ML18114A213

4/25/18 Letter to Alam, Vitale, and Gavitt New York 2018 Draft Impep Report

ML18114A213
Person / Time
Issue date:	04/25/2018
From:	Paul Michalak NRC/NMSS/DMSST/ASPB
To:	Alam R, Gavitt S, Vitale D State of NY, Dept of Environmental Conservation, State of NY, Dept of Health and Mental Hygiene, State of NY, Dept of Health, Bureau of Radiation Protection
Rakovan L
References
Download: ML18114A213 (36)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 25, 2018 Regina Alam, Ph.D., Director Office of Radiological Health New York City Department of Health and Mental Hygiene 42-09 28th Street, 14th Floor, CN-60 Long Island City, NY 11101 David Vitale, Director Division of Materials Management New York Department of Environmental Conservation 625 Broadway, 9th Floor Albany, NY 12233 Stephen Gavitt, CHP, Director Bureau of Environmental Radiation Protection New York State Health Department Empire State Plaza - Corning Tower, 12th Floor Albany, NY 12237

Dear Dr. Alam,

Mr. Vitale, and Mr. Gavitt:

The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the evaluation of Agreement State programs. Enclosed for your review is the draft IMPEP report, which documents the results of the Agreement State review held in New York on March 12-23, 2018. The teams preliminary findings were discussed with you and your staff on the last day of your respective portion of the review. The teams proposed recommendations are that the New York Agreement State Program be found adequate to protect public health and safety and not compatible with the NRCs program.

The NRC conducts periodic reviews of Agreement State 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 process, titled IMPEP, employs a team of NRC and Agreement State staff to assess Agreement States and NRC Regional Offices radioactive materials programs. All reviews use common criteria in the assessment and place primary emphasis on performance.

The final determination of adequacy and compatibility of each Agreement State program, based on the teams report, is made by a Management Review Board (MRB) composed of NRC managers and an Agreement State program manager who serves as a liaison to the MRB.

In accordance with 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 four weeks from your receipt of this letter. This schedule will permit the issuance of the final report in a timely manner that will be responsive to your needs.

R. Alam, et al. 2 The team will review the responses, make any necessary changes to the report, and issue it to the MRB as a proposed final report. The MRB meeting is scheduled for June 21, 2018, at 1:00 PM ET. The NRC will provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland. The NRC has video conferencing capability if it is more convenient for the State to participate through this medium.

Please contact me if you desire to establish a video conference for the meeting.

If you have any questions regarding the enclosed report, please contact me at 301-415-5804.

Thank you for your cooperation.

Sincerely,

/RA/

Paul Michalak, Chief Agreement State Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

2018 New York Draft IMPEP Report cc: Alyse Peterson, NYSERDA

R. Alam, et al. 2

SUBJECT:

NEW YORK FY2018 DRAFT IMPEP REPORT DISTRIBUTION:

J. Miller, RSAO, Region I R. Elliott, Region I E. Ullrich, Region I L. Sepulveda, NMSS Z. Sulaiman, Region III A. Wilbers, Kentucky J. Trapp, Region I J. Nick, Region I K. Williams, NMSS/MSST L. Howell, NMSS/MSST AStrainingandtravel.Resource@nrc.gov OAS Board ML18114A213 OFFICE TL ASPB:PM ASPB:BC NAME BTharakan LRakovan PMichalak DATE 4/23/2018 4/25/18 4/25/18 OFFICIAL RECORD COPY

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE NEW YORK AGREEMENT STATE PROGRAM MARCH 12 - 23, 2018 DRAFT REPORT Enclosure

EXECUTIVE

SUMMARY

This report presents the results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the New York Agreement State Program. The review was conducted during the period of March 12 - 23, 2018, by a team comprised of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Kentucky. Additionally, a team member from the State of Arizona conducted inspector accompaniments prior to the onsite review.

Based on the results of this review, the team is recommending that New York be found satisfactory for six of the eight performance indicators reviewed: Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; Sealed Source and Device Evaluation Program; and Low-Level Radioactive Waste Disposal Program. The team is recommending that New York be found satisfactory but needs improvement for the common performance indicator, Technical Staffing and Training, and unsatisfactory for the non-common performance indicator, Compatibility Requirements. These ratings are unchanged from the previous IMPEP review, which concluded on March 28, 2014.

When one or more performance indicators is found unsatisfactory, NRC Management Directive 5.6 directs the Management Review Board (MRB) to consider placing the program on Heightened Oversight. At the end of the previous IMPEP review, the MRB considered the progress New York made in adopting several overdue regulations and New Yorks performance improvement from unsatisfactory to satisfactory during the review period with respect to the indicator Technical Quality of Incident and Allegation Activities. The MRB chose to discontinue the period of Heightened Oversight and initiate a period of Monitoring.

As of March 23, 2018, the New York City Department of Health and Mental Hygiene and the New York Department of Environmental Conservation were nearing adoption of compatible regulations. The New York Department of Health had decided to adopt NRC regulations by reference and was in the process of developing those new regulations. Because New Yorks regulation development process is lengthy but defined, the team determined that the benefit of having a written performance improvement plan or quarterly monitoring calls would not expedite or facilitate the process. Additionally, to fill vacancies, the DOH is required to apply for approval, in the form of a vacancy waiver with the State of New York Governors Office. The DOH Director had applied for vacancy waivers for both vacant positions with the Governors Office. The DOH and DEC are required to have travel authorizations for NRC-sponsored training approved by the State of New York Governors office. Delays in these approvals have resulted in several late withdrawals from the training courses by DOH personnel. Therefore, In lieu of Heightened Oversight or Monitoring, the team is recommending to the MRB that New York be removed from Monitoring and that a periodic meeting be held 1 year from the MRB meeting to assess New Yorks progress with respect to regulation development and adoption, as well as filling vacancies.

The team made one new recommendation (see Section 5.0) and believes that two of the three recommendations from the 2014 review should be closed. The team determined that the recommendation to make appropriate regulatory changes to resolve NRC-generated comments

as noted in regulation review letters, and adopt NRC regulations in accordance with the current NRC policy on adequacy and compatibility should be kept open (see Section 2.0).

Accordingly, the team recommends that the New York Agreement State Program be found adequate to protect public health and safety and not compatible with the NRC's program. The team recommends that the next IMPEP review take place in approximately 4 years with a periodic meeting in approximately 1 year for the reasons stated above.

New York Draft IMPEP Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the New York Agreement State Program radioactive materials safety program. The review was conducted during the period of March 12 - 23, 2018, by a team comprised of technical staff members from the U.S.

Nuclear Regulatory Commission (NRC) and the Commonwealth of Kentucky. Prior to March 12, 2018, a team member from the State of Arizona performed inspector accompaniments in New York City, but did not participate in the onsite review. Team members are identified in Appendix A.

