ML23212B157
| ML23212B157 | |
| Person / Time | |
|---|---|
| Issue date: | 08/23/2023 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
| To: | Abbott M State of ME, Dept of Health & Human Services |
| References | |
| Download: ML23212B157 (23) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Michael Abbott, Associate Director Division of Environmental and Community Health Maine Department Health and Human Services 286 Water Street, Key Plaza Augusta, ME 04333-0011
Dear Michael Abbott:
The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the review of Agreement State and NRC radiation control programs. Enclosed is the draft IMPEP report, which documents the results of the Maine Agreement State Program review conducted on July 10 -14, 2023. The teams preliminary findings were discussed with you and your staff on the last day of the review. The teams proposed recommendations are that the Maine Agreement State Program 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 process uses a team comprised of Agreement State and NRC staff to perform the reviews. 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 Chair of the Management Review Board (MRB) after receiving input from the MRB members. The MRB is composed of NRC senior managers and an Agreement State program manager.
In accordance with the procedures for implementation of IMPEP, we are 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 on the IMPEP report, the MRB will receive the draft IMPEP report. If there are comments on 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 at NRC Headquarters in Rockville, Maryland, on October 12, 2023, at 1:00 pm ET (conference room OWFN17-B04 and streamed via Teams).
The NRC will provide invitational travel for you or your designee to attend the MRB meeting.
Alternatively, since the team did not identify any significant performance issues with the Maine Agreement State Program, you may prefer to attend the MRB meeting remotely.August 23, 2023 If you have any questions regarding the enclosed report, please contact me at 301-415-0324 or Sherrie Flaherty 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:
2023 Maine Draft IMPEP Report cc: Nathan Saunders, Program Manager Radiation Control Program Division of Environmental and Community Health Signed by Giantelli, Adelaide on 08/23/23
ML23212B157 OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NAME SFlaherty RJohnson AGiantelli DATE 07/31/2023 08/31/2023 08/23/2023 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW
OF THE MAINE AGREEMENT STATE PROGRAM
JULY 10-14, 2023
DRAFT REPORT
Enclosure EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Maine Agreement State Program (Maine) are discussed in this report. The review was conducted from July 10-14, 2023. An in-person inspector accompaniment was conducted during the week of May 30, 2023.
The team found Maines programs performance to be satisfactory for six of the seven performance indicators: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Sealed Source and Device Evaluation Program.
The team also found Maines performance to be satisfactory, but needs improvement for the Legislation, Regulations, and Other Program Elements performance indicator. The finding for the Legislation, Regulations, and Other Program Elements performance indicator remains unchanged from the previous IMPEP review. During this review period, Maine issued final regulations to adopt the required NRC regulations for compatibility. However, these were not all adopted timely, are missing regulations on reporting requirements, and resulted in several NRC staff comments.
Accordingly, the team recommends that the Maine Agreement State Program be found adequate to protect public health and safety and compatible with the NRC's program. The team also recommends that a periodic meeting take place in approximately two years with the next full IMPEP review taking place in approximately four years.
Maine Draft IMPEP Report Page 1
1.0 INTRODUCTION
The Maine Agreement State Program (Maine) review was conducted from July 10-14, 2023, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of New York. Team members are identified in Appendix A. An in-person inspector accompaniment was conducted during the week of May 30, 2023. The inspector accompaniment is 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 July 26, 2019, to July 14, 2023, were discussed with the Maine 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 Maine on November 18, 2022. Maine provided its response to the questionnaire on June 26, 2023.
A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML23181A090.
Maine is administered by the Radiation Control Program which is located within the Division of Environmental and Community Health (the Division). The Division is part of the Maine Center for Disease Control and Prevention within the Maine Department of Health and Human Services. Organizational charts for Maine are available in ADAMS ML23181A087.
At the time of the review, Maine regulated 89 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 Maine.
The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicator and made a preliminary assessment of Maines performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS
The previous IMPEP review concluded on July 22-26, 2019. The final report is available in ADAMS ML19288A291. 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 Maine Draft IMPEP Report Page 2
Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Legislation, Regulations, and Other Program Elements (formerly Compatibility Requirements): Satisfactory, but needs improvement Recommendation: None Sealed Source and Device Evaluation Program: 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 a sufficient number of 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-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Maines 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, 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 of time.
