Dose, of its LRA, NIST stated that it shall maintain documentation demonstrating that unmonitored individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502. Results exceeding 100 mrem in a year are reported to the monitored individual(s).

In section 2.2.2.1, External Dose Monitoring, of its LRA, NIST stated that the RSD shall comply with the requirements in 10 CFR 20.1502, Conditions requiring individual monitoring of external and internal occupational dose, (a). NIST further states that the RSD shall conduct a personnel external dosimetry program, using devices requiring processing and meeting quality assurance criteria as required by 10 CFR 20.1501, Subpart F, Surveys and Monitoring; personnel dosimetry from a provider that is accredited by the National Voluntary Laboratory Accreditation.

In section 2.2.2.2, Internal Dose Monitoring, of its LRA, NIST states that the RSD shall comply with the regulatory requirements in 10 CFR 20.1502, Conditions requiring individual monitoring of external and internal occupational dose, (b). NIST further states that analysis of significant positive bioassay results shall be used to assign values to the individuals dose of record and that any result greater than 10% of the regulatory limits shall be reviewed by RSD and the IRSC and reported to appropriate NIST management.

In section 2.2.2.3, Direct or Area Monitoring, NIST states that, in lieu of personnel monitoring, it also performs direct area monitoring, sampling, or source term analysis combined with occupancy, time and motion, or similar calculation-based methods to assign doses of record.

In section 2.2.2.4, Personnel Contamination Monitoring, of its LRA, NIST states that personnel contamination monitoring shall be performed as indicated in the hazard analysis associated with a source specific protocol and when exiting contamination control zones. NIST ensures that personnel contamination equipment is appropriate for all reasonably expected isotopes.

3.2.8 Public Doses In section 2.2.3, Public Dose, of its LRA, NIST discusses its commitment for ensuring that radiation doses to members of the public do not exceed NRC regulatory limits. NIST stated that it will use, transport, store, and dispose of licensed materials in a way that the total effective dose equivalent (TEDE) to any member of the public will not exceed more than 100 mrem in one year, and that the doses in any unrestricted area will not exceed two (2) mrem in any one hour. NIST further stated that the RSD shall comply with the requirements in 10 CFR 20.1301, Dose limits for individual members of the public, 10 CFR 20.1302, Compliance with dose limits for individual members of the public, and 20.2107, Records of dose to individual members of the public.

3.2.9 Minimization of contamination In section 2.2.4, Minimization of Contamination, of its LRA, NIST states that it considers work processes to minimize the spread of contamination and that, when practical, it incorporates appropriate dose reduction features into its processes and facilities to minimize contamination.

In addition, NIST stated that laboratory areas in buildings 245 and 235, where radiochemistry operations are conducted, there are personnel contamination monitors and continuous air

22 monitors as well as a robust survey protection program. NIST stated that the design and layout of the facilities with radiochemistry operations are intended to minimize the area of operations, when practicable, and that it also maximizes surveillance activities, including post-experiment checks by source users, and that RSD personnel conducts weekly surveys to ensure contamination is avoided, reduced to a minimum, or that contaminated areas are immediately taken care of. The area in building 245 also has a dedicated decontamination room and waste retention tanks. The labs have ventilated enclosures (e.g., chemical fume hoods) to prevent spread of material and nonporous floor and bench materials.

3.2.10 Ventilation and Respiratory Protection In section 2.2.5, Ventilation and Respiratory Protection, of its LRA, NIST discusses its ventilation and respiratory controls to adequately protect its workers, the public, and the environment from airborne radiation exposures.

In addition to radiation considerations, such as dose rate and contamination, NIST also evaluates ventilation controls where work with unsealed material might be conducted. In this respect, NIST also evaluates room and/or local ventilation, as well as air filtration, to determine if airborne exposures need to be limited, and primarily uses engineering controls to limit exposures as necessary. NIST further stated that most radiochemistry laboratories are equipped with chemical fume hoods or other forms of local exhaust ventilation. The hoods may be configured with High Efficiency Particulate Air filters when source term analysis or measurements indicate the need for filtration to ensure effluent control. Chemical fume hoods are monitored quarterly to ensure face velocities remain at a minimum of 80 linear feet/minute.

Hoods which fail to meet the required face velocity are taken out of service and operations suspended until corrective action is taken. In its LRA, NIST stated that its respiratory control commitments are in accordance with the requirements in 10 CFR 20.1701.

3.2.11 Waste management The NRC staff reviewed the information discussed in section 2.2.6, Waste Management, of the NISTs LRA against the applicable waste management regulatory requirements in 10 CFR Parts 20 and 70 and associated guidance and regulatory criteria presented in draft NUREG-2212, Standard Review Plan for Applications for Title 10 of the Code of Federal Regulations (10 CFR)

Part 70, Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H - Draft Report for Comment (ML22335A087), section 2.2.2.6, Waste Management, to determine whether the LRA adequately described NISTs radioactive waste management program and activities.

The applicable 10 CFR radioactive waste management regulatory requirements are:

10 CFR 20.2001 - requires a licensee to dispose of licensed material only by stated methods. Specifically, the regulations in 10 CFR 20.2001(a)(2) provide that licensees may dispose of licensed material by decay in storage; 10 CFR 20.2003 - provides that a licensee may discharge licensed material into sanitary sewerage when specific criteria are met; 10 CFR 20.2004 - allows, in part, treatment or disposal of radioactive wastes by incineration if the waste is in a form and concentration specified in 10 CFR 20.2005, or as specifically approved by the Commission; 10 CFR 20.2005 - provides for licensees to dispose of certain licensed materials as if

23 they were not radioactive; 10 CFR 20.2006 - describes the requirements for shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility; 10 CFR 20.2007 - provides that nothing in 10 CFR Part 20, Subpart K, Waste Disposal, relieves the licensee from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this subpart; 10 CFR 20.2008 - states that byproduct materials can dispose of at a facility authorized to do so, that byproduct materials being disposed must meet the requirements in 10 CFR 20.2006, and that disposal facilities must comply with any federal or state solid or hazardous waste laws, including the Solid Waste Disposal Act; and 10 CFR 70.22(a)(7) - requires, in part, that each application for a license shall provide a description of the equipment and facilities which will be used by the applicant to protect health and minimize danger to life or property, such as handling devices, working areas, shields, measuring and monitoring instruments and devices for the disposal of radioactive wastes.

In its LRA, NIST listed the methods it will use for disposing of radioactive materials. NIST indicated that, radioactive waste shall be disposed of in a manner that protects the health and safety of NIST staff, members of the public, and the environment by applying the ALARA policy both for the short-term handling phases and long-term storage or disposal phases of waste management.

NIST stated that radioactive waste is transferred to areas within either Building 235 or Building 245, where it is characterized and packaged for disposal. The primary radioactive waste streams are as follows:

dry active wastes including:

o gloves, wipes, paper, and miscellaneous containers and tools used during handling of licensed material or cleanup of contaminated objects; o

glassware, vials, dried filters, and other expendable chemistry equipment; o

components and equipment contaminated or activated during use; and o

activated sample materials or sample containers.

liquid wastes including:

o liquid scintillation materials; o

aqueous solutions of acids or bases used during chemistry processes; and o

water or cleaning liquids used during decontamination processes.

In its LRA, NIST stated that waste will be disposed of by any of the following: (1) decay in storage; (2) discharge into the sanitary sewer; or (3) transfer to either a licensed waste processing contractor or shipping directly to a licensed disposal site.

3.2.11.1 Disposal of radioactive waste by decay in storage In section 2.2.6.1., Decay-In-Storage, of its LRA, NIST stated that it may utilize decay in storage prior to disposal as provided in 10 CFR 20.2001(a)(2) and in accordance with the following conditions:

isotopes must have a half-life of less than 120 days;

24 radioactive wastes shall be in stable chemical and physical forms prior to placement in storage; incompatible materials shall not be stored together; radioactive wastes shall be maintained in segregated storage for at least ten (10) half-lives; following the decay period, wastes shall be monitored at the surface with an appropriate survey meter on the most sensitive scale (or an equivalently sensitive monitoring device) with no intervening shielding material, in a low background area; if monitoring results are indistinguishable from background, all radioactive material (RAM) labels shall be removed or defaced and the material may be disposed of without regard to the radiological concerns (this does not release NIST from regulatory compliance regarding chemical or other physical waste disposal hazards); and if the monitoring detects additional activity above background, the waste shall be analyzed to identify longer half-life impurities and evaluated for disposal as radioactive waste.

3.2.11.2 Disposal of waste into sanitary sewage In section 2.2.6.2., Radioeffluents, of its LRA, NIST stated that releases of liquid and gaseous radioeffluents shall be verified to comply with the public dose limits specified in 10 CFR 20.1301 and in accordance with the requirements of 10 CFR 20.1302.

In its LRA, NIST stated that radioeffluent releases into the air or water shall be assessed by sampling, direct measurement of the source terms, and/or calculation methods to ensure compliance with the release criteria. Records shall be maintained to document annual effluents and verify regulatory compliance. NIST further stated that in Building 235 and Building 245 some drains from specific radiochemistry laboratories and other areas are directed to a set of waste tanks. Those tanks are sampled, analyzed, and released to the sanitary sewer in accordance with written procedures in compliance with 10 CFR 20.2003. In addition, NIST stated that bulk liquid wastes shall be collected and transferred to NISTs Radiation Safety Division (RSD), which shall determine the disposition of the waste, which may include release via the waste tanks or disposal by transfer to contracted processing brokers.

In section 6.1, Classification of Licensing and Regulatory Actions, of its LRA, NIST stated that gaseous and liquid effluents, if any, will be within 10 CFR Part 20 limits and will be subject to appropriate effluent monitoring and controls. For example, any laboratory operations determined to have significant potential for exceeding 10% of the release limitations in 10 CFR 20, appendix B, Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage, Table 2, "Effluent Concentrations," shall be monitored on an as needed basis, and liquid effluents collected in holding tanks will be sampled to assure compliance with 10 CFR Part 20, appendix B, limits prior to any release to the sanitary sewer.

3.2.11.3 Onsite incineration and onsite burial of radioactive waste In section 2.2.6.3, Incineration and On-site Burial, of its LRA, NIST stated that no onsite incineration or onsite burial of radioactive wastes, pursuant to 10 CFR 20.2004, shall be performed.

25 3.2.11.4 Disposal of specific radioactive wastes In its LRA, NIST did not propose to dispose of specific radioactive wastes under 10 CFR 20.2005.

3.2.11.5 Transfer of radioactive waste for disposal and manifests In section 2.2.6, Radioactive Waste, of its LRA, NIST stated that the RSD shall train individuals who generate waste to ensure appropriate collection of all waste materials that could contain radioactivity. Wastes are segregated and collected in accordance with written procedures, documenting the source term, activity, physical and chemical state, and any other information necessary to ensure safety of the handlers and compliance with processor and disposal facility contractual and license requirements. On request from the individual, RSD collects the waste for packaging and shipment. The wastes shall be disposed of either by transfer to a licensed waste processing contractor or by shipping directly to a licensed disposal site. The waste shall be packaged in compliance with the appropriate shipping regulations. If the shipment is direct to a licensed disposal site, then all applicable waste-form regulations and restrictions on packaging shall be followed. Wastes that cannot be accommodated in drums are packaged in U.S. Department of Transportation compliant shipping containers, as specified by the contractor.

In its LRA, NIST stated that it is committed to conduct its waste management program in accordance with 10 CFR 20.2006, Transfer for disposal and manifests, and that it will work with waste brokers that adhere to Appendix G to Part 20, Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests. NIST will ensure that all materials are properly packaged, marked and labeled for disposal. NIST will review radioactive waste manifests (NRC Forms 540 and 541) and uniform hazardous waste manifests prepared by the broker. NIST will use established method for manifest tracking from shipment to final disposition. Trained NIST staff will sign the manifests as shipper. For uniform hazardous waste manifests, the shipper must be trained for radioactive material and hazardous chemicals.

3.2.11.6 Compliance with environmental and health protection regulations In section 2.1.2., Radiation Safety Officer, of its LRA, NIST stated that the Radiation Safety Officer responsibilities include: establishing and maintaining an effective radiation safety program that allows for the safe and regulatorily compliant use of ionizing radiation sources in a manner that conforms with ALARA principles; applicable Federal, State, and local regulations; and NIST policy.

In its LRA, NIST stated that it is committed to comply with the requirements in 10 CFR 20.2007 and that it understands that nothing in the requirements of 10 CFR 20 Subpart K relieves them from complying with other applicable Federal, State, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this subpart. NIST ensures compliance with 10 CFR 20.2007 by confirming that waste contracts are only established with brokers and disposal sites that have proper procedures, permits, and certifications.

3.2.11.7 Disposal of byproduct material In its LRA, NIST did not propose to dispose of Byproduct Material under 10 CFR 20.2008.

26 3.2.11.8 Alternative radioactive waste disposal methods In the LRA, NIST did not propose any alternative radioactive waste disposal method.

3.2.12 Audit Program In section 2.2.7, Audit Program, of its LRA, NIST describes its program for evaluating the performance of the RPP, which is based on the guidance in section 8.10.1, Audit and Review of Program, of NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses:

Program-Specific Guidance About Licenses of Broad Scope, Revision 1 (ML17059D332, referenced in section 1.6.3.3, License Flexibility, of NISTs LRA). NIST states that the IRSC ensures that the RPP is audited by individuals, other than RSD staff, annually to assess the RPPs performance, quality of operations, targeted aspects of protocols and procedures, security program content and implementation, and facilities where potential for radiation exposures or releases in excess of 10% of the applicable limits is low or potentially not significant. Audits of facilities that have significant potential for radiation exposures or releases in excess of 10% of the applicable limits shall be conducted quarterly. Audit results shall be reported to the IRSC which, in turn, reports any findings to NIST management. The RSD reviews and documents program actions, surveillance monitoring, dosimetry trends, and other program metrics for each calendar year as the data required by the report become available.

This information is submitted to the IRSC in routine meetings. The RSO is responsible for maintaining audit records in accordance with NRC regulatory requirements.

In section 1.6.3.3, License Flexibility, of its LRA, NIST stated that it follows the guidance in section 8.10.1, Audit and Review of Program, of NUREG-1556, Consolidated Guidance About Materials Licenses Volume 11, Program-Specific Guidance About Licenses of Broad Scope, Revision 1, for conducting audits of its operations. Through these audits, NIST verifies the adequacy of any implemented changes to its safety program and the changes compliance with regulatory requirements. NIST also stated that the audits also serve to ensure that appropriate actions are taken when non-compliances are identified, including analysis of the cause(s), and development and implementation of corrective actions to prevent recurrence.

In section 2.2.7.2, Radiation Facilities Quarterly Audit, of its LRA, NIST stated that RSD conducts quarterly audits of radiation facilities that are approved and posted for use and/or storage of licensed materials with significant potential for radiation exposures or releases in excess of ten (10) percent of the applicable regulatory limits. In section 2.2.7.3, Radiation Facilities Annual Audit, of the LRA, NIST stated that the audits are conducted annually for facilities approved and posted for use and/or storage of licensed materials that do not have significant potential for radiation exposures or releases in excess of ten (10) percent of the applicable regulatory limits. In both cases, the audits shall include an assessment of radiological conditions and a review of security, posting, and labeling requirements. NIST further stated that, where feasible, the audits include observation and discussion of work practices with source custodians and/or users, that the audit results shall be documented, and that any needs for corrective actions shall be transmitted to source custodians and/or other appropriate individuals.

27 3.2.13 Equipment and monitoring practices The regulations in 10 CFR 70.22(a)(7) require that each application for a license shall contain a description of equipment that will be used by the applicant to protect health and minimize danger to life or property. The description should include written commitments that the applicant will:

possess or have access to radiation monitoring instruments that are necessary to protect health and minimize danger to life or property; conduct testing to determine whether there is any radioactive leakage from licensed material; and conduct surveys of potential radiological hazards in the workplace.

3.2.14 Radiation monitoring instruments In section 2.3.1, Radiation Monitoring Instruments, of its LRA, NIST discusses its radiation detection equipment. Table 1, Typical NIST Instrumentation, of the LRA lists NISTs radiation detecting instruments and their characteristics. Portable instruments used for contamination and ambient radiation surveys include:

exposure rate meters; count rate meters; Geiger-Mueller detectors; sodium iodide scintillators; zinc sulfide proportional counters; plastic scintillators; and centronic boron trifluoride and helium proportional tubes.

Stationary instruments for measuring wipe, bioassay, and effluent samples include:

liquid scintillation counter; high-purity germanium gamma counter; and gas proportional counters.

Equivalent substitutions or alternative instruments are acceptable as long as there is no degradation of the radiation monitoring program. An inventory of instrumentation is available in numbers commensurate with license activities.

NIST staff that uses radiation monitoring instrumentation as part of their work activities are qualified and well trained in the operating characteristics of the instrumentation as well as in the techniques and procedures of instrument calibration. Calibrated and functional survey instrumentation shall be maintained to support monitoring needs in each of its radiation facilities where external dose rates are likely to reach the criteria for a radiation area as defined in 10 CFR 20 or where surface contamination control limits, as defined in section 2.3.3 of the LRA, are likely to be exceeded. NIST also stated that calibration of instruments is either performed by a vendor licensed by the NRC or by NIST, which applies the calibration model procedures in appendix H of NUREG 1556, Volume 11, Program-Specific Guidance About Licenses of Broad Scope, Revision 1, and that all in-service instruments used for health and safety, or regulatory compliance monitoring, shall be routinely evaluated for functionality. Portable survey instruments used for dose-rate measurements shall be calibrated annually or after repairs or

28 modifications that could affect response and that portable survey instruments used for contamination monitoring shall be calibrated electronically and source response checked annually or after repairs or modifications that could affect response. Portable survey instruments shall be calibrated in accordance with the manufacturers recommendations or written procedures. Survey instruments shall be evaluated at approximately 20% and 80% of each scale or decade as practicable and shall be removed from service if they cannot be adjusted to within 20% of the expected value. Records of calibrations and instrument quality assurance shall be retained for inspection for a minimum of 3 years. In-service portable instrumentation shall be labeled to verify calibration. Finally, NIST stated that individuals who use radiation monitoring instrumentation as part of their work are qualified and trained in the operating characteristics of the instrumentation as well as in the techniques and procedures of instrument calibration.