The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017, and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated February 26, 2004. Preliminary results of the review, which covered the period of March 29, 2014, to March 23, 2018, were discussed with New York managers on the last day of the review.

In preparation for the review, a questionnaire addressing the common and applicable non-common performance indicators was sent to New York on September 11, 2017. A copy of the questionnaire is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using Accession Number ML17249A297.

The New York Agreement State Program is currently administered by three agencies:

(1) the New York State Department of Health (DOH), which has jurisdiction over industrial uses of radioactive materials throughout the State, as well as medical, academic, and research uses outside of New York City; (2) the New York City Department of Health and Mental Hygiene (NYC), which has jurisdiction over medical, academic, and research uses of radioactive materials within the five boroughs of New York City; and (3) the New York State Department of Environmental Conservation (DEC), which has jurisdiction over discharges of radioactive material to the environment, including releases to the air and water, and the land disposal of radioactive wastes.

Organization charts for DOH, NYC, and DEC, are available in ADAMS (Accession Numbers ML18064A180, ML18058A704, and ML18044A167, respectively).

The three agencies (DOH, NYC, and DEC) provided separate questionnaire responses on March 1, February 23, and February 9, 2018, respectively. The questionnaire responses can be found in ADAMS using ML18064A182, ML18058A726, and ML18044A153.

At the time of the review, New York regulated 1,285 specific licensees (DOH-986 and NYC-299) authorizing possession and use of radioactive materials. Additionally, DEC regulates 29 permit holders for radioactive discharges and radioactive waste disposal from all state-regulated radioactive materials licensees. The review focused on the radioactive materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of New York.

New York Draft IMPEP Report Page 2 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 the New York Agreement State Programs performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on March 28, 2014. The final report is available in ADAMS (Accession Number ML14261A351). The results of the review and the status of the recommendations are as follows:

Technical Staffing and Training: Satisfactory but Needs Improvement Recommendation: The review team recommends that the DOH and DEC continue to pursue vacancy waivers and implement a strategy to address current and future staffing vacancies in order to maintain effectiveness, and that NYC should update its staffing and training qualification program to include approved documentation of staffs qualifications.

(Section 3.1 of the 2014 IMPEP report)

Status: The 2018 team identified that DOH and DEC consistently pursue vacancy waivers in an effort to maintain appropriate staffing levels when an employee leaves or a retirement is imminent. To fill vacancies, the DOH and DEC are required to apply for approval, in the form of a vacancy waiver with the State of New York Governors Office.

A vacancy waiver is an application to the Governors office that provides justification for filling a position that has been vacant to override the moratorium on new hires. Vacancy waivers remain under review in the Governors Office for up to 2 years before the DOH or DEC are permitted to hire personnel to fill the vacant positions. Since the 2014 IMPEP review, NYC has developed a qualification journal modeled on NRCs Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs, and initiated the use of qualifications journals for their employees to track NRC training, supervised inspections, and in-house training. One staff member has been assigned to maintain the journal and records of employee training. The team believes that this recommendation should be closed.

Status of Materials Inspection Program: Satisfactory Recommendation: None Technical Quality of Inspections: Satisfactory Recommendation: None Technical Quality of Licensing Actions: Satisfactory Recommendation: The review team recommends that NYC (1) provide additional training to technical staff members regarding technical review of licensing actions, including training to ensure that the staff acquires increased familiarity with the regulations under NYCs equivalent to Title 10 of the Code of Federal Regulations

New York Draft IMPEP Report Page 3 (10 CFR) Parts 30, 33, and 35, and applicable licensing guidance documents and license conditions, and (2) take measures to ensure that the NYCs review of licensing actions are complete and well-documented. (Section 3.4 of the 2014 IMPEP report)

Status: Since the 2014 IMPEP review, the team confirmed a number of actions taken by NYC. These included using a variety of training opportunities, including on-the-job training, NRC-sponsored training, and NYC customized training classes. NYC has implemented a peer review process for all licensing actions to ensure that the actions are complete and well-documented. NYC uses the NUREG-1556, Consolidated Guidance About Materials Licenses, series and the NRC pre-licensing guidance on applicable licensing actions. NYC has increased staffing and at the time of the review had two qualified license reviewers, as well as a third new license reviewer undergoing training. Training for license reviewers has included NRC-sponsored training, 40-hour radiation safety officer training, and other in-house and on-the-job training. In addition, license review procedures have been revised and new forms have been created to include better documentation of license actions, peer review, and communications with licensees. At the time of the 2018 IMPEP review, NYC had no backlog of license actions. The team believes that this recommendation should be closed.

Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Compatibility Requirements: Unsatisfactory Recommendation: The review team recommends that the Program make appropriate regulatory changes to resolve NRC-generated comments as noted in regulation review letters, and adopt NRC regulations in accordance with the current NRC policy on adequacy and compatibility. (Section 4.1 of the 2014 IMPEP report)

Status: The 2006 and 2011 IMPEP teams recommended that DOH, NYC, and DEC develop and implement an action plan to adopt NRC regulations in accordance with the current NRC policy on adequacy and compatibility. The 2014 IMPEP team determined each agency had developed and implemented an action plan. The DOH and DEC regulation adoption process, which is similar for both agencies, takes approximately 2 to 3 years. The NYC uses a different process which takes approximately six months to complete, if there are no mitigating factors. The NYC agency was able to clear its backlog, but due to an arduous rulemaking process for both DOH and DEC, these agencies were not able to clear their backlog of overdue regulations. The 2014 IMPEP team determined that each agency is cognizant of the requirements to adopt compatible rules or use legally binding requirements within 3 years of the NRCs effective date and recommended closing the open recommendation from 2006 and 2011. The Management Review Board (MRB) agreed; however, the MRB directed the team to open a new recommendation to address New Yorks continued backlog of overdue regulations in order to be compatible with the NRCs program.

During the current IMPEP review period, 17 regulation amendments became due for adoption by New York (DOH-10, NYC-5, and DEC-2). At the time of the review, all

New York Draft IMPEP Report Page 4 these regulation amendments were overdue for adoption. Both DOH and NYC have proposed adopting NRC regulations by reference. The DOH was in the process of developing rules to incorporate NRC regulations by reference; however, DOH had implemented some license conditions to prevent significant health and safety gaps in New York regulations and to maintain compatibility, e.g., license conditions for 10 CFR Part 35, 37, and 71. These license conditions were not reviewed by the NRC before implementation.

