ML22199A074

624914 Niowave Safety Evaluation Report for Niowave, Inc. to License No. 21-35144-04

ML22199A074
Person / Time
Site:	07007031
Issue date:	11/03/2021
From:	NRC/RGN-III
To:
References
624914
Download: ML22199A074 (10)

Text

SAFETY EVALUATION BY THE OFFICE OF NUCLEAR SECURITY AND INCIDENT RESPONSE RELATED TO AMENDMENT NO. 03 TO LICENSE NO. 21-35144-04 NIOWAVE, INCORPORATED DOCKET NO. 070-07031

1.0 INTRODUCTION

Niowave, Incorporated (Niowave) produces, extracts, and purifies several radioisotopes to meet a growing need for radioisotopes for strategic and medical applications. Niowave uses a superconducting electron linear accelerator to produce radioisotopes from uranium and radium targets through photonuclear reactions at its existing headquarters facilities. Niowave is increasing its operations at these facilities and building new equipment to extract radioisotopes from special nuclear material (SNM) scrap and Sr-90 at its facility located in Lansing, Michigan at the Capital Region International Airport. Niowave is the holder of NRC Materials License No. 21-35144-04, issued pursuant to the Atomic Energy Act of 1954, as amended, and Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, of Title 10 of the Code of Federal Regulations (10 CFR).

By letter dated May 19, 2021 (Reference 1), as supplemented by letters dated August 11, 2021 (Reference 2), September 24, 2021 (Reference 3) and October 15, 2021 (Reference 4),

Niowave submitted a document titled, Emergency Plan for Responding to a Release of Radioactive Material, (hereafter referred to as the Niowave Emergency Plan) in accordance with 10 CFR 30.32(i)(3) for prior approval by the U.S. Nuclear Regulatory Commission (NRC).

This safety evaluation addresses the acceptability of the proposed Niowave Emergency Plan.

2.0 REGULATORY EVALUATION

The regulatory requirements and guidance on which the NRC staff based its review are provided below.

2.1 Regulatory Requirements 10 CFR 30.32(i)(1), states that each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in

§ 30.72, "Schedule CQuantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release," must contain either:

(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or (ii) An emergency plan for responding to a release of radioactive material.

10 CFR 30.32(i)(3) states, in part, an emergency plan for responding to a release of radioactive material submitted under paragraph (i)(1)(ii) of this section must include the following information....

2.2 Guidance The associated guidance document on which the NRC based its evaluation and acceptance of the proposed Niowave Emergency Plan is:

Regulatory Guide (RG) 3.67, Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities, Revision 1 dated April 2011 (Reference 5), which provides guidance acceptable to the NRC staff for the information to be included in emergency plans and establishes a format for presenting the information.

3.0 TECHNICAL EVALUATION

The purpose of reviewing Niowave Emergency Plan is to determine if Niowave has established adequate emergency facilities and procedures to protect workers, the public and the environment. The adequacy of the emergency plan has been evaluated against the requirements in 10 CFR 30.32(i)(3) and the guidance provided in RG 3.67. The information to support the review was provided in its application dated May 19, 2021, as supplemented by letters dated August 11, 2021, September 24, 2021 and October 15, 2021.

3.1 Facility Description 10 CFR 30.32(i)(3)(i) requires that the emergency plan provide a brief description of the facility and area near the site. Section 1, Facility Description, of RG 3.67 provides guidance for the review of the description of the facility and the licensed activity.

Section 1.0, Facility Description, of the Niowave Emergency Plan contains descriptions of the licensed activity, the facility and site, and the area near the site. The information provided includes:

1. A description of the proposed licensed activity to extract radioisotopes from special nuclear material (SNM) scrap and Strontium-90 (Sr-90);

2. A discussion of the types, forms, and quantities of other hazardous materials at Airport Facility ;

3. A detailed description of the site location and layout;

4. A description of the major structures located at the site;

5. A description of the area near the site, including area land-use information; and

6. Detailed maps of the facility and surrounding area showing key landmarks, facilities related to emergency response, and universities.

The level of detail provided meets the requirements of 10 CFR 30.32.(i)(3)(i).

