ML24107B020
ML24107B020 | |
Person / Time | |
---|---|
Issue date: | 04/24/2024 |
From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
To: | Steitz F State of NJ, Dept of Environmental Protection |
References | |
Download: ML24107B020 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Francis Steitz, Director Division of Air Quality & Radiation Protection New Jersey Department of Environmental Protection Mail Code 401-02, P.O. Box 420 Trenton, NJ 08625-0420
SUBJECT:
NEW JERSEY FY2024 DRAFT IMPEP REPORT
Dear Francis Steitz:
The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) to review radiation control programs. The enclosed draft report documents the results of the New Jersey Agreement State Program (New Jersey) review conducted on March 18-21, 2024. The teams preliminary findings were discussed with New Jersey on the last day of the review. The teams proposed recommendations are that New Jersey be found adequate to protect public health and safety and compatible with the NRCs program.
The NRC conducts periodic reviews of radiation control programs to ensure that public health and safety are adequately protected from the potential hazards associated with the use of radioactive materials, and that Agreement State programs are compatible with the NRCs program. The IMPEP reviews are conducted by a team of Agreement State and NRC staff. All reviews use common criteria in the assessment and place primary emphasis on performance.
The final determination of adequacy and compatibility of each program, based on the teams report, is made by the Management Review Board (MRB) Chair after receiving input from the MRB members, the IMPEP team, and the radiation control program being reviewed. The MRB is composed of NRC senior managers and an Organization of Agreement States program manager.
In accordance with the IMPEP implementation procedures, the NRC is providing you with a copy of the draft report for your review and comment prior to submitting the report to the MRB.
Comments are requested within 28 days from your receipt of this letter. This schedule will permit the issuance of the final report in a timely manner. If there are no comments to the IMPEP report, the MRB will receive the draft IMPEP report. If there are comments to the report, the team will review your response, make the necessary changes, and issue a proposed final report to the MRB.
The MRB meeting is scheduled to be conducted as a hybrid meeting on June 27, 2024, at 1:00 pm ET via Microsoft Teams. The NRC will provide you with Microsoft Teams connection information prior to the MRB meeting. The NRC will also provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland.April 21, 2024 If you have any questions regarding the enclosed report, please contact R. Lee Smith, IMPEP Project Manager, at Randolph.Smith@nrc.gov or Sherrie Flaherty, IMPEP Team Leader, at Sherrie.Flaherty@nrc.gov.
Thank you for your cooperation.
Sincerely, Adelaide S. Giantelli, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
2024 New Jersey Draft IMPEP Report cc:
Patrick Mulligan, Assistant Director Radiation Protection Element Jenny Goodman, Manager Bureau of Environmental Radiation Signed by Giantelli, Adelaide on 04/21/24
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM
REVIEW OF THE NEW JERSEY AGREEMENT STATE PROGRAM
March 18-21, 2024
DRAFT REPORT
Enclosure EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the New Jersey Agreement State Program (New Jersey) are discussed in this report. The review was conducted from March 18-21, 2024. Inspector accompaniments were conducted February 14-15, February 23, and March 5-7, 2024.
The team found New Jerseys performance to be satisfactory for the following five performance indicators: Technical Staffing and Training; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Legislation, Regulations, and Other Program Elements. The team also found New Jerseys performance to be satisfactory but needs improvement for the performance indicator Status of Materials Inspection Program.
As a result of issues regarding the radiation safety officer being listed as an authorized user without supporting documentation identified in Section 3.4, Technical Quality of Licensing Actions, the team is making the following recommendation that New Jersey:
- Perform a review of all research and development licenses to ensure that radiation safety officers who are also designated as authorized users on the licenses are appropriately qualified for the authorized use and take corrective actions as needed.
Accordingly, the team recommends that the New Jersey radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. Based on the results of the IMPEP review, the team recommends that a periodic meeting take in approximately 2 years with the next IMPEP review taking place in approximately 4 years.