During the review period, NYC proposed to repeal and reenact Article 175 of the radiation regulations, which includes the regulation of radioactive material in New York City per the Agreement State Program. In February 2017, NYC submitted proposed regulations to NRC for review. The NRC issued 16 comments on the proposed regulations in May 2017 and NYC proceeded to promptly resolve the comments. The updated reenactment of Article 175 regulations were submitted to the City Law Department in July 2017 for review. In March 2018, the regulations were still under review at the City Law Department; however, NYC executive management indicated that the regulations would go to the City Health Board in June and could be adopted as early as October 2018, thereby restoring compatibility with NRC regulations.

There are eight overdue NRC amendments which need to be adopted by DEC. Of the overdue rules, four are incorporated into the amendment of Title 6 of New York Codes, Rules and Regulations (NYCRR) Part 380 (6 NYCRR 380), Prevention and Control of Environmental Pollution by Radioactive Materials, which is expected to be finalized by May 2018. Two other overdue regulations will be adopted as the new 6 NYCRR Part 384, Cleanup Criteria for Remediation of Sites Contaminated with Radioactive Material, which is expected to be submitted for executive approval in 2018. The last two overdue rules are to be incorporated into 6 NYCRR Part 381, Transporters of Low-Level Radioactive Waste, which will be developed later.

Given that very little progress was made in adopting regulations over the course of the review period, the team believes that this recommendation should be kept open.

Sealed Source and Device Evaluation Program: Satisfactory Recommendation: None Low-Level Radioactive Waste Disposal Program: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and not compatible with the NRC's program. Additionally, the MRB chose to discontinue the period of Heightened Oversight and initiate a period of Monitoring.

3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC regional and Agreement State radioactive materials programs. These indicators are: (1) Technical Staffing and Training; (2) Status of Materials Inspection Program; (3) Technical Quality

New York Draft IMPEP Report Page 5 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 explored. 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 New Yorks performance with respect to the following performance indicator objectives:

• A well-conceived and balanced staffing strategy has been implemented throughout the review period.

• Agreement State training and qualification program is equivalent to NRC IMC 1248.

• Qualification criteria for new technical staff are established and are 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.

• There is a balance in staffing of the licensing and inspection programs.

• Management is committed to training and staff qualification.

• 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.

b. Discussion At the DOH, the radioactive materials program is implemented by the Bureau of Environmental Radiation Protection (the Bureau). The Bureau is comprised of the Director and Associate Director, who have responsibility for radioactive material and radiation producing equipment, two Section Chiefs for Radioactive Materials, and 16 staff members which equals 12 full-time equivalents (FTE) for the radioactive materials program when fully staffed. Two of the 12 FTE are clerical positions. At the time of the review, there were two vacancies. To fill vacancies, the DOH is required to apply for approval, in the form of a vacancy waiver with the State of New York Governors Office.

A vacancy waiver is an application to the Governors office that provides justification for filling a position that has been vacant to override the moratorium on new hires. The DOH Director had applied for vacancy waivers for both positions with the Governors Office approximately a year before the review. One of the vacancy waivers was approved just prior to the IMPEP review. During the review period, six staff members

New York Draft IMPEP Report Page 6 left the program and four staff members were hired. Four of the six departed employees principally supported the radioactive materials program while the other two were primarily support for the x-ray safety program, although these staff at times performed radioactive materials inspections. Of the four people newly hired, 0.7 FTE of their combined efforts are committed to the x-ray program.

The DOH has a training and qualification program compatible with the NRCs IMC 1248.

Candidates for employment are required to pass a New York State Civil Service Examination and then apply for jobs under strict hiring guidelines consistent with the technical skills required of the position. Employees are required to have a minimum of a Bachelor of Science. The DOH uses on-the-job training to supplement course work so that individuals may broaden their work experience. Staff members are assigned increasingly complex duties as they progress through the qualification process. Training is implemented through a mentoring program with a senior staff person who assigns inspections and licensing actions in accordance with their expertise and complexity of the action. The NRC-sponsored training attendance is tracked in an excel spreadsheet.

The DOH also maintains a spreadsheet of the licensed programs that each employee is authorized to inspect. The DOH conducts a 2-day annual meeting in October for the bureau employees. The meeting covers a host of regulatory and technical topics and is part of the employees continuing education program.

The DOH and DEC are required to have travel authorizations for NRC-sponsored training approved by the State of New York Governors office. Delays in these approvals have resulted in several late withdrawals from the training courses by DOH personnel (i.e., less than 1 week before the scheduled class). These withdrawals from NRC-sponsored training have the potential to delay the DOH staffs completion of their technical qualifications. DOH management has engaged the NRC in this matter and a letter has been sent from the NRC to DOH management indicating the impact of these withdraws. The DEC has not utilized NRC-sponsored training recently and therefore this has not been an issue for that program. NYC is not subject to this approval process.

The team identified performance issues involving the backlog of licensing actions that would indicate that DOH did not have adequate staffing, specifically in Section 3.4 of the report. At the time of the 2014 IMPEP, there were 187 renewal applications that had not been processed and were older than 1 year. During the Periodic Meeting performed on May 5, 2016, the number of renewals that were older than 1 year had been reduced to 150. However, the team observed continued backlogs in licensing actions at the DOH as detailed in Section 3.4 of the report. The team identified that, at the time of the review, the DOH had 331 outstanding licensing actions that had not been started: 157 renewals, 13 Part 37 actions, and 161 amendments. Forty-one amendment requests were greater than 1 year old and 83 renewal applications were greater than 1 year old.

The team did not identify issues in DOHs inspection program related to staffing levels.

In addition, during the 2014 IMPEP, New York was rated incompatible with the NRCs program because of its backlog of overdue regulations. Minimal progress was made by the DOH to reduce this backlog as detailed in Section 4.1 of the report. The Director of the DOH program informed the team that the lack of progress toward compatibility with regard to regulations could be attributed to a lack of resources.

New York Draft IMPEP Report Page 7 The NYC staff is comprised of the Director, who has responsibility for radioactive material and radiation producing equipment, the Unit Chief of Radioactive Materials, and six staff members which equals 6.75 FTE for the radioactive materials program when fully staffed. At the time of the review, there was one vacancy for a license reviewer.

The Director was working to fill the position promptly. This vacancy was created the week of the IMPEP review when a license reviewer was promoted to the position of Unit Chief of Radioactive Materials. During the review period, three staff members left the NYC program and four staff members were hired. The Director of the Office of Radiological Health left the program in March 27, 2017, and was replaced immediately by the former Unit Chief of Radioactive Materials who also continued to act as the Unit Chief of Radioactive Material until that position was filled in March 2018.

NYC has a training and qualification program compatible with the NRCs IMC 1248.

