UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

October 3, 2014 

Nathan Graber, M.D., M.P.H. 

Director 

Center for Environmental Health 

Empire State Plaza-Corning Tower-Room 1619 

Albany, NY 12237 

Dear Dr. Graber: 

On August 4, 2014, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the New York 

Agreement State Program. The MRB found the New York program adequate to protect public 

health and safety, and not compatible with the U.S. Nuclear Regulatory Commission's (NRC) 

program. 

Section 5.0, page 18 of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. The review team determined that the recommendations from 

the 2011 IMPEP review, regarding reciprocity inspections, development of an action plan to 

adopt NRC regulations, and incident reporting and incident procedures should be closed. The 

review team made three recommendations regarding program performance in technical staffing, 

quality of licensing, and compatibility requirements. We request your written response to the 

recommendations in the report within 30 days from receipt of this letter. Your response to the 

recommendations should be submitted to Laura Dudes, Director, Division of Materials Safety 

and State Agreements. The MRB suggests the Program carefully review the IMPEP report 

sections on Technical Staffing and Training, Technical Quality of Licensing Actions, and 

Compatibility Requirements as it prepares the responses to the recommendations. Based on 

the results of the current IMPEP review, the next full review of the New York Agreement State 

Program will take place in approximately 4 years from the current IMPEP, with a periodic 

meeting tentatively scheduled for March 2016. 

The MRB commends the Program for progress made under the indicator Technical Quality of 

Incident and Allegations Activities, where performance was improved from unsatisfactory to 

satisfactory during the review period, and the progress made in adopting several overdue rules. 

As a result, the MRB directed that the period of Heightened Oversight be discontinued and a 

period of Monitoring be initiated. 
Dr. Graber -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I 

also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Roy P. Zimmerman 

 Acting Deputy Executive Director for 

 Materials, Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

New York Final IMPEP Report 

cc: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 

Stephen Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

Robert Dansereau, Asst. Director 

 Bureau of Environmental Radiation Protection 
UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

October 3, 2014 

Mr. Robert W. Schick 

New York State Department of 

 Environmental Conservation 

625 Broadway, 11th Floor 

Albany, NY 12233 

Dear Mr. Schick: 

On August 4, 2014, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the New York 

Agreement State Program. The MRB found the New York program adequate to protect public 

health and safety, and not compatible with the U.S. Nuclear Regulatory Commission's (NRC) 

program. 

Section 5.0, page 18 of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. The review team determined that the recommendations from 

the 2011 IMPEP review, regarding reciprocity inspections, development of an action plan to 

adopt NRC regulations, and incident reporting and incident procedures should be closed. The 

review team made three recommendations regarding program performance in technical staffing, 

quality of licensing, and compatibility requirements. We request your written response to the 

recommendations in the report within 30 days from receipt of this letter. Your response to the 

recommendations should be submitted to Laura Dudes, Director, Division of Materials Safety 

and State Agreements. The MRB suggests the Program carefully review the IMPEP report 

sections on Technical Staffing and Training, Technical Quality of Licensing Actions, and 

Compatibility Requirements as it prepares the responses to the recommendations. Based on 

the results of the current IMPEP review, the next full review of the New York Agreement State 

Program will take place in approximately 4 years from the current IMPEP, with a periodic 

meeting tentatively scheduled for March 2016. 

The MRB commends the Program for progress made under the indicator Technical Quality of 

Incident and Allegations Activities, where performance was improved from unsatisfactory to 

satisfactory during the review period, and the progress made in adopting several overdue rules. 

As a result, the MRB directed that the period of Heightened Oversight be discontinued and a 

period of Monitoring be initiated. 
R. Schick -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I 

also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Roy P. Zimmerman 

 Acting Deputy Executive Director for 

 Materials, Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

New York Final IMPEP Report 

cc: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 

Timothy Rice, Chief 

Radiological Sites Section 

Remedial Bureau A 

Sandra Hinkel, Chief 

Radiation Control Permits Section 

Remedial Bureau
UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

October 3, 2014 

Mr. Christopher Boyd 

Assistant Commissioner 

Bureau of Environmental Sciences 

 and Engineering 

42-09 28th Street, 14th Floor CN#56 

Long Island City, NY 11101 

Dear Mr. Boyd: 

On August 4, 2014, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the New York 

Agreement State Program. The MRB found the New York program adequate to protect public 

health and safety, and not compatible with the U.S. Nuclear Regulatory Commission's (NRC) 

program. 

Section 5.0, page 18 of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. The review team determined that the recommendations from 

the 2011 IMPEP review, regarding reciprocity inspections, development of an action plan to 

adopt NRC regulations, and incident reporting and incident procedures should be closed. The 

review team made three recommendations regarding program performance in technical staffing, 

quality of licensing, and compatibility requirements. We request your written response to the 

recommendations in the report within 30 days from receipt of this letter. Your response to the 

recommendations should be submitted to Laura Dudes, Director, Division of Materials Safety 

and State Agreements. The MRB suggests the Program carefully review the IMPEP report 

sections on Technical Staffing and Training, Technical Quality of Licensing Actions, and 

Compatibility Requirements as it prepares the responses to the recommendations. Based on 

the results of the current IMPEP review, the next full review of the New York Agreement State 

Program will take place in approximately 4 years from the current IMPEP, with a periodic 

meeting tentatively scheduled for March 2016. 

The MRB commends the Program for progress made under the indicator Technical Quality of 

Incident and Allegations Activities, where performance was improved from unsatisfactory to 

satisfactory during the review period, and the progress made in adopting several overdue rules. 

