ML22131A273

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Shine OL SER Chapter 12.7 with No Open Items
ML22131A273
Person / Time
Site: SHINE Medical Technologies
Issue date: 05/11/2022
From: Gavello M
NRC/NRR/DANU/UNPL
To:
Gavello M
Shared Package
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References
Download: ML22131A273 (18)
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12.4.7 Emergency Planning The NRC staff evaluated SHINE document EMG-01-01, Revision 1, Emergency Plan (ADAMS Accession No. ML22027A666) (hereafter referred to as the SHINE Emergency Plan), against applicable regulatory requirements using regulatory guidance to assess the sufficiency of the emergency plan. Previously, the staff reviewed the SHINE Preliminary Emergency Plan submitted as part of the construction permit application. In its safety evaluation report associated with the construction permit application (ADAMS Accession No. ML16229A140), the staff identified several regulatory commitments concerning the emergency plan that the applicant was to address in the SHINE Emergency Plan and the SHINE final safety analysis report (FSAR) supporting the operating license application. As documented in this safety evaluation report associated with the operating license application, the staff has confirmed that all of the regulatory commitments previously identified have been satisfactorily addressed. The specific regulatory commitments are not individually documented in this safety evaluation report, as the review effort was conducted to ensure that the current emergency plan satisfies the applicable guidance and, therefore, appropriately meets the applicable regulatory requirements.

10 CFR 50.34(b)(6)(v) requires that each application for an operating license include an FSAR that contains, among other things, the applicants plans for coping with emergencies, including the items specified in Appendix E, Emergency Planning and Preparedness for Production and Utilization Facilities, to 10 CFR Part 50.

Footnote 2 to Section I.3 of Appendix E to 10 CFR Part 50 specifies that Regulatory Guide (RG) 2.6 will be used as guidance for the acceptability of research and test reactor emergency response plans. RG 2.6, Revision 2, Emergency Planning for Research and Test Reactors and Other Non-Power Production and Utilization Facilities, in turn endorses American National Standards Institute (ANSI)/American Nuclear Society (ANS) standard ANSI/ANS 15.16-2015, Emergency Planning for Research Reactors. This standard identifies the elements of an emergency plan for minimizing the accident consequences at non-power reactors. NUREG-1537, Part 2, Chapter 12, Conduct of Operations, Section 12.7, Emergency Planning, provides the guidelines for reviewing applications and references NUREG-0849, Standard Review Plan for the Review and Evaluation of Emergency Plans for Research and Test Reactors, which provides the guidelines for the review and evaluation of emergency plans at non-power reactors. Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors:

Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, updates and expands the content of NUREG-1537, Part 2. In addition, NUREG-1520, Revision 2, Standard Review Plan for Fuel Cycle Facilities License Applications, suggests additional information that should be included for the SHINE production facility.

The guidance in NUREG-0849, Section 1.0, Introduction, as supplemented by the Interim Staff Guidance (ISG) augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.1, Introduction, provides that the emergency plan should contain a description of the facility including authorized power level, location, and access routes to the facility. The owner and operator of the facility should be identified, and the objectives of the emergency plan explained. The NRC staff reviewed the information provided in Section 1, Introduction, of the SHINE Emergency Plan, including associated figures, site layout, and maps provided in the plan. The staff identified that the SHINE facility is owned and operated by SHINE Medical Technologies, LLC and is located at 4021 South US Highway 51, Janesville WI, 53546.

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The SHINE facility includes the following structures:

  • Main production facility,
  • Resource building,
  • Material staging building,
  • Storage building, and
  • Nitrogen purge system (N2PS) structure The SHINE facility involves the use of a non-reactor based, subcritical fission process for the purpose of manufacturing medical isotopes. The SHINE facility contains irradiation units (IUs),

each with a target solution vessel with a licensed fission power of 125 kilowatts-thermal (kWth),

located in the irradiation facility area of the main production facility. Also located in the irradiation facility are rooms and cells housing off-gas handling equipment, cooling equipment, tritium purification equipment, and an area for servicing neutron drivers.

The radioisotope production facility area of the main production facility contains a hot cell bank; below-grade vaults containing tanks, other process components, and storage space; two laboratories; and areas for waste handling, cooling, and other equipment. The remaining areas of the facility (the control room area and the administrative annex area) contain the control room, electrical equipment, additional auxiliary equipment, and other miscellaneous areas.

The SHINE site consists of an approximately 91-acre parcel in the City of Janesville, Rock County, Wisconsin and is accessed from U.S. Highway 51. Figure 1, SHINE Facility Site Layout, of Appendix 1, Figures, to the SHINE Emergency Plan depicts the site boundary, fences, gates, roads and parking lots on site, onsite structures and tanks, and U.S. Highway 51.

Figure 2, SHINE Main Production Facility General Arrangement, depicts the general arrangement layout of the main production facility, which includes the irradiation facility, radioisotope production facility, control room area, and administrative annex area. Figure 3, SHINE Site Buildings and Surrounding Area, provides an aerial view of the area surrounding the SHINE site, including the location of onsite structures and sensitive facilities near the SHINE site (0-1 mile), including churches, parks, residences, airstrips, and educational facilities. Farms are distributed throughout the one-mile radius of the SHINE site. There are no medical facilities within one mile of the SHINE site. Figure 4, SHINE Site General Area Map, contains a general area map constructed from U.S. Geological Survey topographical quadrangles and includes the SHINE facility site boundary.