New Jersey Draft IMPEP Report Page 1
1.0 INTRODUCTION
The New Jersey Agreement State Program (New Jersey) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on March 18-21, 2024, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the States of Alabama and Tennessee. Team members are identified in Appendix A. Inspector accompaniments were conducted on February 14, 15, and 23, and March 5-7, 2024. The inspector accompaniments are identified in Appendix B. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019.
Preliminary results of the review, which covered the period of March 30, 2019, to March 21, 2024, were discussed with New Jersey managers on the last day of the review.
In preparation for the review, a questionnaire addressing the common performance indicators and applicable non-common performance indicators was sent to New Jersey on December 8, 2023. New Jersey provided its response to the questionnaire on February 22, 2024. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession Number ML24061A212.
The New Jersey Agreement State Program is administered by the Bureau of Environmental Radiation, which is in the Division of Climate, Clean Energy & Radiation Protection of the New Jersey Department of Environmental Protection. Organizational charts for New Jersey are available in ML24061A166.
At the time of the review, New Jersey regulated 512 specific licenses authorizing possession and use of radioactive materials. The review focused on the radiation control program as it is carried out under Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of New Jersey.
The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicators and made a preliminary assessment of New Jerseys performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS
The previous IMPEP review was conducted on March 25-29, 2019 (ML19176A361). The results of the review are as follows:
Technical Staffing and Training: Satisfactory Recommendation: None
Status of Materials Inspection Program: Satisfactory Recommendation: None
Technical Quality of Inspections: Satisfactory Recommendation: None
Technical Quality of Licensing Actions: Satisfactory Recommendation: None New Jersey Draft IMPEP Report Page 2
Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None
Legislation, Regulations, and Other Program Elements: Satisfactory Recommendation: None
Overall finding: Adequate to protect public health and safety and compatible with the NRC's program.
3.0 COMMON PERFORMANCE INDICATORS
Five common performance indicators are used to review the NRC and Agreement State radiation control programs. These indicators are: (1) Technical Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities.
3.1 Technical Staffing and Training
The ability to conduct effective licensing and inspection programs is largely dependent on having experienced, knowledgeable, well trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs and could affect public health and safety. Apparent trends in staffing must be assessed. Review of staffing also requires consideration and evaluation of the levels of training and qualification. The evaluation standard measures the overall quality of training available to, and taken by, materials program personnel.
- a. Scope
The team used the guidance in State Agreements procedure (SA) SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated New Jerseys performance with respect to the following performance indicator objectives:
- A well-conceived and balanced staffing strategy has been implemented throughout the review period.
- Any vacancies, especially senior-level positions, are filled in a timely manner.
- There is a balance in staffing of the licensing and inspection programs.
- Management is committed to training and staff qualification.
- Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) 1248, Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.
- Qualification criteria for new technical staff are established and are followed, or qualification criteria will be established if new staff members are hired.
- Individuals performing materials licensing and inspection activities are adequately qualified and trained to perform their duties.
- License reviewers and inspectors are trained and qualified in a reasonable period.
New Jersey Draft IMPEP Report Page 3
- b. Discussion
The New Jersey radiation control program is comprised of 14 staff members consisting of 4 supervisory staff, 9 technical staff and 1 administrative position. This is equivalent to 10.1 full-time equivalents (FTE) for the radiation control program, when fully staffed. There were no vacancies at the time of the on-site review. During the review period, three of the staff members left the program and three staff members were hired. Staff positions were vacant ranging from 403 to 521 days. During the review period, New Jersey converted administrative positions into a technical staffing position to better support its Agreement State Program. As senior technical staff members exited the program, the positions were converted to entry level positions and subsequently filled.
Staff were very knowledgeable, well trained, and safety conscious. New Jersey ensured that all staff received the required core training courses, and that progress in obtaining interim and full qualification for licensing and inspection modalities was well documented with adequate justification provided. Staff who possessed advanced education degrees and pertinent experience prior to joining New Jersey were evaluated on a case-by-case basis and the rationale for granting equivalency was thoroughly indicated. The team noted that New Jerseys training and qualification program was compatible with the NRCs IMC 1248.