As a result, the MRB directed that the period of Heightened Oversight be discontinued and a 

period of Monitoring be initiated. 
C. Boyd -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I 

also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Roy P. Zimmerman 

 Acting Deputy Executive Director for 

 Materials, Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

New York Final IMPEP Report 

cc: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 

Geoffrey Korir, Director 

Office of Radiological Health 
C. Boyd -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I 

also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Roy P. Zimmerman 

 Acting Deputy Executive Director for 

 Materials, Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

New York Final IMPEP Report 

cc: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 

Stephen Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

Robert Dansereau, Asst. Director 

 Bureau of Environmental Radiation Protection 

Distribution: (See Next Page) 

Identical letters sent to N. Graber, R. Schick and C. Boyd 

ML14231A059 

OFC MSSA:TL MSSA MSSA MSSA:D TechEd FSME:D EDO:Acting 

DEDMRT 

NAME LDimmick 

w/edits 

MBeardsley 

via email 

w/edits 

DWhite 

w/edits 

LDudes CPoland BHolian 

w/edits 

RZimmerman 

DATE 09/23/14 09/23/14 09/23/14 09/24/14 09/24/14 09/29/14 10/ 03 /14 

OFFICIAL RECORD COPY
Letter to N. Graber, R. Schick and C. Boyd from Roy P. Zimmerman dated: October 3, 2014 

 

SUBJECT: NEW YORK FY2014 FINAL IMPEP REPORT 

DISTRIBUTION: (SP05) 

RidsEdoMailCenter 

JFoster, OEDO 

RidsFsmeOd 

RidsOgcMailCenter 

JOlmstead, OGC 

RidsRgn3MailCenter 

DRoberts, RIII 

RidsRgn1MailCenter 

DLew, RI 

DCollins, RI 

JDwyer, RI 

RidsSecyCorrespondenceMailCenter Chairman Macfarlane 

RidsFsmeMssa Commissioner Svinicki 

SAbraham, MSSA Commissioner Ostendorff 

PHenderson, MSSA SECY 

DJanda, RI/RSAO 

DLawyer, RI 

MFord, RI 

KLambert, RIII 

LRoldenOtero, RIV 

AGaines, RIV 

JOhara, MSSA 

MArribasColon, MSSA 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NEW YORK AGREEMENT STATE PROGRAM 

MARCH 17–28, 2014 

FINAL 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 17–28, 2014, by a review team composed of technical staff members from 

the U.S. Nuclear Regulatory Commission (NRC) and the State of Florida.

Based on the results of this review, New York’s performance was found satisfactory for the 

indicators Status of the Materials Inspection Program, Technical Quality of Inspection, Technical 

Quality of Incidents and Allegations, Sealed Source and Device Evaluation Program, and 

Low-level Radioactive Waste Disposal Program. The indicator, Technical Staffing and Training 

was found satisfactory, but needs improvement, and remains unchanged from the previous 

IMPEP review. The indicator, Compatibility Requirements was found unsatisfactory and 

remains unchanged from the previous IMPEP review. Progress has been made on this 

indicator, but the State has not yet addressed a number of overdue regulation amendments and 

outstanding NRC comments regarding earlier regulation packages. The indicator, Technical 

Quality of Licensing Actions, was found satisfactory, but needs improvement by the IMPEP 

team. However, the Management Review Board (MRB) determined this indicator should be 

found satisfactory. 

The review team made three recommendations regarding program performance in technical 

staffing, technical quality of licensing, and compatibility requirements, and determined that the 

six recommendations from the 2011 IMPEP review, regarding reciprocity inspections, 

development of an action plan to adopt NRC regulations, and incident reporting and incident 

procedures should be closed. 

Accordingly, the review team recommended, and the MRB agreed, that the New York 

Agreement State Program is adequate to protect public health and safety and is not compatible 

with the NRC's program. Considering the progress New York made under the indicator 

Technical Quality of Incident and Allegations (i.e., performance was improved from 

unsatisfactory to satisfactory during the review period) and the progress made in adopting 

several overdue rules, the review team recommended, and the MRB agreed, that the period of 

Heightened Oversight be discontinued and a period of Monitoring be initiated. The review team 

recommended and the MRB agreed that the next IMPEP review take place in approximately 4 

years. 
New York Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the New York Agreement State Program. The 

review was conducted during the period of March 17–28, 2014, by a review team composed of 

technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of 

Florida. Team members are identified in Appendix A. The review was conducted in accordance 

with the “Implementation of the Integrated Materials Performance Evaluation Program and 

Rescission of Final General Statement of Policy,” published in the Federal Register on 

October 16, 1997, and NRC Management Directive 5.6, “Integrated Materials Performance 

Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary results of the review, 

which covered the period of June 16, 2011, to March 27, 2014, were discussed with New York 

managers on the last day of the review. 

A draft of this report was provided to New York for factual comment on April 30, 2014. New 

York responded to the findings and conclusions of the review by (1) e-mail dated May 14, 2014, 

from Sandra Hinkel, Chief, Radiation Control Permit Section, NYS Department of Environmental 

Conservation; (2) e-mail dated June 3, 2014, from Stephen Gavitt, Director, Bureau of 

Environmental Radiation Protection; and (3) letter dated June 4, 2014, Christopher Boyd, 

Assistant Commissioner, Bureau of Environmental Sciences and Engineering. Copies of the 

State’s responses are included as an Attachment to this report. A Management Review Board 

(MRB) met on August 4, 2014, to consider the proposed final report. The MRB found the New 

York Agreement State Program adequate to protect public health and safety and not compatible 

with the NRC’s program. 

The New York Agreement State Program (the 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 disposal 

of radioactive wastes in the ground. Organization charts for the three agencies are included as 

Appendix B. 

At the time of the review, the Program regulated 1,349 specific licenses authorizing possession 

and use of radioactive materials, and 30 permits for radioactive discharges and radioactive 

waste disposals 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. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the New York agencies on May 6, 2013. Each 

agency provided an electronic response to the questionnaire–DEC on February 12, 2014; DOH 

on March 7, 2014; and NYC on March 11, 2014. A copy of the respective questionnaire 

responses can be found in the NRC’s Agencywide Documents Access and Management 

System (ADAMS) using the Accession Numbers ML14070A275, ML14070A282, and 

ML14072A041. 
New York Final IMPEP Report Page 2 

The review team's general approach for conduct of this review consisted of (1) examination of 

the Program’s responses to the questionnaires, (2) review of applicable New York statutes and 

regulations, (3) analysis of quantitative information from the Program’s databases, (4) technical 

review of selected regulatory actions, (5) field accompaniments of 11 inspectors, and 

(6) interviews with staff and managers. The review team evaluated the information gathered 

against the established criteria for each common and the applicable non-common performance 

indicator and made a preliminary assessment of the Program’s performance. 