The major activities conducted at the SHINE facility are: (1) preparation and irradiation of uranyl sulfate target solution and (2) extraction, purification, and packaging of medical isotopes from irradiated target solution inside hot cells. The SHINE facility contains radioactive and hazardous materials that are part of the overall medical isotope production process. Appendix 2, Radioactive and Hazardous Materials, to the SHINE Emergency Plan provides the types, quantities, and locations of radioactive and hazardous materials normally on the SHINE site.

The SHINE main production facility contains a facility vent stack for facility emissions. The stack uses high efficiency particulate air filters and single stage high efficiency gas adsorption filter equipment for emission control. There is a stack release monitor present that provides information on radiation released from the facility stack.

Section 1.9, Accident Summary, of the SHINE Emergency Plan describes the general types of accidents that may require the implementation of protection actions. Additional information on potential facility accidents is contained in Chapter 13, Accident Analysis, of the SHINE FSAR.

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Measures and equipment used to respond to and detect accidents and releases are described in Section 9, Emergency Facilities and Equipment, of the SHINE Emergency Plan.

The NRC staff finds that the information in the SHINE Emergency Plan concerning the site layout and location, consideration of access routes, surrounding population distribution, land use and jurisdictional boundaries, authorized power level, identification of the owner and operator of the facility, and an explanation of the objectives of the emergency plan are acceptable and meet the relevant standards set forth in NUREG-0849 and the ISG augmenting NUREG-1537, Part 2. The NRC staff concludes that this information meets the applicable regulatory requirements and acceptance criteria and is therefore sufficient for the issuance of an operating license.

The guidance in NUREG-0849, Section 2.0, Definitions, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.2, Definitions, provides that the emergency plan should identify definitions for terms that are unique to the facility and should include phrases with meanings specific to the facility.

Section 2, Definitions of the SHINE Emergency Plan describes the terms defined as having special meaning unique to the facility, as well as acronyms and abbreviations used throughout the document. The NRC staff finds the defined terms, acronyms, and abbreviations to be complete and to be used consistently throughout the document. The NRC staff finds the information acceptable and determined that the definitions, acronyms, and abbreviations are consistent with the guidance in NUREG-0849, Section 2.0, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.2. The NRC staff concludes that the information provided meets the acceptance criteria and is therefore sufficient for the issuance of an operating license.

The guidance in NUREG-0849, Section 3.0, Organization and Responsibilities, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.3, Organization and Responsibilities, provides that the emergency plan should identify the emergency organization, including the onsite emergency organization, any augmentation from offsite groups, and the identification, by normal everyday title, of all persons or groups that will fill positions in the emergency organization. These criteria include:

  • A description of the emergency planning functions of Federal, State, and local government agencies, and identification of the assistance they would provide and of the applicants emergency organization, including augmentation of the operations staff to provide assistance during an emergency, recovery from the emergency, and maintaining emergency preparedness.
  • The arrangements and written agreements with local support organizations that would augment and extend the capability of the facility's emergency organization.
  • A block diagram illustrating the interrelationship of the facility emergency organization to the total emergency response effort, including specification of the interface between the onsite emergency organization and offsite local support organizations and agencies.
  • The identification by title of the individuals in charge of directing emergency operations; of coordinating emergency preparedness planning, updating emergency plans and procedures, and coordinating plans with other supporting organizations; of relating information about the emergency to the news media and the public, and of both onsite 3

and offsite radiological assessments including a line of succession, and responsibilities and authorities and those responsibilities which may not be delegated (such as notification and protective action decisions).

  • The identification by title of the individuals providing onsite and offsite dose assessments and recommended protective actions; authorizing reentry into radiological controlled areas or portions of the facility that may have been evacuated during the emergency; terminating an emergency and initiating recovery actions and informing the emergency organization of planned organizational actions or changes; and authorizing volunteer emergency workers to incur radiation exposures in excess of normal occupational limits.
  • The identification by title of the individuals who will declare an alert or site area emergency classification, activate the onsite emergency response organization (ERO) during all shifts, promptly notify offsite response authorities that an alert of site area emergency classification has been declared, notify the NRC Operations Center, initiate onsite and offsite protective actions, request support from offsite organizations, and either terminate the emergency or enter recovery mode.

Section 3.1, Emergency Response Organization, of the SHINE Emergency Plan states that the ERO is responsible for taking actions in an emergency to avoid an accident or to mitigate the consequences of one. At the SHINE facility, the ERO would be staffed with trained and qualified personnel that would be required to attend formal initial and continuing training, as well as participate in drills and exercises. In addition, the applicant explained that the ERO at the SHINE facility would consist of two groups of personnel: (1) the normal facility operating organization and (2) the facility emergency organization.

As summarized below, the on-shift personnel present at the site will initially staff the facility emergency organization. Upon activation of the ERO, designated off-shift personnel will be notified to report to the Emergency Support Center (ESC), once it has been activated, or to the Control Room if the ESC has not yet been activated. Section 7, Activation of the ERO and Notification, of the SHINE Emergency Plan further describes this response effort.

The NRC staff reviewed Section 3, Organization and Responsibilities, of the SHINE Emergency Plan. The organization for managing and operating the SHINE facility is provided in Figure 10, SHINE Normal Facility Operation Organization Chart, of the SHINE Emergency Plan and is summarized below.

  • Chief Executive Officer (CEO): The CEO is responsible for the overall management and leadership of the company.
  • Diagnostics General Manager: The Diagnostics General Manager is responsible for operational aspects of the diagnostics division.
  • Director of Plant Operations: The Director of Plant Operations is responsible for the overall operation of the facility.
  • Director of Corporate Support: The Director of Corporate Support is responsible for facility radiation protection, security, and training.
  • Operations: The facility operations personnel are responsible for the operation of the facility and the safe, reliable, and efficient plant operations.