Maine Draft IMPEP Report Page 3
- b. Discussion
Maine is comprised of two technical staff members and one program manager which equals 2.3 full-time equivalent (FTE) for the radiation control program when fully staffed.
Currently, there is one vacancy. During the review period, one of the technical staff members left the program and the Radiation Control Program Director (RCPD) assumed another position within the program. After approximately 15 months, the RCPD position was filled. The currently vacant technical staff position has been vacant since January 1, 2023 (approximately 6 months). The staff member who left the program was a fully qualified license reviewer and inspector and met their 24-hour refresher training requirement. The remaining technical staff member is a fully qualified license reviewer and inspector and has met their 24-hour training requirement. Maine has a training and qualification program compatible with the NRCs IMC 1248. No impacts related to the pandemic were noted in this indicator.
Maine has posted an Environmental Specialist-III Materials Inspector position to fill the vacancy. The position had one applicant who was determined to be qualified for the position and hired. However, a week prior to the start date, the individual decided not to move to Maine and rescinded their acceptance. The position was reposted; at the time of the IMPEP, Maine was reviewing the candidates and beginning the interview process.
Additionally, Maine is working to reclassify their two technical positions (Environmental Specialist-III and Assistant Environmental Engineer) to create new position classifications for Health Physicist I and II. Maine is looking to perform rulemaking to raise fees in support of improving salaries for these new position classifications.
- c. Evaluation
The team determined that during the review period Maine met the performance indicator objectives listed in Section 3.1.a, except for:
Any vacancies, especially senior-level positions, were not filled in a timely manner.
The team considered recommending a finding of satisfactory but needs improvement for this indicator. However, the team concluded that, despite the current one-person technical staff, Maine was fully staffed for most of the review period, the staff were/are fully trained and qualified, and there were no performance issues associated with licensing, inspection, or response to incidents.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
- d. Management Review Board (MRB) 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 Maine Draft IMPEP Report Page 4
capability for maintaining and retrieving statistical data on the status of the inspection program.
- a. Scope
The team used the guidance in State Agreements procedure SA-101, Reviewing the Common Performance Indicator: Status of the Materials Inspection Program, and evaluated Maines 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 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
Maine performed 43 Priority 1, 2, 3, and initial inspections during the review period. No Priority 1, 2, 3 or initial inspections were conducted overdue during the review period.
Maines inspection frequencies for initial and routine inspections are the same as those used in NRCs program. A sampling of 20 inspection reports indicated that none of the inspection findings were communicated to the licensees beyond Maines goal of 30 days after the inspection exit. An Access database is used to track all inspection activities.
Reciprocity inspections are conducted in response to a request received from a licensee of another Agreement State or the NRC to perform work within Maines jurisdiction.
Maines procedure states that Maine will, at a minimum, inspect 20 percent of candidate reciprocity licensees each calendar year. Candidate licensees are those licensees that have applied for reciprocity and that were not inspected in the previous calendar year or had a significant event within the last two years. The team determined that Maine inspected greater than 20 percent of candidate reciprocity licensees in each calendar year covered by the review period.
- c. Evaluation
The team determined that, during the review period, Maine met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
- d. MRB Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
Maine Draft IMPEP Report Page 5
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 State Agreements procedure SA-102, Reviewing the Common Performance Indicator: Technical Quality of Inspections, and evaluated Maines performance with respect to the following performance indicator objectives:
of activities on and security.
findiwell-founand propedocumentein reports.
Managpro results.
Proceduare in place useto help iroot cauand poolicense performance.
previiopen violations.
findi to appropriate prompt regaction.
Supervior or as ate, condu annaccompaniof each inspeoto assess p policies.
For Programs with separate licensiion stafures are established owed to provide feedbto license reviewers.
ides th guidance.
An adequpply of calsurveruments is to inspeion program.