3.2.15 Leak tests Section 2.3.2, Leak Tests, of the LRA discusses NISTs procedures for sealed source leakage or contamination testing. NIST states that, unless otherwise specified by the sources respective Sealed Source Device Registration Certificate, leak test procedures apply the model procedures in appendix M of NUREG 1556, Volume 11, Program-Specific Guidance About Licenses of Broad Scope, Revision 1. NIST also stated that each sealed source containing more than 100 microcuries of beta and/or gamma emitting material or more than 10 microcuries of alpha emitting material, other than tritium (3H), with a half-life greater than 30 days and in any form other than gas, shall be tested for leakage and/or contamination semi-annually. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, a sealed source received from another entity shall not be put into use until tested for leakage. The required semiannual test does not apply to sealed sources that are stored and/or not in use but any sealed source in storage must be leak tested prior to usage or removal from storage. This leak testing shall be performed no more than 6 months prior to the date of use or transfer and no sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.

The leak test shall be capable of detecting the presence of 0.005 microcuries of RAM on the test sample. The sample shall be taken from the sealed source or appropriate accessible surfaces of the container or from the device where the sealed source is mounted or stored in which contamination would be expected to accumulate. Records of leak test results are maintained for inspection in accordance with 10 CFR 20.2102, Records of radiation protection programs. If the test reveals the presence of 0.005 microcuries or more of removable contamination due to the sealed source radionuclide, NIST shall immediately withdraw the sealed source from use and shall cause it to be contained or decontaminated and repaired by a person licensed and qualified to make such repairs, or to be disposed of in accordance with the NRC requirements in 10 CFR 20.2001, General requirements, (a). If tests indicate leakage from a source that was distributed or acquired in accordance with requirements of the sealed source registry or that was designed, manufactured, and tested in accordance with special form requirements, within 5 days after determining that the source has leaked, NIST shall file a report with the NRC describing the source, test results, extent of contamination, apparent or suspected cause of source failure, and corrective action taken.

29 3.2.16 Surveys In section 2.3.3, Surveys, of its LRA, NIST states that it performs and documents routine surveys of radiation facilities to ensure health and safety and regulatory compliance. NISTs survey procedures apply the guidance in appendix L of NUREG 1556, Volume 11, Program-Specific Guidance About Licenses of Broad Scope, Revision 1, and take into consideration other modifying factors such as source activity, physical form, containment, utilization, process knowledge, and operational history. NIST performs ambient radiation surveys, contamination surveys, and dose-rate surveys. Monitoring surveys are conducted in locations where individuals might be exposed to doses in excess of 10% of the occupational dose limits in 10 CFR 20.1201. Radiation surveys are also conducted in locations where members of the public could receive a total effective dose equivalent of 1 millisievert (mSv) (100 mrem) in a year, or where the dose in any unrestricted area from external sources could exceed 0.02 mSv (2 mrem) in anyone (1) hour, pursuant to 10 CFR 20.1301(a)(2). Surveys are done in a manner and frequency that is representative of the use of RAM. At a minimum, these surveys are done weekly in areas of RAM use, where exposures to workers could reasonably occur, (e.g., generator storage or elution and dose preparation stations). NIST also stated that surveys are conducted quarterly in those areas where radiological conditions are not expected to change appreciably from day to day (e.g., radioactive waste storage areas).

NIST also performs contamination surveys sufficient to identify areas of contamination that might result in unacceptable levels of exposure to workers or to the public. Combined removable and fixed contamination are surveyed using appropriate radiation detection equipment. Removable contamination can be detected and measured through wipe tests, which should be analyzed using an appropriate counting instrument, and fixed contamination may be measured directly at the surface of the contamination with the appropriate instrument detector in accordance with manufacturer instructions. NIST also stated that the frequency of routine surveys depends on the nature, quantity, and use of RAM, as well as the specific protective facilities, equipment, and procedures that are designed to protect the worker from external and internal exposure. In Table 2, Radiation Facility Surveys: Frequency and Type, of its LRA, NIST provided the typical actions and surveillance frequencies and stated that these may be modified by the RSO based on process knowledge, utilization and monitoring history, and levels of research activity.

3.2.17 Environmental Monitoring In section 2.3.3, Surveys, of its LRA, NIST discusses effluent and environmental monitoring (ambient radiation surveys and contamination surveys). The LRA provides the description of NISTs program for completing and documenting facility surveys for radiation or contamination, as appropriate. NIST has developed criteria to establish survey frequencies depending on the nature and the quantity of RAM being used, as well as the specific protective measures, facilities, equipment, and procedures in place that are designed to protect the workers from external and internal exposures. Contamination surveys are conducted frequently (i.e., weekly, quarterly, and annually) and sufficiently to identify areas of contamination that might result in unacceptable levels of exposure to workers or to the public. Radiologic control action levels have also been established to dictate posting requirements, as necessary. All posted facilities are surveyed at least annually. In addition, NIST conducts and documents environmental monitoring at appropriate locations within the facilities as a means for demonstrating compliance with dose and dose-rate limits for its workers and members of the public as well.

30 3.2.18 Commitment to Written Procedures The regulations in 10 CFR 70.22(a)(8) require that each application for a license shall contain the information discussing the applicants proposed procedures to protect health and minimize danger to life or property (such as procedures to avoid accidental criticality, procedures for personnel monitoring and waste disposal, post-criticality accident emergency procedures, etc.).

In section 2.4, Commitment to Written Procedures, of its LRA, NIST discusses its commitments for preparing and using written radiation protection procedures and RWPs and the process for their development, revision, and implementation.

NIST stated that procedures are developed in accordance with the 10 CFR 20.1101(b) and 10 CFR 70.23(a)(4) requirements and that it has implemented a process for procedure generation, modification, authorization, and distribution. NIST further stated that training to staff is routinely provided to ensure that any changes to procedures are effectively and promptly communicated and that the written procedures provide assurance that safety and safeguards activities are being conducted by trained and qualified individuals, in accordance with procedures and commitments to regulatory agencies. In addition, NIST stated that radiation work permits (RWPs) are also used for conducting its NRC regulated activities safely, and that these RWPs, in combination with its written procedures and staff training, provide the necessary controls to protect health and to minimize danger to life or property. The IRSC reviews any new requests for using RAM and reviews and approves proposed program changes and revisions to procedures that are within the scope of NISTs SNM license. NIST further stated that it conducts hazard assessments requests for the acquisition and use of RAM and that use of new material or new procedures is approved by the IRSC only after the hazard assessment has been completed and reviewed and approved by the RSO. Through the hazard assessments NIST also reviews and evaluate proposals for workable reductions in exposure through the application of ALARA concepts.

Regarding RWPs, NIST noted that these define the authorized activities, the level of approval required, information requirements, period of validity, expiration and termination times, and recordkeeping requirements. The RSO or designated alternate is responsible for the review and approval of RWPs.

3.2.19 Recordkeeping The regulations in 10 CFR 20.2102, Records of Radiation Protection Programs, require that licensees keep records of the radiation protection program, including a description of the program components, audits, and other aspects of program implementation.

In section 2 of the LRA, NIST commits to maintain documentation (records) required pursuant to 10 CFR sections 20.2102, 20.2103, 20.2106, and 20.2107 and making those available for inspection to demonstrate that:

occupational doses and doses to the members of the public are ALARA and for revision by RSD as part of NISTs ALARA program; individuals radiation exposures are monitored and that radiation doses exceeding 10%

of the limits in 10 CFR 20.1201(a) are timely reported and communicated to the monitored individuals; occupational doses are documented, reviewed by RSD and the IRSC, and reported to NIST management for appropriate action when needed;

31 audits and assessments of the RPP are routinely performed, reviewed, and reported to management and communicated to NIST staff for implementation of any necessary actions, with audit records maintained for three years after these are made; program actions, surveillance monitoring, dosimetry trends, and other program metrics are documented and reviewed by the IRSC and RSD, and results are timely communicated to the monitored individuals; staff is adequately trained; annual effluents comply with regulatory requirements; instruments are routinely evaluated for functionality and calibrated annually or in accordance with written procedures or the manufacturers recommendations and calibration records are retained for inspection for a minimum of 3 years; RAM sources leak tests are performed in accordance with written procedures and results are maintained for inspection in accordance with regulatory requirements; and routine radiation surveys of posted radiation facilities are performed in accordance with written procedures or the guidance in appendix L of NUREG 1556 Volume 11, Revision 1.

NIST commits to maintaining records of RAM acquisition, utilization, transfers, and disposal.

NIST further commits to maintaining written records documenting the IRSC activities and physical inventories and reconciling those records as necessary. The CSO is responsible for overseeing the establishment, implementation, and maintenance of the ionizing radiation safety programs supporting the SNM-362 NRC license. The RSO is responsible for maintaining all required RPP written records in accordance with the relevant requirements of 10 CFR Part 20.

3.2.20 Operating and Emergency Procedures Although in section 3.3, Emergency Planning and Response, of its LRA, NIST stated that it is not subject to the requirement for an Emergency Plan (EP) pursuant to 10 CFR 70.22(i)(1)(ii), in section 2.5, Operating and Emergency Procedures, of its LRA NIST stated that it maintains operating and emergency procedures that provide instructions on the following:

contamination controls, including the use of protective clothing and equipment; personnel and area monitoring, including frequency, limits, and instructions for keeping doses ALARA; reporting and recording requirements, including how to respond and whom to contact when an emergency occurs and identifying and reporting defects and noncompliance to the NRC as required; and, waste disposal practices, including instructions for conducting operations to minimize the introduction of residual radioactivity and the proper storing and disposal of radioactive waste.

NIST further stated that RSD staff are provided regular training and instruction on these elements to ensure the safe day-to-day use and handling of materials and that instructions for responding to spills or personnel contamination incidents are compatible with the procedures for the safe use of radionuclides and emergencies as published in Appendix K of NUREG-1556, Volume 11, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope. Additionally, NIST stated that authorized users are provided with copies of operating and emergency procedures that provide instructions in the case of an emergency, including immediate action best practices for preventing the release of RAM or further contamination of workspaces and personnel, as practical without further

32 endangerment. See also the discussions in sections 4.2.3, Emergency Planning and Response, and section 12, Emergency Management, of this document.

3.2.21 Transportation In section 2.6, Transportation, of its LRA NIST stated that it has established a transportation program to ensure adequate protection of workers and members of the public from unnecessary exposures to radiation during the transportation of the material and to verify compliance with NRC and the U.S. Department of Transportation (DOT) regulations. The program includes personnel training and procedures for the activities to receive RAM and shipping of materials and waste. Transportation activities of sources meeting the criteria of the Nuclear Materials Management Safeguards System and the National Source Tracking System are handled in accordance with the NRC guidance and regulations in 10 CFR 20, 10 CFR 37, 10 CFR 71, and 10 CFR 73. In Enclosure 6, Physical Security (ML23221A166, Non-Public, and ML24071A183

- revised) of its LRA, NIST further stated that it has developed a program to meet the requirements in 10 CFR 73.67 (a) and (g) regarding physical protection of Special Nuclear Material (SNM) in transit. All transportation of RAM to and from NIST shall be conducted in accordance with all applicable DOT requirements.

3.2.22 NIST Irradiators Program 3.2.22.1 Irradiator facilities The G-150 gamma-ray facility in the B-wing of Building 245 was approved by the NRC through Amendment 9 (ML17306A976) of the SNM-362 license. The relocation of the irradiator from the B-wing to the new H-wing of Building 245 was approved by the NRC through Amendment 11 of the SNM-362 license (ML21126A114). The access to the facility is through a hallway door as shown in Figure 3-1 of Enclosure 3 of the LRA. Table 3-2 shows the area radiation monitors, the type of detectors and their location as references the Figure 3-1. In its LRA, NIST also stated that it performs annual site-specific tests in accordance with the requirements in 10 CFR 36.61 and 36.23.

3.2.22.2 Irradiator Safety Program The regulations in 10 CFR Part 36, Licenses and radiation safety requirements for irradiators, provide the requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. Enclosure 3, Part 36, Irradiator LRA, (non-public) of NISTs LRA describes NISTs RPP for its irradiator. The NRC staff reviewed NISTs RPP for the irradiator using the guidance in NUREG 1556, Volume 6, Revision 1, Program-Specific Guidance about 10 CFR 36 Irradiator Licenses.

In its LRA, NIST stated that it possesses a vertical beam irradiator and self-contained irradiators as well. Authorized uses for the irradiator include irradiation of devices and dosimeters for the development and maintenance of radiation measurement standards, and the provision of radiation measurement services. No radiation of explosive or small amounts of flammable materials is done unless specifically authorized by the NRC via license amendment.

33 3.2.22.3 Irradiator staff 3.2.22.3.1 Radiation Safety Officer qualifications Section 2.1.2 of NISTs LRA described the RSO qualifications (see section 3.2.4 of this document) and responsibilities which includes 10 CFR Part 36 irradiator facility. The training and experience of NISTs current RSO was provided to the NRC for review and approval on March 31, 2017 (ML17095A956). The NRC staff reviewed the information and determined that the nominated individuals extensive experience, education, and training in the radiation field adequately demonstrated that he possessed the qualifications and resources to oversee NISTs RPP (ML17109A118). NISTs RSO was again approved by the NRC as the RSO for overseeing NISTs irradiators safety program by the NRC staff through Amendment 11 (ML21126A114) of SNM-362 with the commissioning of the new Part 36 Irradiator Facility.

3.2.22.3.2 Irradiator operators qualifications, Part 36 Irradiator LRA, of NISTs LRA discusses the training and qualifications to meet the 10 CFR Part 36 training requirements. NIST states that irradiator operators must successfully complete one of the training courses described in the section 8.8.1 Initial Training and Experience for Irradiator Operators, of NUREG-1556, Volume 6, Revision 1, Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses, Revision 1. NIST further stated that the training complies with the requirements of the 10 CFR 36.51(a), (b), and (c) and the guidance in NUREG 1556 Volume 6, Revision 1. In section 2.1.4.3, Part 36 Training, of its LRA NIST further states that all individuals approved to work with irradiators (meeting 10 CFR 36 criteria) shall also receive facility specific training annually. Initial on-the-job irradiator operator training, and annual safety reviews, testing of the operators knowledge, the experience and training for the trainers, and the experience required for irradiator operators at NIST was previously approved by the NRC in the most recent SNM-362 license renewal, dated September 11, 2013 (ML13207A206) and again through Amendment 11 (ML21126A114) of the SNM-362 license, when the 10 CFR Part 36 Irradiator Facility was finally added to the NIST NRC-licensed program.

3.2.22.3.3 Annual Safety Reviews and Performance Evaluations for Irradiator Operators In Enclosure 3, Part 36 Irradiator LRA, of its LRA, NIST states that the safety reviews and performance evaluations of the irradiator operators are conducted annually, in accordance with the requirements in 10 CFR 36.51(d) and (e). The performance evaluations review the safe operation of the irradiator to ensure regulatory, license, procedural, and safety requirements are being met by the irradiator operator. These activities are overseen by the RSD.

3.2.22.4 Exemptions from 10 CFR Part 36 requirements The regulations in 10 CFR 36.17, Applications for exemptions, (a) specify that the Commission may, upon application of any interested person or upon its own initiative, grant any exemptions from the requirements in 10 CFR Part 36 that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

The regulations in 10 CFR 70.17, Specific exemptions, (a), state, in summary, that the Commission may, upon application of any interested person or upon its own initiative, grant exemptions from specific 10 CFR requirements as it determines that the exemptions are

34 authorized by law, will not endanger life or property or the common defense and security, and are, otherwise, in the public interest. (ML23220A401) of NISTs LRA discussed the specific exemptions to the requirements in 10 CFR Part 36, Licenses and Radiation Safety Requirements for Irradiators.

NIST requested the continuation of the exemptions to the requirements in 10 CFR 36.23(b),

36.23(c), and 36.31(a), and the removal of the exemptions to the requirements in 10 CFR 36.27(a) and 36.27(b). The four exemptions were previously granted to NIST by the NRC.

3.2.22.4.1 Continuation of exemption from the requirements in 10 CFR 36.23(b)

The regulations in 10 CFR 36.23, Access control, (b), require that each entrance to a radiation room at a panoramic irradiator must have an independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of the hazard. In addition, the regulation requires that the alarm must also alert at least one other individual who is onsite of the entry and that this individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance.

In its LRA, NIST requested continuation of an exemption to part of the requirements of 10 CFR 36.23(b). Specifically, NIST requested continuation of the exemption to the requirement that the alarm must also alert at least one other individual who is onsite of the entry. That individual shall be trained on how to respond to the alarm and prepared to promptly render or summon assistance. This exemption was originally granted by the NRC to NIST on November 23, 1999, and again in September 2013 as part of NISTs previews license renewal In its LRA, NIST provided justification for the continuation of this exemption. NIST stated that the access to the Gamma irradiator room is restricted by two independent doors separated by a maze. NIST further stated that there are multiple safety interlocks and independent access control systems in place including:

three factor authentication access to the control room is restricted to a small subset of authorized personnel. This access control system notifies security staff of any inappropriate entry to the control room which would cause security staff to respond to the facility; the source cannot be exposed if the irradiators room door is open; when the source is exposed, the door is held in a mechanically locked configuration and cannot be unlocked until the source is returned to its fully shielded position; when the source is exposed, breaching either the Control/Maze door or the irradiator room door causes audible and visual alarms; and when the source is exposed, breaching either the Control/Maze Door or the irradiator room door causes the irradiator shutter to return to its fully shielded position. Following this interrupt, the irradiator cannot expose the source until the doors are closed and the last man out button is pressed.

NIST also stated that these compensatory safety measures are intended to provide a level of health and safety equivalent to the regulation for which the exemption is being requested. NIST further stated that the facility construction and subsequent installation of the irradiator were previously approved under the SNM-362 Amendments 9 (ML17306A976) and 11

35 (ML21126A114), respectively.

NRC Staff Review The NRC staff evaluated NISTs justification for the exemption. In addition, on November 14, 2023, the NRC staff conducted a visit to NISTs facilities during which the NRC staff had the opportunity to look at the irradiators design, its safety interlocks and independent access control systems described by NIST in its LRA. The NRC staff noted, and confirmed, that the irradiator design and its safety features effectively restrict access to the room. The NRC staff also noted that the irradiators access control system effectively alerts NIST security staff of any inappropriate entry to the control room and concluded that the system effectively allows NISTs security staff to immediately respond accordingly. The NRC staff also verified that the irradiator sources cannot be exposed if the irradiators room door is open, that audible and visual alarms will activate due to a breach of either the Control/Maze door or the irradiator room door when the sources are exposed and/or that the irradiator shutter returns to its fully shielded position if the Control/Maze Door or the irradiator room door are breached.

Based on the information provided by NIST in its LRA, and the NRC staff observations and assessment of NISTs facilities during the November 14, 2023, site visit, the NRC staff finds that NISTs current exemption from the regulations in 10 CFR 36.23(b) requiring that the irradiators room alarm must also alert at least one other individual who is onsite of the entry should be continued as previously granted to NIST. The NRC staff basis and criteria for granting this specific exemption to the requirements in NRCs regulations under 10 CFR 36.17 and 10 CFR 70.17(a) are discussed in more detail below.

a.