Employees are required to have a minimum of a Bachelor of Science degree and are encouraged to attend NRC-sponsored training. The most recent hire attended four NRC courses in less than a year. Attendance at training courses is tracked in an excel spreadsheet along with the completion of specific regulatory study topics, supervised inspections, and other supplemental training. NYC also has on-the-job training to supplement course work so that individuals may broaden their work experience. Staff members are assigned increasingly complex duties as they progress through the qualification process. Licensing and inspection training and qualification is implemented by a mentoring program with a more senior staff member reviewing and monitoring the work of a more junior staff member. In May of 2016, Dade Moeller & Associates was hired to provide 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of continuing education of radioactive materials-associated training for license reviewers and inspectors.

At the DEC, the Radiation Control Permit Section (RCPS) has a supervisor and three staff members plus one vacancy. There were no changes in personnel since the last IMPEP review. The RCPS staff issue permits related to radioactive discharges to the environment, so the staff training is limited to those technical classes in IMC 1248 which directly relate to discharges, as well as those for licensing and inspection. All staff are fully trained to both review permit applications and to inspect permits that are issued. All staff members take refresher and supplementary training. Staff training often includes a lead inspector accompanied by a second staff person; that second staff person becomes the lead inspector for the next inspection of the permit.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 3.1.a., with three exceptions:

• A well-conceived and balanced staffing strategy was not implemented throughout the review period by DOH.

• The DOH license reviewers and inspectors were not always trained and qualified in a reasonable period of time.

New York Draft IMPEP Report Page 8

• Any vacancies, especially senior-level positions, were not always filled by DOH in a timely manner.

Based upon the IMPEP evaluation criteria, the team recommends that New Yorks performance with respect to the indicator, Technical Staffing and Training, be found satisfactory, but needs improvement.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.2 Status of Materials Inspection Program Periodic inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety practices. The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and kind of 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.

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 New Yorks performance with respect to the following performance indicator objectives:

• Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the frequency prescribed in IMC 2800.

• Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 1220, Processing of NRC Form 241, Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and Offshore Waters, and Inspection of Agreement State Licensees Operating Under 10 CFR 150.20.

• 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.

• 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 Inspection frequencies for DOH and NYC are the same as similar license types in the NRCs IMC 2800. During review period, DOH and NYC collectively performed 1,055

New York Draft IMPEP Report Page 9 inspections of Priority 1, 2, and 3, licensees and 250 initial inspections. A total of 29 of 805 Priority 1, 2, and 3, inspections and 10 of 250 initial inspections were conducted overdue for an overdue rate of 3.7 percent for the review period.

A sampling of 58 DOH and NYC inspection reports indicated that three inspection findings were communicated to the licensees beyond New Yorks goal of 30 days after the inspection exit. All three of these reports were issued by the DOH. The overdue documentation was issued approximately 2 weeks beyond the goal of 30 days following the inspection in each case.

The DOH inspected 8.8 percent of candidate reciprocity licensees in 2014 (5 out of 57),

16.3 percent in 2015 (7 out of 43), 18.9 percent in 2016 (10 out of 53), and 20.5 percent in 2017 (9 out of 44). The DOH program self-identified reciprocity inspections as a weakness in their program and placed greater focus and resources on completing these inspections. The result was improved performance in 2016 and 2017.

Reciprocity records for 2014 could not be produced by NYC. Neither the number of reciprocity requests granted nor the number of reciprocity inspections performed in 2014 were available for review by the team. The staff indicated that the missing documents were the result of a change in management in 2014 and poor transition between managers. In all other years of the review period, NYC performed 100 percent of the reciprocity inspections: 2 out of 2 in 2015; 4 out of 4 in 2016; and 3 out of 3 in 2017.

Therefore, the collective performance for New York regarding reciprocity inspections during the review period was 8.8 percent in 2014, 20.0 percent in 2015, 24.6 percent in 2016, and 25.5 percent in 2017.

Since DEC inspections focus is solely on environmental discharges, the inspection frequencies are not based on NRC IMC 2800. Instead, the inspection frequencies are based on the magnitude of environmental discharges. The DEC performed 79 permit inspections since the last IMPEP review. All were conducted on time, or ahead of the required inspection date. Inspection of permits is performed at a frequency determined by RCPS policy, based on the quantity of effluent authorized for release by the permit.

Documentation for seven permit inspections was reviewed, and results of all were issued within 30 days after the inspection exit. Reciprocity inspections are not applicable to the DEC.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 3.2.a., and recommends that New Yorks performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

New York Draft IMPEP Report Page 10 3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide 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 Agreement States 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 New Yorks 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.

• For Agreement States, inspection guides are consistent with NRC guidance.

• An adequate supply of calibrated survey instruments is available to support the inspection program.

b. Discussion The team evaluated inspection reports, enforcement documentation, inspection field notes, and interviewed inspectors for 65 radioactive materials inspections (DOH-32, NYC-26 and DEC-7), conducted during the review period. The casework reviewed included inspections conducted by inspectors from each of the New York agencies, and covered various license types including: academic and medical broad scope; medical institutions with written directives, including unsealed radioiodine therapy, high dose rate remote afterloader therapy, microspheres, intravascular brachytherapy, permanent or temporary implant brachytherapy, and gamma knife therapy; medical institutions without written directives; veterinary; well-logging; waste broker; service provider; cyclotron; fixed gauge; portable gauge; industrial radiography; self-shielded irradiator; nuclear pharmacy; and 10 CFR Part 37 for radioactive materials quantities of concern.

The team accompanied 13 Program inspectors (DOH-6, NYC-3, and DEC-4) between October 6, 2017, and February 22, 2018. The accompaniments are identified in Appendix C. During the accompaniments, the inspectors demonstrated appropriate inspection techniques and knowledge of the regulations, and conducted

New York Draft IMPEP Report Page 11 performance-based inspections. The inspectors were trained, well-prepared for inspections, and thorough in their audits of the licensees radiation safety programs. The inspectors conducted interviews with appropriate personnel, observed licensed operations, conducted confirmatory measurements, and utilized good health physics practices. The inspections were adequate to assess radiological health, safety, and security at the licensed facilities.

The team noted that all three New York agencies have a policy of performing annual supervisory accompaniments of each inspector. Based on a review of records provided by each agency, the team concluded that each inspector was accompanied by their supervisor at least once each year during the review period for the NYC and DEC agencies. The team noted that only three staff in the DOH program were accompanied in calendar years 2014 and 2015, while nine staff were accompanied in calendar year 2016, and ten of 12 staff were accompanied in 2017. The DOH self-identified this issue and DOH management committed to maintaining an adequate level of annual accompaniments in the future.

Based on the evaluation of casework, the team noted that inspections performed by all three New York agencies covered all aspects of the licensees radiation safety programs. The team found that inspection reports were thorough, complete, consistent, and of high quality, with sufficient documentation to ensure that a licensees performance with respect to health, safety, and security was acceptable. The documentation supported violations, recommendations made to licensees, the effectiveness of corrective actions taken to resolve previous violations, and discussions held with licensees during exit interviews. Each New York agency issued either a letter or email indicating a clear inspection or a Notice of Violation (NOV) to the licensee, which details the results of the inspection. When each New York agency issued an NOV, the licensee was required to provide a written response with corrective actions for the violations cited within 30 days. The team also identified that reports and findings were reviewed by the appropriate DOH, NYC, or DEC managers.