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  • Security: The facility security personnel are responsible for the physical security of the facility.
  • Engineering: The facility engineering personnel are responsible for providing technical expertise and support of facility operation and maintenance, and for controlling the physical facility configuration to ensure that facility operation, maintenance, and configuration are maintained in accordance with the design basis.
  • Radiation Protection: The facility radiation protection personnel, which are part of the facility technical staff, are responsible for handling and monitoring of radioactive materials.
  • Maintenance: The facility maintenance personnel are responsible for performing maintenance on facility equipment in accordance with facility procedures, instructions, and technical requirements.
  • Chemistry: The facility chemistry personnel, which are part of the facility technical staff, are responsible for sampling, analysis, and product quality control activities.
  • Executive, support, administrative, and other personnel (support personnel): These individuals have various responsibilities involving procurement, licensing, quality, finance, etc., and may include personnel normally stationed offsite.

On-shift personnel

  • Shift supervisor: A senior licensed operator responsible for the safe operation of the facility.
  • Licensed operators (including any additional on-shift senior licensed operators, if present): Responsible for ensuring licensed activities are conducted safely and in accordance with the facility license and procedures.
  • Non-licensed operating staff: Responsible for conducting operations in the facility in accordance with procedures and under the direction of licensed operators.
  • Security personnel: Responsible for the physical security of the facility.
  • Radiation protection individual: At least one individual capable of monitoring radiation dose rates and contamination levels is present on each shift.

During an emergency, personnel may deviate from actions described in the plan for unusual or unanticipated conditions. The ERO at the SHINE facility is comprised of the following individuals, as illustrated by Figure 11, SHINE Facility Emergency Organization, of the SHINE Emergency Plan:

  • Emergency Director: The Emergency Director is authorized to and responsible for directing and coordinating the overall emergency response. The Emergency Director has the following non-delegable responsibilities:
  • Emergency event classification and decision to declare an emergency; 5
  • Decision to activate the ERO;
  • Decision to initiate onsite protective actions;
  • Decision to notify offsite response authorities;
  • Decision to request support from offsite organizations;
  • Authorization of reentry into portions of the facility or site that may have been evacuated during the emergency;
  • Authorization of volunteer emergency workers to incur radiation exposures in excess of normal 10 CFR Part 20 occupational limits; and
  • Decision to terminate the emergency and initiate recovery actions.

The Emergency Director may delegate the following responsibilities, based on his/her decision (as stated above):

  • Activation of the ERO;
  • Notification of offsite response authorities within 15 minutes of when a Notification of Unusual Event, Alert, or Site Area Emergency classification has been declared;
  • Notification of the NRC Operations Center within one hour of declaring the emergency;
  • Assessment of damage to and status of the facilitys capabilities to safely control radioactive material or hazardous chemicals associated with licensed activities;
  • Prioritizing responses to concurrent emergencies; and
  • Informing the ERO of planned emergency organization actions or changes.
  • Shift Supervisor: The Shift Supervisor acts as the initial Emergency Director upon declaration of an emergency. Additionally, the Shift Supervisor has the following responsibilities:
  • Implementing immediate actions to respond to the emergency in accordance with facility emergency procedures;
  • Directing and supervising the activities of the control room staff; and
  • Safe operation of the plant in compliance with the facility NRC operating license, technical specifications, facility operating procedures, and the requirements for their use.
  • Emergency Communicator: The Emergency Communicator assists in the execution of the Emergency Directors duties. The Emergency Communicator is responsible for:
  • Exchanging information with offsite authorities responsible for coordinating and implementing offsite emergency measures, including transmitting dose projections and monitoring and surveying information;
  • Relating information about the emergency situation to the news media and the public; and
  • Ensuring a record of the events during and following the emergency is maintained.
  • Radiation Safety Coordinator: The Radiation Safety Coordinator is responsible for making radiological assessments and advising the Emergency Director, including responsibility for the following tasks:
  • Making onsite and offsite dose assessments and projections;
  • Recommending protective actions; and 6
  • Identifying exposed personnel and determining their radiation dose.
  • Technical Support Coordinator: The Technical Support Coordinator is responsible for coordinating the technical response to the event, including:
  • Performing technical assessments of facility emergencies;
  • Assisting the Emergency Director and Radiation Safety Coordinator in technical matters; and
  • Coordinating the technical staff to augment the ERO on an as-needed basis to support accident assessment and mitigation activities.
  • Criticality Safety Engineer: A criticality safety engineer is called-in upon activation of the ERO, at the discretion of the Emergency Director or Technical Support Coordinator, if a criticality event is suspected or confirmed. The Criticality Safety Engineer is responsible for the following tasks:
  • Advising and assisting the Emergency Director in responding to the criticality accident; and
  • Assisting the Radiation Safety Coordinator in conducting a radiological dose assessment appropriate for a criticality accident.
  • Security personnel: Security personnel that are present at the facility when an emergency is declared will implement emergency plan implementing procedures (EPIPs) appropriate to the event classification. Security personnel are responsible for the following tasks:
  • Performing personnel accountability, if required; and
  • Implementing access control of facility areas at the direction of the Emergency Director.
  • Operations personnel: Operations personnel that are present at the facility when an emergency is declared will implement EPIPs appropriate to the event classification.