Authorized by law The NRC staff determined that granting NIST an exemption from the regulation in 10 CFR 36.23(b) is permissible under the Atomic Energy Act (AEA) of 1954, as amended, and that no other prohibition of law or the Commissions regulations exists that would preclude the activities to be authorized under the exemption. As such, the NRC staff finds that granting NIST an exemption from the requirement in 10 CFR 36.23(b) is authorized by law, as required by both 10 CFR 36.17 and 10 CFR 70.17(a).

b.

Does Not Endanger Life or Property or Common Defense and Security Consistent with the requirements in 10 CFR 70.22(a)(7), an application for a license shall describe the equipment and facilities to be used by the applicant to protect health and minimize danger to life or property. The NRC staff determined that NIST provided detailed information in its LRA to meet this requirement, in addition to providing sufficient information justifying their request for exemption from the 10 CFR 36.23(b) requirement. After considering all the information provided by NIST in its LRA, and the observations during the site visit, the NRC staff determined that NIST has implemented safety measures comparable to those called for by 10 CFR 36.23(b). The NRC staff also determined that the exemption only relates to the operation of radiation equipment at NISTs facilities and, as such, granting the exemption will not have an impact on the common defense and security and will not adversely endanger life or property or the common defense and security as required by both 10 CFR 36.17 and 10 CFR 70.17(a).

36 c.

In the Public Interest The NRC staff has determined that granting this exemption request is otherwise in the public interest because it promotes regulatory efficiency. The exemption relieving NIST from the requirement that the irradiators room alarm must also alert at least one other individual who is onsite of the entry does not present a risk to public health and safety given safety measures implemented by NIST, which the NRC staff determined to be comparable to those called for by 10 CFR 36.23(b). Specifically, the exemption would relieve the licensee from having additional, unnecessary staff on site at the time when irradiator operations are being conducted, thus, reducing the potential for workers or public exposures to radiation. Granting the exemption will allow NIST to focus the resources required to ensure safety on other activities. In addition, it would reduce the scope of the NRC inspection of NIST activities which do not present a risk to public health and safety.

3.2.22.4.2 Continuation of exemption from the requirements in 10 CFR 36.23(c)

The regulations in 10 CFR 36.23, Access control, (c) require that a radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when radiation levels are high. Attempted personnel entry while the monitor measures high radiation levels, must activate the alarm described in paragraph (b) of this section. The monitor may be located in the entrance (normally referred to as the maze) but not in the direct radiation beam.

In its LRA, NIST requested continuation of this exemption to part of the requirements of 10 CFR 36.23(c) currently granted to NIST. Specifically, NIST requested continuation of the exemption to the requirement in 10 CFR 36.23(c) that states that the alarm described in 10 CFR 36.23(b) must activate as a result of an attempted personnel entry while the radiation monitor in the radiation room of a panoramic irradiator is detecting high radiation levels.

In its LRA, NIST discussed its rationale for the continuation of this exemption. NIST stated that the Gamma irradiator room facility contains multiple independent redundant radiation monitoring systems to detect the presence of high radiation levels in the irradiator room. There are two area radiation monitors located in the irradiator room. The first provides visible and audible alarms in the maze that connects the irradiator room and the Control Room when there is radiation present. The second radiation monitor, also located in the irradiator room, indicates the presence of radiation levels with visible and audible alarms in the irradiator room and a visual alarm in the maze. NIST stated that the first radiation monitor is also interlocked with the irradiator room door and the control room/maze door to produce a visible and audible alarm when either the irradiator room door or control room/maze door is opened when the first radiation monitor detects elevated radiation levels. NIST also stated that the second radiation monitor locks the irradiator door and keeps it locked to prevent access to the room upon detection of elevated radiation levels. NIST further stated that these compensatory safety measures are intended to provide a level of health and safety equivalent to the regulation for which the exemption is being requested.

The NRC staff reviewed NISTs rationale for the exemption from the requirement in 10 CFR 36.23(c) provided in the LRA. In addition, during the November 14, 2023, site visit, the NRC staff had the opportunity to examine the independent radiation monitors NIST described in its LRA and observe them in operation. The NRC staff noted that the indicators work independently to detect the presence of high radiation levels in the irradiator room and that visible and audible

37 alarms activate when high radiation levels in the area are detected. The NRC staff also confirmed that the irradiator door locks to prevent room access upon detection of elevated radiation levels in the maze. Based on the information provided by NIST in its LRA, and the NRC staff observations of the system in operation during the November 14, 2023, site visit, the NRC staff concludes that NISTs Gamma irradiator rooms independent and redundant radiation monitoring systems to detect the presence of high radiation levels in the irradiator room adequately compensate and provide a level of safety comparable to that called for by 10 CFR 36.23(c). The NRC staff, therefore, finds that NIST exemption from the 10 CFR 36.23(c) requirement stating that the alarm described in 10 CFR 36.23(b) must activate as a result of an attempted personnel entry while the radiation monitor in the radiation room of a panoramic irradiator is detecting high radiation levels should be continued as previously granted to NIST by the NRC. The basis and criteria for granting this specific exemption to the requirements in NRCs regulations under 10 CFR 36.17 and 10 CFR 70.17(a) are discussed in more detail below.

a.

Authorized by law Pursuant to the requirements in 10 CFR 36.17 and 10 CFR 70.17, the Commission may grant exemptions from the requirements of the regulations as it determines are authorized by law. The NRC staff determined that granting NIST an exemption from the regulation in 10 CFR 36.23(b) is permissible under the Atomic Energy Act (AEA) of 1954, as amended, and that no other prohibition of law or the Commissions regulations exists that would preclude the activities to be authorized under the exemption. As such, the NRC staff finds that granting NIST an exemption from the requirement in 10 CFR 36.23(b) is, therefore, not prohibited by law and meets this requirement in both 10 CFR 36.17 and 10 CFR 70.17(a).

b.

Does not endanger life or property or common defense and security The NRC staff determined that NISTs safety measures are comparable to those called for by 10 CFR 36.23(c). The NRC staff also determined that NISTs measures adequately protect public health and safety of its workers and the public from exposures to radiation when the irradiator is in operation. The NRC staff, therefore, determined that the measures ensure adequate protection of public health and safety of its workers and, therefore, granting the exemption to the requirements in 10 CFR 36.23(c) will not endanger life or property or the common defense and security.

c.

In the public interest The NRC staff has determined that granting this exemption request is otherwise in the public interest because it promotes regulatory efficiency. The exemption relieves NIST from the specific safety measures specified in the 10 CFR 36.23(c) requirement, which are unnecessary in view of the comparable measures implemented by NIST. Granting the exemption will allow the NRC, NIST and the public to focus resources and attention on other, higher priority, safety program activities and reduce any unnecessary regulatory costs.

3.2.22.4.3 Removal of exemption from the requirements in 10 CFR 36.27(a)

The regulations in 10 CFR 36.27(a) require that The radiation room at a panoramic irradiator must have heat and smoke detectors. The detectors must activate an audible alarm. The alarm must be capable of alerting a person who is prepared to summon assistance promptly. The

38 sources must automatically become fully shielded if a fire is detected.

NIST is currently granted an exemption from this requirement. However, in Enclosure 2, Requested Exemptions of its LRA, NIST stated that it is no longer requesting this exemption since it is currently meeting this requirement. The NRC staff confirmed that NISTs panoramic irradiator room is now equipped with heat and smoke detectors that include audible alarms capable of alerting NIST staff to immediately provide assistance in case the alarms are activated. The NRC staff also confirmed that the irradiator sources would automatically become fully shielded if a fire is detected. Therefore, the NRC staff finds that NIST meets the 10 CFR 36.27(a) requirements and, as such, this exemption should be discontinued for the next 10-year NRC license period, as requested by NIST in its LRA.

3.2.22.4.4 Removal of exemption from the requirements in 10 CFR 36.27(b)

The regulations in 10 CFR 36.27(b) require that The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the radiation room must have a shut-off valve to control flooding into unrestricted areas.

NIST is currently granted an exemption from this requirement. However, in Enclosure 2, Requested Exemptions, of its LRA, NIST stated that it is no longer requesting this exemption since it is currently meeting this requirement. The NRC staff confirmed that NISTs panoramic irradiator room is now equipped with fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room and that the room is equipped with a system for controlling flooding into unrestricted areas. Therefore, the NRC staff finds that NIST meets the 10 CFR 36.27(b) requirements and, as such, the current exemption to the requirements in 10 CFR 36.27(b) should be discontinued for the next 10-year NRC license period as NIST requested in its LRA.

3.2.22.4.5 Continuation of exemption from the requirements in 10 CFR 36.31(a)

The regulations in 10 CFR 36.31(a) require that The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the shielded position. Only one key may be in use at any time, and only operators or facility management may possess it. The key must be attached to a portable radiation survey meter by a chain or cable. The lock for source control must be designed so that the key may not be removed if the sources are in an unshielded position. The door to the radiation room must require the same key.

In its LRA, NIST requested an exemption from the requirement that the key must be attached to a portable radiation survey meter by a chain or cable. This exemption was originally granted by the NRC to NIST on November 23, 1999, and again in September 2013 as part of NISTs previews license renewal. At the time, the NRC staff noted that the purpose of the requirement in 10 CFR 36.31(a) for the key to the door to the radiation room and to operate the irradiator to be the same, to be attached to a portable radiation survey meter by a chain or cable and to only be in possession of the operators of facility management is to ensure that unauthorized individuals inadvertently enters a high radiation area.

In its LRA, NIST stated that: (a) the facility is designed so that the key that controls the Experiment Door connecting the irradiator and maze area is the same key that is used to enable the control panel that operates the irradiator, and, (b) this key design ensures that the irradiator

39 can only be operated if the key used to unlock the Experiment Door is inserted into the irradiator control panel which, as a result, ensures that the doors cannot be opened if the irradiator is being operated and it is in the unshielded position since the key is captured at the console. If the key is removed from the console (i.e., to be used for opening the door), the irradiator will return to the safe condition.

The NRC staff reviewed NISTs justification for the exemption from the requirement that the key that actuates the mechanism that moves the sources of its panoramic irradiator must be attached to a portable radiation survey meter by a chain or cable. The NRC staff also evaluated NISTs current system design for locking both the irradiators sources and the door to the irradiator room. During the November 23, 2023, visit to NIST, the NRC staff observed how these mechanisms work. The NRC staff noted that the key to open the door to access the irradiator room and to put the irradiator in operation is the same. The NRC staff noted that the door to the room is automatically locked once there is entry into the room and that it cannot be opened unless the key is used to either enter or exit the room. Therefore, operating the irradiator and opening the door could not happen simultaneously since the key needs to be used to either operate the irradiator or open the door. As such, entry into the room while the irradiator is in operation could not happen. Based on the information provided by NIST in its LRA, and the observations of the system in operation during the November 14, 2023, site visit, the NRC staff determined that NISTs current system for protection against entry into a room with an exposed source is more effective than maintaining the key to the room and for the operation of the irradiator attached to a survey meter by a chain or cable. The NRC staff, therefore, finds that exempting NIST from the 10 CFR 36.31(a) regulation that requires that the key to the mechanism that moves the sources of a panoramic irradiator must be attached to a portable radiation survey meter by a chain or cable meets the requirements in 10 CFR 36.17, Applications for exemptions, (a), and 10 CFR 70.17, Specific exemptions, (a), and, therefore, should be continued as previously granted to NIST by the NRC. The basis and criteria for granting this specific exemption to the requirements in NRCs regulations under 10 CFR 36.17 and 10 CFR 70.17(a) are discussed in more detail below.

a.

Authorized by law The Commission may grant exemptions from specific requirements pursuant as authorized by law. The NRC staff determined that granting NIST an exemption from the requirement in 10 CFR 36.31(a) is permissible under the Atomic Energy Act (AEA) of 1954, as amended, and that no other prohibition of law or the Commissions regulations exists that would preclude the activities to be authorized under the exemption. As such, the NRC staff finds that granting NIST the exemption from the requirement is not prohibited by law and meets this requirement in both 10 CFR 36.17 and 10 CFR 70.17(a).

b.

Does not endanger life or property or common defense and security The NRC staff determined that NIST implemented safety measures, which are comparable to those called for by 10 CFR 36.31(a) and adequately protect public health and safety of its workers and the public. The NRC staff determined that the measures implemented by NIST ensure adequate protection of the health and safety its workers and the public and does not endanger life or property or the common defense and security. Therefore, granting the exemption to the requirements in 10 CFR 36.23(c) meets this requirement in both 10 CFR 36.17 and 10 CFR 70.17(a).

40 c.

In the public interest The NRC staff has determined that granting this exemption request is otherwise in the public interest because it promotes regulatory efficiency. The exemption relieves NIST from the specific safety measures specified in the 10 CFR 36.31(a) requirement, which are unnecessary in view of the comparable measures implemented by NIST. Granting the exemption will allow the NRC, NIST and the public to focus resources and attention on other, higher priority, safety program activities and reduce any unnecessary regulatory costs. Therefore, granting the exemption to the requirements in 10 CFR 36.31(a) meets this requirement in both 10 CFR 36.17 and 10 CFR 70.17(a).

3.3 Evaluation Findings

Based on its review of the information provided by NIST in its LRA, as discussed above, the NRC staff concludes that NIST has established appropriate administrative procedures to assure:

the control of procurement and use of byproduct material; the completion of safety evaluations of proposed uses of byproduct material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and, that the radiation safety committee reviews, approves, and records safety evaluations of proposed uses of the byproduct material prior to use, in accordance with the requirements in 10 CFR 33.13(c)(3).

In addition, the NRC staff finds that NIST:

has established a comprehensive and effective program that adequately outlines specific goals to ensure that occupational radiation exposures are maintained ALARA; developed, possesses and maintains procedures for implementing the ALARA principles and for adequately protecting the public and its workers health and safety from its radiological activities, in accordance with 10 CFR 20.1101(b);

has implemented ALARA principles into its plant design and operations; has established an ALARA program management organization and structure that defines key positions and specific responsibilities and, under which, the RSO has full authority to manage and implement the radiation safety program and all aspects of the utilization of ionizing radiation sources, as delegated by the NIST Director, including authority to immediately stop any operations that may compromise the health or safety of NIST employees and non-NIST personnel, have an adverse impact on the environment or public, or result in non-compliance with NRC, State, or local requirements; has made additional commitments that are based upon sound radiation protection principles to achieve occupational doses and doses to workers and members of the public ALARA; has established an RPP organizational structure that includes qualified personnel to adequately and efficiently implement program and qualification requirements for the radiation protection personnel; radiation protection training is routinely and timely provided to all personnel who have access to restricted areas;

41 has committed to not perform either onsite incineration or onsite burial of radioactive waste; has committed to not dispose of the specific radioactive wastes specified in 10 CFR 20.2005; has established an audit program, conducted by qualified personnel without direct responsibility for the function and area being audited, to independently assess its operations and verify that these are being conducted in accordance with regulatory requirements and license commitments; that specifies the level of management to which results are reported, and that also describes and documents corrective actions to be taken when non-compliances are identified, including analysis of the cause(s), to prevent recurrence; has implemented engineered ventilation and respiratory controls to ensure concentration of radioactive material in the air are maintained within or below regulatory limits; maintains a radiation survey and monitoring program that includes requirements for controlling radiological contamination within the facility and monitoring of external and internal radiation exposures; has established a program to adequately maintain records and report incidents to the NRC in accordance with applicable 10 CFR Parts 20, 70 and 74 requirements; maintains an adequate and robust corrective action program for analyzing deficiencies and document actions taken to prevent occurrence of similar or identical events in the future; and has established a transportation program to ensure adequate protection of workers and members of the public from unnecessary exposures to radiation during the transportation of the material and to verify compliance with NRC and DOT regulations.

Based on the information discussed above, the NRC staff finds that the NIST LRA adequately described:

the staff technical qualifications in accordance with 70.22(a)(6);

the equipment and facilities for protecting health and minimize danger to life or property in accordance with 70.22(a)(7); and the proposed procedures to protect health and minimize danger to life or property in accordance with 70.22(a)(8).

The NRC staff also finds that NISTs:

description of its RPP meets the requirements in 10 CFR 70.23, Requirements for the approval of applications, (a)(3) and (4);

management and staff are qualified by reason of training and experience to use the material for the purpose requested in accordance with 10 CFR 70.22(a)(6) through (8),

70.23(a)(2 and (3), and 10 CFR 30.33(a)(2) and (3)

ALARA program ensures adequate protection of public health and safety and the environment from radiation hazards and meets the requirements in 10 CFR 20.1101(b) and (c);

training program will continue to ensure that personnel is qualified by reason of training and experience to safely use licensed material in accordance with the requirements in 10 CFR 70.23(a)(2);

Irradiator Safety Program meets applicable criteria in NUREG-1556 Volumes 6, 11, and 12 and applicable requirements in 10 CFR Parts 20 and 36; radiation surveys and radiation monitoring program meet the requirements in 10 CFR

42 70.23(a)(3) and (a)(4);

ventilation protection equipment and procedures and respiratory control commitments meet the requirements in 10 CFR 20.1701 and 70.23(a)(3) and (a)(4);

LRA adequately described the activities, facilities, and equipment for managing and disposing of radioactive wastes in accordance with the requirements in 10 CFR 70.22(a)(7);

description of its disposal of waste by decay in storage meet the requirements in 10 CFR 20.2001(a)(2);

means for disposing of radioactive waste into sanitary sewage meet the requirements of 10 CFR 20.2003; disposal of wastes by shipping them for ultimate disposal at a licensed land disposal meet the requirements in 10 CFR 20.2006; commitment to ensure it complies with all other Federal, State, and local regulations governing any other environmental and health protection regulations meet the requirements in 10 CFR 20.2007; environmental monitoring program meets the requirements in 10 CFR 20.1502; recordkeeping program meets the requirements in 10 CFR 20.2103; and the additional program commitments provide assurance that NIST will comply with the 10 CFR 20.2202, 20.2206 and 70.74 regulatory requirements.

The NRC staff also finds that, while NIST has an established radiation safety committee (i.e.,

the IRSC) in accordance with the requirement in 10 CFR 33.13(c)(1), it has also committed to establish additional administrative controls and requirements, in accordance with the guidance in NUREG-1556, Consolidated Guidance About Materials Licenses, Volume 11, Program-Specific Guidance About Licenses of Broad Scope (ML17059D332), for increased flexibility in decision making. This flexibility would allow NIST to make changes within the scope of their license provided that such changes are in accordance with regulatory requirements, will not change license conditions, will not decrease the effectiveness of NISTs safety programs, and are adequately evaluated and documented. This flexibility would improve the efficiency of the NRC review, approval, and issuance by requiring amendments for only substantive changes to the license application. This flexibility should be documented by amending the SNM-362 license to include the following Condition (17):

17. The licensee may make changes to its NRC-regulated programs provided that the changes are in accordance with regulatory requirements, will not change license conditions, will not decrease the effectiveness of the program, and the changes are documented.