3.2 Types of Accidents 10 CFR 30.32(i)(3)(ii) requires the emergency plan provide an identification of each type of radioactive materials accident. Section 2, Types of Accidents, of RG 3.67 provides guidance for the review of postulated accidents.

Section 2.1, Description of Postulated Accidents, of the Niowave Emergency Plan lists the potential accidents involving radioactive material (RAM), which may require protective actions to prevent or minimize exposure of persons offsite to radiation or RAM are described. Mitigating measures are described in Table 5.1, Mitigation actions for potential accidents involving radiation or RAM that would require actions to prevent or minimize exposure of offsite persons.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(ii).

3.3 Classification of Accidents 10 CFR 30.32(i)(3)(iii) requires that the emergency plan provide a classification system for classifying accidents as Alerts and Site Area Emergencies (SAEs). Section 3.1, Classification System, of RG 3.67 provides guidance on the types of events that the emergency plan may consider.

Section 3.1, Classification Systems, of the Niowave Emergency Plan describes the classifications of accidents at the facility. The classification system includes the Alert and SAE classifications as defined in RG 3.67. Table 3.1, Types of Conditions that would initiate the declaration of an Alert or a SAE, provides a description of the types of incidents, the conditions that indicate an emergency classification and a means of detection of the incident.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(iii).

3.4 Detection of Accidents 10 CFR 30.32(i)(3)(iv) requires that the emergency plan describes the means of detecting accident conditions for each type of accident in a timely manner. Section 2.2, Detection of Accidents, of RG 3.67 provides guidance for the means for detection of the accidents.

Methods and systems to detect accidents are explained in Section 2.2, Detection of Accidents, of the Niowave Emergency plan. It describes multiple instruments and equipment to detect emergency situations including: (1) hot cell temperature sensors; (2) fire alarms are wireless smoke detectors; (3) security cameras; (4) continuous airborne radioactivity monitors; and (5) area radiation monitors. Table 6.1, Equipment for Area Monitoring and Assessing Releases of RAM, describes the types of instruments used for radiation monitoring. The Niowave Emergency Plan states that all of the equipment that is permanently stored in the RAM storage locations located at the Capital Region International Airport have duplicated at the nearby Niowave Headquarters Facility for access during all postulated accidents.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(iv).

3.5 Mitigation of Consequences 10 CFR 30.32(i)(3)(v) requires that the emergency plan briefly describe the means and equipment provided to mitigate the consequences of each type of accident. The mitigation of consequences must also be described in terms of protection of workers and a description of the program to maintain equipment provided. Section 5, Emergency Response Measures, of RG 3.67 provides guidance for means and equipment provided to mitigate the consequences of each type of accident.

Section 5.3, Mitigation Actions, of the Niowave Emergency Plan describes measures and equipment used for safe shutdown and mitigation of consequences of emergency events that could occur at the facility. Table 5.1, Mitigation actions for potential accidents involving radiation or RAM that would require actions to prevent or minimize exposure of offsite persons, provides the types of incidents; potential causes; potential process/location of the accident, and mitigating actions.

Section 5.4, Protective Actions, describes the onsite and offsite protective actions. Examples of onsite protective actions may be evacuation and accountability, and the use of protective equipment. In the event of an emergency, there are remote monitoring tools available to help identify the order of magnitude of a potential release. This will allow the Niowave Emergency Response Team to inform first responders of a safe approach distance if an event has occurred.

The information can also be used to inform offsite protective actions, if required, such as shelter-in-place or evacuation are warranted for nearby structures within a 100-meter radius of the site.

Section 7.6, Maintenance and Inventory of Emergency Equipment, Instrumentation and Supplies, of the Niowave Emergency Plan describes the maintenance program for emergency specific equipment.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(v).

3.6 Assessment of Releases 10 CFR 30.32(i)(3)(vi) requires that the emergency plan provide a brief description of the methods and equipment that will be used to assess releases of radioactive material.

Section 5.2, Assessment Actions, of RG 3.67 provides guidance on the actions taken to assess releases of radioactive or hazardous material.