Operations personnel are responsible for performing the following tasks:

  • Monitoring facility instrumentation and reporting results to the Emergency Director; and
  • Implementing corrective actions at the direction of the Emergency Director.
  • Assessment Teams: Assessment Teams are comprised of facility operations, technical staff, or support personnel that may be called upon by the Emergency Director following activation of the ERO. Assessment Teams are responsible for the following tasks:
  • Collecting onsite and offsite field monitoring data;
  • Monitoring radiation dose rates and contamination levels; and
  • Assessing collateral damage to the facility.
  • Reentry and Damage Control Teams: Reentry and Damage Control Teams are comprised of facility operations, technical staff, or support personnel who may be called-in by the Emergency Director upon activation of the ERO. Reentry and Damage Control Teams are responsible for the following tasks:

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  • Reentering an immediate evacuation zone during the emergency on a voluntary basis after being informed of the potential hazards and risks; and
  • Performing actions at the direction of the Emergency Director associated with controlling and stabilizing emergency events in-progress.

Section 3.4, Emergency Support Organizations, of the SHINE Emergency Plan states that in the event that the Emergency Director makes the decision to request support from offsite organizations, the following offsite support agencies and organizations would aid:

  • Janesville Fire Department: Fire support, first aid support, ambulance services, and hazardous materials response;
  • Janesville Police Department: Law enforcement support;
  • SSM Health St. Marys Hospital: Support services for any radiation exposed or contaminated injured individuals from the site;
  • Rock County Emergency Management: Responsible for coordinating major emergencies, disaster response, and recovery efforts in support of county and local governments; and
  • The State of Wisconsin: Has the general authority and responsibility to assist local units of government and local law enforcement agencies in responding to a disaster or the imminent threat of a disaster. The State of Wisconsin coordinates its response with Rock County Emergency Management as needed.

The applicant stated that local government agencies and organizations, as described above, will be initially notified as described in Section 7 of the SHINE Emergency Plan by contacting the Rock County 911 Communications Center. The applicant further explained that the SHINE facility does not anticipate the need for State or Federal assistance. The NRC staff confirmed that Appendix 3, Agreement Letters of the SHINE Emergency Plan provides arrangements and agreements with the support organizations described above that would augment and extend the capability of the facilitys emergency organization as specified in NUREG-0849, as supplemented by the ISG augmenting NUREG-1537, Part 2.

Section 3.3, paragraph (2) of ANSI/ANS 15.16-2015 states, in part, that the organizational description shall include, as applicable, the authority and responsibility of each support agency or organization (local, county, state, or all three) having radiological emergency responsibilities for emergency preparedness planning and emergency response assistance. Section 3.4 of the SHINE Emergency Plan states, in part, that in the event that the decision is made by the Emergency Director to request support from those offsite agencies and organizations, assistance as outlined above would be provided. The applicant further stated that the State of Wisconsin has the general authority and responsibility to assist local units of government and local law enforcement in responding to a disaster or the imminent threat of a disaster and will coordinate its response with Rock County Emergency Management, as needed.

Section 3.7.1, Activation of emergency organization, of ANSI/ANS 15.16-2015 states the specific actions to notify and mobilize the emergency organization, and the applicable offsite support organizations for each emergency class. Section 7.3, Notification of Off-site Organizations, of the SHINE Emergency Plan states that the Emergency Director ensures that emergency notifications are promptly made to off-site emergency response organizations and 8

that a notification will be made to the State of Wisconsin promptly after notification to the NRC.

Section 3.5, Maintaining Emergency Preparedness, of the SHINE Emergency Plan describes the roles and responsibilities of individuals that have roles related to maintaining emergency preparedness. The SHINE Emergency Plan provides a description of how the effectiveness of the emergency plan will be maintained, including training, review, and update of the emergency plan and associated implementing procedures along with maintenance and inventory of equipment and supplies that would be used in an emergency.

Section 3.10.1, Training and drills, of ANSI/ANS 15.16-2015 identifies and describes training and drill criteria to demonstrate emergency preparedness. Section 11.4.4, Exercises, of the SHINE Emergency Plan states that at least every two years, exercise drills shall contain provisions for coordination with off-site emergency personnel. Section 11.4.2, Planning and Controlling Drill and Exercises, of the SHINE Emergency Plan states that off-site organizations or governments, including city, county, and State agencies, shall be invited and allowed to participate in drills or exercises at their request.

Based on the above, the NRC staff concludes that the SHINE Emergency Plan, Section 3, provides an adequate description of the emergency organization that would be activated to cope with radiological emergencies as it pertains to the onsite emergency organization and any augmentation necessary from offsite groups. Personnel or groups that will fill positions in the emergency organization are adequately identified by title and described within the SHINE Emergency Plan as specified in NUREG-0849, as supplemented by the ISG augmenting NUREG-1537, Part 2, and ANSI/ANS 15.16-2015. Therefore, the NRC staff finds the above information sufficient for the issuance of an operating license.

The guidance in NUREG-0849, Section 4.0, Emergency Classification System, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.4, Emergency Classification System, provides the following standard emergency classifications; however, it states that each emergency plan shall include only those standard classifications appropriate for dealing with accident consequences determined to be credible for the specific facility:

  • Notification of Unusual Event,
  • Alert,
  • Site Area Emergency, and
  • General Emergency.

The NRC staff reviewed Section 4, Emergency Classification System, of the SHINE Emergency Plan. The SHINE Emergency Plan provides for the classification of emergencies according to the severity of offsite radiological consequences. The standard classifications for the SHINE facility are: Notification of Unusual Event, Alert, and Site Area Emergency, which is consistent with the guidance in NUREG-0849, as supplemented by the ISG augmenting NUREG-1537, Part 2, and ANSI/ANS 15.16-2015. The applicant identified no credible accidents for the SHINE facility that would result in radiological levels exceeding the action levels for a General Emergency classification level at the site boundary. As a result, the SHINE Emergency Plan does not include provisions for a General Emergency classification.