Section 2.0 of this report covers the State’s actions in response to recommendations made 

during previous reviews. Results of the current review of the common performance indicators 

are presented in Section 3.0. Section 4.0 details the results of the review of the applicable 

non-common performance indicators, and Section 5.0 summarizes the review team's findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on June 16, 2011, the review team made 

six recommendations regarding the New York’s Agreement State Program’s performance. The 

status of the recommendations is as follows: 

Recommendation 1: “The review team recommended that DOH develop and implement a 

process to track reciprocity inspections to ensure at least 20 percent of candidate licensees for 

reciprocity are inspected. (Section 3.2)” 

Status: Since the June 2011 IMPEP, DOH implemented the use of a tracking system which 

allows for tracking and completion of reciprocity inspections. The review of New York DOH 

reciprocity records confirmed an electronic tracking system was developed which allows for 

tracking completion of reciprocity inspections. Staff was able to provide printout lists of 

reciprocity inspections with correlating data for the entire review period showing that the DOH 

performed inspections of at least 20 percent of the candidate licensees for reciprocity. This 

recommendation is closed. 

Recommendation 2: “The review team recommended that DOH develop comprehensive 

incident response and allegation procedures, and ensure that reportable incidents are reported 

to the NRC Operations Center in accordance with the timelines identified in FSME Procedure 

SA-300. (Section 3.5)” 

Status: Based on a review of the DOH incident and allegation procedures, the review team 

determined that DOH developed comprehensive incident response and allegation procedures 

which include the event reporting timelines identified in SA-300. In addition, based on a review 

of selected NMED casework, the review team determined that DOH is reporting incidents to the 

NRC Operations Center in accordance with the timelines identified in SA-300. This 

recommendation is closed. 

Recommendation 3: “The 2006 IMPEP review team recommended that DOH, NYC, DEC 

develop and implement an action plan to adopt NRC regulations in accordance with the current 

NRC policy on adequacy and compatibility. (Open recommendation from the 2006 and 2011 

IMPEP reviews).” 
New York Final IMPEP Report Page 3 

Status: The team determined that each agency developed and implemented an action plan to 

adopt the NRC regulations in accordance with current NRC policies on adequacy and 

compatibility. Each NY agency had developed and implemented an action plan as directed by 

the recommendation. 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 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 

NRC’s effective date. This recommendation is closed. 

Recommendation 4: “The review team recommended that NYC respond to each incident 

received in accordance with its established Incident Response Procedure. (Section 3.5)” 

Status: Since the 2011 IMPEP review, NYC revised its Incident Response Procedure and has 

trained the staff on the contents of the revised procedure. Program managers reminded the 

staff to follow the established protocol for medical events reported to NYC and to follow the 

proper sequence of events to close out all incidents reported to NYC. Based on a review of 

selected casework files, the review team determined that NYC responded to each incident 

received in accordance with its established Incident Response Procedure. This 

recommendation is closed. 

Recommendation 5: “The review team recommended that NYC modify its Incident Response 

Procedure to add timely notifications to the NRC Operations Center in accordance with the 

timelines identified in SA-300. (Section 3.5)” 

Status: The NYC manager stated that program staff was made aware of and instructed to 

review the reporting requirements as listed in SA-300. The Incident Response Procedure was 

modified to add the requirement for timely notifications. Based on a review of the NYC Incident 

Response Procedure, the review team determined that the procedure has been updated to 

include information on timely notifications to the NRC Operations Center in accordance with the 

timelines identified in SA-300. This recommendation is closed 

Recommendation 6: “The review team recommended that NYC evaluate all incident statistical 

information received from licensees, both retrospectively and prospectively, and follow up in a 

manner to ensure that each incident is properly evaluated for health, safety, and security 

implications. (Section 3.5)” 

Status: During the 2011 IMPEP review, NYC performed the retrospective review of the incident 

statistical information received from licensees. Twelve medical events were identified, two of 

which were initially determined to be reportable to the NRC. The NYC reported these events to 

the NRC on June 15, 2011. Subsequent to the 2011 IMPEP review, NYC determined that one 

of the two events reported to the NRC was actually not reportable. Based on a review of 

selected casework and discussions with NYC inspection staff, the review team determined that 

NYC evaluates each incident for health, safety and security implications and follows up in an 

appropriate manner. This recommendation is closed. 

 
New York Final IMPEP Report Page 4 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review 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 of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include staffing level and staff turnover, as well 

as the technical qualifications and training histories of the staff for each of the New York 

agencies. To evaluate these issues, the review team examined the respective agency’s 

response to the IMPEP questionnaire relative to the indicator, interviewed management and 

staff, reviewed job descriptions and training records, and considered any workload backlogs. 

The NYC radioactive materials program is administered by the Office of Radiological Health 

(ORH) which is staffed by the Office Director, the Unit Chief, and six technical staff members 

totaling 5.4 full-time equivalents (FTE). Over the review period, there were three vacancies, the 

Office Director position and two technical staff positions. Since the retirement of the Office 

Director in the fall of 2013, management of the ORH is being conducted by the Assistant 

Commissioner of Environmental Sciences and Engineering until a replacement is hired. The 

ORH has interviewed candidates for the vacancies and has extended offers of employment for 

the Director position and one technical position. During the review period, one technical 

position was eliminated. Subsequent to the onsite review, an offer was accepted for the 

Director’s position and one technical staff position. The new Office Director started in June 

2014. The new technical staff member has a background in radiation producing equipment and 

will allow the two current Radiation Scientist II staff to be cross-trained to perform material 

inspections and licensing to focus more of their effort on those activities and complete the 

training after a dedicated mentoring period. This will assist the agency in addressing the loss of 

three long-term staff that supported the radioactive materials program. 

At the time of the review, the materials inspectors were fully qualified, and the license reviewers 

were fully qualified and have full signatory authority for licensing actions. The ORH, however, 

provides cross qualification training to its X-ray inspectors to best leverage resources. Currently 

two x-ray inspectors are working on materials qualifications for inspection and licensing. Since 

the 2011 IMPEP, the NYC staff has attended NRC technical training courses, which is an 

improvement over the previous review period. 