- b. Discussion
ated 20 inspection reports and associateenforcement documentation, tei in materials inspections conducted ng ew period. The team reviewed casework spections condue inspeors and covered medical, industrial,mic licenses. The team determined that Maine inspeors used checklists as a reference a for each inspection checklist as app d eto show that inpentified violatiit and had approressed the violatiohat the d be closed. For inspeions with no violations, Maine inspectors have the option to use Maiorm HHE-891 to document and leave inspection findinform HH or if the inspection results in violatioinspection findi u ssed to the licensee.
anied one ig th inspeoaccompaniment -person and is idThe team determined that thd, tholuation of the licensee, and assessed the iof li h an The inspeooand was to develop a basis of confidence that radioactive teng used safely rely. All findinga appropriatel nted.
Maine Draft IMPEP Report Page 6
The team reviewed Maines supervisory accompaniments completed during the review period. The team found that a supervisory accompaniment was performed for each inspector in calendar years 2019, 2020, 2021, and 2022. No supervisory accompaniments had been performed in calendar year 2023 as of the date of the onsite review. Management stated that they plan to complete and document the supervisory accompaniment of the qualified inspector before the end of the calendar year.
The team reviewed Maines supply of radiation detection equipment. The team determined that Maine had an ample supply of equipment to support its inspection program and that the equipment was calibrated in a timely manner. No impacts related to the pandemic were seen related to this indicator.
- c. Evaluation
The team determined that, during the review period, Maine met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
- d. MRB 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 Maines 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 State Agreements procedure SA-104, Reviewing the Common Performance Indicator: Technical Quality of Licensing Actions, and evaluated Maines 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 Regulation (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.).
Maine Draft IMPEP Report Page 7
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).
Documents containing sensitive security information are properly marked, handled, controlled, and secured.
- b. Discussion
During the review period, Maine performed 190 radioactive materials licensing actions.
The team evaluated 28 of those licensing actions. The licensing actions selected for review included 2 new applications, 20 amendments, 3 renewals, and 3 terminations.
The team evaluated casework from current and former license reviewers, which included the following license types and actions: broad scope, medical diagnostic and therapeutic, industrial radiography, academic, nuclear pharmacy, gauges, self-shielded irradiators, and financial assurance.
Licensing actions were well documented and addressed health, safety, and security issues. All licensing actions included a checklist to ensure that all the essential elements were covered. Renewal applications demonstrated a thorough analysis of the licensees inspection and enforcement history.
The team noted that all necessary licensee commitments were obtained, and deficiency letters and license conditions were well supported by information contained in the licensing files. All new licenses included the NRCs Checklist to Provide a Basis for Confidence that Radioactive Material will be used as Specified on the License (Pre-Licensing Guidance). The team also determined that Maine adopted and properly implemented the most current version of the Risk Significant Radioactive Materials Checklist (RSRM) checklist during the review period.
The team determined that appropriate financial assurance instruments were properly submitted when required, and that licenses containing security related information were properly marked. Each license reviewer had the proper signature authority.
No impacts related to the pandemic were noted in this indicator.
- c. Evaluation
The team determined that, during the review period, Maine met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
- d. MRB 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.
Maine Draft IMPEP Report Page 8
- a. Scope
The team used the guidance in State Agreements procedure SA-105, Reviewing the Common Performance Indicator: Technical Quality of Incident and Allegation Activities, and evaluated Maines 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.
Incidents are reported to the Nuclear Material Events Database (NMED) 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.
- b. Discussion
During the review period, seven incidents were reported to Maine. The team evaluated all seven radioactive materials incidents which included two lost or stolen radioactive materials, one medical event, one damaged industrial radiography equipment, two leaking sources, and one building fire. Maine dispatched inspectors for onsite follow-up for one potentially risk-significant case.
When notified of an incident, management and staff meet to discuss the incident and determine the appropriate level of response, which can range from an immediate response to reviewing the incident during the next routine scheduled inspection. Those determinations are made based on both the circumstances and the health and safety significance of the incident. The team found that Maines evaluation of incident notifications and its response to those incidents was thorough, well balanced, complete, and comprehensive.
The team also evaluated Maines reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, Maine reported the incidents within the required timeframe. The team also evaluated whether Maine had failed to report any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, one allegation was received by Maine. The team evaluated the allegation and determined that Maines evaluation of the allegation was thorough, well balanced, complete, and comprehensive. No allegations were referred to the State by the NRC during the review period.
No impacts related to the pandemic were noted in this indicator.