New Jersey deems staff fully qualified when an individual has obtained qualifications in two of the three focus areas that comprise the Agreement State Program. These three focus areas are the industrial section, medical section, and the radiological and environmental assessment section. New Jersey had six staff members who were fully qualified and seven individuals who are in the process of obtaining full qualification. Staff obtain refresher training across a broad range of health physics topics as well as specific licensing and inspection modalities.
New Jersey ensured that staff received a minimum of 24-hours of retraining every 24-month cycle.
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
- d. MRB Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
3.2 Status of Materials Inspection Program
Inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety and security practices.
The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and type of radioactive material, the type of operation licensed, and the results of previous inspections. There must be a capability for maintaining and retrieving statistical data on the status of the inspection program.
New Jersey Draft IMPEP Report Page 4
- a. Scope
The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated New Jerseys performance with respect to the following performance indicator objectives:
- Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the prescribed frequencies (https://www.nrc.gov/materials/miau/mat-toolkits.html).
- Deviations from inspection schedules are normally coordinated between technical staff and management.
- There is a plan to perform any overdue inspections and reschedule any missed or deferred inspections or a basis has been established for not performing any overdue inspections or rescheduling any missed or deferred inspections.
- Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 2800, Materials Inspection Program, and other applicable guidance or compatible Agreement State Procedure.
- Inspection findings are communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection), as specified in IMC 0610, Nuclear Material Safety and Safeguards Inspection Reports.
- b. Discussion
New Jersey performed 425 Priority 1, 2, 3 inspections and 54 initial inspections during the review period. New Jersey conducted four Priority 1, 2, 3 inspections and seven initial inspections overdue, which equates to approximately two percent. Two overdue inspections were attributed to the licensees not performing work in the state and in one instance the radiation safety officer was out of the country and unavailable for an initial inspection. The remaining overdue inspections were attributed to staff difficulties managing a heavy workload.
The team noted that Temporary Instruction (TI) TI-003, Evaluating the Impacts of the Coronavirus Disease 2019 Public Health Emergency as Part of the Integrated Materials Performance Evaluation Program, states, in part, that for inspections that exceed the scheduling window with overdue dates falling inside the defined time frame of the pandemic, the number of overdue inspections should be noted in the report but should not be counted, provided that the State continues to maintain health, safety, and security. Of the overdue inspections noted above, one inspection was performed overdue due to impacts related to the pandemic. During New Jerseys defined time frame of the pandemic, March 19, 2020, through March 4, 2022, New Jersey maintained health, safety, and security, therefore, the team did not include that inspection when performing the calculation.
New Jerseys inspection frequencies were consistent with the NRCs program except for fixed and portable gauges license types, which New Jersey inspects more frequently than the NRC.
During the review period, New Jersey communicated inspection findings to the licensees beyond 30 days after the inspection exit, or 45 days after the team inspection exit, at a rate of 14.6 percent. New Jersey had been operating under an internal policy of communicating findings to the licensees within 90 days. This policy had not been identified as compatible with NRC inspection procedures program element. While New Jersey has been New Jersey Draft IMPEP Report Page 5
implementing this policy since the inception of its Agreement, it has not previously impacted New Jersey meeting the 30-day requirement. New Jersey notified the IMPEP team that they will immediately implement the 30-day requirement and will incorporate it, along with other required changes, into their upcoming revision of IMC 2800 before the due date in June 2024.
New Jersey conducts reciprocity inspections using a procedure compatible with IMC 2800.
Candidates are identified using a risk-informed approach and offered to inspectors for inspection. Based on their procedure, New Jersey was expected to annually inspect 15 percent of identified candidates. During the review period, New Jersey completed the following percentages of reciprocity candidates: 41 percent in 2019, 0 percent in 2020, 10 percent in 2021, 38 percent in 2022, and 11 percent in 2023, and 20 percent to date in 2024. New Jersey did not meet the criteria for three years during the review period. New Jersey indicated that they will be implementing corrective actions to ensure they are meeting their criteria to include closer monitoring of the reciprocity inspection program and assigning inspections to individual inspectors as necessary.