The ORH requires a bachelor’s degree in engineering, physical, or biological sciences for all 

technical positions. NYC has written qualifications requirements which include the minimum 

casework reviews and training courses for full qualification. The review team discussed with 

NYC managers the need to fully document its technical staff’s training qualifications, i.e. course 

and casework completion dates and management sign-off. 

The DEC Radiation Program Staff consists of two branches, the Radiation Control Permit 

Section and the Radiological Sites Section which totals 7.8 FTE for Agreement State work. 

There are two vacancies in the Radiological Sites Section, one of which was eliminated during 

the review period. The DEC and DOH both face difficulties in hiring due to State budget 
New York Final IMPEP Report Page 5 

constraints and a hiring freeze. Positions are often eliminated once they are vacated. The 

agency is required to request a waiver in order to fill vacancies. The waiver process is lengthy, 

and requires approval through multiple State offices. The team determined that DEC staff is 

balanced between permitting and inspection functions. The DEC maintains a Radiation 

Program Staff Training Requirements which are consistent with the NRC requirements for 

training and qualification. With the exception of one person, all DEC staff are fully qualified. 

There is management support for staff training and qualification. The DEC has one field 

inspector located in the Buffalo office. Since the employee is not yet qualified, the section chief 

for the Radiological Sites Section is performing field work at the West Valley site until this 

employee is fully qualified and can inspect independently. Travel logistics and State travel 

restrictions make it difficult for this employee to travel to the Albany central office for training. 

The DOH radioactive materials program is administered by the Bureau of Environmental 

Radiation Protection and consists of the Office Director, the Environmental Radon/Emergency 

Response Section, the Radioactive Materials Section, the Radiation Equipment/X-ray Section, 

and the Inspection and Enforcement Section. Currently, there are 11.9 FTE that support the 

radioactive materials program. There are four DOH Regions. In the Western Region, there is 

one staff member in Buffalo and one in Rochester. In the Central region, there are two staff 

members in Syracuse. On Long Island, there are two staff members, and in New York City, 

there are two staff. There are currently three vacancies in the Radioactive Materials Program 

including the Chief, Radioactive Materials Section and two Associate Radiological Health 

Specialists. These positions were vacated during the review period. Additional vacancies also 

exist in the other sections of the Bureau of Environmental Radiation Protection. Since the last 

IMPEP, DOH has requested eight waivers to fill vacancies from the last review period. Four 

positions were approved and DOH hired two trainees, one experienced Radiation Health 

Specialist, and promoted one individual. 

The DOH has a documented training plan for technical staff that is consistent with the 

requirements in the NRC’s formal qualification and training procedure. The DOH also has 

on-the-job training to supplement course work so that individuals may broaden their work 

experience. All technical staff has at minimum, Bachelor’s degrees in the sciences. Staff 

members are assigned increasingly complex duties as they progress through the qualification 

process. Licensing training and qualification is implemented by a mentoring program with a 

senior staff person leading the group and assigning licensing actions in accordance with their 

expertise and complexity of the action. 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. This system appears rigorous and 

thorough in hiring competent staff. The review team concluded that the Program’s training 

program is adequate to carry out its regulatory duties and noted that Program management is 

supportive of staff training opportunities. 

The review team observed backlogs in licensing actions and inspection reporting as detailed in 

Sections 3.3 and 3.4 of the report. These backlogs have increased over the prior review period. 

The review team found no instances where the backlogs compromised health, safety and 

security, but the review team determined that insufficient staffing levels attributed to the 

increasing backlogs. Both the DOH and DEC have managed their chronic staffing shortages. 

Given the restricted hiring and waiver process for New York State agencies, coupled with a 
New York Final IMPEP Report Page 6 

lengthy training and qualification process for technical staff, the review team is concerned that 

any additional losses in staff could severely impact both DOH and DEC’s performance. 

Based on the review team’s assessment of the technical staffing and training process for the 

NYC, and taking into consideration that NYC has new hires and other staff undergoing the 

training process, the review team determined that NYC should memorialize its training 

qualifications program. The review team made two recommendations: The review team 

recommended that the NYC update its training qualification program to be consistent with IMC 

1248, “Formal Qualification Program for Federal and State Material and Environmental 

Management Programs,” and apply this program to all technical staff currently going through the 

qualification process and all new staff that are hired. Second, the review team recommended 

that DOH and DEC should develop and implement a strategy to address current and future 

staffing vacancies in order to maintain the effectiveness and efficiency of the Program. The 

MRB discussed the recommendations and directed that the recommendations be combined and 

revised as follows: 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 staff’s qualifications. 

Based upon the IMPEP evaluation criteria, the review team recommended, and the MRB 

agreed, that New York’s performance with respect to this indicator, Technical Staffing and 

Training, be found satisfactory, but needs improvement. 

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Program’s responses to the questionnaire relative to this indicator, data gathered from 

agency databases, examination of completed inspection casework, and interviews with 

management and staff for each agency. 

The review team verified that New York’s inspection frequencies for all types of radioactive 

material licenses are as frequent or more frequent as similar license types listed in Inspection 

Manual Chapter (IMC) 2800, “Materials Inspection Program.” The review team confirmed that 

Increased Control inspections are conducted in conjunction with routine health and safety 

inspections. 