Section 4.2, Emergencies Less Severe Than Notification of Unusual Events, of the SHINE Emergency Plan also recognizes emergencies of lesser consequences than the Notification of Unusual Event classification level. The applicant explained that these include physical 9

occurrences within the facility requiring facility emergency organization response. Responses to these emergencies of lesser consequence than a Notification of Unusual Event are based on the recognition of immediate need for onsite staff to implement emergency measures to provide aid to affected persons or to mitigate the consequences of damage to equipment, coupled with assessing radiological monitors to determine if the possibility of a more serious emergency is present. Situations of lesser consequence than Notification of Unusual Events that may warrant implementation of portions of the SHINE Emergency Plan or select EPIPs are identified within Section 4.2 of the emergency plan.

Section 4.3, Notification of Unusual Event, of the SHINE Emergency Plan defines a Notification of Unusual Event, also referred to as an Unusual Event, as man-made events and natural phenomena creating a significant hazard potential that was previously non-existent. At the Unusual Event classification level, time is expected to be available to take precautionary and corrective steps to prevent the escalation of the accident or to mitigate the consequences should it occur. As a result, no releases of radioactive or hazardous materials requiring offsite responses are anticipated.

Section 4.4, Alert, of the SHINE Emergency Plan defines an Alert classification level as an event that may occur, is in progress, or has occurred, that could lead to a release of radioactive material or hazardous chemicals incident to the processing of licensed materials. However, a release is not expected to require a response by an offsite response organization to protect persons offsite. The applicant explained that modification of facility operating status at the Alert classification level is a probable corrective action.

Section 4.5, Site Area Emergency, of the SHINE Emergency Plan defines this emergency classification level as an event that may occur, is in progress, or has occurred that could lead to a significant release of radioactive material or hazardous chemicals incident to the processing of licensed material and that could require a response by offsite emergency response organizations to protect persons offsite. The applicant stated that a Site Area Emergency may be initiated when events such as major damage of primary boundaries containing radioactive or hazardous materials has occurred and actual or imminent failure of other physical barriers preventing releases have occurred and the projected offsite radiological consequences exceed the action levels. The applicant explained that monitoring at the site boundary will be conducted to assess the need for offsite protective actions and protective measures on site will be implemented.

Section 4.0 of NUREG-0849 states that the submitted emergency plan should include an appendix that contains titles and descriptions of implementing procedures for each emergency class described above. Appendix 5, Emergency Plan Implementing Procedure (EPIP) List, to the SHINE Emergency Plan provides a listing by title of implementing procedures for each class of emergency at the SHINE facility. The NRC staff confirmed that that the EPIPs as described would adequately provide the facility personnel with the guidance on actions to provide a graded response in order of increasing severity based on the standard of emergency classifications at the site in the event of an emergency.

The NRC staff confirmed that the emergency classifications identified in the SHINE Emergency Plan are consistent with the guidance in NUREG-0849, as supplemented by the ISG augmenting NUREG-1537, Part 2, and ANSI/ANS 15.16-2015, Section 3.4 and are in conformance with Appendix I, Emergency Classes, of NUREG-0849. Therefore, the NRC staff concludes that the information provided in Section 4 of the SHINE Emergency Plan is acceptable and meets the requirements and acceptance criteria for the issuance of an operating 10

license.

The guidance in NUREG-0849, Section 5.0, Emergency Action Levels, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.5, Emergency Action Levels (EAL), provides that the emergency plan should include methods for identifying the degree of seriousness and potential scope of radiological consequences of emergency situations within and outside the site boundary and assessing recommended protective actions. The guidance states, in part, that:

  • The emergency action levels (EALs) should be appropriate to the specific facility and consistent with the emergency classes;
  • To the extent possible, specify the effluent monitors used to project dose rates and radiological effluent releases at the site boundary;
  • The emergency plan should include EALs to initiate protective actions for facility staff and members of the general public onsite, and
  • The protective action guides shall be 10 milliSievert (mSv) deep dose (1 rem whole body) or 50 mSv (5 rem) thyroid.

The NRC staff reviewed Section 5, Emergency Action Levels, of the SHINE Emergency Plan.

The SHINE Emergency Plan does not identify any events that could lead to a release of hazardous chemicals incident to the processing of licensed material that would require activation of the SHINE ERO to protect persons onsite, or that would require a response by an offsite response organization (ORO) to protect persons offsite. For this reason, the applicant did not identify any EALs related to releases of hazardous chemicals incident to the processing of licensed material.

Appendix 4, Emergency Action Levels, of the SHINE Emergency Plan provides a full list of events under the three standard classifications of emergencies: Notification of Unusual Event, Alert, and Site Area Emergency for the SHINE facility. Included in Appendix 4 are specific dose values/set points used for each emergency classification. The NRC staff confirmed that the information contained in Appendix 4 is consistent with the emergency classifications identified in Section 4 of the SHINE Emergency Plan. The staff also determined that the EALs have been established in terms of effluent monitors and other facility parameters from which the dose rates and radiological effluent releases at the site boundary can be projected. The staff finds that the SHINE Emergency Plan adequately includes appropriate EALs that contain specific values and setpoints used for determining when and what type of protective actions are necessary to protect the health and safety of the facility staff onsite. The protective actions identified by the applicant are defined by the protective action guides (PAGs) identified in U.S Environmental Protection Agency (EPA) document EPA-400/R-17/001, PAG Manual: Protective Action Guides and Planning Guidance for Radiological Incidents. As a result, the staff concludes that the information provided in the SHINE Emergency Plan, Section 5 and Appendix 4 is acceptable and meets the requirements and acceptance criteria for the issuance of an operating license.