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 3.2.a, except for:
- Inspection findings were not communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection).
- Candidate licensees working under reciprocity were not inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance or compatible Agreement State Procedure.
The team found that New Jersey did not issue inspection findings to licensees in a timely manner in more than a few, but less than most, cases. Because New Jersey inspectors routinely verbally communicate inspection findings and necessary items in need of corrective actions during the exit briefing, the overall impact on health and safety was small.
To be compatible with NRCs procedures, New Jersey described their plan to include the 30-day inspection finding timeliness requirement in their upcoming revision of IMC 2800, which is due to be completed by June 2024. New Jersey reported that they will begin to implement this requirement immediately.
New Jersey did not meet the reciprocity inspection criteria defined in its procedure for three of five years during the review period. New Jersey plans to implement additional oversight to the reciprocity inspections.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory, but needs improvement.
- d. Management Review Board (MRB) Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
New Jersey Draft IMPEP Report Page 6
3.3 Technical Quality of Inspections
Inspections, both routine and reactive, provide reasonable assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections and the critical evaluation of inspection records are used to assess the technical quality of an inspection program.
- a. Scope
The team used the guidance in SA-102, Reviewing the Common Performance Indicator:
Technical Quality of Inspections, and evaluated New Jerseys performance with respect to the following performance indicator objectives:
- Inspections of licensed activities focus on health, safety, and security.
- Inspection findings are well-founded and properly documented in reports.
- Management promptly reviews inspection results.
- Procedures are in place and used to help identify root causes and poor licensee performance.
- Inspections address previously identified open items and violations.
- Inspection findings lead to appropriate and prompt regulatory action.
- Supervisors, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.
- For Programs with separate licensing and inspection staffs, procedures are established and followed to provide feedback information to license reviewers.
- Inspection guides are compatible with NRC guidance.
- An adequate supply of calibrated survey instruments is available to support the inspection program.
- b. Discussion
The team evaluated 21 inspection reports, including any associated enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The team reviewed casework for inspections conducted by 14 of New Jerseys inspectors during the review period which covered medical, industrial, commercial, academic, research, and service license types.
Team members performed six inspector accompaniments on February 14-15, 23, and March 5-7, 2024. The inspector accompaniments are identified in Appendix B. The team determined that the inspectors performances observed during the inspector accompaniments indicated that the inspectors were knowledgeable of the requirements for each license type, applied performance-based techniques, and were able to identify potential health, safety, and security concerns.
During the review period, supervisory accompaniments were performed annually for each inspector. The accompaniments were well documented and provided detailed feedback for the inspectors review.
Due to the pandemic, New Jersey established virtual inspection procedures which were implemented between March 19, 2020-March 4, 2022. The team noted that the start of the New Jersey Draft IMPEP Report Page 7
inspection would include a document review performed virtually by the inspectors. This document review was followed by an on-site visit scheduled within 90 days after the start of the inspection.
The team noted that New Jersey maintains a wide variety of appropriately calibrated radiation detection equipment for their inspection program. Detection instruments were available for gamma, beta, and alpha contamination, as well as dose rates.
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
- d. MRB Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
3.4 Technical Quality of Licensing Actions
The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health and safety, as well as security. An assessment of licensing procedures, implementation of those procedures, and documentation of communications and associated actions between the New Jersey licensing staff and regulated community is a significant indicator of the overall quality of the licensing program.
- a. Scope
The team used the guidance in SA-104, Reviewing the Common Performance Indicator:
Technical Quality of Licensing Actions, and evaluated New Jerseys performance with respect to the following performance indicator objectives:
- Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.
- Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., pre-licensing guidance, Title 10 Code of Federal Regulations (10 CFR) Part 37, financial assurance, etc.).
- License reviewers, if applicable, have the proper signature authority for the cases they review independently.
- License conditions are stated clearly and can be inspected.
- Deficiency letters clearly state regulatory positions and are used at the proper time.
- Reviews of renewal applications demonstrate a thorough analysis of a licensees inspection and enforcement history.