Section 5.2, Assessment Actions, describes the assessment actions to be taken in the event of emergencies. The Niowave Emergency Plan states that assessment actions will be performed by members of the Niowave Emergency Response Team during an emergency to determine the severity and extent of the emergency and characterize hazards to on-site and off-site personnel. The order and type of assessment actions are highly dependent on the emergency.

Niowave states that it maintains a fleet of radiation detection equipment which is capable of identifying and quantifying surface contamination, airborne radioactivity levels, and ambient dose rates. Active and passive air sampling in conjunction with survey equipment will be performed in key locations to assess the radiation source term emanating from the facility. The collected data from radiation surveys and monitors can be utilized in conjunction with predetermined models for off-site dose projection to determine if protective actions are required.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(vi).

3.7 Responsibilities 10 CFR 30.32(i)(3)(vii) requires that the emergency plan provide a brief description of the responsibilities of personnel should an accident occur, including the prompt notification of off-site response personnel and the NRC, as well as responsibilities for developing, maintaining, and updating the plan. Section 4, Responsibilities, of RG 3.67 provides guidance on describe the emergency organization to be activated onsite for possible events, as well as its augmentation and support offsite. Section 7, Maintaining Emergency Preparedness Capability, of RG 3.67 provides guidance for the responsibilities for developing, maintaining, and updating the plan.

Section 4, Responsibilities, of the Niowave Emergency Plan describes the normal facility organization and the onsite emergency response organization. Niowaves Radiation Safety Officer (RSO) is responsible for the radiation safety program and compliance with NRC regulations. The RSO has overall authority and responsibility for directing an emergency response. The RSO has the authority to designate these responsibilities to another member of the Niowave Emergency Response Team. The RSO or designee maintains the following responsibilities and authorities during an emergency response:

Declaration of Alert or SAE; Requesting support from offsite response organizations (medical, fire, and police);

Providing guidance to offsite agencies; Coordination of the Niowave Emergency Response Team; Ensuring procedures are followed, and Termination of emergency.

Members of the Niowaves Emergency Response Team provide support in the following categories with the associated responsibilities:

Radiological o Able to operate and understand the readings from radiological survey and monitoring instruments; o Knowledge of facility procedures, including evacuation and accountability protocols; o Training and authorization to handle the RAM and perform personnel decontamination; o Knowledge of available fire alert and fire suppression systems; o Basic first aid skills, and o Potential team members include: RSO, authorized users, radiation workers and health physicists.

Facilities o Knowledge of the building infrastructure, utilities, and surrounding areas of the facility; o Capable of checking several monitoring and communications systems, and o Potential team members include: information technology specialist, building or facility manager.

Communication and Command o Executive level knowledge of Niowaves radioisotope programs; o Authority to speak for the company to offsite response organizations and media, and o Potential team members include: Niowave management staff.

Section 7, Maintain Emergency Preparedness Capability, of the Niowave Emergency Plan describes the developing, maintaining, and updating the Niowave Emergency Plan and its elements.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(vii) 3.8 Notification and Coordination 10 CFR 30.32(i)(3)(viii) requires that the emergency plan contain a commitment to and a brief description of the means to promptly notify off-site response organizations; that a control point be established; that notification and coordination be planned, and that the unavailability of some personnel, parts of the facility and some equipment will not prevent notification and coordination. The licensee must also commit to notify the NRC Operations Center immediately after notification of the appropriate off-site response organizations and not later than one hour after the licensee declares an emergency. Section 3.2, Notification and Coordination, of RG 3.67 provides guidance for notification of off-site response personnel.

Section 3.2, Notification and Coordination, of the Niowave Emergency Plan states that if an incident occurs at Niowaves Airport Facility that would initiate an Alert or SAE, the RSO or their designee if the RSO is unavailable, would make the decision to declare the appropriate emergency classification level. Some of the actions that the RSO or their designee is also responsible for:

Activation of onsite emergency response organization, as needed; Notification of offsite response authorities to inform them that an emergency has been declared at the facility, as needed; Notification of the NRC Operations Center immediately after notifying appropriate offsite response organizations and no later than one hour after declaring an emergency; Decisions to initiate onsite protective actions, as needed; Decisions to escalate the emergency classification level, as needed; Decisions to request support from offsite organizations, as needed, and Decisions to terminate the emergency classification level or enter the recovery process.