The Program conducted 388 Priority 1, 2, and 3 inspections during the review period, based on 

the inspection frequencies established in IMC 2800. Only four of these inspections were 

conducted overdue by more than 25 percent of the inspection frequency prescribed in IMC 

2800. In addition, the Program performed 108 initial inspections during the review period. 

Thirteen of the initial inspections were conducted overdue. As required by IMC 2800, initial 

inspections should be conducted within 12 months of license issuance. The team discussed the 

late initial inspections with the DOH inspection manager and determined the causes were due to 

lack of resources and travel restrictions for the DOH agency. The Program is cross training 

x-ray and materials inspectors to improve efficiency. Overall, the review team calculated that 

the Program performed 3.3 percent of its inspections overdue during the review period. 
New York Final IMPEP Report Page 7 

The review team evaluated the Program’s timeliness in providing inspection findings to 

licensees. A review of the Program’s database printouts indicated 79 out of 281 (28 percent) 

inspection reports were communicated to the licensees beyond the Program’s goal of 30 days 

after the inspection. Nearly all (78) of the late inspections reports were observed in the DOH 

agency. The review team noted that the inspection reports issued beyond 30 days is an 

increase over the 20 percent of inspection reports issued beyond 30 days from the 2011 IMPEP 

review. The team discussed the late inspections reports with the inspection manager and 

determined the primary cause is attributed to late transmittal of compliance letters by the 

inspectors. In 2014, DOH implemented a monthly inspection reporting QA process that requires 

each inspector to submit a report listing the inspections performed and their status to materials 

management. The DOH also conducts a conference call every other week to discuss issues, 

unusual observations, and inspection findings. 

During the review period, the Program granted 164 reciprocity permits, 34 of which were 

inspected. The review team determined that the Program met the NRC’s criteria of inspecting 

20 percent of candidate licensees operating under reciprocity in each year of the review period. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that New York’s performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated inspection reports, enforcement documentation, inspection field 

notes, and interviewed inspectors for 35 radioactive materials inspections (DOH-14, NYC-13, 

DEC-8), 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 institutions, medical institutions with written 

directives including unsealed radioiodine therapy, high dose rate remote afterloader therapy, 

permanent or temporary implant brachytherapy, and gamma knife therapy, medical institutions 

without written directives, portable gauge, industrial radiography, panoramic and self-shielded 

irradiators, nuclear pharmacy, and increased security controls for radioactive materials 

quantities of concern (Increased Controls). Appendix C lists the inspection casework files 

reviewed, with case-specific comments, as well as the results of the inspector accompaniments. 

Based on the evaluation of casework, the review team noted that inspections covered all 

aspects of the licensee’s radiation safety programs. The review team found that inspection 

reports were thorough, complete, consistent, and of high quality, with sufficient documentation 

to ensure that a licensee’s performance with respect to health and safety 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. The Program issued to the licensee, either a letter indicating a clear 

inspection or a Notice of Violation (NOV), in letter format or as an attachment, which detailed 

the results of the inspection. When the Program issued an NOV, the licensee was required to 

provide a written response with corrective actions for the violations cited within 30 days. The 

review team also noted that reports and findings were reviewed by Program managers 
New York Final IMPEP Report Page 8 

The inspection procedures and techniques utilized by the Program were evaluated by the 

review 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 procedures manuals and/or inspection checklists. 

The review team determined that Program Increased Controls security inspection files were 

stored in a secure location. The inspection files were marked as containing sensitive 

information or withhold from the public. The review team noted that NYC agency does not mark 

its files folders as containing security-related information; however, inspection checklists for 

Increased Controls inspections, containing sensitive security information, are marked to be 

withheld from the public. 

The review team accompanied 11 Program inspectors (DOH-6, NYC-3, and DEC-2) during the 

periods of July 16 to August 30, 2013. The inspectors were accompanied during health and 

safety inspections of medical institutions with the following uses: written directives including 

unsealed radioiodine therapy, high dose rate remote afterloader therapy, permanent or 

temporary implant brachytherapy, and gamma knife therapy. Other accompaniments included 

medical institutions without written directives, industrial radiography, Increased Controls, and 

disposal site and discharge permittees. The accompaniments are identified in Appendix C. 

During the accompaniments, the inspectors demonstrated appropriate inspection techniques, 

knowledge of the regulations, and conducted performance-based inspections. The inspectors 

were trained, well-prepared for the inspection, 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 and safety and 

security at the licensed facilities. 

The review team noted that the Program has a policy of performing annual supervisory 

accompaniments of each inspector. Based on a review of records provide by each agency, the 

review team concluded that each inspector was accompanied by their supervisor at least once a 

year during the review period for the NYC and DEC agencies. The team noted that only 7 of 18 

staff in the DOH program were accompanied in calendar year 2012, and 12 of 18 in calendar 

year 2013. The DOH self-identified this issue and DOH inspection management developed an 

accompaniment checklist, implemented discussing the accompaniment status at monthly 

supervisor meetings, and added inspector accompaniments to supervisor performance 

appraisal plans. 

The review team noted that the Program has an ample supply of radiation survey instruments 

such as Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, micro-R meters, and 

neutron detectors to support its inspection program. The Program also had portable 

multi-channel analyzers located in offices across the State 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. The Program uses databases to track 

each instrument, its current location, and next calibration date. The portable instruments used 

during the inspector accompaniments were operational and calibrated. 
New York Final IMPEP Report Page 9 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that the State of New York’s performance with respect to the indicator, Technical Quality of 

Inspections, be found satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

30 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

proper radioisotopes and quantities, qualifications of authorized users, adequacy of facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for timeliness, use of appropriate deficiency letters and cover 

letters, reference to appropriate regulations, supporting documentation, consideration of 

enforcement history, pre-licensing visits, peer/supervisory review, and proper signatures. 

The licensing casework was selected to provide a representative sample of licensing actions 

completed by the Program during the review period. Licensing actions selected for evaluation 

included 4 new licenses, 3 renewals, 1 decommissioning, 5 termination actions, 1 financial 

assurance, 12 amendments, and 4 permits. Files reviewed included a cross-section of license 

types: industrial radiography, medical diagnostic, medical therapy including permanent implant 

brachytherapy and stereotactic radiosurgery, nuclear pharmacy, and broad scope licensees. 

The casework sample represented work from thirteen license reviewers (DOH-7, NYC-2, 

DEC-4). The casework for the DEC permit reviewers is presented in Section 4.3.3. A list of the 

licensing casework evaluated with case-specific comments is provided in Appendix D. 