- Applicable guidance documents are available to reviewers and are followed (e.g.,
NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.).
- Licensing practices for risk-significant radioactive materials are appropriately implemented including the physical protection of Category 1 and Category 2 quantities of radioactive material (10 CFR Part 37 equivalent).
New Jersey Draft IMPEP Report Page 8
- Documents containing sensitive security information are properly marked, handled, controlled, and secured.
- b. Discussion
During the review period, New Jersey performed 1615 radioactive materials licensing actions. The team evaluated 30 of those licensing actions. The licensing actions selected for review included 2 new applications, 11 amendments, 5 renewals, 3 decommissioning, 3 change of ownership notifications, 2 financial assurances, and 4 terminations. The team evaluated casework represented by eight license reviewers which included the following license types: broad scope, medical diagnostic and therapeutic, production of radioactive material using accelerator, commercial manufacturing and distribution, industrial radiography, research and development, academic, nuclear pharmacy, gauges, self-shielded irradiators, and service providers.
Licensing actions were well documented and addressed health, safety, and security issues.
New Jersey developed and used a master checklist for every licensing action. The master checklist assisted the license reviewers in screening the license application and directed the license reviewers to complete other checklists, as required. Licensing actions were assigned to the license reviewers and tracked in the computer database system called New Jersey Environmental Management System. Completed licensing action were reviewed by a second qualified license reviewer.
All necessary statements and commitments from the licensee were obtained and appropriately tied down. License conditions were appropriate for each license and enforceable. All documentation related to the licenses were well maintained in the licensing files and accessible only by authorized persons. Licenses and licensing documents were not publicly available.
During the review of the financial assurance licensing actions, the team found that financial assurances for applicable licenses were requested, appropriately reviewed, and properly secured. The team interviewed an individual who has reviewed the decommissioning financial assurances and determined that the individual is knowledgeable.
The team found that New Jersey adapted and used the NRC standard license conditions and licensing guidance (such as NUREG-1556 Series, NUREG-1757 Series, Pre-licensing Guidance, Risk-Significant Radioactive Materials checklist, and all licensing guidance for medical and animal use). New Jersey conducted pre-licensing site visits for all new licenses.
New Jersey also utilized the Pre-licensing Guidance for reviewing the change of ownership notifications.
The team identified two instances on research and development licenses where the radiation safety officer was also listed on the license as an authorized user for all licensed material and use without supporting documentation. Based on the information documented in the licensing files, it appeared the licensees did not request authorization for those radiation safety officers to be listed as authorized users and did not provide training and experience documentation requirements to support the qualification for such authorized use.
While the team did not identify similar instances when they reviewed additional license types, the team recommends New Jersey review all research and development licenses to ensure proper authorization is allowed.
New Jersey Draft IMPEP Report Page 9
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
Due to the issue regarding the radiation safety officer being listed as an authorized user without supporting documentation on research and development licenses, the team is making the following recommendation:
- Perform a review of all research and development licenses to ensure that radiation safety officers who are also designated as authorized users on the licenses are appropriately qualified for the authorized use and take corrective actions as needed.
- d. MRB Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
3.5 Technical Quality of Incident and Allegation Activities
The quality, thoroughness, and timeliness of response to incidents and allegations of safety concerns can have a direct bearing on public health, safety, and security. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, timely incident reporting, and investigative and follow-up actions, are a significant indicator of the overall quality of the incident response and allegation programs.
- a. Scope
The team used the guidance in SA-105, Reviewing the Common Performance Indicator:
Technical Quality of Incident and Allegation Activities, and evaluated New Jerseys performance with respect to the following performance indicator objectives:
- Incident response and allegation procedures are in place and followed.
- Response actions are appropriate, well-coordinated, and timely.
- On-site responses are performed when incidents have potential health, safety, or security significance.
- Appropriate follow-up actions are taken to ensure prompt compliance by licensees.
- Follow-up inspections are scheduled and completed, as necessary.
- Notifications are made to the NRC Headquarters Operations Center for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.