Inspection procedures and techniques utilized by all three New York agencies were evaluated by the team and were determined to be consistent with the inspection guidance outlined in IMC 2800. Specific guidance for the various license types/activities was also included in the respective agency procedure manuals and/or inspection checklists. The team determined that 10 CFR Part 37 security inspection files were stored in a secure location for all three agencies. The inspection files were marked as containing sensitive information or to withhold from the public. The team noted that NYC does not mark its file folders as containing security-related information; however, inspection checklists for 10 CFR Part 37 inspections, containing sensitive security information, are marked to be withheld from the public.

The team noted that seven inspections conducted by NYC indicated that the licensees returned radioactive material, nuclear medicine doses, to the radiopharmacy; however, the transportation section of NYCs inspection checklist was marked as not applicable.

After discussing this issue with NYC inspectors, the team learned that compliance with certain Department of Transportation (DOT) regulations for radioactive materials returned to the radiopharmacy was not being inspected, e.g., training requirements for

New York Draft IMPEP Report Page 12 shippers and verification of package contamination levels. The team recommends that the NYC inspectors obtain additional training regarding the application of DOT regulations to material licensee inspections and take steps to properly perform associated inspections.

The team noted that all three New York agencies have ample supplies of radiation survey instruments such as Geiger-Mueller meters, scintillation detectors, ion chambers, micro-R meters, and neutron detectors to support its inspection program. The DOH also has portable multi-channel analyzers located in offices across New York, which are used to analyze samples and wipes for alpha, beta, and gamma radiation. Instruments were calibrated at least annually, or as needed, by an outside vendor for instrument service and calibration and/or had an in-house capability to perform instrument calibrations.

New York uses databases to track each instrument, its current location, and the next calibration date. The portable instruments used during the inspector accompaniments were operational and calibrated.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 3.3.a., and recommends that New Yorks performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion 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, actual implementation of those procedures, and documentation of communications and associated actions between the New York 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 New Yorks 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., financial assurance, increased controls, pre-licensing guidance).

New York Draft IMPEP Report Page 13

• 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 increased controls and fingerprinting orders (Part 37 equivalent).

• Documents containing sensitive security information are properly marked, handled, controlled, and secured.

b. Discussion During the review period, the three New York agencies collectively performed 3,618 radioactive materials licensing actions. The team evaluated 54 of those licensing actions. The licensing actions selected for review included 7 new applications, 22 amendments, 11 renewals, 10 terminations, 3 denials, and 1 variance. The team evaluated casework which included the following license types and actions: broad scope, medical diagnostic and therapy, accelerator, commercial manufacturing and distribution, industrial radiography, research and development, academic, nuclear pharmacy, gauges, panoramic and self-shielded irradiators, well-logging, service providers, decommissioning actions, financial assurance, notifications. The casework sample represented work from 15 license reviewers.

The team noted that DOHs licensing actions were of acceptable technical quality with sufficient attention to health, safety, and security issues. At the time of the 2018 IMPEP review, the DOH reported having approximately 986 specific radioactive materials licenses with a current backlog of 331 outstanding license actions including 161 amendments outstanding and 157 outstanding renewals with 83 renewals pending over 1 year. This is an increase from 29 amendments identified during the 2014 review, and an improvement from 187 renewal actions greater than 1 year identified during the 2014 IMPEP review. The DOH continues to make efforts to address renewal backlog utilizing a quick review process while ensuring public health and safety by continuing inspections and amendments.

At the time of the review, NYC reported having approximately 299 specific radioactive materials licenses. During the review period, NYC performed 784 license actions.

There was no backlog noted during the review period. The team found licensing actions to be thorough, complete, consistent, and of high quality with health, safety, and security issues properly addressed. License tie-down conditions were stated clearly and were supported by information contained in the file. Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified deficiencies in the licensees documents. Terminated licensing actions were well documented, showing appropriate transfer and survey records. The NYC Program performs Transfer of Control utilizing

New York Draft IMPEP Report Page 14 Termination of existing licenses and issue of new license. The NYC Program does not issue reciprocity or general licenses.

At DEC, the Radiation Control Permit Section (RCPS) performed 47 permit actions since the last IMPEP. In addition, RCPS staff reviewed 7 permit applications which were determined to not require a permit. The team reviewed seven permit actions, including one new air permit, five renewals (one incinerator and four air permits), and one air permit modification, representing work from three permit reviewers. The team determined the actions were of high quality. The RCPS staff used staff-developed guidance provided to applicants for typical air permits, and a separate guidance document for cyclotron applicants for an air permit. Two internal documents were developed since the last IMPEP: guidance for treating multiple stacks as a single release point; and a technical basis document for determining when stack monitoring results are sufficient to demonstrate compliance with the constraint rule.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 3.4.a., and recommends that New Yorks performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion 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 and safety. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, and investigative and followup actions, are a significant indicator of the overall quality of the incident response and allegation programs.

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 New Yorks performance with respect to the following performance indicator objectives:

• Incident response, investigation, 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.

New York Draft IMPEP Report Page 15

• Appropriate followup actions are taken to ensure prompt compliance by licensees.

• Followup 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 (NMED).

• Allegations are investigated in a prompt, appropriate manner.

• Concerned individuals are notified of investigation conclusions.

• Concerned individuals identities are protected, as allowed by law.

b. Discussion During the review period, 155 (DOH-138, NYC-12, and DEC-5) incidents were reported to New York, of which 42 were reportable to the NRC. The team evaluated 28 radioactive materials incidents, which included seven events involving lost/stolen radioactive material, one potential overexposure, 17 medical events, one event involving damaged equipment, and two events involving leaking sources. The appropriate New York agency dispatched inspectors for onsite followup for 15 of the cases reviewed.

The team reviewed each agencys implementation of its incident and allegation processes, including written procedures for handling incident and allegation response, file documentation, and notification of incidents to the NRC Headquarters Operations Officer for inclusion in NMED. When a notification of an incident or allegation is received, the respective New York agencys managers review the information, determine its health and safety significance, and decide on the appropriate level of initial response.

The team found that inspectors from all three agencies properly evaluated each event, interviewed involved individuals, and thoroughly documented their findings.

Enforcement actions were taken where appropriate.

In regards to the reporting of events to the NRC, if the event meets the NRC reporting thresholds as established in NMSS Procedure SA-300, the appropriate New York agency notified the NRC in a prompt manner, with exception of six incidents (DOH-2 and NYC-4) where five events were reported to the NRC approximately six days late and one incident was reported 79 days late.