Licensing actions are all tracked via Program databases. Licensing actions are received by the 

Program via mail, fax, or electronic mail. Licensing actions are assigned to a reviewer and 

subsequently updated in the Program’s databases with the status and assignment of the 

licensing action. The licensing staff uses formal correspondence for technical notices or 

deficiencies. Routinely staff used electronic mail and phone calls to follow up with deficiency 

notices. Licenses are issued for a 10 year period under a timely renewal system. In NYC all 

license reviewers have signature authority for licensing actions. In DOH, the Radioactive 

Materials Section Chief has signature authority, and performs a technical and supervisory 

review on all licensing actions before issuance to the licensee. The DOH Bureau Director and 

Assistant Director also have signature authority for licensing actions. 

The DOH enters licensing information into a primary database upon receipt, but requires the 

original documents from the licensee before a license action is approved. The licensing 

manager performs a preliminary review of the actions and assigns the licensing action in 

accordance with its complexity and modality. After the reviewer completes the review, the 

licensing manager performs a second technical and supervisory review on all licensing actions 

before issuance to the licensee. The administrative staff then process and dispatch signed 

licenses. At the time of the review there were 92 licensing actions (52 renewals and 40 

amendments) waiting to be reviewed and signed by the licensing manager. There was a 

backlog of 29 amendments, and 187 renewal requests greater than one year at the time of the 

review. The review team noted that the number of renewal requests greater than one year is an 

increase over the 73 renewals in backlog noted during the 2011 IMPEP review. The DOH 

indicated that the licensing actions in backlog are triaged for priority. The review team noted the 
New York Final IMPEP Report Page 10 

administrative process creates a constraint on the issuance of licensing actions and increasing 

backlog is cause for concern. 

The review team evaluated the Program’s application of the financial assurance requirements. 

The review team verified that the proper financial assurance documentation was on file and that 

the information was appropriately protected. 

The review team assessed the Program’s implementation of pre-licensing guidance. The 

review team found that the casework reviewed, including four new licenses and two change of 

ownership requests, had the documentation to support a basis of confidence that the radioactive 

material would be used as requested. 

The review team examined the Program’s licensing practices in regard to requests for risk 

significant radioactive materials (i.e. Increased Controls and Fingerprinting Orders). The review 

team determined that the Program has a licensing procedure to identify new and amended 

licenses that should be subject to additional security measures. While the Program did not 

always document this process, the team did not identify any new or amended licenses that were 

missing the required license conditions and concluded that the Program added legally binding 

license conditions to the licenses that met the criteria for Increased Controls, including 

fingerprinting, as appropriate. 

The review team found that the licensing actions from DOH were 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. Follow up requests were fully documented in the license files. Deficiency letters clearly 

stated regulatory positions, were used at the proper time, and identified substantive deficiencies 

in the licensees’ documents. Terminated licensing actions were well documented, showing 

appropriate transfer and survey records. License reviewers use licensing guides and/or NRC 

NUREG-1556 series guidance documents, policies, checklists, and standard license conditions 

specific to the type of licensing actions to ensure consistency in licenses, and review 

enforcement history during the license renewal process. 

The review team identified a few licensing actions from NYC which had incomplete evaluations 

of health and safety issues and a lack of technical quality (see Appendix D). The review team 

determined that NYC did not review the licensee’s enforcement history during the license 

renewal process in two cases reviewed. Since there have been staff losses during the review 

period and considering the NYC’s cross training initiative, the review team expressed to current 

staff that license renewals are opportunities for the staff to review the licensee’s history and to 

evaluate the historical licensing and inspection documentation and to perform a quality 

assurance assessment of the license file. In one instance, a case for a terminated license was 

reviewed; however, the licensing case file did not contain any supporting documentation 

regarding the termination. In another case, applicable and current guidance were not adhered 

to for a license renewal request from a veterinary clinic. The review did not identify that the 

renewal application lacked all the radiation safety program procedures that should have been 

added as tie-down conditions. The review also identified two instances where licensing actions 

for NYC medical use licensees were authorized with incomplete documentation of the training 

and experience of a Radiation Safety Officer. 
New York Final IMPEP Report Page 11 

Since the last review, the team observed that NYC had implemented the use of the checklists 

from the NUREG -1556 series as well as the pre-licensing guidance. However, the review 

team found that license reviewers identified deficiencies in applications, but documentation of 

the resolution of addressed deficiencies was not found in the files. In addition, license 

reviewers accept the use of older and superseded licensing guidance by applicants. The 

review team discussed, with the NYC management and staff, the importance of fully 

documenting licensees’ responses to license application deficiencies, noting that a complete 

and well documented licensing action assists the inspectors and demonstrates the steps taken 

by the license reviewer and the licensee, in order to issue an amended license. 

The review team discussed the identified licensing deficiencies with NYC management and 

suggested additional technical licensing training for the NYC staff as an adjunct to any 

licensing training already received. 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 New York City’s equivalent to 10 CFR Parts 30, 33, and 35, and applicable licensing 

guidance documents and license conditions, and (2) take measures to ensure that the NYC’s 

review of licensing actions are complete and well-documented. 

Based on the IMPEP evaluation criteria, the review team recommended that New York’s 

performance with respect to the indicator, Technical Quality of Licensing Actions, be found 

satisfactory, but needs improvement. The IMPEP team based its recommendation on the 

observation that some licensing actions did not fully address health and safety concerns and 

there were repeated problems with thoroughness, completeness, consistency, technical quality, 

and adherence to existing guidance in licensing actions. The MRB acknowledged the IMPEP 

team’s findings, yet concluded that New York’s performance with respect to the indicator, 

Technical Quality of Licensing Actions, be found satisfactory. The MRB found that licensing 

issues presented by the IMPEP team were central to the NYC agency and not reflective of the 

entire Program; some of the licensing weaknesses observed during the onsite review were 

resolved during the MRB meeting and were attributed to staff training which the MRB believed 

would be resolved with the new performance recommendations made under the indicators, 

Technical Staffing and Training, and Technical Quality of Licensing Actions. The MRB also took 

into consideration that the NYC agency had made some improvements in licensing since the 

last review with the incorporation of pre-licensing guidance and use of the NUREG-1556 series 

licensing guidance. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Program’s actions in responding to incidents and 

allegations, the review team examined the Program’s responses to the questionnaire relative to 

this indicator, evaluated selected incidents reported for New York in the Nuclear Material Events 

Database (NMED) against those contained in the Program’s files, and evaluated the casework 

for radioactive materials incidents. A list of the incident casework examined, with case-specific 

comments, may be found in Appendix E. The review team also evaluated the Program’s 

response to allegations involving radioactive materials, including allegations transferred to New 

York by the NRC during the review period. 
New York Final IMPEP Report Page 12 

The review team examined the Program’s implementation of its incident and allegation 

processes, including written procedures for handling allegations and incident response, file 

documentation, notification of incidents to the NRC Headquarters Operations Center, and the 

use of NMED software. When notification of an incident or an allegation is received, the 

Program’s managers review the event information and determine the appropriate level of initial 

response. 