- c. Evaluation
The team determined that, during the review period, Maine met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team Maine Draft IMPEP Report Page 9
recommends that Maines performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
- d. MRB 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 Program. The NRC retains regulatory authority for LLRW Disposal, and Uranium Recovery Programs therefore, only the first two non-common performance indicators applied to this review.
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://scp.nrc.gov/regtoolbox.html.
- a. Scope
The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Maines 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://scp.nrc.gov/regtoolbox.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, 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.
Maine Draft IMPEP Report Page 10
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
Maine became an Agreement State on April 1, 1992. Maine s current effective statutory authority is contained in the Title 22 Health and Welfare, Chapter 160 Radiation Protection Act, of the Maine Statutes. The Department is designated as the States radiation control agency. No legislation affecting the radiation control program was passed during the review period.
Maines administrative rulemaking process takes approximately 180 days to finalize a rule after a pre-legal review has been completed by the Attorney General. After the completion of the pre-legal review, the public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated, as appropriate, before the regulations are finalized and approved by the Attorney General and the Governor.
During the pre-legal review, which does not have a defined time period, the Attorney General reviews and provides comments. Maine briefly mentioned experiencing additional delays in rulemaking because of the pandemic. Maine described that their rulemaking efforts were not given high priority. The team noted that Maines rules and regulations are not subject to sunset laws.
During the review period, Maine submitted no proposed regulation amendments, 21 final regulation amendments, and no legally binding requirements or license conditions to the NRC for a compatibility review. In a letter dated January 26, 2023, the NRC received the final regulation amendments incorporating 21 Regulation Amendment Tracking System Identification Numbers (RATS IDs). These final regulations had been adopted in October 2022. At the time of the submission, 14 of these amendments were overdue (e.g., past the time for State adoption). However, 11 of the 14 were due during the previous IMPEP review period. During this review period, three amendments were overdue and seven were adopted timely.
The following RATS IDs were overdue for adoption, but are now complete:
Overdue by the 2019 IMPEP review period ending July 26, 2019
- 1. 2011-1, Decommissioning Planning, Parts 20, 30, 40, and 70
- 2. 2012-2, Advance Notification to Native American tribes of Transportation of Certain Types of Nuclear Waste
- 3. 2012-3, Technical Corrections - Parts 30, 34, 40, and 71
- 4. 2012-4, Requirements for Distribution of Byproduct Material, Parts 30, 31, 32, 40, and 70
- 5. 2013-1, Physical Protection of Byproduct Material, 10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, 51, 71 and 73
- 6. 2013-2, Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions, 10 CFR Parts 30, 40, 70, 170, and 171 Maine Draft IMPEP Report Page 11
- 7. 2015-1, Domestic Licensing of Special Nuclear Material - Written Reports and Clarifying Amendments, 10 CFR Part 70
- 8. 2015-2, Safeguards Information - Modified Handling Categorization, Change for Materials Facilities, 10 CFR Parts 30, 37, 73, and 150
- 9. 2015-3, Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements, 10 CFR Part 71 10.2015-4, Miscellaneous Corrections, 10 CFR Parts 37 and 40 11.2015-5, Miscellaneous Corrections, 10 CFR Parts 19, 20, 30, 32, 37, 40, 61, 70, 71, and 150
Overdue by the October 2022 adoption and within the 2023 IMPEP review period
12.2018-1, Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, 10 CFR Parts 30, 32 and 35 13.2018-2, Miscellaneous Corrections - Organizational Changes, 10 CFR Parts 37, 40, 70, and 71 14.2018-3, Miscellaneous Corrections to 10 CFR Parts 1, 2, 34, 37, 50, 71, 73, and 140
The following were adopted timely:
15.2019-1, Miscellaneous Corrections to 10 CFR Parts 2, 21, 37, 50, 52, 73, and 110 16.2019-2, Organizational Changes and Conforming Amendments to 10 CFR Parts 1, 2, 37, 40, 50, 51, 52, 55, 71, 72, 73, 74, 100, 140, and 150 17.2020-1, Individual Monitoring Devices 10 CFR Parts 34, 36, and 39 18.2020-2, Social Security Number Fraud Prevention 10 CFR Parts 9 and 35 19.2020-3, Miscellaneous Corrections 10 CFR Parts 1, 2, 19, 20, 21, 30, 34, 35, 40, 50, 51, 52, 60, 61, 62, 63, 70, 71, 72, 73, 74, 75, 76, 110, and 140 20.2021-1, Miscellaneous Corrections, 10 CFR Parts 2, 11, 20, 25, 32, 35, 37, 50, 52,55, 70, 72, 73, 95, and 110 21.2021-2, Miscellaneous Corrections, 10 CFR Parts 9, 37, 40, 50, 51, 52, 55, 71, 73, and 110
At the time of the review, Maine had completed all necessary regulations submittals that is, no regulations were overdue and incomplete.