During the review period, 16 allegations (DOH-11, NYC-3, and DEC-2) were received by New York. The team evaluated the effectiveness of the three New York agencies response to 13 allegations during the review period, including 9 allegations (DOH-7, NYC-1, and DEC-1) referred to New York by the NRC. The team concluded that, with one exception, all three agencies took prompt and appropriate actions in response to concerns raised. Staff documented the investigations of concerns and retained all necessary documentation appropriately to close the allegation and concerned individuals were notified of the conclusion of its investigation. The exception involved one allegation that was referred to the NYC by the NRC on September 12, 2014. The NYC could not find any documentation or record involving this allegation. Two individuals at NYC were aware of the allegation and both have since left the agency. NYC could not find any documentation or record about NYCs response to the allegation.

New York Draft IMPEP Report Page 16

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 3.5.a., and recommends that New Yorks performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Compatibility Requirements; (2) Sealed Source and Device (SS&D)

Evaluation Program; (3) Low-Level Radioactive Waste Disposal (LLRW) Program; and (4) Uranium Recovery Program. The NRCs Agreement with New York retains regulatory authority for a uranium recovery program; therefore, only the first three non-common performance indicators applied to this review.

4.1 Compatibility Requirements 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 agreement. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of 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.

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, as defined in Appendix A of State Agreements procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and 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 six months following NRC designation.

a. Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Compatibility Requirements, and evaluated New Yorks performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC Web site at the following address: https://scp.nrc.gov/regtoolbox.html.

New York Draft IMPEP Report Page 17

• 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 six 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.

• Impact of sunset requirements, if any, on the States regulations.

b. Discussion New York became an Agreement State on October 15, 1962. There are three separate agencies regulating ionizing radiation in the State of New York: DOH, NYC, and DEC. The DOH legislative authority to administer its portion of the Agreement is granted in New York Public Health Law, Article 2, Title II, Sections 201 and 225. The NYC regulatory authority is delegated from DOH under Part 16 of the New York State Health Sanitary Code which provides for delegation to local governments when covering greater than two million individuals. The local legislative authority for NYCs portion of the Agreement State program is granted in Chapter 22 of the New York City Charter, specifically Section 556(c)(11). This regulatory authority is implemented by NYC through Article 175 of the New York City Health Code. Articles 1, 3, 17, 19, 29, and 37 of the Environmental Conservation Law provide DEC with the authority to implement its radiation program. The DEC regulations are found in 6 NYCRR Chapter IV, Subchapter C, Parts 380, 381, 382 and 383, and apply to environmental releases and disposal of radioactive material. The DEC requires a permit for release of radioactive material to the environment, including the disposal of radioactive material, for all radioactive material. These regulations also cover the transportation of LLRW shipments into, within, and through New York State.

The three agencies reported to the IMPEP team that no legislation affecting the radiation control programs was passed during the review period. The team noted that New Yorks rules and regulations are not subject to sunset laws.

The DOH and DEC regulation adoption process, which is similar for both agencies, takes approximately 2 to 3 years. The NYC uses a different process which takes approximately six months to complete, if there are no mitigating factors. The public, the NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during each process.

New York Draft IMPEP Report Page 18 At the DOH, once proposed regulations are developed within the Bureau of Environmental Radiation Protection, it typically takes approximately 1 year to complete internal reviews before transmitting a proposed rule to the Governors office for review and approval. The Governors office has been taking one to 2 years to complete its review and approval before being sent to the Public Health Council for review. Once the proposed rules are reviewed by the Public Health Council, they are published in the New York State Register for a mandatory 45-day public comment period. When the public comment period is completed, and if there are no substantive changes needed, the proposed rules and resolution of comments are reviewed by the Public Health Council and published in the State Register as final rules with an effective date.

The DEC follows a similar process to DOH; however, there is no Public Health Council or Environmental Review Board involvement. At the DEC, rules are developed in conjunction with a program attorney. This process can take anywhere from 3 months to a year for more complex rules. Once the rules are developed, the DEC Office of General Counsel performs a review which can take about one to two months. After that, the proposed rules go to the DEC Executive Commissioner for review, which for the 6 NYCRR Part 380 amendments, took approximately 1 year. After leaving the DEC, the proposed rules go to the Governors Office for review. For the 6 NYCRR 380 review, the Governors office review took 2 years. The proposed rules then go out for a 30 to 90-day public comment period during which time a public hearing is held. After the public comment period and comments are resolved, the DEC has 1 year from the public hearing date to file the final rules with the New York Department of State. For the 6 NYCRR 380 amendments, the public hearing date was May 25, 2017. The final rules were filed with the New York Department of State on April 10, 2018 and will become effective on May 10, 2018.

The NYC follows a different process. The NYC develops a regulation package and sends it to the mayors office and the City Law Department for review and approval.

Once the rules are approved by the mayors office and the Citys Law Department, they are placed on the Departments Board of Health agenda. The Board of Health meets quarterly in March, June, September, and December. The first time that it is presented with proposed rules, the Board of Health determines whether to approve them for publication on the Citys proposed rules website and in the City Record (a newspaper which publishes City agencies proposed and adopted rules) at that point, the rules are open for general public comment. Once the Board approves for publication, the proposed rule is also disseminated to various stakeholders, the media, and City officials.

The agency also holds a public hearing on the proposed rule, usually about 30 days after the Board has approved it for publication. The overall public comment period is usually 60 days.

During the current IMPEP review period, 17 regulation amendments became due for adoption by New York (DOH-10, NYC-5, and DEC-2). At the time of the review, these regulation amendments had not been adopted and were all overdue. Prior to the review period, several regulation amendments were not adopted by the due date and several outstanding comments on those amendments were unresolved. Since both DOH and NYC proposed and worked on the revisions to adopt NRC regulations by reference; neither program worked on individual NRC amendments that were due or past due. At

New York Draft IMPEP Report Page 19 the time of the 2018 IMPEP review, the DOH was in the process of developing rules to incorporate NRC regulations by reference; however, DOH had implemented some license conditions to prevent significant health and safety gaps in the regulations and to maintain compatibility, e.g., license conditions for 10 CFR Part 35, 37, and 71. These license conditions were not reviewed by the NRC before implementation.

During the review period, NYC proceeded to adopt NRC regulations by reference by repealing and reenacting Article 175 of the NYC Health Code, which includes the regulation of radioactive material in New York City per the Agreement State Program. In 2016, NYC developed and submitted the proposed Article 175 revisions to the NRC for review. The NRC issued 16 comments on the proposed regulations in May 2017, and NYC proceeded to promptly resolve the comments. The updated reenactment of Article 175 regulations were submitted to the City Law Department in July 2017 for review. In March 2018, the regulations were still under review at the City Law Department; however, NYC management indicated that the regulations would go to the City Health Board in June and could be adopted as early as October 2018.