The review team identified a total of 105 incidents that were reported to the Program during the 

review period. The review team identified 32 radioactive material incidents in NMED for New 

York (DOH-23, NYC-9, and DEC-0) which were reported during the review period. Nine of the 

reported incidents involved events which had occurred during the previous IMPEP review period 

and were not reported to the NRC as required. These incidents were subsequently reported to 

the NRC within two weeks of the end of the 2011 IMPEP review. The review team evaluated 

the casework for eight non-reportable incidents for New York and determined that the events 

were correctly categorized as non-reportable by the Program. 

The 13 reported incidents selected for review included the following categories: lost/stolen 

radioactive material, potential overexposure, medical event, and/or damaged equipment. The 

review team determined that the Program’s response to incidents was complete and 

comprehensive. Initial responses were prompt and well-coordinated, and the level of effort was 

commensurate with the health and safety significance. The Program dispatched inspectors for 

on-site investigations in seven of the cases reviewed and took suitable enforcement and 

follow-up actions. If the incident met the reporting thresholds, as established in the Office of 

Federal and State Materials and Environmental Management Programs (FSME) Procedure 

SA-300 “Reporting Material Events,” the State notified the NRC Headquarters Operations 

Center and entered the information into NMED, in a prompt manner with the exception of two 

incidents which were reported to NRC approximately 2 months late. In addition, the review 

team identified one medical event for the NYC agency which had not been reported to the NRC 

and appeared to meet the NRC reporting requirements. After discussions between the review 

team and the NYC Radioactive Materials Chief, the NYC agency indicated that NYC will review 

the event and report the information to NRC if it determines that the event meets the NRC 

reporting criteria. 

In evaluating the effectiveness of the Program's response to allegations, the review team 

evaluated the completed casework for 12 allegations (DOH-6, NYC-5, and DEC-1) including 

7 that the NRC transferred to New York during the review period. The review team concluded 

that the Program took prompt and appropriate actions in response to concerns raised. The 

review team noted that the Program documented the investigations of concerns and retained all 

necessary documentation to appropriately close the allegations. The Program notified the 

concerned individuals of the conclusion of its investigations. The review team determined that 

the Program adequately protected the identity of concerned individuals. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that New York’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

 
New York Final IMPEP Report Page 13 

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 Evaluation Program, 

(3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The 

NRC’s Agreement with New York does not relinquish regulatory authority for a uranium recovery 

program; therefore, only three non-common performance indicators applied to this review. 

4.1 Compatibility Requirements

4.1.1 Legislation

New York became an Agreement State on October 15, 1962. There are three separate 

agencies regulating ionizing radiation in the State of New York: NYC, DOH, and DEC. The 

legislative authority for NYC’s portion of the Agreement State program is granted in Chapter 22 

of the New York City Charter, specifically Section 556(s). The NYC regulatory authority is 

delegated from DOH under Part 16 of the New York State Health Code which provides for 

delegation to local governments when covering greater than two million individuals. 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. 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 and manifesting of Low-Level Radioactive Waste (LLRW) shipments into, within, 

and through New York State. The DEC’s regulatory adoption process takes approximately two 

years to complete if there are no mitigating factors. 

The agencies reported to the IMPEP team that no legislation affecting the radiation control 

programs was passed during the review period. 

4.1.2 Program Elements Required for Compatibility 

The review team evaluated New York’s response to the questionnaire relative to this indicator, 

reviewed the status of regulations required to be adopted by the State under the Commission’s 

adequacy and compatibility policy, and verified the adoption of regulations with data obtained 

from the State Regulation Status Sheet (SRS) that FSME maintains. Interviews were 

conducted with staff, and files were reviewed to confirm the use of license conditions in lieu of 

regulations. The review team found that New York provides the opportunity for public comment 

during the regulatory adoption process. The regulations are not subject to sunset provisions. 

Both the DOH and DEC regulatory adoption processes take approximately two years to 

complete if there are no mitigating factors. The NYC regulatory promulgation process takes 

approximately one year to complete depending on the complexity of the rule. 

During the review period, the Program made progress in adopting overdue rules. There were 

31 rules overdue for adoption (DOH–13, NYC–12, DEC–6) at the start of the review period. 

Appendix F summarizes the status of each NRC amendment (e.g., Regulation Amendment 
New York Final IMPEP Report Page 14 

Tracking System (RATS) identification number for each New York agency in the Program for the 

current IMPEP review period). The Program submitted 20 rule packages as final rules (13 

regulation amendments, 3 legally binding license conditions, and 4 partial regulation 

amendments) to the NRC for a compatibility review. Current NRC policy requires that 

Agreement States adopt certain equivalent regulations or legally-binding requirements no later 

than 3 years after they become effective. All of the final rules were several years overdue for 

adoption at the time they were submitted. The NRC’s compatibility review resulted in nine final 

rules (DOH–3, NYC–6, DEC–0) with comments that identified corrections needed in order to 

fully address the compatibility designations of these final rules. These comments need to be 

addressed by the Program in upcoming rulemaking activities to avoid gaps, conflicts, and 

duplications between New York’s regulations and other regulatory programs nationally. 

Furthermore, from the SRS sheet for each agency, the IMPEP team observed there are 10 

outstanding comment letters (DOH–5, NYC–4, DEC-1) from prior IMPEP review periods that still 

need to be addressed. At the time of this review, there were nine NRC amendments overdue 

for adoption, and six final regulations adopted by the Program with unresolved comments 

(Appendix F). 