The NRC staff finds that NISTs RPP and commitments, as described in its LRA, provide reasonable assurance that public health and safety and the environment will be adequately protected during the requested 10 years period licensing term and that it meets the requirements in 10 CFR 20.1101 and applicable requirements in 10 CFR Parts 19, 20, and 70 and, as such, is acceptable.

The NRC staff also finds that NIST has adequately justified the required exemptions from the requirements in 10 CFR 36.23(b) and (c), and 36.31(a) and that the specific exemptions requested by NIST meet the requirements in 10 CFR 36.17, Applications for exemptions, (a),

and 10 CFR 70.17, Specific exemptions, (a), and, therefore, should continue as previously granted to NIST by the NRC for the 10-year license renewal period.

43 4.0 NUCLEAR CRITICALITY SAFETY 4.1 Purpose of Review The (U.S. Nuclear Regulatory Commission (NRC) staff performed a detailed technical review of the U.S. Department of Commerce, National Institute of Standards and Technology (NIST) license renewal application (LRA) to ensure that the statements and commitments described within the LRA are consistent with the applicable Nuclear Criticality Safety (NCS)-related requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 70 and to ensure that the risk of inadvertent criticality is adequately managed.

4.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the applicable requirements in 10 CFR and associated guidance presented in section 3, Nuclear Criticality Safety, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087), as well as applicable portions of NUREG/CR-6698, Guide for Validation of Nuclear Criticality Safety Calculational Methodology and the following regulations in 10 CFR Part 70:

10 CFR 70.22, Contents of applications; 10 CFR 70.33, Applications for renewal of licenses; 10 CFR 70.24, Criticality accident requirements; 10 CFR 70.50, Reporting requirements; and 10 CFR 70.52, Reports of accidental criticality.

NIST described its NCS program and associated commitments in chapter 3.0 of its LRA. While NIST requested the possession, use, and storage of SNM, its proposed activities do not include enriched uranium processing, fabrication of uranium fuel or fuel assemblies, uranium enrichment, enriched uranium hexafluoride conversion, plutonium processing, fabrication of mixed-oxide fuel or fuel assemblies, or scrap recovery of SNM. Therefore, the criticality safety-related requirements of 10 CFR Part 70, Subpart H, do not apply.

4.2.1 Use of Industry Standards In section 3.1, Use of Industry Standards, NIST committed to follow the American National Standards Institute/American National Standard ANSI/ANS-8.19-2014, Administrative Practices for Nuclear Criticality Safety, for the administration of its NCS program. NIST further stated that no other standard is used for conducting its NCS Program.

4.2.2 Criticality accident alarm system requirements In section 3.5, Organization and Administration of the NCS Program, of its LRA, NIST stated that it has historically been granted an exemption from the requirement to maintain a Criticality Accident Alarm System (CAAS) and the associated response procedures due to the administrative controls mentioned in the previous sections. NISTs LRA included a request for the continued exemption from the 10 CFR 70.24 CAAS requirements (see section 4.2.2.1, CAAS Exemptions or authorizations, below). The request was discussed in Enclosure 2

44 (ML23220A401) of NISTs LRA.

4.2.2.1 CAAS Exemptions or authorizations The regulations in 10 CFR 70.24, Criticality accident requirements, (a) require that each licensee authorized to possess a critical mass of SNM, as defined in 10 CFR 70.4, maintain a criticality accident alarm system (CAAS) that is capable of detecting a criticality that produces an absorbed dose in soft tissue of 20 rads (combined neutron and gamma radiation) at an unshielded distance of 2 meters from the reacting material within one minute for all areas in which such licensed SNM is handled, used, or stored. Such areas must be covered by two detectors.

NIST is subject to the requirements of 10 CFR 70.24(a) given its possession of SNM quantities exceeding a critical mass (i.e., greater than 450 g combination of 233U, 235U, and Pu) as defined by 10 CFR 70.4. However, the current SNM-362 license grants an exemption from the requirements of 10 CFR 70.24(a), and in its LRA, NIST requested that the exemption be carried forward to the renewed license. NISTs exemption request is based on the low mass quantities of SNM it has requested authorization to continue to possess, the number of individual sources of SNM, laboratory segregation, and inventory controls. As discussed above, the NRC staff determined that no credible criticality hazards exist for the requested materials, quantities, and activities described in the LRA.

In accordance with 10 CFR 70.17, Specific exemptions, the Commission may grant exemptions from the requirements in 10 CFR Part 70 if determined to be authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. Nothing in the NRCs regulations or in any other law prevents the NRC from granting an exemption from the requirements of 10 CFR 70.24(a); therefore, an exemption from the requirements of 10 CFR 70.24(a) is authorized by law. As discussed in this safety evaluation the NRC staff determined that no credible criticality hazards exist for the requested materials, quantities, and activities described in the LRA. Given there is no credible criticality concern, the installation and maintenance of a CAAS would not provide a meaningful reduction in risk to workers or the public; therefore, the absence of CAAS monitoring in this context would not endanger life or property or the common defense and security. The NRC staff determined that an exemption from the requirements of 10 CFR 70.24(a) would otherwise be in the public interest because NIST is a public entity possessing SNM to conduct research activities. Such an exemption would preserve resources for NIST as it will not have to install and maintain a CAAS, which as discussed above, is not necessary for reasonable assurance of safety in this context.

In sum, the NRC staff determined that NISTs request for exemption from the requirements of 10 CFR 70.24(a) remains acceptable, is authorized by law, and will not endanger life or property or the common defense and security and is otherwise in the public interest.

4.2.3 Emergency Planning and Response In section 3.3, Emergency Planning and Response, of its LRA, NIST stated that it is not subject to the requirement for an Emergency Plan (EP) pursuant to 10 CFR 70.22(i)(1)(ii).

Section 10 of NISTs LRA further discussed the justification for not requiring an EP (see additional discussion in section 12, Emergency Management, of this document).

45 4.2.4 Subcriticality and Double Contingency Principle In section 3.4, Subcriticality and Double Contingency Principle, of its LRA NIST stated that it uses criticality controls to meet the requirements of 10 CFR 70.22(a)(8), which mandates procedures to avoid and mitigate accidental criticality events to protect health and minimize danger to life or property. NIST also stated that discrete sources exceeding the Nuclear Materials Management and Safeguards System reporting mass are segregated into three reporting areas in three separate buildings and that it is committed to practices to ensure that, by applying the sum of the fractions rule, no combination of fissile uranium and plutonium exceeding eighty (80) percent of a critical mass, as specified in 10 CFR 70.4, shall be used, or stored at any single location. NIST further stated that its practices provide adequate assurance that the requirements of 10 CFR 70.22(a)(8) are met and that inventory management databases are used to maintain up-to-date totals for SNM.

4.2.5 Organization and Administration of the NCS Program In section 3.5 of its LRA, NIST stated that its NCS program meets the requirements of 10 CFR Part 70 and ensures adequate protection against the occurrence of accidental criticality with a primary focus on prevention of incidents and utilizing a graded approach that is commensurate with the complexity and scope of proposed uses. NIST also stated that its NCS Program will maintain a preestablished subcritical level, by applying the sum of the fractions rule so no combination of fissile uranium and plutonium exceeding eighty (80) percent of a critical mass, as specified in 10 CFR 70.4, shall be used, or stored at any single location. NIST also stated that its internal procedures provide guidance and procedural requirements for maintaining accurate, current, and reliable information on, and for confirming, the quantities and locations of SNM.

The NIST Director has the ultimate responsibility for ensuring the establishment and maintenance of the radiation safety and NCS programs and provides executive leadership on issues involving compliance with regulatory requirements and the conditions of the license. The Ionizing Radiation Safety Committee is responsible for the oversight of the operations and activities of NISTs ionizing radiation safety programs. The radiation safety officer (RSO) is the head of NISTs Radiation Safety Division (RSD) and, with support from the RSD staff, establishes, runs, and maintains NISTs radiation safety programs (including NCS), establishes and updates guidance, procedures, instructions, and other requirements to promote radiation safety and regulatory compliance to allow for the safe and regulatorily compliant use of ionizing radiation sources (see section 2.2.7.4, Radiation Safety Officer, and 3.2.2, Radiation Safety Officer, of this document for information on the RSO qualifications and responsibilities). NIST further stated that it has established roles carried out by a Nuclear Material Accountability Assistant, a health physicist, an Item Control Area Custodians and source custodians who, with support from the RSO, are responsible for inventorying all SNM under NIST possession and for SNM transaction control. The roles of these individuals, who have vast experience in radiation safety, are established and described in NISTs internal NCS procedures.

With regard to potential incidents, two groups at NIST, the Fire Protection Group (Emergency Services Office) and the Environmental Management Group (Office of Safety Health and Environment) have trained hazardous materials responders who work with, and supports the RSD, as necessary, to respond to incidents involving radioactive and other hazardous materials.

46 4.2.6 Nuclear Criticality Safety Program Management Measures In section 3.6, Nuclear Criticality Safety Program Management Measures, of its LRA, NIST stated that new or revised procedures that have an impact on NCS are reviewed and approved by the Radiation Safety Officer (RSO). In addition, NIST stated that the NCS program is audited internally and externally on a periodic basis.

Section 3.7 of the LRA states that SNM use requirements are periodically reviewed, and section 3.10 of the LRA states that periodic audits to evaluate the effectiveness of implementation and control parameters is performed at least annually. Section 3.4 of the LRA states that discrete sources that exceed the Nuclear Materials Management and Safeguards System reporting mass are segregated into three reporting areas in three separate buildings, and the source acquisition approval process includes checks to verify and limit source inventories and use locations to ensure that no single location can aggregate a critical mass of SNM. Section 3.4 of the LRA further states that NIST is committed to practices to ensure that, by applying the sum of the fractions rule, no combination of fissile uranium and plutonium exceeding 80% of a critical mass, as defined in 10 CFR 70.4, shall be used or stored at any single location.

4.2.7 Technical Practices for NCS In section 3.7, Technical Practices for NCS, of its LRA NIST stated that its technical practices are centered in SNM inventory management and use/storage areas segregation. NIST further stated that researchers and health physicists periodically review the basis for SNM use requirements designed to ensure criticality safety including, review of normal conditions, credible abnormal conditions, controls, and limits. NIST further assured that these practices meet the requirements in 10 CFR 70.22(a)(8) and that inventory management databases are used to maintain up-to-date totals for SNM and for evaluating proposals for moving SNM between locations.

4.2.8 Calculational Method Validation In section 3.8, Calculational Method Validation, of its LRA NIST discusses how it maintains subcriticality of its SNM. NIST stated that its NCS program will maintain a preestablished subcritical level, by applying the sum of the fractions rule and that no combination of fissile uranium and plutonium exceeding eighty (80) percent of a critical mass shall be used or stored at any single location in accordance with the requirements in 10 CFR 70.4.

4.2.9 Criticality Safety Evaluations In section 3.9, Criticality Safety Evaluations, of its LRA, NIST states that it follows guidance from American National Standards Institute/American Nuclear Society (ANSI/ANS)-8.19-2014, Administrative Practices for Nuclear Criticality Safety. This standard is endorsed by NRC in Regulatory Guide (RG)-3.71, Revision 3, Nuclear Criticality Safety Standards for Nuclear Materials Outside Reactor Cores, for developing criticality safety evaluations. NIST also committed to, once a proposed use of SNM is presented or before an operation with SNM is changed, it shall be determined and documented that the entire process will be subcritical under normal and credible abnormal conditions. NIST makes this determination by utilizing the calculational method validation discussed in section 4.2.8 of this document (see above).

47 The initial hazards analysis is performed by RSD. This initial evaluation may include direct observation of the proposed use locations and equipment. The CSEs are documented with sufficient detail to allow the IRSC sufficient judgement to review and approve. The safety evaluations for the NCS program are in line with the hazard assessments described in section 2.3.4, Hazard Assessment, of NISTs LRA, which state that the assessment, prior to using radioactive materials, must consider the following issues:

• doses and dose rates to individuals in posted areas of a radiation facility;

• doses and dose rates to members of the public;

• doses and dose rates in un-posted areas (hallways, adjacent areas, or areas outside of buildings);

• contamination or dispersion of the material outside of a radiation facility;

• contamination or dispersion of the material within a radiation facility;

• personnel contamination or uptake; and

• effluent release (airborne or liquid) of the material.

4.2.10 Evaluation and Implementation of Controlled Parameters In section 3.10, Evaluation and Implementation of Controlled Parameters, NIST discusses its parameters for NCS control. NIST stated that, at least annually, it conducts audits to evaluate the effectiveness of the NCS program implementation and control parameters. NIST further stated that, through the audits, it verifies that procedures are being followed and that process conditions have not been altered in such way to affect the criticality safety evaluations. NIST also stated that the reviews shall be conducted by individuals who are knowledgeable in criticality safety and that not immediately responsible for the operations in consultation with the researchers.

4.2.11 Additional NCS Program Commitments In section 3.11, Additional NCS Program Commitments, of its LRA, NIST stated that, since its NCS program is audited annually and that the RSD has a robust corrective action program for analyzing deficiencies and documenting any actions that may be necessary and/or taken, no additional NCS program commitments are necessary. NIST further stated that facility changes that impact NCS are reviewed and approved by the IRSC.

4.2.12 Emergency Plan In section 3.12, Emergency Plan, its LRA, NIST stated that it is not subject to the requirement for an Emergency Plan (EP) pursuant to 10 CFR 70.22(i)(1)(ii). Section 10 of NISTs LRA further discussed the justification for not requiring an EP (see also the discussions in sections 3.6, Operating and Emergency Procedures, 4.2.3, Emergency Planning and Response, and section 12, Emergency Management, of this document).

4.3 Evaluation Findings

Based on the review of the information provided by NIST and as discussed in this report, the NRC staff concludes that NISTs LRA provides reasonable assurance of subcriticality under normal and all credible abnormal conditions, provides reasonable assurance of adequate protection against the risk of criticality accidents, and otherwise satisfies the applicable NCS-related requirements in 10 CFR Part 70.

48 Additionally, the NRC staff concludes that the exemption from the requirement in 10 CFR 70.24(a) for maintaining a CAAS, is in accordance with 10 CFR 70.17, it is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. As such, the NRC staff finds that NISTs request to continue to be exempted from this requirement is acceptable.

The NRC staff determined that NIST has committed to follow ANSI/ANS-8.19-2014, Administrative Practices for Nuclear Criticality Safety, for the administration of its NCS program. In addition, the NRC staff determined that NISTs request to renew its SNM-362 license does not present any credible criticality hazards, does not represent any substantial changes to SNM material composition, quantities, or activities, and does not present any new or revised normal or credible abnormal conditions beyond those previously evaluated by the NRC staff as part of the 2013 license renewal. The staff also determined that, consistent with the NRC staffs previous conclusions, as documented in the September 10, 2013, Safety Evaluation Report for the [SNM] License SNM-362 Renewal Application (ML13212A132), that NISTs NCS program is adequate to provide reasonable assurance for the protection of public health and safety and the environment and meets the applicable NCS-related requirements of 10 CFR Part 70.

5.0 CHEMICAL SAFETY 5.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) staff conducted a review of the U.S.

Department of Commerce, National Institute of Standards and Technology (NIST) license renewal application (LRA) to determine if there is reasonable assurance that NIST will adequately protect workers, the public, and the environment from chemical hazards of licensed material and hazardous chemicals produced from licensed material. This section of this document discusses the staffs review and evaluation of NISTs program for identifying and managing chemical hazards that could arise from the activities NIST will conduct under special nuclear materials license 362 (SNM-362). The review focused on licensee commitments made in the NIST LRA related to the identification and management of the potential chemical hazards for activities that are regulated under the SNM-362 license.

5.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the applicable regulatory requirements in 10 CFR Parts§ 70.22(a)(2), 70.22(a)(6), 70.22(a)(7), 70.22(a)(8), 70.23(a)(2),

70.23(a)(3), 70.22(a)(4), and associated guidance presented in section 4, Chemical Safety, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087). The discussion below identifies the information required to be provided in a license application and the requirements for the NRCs approval of applications, respectively. The review focused on those areas identified in the regulations (i.e., applicant qualifications, equipment and facilities, procedures) to the extent they support the identification and management of chemical hazards under NRCs regulatory jurisdiction.

49 5.2.1 Review areas 5.2.1.1 Proposed activities In section 4, Chemical Safety, of its LRA, NIST stated that its primary mission is as a measurement science, standards, and technology laboratory and that materials are primarily used for research and development, calibration and testing, and training. Approved activities involving the use of licensed materials that may pose a chemical hazard include chemical analyses to measure radioisotopes and preparation of isotopic standards or calibration solutions. Authorized uses are primarily activities associated with the development and maintenance of radiation measurement standards, radioactivity assessment, the provision of radiation measurement services, and the study of radiation interactions and processes in materials. There shall be no authorizations for intentional administration of radiopharmaceuticals or intentional direct exposures of human or live animal subjects (i.e., no medical 10 CFR Part 35 or veterinary uses).

Management of hazardous chemicals are generally designed to meet both the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200) and the OSHA Occupational Exposure to Hazardous Chemicals in Laboratories Standard (29 CFR 1910.1450, i.e., Lab Standard), which requires employers to, among others, develop and implement a written Chemical Hygiene Plan, establish standard operating procedures, require personal protective equipment, use engineering controls (such as chemical fume hoods), establish waste disposal procedures, and monitor the work environment for chemicals. All of the work with licensed materials involving potential chemical hazards meets the OSHA definition of laboratory use of hazardous chemicals4 and falls under the Lab Standard. Laboratory scale operations are limited to amounts that can be easily and safely manipulated by one person.

5.2.1.2 Applicants qualifications NISTs IRSC (or a subcommittee with the relevant expertise and technical backgrounds, as appointed by the IRSC) approves and authorizes all uses of licensed material based on the safety evaluations of proposed work (e.g., research analyses, preparation of radioactive standards or calibration solutions) to ensure that the work is safely conducted, and that mitigation plans for avoiding exposures and/or maintaining radiation doses ALARA are adequate. The safety evaluations are conducted by the Radiation Safety Division (RSD) with assistance from subject matter experts (SME) at NIST (i.e., chemists, radiochemists, health physicists, others as needed) as approved by the IRSC.