There are eight overdue NRC amendments which need to be adopted by DEC. Of the overdue rules, four are incorporated into the amendment of 6 NYCRR 380, which is expected to be finalized by May 2018. Two other overdue regulations will be adopted as the new 6 NYCRR Part 384, which is expected to be submitted for executive approval in 2018. The last two overdue rules are to be incorporated into 6 NYCRR Part 381, which will be developed later.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 4.1.a., with one exception:

• 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.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that New Yorks performance with respect to the indicator, Compatibility Requirements, be found unsatisfactory.

d. MRB Decision The final report will present the MRBs conclusion 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 SS&D reviews and establishes useful guidance for teams.

New York Draft IMPEP Report Page 20 Under this guidance, 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 New Yorks 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 NRC, Agreement States, and others, as appropriate, occur in a timely manner.

b. Discussion Technical Staffing and Training The SS&D program is administered by DOH. At the time of the review, New York had two staff members qualified who perform SS&D reviews. Both reviewers have attended the NRC SS&D Workshop. There were no changes to the staff who perform SS&D evaluations during the review period and, at the time of the review, there were no

New York Draft IMPEP Report Page 21 vacancies. New York has a training program equivalent to NRC training requirements listed in IMC 1248, Appendix D.

Technical Quality of the Product Evaluation New York has three SS&D licensees. The team evaluated the only SS&D action DOH processed during the review period. The action included an amendment to an existing registration certificate and featured changes to the dimensions of a registered sealed source. The reviewer performed a complete and technically accurate review, evaluated the new submitted prototype test results, and was able to identify the shortcoming of the application. The review was thorough and completed in a timely manner. The casework indicated that staff followed the guidance in NUREG 1556 Vol.3, Rev. 2 and completed the Safety Evaluation Checklist.

Evaluation of Defects and Incidents Regarding SS&Ds The team evaluated both incidents involving New York SS&D registered products that occurred during the review period. Neither of the incidents were related to manufacturing or design of the sources/devices manufactured or distributed by a licensee with a SS&D registered by New York. The team found that DOH properly evaluated each event, took appropriate action, and documented its findings.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 4.2.a., and recommends that New Yorks performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program The objective is to determine if New York LLRW disposal program is adequate to protect public health and safety. Five sub-elements are used to make this determination:

(1) Technical Staffing and Training; (2) Status of LLRW Inspection Program; (3) Technical Quality of Inspections; (4) Technical Quality of Licensing Actions; and (5) Technical Quality of Incident and Allegation Activities.

a. Scope The team used the guidance in State Agreements procedure SA-109, Reviewing the Non-Common Performance Indicator: Low-Level Radioactive Waste Disposal Program, and evaluated New Yorks performance with respect to the following performance indicator objectives:

New York Draft IMPEP Report Page 22 Technical Staffing and Training

• Qualified and trained technical staff are available to license, regulate, control, inspect, and assess the operation and performance of the LLRW disposal facility.

• Qualification criteria for new LLRW technical staff are established and are 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.

• There is a balance in staffing the LLRW licensing and inspection programs.

• Management is committed to training and staff qualification.

• Individuals performing LLRW licensing and inspection activities are adequately qualified and trained to perform their duties.

• LLRW license reviewers and inspectors are trained and qualified in a reasonable period of time.

Status of LLRW Inspection Program

• The LLRW facility is inspected at prescribed frequencies.

• Statistical data on the status of the inspection program is maintained and can be retrieved.

• Deviations from inspection schedules are coordinated between LLRW 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.

• Inspection findings are communicated to licensees in a timely manner.

Technical Quality of Inspections

• Inspections of LLRW 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 LLRW inspector to assess performance and assure consistent application of inspection policies.

• Inspection guides are consistent with NRC guidance.

• An adequate supply of calibrated survey instruments is available to support the inspection program.

Technical Quality of Licensing Actions

• Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.

New York Draft IMPEP Report Page 23

• Applicable LLRW guidance documents are available to reviewers and are followed (e.g., pre-licensing guidance, regulatory guides, etc.).

• Essential elements of license applications have been submitted and elements are consistent with current NRC or Agreement State regulatory guidance for describing the isotopes and quantities used, qualifications of authorized users, facilities, equipment, locations of use, operating and emergency procedures, and any other requirements necessary to ensure an adequate basis for the licensing action, e.g.,

financial assurance, increased controls/Part 37, etc.

• LLRW license reviewers, if applicable, have the proper signature authority for the cases they review independently.

• License tie-down 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.

• Licensing practices for risk significant radioactive materials are appropriately implemented including increased controls and fingerprinting orders (Part 37 equivalent).

• Documents containing sensitive security information are properly marked, handled, controlled, and secured.

Technical Quality of Incident and Allegation Activities

• LLRW incident response, investigation, 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 followup actions are taken to ensure prompt compliance by licensees.

• Followup 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 NMED.

• Allegations are investigated in a prompt, appropriate manner.

• Concerned individuals are notified of investigation conclusions.

• Concerned individuals identities are protected, as allowed by law.

b. Discussion New York does not have any active LLRW sites. The DECs Radiological Sites Section (RSS) oversees two closed land burial facilities at locations where LLRW was buried in the past in accordance with regulations at the time of burial. The State-licensed Disposal Area (SDA) located at West Valley is authorized under a land burial permit to monitor and maintain the SDA facility. The Cornell Radioactive Disposal Site (RDS) performs monitoring and maintenance of the facility under a Consent Order issued by the State of New York. The RDS also is authorized by a water permit to release effluent water.

New York Draft IMPEP Report Page 24 Technical Staffing and Training The RSS has two qualified staff members currently performing oversight of the two closed land burial sites. Other qualified staff in RSS perform work not related to activities under the Agreement. Currently, there is one vacancy in RSS. There were no changes in the staff members who oversee the closed land burial sites since the last IMPEP. The RSS training program for the staff performing oversight of the two closed land burial sites is equivalent to NRC training requirements listed in IMC 1248, Appendix E for both initial and refresher training.

Status of LLRW Disposal Inspection Program The RSS staff performed 12 inspections during the review period. The review determined that RSS completed the inspections in accordance with the frequency in IMC 2800. The more complex land burial site is inspected a minimum of twice each year; the smaller, less complex site is inspected annually.

Inspection findings for the LLRW disposal program were communicated by formal correspondence to the licensee within 30 days following the inspection.

Technical Quality of LLRW Inspections On October 6, 2017, the team accompanied two inspectors and a supervisor at the Cornell RDS. Under the Consent Order issued to Cornell University, site security, environmental monitoring, and facility posting of the Cornell RDS were observed.