Section 4.4, Coordination with Participating Government Agencies, of the Niowave Emergency Plan states that in the event of a SAE, Niowave will work with local OROs (fire, medical, and police) along with the NRC and the State of Michigan, where applicable. Niowave states that there is no county-level regulatory entity for Clinton County.

Section 6.1, Command Center, of the Niowave Emergency Plan states the command center is the central location that coordinates the response to a SAE. Personnel will be briefed and dispatched from this location for radiation survey, damage assessment, emergency repair, or other mitigating tasks. Coordination with Niowave staff dispatched to an emergency and with external responders (Fire, Police) will be performed in the command center. The principal command center is the conference room in the north corner of the Airport Facility. The alternative command center location is the Board Room at Niowaves headquarters facility located at 1012 North Walnut St., Lansing, Michigan (5-minute drive by car from the Airport Facility).

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(viii).

3.9 Information to be Communicated 10 CFR 30.32(i)(3)(ix) requires that the emergency plan provide a brief description of the types of information on facility status, radioactive releases and recommended protective actions, if necessary, to be given to offsite response organizations and the NRC. Section 3.3, Information to be Communicated, of RG 3.67 provides guidance for the types of information on facility status, radioactive releases and recommended protective actions.

Section 3.3, Information to be Communicated, of the Niowave Emergency Plan states the RSO or their designee should be prepared to be the primary source of information to be communicated to offsite response organizations including emergency responders. The following are items to be considered for communication (the RSO or designee must remember to communicate without using technical terms and jargon that OROs may not understand):

Facility status including all hazards inside or around the facility; Location of employees or emergency responders inside the facility; Location of RAM and its status, if known; Protective action recommendations for emergency responders; Any injuries to employees or emergency responders; Timely updates to any of the above information if the status has changed, and Location of Command Center and the status of the emergency response.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(ix).

3.10 Training 10 CFR 30.32(i)(3)(x) requires that the emergency plan briefly describe the training that the licensee will provide to workers on how to respond to an emergency and any special instructions, and on orientation tours that will be offered to fire, police, medical, and other emergency personnel. Section 7.2, Training, of RG 3.67 provides guidance for the general content of training program for onsite workers, as well as special instructions and orientation tours the licensee will to offsite emergency response personnel.

Section 7.2, Training. of the Niowave Emergency Plan provides information about emergency response training. The following training is organized for emergency response personnel:

General radiation safety training (annual, required);

Laboratory specific safety and radiation training if performing work in these areas (required);

Respiratory protection training (annual, required), and Automated external defibrillator (AED) training (annual, optional).

Personnel who prepare, maintain, and implement the emergency plan receive the above training in addition to ongoing training and seminars offered by the Office of Radiological Security including Distance Alarm Response Training.

The following training is afforded to non-emergency response personnel:

General radiation safety training; Laboratory specific safety and radiation training (if performing work in these areas), and AED training (optional).

During laboratory specific safety and radiation training non-emergency response personnel are trained on what to do during a declaration of an emergency. Niowave states that as part of the biennial exercise it will make the facility available to fire, police, and medical personnel for tours and information about the material and processes occurring at the facility.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(x).

3.11 Safe Shutdown 10 CFR 30.32(i)(3)(xi) requires that the emergency plan provide a brief description of means for restoring the facility to safe operation after an accident. Section 9, Recovery and Plant Restoration, of RG 3.67 provide guidance for the plans for restoring the facility to a safe status.

Section 9.0, Recovery and Plant Restoration, of the Niowave Emergency Plan provides that the RSO will lead efforts with members of Niowaves Emergency Response Team and other radiation workers to restore to safe operational status. Niowave maintains restoration procedures and checklists of operational systems required before the facility, command center, and assembly and relocation area is returned to safe operational status. After a careful assessment of the status of the material, immediate measures will be taken to ensure there is no continuing release of RAM. The security and radiation monitoring systems will be re-established and tested.

The level of detail meets the requirements of 10 CFR 30.32(i)(3)(xi).