When conducting their evaluations, the SMEs must consider all hazards associated with the proposed work, including chemical hazards in addition to the training and experience of personnel involved in the operations (e.g., source custodians and source users). NIST further stated that all staff who work with chemicals are required to be trained on the NIST Chemical Management Plan (the hygiene plan) and the OSHA Hazards Communication Standard (29 CFR 1910.1200) requirements before the proposed work is conducted. NISTs hygiene plan defines the procedures for protecting employees and covered associates from the health and 4 OSHA defines "laboratory use of hazardous chemicals" as the handling or use of chemicals in a laboratory setting where chemicals are handled on a "laboratory scale," multiple chemicals or procedures are used, procedures are not part of a production process, and protective laboratory practices and equipment are available and used to minimize employee exposure.

50 physical hazards presented by chemicals and for keeping exposures to hazardous chemicals below the OSHA and the American Conference of Governmental Industrial Hygienists permissible exposure limits. The training and experience of personnel involve in the operations (e.g., source custodian and source user) are reviewed and approved by the independent IRSC.

The makeup of the IRSC and the minimum qualifications for the IRSC members are identified in the LRA (see discussion on the makeup of the IRSC in section 2.2.7.3, Ionizing Radiation Safety Committee, of this document. See also section 3.2.1.3, Ionizing Radiation Safety Committee, of this document for the discussion on the IRSC members qualifications).

5.2.1.3 Proposed equipment and facilities NIST states that work on unsealed sources that involve hazardous material are typically conducted in chemical fume hoods and that eyewashes and safety showers are also available.

Chapter 4 of the LRA discusses controls that are available to minimize chemical exposures.

These controls include consideration of less hazardous alternative chemicals, administrative controls such as training on safety data sheets and hazard classes, proper labeling of chemicals, and following safe operating practices or procedures. NIST also stated that, based on the specific hazards and use scenarios, safe use protocols must specify when engineering controls, e.g., chemical fume hoods or glove boxes, are needed, and the type of personal protective equipment required, e.g., gloves, lab coats, eye protection. Typically, a combination of controls is required to work safely. Required controls are specified in the procedures that describe the conduct of work and are part of the safety evaluation 5.2.1.4 Proposed procedures In its LRA, NIST commits to the use of written procedures for operations and emergency response. It also commits to the preparation of a safety evaluation for proposed work that includes operating procedures and safety control and to the independent review of the safety evaluation by the IRSC. The IRSC reviews and approves all operations and changes to operations. The IRSC review process takes into consideration all hazards associated with the proposed work including chemical hazards. The LRA states that IRSC approval of proposed activities indicates that the IRSC concludes that proposed procedures adequately specify controls to protect the user from exposure to chemical hazards and minimize the potential for property damage. The application also commits to the verification of functioning of required safety equipment.

The NRC staff reviewed NISTs safety evaluation for proposed facility procedures changes. For this purpose, NIST granted NRC staff access to its internal procedures database. The NRC staff reviewed NISTs report titled Analysis of Large Alpha-Emitting Solid Source SRM/CRM and PT Materials, which discussed NISTs activities and operations, and the safety issues associated with the activities. There are multiple instances where the evaluation identified chemical hazards, both toxic [e.g., hydrogen fluoride (HF), perchloric acid (HClO4)] and reactive (e.g.,

hydrazine, perchloric acid, organic ion exchange resins)]. The document called out the need for calcium gluconate to be available for operations that use HF or ammonium bifluoride (NH4F2).

The evaluation specifically noted the potential for incompatible materials in several activities.

The document also noted that in some instances the chemical hazard could be greater than the radiological hazard. The document noted the need for special chemical safety training for some operations. Overall, the staff finds that the identification of chemical hazards for the various activities is consistent with the commitment in the application.

The NRC staff also reviewed the NRC Nuclear Material Events Database (https://nmed.inl.gov/)

51 for events at the NIST facility that involve chemical hazards. The review did not identify any events that involved chemical hazards or events that could have been precursors to chemical hazards.

The NRC staff noted that the SNM-362 license authorizes possession of a very small quantity of UF6, which can present significant chemical hazards from both toxicity and reactivity standpoints. During the February 6, 2024, NRC staff visit, NIST staff noted that NIST will be disposing of this material in the future.

5.3 Evaluation Findings

Based on the information provided by NIST and as discussed above, the NRC staff finds that NISTs chemical safety program adequately supports the identification and control of chemical hazards associated with licensed material activities that would be authorized under the proposed renewed license. The NRC staff also finds that NIST adequately:

described the proposed activities and potential chemical hazards that are within the NRCs regulatory authority, in accordance with the requirements in 10 70.22(a)(2);

adequately discussed the technical qualifications of its staff, in accordance with the requirements in 10 CFR 70.22(a)(6);

described the equipment and facilities that it will use to protect health and minimize danger to life or property, in accordance with the requirements in 10 CFR 70.22(a)(7);

and described the proposed procedures that would be used to protect health and minimize danger to life or property, in accordance with the requirements in 10 CFR 70.22(a)(8).

The NRC staff finds that NISTs commitments to conduct safety evaluations for new or revised operations which includes assessment of chemical hazards, to identify appropriate controls for managing chemical hazards, and to use written operating procedures provide reasonable assurance that there will be adequate protection of health and minimization of danger to life or property from chemical hazards that are under NRCs regulatory jurisdiction. The NRC staff finds that NISTs chemical safety program, as described in its LRA, meets the requirements in 10 CFR 70.23 and, therefore, NISTs LRA should be approved.

6.0 FIRE SAFETY 6.1 Purpose of Review The purpose of this fire safety review is to determine whether the U.S. Department of Commerce, National Institute of Standards and Technology (NIST) license renewal application (LRA) and supplemental letters provide reasonable assurance of adequate fire protection of workers, the public, and the environment from fire hazards that are under the U.S. Nuclear Regulatory Commissions (NRCs) regulatory jurisdiction.

6.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the regulatory requirements in 10 CFR 70.22, Contents of Applications, (a)(6) through (8) and 10 CFR 70.23, Requirements for the approval of applications, (a)(3) and (4) and associated guidance presented in section 5, Fire Safety, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70

52 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087). The National Fire Protection Association (NFPA) National Fire Codes are also used, as appropriate, to evaluate a reasonable assurance of fire safety.

6.2.1 Facility design In section 5, Fire Protection, of its LRA, NIST stated that the primary buildings where radioactive materials are used, possessed, or stored are built with noncombustible materials.

With the LRA, NIST provided building layouts showing the buildings fire safety features and specifications. NIST further stated that the buildings were recently renovated in accordance with the 2015 International Code Council suite of codes and NFPA codes described in section 5 of NISTs LRA.

The NRC staff reviewed NISTs building layouts and determined that the layouts appropriately describe the buildings fire safety features. In addition, the NRC staff confirmed that NISTs facilities comply with the applicable building code regulations and that all laboratory renovations and all building construction, renovations, and that its operations are reviewed by the NISTs Fire and Facility Safety Group, including a fire alarm system administrator who is cross trained in sprinkler system and the Life Safety Code, one mechanical engineer, one electrical safety engineer, and six fire protection engineers. The NRC staff also determined that NIST adequately described the fire protection features and measures it has in place for the protection of its workers, public health and safety, and the environment from radiation hazards that could result from potential fires.

6.2.2 Fire protection 6.2.2.1 Fire protection systems In section 5.2, Fire Protection, of its LRA, NIST stated that, (a) Building 245 is equipped with a fire suppression system, an emergency lighting system, and an egress systems per NFPA 101, Life Safety Code, and a fire alarm system per NFPA 72, National Fire Alarm and Signaling Code, and that all renovated portions of the building are fully sprinklered per NFPA 13, Standard for the Installation of Sprinkler Systems, and, (b) the new irradiator facility is equipped with a fire extinguishing system that was designed with a separate double interlock pre-action system activated by separate heat and smoke detectors, and the portable fire extinguishers are located throughout the facility per NFPA 10, Standard for Portable Fire Extinguishers. Additionally, the building stairwells have standpipe connections; fire hydrants are located at various positions on the exterior of buildings.

In section 5.2 of its LRA, NIST stated that Building 235 is similarly equipped with the emergency lighting, a fire alarm system, a smoke detection system, and an early warning air aspirating smoke detection system, and is partially sprinklered but equipped with a full detection system in areas that are not sprinklered.

The NRC staff finds that NISTs description of the fire protection systems installed at Buildings 235 and 245, respectively, is appropriate. The fire protection system at NIST includes smoke detection, heat detection, manual fire alarm pull-boxes, standpipes, and sprinkler systems. The NRC staff confirmed that fire protection systems are maintained by NISTs Office of Facilities

53 and Property Management in accordance with applicable NFPA codes and the on-campus Fire Department ensures a quick response in the event of an emergency.

6.2.2.2 Employee training In section 5.2.2 of its LRA NIST noted that training is discussed in section 2 of the LRA. Section 2.1.4, Radiation Safety Training, of the LRA lists the training that NIST staff should receive in accordance with the requirements in 10 CFR Part 19. The list includes training in fire and other non-radiological safety and emergency response procedures, including emergency reporting, egress, and personnel accountability, and is commensurate with the staff duties and responsibilities, and their degree of access (i.e., full vs. limited) to sources of ionizing radiation prior to receiving approval to work independently with RAM or other sources of ionizing radiation. Fire training covers the general topics found in NUREG 1556, Volume 11, Rev. 1, Appendix K on minor and major fires and any other fire safety related topics.

6.2.2.3 Emergency response In section 5.2.3, Emergency Response, of its LRA NIST its fire protection and fire emergency response program. NIST stated that its Fire Department conducts fire drills and shelter in-place drills annually for all buildings on the NIST Gaithersburg campus and also has a mutual aid agreement with Montgomery County, Maryland. The NIST Fire Department staffs a minimum of five full-time Federal employee firefighters on site per day who are provided with two class A engine pumpers which both carry 1,000 gallons of water. The pumpers have a 1,250 and 2,000 gallon per minute pump. All NIST firefighters are certified Emergency Medical Technicians, Firefighter 2, Hazmat Materials Technicians, and Confined Space Technicians. Also, each NIST firefighter is a certified fire inspector which enables the monthly fire inspection of each building on the NIST campus. Additionally, all NIST firefighting staff are provided with radiation safety training.

6.2.3 Process fire safety In section 5.3, Process Fire Safety, of its LRA, NIST stated that, compliant with NFPA codes, flammable and combustible liquid containers at NIST are limited in size, and quantities above the allowable limit are stored in flammable liquid storage cabinets. Storage of combustible is regulated by NISTs Inspection, Testing, and Maintenance of Fire Protection and Life Safety Systems Program.

In section 5.3 of the LRA 2023, NIST stated that, (a) any hot work at NIST needs to meet the requirements of NISTs Fire Prevention During Welding, Cutting, and Other Hot Works Program and, (b) users and their managers must complete in-house training and the activity is reviewed during a permitting process for safe practice by the Fire and Facilities Safety Group.

Additionally, operation of cranes or other activity that requires impairment of a fire safety system is permitted through the requirements of NISTs Impairment of Fire Protection and Life Safety Systems Program, to ensure there are other means of protection or that the activity has safeguards such as a fire watch to ensure fire safety.

The NRC staff confirmed that the applicant will continue the current Fire Protection Program, Workplace Inspection Program, and Inspection, Testing, and Maintenance of Fire Protection and Life Safety Systems Program, which were reviewed by the NRC. The NRC staff, therefore, finds that NISTs facilities have complied with the applicable building code regulations for Federal buildings.

54 6.2.4 Combustible Loading and Potential Fire Scenarios In section 5.4, Combustible Loading and Potential Fire Scenarios, of its LRA NIST its combustible loading practices for minimizing the occurrence of potential fires. NIST stated that combustible loading within buildings is maintained in several ways. Chemicals are entered and tracked in a Chemical Inventory Management System. NIST complies with NFPA 30, Flammable and Combustible Liquids Code, 45, Standard on Fire Protection for Laboratories Using Chemicals, and 55, Compressed Gases and Cryogenic Fluids Code, for storage of chemicals, compressed gases, and cryogenic fluids.

Storage of combustible items is maintained and limited through regulation, inspection, and maintenance. NISTs inspection, testing, and maintenance of Fire Protection and Life Safety Systems Program regulates what is permitted to be stored in corridors.

NIST has a Workplace Inspection Program through which NISTs Office of Safety, Health, and Environment staff ensures general safety measures are followed. Any deviation is cited for Organizational Unit correction. A janitorial service ensures that trash is collected and disposed of weekly from labs and offices. Each building is equipped with either a sprinkler system or a full fire detection and alarm system.

Control areas and noncombustible construction ensure that the facilities are reasonably protected from fires and explosions that would be expected to spread or be uncontrolled. The on-campus Fire Department ensures a quick response in the event of an emergency.

6.3 Evaluation Findings

The NRC staff reviewed the information provided by NIST in its LRA and supporting letters and, based on this review, determined that NISTs fire protection program provides reasonable assurance for adequate protection against fires and explosions that could affect the safety of licensed materials. The NRC staff finds that, in accordance with the requirements of 10 CFR 70.22(a)(6)-(8), NISTs LRA adequately:

discussed the SNM locations and physical barriers separating the material with applicable fire ratings; described of the facilitys building construction, fire area determination, fire rated walls and opening protection, electrical installation, lightning protection, emergency lighting, life safety and egress, ventilation systems, and fire water drainage; discussed its fire protection systems (i.e., suppression, alarm, and detection);

described the protection for laboratory equipment that may handle nuclear material (e.g.,

glove boxes, hot cells, fume hoods);

discussed its inspection, testing, and maintenance of fire protection systems; discussed its fire safety training requirements; discussed its emergency response capabilities for the facility, including the proximity, qualifications, training of the responding fire department, pre-fire coordination with the fire department (e.g., fire drills, hazardous materials training), and the water supply for firefighting; discussed chemical processes that may present a fire hazard in radiological areas; and described any potential combustible loading, possible fire scenarios, and safety controls.

Therefore, the NRC staff concludes that the information in NISTs LRA meets the requirements in 10 CFR 70.22, Contents of applications, and provides reasonable assurance that adequate

55 fire protection will be provided to meet the safety performance requirements in 10 CFR 70.23, Requirements for the approval of applications, (a)(3) and (4).

7.0 NATIONAL ENVIRONMENTAL POLICY ACT AND ENVIRONMENTAL PROTECTION 7.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) conducted this review in accordance with the guidance in NUREG-1748, Environmental Review Guidance for Licensing Actions Associated with NMSS Programs (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML032450279) and NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (ML22335A087) to determine whether the renewal of special nuclear materials license number 362 (SNM-362) for the U.S.

Department of Commerce, National Institute of Standards and Technology (NIST) requires the development of an Environmental Assessment (EA) or an Environmental Impact Statement (EIS), or if it is an action that falls within a category of actions listed in Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 51.22, Criterion for categorical exclusion; identification of licensing and regulatory actions eligible for categorical exclusion or otherwise not requiring environmental review, (c). These are licensing actions that the U.S. Nuclear Regulatory Commission (NRC) has determined that are excluded from the requirements to prepare an EA or EIS.

The NRC staff also conducted this review to determine whether NISTs Environmental Protection Program and measures are adequate to protect the environment and public health and safety and meets the environmental protection requirements in 10 CFR Parts 20 and 70.

7.2 Staff Review and Analysis 7.2.1 National Environmental Policy Act: Classification of Regulatory Action The National Environmental Policy Act of 1969 (NEPA) was enacted by Congress to ensure Federal agencies consider the environmental impacts of their actions and decisions. Federal agencies are required to systematically assess the environmental impacts of their proposed actions and consider alternative ways of accomplishing their missions, which are less damaging to and protective of the environment. The regulations in 10 CFR Part 51 implement NEPA and contain environmental protection regulations applicable to NRC's domestic licensing and related regulatory functions.

7.2.2 Environmental Protection Program The NRC staff reviewed NISTs environmental protection program to determine whether its proposed environmental protection measures are adequate to protect the environment and public health and safety and to comply with the regulatory requirements in 10 CFR Part 20.

In section 2.3.7, Unsealed Source Radiation Facilities, of its LRA, NIST stated that most laboratories authorized for unsealed source work qualify as Type II laboratories5 and that laboratories approved for the use of unsealed radioactive materials having activities above those listed in 10 CFR 20 appendix C, Quantities of Licensed Material Requiring Labeling, 5 See Handbook of Health Physics and Radiological Health, Third Edition, 1999, Activity Limits for Use of Radionuclides in Various Types of Workplace - Chapter 11.

56 shall, at a minimum, meet the requirements of a Type I laboratory.6 Most of NISTs radiochemistry laboratories are equipped with chemical fume hoods or other forms of local exhaust ventilation. The hoods may be configured with high efficiency particulate air filters as required when source term analysis or measurement indicates the need for filtration to ensure effluent control. Hoods approved to be used for radioiodine standards preparation may be configured with activated charcoal filters for the duration of the batch operations when source term analysis or measurement indicates the need for filtration to ensure effluent control.

Certain specialty hoods designed for significant use of acids are provided with scrubber wash down systems. Chemical fume hoods required to be used for control of radiological operations shall be monitored quarterly for flow velocity. Any chemical fume hood failing to meet the required average minimum face velocity of 80 linear feet per minute shall be taken out of service and operations suspended until appropriate corrective action is taken.

In section 6.1, Classification of Licensing and Regulatory Actions, of its LRA, NIST stated that all gaseous and liquid effluents will be subject to appropriate effluent monitoring and controls as needed. In section 2.3.7, Unsealed Source Radiation Facilities, of its LRA, NIST stated that any laboratory operations determined to have significant potential for exceeding 10% of the 10 CFR 20, appendix B, Table 2, release limitations shall be monitored on an as needed basis and that building 245 is equipped with holding tanks that collect liquids from specific sinks and floor drains in some radiochemistry laboratories. NIST further stated that liquid from these tanks shall be sampled and analyzed to ensure compliance with effluent release limitations in 10 CFR 20, appendix B, Table 3, prior to any release to the sanitary sewer.

With regard to personnel contamination, in section 2.3.7, Unsealed Source Radiation Facilities, of its LRA NIST also stated that contamination monitors (e.g., hand and foot monitors) are placed in the near vicinity of some unsealed source radiation facilities, and that survey instruments are available at key locations for use in unsealed source radiation facilities.

Personnel contamination monitoring or surveying with hand-held detectors shall be required following work with moderate and/or high-level unsealed radioactive sources. Section 2.5, Operating and Emergency Procedures, of its LRA discusses NISTs operating and emergency procedures that provide instructions on contamination controls, personnel and area monitoring, reporting and recording requirements, and waste disposal practices.

7.3 Evaluation Findings

7.3.1 Classification of Regulatory Action: NEPA Requirements The NRC staff determined that the renewal of NISTs materials license, which is being issued pursuant to the requirements in 10 CFR Parts 30 and 70 (among others) for research and development and for educational purposes, meets the categorical exclusion in 10 CFR 51.22(c)(14)(v). Therefore, the NRC staff finds that the renewal of the SNM-362 license for NIST exempt from the requirement to prepare an EA or an EIS.