The team evaluated two inspection files, which included hydrogeological, radiological, security, and environmental hazards, and determined that the inspection reports were thorough, complete, consistent, and had sufficient documentation to ensure that licensee performance with respect to health, safety and security was acceptable. The findings were well-founded, supported by regulations, and were appropriately documented.

Technical Quality of LLRW Licensing Actions The RSS completed one land burial permit action during the review period. This was the renewal of the West Valley SDA land burial permit. The review was thorough and completed in a timely manner.

Technical Quality of Incident and Allegation Activities The team evaluated the one incident and all three allegations that RSS received during the review period. All three allegations were referred to the State of New York by the NRC and were determined to involve activities under RSS oversight. The incident and allegations were not related to either land burial site, but were evaluated by RSS because the nature of the issues best fell under RSS oversight. The DEC has written procedures for the handling, review, analysis, response and follow-up of incidents and allegations. These procedures were undergoing revision at the time of the review.

New York Draft IMPEP Report Page 25 The single incident was a request for assistance from another state agency. Two of the three allegations referred by the NRC were related to issues and facilities with which RSS already was familiar. RSSs response to the single incident was adequate and appropriate follow-up actions were taken with all three allegations.

c. Evaluation The team determined that, during the review period, New York met the performance indicator objectives listed in Section 4.3.a., and recommends that New York performance with respect to the indicator, Low-Level Radioactive Waste Disposal Program, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

5.0

SUMMARY

As noted in Sections 3.0 and 4.0 above, New Yorks performance was found to be satisfactory for six out of eight performance indicators reviewed, satisfactory but needs improvement for the performance indicator Technical Staffing and Training, and unsatisfactory for the performance indicator Compatibility Requirements. The team made one new recommendation regarding New Yorks performance and determined that two of the three recommendations from the 2014 IMPEP review should be closed. The team believes that the recommendation from 2014 IMPEP review regarding regulation development should be kept open.

When one or more performance indicators is found unsatisfactory, NRC Management Directive 5.6 directs the MRB to consider placing the program on Heightened Oversight.

At the end of the previous IMPEP review, the MRB considered the progress New York made in adopting several overdue regulations and New Yorks performance improvement from unsatisfactory to satisfactory during the review period with respect to the indicator Technical Quality of Incident and Allegation Activities. The MRB chose to discontinue the period of Heightened Oversight and initiate a period of Monitoring.

As of March 23, 2018, the NYC and DEC were both nearing adoption of compatible regulations. The DOH had decided to adopt NRC regulations by reference and was in the process of developing those new regulations. Because New Yorks regulation development process is lengthy but defined, the team determined that the benefit of having a written performance improvement plan or quarterly monitoring calls would not expedite or facilitate the process. Additionally, the DOH Director had applied for vacancy waivers for both vacant positions with the Governors Office. The DOH and DEC are required to have travel authorizations for NRC-sponsored training approved by the State of New York Governors office. Delays in these approvals have resulted in several late withdrawals from the training courses by DOH personnel. Therefore, in lieu of Heightened Oversight or Monitoring, the team is recommending to the MRB that New York be removed from Monitoring and that a periodic meeting be held 1 year from the

New York Draft IMPEP Report Page 26 MRB meeting to discuss the status of the actions taken to adopt regulations as discussed in Section 4.1, as well as to fill the vacancies discussed in Section 3.1.

Accordingly, the team recommends that the New York Agreement State Program be found adequate to protect public health and safety and not compatible with the NRC's program. Based on the results of the current IMPEP review, the team recommends that the next full IMPEP review take place in approximately 4 years, with a periodic meeting in approximately 1 year.

Below are the teams recommendations, as mentioned in the report, for evaluation and implementation by New York:

1. The team recommends that the NYC inspectors obtain additional training regarding the application of DOT regulations to material licensee inspections and take steps to properly perform associated inspections (Section 3.3).

2. The team recommends that the Program make appropriate regulatory changes to resolve NRC-generated comments as noted in regulation review letters, and adopt NRC regulations in accordance with the current NRC policy on adequacy and compatibility (Section 4.1 of the 2014 IMPEP report).

LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspection Accompaniments

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Binesh Tharakan, Region IV Team Leader Compatibility Requirements John Miller, Region I Technical Staffing and Training Status of Materials Inspection Program DOH Inspector Accompaniments Robin Elliott, Region I Technical Quality of Inspections DOH Inspector Accompaniments Angela Wilbers, Kentucky Technical Quality of Licensing Actions Zahid Sulaiman, Region III Technical Quality of Incident and Allegation Activities Lymari Sepulveda, NMSS Sealed Source and Device Evaluation Program Betsy Ullrich, Region I Low-Level Radioactive Waste Disposal Program DEC Common Indicators DEC Inspector Accompaniments Brian Goretzki, Arizona NYC Inspector Accompaniments

APPENDIX B INSPECTION ACCOMPANIMENTS The following inspection accompaniments were performed prior to the on-site IMPEP review:

Accompaniment No.: 1 Permit No.: NA - Consent Order Permit Type: Land Burial Priority: I Inspection Date: 10/6/17 Inspector: JA and KM Accompaniment No.: 2 License No.: 91-3079-01 License Type: Medical, written directive required Priority: 3 Inspection Date: 12/11/17 Inspector: MR Accompaniment No.: 3 License No.: 91-3018-01 License Type: Medical, written directive required Priority: 3 Inspection Date: 12/12/17 Inspector: OA Accompaniment No.: 4 License No.: 91-2902-01 License Type: Medical, written directive required Priority: 3 Inspection Date: 12/13/17 Inspector: JL Accompaniment No.: 5 Permit No.: 181-3 Permit Type: Air Priority: II Inspection Date: 12/19/17 Inspector: TF Accompaniment No.: 6 Permit No.: 53-3 Permit Type: Air Priority: III Inspection Date: 1/30/18 Inspector: FF Accompaniment No.: 7 License No.: C3244 License Type: Fixed gauge Priority: 5 Inspection Date: 2/5/18 Inspector: NK Accompaniment No.: 8 License No.: C3034 License Type: Radiography Priority: 1 Inspection Date: 2/15-16/18 Inspector: AB Accompaniment No.: 9 License No.: C2610 License Type: Portable gauge Priority: 5 Inspection Date: 2/16/18 Inspector: MSu Accompaniment No.: 10 License No.: 1195 License Type: Medical, no WD required Priority: 5 Inspection Date: 2/20/18 Inspector: MS

Accompaniment No.: 11 License No.: 437 License Type: Medical : HDR Priority: 2 Inspection Date: 2/21/18 Inspector: JK Accompaniment No.: 12 License No.: 5124 License Type: Medical: No WD required Priority: 5 Inspection Date: 2/22/18 Inspector: JC