The NRC staff reviewed the January 2023 submittal of the final revisions of these regulations (ML23205A161). The NRCs regulatory review process requires the NRC to send a letter to Maine with these comments and Maine is required to address these comments. The staffs review of the 21 RATS IDs identified 43 comments. These comments include:
34 comments on regulations designated as a compatibility category B, which are considered significant under SA-107 and must be adopted in an essentially identical manner.
1 comment on a regulation whose authority is solely that of the NRC.
5 comments on regulations designated as compatibility category C, which can be more restrictive than NRC regulations and are important to avoid conflict, duplication, or gaps between Maine and the NRC.
3 covering multiple sections and compatibility categories, including compatibility category B and NRC.
Maine Draft IMPEP Report Page 12
During NRCs review of the January 2023 submittal, the NRC staff recognized that Maine is missing equivalent regulations for 10 CFR 30.50, 40.60, and 70.50 event reporting requirements. These regulations are designated as compatibility category C and so missing them creates a gap between Maine and NRC regulations. The IMPEP review team found that these regulations have been missing since at least 1999.
Although these reporting requirements were likely never included in the regulations, events have been reported accurately and timely to the NRC and Maine. However, these missing regulations could have potentially resulted in enforcement challenges using Maines regulations. Maine stated that they had never needed to enforce using these regulations. Maine is considering possible short-term solutions to include these regulations, either through issuing an order or through license conditions until rulemaking is complete.
The team reviewed guidance documents that Maine uses to meet the requirements of other program elements (e.g., Pre-Licensing Guidance, Inspection Procedures, etc.) that the NRC has designated as necessary for the maintenance of an adequate and compatible program. All changes to these documents were made within 6 months of the NRCs changes and were determined to be compatible.
Maine intends to adopt RATS IDs 2022-1 and 2022-2 in FY 2024 when they expect to amend their fee rules.
- c. Evaluation
The team determined that during the review period Maine met the performance indicator objectives listed in Section 4.1.a, except for:
Regulations adopted by the Agreement State for purposes of compatibility or health and safety were not adopted within 3 years after the effective date of the NRC regulation.
The team reviewed the MD 5.6 evaluation criteria for satisfactory but needs improvement for this indicator. In reviewing MD 5.6, the team noted Maine was overdue adopting three RATS IDs within this IMPEP review period and their adoption resulted in several comments. Therefore, more than a few, but less than most RATS IDs had a delayed adoption. Additionally, Maine had been missing equivalent regulations for 10 CFR 30.50, 40.60, and 70.50 reporting requirements. Therefore, there are more than a few, but less than most regulations missing. Despite this, Maine did not experience significant impacts as licensees have historically been adequately reporting and there had been no need for enforcement action. Maine committed to addressing the NRC staff comments. Although the January 2023 submittal resulted in many comments, the IMPEP team observed that these comments do not result in any significant public health and safety gap. The IMPEP team expects that the comments will be resolved through the regulatory review process.
The IMPEP team notes that Maine adopted seven RATS IDs in a timely manner. After the previous IMPEP review, one of the two staff members at that time dedicated a portion of their time to adopting the RATS IDs and prepared the January 2023 submittal.
This same staff member will be addressing the NRC comments on the submittal.
Additionally, Maine is developing a near-term solution to ensure the ability to enforce on the reporting requirements.
Maine Draft IMPEP Report Page 13
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory but needs improvement.
- d. MRB Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
4.2 SS&D Evaluation Program
Adequate technical evaluations of SS&D designs are essential to ensure that SS&Ds will maintain their integrity and that the design is adequate to protect public health and safety. NUREG-1556, Volume 3, Consolidated Guidance about Materials Licenses:
Applications for Sealed Source and Device Evaluation and Registration, provides information on conducting the SS&D reviews and establishes useful guidance for teams.