7.3.2 Protection of the Environment Based on the information provided by NIST, and as discussed above, the NRC staff finds that NISTs environmental protection program provides reasonable assurance that public health and 6 See Handbook of Health Physics and Radiological Health, Third Edition, 1999, Activity Limits for Use of Radionuclides in Various Types of Workplace - Chapter 11.

57 safety and the environment will be adequately protected. Although most of the radioactive sources to be possessed and used by NIST under the SNM-362 license are sealed, authorized unsealed sources will be used in accordance with NISTs approved radiation safety procedures, effluents will be monitored as needed to ensure effluent control, and NISTs personnel will be required to follow NISTs approved procedures when working with moderate and/or high-level unsealed radioactive sources. The NRC staff also finds that the likelihood of contamination from NISTs operations involving SNM sources is minimal.

Therefore, based on its review of the information provided by NIST in its LRA, and as discussed above, the NRC staff finds that NISTs environmental protection program provides reasonable assurance that, during the renewed license term, it will meet the requirements of 10 CFR 20.1101, 20.1406, and 20.2007 for protecting the environment.

8.0 MATERIAL CONTROL AND ACCOUNTING 8.1 Purpose of Review The purpose of this review is to determine whether the information provided by the U.S.

Department of Commerce, National Institute of Standards and Technology (NIST) in its license renewal application (LRA) meets the requirements in Title 10 of the Code of Federal Regulations (10 CFR) section 70.22(b) and whether the NIST material control and accounting (MC&A) practices are adequate to detect and protect against the loss, theft, or diversion of special nuclear material (SNM) that NIST possesses, stores, and utilizes at its facility, and to comply with the applicable regulatory requirements in 10 CFR Part 74, Material Control and Accounting of Special Nuclear Material.

8.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the applicable regulatory requirements and associated guidance presented in section 7, Material Control and Accounting, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087).

In accordance with 10 CFR 70.22(b), certain applicants requesting a license to possess SNM must submit a full description of their program for the control and accounting of SNM in the applicants possession and to show compliance with 10 CFR 74.31, 74.33, 74.41, or 74.51, as applicable. However, the requirements in 10 CFR 70.22(b) apply to licenses to possess SNM in a quantity exceeding 1 effective kilogram. Additionally, 10 CFR 70.22(b) contains an exclusion for licensees governed by 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, including non-power reactors (e.g., research and test reactors), and for uses of SNM as sealed sources. The same applicability and exclusions are contained in the MC&A requirements in 10 CFR Parts 74.31, 74.33, 74.41, or 74.51, which contain specific control and accounting requirements for certain licensees, depending on the different types and quantities of SNM in possession.

In its LRA, NIST stated that its primary mission is to conduct measurements science, standards, and technology laboratory work, and that the SNM in radiation sources authorized to possess and use under SNM-362 is used for research and development, calibration and testing, and training activities. In section 2.3, Facilities and Equipment, of its LRA, NIST describes the

58 facilities and equipment that house the sealed sources and their uses in performing licensed activities. Consistent with the applicability and exclusion in 10 CFR 70.22(b), NIST is not subject to the MC&A requirements in 10 CFR 74.31, 74.33, 74.41, and 74.51 because it possesses less than one effective kilogram, and applications for use of SNM in the form of sealed sources are excepted.

The MC&A requirements applicable to NIST are contained in 10 CFR Part 74, Subpart B, General Reporting and Recordkeeping Requirements. Licensees who possess, transfer, or receive SNM in a quantity of one gram or more of contained uranium-235, uranium-233, or plutonium are subject to the applicable general reporting and recordkeeping requirements of 10 CFR 74.11, 74.13, 74.15, and 74.19. The following discussion identifies each of the applicable MC&A requirements and summarizes the Nuclear Regulatory Commission (NRC) staffs evaluation as to whether the information provided by NIST in the LRA meets the above listed regulatory requirements.

8.2.1 Reports of loss or theft or attempted theft The regulation in 10 CFR 74.11 requires that each licensee who possesses 1 gram or more of contained uranium-235, uranium-233, or plutonium is to notify the NRC Operations Center within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of discovery of any loss or theft or other unlawful diversion of SNM which the licensee is licensed to possess, or any incident in which an attempt has been made to commit a theft or unlawful diversion of SNM.

In section 7.1, Reports of Loss of Theft or Attempted Theft of SNM, of its LRA, NIST states that the Gaithersburg Radiation Safety Division (RSD) has established procedures which identify the reporting, investigation, and resolution of missing SNM, including instances arising from errors. NIST further states that it will provide notification to the NRC Operations Center within 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of discovery of an event of any lost, stolen, or unlawfully diverted SNM, including attempts, in accordance with 10 CFR 74.11. NIST further states that it maintains SNM reporting requirements in accordance with 10 CFR 74.11.

The NRC staff reviewed NISTs description of its process for notifying the NRC of the loss, theft, or diversion of SNM. NIST affirms that activities are performed as to ensure compliance with the reporting requirements in 10 CFR 74.11. Based on its review of this information, the NRC staff determined that NISTs MC&A measures include adequate procedures to ensure that the NRC is notified in a timely manner in the event of a loss, theft, or diversion of SNM. Therefore, the NRC staff finds that NIST meets the requirement of 10 CFR 74.11.

8.2.2 Material status reports The requirement in 10 CFR 74.13(a) states that each licensee possessing SNM in a quantity totaling one gram or more of contained uranium-235, uranium-233, or plutonium must complete and submit, in computer-readable format Material Balance Reports concerning SNM that the licensee has received, produced, possessed, transferred, consumed, disposed, or lost. The Physical Inventory Listing Report must be submitted with each Material Balance Report. Each licensee shall prepare and submit the reports as specified in the instructions in NUREG/BR 0007, Instructions for the Preparation and Distribution of Material Status Reports (DOE/NRC Forms 742 and 742C).

In section 7.2, Material Status Reports, of the LRA, the licensee states that the RSD maintains

59 the SNM accountability office for the license and administers the accountability system. The licensee states that the RSD prepares material status reports, including the beginning and ending inventory balances, activities such as shipments and receipts involving other facilities, and calculations for decay, transmutation, and production. The licensee states that the RSD reports SNM transactions and balances to the Nuclear Materials Management and Safeguards System (NMMSS) for each Reporting Identification Symbol in accordance with NUREG/BR-0007. The licensee states that the RSD procedures ensure that reports are made and filed within the required time periods to NMMSS, the National Source Tracking System, and the Department of Energy (DOE), as applicable. The licensee states that NIST maintains SNM reporting requirements in accordance with 10 CFR 74.13.

The NRC reviewed NISTs description of preparing and submitting material status reports. In its LRA, NIST affirms that activities are performed to ensure compliance with the reporting requirements of 10 CFR 74.13. Based on the review of this information, the NRC staff has determined that the licensees MC&A measures include adequate procedures to ensure that material status reports are prepared and submitted as required. Therefore, the NRC staff finds that NIST meets the requirement in 10 CFR 74.13(a).

8.2.3 Nuclear material transaction reports The regulations in 10 CFR 74.15 require that each licensee who transfers or receives SNM in a quantity of one gram or more of contained uranium-235, uranium-233, or plutonium is to complete, in computer-readable format, a Nuclear Material Transaction Report. In addition, each licensee who adjusts the inventory in any manner, other than for transfers and receipts, shall submit a Nuclear Material Transaction Report, in computer-readable format, to coincide with the submission of the Material Balance report. Each licensee who transfers SNM shall submit a Nuclear Material Transaction Report no later than the close of business the next working day.

Each licensee who receives SNM shall submit a Nuclear Material Transaction Report within 10 days after the material is received. Each licensee shall prepare and submit the reports as specified in the instructions in NUREG/BR-0006, Instructions for Completing Nuclear Material Transaction Reports (DOE/NRC Forms 741 and 704M).

In section 2.6, Transportation, of its LRA, NIST stated that the transportation program includes procedures for the activities to receive radioactive materials and shipping of materials and waste. NIST further states that transportation activities of sources are handled in accordance with NRC guidance and regulations in 10 CFR Part 737. In section 7, Material Control and Accounting, of its LRA, NIST states that shipments of license radioactive material or devices containing licensed sources shall be coordinated with RSD to document proper packaging, labeling, and inventory control in accordance with applicable NRC regulations. NIST states that license-to-license transfer of radioactive materials to individuals or entities shall be made in accordance with appropriate NRC licenses. In section 7.3, Nuclear Material Transaction Reports, of its LRA, NIST stated that the RSD tracks licensed materials from receipt to disposal to ensure accurate accounting records. NIST also stated that physical transfers of nuclear materials between facilities and other onsite transactions such as inventory corrections are reported to NMMSS as required by 10 CFR Part 74 and NUREG/BR-0006. NIST stated that it maintains SNM reporting requirements in accordance with 10 CFR 74.15. In section 7.5, Written Material, Control, & Accounting Procedures, NIST stated that it has developed, 7 Specifically, 10 CFR 73.67(g) In-transit requirements for special nuclear material of low strategic significance, (2)ii, which requires that each licensee who receives quantities and types of special nuclear material of low strategic significance shall notify the shipper of receipt of the material as required in 10 CFR 74.15.

60 implemented, and maintains written procedures for receipt of radioactive materials, for ensuring control and accountability of license material at all times, and for maintaining records of receipt, transfer, and disposal of licensed material.

The NRC staff reviewed NISTs description for material transaction reports. NIST affirms that activities are performed to ensure compliance with the reporting requirements of 10 CFR 74.15.

Based on the review of the information provided by NIST in its LRA, the NRC staff determined that NISTs MC&A measures include adequate procedures to ensure that transfers and receipts of SNM are reported through nuclear material transaction reports as required. Therefore, the NRC staff finds that NIST meets the requirement of 10 CFR 74.15.

8.2.4 Recordkeeping The regulations in 10 CFR 74.19(a)(1)-(4) require that a licensee keep records showing the receipt, inventory (including location and unique identity), acquisition, transfer, and disposal of all SNM in its possession regardless of its origin or method of acquisition. Each record relating to material control or material accounting must be maintained and retained for the period specified by the appropriate regulation or license condition. Each record of receipt, acquisition, or physical inventory of SNM must be retained as long as the licensee retains possession of the material and for 3 years following transfer or disposal of the material. Each record of transfer of SNM to other persons must be retained by the licensee who transferred the material until the Commission terminates the license authorizing the licensees possession of the material.

The regulations in 10 CFR 74.19(d) require that records that must be maintained pursuant to this part may be the original or reproduced copy or a microform if the reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability of producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, or specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

In section 2.1.2, Radiation Safety Officer, of its LRA, NIST described the Radiation Safety Officers (RSOs) responsibilities, which include maintaining records of source acquisition, utilization, transfers, and disposal. In section 2.1.3, Authorized Users, of the LRA, NIST stated that the source custodian responsibilities with respect to material accountability include maintaining source inventory records of utilization, transfer, and disposal.

In section 7.4, Recordkeeping, of the LRA, NIST stated that it is not exempt from the recordkeeping requirements in 10 CFR 74.19(a)(1)-(4)8. In section 7.5, Written Material, Control, & Accounting Procedures, of the LRA, NIST stated that it maintains written procedures for maintaining records of receipt, transfer, and disposal of licensed material. In section 7.6, Physical Inventories, of the LRA, NIST stated that source custodians shall maintain inventory records of the licensed sources under their responsibility. In section 7.7, Records Access and Storage, of the LRA, NIST stated that it maintains adequate safeguards against tampering and 8 In an electronic communication dated April 3, 2024 (ML24096B503), NIST noted that an error was identified in its March 7, 2024, revision (1) of the LRA. In its communication NIST stated that, in section 7.4, Recordkeeping, the LRA incorrectly stated that NIST was exempt from the requirements in 10 CFR 74.19(b)-(d). Attached to the electronic communication NIST provided a corrected page number 48 NIST (ML24089A225) with this information being deleted to correct the error.

61 loss by storing records in an access-controlled facility. NIST further stated that records are legible and maintained for the minimum time periods specified in the applicable sections of 10 CFR Part 74 and license conditions. In addition, in its LRA NIST stated that the RSD shall maintain inventory records in accordance with 10 CFR 74.19, and if a retention period is not otherwise specified by regulation or license condition, the RSD shall retain the record until the NRC terminates the SNM license.

The NRC staff reviewed NISTs description for maintaining MC&A records. NIST affirms that activities are performed to ensure compliance with the recordkeeping requirements of 10 CFR 74.19. Based on the review of the information provided by NIST, the NRC staff has determined that NISTs MC&A measures include adequate procedures to ensure MC&A records are completed, maintained, and retained. Therefore, the NRC staff finds that NIST meets the requirements in 10 CFR 74.19(a) and (d).

8.2.5 Written Material, Control, & Accounting Procedures The regulation in 10 CFR 74.19(b) states that a licensee authorized to possess SNM in a quantity exceeding one effective kilogram at any one time shall establish, maintain, and follow written MC&A procedures that are sufficient to enable the licensee to account for the SNM in its possession under license. The license shall retain these procedures until the Commission terminates the license and retain any superseded portion of the procedures for 3 years after the portion is superseded.

In section 7.5, Written Material, Control, & Accounting Procedures, of its LRA, NIST stated that the SNM-362 license limits do not exceed one effective kilogram as defined in 10 CFR 74.4 and, therefore, the requirements in 10 CFR 74.19(b) are not applicable to NIST. However, NIST stated that, pursuant to applicable requirements in 10 CFR Parts 20, 30, 33, 40, and 70, it has developed, implemented, and maintained the following written procedures that it follows for controlling and accounting for SNM:

Purchasing and receipt of RAM; Safely receiving and opening packages; Ensuring control and accountability of licensed material at all times; Maintaining records of receipt, transfer, and disposal of licensed material; Updating transactions in the NSTS, including performing annual inventory reconciliation, if applicable; Use of the NRCs license verification system before transferring aggregated Category 1 or Category 2 quantities of RAM listed in Appendix A to 10 CFR Part 37, to verify that the recipient licensee is authorized to possess the RAM; and Preplanning, coordinating, and providing advance notification of shipment of Category 1 quantities of RAM and coordinating shipment of Category 2 quantities of RAM listed in Appendix A to 10 CFR Part 37.

The NRC staff reviewed the information provided by NIST in its LRA describing its procedures.

Based on this information, the NRC staff determined that the licensees has developed and maintained adequate written MC&A procedures to ensure that the license adequately accounts for all SNM in its possession. Therefore, although NIST is not required to meet the requirement, the NRC staff finds that NISTs procedures meet the NRC requirements for establishing, maintaining, and following written procedures for the control and accounting of its SNM.

62 8.2.6 Physical inventories The requirement in 10 CFR 74.19(c) states that certain licensees who are authorized to possess SNM in a quantity greater than 350 grams of contained uranium-235, uranium-233, or plutonium, are to conduct a physical inventory of all SNM in its possession under license at intervals not to exceed 12 months. The results of these physical inventories shall be retained in records by the licensee until the Commission terminates the license authorizing the possession of the material.

In section 2.1.3, Authorized Users, of its LRA, NIST stated that the source custodian responsibilities with respect to material accountability include performing physical inventory verifications and reconciling documentary records as necessary. In section 7.6, Physical Inventories, of the LRA, NIST stated that the RSD maintains procedures that provide guidance on the planning, conducting, assessing, and reporting of physical inventories of SNM. NIST affirms that physical inventories of all SNM under the license are conducted at intervals not to exceed 12 months. NIST also stated that source custodians shall maintain inventory records of and conduct an annual physical inventory for the licensed sources under their responsibility. In section 7.7, Records Access and Storage, of its LRA, NIST stated that the RSD shall maintain inventory records under applicable provisions in 10 CFR 74.19. NIST also stated that it maintains SNM inventory and reporting requirements in accordance with 10 CFR 74.19.

The NRC staff reviewed NISTs description for physical inventory. In its LRA, NIST stated that activities are performed to ensure compliance with the inventory and related recordkeeping and reporting requirements of 10 CFR 74.19. Based on the review of this information, the NRC staff determined that NISTs MC&A measures include adequate procedures to ensure physical inventories of its SNM are completed at the required frequency and the results are reported.

Therefore, the NRC staff finds that NIST meets the requirement of 10 CFR 74.19(c).

8.2.7 Records Access and Storage The regulation in 10 CFR 74.19(d) requires licensees to ensure that the recordkeeping system can produce clear and legible copies of records after storage for the period specified by the regulations. The section also states that the licensee shall maintain adequate safeguards against tampering with and loss of records.

The NRC staff reviewed NISTs description about how it stores and controls access to its records. In section 7.7, Records Access and Storage, of its LRA, NIST stated that it maintains adequate safeguards against tampering and loss of records by storing these in an access-controlled facility. Records are legible and maintained for the minimum time period specified by the applicable sections of 10 CFR 74 and license conditions. RSD shall maintain inventory records under applicable provisions in 10 CFR 74.19 as well as for unsealed licensed sources with activity greater than or equal to 10 CFR 20, Appendix C quantities and all sealed sources requiring leak testing. If a retention period is not otherwise specified by regulation or license condition, the RSD shall retain the record until the NRC terminates the SNM - 362 license that authorizes the activity subject to the recordkeeping requirement. Based on the review of this information, the NRC staff determined that NISTs measures ensure that it can store, protect and produce legible records after storage for the period specified by the regulations. Therefore, the NRC staff finds that NIST meets the requirement in 10 CFR 74.19(d).

63

8.3 Evaluation Findings

The NRC staff determined that NIST has developed and maintained adequate written MC&A procedures to ensure that it adequately accounts for all SNM in its possession in accordance with the requirement in 10 CFR 74.19(b). The NRC staff also determined that NISTs MC&A program:

includes adequate procedures to ensure that the NRC is notified in a timely manner in the event of a loss, theft, or diversion of SNM, in accordance with the requirements in 10 74.11; includes adequate procedures to ensure that material status reports are prepared and submitted as required, in accordance with the requirement in 10 CFR 74.13(a);

includes adequate procedures to ensure that transfers and receipts of SNM are reported through nuclear material transaction reports, in accordance with the requirement in 10 CFR 74.15; includes adequate procedures to ensure MC&A records are completed, maintained, and retained, in accordance with the requirement in 10 CFR 74.19(a) and (d);

includes adequate procedures to ensure physical inventories of its SNM are completed at the required frequency and the results are reported, in accordance with the requirement in 10 CFR 74.19(c); and ensures that NIST can store, protect and produce legible records after storage for the period specified by the regulations, in accordance with the requirement in 10 CFR 74.19(d).