3.12 Exercises and Drills 10 CFR 30.32(i)(3)(xii) requires that the emergency plan provide a description of the program for conduct of exercises, drills, and communications tests. Section 7.3, Drills and Exercises, of RG 3.67 provides guidance for the provisions for periodic drills and exercises to test the adequacy of implementing procedures, to test emergency equipment and instrumentation, and to ensure that the emergency personnel are familiar with their duties.

Sections 7.3, Drills and Exercises, of the Niowave Emergency Plan provide descriptions of drills and exercises respectively at the airport facility. Emergency response drills are conducted annually to ensure emergency personnel are familiar with duties, emergency equipment and instrumentation is tested, and procedures are implemented effectively. Emergency response drills include:

Table read through of relevant procedures and documents with all emergency response staff; Full equipment and alarm function checks, and Walk through of at least one Alert and at least one SAE scenario and response.

Niowave will perform an exercise biennially of a SAE scenario. All relevant offsite organizations will be invited to participate, including the NRC. The NRC will be provided a notice 60 days before the exercise that includes objectives and description of the scenario.

Niowave will communicate with local response organizations each quarter to ensure that personnel and telephone records are kept up to date.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(xii).

3.13 Hazardous Chemicals 10 CFR 30.32(i)(3)(xiii) requires that the emergency plan certify that the licensee has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L.99-499, if applicable to the applicants activities at the proposed place of use of the byproduct material. Section 10, Compliance with Community Right-to-Know Act, of RG 3.67 provides the emergency plan certify compliance with respect to any hazardous materials possessed at the plant site.

Section 10, Compliance with Community Right-to-Know Act, of the Niowave Emergency Plan states, Niowave certifies that with respect to the hazardous materials possessed at its Airport Facility, operations are conducted in compliance with Title III of the Superfund Amendments and Reauthorization Act of 1986, Pub. L.99-499, entitled Emergency Planning and Community Right-to-Know Act of 1986.

The level of detail provided meets the requirements of 10 CFR 30.32(i)(3)(xiii).

3.14 Comments on the Niowave Emergency Plan 10 CFR 30.32(i)(4) requires that the licensee allow off-site response organizations, expected to respond in case of an accident, a period of 60 days to comment on the initial submission of the licensees emergency plan before submitting it to the NRC, and provide any comments received to the NRC with the emergency plan.

The Niowave Emergency Plan was provided to off-site response organizations for review and no comments were received.

4.0 CONCLUSION

The NRC staff reviewed the Niowave Emergency Plan as provided in its application dated May 19, 2021, as supplemented by letters dated August 11, 2021, September 24, 2021 and October 15, 2021, with respect to the regulatory requirements of 10 CFR 30.32(i), and the guidance in RG 3.67. The NRC staff finds that the Niowave Emergency Plan demonstrates compliance with regulatory requirements of 10 CFR 30.32(i) and 10 CFR 30.34(f).

7.0 REFERENCES

1.

Letter from Niowave, Inc. to U.S. Nuclear Regulatory Commission, Additional Information for Amendment to NRC License Number 21-35144-04, May 19, 2021 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML21140A171).

2.

Letter from Niowave, Inc. to U.S. Nuclear Regulatory Commission, Response to RAI

[Request for Additional Information] from NSIR Office, Docket 70-7031, NRC License Number 21-35144-04, August 11, 2021 (ADAMS Accession No. ML21224A100).

3.

Letter from Niowave, Inc. to U.S. Nuclear Regulatory Commission, Response to second RAI from NSIR Office, Mail Control 624914, NRC License Number 21-35144-04, September 24, 2021 (ADAMS Accession No. ML21270A051).

4.

Letter from Niowave, Inc. to U.S. Nuclear Regulatory Commission, Response to third RAI from NSIR Office, Mail Control 624914, NRC License Number 21-35144-04, October 15, 2021 (ADAMS Accession No. ML21293A335).

5.

U.S. Nuclear Regulatory Commission, Regulatory Guide 3.67, Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities, Revision 1, dated April 2011 (ADAMS Accession No. ML103360487).

Principal Contributor: Michael Norris, NSIR/DPR/RLB