- Incidents are reported to the Nuclear Material Events Database and closed when all required information has been obtained.
- Allegations are investigated in a prompt, appropriate manner.
- Concerned individuals are notified within 30 days of investigation conclusions.
- Concerned individuals identities are protected, as allowed by law.
New Jersey Draft IMPEP Report Page 10
- b. Discussion
During the review period, 38 incidents were reported to New Jersey. The team evaluated 19 radioactive materials incidents which included 5 lost or stolen radioactive materials, 2 potential overexposures, 4 medical events, 5 damaged equipment, and 3 leaking sources.
New Jersey dispatched inspectors for on-site follow-up for 14 of the cases reviewed.
When notified of an incident, management and staff met to discuss the incident and determine the appropriate level of response, which ranged from an immediate on-site response to reviewing the incident during the next routine scheduled inspection. Those determinations were made based on both the circumstances and the health and safety significance of the incident. The team found that New Jerseys evaluation of incident notifications and its response to those incidents was thorough, well balanced, complete, and comprehensive.
The team also evaluated New Jerseys reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, New Jersey reported the incidents within the required time frame. The team also evaluated whether New Jersey had not reported any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, nine allegations were received by New Jersey. The team evaluated all nine allegations, including four allegations that the NRC referred to the State.
The team found that inspectors properly evaluated each event, interviewed involved individuals, and thoroughly documented their findings. Although the enforcement program is not evaluated as part of the IMPEP process, the team noted that enforcement actions were taken where appropriate to address violations identified during follow-up inspections.
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
- d. MRB Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
4.0 NON-COMMON PERFORMANCE INDICATORS
Four non-common performance indicators are used to review Agreement State programs:
(1) Legislation, Regulations, and Other Program Elements; (2) Sealed Source and Device (SS&D) Evaluation Program; (3) Low-Level Radioactive Waste (LLRW) Disposal Program; and (4) Uranium Recovery (UR) Program. The NRC retains regulatory authority for SS&D Evaluation, LLRW Disposal, and UR Programs; therefore, only the first non-common performance indicator, Legislation, Regulations, and Other Program Elements, applied to this review.
New Jersey Draft IMPEP Report Page 11
4.1 Legislation, Regulations, and Other Program Elements
State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses.
The NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame so that the effective date of the State requirement is not later than 3 years after the effective date of the NRC's final rule.
Other program elements that have been designated as necessary for maintenance of an adequate and compatible program should be adopted and implemented by an Agreement State within 6 months following NRC designation. A Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC web site at the following address: https://www.nrc.gov/materials/toolboxes/regulation.html.
- a. Scope
The team used the guidance in SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated New Jerseys performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC website at the following address: https://www.nrc.gov/materials/toolboxes/regulation.html.
- The Agreement State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of radioactive materials under the Atomic Energy Act of 1954, as amended.
- Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.
- Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.
- The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.
- The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.
- Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.
- b. Discussion
New Jerseys current effective statutory authority is contained in the Radiation Protection Act (N.J.S.A. 26:2D-1) and the Atlantic Interstate LLRW Compact Implementation Act. The Department of Environmental Protection is designated as the States radiation control agency. No legislative amendments affecting the radiation control program were passed during the review period.
New Jersey Draft IMPEP Report Page 12
New Jersey incorporates NRC requirements by reference except for Title 10 of the Code of Federal Regulations (10 CFR) 20.1401 - 20.1405. The State has requirements compatible with 10 CFR 20.1401 - 20.1405. For NRC rules that New Jersey incorporates by reference, amendments to the requirements are automatically adopted by New Jersey without further rulemaking activities.
In instances where New Jersey needs to amend its rules, the administrative rulemaking process takes approximately 18 months from drafting to finalizing a rule. The public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. The team noted that the States rules and regulations were subject to sunset laws. New Jersey Radiation Protection Programs rules (N.J.S.A. 7:28) are set to expire February 19, 2027. To readopt the rules, a notice is filed for publication in the New Jersey Register.