Based on its review of the information provided by NIST in its LRA and supplemental letter, and as discussed above, the NRC staff finds that NISTs MC&A program will adequately account for all SNM it possesses, uses, and stores at its facility, and is adequate to detect and protect against its loss, theft, or diversion. The NRC staff finds that NISTs MC&A program and practices provide reasonable assurance of adequate protection of its workers, the public health and safety, and the environment and will satisfy the applicable MC&A requirements in 10 CFR Part 74 during the renewed license term.

9.0 DECOMMISSIONING FINANCIAL ASSURANCE 9.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) staff conducted this review to determine whether the U.S. Department of Commerce, National Institute of Standards and Technology (NIS,) will be able to decommission its facility safely and in accordance with the NRC requirements. Applicants or licensees may be required to submit a decommissioning cost estimate and decommissioning funding plan (DCE/DFP) in accordance with the requirements in Title 10 of the Code of Federal Regulations (10 CFR) 70.25(b). The purpose of the NRCs evaluation of the DCE/DFP is to determine whether NIST: (1) considered and performed a credible site-specific cost estimate for decommissioning activities that may be needed in the future; and (2) presented the NRC with financial assurance to cover the cost of those activities.

9.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the requirements in 10 CFR 70.25, Financial assurance and recordkeeping for decommissioning, (e) and associated guidance

64 presented in section 8, Decommissioning Financial Assurance, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS)

Accession No. ML22335A087). The NRC staff also utilized NUREG-1757, Vol. 3, Rev. 1, Consolidated NMSS Decommissioning Guidance - Financial Assurance, Recordkeeping, and Timeliness, dated February 2012 (ML12048A683) and Interim Staff Guidance (ISG) on Decommissioning Funding Plans for Materials Licensees, dated June 2019, (ML19079A314) as guidance to evaluate NISTs DFP.

Pursuant to the regulations in 10 CFR 70.25(e)(2), Financial assurance and recordkeeping for decommissioning, NIST is required to submit an updated DCE/DFP for the NRCs review at the time of license renewal and at intervals not to exceed 3 years.

By letter dated September 27, 2022 (ML22293A269), NIST submitted an updated DCE/DFP for its radiological facilities located in Gaithersburg, Maryland. NIST supplemented its submittal by letters dated January 24, 2023 (ML23060A262), May 16, 2023 (ML23136B285), and January 10, 2024 (ML24022A295). The NRC staff evaluated the information submitted by NIST and based on the review of this information, determined that NISTs updated DCE is for the amount of $9,809,294. This amount is reflected in NISTs certification of financial assurance submitted in support of the updated DCE/DFP. The NRC staff found that the updated DCE of

$9,809,294 is based on reasonable and documented assumptions, and that it reasonably estimates the cost, at this time, to decommission the facility, if necessary. Accordingly, the NRC staff found that NISTs DCE satisfies the requirements of 10 CFR 30.35(e) and 10 CFR 70.25(e) and is consistent with the guidance in NUREG-1757, Volume 3, Revision 1.

9.3 Evaluation Findings

Based on the NRC staff review of the information provided by NIST in its September 2022 submittal and supplemental letters, the NRC staff determined that the updated DCE/DFP was acceptable. The NRC staff determined that there is reasonable assurance that NISTs updated DCE/DFP provides reasonable and adequate protection of public health, safety, safeguards, security, and the protection of the environment. Therefore, the NRC staff found that the proposed DCE/DFP update is acceptable and meets the requirements in 10 CFR 30.35(e) and 10 CFR 70.25(e). NIST remains liable for any costs not covered by the financial instrument(s).

The NRC staff detailed technical evaluation report of NISTs updated DCE/DFP can be found under ML24113A294.

10.0 DECOMMISSIONING 10.1 Purpose of Review The purpose of this review to determine whether NIST will be able to decommission the facility safely and in accordance with the NRC regulations in 10 CFR 70.38(g) and the guidance in NUREG-1757, Volume 2, Consolidated Decommissioning Guidance: Characterization, Survey, and Determination of Radiological Criteria - Final Report, Revision 2 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22194A859). The NRC staff also evaluated the LRA to determine whether NIST will maintain records important to decommissioning in accordance with the requirements in 10 CFR 70.25(g).

65 10.2 Staff Review and Analysis 10.2.1 Decommissioning plan Nuclear facilities licensed under 10 CFR Part 70 must submit decommissioning plans (DPs) for NRC approval. In accordance with the regulations in 10 CFR 70.38(g)(1), NIST must submit a DP at the time that operations are to be terminated.

NIST currently does not have a DP nor has any current plans to decommission the site.

However, in section 5.0, Release Criteria, of NISTs Decontamination and Decommissioning Cost Estimate (DCE, ML23136B278), it discusses its future plans for when it decides to permanently cease principal activities. Based on the information in the DCE, NIST assumes that at the time of cessation of principal activities, the Gaithersburg, Maryland, facilities will be reused for some other, as yet unknown, purpose under unrestricted use conditions. In its LRA, NIST nevertheless commits to keeping all applicable records and use the appropriate guidance documents to ensure the majority of the buildings are released for unrestricted use, except for the accelerator facility in Building 245, which, due to technical and safety difficulties, is intended to be released by NIST for restricted use only. Since the accelerator facility is not a separate building or area, and the building is still in active use, the timeliness rule (i.e., 10 CFR 70.38),

does not apply and as such a DP is not currently required. However, at the time when the area housing the accelerator facility in Building 245 is no longer used, and the timeliness rule applies, NIST must take the necessary steps, as outlined in NUREG-1727, NMSS Decommissioning Standard Review Plan, section 7.8, Group 6: Restricted Release; Decommissioning Plan Required, to be considered for restricted release.

10.2.2 Recordkeeping The regulation in 10 CFR 70.25(g) requires that licensees shall keep records of information important to the decommissioning of a facility in an identified location until the site is released for unrestricted use. The NRC staff reviewed the LRA to determine if NIST will maintain records important to decommissioning until the facility is decommissioned and released for unrestricted use.

In section 8.2, Recordkeeping, of its LRA, NIST stated that it maintains records of all program actions and activities in accordance with the requirements in 10 CFR 30.35(g) and 10 CFR 70.25(g). Records include written descriptions of the specific locations or room numbers where SNM is used or stored and any records of spills in or around the licensees facilities or information relevant to damaged devices or leak tests of radioactive sources. NIST is responsible for maintaining these records until the license is terminated. These records are intended to form the basis for NISTs decommissioning activities. NIST further stated that, at the time of license termination, these records shall be transferred to the NRC.

10.3 Evaluation Findings The NRC staff finds that NISTs plans for decommissioning its facilities at its principal activities cessation are in accordance with the requirements in 10 CFR 70.38(g) and is consistent with the guidance in NUREG-1757, Volume 2. The NRC staff also finds that NIST committed to maintain all records important to decommissioning in accordance with the requirement in 10 CFR 70.25(g). Therefore, the NRC staff finds that NISTs plans for decommissioning its facilities comply with the NRCs applicable regulations and provide reasonable assurance of

66 adequate protection of the workers, and the publics, health and safety and the environment, from the potential hazards of its NRC regulated activities.

11.0 EMERGENCY MANAGEMENT 11.1 Purpose of Review The U.S. Nuclear Regulatory Commission (NRC) staff reviewed the information discussed in the U.S. Department of Commerce, National Institute of Standards and Technology (NIST) license renewal application (LRA) to determine if NIST is subject to the requirement for an Emergency Plan (EP) pursuant to the requirements in Title 10 of the Code of Federal Regulations (10 CFR) 70.22(i)(1)(ii).

11.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the applicable regulatory requirements in 10 CFR 30.32(i) and 10 CFR 70.22(i), which require, in part, that licensees authorized to possess radioactive material (RAM) exceeding certain thresholds must either (1) submit an emergency plan, or (2) submit an evaluation showing that the maximum dose to a person offsite due to a release would not exceed one rem effective dose equivalent or an intake of two milligrams of soluble uranium.

In section 10, Emergency Management, of its LRA, NIST stated that an EP is not required and discusses the justification for why it is not necessary. NIST stated that, in response (Agencywide Documents Access and Management System (ADAMS) Accession No. ML12313A127) to an NRC staff request for additional information dated September 10, 2012 (ML12255A114), regarding its June 29, 2007, LRA (ML13207A206), it reassessed its 1992 evaluation for the need for an emergency plan that supported its previous license renewal application (ML071930317). Based on the 1992 evaluation, NIST determined that, based on their possession limits at the time, should a release of radioactive materials (RAM) occur, the maximum dose to a person offsite would not exceed one (1) rem total effective dose equivalent (TEDE), 5 rem to the thyroid or an intake of 2 milligrams of soluble uranium in accordance with the requirements in 10 CFR 70.22(i)(1)(i) and 10 CFR 30.32(i)(1)(i). NIST stated that this evaluation was reviewed and approved by the NRC on July 30, 2013 (ML13212A132). NIST further stated that, while the possession limits requested in the current LRA exceed the values listed in 10 CFR 70.22(i)(1) and 10 CFR 30.72, it reviewed the 2012 re-evaluation and determined that there are no significant changes in offsite doses associated with the possession limits proposed in the current LRA.

By letter dated February 9, 2024 (ML23320A135) and Enclosure 2 (ML23320A136, non-public) to the letter, the NRC staff requested NIST to provide additional information justifying why an EP was not needed. In its response to the RAI (ML24071A177, non-public) NIST enclosed a spreadsheet that showed the updated calculations. The NRC staff reviewed the spreadsheet that reflected an update of the 2012 analysis to consider the proposed changes in possession limits and noted that NISTs updated calculations estimated the maximum dose to offsite personnel to be 0.824 rem. Major assumptions in the analysis included meteorological conditions (F stability, 1 meter/second windspeed), release duration (30 minutes) and release fractions for specific elements. The NRC staff determined that these assumptions are consistent with guidance in NUREG-1140, A Regulatory Analysis for Fuel Cycle and Other Radioactive Material Licensees, Final Report (ML101460227) and are acceptable.

67 The NRC staff conducted an independent analysis of NISTs calculations to verify the dose estimates presented in their analysis. For the dose calculations evaluated, the NRC staffs independent analysis confirmed NISTs calculations. As such, the NRC staff found that NISTs updated dose calculations were acceptable.

11.3 Evaluation Findings Based on the information discussed above, the NRC staff finds that the NIST evaluation has established that the maximum dose to a member of the public offsite due to a release of radioactive materials would not exceed the limits outlined in the regulations, and thus, NIST is not required to have an EP for the proposed license renewal 10-year period.

12.0 PHYSICAL SECURITY 12.1 Purpose of Review The purpose of the U.S Nuclear Regulatory Commission (NRC) staff review of the license renewal application (LRA) was to determine if the renewal of the U.S. Department of Commerce, National Institute of Standards and Technologys (NIST) special nuclear materials license number 362 (SNM-362) meets the applicable regulatory requirements in Title 10 of the Code of Federal Regulations (10 CFR) Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, to ensure that NISTs byproduct materials are adequately protected.

The NRC staff also reviewed the information in the application to determine if the renewal of NISTs SNM-362 license meets applicable physical security requirements in 10 CFR Part 73, Physical Protection of Plants and Materials, (f), Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance, for the protection of special nuclear material (SNM). In addition, the NRC staff reviewed the information provided by NIST in its LRA to determine if the renewal of the SNM-362 license ensures that NISTs licensed activities are not inimical to the common defense and security, and do not constitute an unreasonable risk to the public health and safety.

12.1.1 Applicability The regulations in 10 CFR Part 37 provide the requirements for the physical protection for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material (RAM) listed in Appendix A of 10 CFR Part 37 for protecting these materials from theft or diversion.

The regulations in 10 CFR Part 70.22(k) require, in part, that each application for a license to possess or use, at any site or contiguous sites subject to licensee control, 10 kg or more of SNM of low strategic significance (LSS), as defined in 10 CFR 70.4, must include a physical security plan (PSP) that demonstrates how the applicant plans to meet the requirements of paragraphs (d), (e), (f), and (g) of 10 CFR 73.67.

The regulations in 10 CFR Part 73.67 prescribe, in general, requirements for the establishment and maintenance of a physical protection system which will have capabilities for the protection of SNM at fixed sites and in transit and of facilities in which SNM is used.

The general performance objectives in 10 CFR 73.67(a), applicable to fixed sites and transit of SNM, require that licensees who possess, use, or transport SNM of MSS or LSS shall establish

68 and maintain a physical protection system to minimize the possibilities for unauthorized removal of SNM consistent with the potential consequences of such actions, and facilitate the location and recovery of missing SNM.

12.2 Staff Review and Analysis The NRC staff conducted its review of NISTs LRA against the applicable regulatory requirements in 10 CFR Part 37, 10 CFR 73.67 and the associated guidance presented in section 9, Physical Security, of draft NUREG-2212, Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22335A087) and Regulatory Guide 5.59, Standard Format and Content for a Licensee Physical Security Plan for the Protection of Special Nuclear Material of Moderate or Low Strategic Significance (ML100341301).

In its LRA, NIST stated that it is not required to develop a Physical Security Plan, pursuant to 10 CFR 70.22(k). However, NIST must meet the regulatory requirements in 10 CFR Part 73, Physical Protection of Plants and Materials, for the protection of its SNM of low strategic significance (LSS).

NIST stated that it maintains a physical protection program based on physical security requirements from 10 CFR Part 37 and that it is intended to implement both 10 CFR Part 37 and Part 73, requirements. NIST stated that the plan specifically meets the 10 CFR 73.67(f) physical protection requirements and that it also applies to any materials recognized by the International Atomic Energy Agency (IAEA) and to those specified in Appendix A of 10 CFR Part 37 as quantities of radioactive material Category 1 and Category 2. According to NIST, the plan follows the format and content provided in NRC Regulatory Guide 5.59, Standard Format and Content for a Licensee Physical Security Plan, and meets the requirements in 10 CFR 73.67(a).

The NRC staff reviewed NISTs August 8, 2023, LRA against the requirements in 10 CFR Part 37 and 73.67(f) and (g). On February 6, 2024, the NRC staff conducted a visit to the NIST facilities to, specifically, verify NISTs measures and features implementing the applicable 10 CFR 73.67(f) physical security requirements. Based on the review of the information provided by NIST and the site visit, the NRC staff determined that additional information was still necessary before making its final determinations and findings on the LRA. As such, by letter dated February 9, 2024 (ML23320A135), the NRC staff requested that NIST provide additional information regarding its physical security program. The NIST provided its response to this RAI by letter dated March 11, 2024 (ML24071A178 [public] and ML23320A136 [non-public]). In its response to the RAI, NIST also included revisions to its LRA and Enclosure 6 (Physical Protection Plan9, ML24071A183) that incorporated the information provided by NIST in its response to the RAI.

9 Since it is not required, NIST provided a copy of the physical protection plan to the NRC for information only.

69 12.2.1 Physical security of SNM at fixed sites Controlled Access Areas The regulation in 10 CFR 73.67, Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance," (f) Fixed site requirements for special nuclear material of low strategic significance, (1) requires the licensee to store or use the material only within a controlled access area (CAA).The NRC staff conducted a site visit on February 6, 2024, to verify that NIST meets the requirements of a CAA. In, section 9.2.3, Physical Protection Requirements at Fixed Sites, NIST stated that Category III quantities of SNM are only used and stored in permanent or temporary CAAs that are demarcated. CAAs provide both controlled access and isolation of material through physical barriers, intrusion systems, and procedures. NISTs Radiation Safety Division (RSD) procedures describe how the permanent CAA is monitored. Based on this information and the observations during the site visit, the NRC staff finds that NIST meets the requirements of 10 CFR 73.67(f)(1) for storing and use of the Cat III SNM in a CAA.

Intrusion Alarms, Motion Sensors and Closed-Circuit Monitoring The regulation in 10 CFR 73.67, Licensee fixed site and in-transit requirements for the physical protection of special nuclear material of moderate and low strategic significance, (f) Fixed site requirements for special nuclear material of low strategic significance, (2) requires licensees to monitor with an intrusion alarm or other device or procedures the controlled access areas to detect unauthorized penetrations or activities. During the February 6, 2024, the NRC staff noted that NIST isolates SNM in a room that has an intrusion alarm and motion sensors to detect unauthorized intrusions.

The regulation in 10 CFR 73.67(f), Fixed site requirements for special nuclear material of low strategic significance, (3) requires the licensee to assure that a watchman or offsite response force will respond to all unauthorized penetrations or activities. During the February 6, 2024, the NRC staff noted that the room where NIST stores and isolates the SNM that has an intrusion alarm and is equipped with cameras that feed to a NIST alarm station staffed by NIST response force which will timely respond to any unauthorized intrusions.

The regulation in 10 CFR 73.67(f)(4) requires the licensee to establish and maintain response procedures for dealing with threats of thefts or thefts of this material. The licensee shall retain a copy of the current response procedures as a record for three years after the close of period for which the licensee possesses the special nuclear material under each license for which the procedures were established. Copies of superseded material must be retained for three years after each change. In its LRA, NIST committed to establishing and maintaining response procedures for dealing with threats of thefts or thefts of the Cat III SNM. Additionally, NIST committed to maintaining the response procedures for a period of three years after the close of period for which the licensee possesses the SNM under each license for which the procedures were established.

70 12.2.2 Security of SNM during transport Notification to the receiver The regulation in 10 CFR 73.67(g), In-transit requirements for special nuclear material of low strategic significance, (1)(i) requires the licensee to provide advance notification to the receiver of any planned shipments by specifying the mode of transport, estimated time of arrival, location of the nuclear material transfer point, name of carrier and transport identification, and (ii) receive confirmation from the receiver prior to commencement of the planned shipment that the receiver will be ready to accept the shipment at the planned time and location and acknowledges the specified mode of transport. In its PSP NIST described a methodology to provide advance notifications from the licensee/shipper to the receiver and the receiver confirming they are ready to receive the shipment, prior to commencing the shipment.

Trace investigations The regulation in 10 CFR 73.67(g)(1)(iii)(A) requires a licensee to conduct a trace investigation of any shipment that is lost or unaccounted for after the estimated arrival time. In its LRA, NIST described and committed to a process for conducting trace investigations of any shipment that may be lost or unaccounted for after the estimated arrival time.

Integrity of containers and seals check prior to shipment The regulation in 10 CFR 73.67(g)(1)(iv) requires that each licensee who transports or who delivers to a carrier for transport SNM of low strategic significance shall describe the actions it must take to check integrity of containers and seals prior to shipment. In its LRA NIST did not clearly state when NIST staff will check the integrity of the containers and seals and that the check must be performed prior to shipping Cat III SNM. As such, in its February 9, 2024, RAI letter the NRC staff requested NIST to revise its PSP to include language requiring that the integrity of the containers and seals be checked prior to shipment. In its March 11, 2024, response to the RAI NIST stated that it had revised the PSP to state an integrity check of containers and seals shall be performed prior to shipment. NISTs RAI response included a revised version of its PSP. The NRC staff confirmed that the revision incorporated this information.