Section 7, Activation of the ERO and Notification, of the SHINE Emergency Plan provides that elements of the ERO will be activated or notified to increase the state of readiness as warranted by the circumstances. Although the situation may not have resulted in damage to the facility, it may warrant preventative or mitigative actions or interruption of nonessential routine functions.

As a result, the applicant explained that protective evacuations or isolation of certain areas of 11

the facility may be necessary. The NRC staff verified that Appendix 4 to the SHINE Emergency Plan describes the classes of emergency situations covering the spectrum of emergency conditions that involve the alerting or activating of progressively larger segments of the emergency organization. The staff also verified that for each class of emergency associated with an EAL there was a particular immediate action to provide an appropriate graded response.

The guidance in NUREG-0849, Section 6.0, Emergency Planning Zones, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.6, Emergency Planning Zones, provides, in part, that:

  • The size of the EPZ should be established so that the dose to individuals beyond the EPZ is not projected to exceed the EPA PAGs.

The potential radiological hazards to the public associated with the operation of research and test reactors and fuel facilities licensed under 10 CFR Part 50 involve considerations different than those associated with nuclear power reactors. As endorsed by RG 2.6, ANSI/ANS 15.16-2015 describes an acceptable approach for emergency planning commensurate with the potential risk involved for facilities of various authorized power levels. This approach to an acceptable EPZ size is also described in NUREG-0849, Appendix II, and was adopted by the applicant.

The NRC staff reviewed Section 6, Emergency Planning Zones, of the SHINE Emergency Plan, which states that there are no identified emergencies at the SHINE facility that would result in radiological emergencies that involve an off-site plume exposure exceeding 1 rem whole body or 5 rem thyroid. Therefore, the EPZ for the SHINE facility is identified as the operational boundary. Consistent with the guidance in NUREG-0849 and ANSI/ANS 15.16-2015, for a facility with an authorized power level like the SHINE facility, an acceptable EPZ size would be the operational boundary.

Based on the above, the NRC staff concludes that the information provided in the SHINE Emergency Plan, Section 6 adequately addresses the establishment of an appropriate EPZ for the SHINE facility, in accordance with applicable guidance and meets the established regulatory requirement.

The guidance in NUREG-0849, Section 7.0, Emergency Response, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.7, Emergency Response, provides criteria for emergency response measures that should be identified for each emergency. The criteria include the review and evaluation of the following:

  • The notification information for emergency response, including the actions to notify and mobilize the emergency organization and the applicable offsite support organizations for each emergency class and the location of current notification lists. Initial and follow-up emergency messages to the NRC and to offsite authorities, as applicable, should include: caller information such as name, title, and telephone number; a description of the emergency event; date and time of incident initiation; the location of the incident and the emergency class; the quantity and type of radionuclides released or expected to be released; and the impact of releases and recommended offsite emergency actions. A 12

method to ensure that offsite authorities have received the initial message and that it is authentic and that appropriate follow-up messages to offsite authorities are issued promptly.

  • The methods for gathering and processing information for assessment actions should be described in the emergency plan, and PAGs are available and used by the appropriate personnel in a timely manner.
  • The actions that could be taken to mitigate or correct the problem for each emergency class should be summarized in the emergency plan.
  • The emergency plan should describe protective actions appropriate for the emergency class and should include: conditions for either partial or complete onsite evacuation, evacuation routes, and primary and alternate assembly areas; methods to ensure personnel accountability and the segregation of potentially contaminated personnel; protective measures and exposure guidelines for emergency personnel; provisions for isolating and access control of facility areas to minimize exposures to radiation and the spread of radioactive contamination; and the methods for monitoring radiation dose rates and contamination levels, both onsite and offsite, including provisions for transmitting collected information and data to those responsible for accident assessment.
  • The emergency plan should describe the ability to promptly and effectively assess a release of radioactive material or hazardous chemicals, including: a description of procedures for estimating or measuring the release rate or source term; a description of the computer codes used to project doses, along with adequate justifications to show the validity of the assumptions; and a description of the method for assessing collateral damage to the facility.

The applicant addressed these criteria in Section 7, Activation of the ERO and Notification, and Section 8, Emergency Response, of the SHINE Emergency Plan. The NRC staff reviewed Section 7 of the SHINE Emergency Plan to evaluate the applicants planned emergency response measures related to activation and notification of the ERO. Section 7 identifies that the Shift Supervisor will become the Emergency Director when conditions exist that exceed EALs, or other conditions exist that warrant activation of the facility emergency organization. Notification of the emergency declaration will be made in accordance with established EPIPs. Rosters for emergency notifications are maintained in the Control Room and the ESC, and in controlled copies of the EPIPs. Progressive notifications to ERO members are planned dependent on classification of the emergency with full activation at the Site Area Emergency classification. The ESC is to be activated at an Alert or higher classification level.

The OROs are activated by calling the Rock County 911 Communications Center, using established EPIPs, which contain message authentication instructions. Notifications to OROs are to be made within 15 minutes of an emergency declaration. Notifications to the NRC Operations Center are to be made within one hour after event declaration. Preformatted messages and reporting checklists are used and include information consistent with that called for in guidance documents. The staff noted that after notification of the Rock County 911 Communication Center and the NRC, the State of Wisconsin will be promptly notified following the declaration of an emergency.

The NRC staff reviewed Section 8 of the SHINE Emergency Plan to evaluate the applicants planned emergency response measures. This section sets forth voluntary emergency work exposure guidelines that the Emergency Director can authorize when called for. The use of 13

respiratory protection and protective clothing is outlined.