During the review period, New Jersey submitted 12 final regulation amendments to the NRC for a compatibility review. None of the amendments were overdue for State adoption at the time of submission. Other program elements that have been designated as necessary for maintenance of an adequate and compatible program were adopted within six months or other time frame specified in the State and Tribal Communication Letter.
As discussed under the Status of the Materials Inspection Program indicator, New Jersey has a 90-day timeliness requirement for issuance of inspection reports. However, the NRCs inspection program has a 30-day timeliness requirement for inspection report issuance.
While this is a compatibility issue, it does not impact the performance of this indicator.
New Jersey described their plan to include the 30-day inspection finding timeliness requirement in their upcoming revision of IMC 2800, which is due to be completed by June 2024.
- c. Evaluation
The team determined that, during the review period, New Jersey met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that New Jerseys performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
- d. MRB Discussion and Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
4.2 LLRW Disposal Program
Although New Jersey has authority to regulate a LLRW disposal facility, the NRC has not required States to have a program for licensing a disposal facility unit until such time as the State has been designated as a host State for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, it is expected to put in place a regulatory program that will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a commercial LLRW disposal facility in New Jersey. Accordingly, the team did not review this indicator.
New Jersey Draft IMPEP Report Page 13
5.0
SUMMARY
The team found New Jerseys performance to be satisfactory for the following five performance indicators: Technical Staffing and Training; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Legislation, Regulations, and Other Program Elements. The team also found New Jerseys performance to be satisfactory but needs improvement for the performance indicator Status of Materials Inspection Program.
The team made one new recommendation that New Jersey:
- Perform a review of all research and development licenses to ensure that radiation safety officers who are also designated as authorized users on the license are appropriately qualified for the authorized use and take appropriate corrective action, if needed.
Accordingly, the team recommends that the New Jersey radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. The team recommends that a periodic meeting take place in approximately 2 years with the next IMPEP review taking place in approximately 4 years.
LIST OF APPENDICES
Appendix A IMPEP Review Team Members
Appendix B Inspector Accompaniments APPENDIX A
IMPEP REVIEW TEAM MEMBERS
Name Areas of Responsibility
Sherrie Flaherty, NMSS Team Leader Status of Materials Inspection Program Inspector Accompaniments
Allyce Bolger, NMSS Team Leader in Training Legislation, Regulations, and Other Program Elements Inspector Accompaniments
Lisa Forney, Region I Technical Staffing and Training
Frank Tran, Region III Technical Quality of Licensing Actions
Cortney Dillard, Technical Quality of Inspections State of Alabama
Stuart Belva, Technical Quality of Incident and Allegation Activities State of Tennessee APPENDIX B
INSPECTOR ACCOMPANIMENTS
The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: 506963 License Type: Industrial Radiography Priority: 1 Inspection Date: 2/14/2024 Inspectors initials: CG
Accompaniment No.: 2 License No.: 535776 License Type: Research and Development and special Priority: 3 nuclear material plutonium unsealed, less than critical mass Inspection Date: 2/15/2024 Inspectors initials: JT
Accompaniment No.: 3 License No.: 507164 License Type: Portable Gauge Priority: 5 Inspection Date: 2/23/2024 Inspectors initials: DT
Accompaniment No.: 4 License No.: 450695 License Type: Gamma Knife Priority: 2 Inspection Date: 03/05/2024 Inspectors initials: RP
Accompaniment No.: 5 License No.: 332593 License Type: HDR Priority: 2 Inspection Date: 03/06/2024 Inspectors initials: CD
Accompaniment No.: 6 License No.: 440570 License Type: HDR and therapy, written directive Priority: 2 required Inspection Date: 03/07/2024 Inspectors initials: KF
ML24107B020 OFFICE NMSS/MSST/SLPB R-IV/DNMS/MIB NMSS/MSST NMSS/MSST/SLPB NAME SFlaherty SF ABolger AB LSmith LS RJohnson RJ DATE Apr 16, 2024 Apr 16, 2024 Apr 16, 2024 Apr 16, 2024 OFFICE NMSS/MSST/SMPB NAME AGiantelli AG DATE Apr 21, 2024