Required actions for receivers The regulation in 10 CFR 73.67(g)(2)(i) requires that each licensee who receives quantities and types of SNM of low strategic significance shall check the integrity of the containers and seals upon receipt of the shipment. In its PSP, NIST committed to a methodology to conduct checks of the integrity of containers and seals upon receipt of shipments and to notify the shippers of receipt of the material as required in 10 CFR 74.15.

The regulation in 10 CFR 73.67(g)(2)(ii) requires that each licensee who receives quantities and types of SNM of low strategic significance shall notify the shipper of receipt of the material as required in 10 CFR 74.15. In its PSP, NIST committed to a methodology to check the integrity of containers and seals upon receipt of shipments and to notify the shippers of receipt of the material as required in 10 CFR 74.15.

Record keeping requirements The regulation in 10 CFR 73.67(g)(3) requires that each licensee, either shipper or receiver,

71 who arranges for the physical protection of special nuclear material of low strategic significance while in transit or who takes delivery of such material free on board (f.o.b.) the point at which it is delivered to a carrier for transport shall:

(i) Establish and maintain response procedures for dealing with threats or thefts of this material. The licensee shall retain a copy of the current response procedures as a record for three years after the close of period for which the licensee possesses the special nuclear material under each license for which the procedures were established. Copies of superseded material must be retained for 3 years after each change; (ii) Make arrangements to be notified immediately of the arrival of the shipment at its destination, or of any such shipment that is lost or unaccounted for after the estimated time of arrival at its destination; and (iii) (A) Immediately conduct a trace investigation of any shipment that is lost or unaccounted for after the estimated arrival time.

In its LRA NIST described and committed to a process for the establishment and maintenance of response procedures for dealing with threats of thefts or thefts Involving Cat III SNM/LSS.

Additionally, NIST committed to retain these response procedures as a record for 3 years after the close of period for which it possesses the Cat III SNM/LSS. In addition, NIST committed to In addition, NIST committed to notify the shipping licensee of the arrival of shipments or of lost or unaccounted for shipments and to conducting a trace investigation for a lost or unaccounted for shipment.

Notification to the NRC Operations Center The regulation in 10 CFR 73.67(g)(iii)(B) requires licensees to notify the NRC Operations Center after the discovery of the loss of a shipment and after recovery of, or accounting for, such lost shipment, in accordance with the provisions of 10 CFR 73.1200 and 73.1205.

The NRC staff noted that NISTs PSP did not include the telephone number for notifying the NRC Operations Center of a lost shipment and after it has been recovered and/or accounted for. Additionally, for both the loss of the shipment, and after it has been recovered and/or accounted for, NIST did not state that it must follow the NRC notification and reporting requirements of 10 CFR 73.1200 and 73.1205. Therefore, in its February 9, 2024, RAI letter the NRC staff requested NIST to revise the PSP to include this information. In its March 11, 2024, response to the RAI NIST stated that it had revised the PSP to include this information and provided a copy of the revised PSP. The NRC staff revised the revised PSP and confirmed that NIST had incorporated this information into the document in accordance with the provisions of 10 CFR 73.1200 and 73.1205.

72 12.2.3 Physical security for category 1 and category 2 byproduct materials The regulations in 10 CFR Part 37 provide the requirements for the physical protection program for any licensee that possesses an aggregated category 1 or category 2 quantity of radioactive material listed in Appendix A to this part. These requirements provide reasonable assurance of the security of category 1 or category 2 quantities of radioactive material by protecting these materials from theft or diversion. Specific requirements for access to material, use of material, transfer of material, and transport of material are included.

In its LRA, NIST stated that it maintains a physical protection program based on physical security requirements from 10 CFR Part 37 that is applicable to any materials recognized by the IAEA and the NRC as category 1 and category 2 quantities of radioactive material. NIST also stated that it uses a layered approach to security of all radioactive materials based on the characterization of material type and quantity. Under this approach, NIST applies the general requirements of 10 CFR 20.1801 and 20.1802 to all sources. When the quantities of material meet or exceed the quantities listed on Appendix A to 10 CFR Part 37, the additional 10 CFR 37, Subpart B, Background Investigations and Access Authorization Program, and 10 CFR 37.49, Monitoring, detection, and assessment, physical security requirements are applied. No individual is granted unescorted access to category 1 or category 2 quantities of RAM or protected information prior to being determined trustworthy and reliable by a Reviewing Official and determined by management and the protected information owner to have a need for unescorted access in order to perform assigned duties and/or a need to know the protected information. Security training is provided in accordance with 10 CFR 37.23(a)(2) and personal information is protected against unauthorized disclosure in accordance with 10 CFR 37.31.(a).

In its LRA, NIST also stated that it has developed, implemented, and maintains written procedures for the use of the NRCs license verification system before transferring aggregated category 1 or category 2 quantities of RAM to verify that the recipient is authorized to possess the RAM, and for the preplanning, coordination, and provision of advanced notification of shipments of category 1 quantities of RAM and for coordinating the shipment of category 2 quantities of RAM listed in A to 10 CFR Part 37.

In its LRA NIST stated that it implements the requirements of 10 CFR Part 37, Subpart D, for the physical protection of all RAM during transit. In addition, NIST stated that it is required to implement the requirements in 49 CFR Part 172, Subpart I, Safety and Security Plans. In accordance with the NRC and DOT regulations. NIST also stated that it uses protective measures established in 10 CFR Part 37 to satisfy elements of the DOT requirements in 49 CFR Parts 107, 171 through 180, and 390 through 397.

73 12.3 Evaluation Findings 12.3.1 Physical security of SNM at fixed sites Based on its review of the information provided by NIST in its August 8, 2023, LRA, PSP, and March 2024 PSP revisions, NISTs responses to the February 9, 2024, RAI, and the observations during the February 6, 2024, site visit, the NRC finds that NIST:

has established CAAs that are clearly demarked and that these provide both controlled access and isolation of material through physical barriers, intrusion systems, and procedures. The NRC staff also verified that NIST staff uses and stores Cat III SNM in the CAA in accordance with its radiation safety procedures and physical protection plan in accordance with the requirements in 10 CFR 73.67(f)(1);

isolates SNM in a room that has an intrusion alarm and is equipped with motion sensors that feed to a NIST alarm station staffed by NIST response force in accordance with the requirements in 10 CFR 73.67(f)(2);

isolates SNM in a room that is equipped with cameras that feed to a NIST alarm station staffed by NIST response force that will respond to all unauthorized penetrations or activities in accordance with the requirements in 10 CFR 73.67(f)(3); and committed to establishing and maintaining response procedures for dealing with threats of thefts or thefts of the Cat III SNM and maintaining the response procedures for a period of 3 years after the close of period for which the licensee possesses the SNM under each license for which the procedures were established in accordance with the requirements in 10 CFR 73.67(f)(4).

The NRC staff finds that NISTs program meets applicable 10 CFR Part 73 regulatory requirements for the security of SNM at a fixed site. The NRC staff finds that the proposed renewal of the SNM-362 license for a period of 10 years meets the requirements of 10 CFR 73.67(f) and is consistent with the guidance in RG 5.59. Accordingly, the NRC staff finds that the renewal of the license will not be inimical to the common defense and security and does not constitute an unreasonable risk to the public health and safety.

12.3.2 Security of SNM in transport Based on its review of the information provided by NIST in its August 8, 2023, LRA, PSP and March 2024 PSP revisions, and NISTs responses to the February 9, 2024, RAI, the NRC staff finds that NISTs:

methodology to communicate advance notices to the receiver and receiving confirmation from the receiver they are ready to receive the shipment, prior to commencing the shipment is in accordance with the requirements in 10 CFR 73.67(g)(1)(i) and (ii);

description of a process for conducting trace investigations of any shipment that is lost or unaccounted for after the estimated arrival time is in accordance with the requirement in 10 CFR 73.67(g)(1)(iii)(A);

revisions to its PSP to include notification to the NRC Operations Center after the discovery of the loss of the shipment and after recovery of or accounting for such lost shipment is in accordance with the requirement in 10 CFR 73.67(g)(1)(iii)(B);

revisions to its PSP to state that a description regarding the integrity check of the containers and seals shall be performed prior to shipment in accordance with the

74 requirement in 10 CFR 73.67(g)(1)(iv);

description in its PSP of a methodology to check the integrity of the containers and seals upon receipt of the shipment and to notify the shipper of receipt of the material is in accordance with the requirement in 10 CFR 73.67(g)(2);

description of a process in its PSP for the establishment and maintenance of response procedures for dealing with threats of thefts or thefts involving Cat III SNM/LSS material and for retaining response procedures as a record for three years after the close of period for which the licensee possesses the Cat III SNM/LSS material is in accordance with the requirement in 10 CFR 73.67(g)(3)(i).

The NRC staff also finds that NISTs PSP meets the following 10 CFR requirements:

10 CFR 73.67(g)(3)(ii) for including a requirement that the shipping licensee should be notified, by the receiver, of the arrival of the shipment or if the shipment is lost/unaccounted for is in accordance with the requirement in 10 CFR 73.67(g)(3)(iii)(A) for including a description and commitment to establishing a process for conducting trace investigations for a lost/unaccounted for shipment and, 10 CFR 73.67(g)(iii)(B) for requiring notification to the NRC Operations Center at 301-816-5100 after the discovery of the loss of the shipment and after it has been recovered and/or accounted for, in accordance with the provisions of 10 CFR 73.1200 and 73.1205.

The NRC staff finds that NISTs program meets applicable 10 CFR Part 73 regulatory requirements for the security of SNM in transport. The NRC staff finds that the proposed renewal of the SNM-362 license for a period of 10 years meets the requirements of 10 CFR 73.67(g) and is consistent with the guidance in RG 5.59. Accordingly, the NRC staff finds that the renewal of the license will not be inimical to the common defense and security and does not constitute an unreasonable risk to the public health and safety.

12.3.3 Physical security for category 1 and category 2 byproduct materials The NRC staff finds that NISTs layered approach to security of all radioactive materials under which NIST applies the 10 CFR Part 37 security requirements to quantities of byproduct materials meeting or exceeding the quantities listed on Appendix A to 10 CFR 37, provides reasonable assurance of adequate security of category 1 or category 2 quantities of radioactive material from theft or diversion while on site and during transport. The NRC staff, therefore, finds that NIST meets the 10 CFR Part 37 requirements applicable to its activities using byproduct materials and that the proposed renewal of the SNM-362 license for a period of 10 years meets the requirements of 10 CFR Part 37. Accordingly, the NRC staff finds that the NISTs physical security program provides reasonable assurance of adequate protection of all radioactive material and, as such, the SNM-362 license should be renewed for the requested 10-year period.

75

13.0 CONCLUSION

The U.S. Nuclear Regulatory Commission (NRC) staff finds that the U.S. Department of Commerce, National Institute of Standards and Technology (NIST), program under special nuclear materials license number 362 (SNM-362) will provide adequate protection of public health and safety and that an adequate level of safety will be maintained during the proposed license renewal term. The NRC staff also finds that NISTs LRA, and its supporting/supplemental information, meets the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 70.23, Requirements for the approval of applications, and provides reasonable assurance that the proposed operations at NIST will not have an adverse impact on the public health and safety, the common defense and security, or the environment.

Based on the information provided by NIST, as discussed in this safety evaluation report, the NRC staff concludes that NISTs safety programs will continue to meet the applicable requirements in 10 CFR Parts 19, 20, 33, 36, 70, 73, and 74. The NRC staff recommends that NISTs SNM-362 license be renewed for a 10-year term in accordance with the statements, representations, and conditions in its August 8, 2023, LRA (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23221A162), and Enclosures, supplemental letter dated March 11, 2024, (ML24071A178) and Enclosures, letters dated September 27, 2022 (ML22293A269), January 24, 2023 (ML23060A262), May 16, 2023 (ML23136B285), and January 10, 2024 (ML24022A295).

14.0 REFERENCES

The following references are listed in the order they appear in this document.

1.

U.S. Department of Commerce, National Institute of Standards and Technology (NIST),

License Renewal Application, August 8, 2023, ML23221A162.

2.

Title 10 of the Code of Federal Regulations (10 CFR).

3.

U.S. Nuclear Regulatory Commission (NRC), Acknowledgement of application, August 29, 2023, ML23237B469.

4.

NRC, Acceptance of NIST application, October 6, 2023, ML23271A220.

5.

NRC, NRC Request for Additional Information, February 9, 2024, ML23320A132.

6.

NIST, NIST Response to RAI, March 11, 2024, ML24071A177 (Package).

7.

NRC, NUREG-2212 (Draft), Standard Review Plan for Applications for 10 CFR Part 70 Licenses for Possession and Use of Special Nuclear Materials of Critical Mass but not Subject to the Requirements in 10 CFR Part 70, Subpart H, September 2022, ML22335A087.

8.

NRC, NUREG-1520, Standard Review Plan for Fuel Facilities License Applications, Revision 2, June 2015, ML15176A258.

9.

NRC, NUREG 1556 Volume 6, Consolidated Guidance About Materials Licenses:

Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses, Revision 1,

76 January 2018, ML18026A698.

10. NRC, NUREG-1556, Volume 11, Consolidated Guidance About Materials Licenses:

Program-Specific Guidance About Licenses of Broad Scope, Revision 1, February 2017, ML17059D332.

11. NIST, Physical Security Plan, August 2023, ML23221A166 (non-public).

12. NIST, NIST RAI Response, March 11, 2024, ML24071A179 (Public).

13. NIST, NIST RAI Response, March 11, 2024, ML24071A180(non-public).

14. NIST, NIST 2023 LRA Revision 1, March 7, 2024, ML24071A181.

15. NIST, NIST Revised Enclosure 4, Radioactive Materials for which the license is requested, March 2024, ML24071A182 (non-public).

16. NIST, NIST Revised Enclosure 6, Physical Security Plan, section 9, March 11, 2024, ML24071A183 (non-public).

17. Atomic Energy Act of 1954, as amended.

18. NRC, NUREG-1556, Volume 12, Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution, Revision 1, May 2018, ML18136A704.

19. NIST, NIST License Amendment Request to Propose Permanent Radiation Safety Officer, March 31, 2017, ML17095A956.

20. NIST, Special Nuclear Materials License 362, License Amendment 11 (New 10 CFR Part 36 Irradiator Facility), May 20, 2021, ML21126A114.

21. American National Standards Institute/American Nuclear Society (ANSI/ANS) 8.19-2014, Administrative Practices for Nuclear Criticality Safety, July 2014.

22. NRC, Safety Evaluation Report for the [SNM] License SNM-362 Renewal Application July 25, 2013, ML13212A132.

23. NRC, Regulatory Guide (RG)-3.71, Rev. 3, Nuclear Criticality Safety Standards for Nuclear Materials Outside Reactor Cores, October 2018, ML18169A258.

24. NIST, NIST SNM-362 License Renewal Application, June 29, 2007, ML071930317 (Package).

25. NRC, NRC Renewal of SNM-362 License, September 10, 2013, ML13207A206 (Package).

26. NIST, NIST License Renewal Application, Revision 1, Enclosure 7, Fire Safety Facility Schematics, March 11, 2024, ML24071A184.

27. National Fire Protection Association (NFPA) 101, Life Safety Code.

28. NFPA 72, National Fire Alarm and Signaling Code.

77

29. NFPA 13, Standard for the Installation of Sprinkler Systems.

30. NFPA 10, Standard for Portable Fire Extinguishers.

31. NFPA 30, Flammable and Combustible Liquids Code.

32. NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals.

33. NFPA 55, Compressed Gases and Cryogenic Fluids Code.

34. NRC, NUREG-1748, Environmental Review Guidance for Licensing Actions Associated with NMSS Programs, August 2003, ML032450279.

35. NRC, NUREG/BR-0006, Instructions for Completing Nuclear Material Transaction Reports (DOE/NRC Forms 741 and 704M), Revision 9, August 2020, ML20240A155.

36. NIST, Updated Decommissioning Cost Estimate and Decommissioning Funding Plan (DCE/DFP), September 27, 2022, ML22293A269.

37. NIST, Reply to Request for Supplemental Information - 2022 Triennial Update to Decommissioning Funding Plan, January 24, 2023, ML23060A262.

38. NIST, 2022 DFP Update: Response to Request for Additional Information),

January 10,2024, ML24022A295.

39. NIST, Decontamination and Decommissioning Cost Estimate (DCE) for the National Institute of Standards and Technology, May 16, 2023, ML23136B278.

40. NRC, Approval of NIST's 2022 DFP Update, April 22, 2024, ML24113A294.

41. NRC, NUREG-1757, Consolidated Decommissioning Guidance: Characterization, Survey, and Determination of Radiological Criteria, Volume 2, Revision 2 (Final Report),

July 2022, ML22194A859.

42. NRC, NRC Form 540, Uniform Low-Level Radioactive Waste Manifest - Shipping Paper, ML13083A180.

43. NRC, NRC Form 541, Uniform Low-Level Radioactive Waste Manifest - Container and Waste Description, ML13083A182.

44. NIST, Response to NRC Request for Additional Information, October 25, 2012, ML12313A127.

45. NRC, Request for additional information, September 10, 2012, ML12255A114.

46. NRC, NUREG-1140, A Regulatory Analysis for Fuel Cycle and Other Radioactive Material Licensees, Final Report, January 1988, ML101460227.

47. NRC, Regulatory Guide (RG) 5.59, Standard Format and Content for a Licensee Physical Security Plan for the Protection of Special Nuclear Material of Moderate or Low Strategic Significance, February 1983, ML100341301.

78 15.0 PRINCIPAL CONTRIBUTORS Suzanne Ani Material Control and Accounting Jeannette Arce Emergency Management Jimmy Chang Fire Safety, Irradiator and 10 CFR Part 36 Exemptions Nicole Cortés Chemical Safety Logan Crevelt Nuclear Criticality Safety Harry Felsher Radioactive Waste Management Eliezer Goldfeiz Radiation Protection, 10 CFR Part 36 Irradiator and Exemptions, 10 CFR Part 32 Manufacturing, 10 CFR Part 33 Broad Scope James Hammelman Emergency Management, Chemical Safety Isaac Johnston Environmental Review Kenneth Kline Decommissioning Financial Assurance Elizabeth Kurz Decommissioning Financial Assurance Marla Morales Environmental Review Jeremy Munson Nuclear Criticality Safety Michael Norris Emergency Management Michael Reichard Radiation Protection, 10 CFR Part 36 Irradiator, 10 CFR Part 32 Manufacturing, 10 CFR Part 33 Broad Scope Alex Sapountzis Physical Security (Fixed/In Transit)

Osiris Siurano Project Management, General Information, Purpose/Use/Location of Radioactive Materials, Integrated Safety Analysis, Management Measures James Smith Decommissioning