Actions that the applicant will take in response to events to assess the event and activate appropriate facilities and notify personnel, and corrective actions that could be taken for events and personnel protective actions, are discussed for each emergency classification level.

Consideration of evacuation of personnel from impacted areas of the facility, along with assembly and accountability processes are described. The control room, main production facility break room, and main production facility conference room are identified as primary assembly areas for ERO personnel on site and non-essential personnel. The main production facility conference room has been designated as the alternate on-site assembly area for non-essential personnel. Back-up assembly locations in the storage building office area and the SHINE Headquarters breakroom are also identified.

The SHINE Emergency Plan identifies provisions for isolation and access control of facility areas to minimize exposures to radiation and the spread of contamination. Methods for monitoring radiation dose rates and contamination levels both onsite and offsite using installed monitoring equipment and portable survey equipment is described.

Section 8.7.3, On-site and Off-site Surveying, of the SHINE Emergency Plan states, in part, that Monitoring outside the facility and at the site boundary shall be implemented within two hours of declaring a Site Area Emergency involving a potential or actual release. Per Section 3.3.4, Radiation Safety Coordinator, of the SHINE Emergency Plan, the Radiation Safety Coordinator has the responsibility of making onsite and offsite dose assessments and projections. This position is identified as called-in as part of the activation of the ERO. The role of the Radiation Safety Coordinator is initially filled by an on-site individual with radiation protection experience. A relief Radiation Safety Coordinator may be called-in as part of the activation of the ERO, if required. Additionally, Section 3.3.9, Assessment Teams, of the SHINE Emergency Plan identifies collecting onsite and offsite field monitoring data as one of the responsibilities of an Assessment Team, which will assist the Radiation Safety Coordinator in making radiological assessments by monitoring or collecting radiation dose rates and contamination levels.

In addition, Section 8.7, Assessment Action Information, and Section 9.4, Assessment Facilities and Equipment, of the SHINE Emergency Plan provide protective actions in conformance to Section 8.4.3.1.7, Assessment of Releases, of NUREG-1520.

Based on the above, the NRC staff concludes that the information provided in the SHINE Emergency Plan, Sections 7 and 8, adequately addresses the emergency response measures for the SHINE facility, in accordance with applicable guidance and meets the established regulatory requirement.

The guidance in NUREG-0849, Section 8.0, Emergency Facilities and Equipment, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.8, Emergency Facilities and Equipment, provides criteria for emergency facilities, and the type of equipment and their location that should be addressed in the emergency plan. The acceptance criteria for information on emergency facilities and equipment are:

  • Representative types of monitoring and sampling equipment that would be used for 14

accident assessment and their location are described. For each type of accident identified, the emergency plan should describe the means of detecting the accident, the means of detecting any release of radioactive material or hazardous chemicals incident to the processing of licensed material, and the means of alerting operating staff.

  • The sampling and monitoring equipment types should include portable and fixed radiation monitors, sampling equipment, equipment for personnel monitoring, equipment for specific radionuclide identification and analysis, and to assess the release to the environment of radioactive or hazardous chemicals incident to the processing of licensed material. The plan should also describe non-radiological monitors or indicators such as fire detectors, earthquake sensors, etc.
  • The emergency plan should identify those measures that would be used to aid injured persons or those exposed to radiation. The capability to decontaminate, administer first aid, transport injured personnel, and arrange for treatment should be described including a description of both onsite and offsite services that support emergency response such as first aid personnel, firefighters, law enforcement assistance, and ambulance service.

A list and description of both onsite and offsite emergency facilities, by location and purpose, should be provided.

  • The emergency plan should identify the emergency communications systems that would be available to communicate instructions and information both onsite and offsite throughout the course of an emergency.

The NRC staff reviewed Section 9, Emergency Facilities and Equipment, of the SHINE Emergency Plan to evaluate what emergency facilities and equipment will be available. The emergency plan identifies the control room as the centralized onsite location from which effective control can be provided during an emergency. The plan also describes an ESC, both a primary and back-up location, to oversee operations in the control room and the rest of the facility in emergency conditions. The ESC is sized for at least six people.

The assessment of conditions of the facility and identification of emergency events is aided by the use of installed radiological instrumentation, a criticality accident alarm system, area radiation monitors, process radiation monitors, process tritium monitoring, a continuous air monitoring system, criticality accident dosimeters, and the ability to collect environmental monitoring information. Portable radiological monitoring equipment is available, as well as sampling kits and hand-held lights.

Two onsite laboratory facilities are available with instrumentation for specific radionuclide identification and analysis.

Non-radiological monitors and instrumentation for fire detection and seismic monitoring are available. Weather band radio receiver in the Control Room allows for the assessment of potential meteorological threats to the facility.

Section 9.5, Decontamination Facilities, Supplies, and Controls, of the SHINE Emergency Plan states that personnel are considered contaminated if they are found by direct frisk or use of a portal monitor to have contamination above background levels, as defined in the EPIP addressing emergency radiation exposure control. Equipment is considered contaminated if a survey of accessible surfaces results in contamination above background levels, as defined in the EPIP addressing emergency radiation exposure control.

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A decontamination room is provided at the main exit from the radiologically controlled area of the facility. Supplies for temporary decontamination areas are available if needed. The normal personnel monitoring equipment used by the facility staff is also used in emergency conditions, supplemented with any additional specialized dosimetry deemed necessary. Emergency support organization personnel are provided dosimetry prior to entering affected areas.

First aid supplies are maintained in the control room, ESC, the storage building office, and the main production facility shipping and receiving dock area. Offsite medical arrangements with the City of Janesville Fire Department and the SSM Health St. Marys Hospital are described in the SHINE Emergency Plan.