In accordance with MD 5.6, three sub-elements: Technical Staffing and Training, Technical Quality of the Product Evaluation Program, and Evaluation of Defects and Incidents Regarding SS&Ds, are evaluated to determine if the SS&D program is satisfactory. Agreement States with authority for SS&D evaluation programs who are not performing SS&D reviews are required to commit in writing to having an SS&D evaluation program in place before performing evaluations.
- a. Scope
The team used the guidance in State Agreements procedure SA-108, Reviewing the Non-Common Performance Indicator: Sealed Source and Device Evaluation Program, and evaluated Maines performance with respect to the following performance indicator objectives:
Technical Staffing and Training
A well-conceived and balanced staffing strategy has been implemented throughout the review period.
Qualification criteria for new technical staff are established and are being followed or qualification criteria will be established if new staff members are hired.
Any vacancies, especially senior-level positions, are filled in a timely manner.
Management is committed to training and staff qualification.
Individuals performing SS&D evaluation activities are adequately qualified and trained to perform their duties.
SS&D reviewers are trained and qualified in a reasonable period of time.
Technical Quality of the Product Evaluation Program
SS&D evaluations are adequate, accurate, complete, clear, specific, and consistent with the guidance in NUREG-1556, Volume 3.
Evaluation of Defects and Incidents
SS&D incidents are reviewed to identify possible manufacturing defects and the root causes of these incidents.
Incidents are evaluated to determine if other products may be affected by similar problems. Appropriate action and notifications to the NRC, Agreement States, and others, as appropriate, occur in a timely manner.
Maine Draft IMPEP Report Page 14
- b. Discussion
Technical Staffing and Training
Maine utilizes qualified staff from the State of New Hampshire to perform these reviews.
New Hampshire staff reviewed one new action submitted during the review period. The team confirmed that the New Hampshire staff that reviewed the action were qualified to perform SS&D reviews.
Technical Quality of the Product Evaluation
Maine has three SS&D licensees and five registration certificates. The team evaluated the one SS&D action processed during the review period. This action was a new application. This SS&D evaluation was thorough and of acceptable technical quality and addressed product integrity under normal and likely accident conditions. Health and safety issues were properly addressed, and the registration clearly summarized the product evaluation. The New Hampshire SS&D reviewers used the NUREG-1556, Volume 3 checklist for the SS&D action to ensure that all health and safety aspects had been adequately addressed. The checklists were signed and dated by the lead reviewer and a concurrence reviewer. The concurrence review provided an additional quality check to the safety evaluation process.
Evaluation of Defects and Incidents Regarding SS&Ds
There were no incidents involving Maine SS&D registered products related to manufacturing or design of the sources/devices manufactured or distributed during the review period. The team performed an NMED search to verify no relevant incidents were reported.
- c. Evaluation
The team determined that, during the review period, Maine met the performance indicator objectives listed in Section 4.2.a. Based on the criteria in MD 5.6, the team recommends that Maines performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.
- d. MRB Chairs Determination
The final report will present the MRB Chairs determination regarding this indicator.
5.0
SUMMARY
Maines performance was found to be satisfactory for six of seven performance indicators reviewed and satisfactory, but needs improvement for the indicator Legislation, Regulations, and Other Program Elements.
The team did not make any recommendations and there were no recommendations from the previous review for the team to consider.
Accordingly, the team recommends that Maine be found adequate to protect public health and compatible with the NRC's program. Based on the results of the current Maine Draft IMPEP Report Page 15
IMPEP review, the team recommends that a periodic meeting take place in approximately two years and the next full IMPEP review take place in approximately four 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 Technical Quality of Incident and Allegation Activities Inspector Accompaniment
Monica Ford, Region I Status of Materials Inspection Program Technical Quality of Inspections
Huda Akhavannik, NMSS Technical Staffing and Training Legislation, Regulations, and Other Program Elements
Daniel Samson, New York Technical Quality of Licensing Actions Sealed Source and Device Evaluation Program APPENDIX B
INSPECTOR ACCOMPANIMENTS
The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: 23209 License Type: Industrial Radiography Priority: 1 Inspection Date: 05/31/2023 Inspectors initials: TH