Communications systems using the normal facility phone system, which has a battery backup power supply, is relied upon for most communications in the event of an emergency. A public address system is also available throughout the facility. Sound powered phones are available in four strategic locations if needed. Handheld radios and base stations are also available and serve as a backup communications system. Radios are also capable of communication with the police and fire departments in Janesville, Wisconsin. The facility maintains an emergency mobile phone in the control room, and personal mobile phones are expected to be available if needed.

Based on the above, the NRC staff concludes that the information provided in the SHINE Emergency Plan, Section 9, adequately addresses the emergency facilities and equipment for the SHINE facility, in accordance with applicable guidance and meets the established regulatory requirement.

The guidance in NUREG-0849, Section 9.0, Recovery, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.9, Recovery, provides the criteria for recovery and reentry planning that should be addressed in the emergency plan, which are:

  • The emergency plan specifies that recovery procedures will be written and approved as needed.
  • The emergency plan describes the procedures for promptly determining the actions necessary to reduce any ongoing releases of radioactive material or hazardous chemicals incident to the processing of licensed material and to prevent further incidents.
  • The emergency plan describes the provisions for promptly and effectively accomplishing required restoration plans.

The NRC staff reviewed Section 10, Recovery, of the SHINE Emergency Plan to ensure that the applicant considered the recovery phase of an accident. According to the SHINE Emergency Plan, the Emergency Director will determine when emergency conditions no longer exist, and criteria are provided in the emergency plan for making this determination.

Assessment Teams, using established procedures, will conduct recovery assessments.

Recovery plans and procedures will be prepared by facility technical staff based on current conditions and approved by an individual qualified as an emergency director at the facility.

Personnel will be trained in specific recovery actions.

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Based on the above, the NRC staff concludes that the information provided in the SHINE Emergency Plan, Section 10, adequately addresses recovery actions for the SHINE facility, in accordance with applicable guidance and meets the established regulatory requirement.

The guidance in NUREG-0849, Section 10.0, Maintaining Emergency Preparedness, as supplemented by the ISG augmenting NUREG-1537, Part 2, Section 12.7, and ANSI/ANS 15.16-2015, Section 3.10, Maintaining Emergency Preparedness, provides the criteria for maintaining an acceptable state of emergency preparedness, which are:

  • The emergency plan should describe initial and periodic training for emergency response employees assigned functions for decision making and transmitting instructions, accident assessment, radiological monitoring and analysis teams, and for personnel involved in first aid and rescue, medical support, police, security, and ambulance and firefighting personnel.
  • The emergency plan should describe the conduct of annual onsite emergency drills, include provisions for drill critiques, including timely evaluation of observer comments and correction of identified deficiencies, and discuss the development of written scenarios for the conduct of annual action drills.
  • The emergency plan should provide for a biennial review and update of the emergency plan and implementing procedures and agreements with OROs and agencies that includes review and approval by those responsible for emergency planning, incorporating modifications resulting from drill results or changes to the facility, and timely forwarding changes to the plan and implementing procedures and agreements to the appropriate individuals, agencies, and supporting organizations.
  • The emergency plan should describe the provisions to ensure the operational readiness of emergency communications and emergency health physics equipment including the required maintenance and minimum calibration frequency, functional testing, and inventory of equipment and supplies.

The NRC staff reviewed Section 11, Maintaining Emergency Preparedness, of the SHINE Emergency Plan, to evaluate the applicants maintenance of emergency preparedness and training of facility staff. The plan calls for initial (eight hours) and annual refresher (two hours) training on topics such as an overview of the emergency plan, emergency procedure usage, facility layout, characteristics of a critically event, radiation safety, first aid, and the use of protective equipment and monitoring devices. Position-specific training is also provided for members of the response organization.

Training is offered annually to offsite emergency support organization personnel. This training could include facility tours for familiarization, reentry procedures, facility hazards, access control, permitted fire suppression techniques, potential accident scenarios, emergency action levels, notification procedures, exposure guidelines, personnel monitoring devices, communications, contamination control, and the responding organizations roles in emergency conditions.

Radiological and SHINE facility orientation opportunities are offered biannually to local service personnel, such as news media and local government officials.

The SHINE Emergency Plan states that drills are primarily onsite tests of one or more portions 17

of the integrated capability of emergency response plans, equipment, and organizations, with offsite support functions being simulated. An exercise is a type of drill that is a full-scale test of the ERO, in which offsite organizations are invited to participate. Drills of the onsite ERO are to be conducted annually and exercises where the OROs will be invited to participate are to be conducted every two years. Critiques of drills and exercise are to be conducted to identify items that need correction. An annual review of the emergency plan, EPIPs, and EALs will be conducted. A review of agreement letters, the emergency plan, and EPIPs will also be conducted every two years with responsible OROs.

Based on the above, the NRC staff concludes that the information provided in the SHINE Emergency Plan, Section 11, adequately addresses the elements necessary for maintaining an acceptable state of emergency preparedness for the SHINE facility, in accordance with applicable guidance and meets the established regulatory requirement.

Based on the above conclusions, the NRC staff finds that the SHINE Emergency Plan meets the guidance in NUREG-0849, as supplemented by the ISG augmenting NUREG-1537, and ANSI/ANS 15.16-2015. Therefore, the staff concludes that SHINE has satisfied the requirement of 10 CFR 50.34(b)(6)(v) that each application for an operating license include an FSAR that contains, among other things, the applicants plans for coping with emergencies, including the items specified in Appendix E to 10 CFR Part 50.

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