The 2006 and 2011 IMPEP review teams recommended that DOH, NYC, DEC develop and 

implement an action plan to adopt NRC regulations in accordance with the current NRC policy 

on adequacy and compatibility. The IMPEP team determined each agency had developed and 

implemented an action plan as directed by the recommendation. 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 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 NRC’s effective date and recommended 

closing the recommendation. The MRB agreed; however, the MRB directed the team open a 

new recommendation to address the Program’s continued backlog of overdue regulations in 

order to be compatible with the NRC’s program. 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. 

A complete list of regulation amendments can be found on the NRC website at the following 

address: http://nrc-stp.ornl.gov/rss_regamendents.html. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that New York’s performance with respect to the indicator, Compatibility Requirements, be 

found unsatisfactory. 

4.2 Sealed Source and Device Evaluation Program

The regulatory responsibility for the Sealed Source and Device (SS&D) Evaluation Program 

resides with DOH. In reviewing this indicator, the review team used three sub-elements to 

evaluate DOH’s performance regarding the SSD Evaluation Program. These sub-elements 

were (1) Technical Staffing and Training, (2) Technical Quality of the Product Evaluation 

Program, and (3) Evaluation of Defects and Incidents Regarding SS&Ds. 
New York Final IMPEP Report Page 15 

In assessing the DOH SS&D evaluation activities, the review team examined the information 

provided in response to the IMPEP questionnaire and evaluated the SS&D registry sheets and 

supporting documents processed during the review period. The team also evaluated SS&D 

staff training, the use of guidance documents and procedures, and interviewed the staff and 

management involved in SS&D evaluations. 

4.2.1. Technical Staffing and Training

The SS&D safety evaluation responsibilities are distributed between two reviewers. Both 

reviewers have attended the NRC SS&D Workshop. The DOH does not have a formal SS&D 

qualification program. The DOH has used on-the-job training for new reviewers with oversight 

from the qualified SS&D reviewers. The DOH also does not have a set number of reviews to be 

conducted by each individual prior to being considered qualified to independently perform 

reviews. This is primarily due to the infrequent SS&D applications or amendment requests. 

The review team interviewed the reviewers and found them to be familiar with the SS&D safety 

evaluation process, as well as guidance and reference documents. The review team 

determined that the reviewers are qualified to review and sign SS&D registrations and that the 

DOH has a sufficient number of qualified reviewers to adequately handle the workload. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, DOH processed one SS&D action. The action was an ownership 

change and the addition of a new device. There were no inactivations of SS&D registrations or 

emerging technology evaluations processed during the review period. The review team 

evaluated the action processed during the review period. The SS&D certificate evaluated by the 

review team may be found in Appendix G. 

The casework review indicated that staff followed NRC guidance during the review process to 

ensure that licensees submit the information necessary to support the product. The tie-down 

conditions on the certificates were stated clearly and are enforceable. Deficiency letters clearly 

stated regulatory positions and were used at the appropriate time. A concurrence review was 

performed by a second SS&D qualified reviewer. 

In assessing the DOH’s SS&D evaluation activities, the review team examined information 

contained in the questionnaire response and interviewed program staff and managers. The 

review team confirmed that the DOH follows the recommended guidance from the NRC SS&D 

Workshop, NUREG-1556 Series Guidance, applicable and pertinent American National 

Standards Institute (ANSI) standards and Military Standards, ISO-9001 and NY regulations, 

statutes, policies and procedures. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The DOH was not aware of any defects or incidents involving sources and devices evaluated by 

the agency. The review team confirmed the lack of defects or incidents by a search of NMED 

and case files. 
New York Final IMPEP Report Page 16 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that New York’s performance with respect to the indicator, Sealed Source and Device 

Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste Disposal Program 

In reviewing this indicator, the review team used five sub-elements to evaluate New York’s 

performance regarding the low-level radioactive waste (LLRW) disposal program. These 

sub-elements were (1) Technical Staffing and Training, (2) Status of LLRW Disposal Inspection, 

(3) Technical Quality of Inspections, (4) Technical Quality of Licensing Actions, and (5) 

Technical Quality of Incident and Allegation Activities. Performance of the Technical Staffing 

and Training and Technical Quality of Incident and Allegation Activities sub-elements are 

included in the discussions of the respective common performance indicators in sections 3.1 

and 3.5. 

New York has two former radioactive waste disposal sites: the State-licensed Disposal Area 

(SDA) on the Western New York Nuclear Service Center at West Valley (West Valley site), and 

the University of Cornell Radiation Disposal Site (RDS) in Lansing. 

The SDA has been owned by the State of New York since its creation in 1963, and was 

operated by Nuclear Fuel Services from inception until they turned over control of the site to the 

New York State Energy Research and Development Authority (NYSERDA) in 1976. Disposal of 

radioactive wastes was originally authorized by DOH. In 1974, regulation of the site passed 

from DOH to the newly created DEC Radiation program. In 1975, DEC required the closure of 

the SDA due to uncontrolled leachate releases. At SDA, approximately 2.4 million cubic feet of 

waste received from various places such as nuclear power plants, government facilities, 

industries, waste brokers, decontamination companies, and the adjacent West Valley spent 

nuclear fuel reprocessing center were placed in 14 parallel disposal trenches capped with 

compacted native clay. With the exception of two smaller special purpose trenches, the 

trenches range from approximately 350 to nearly 700 feet in length and were approximately 33 

feet wide and 20 feet deep. In addition to the trenches, the SDA contains three excavated 

lagoons (now filled) which were formerly used to manage water pumped from the trenches 

during operation. 

Currently NYSERDA holds one Part 380 permit for the SDA from the DEC, which regulates 

monitoring and maintenance of the facility. The NYSERDA also holds a radioactive materials 

license from DOH for the SDA. 

Disposal operations at the Cornell RDS occurred between 1956 and 1978. The trenches cover 

an area roughly 290 by 300 feet in size. Wastes were buried in narrow trenches 6 to 12 feet 

deep. LLRW radioactive laboratory wastes were disposed of at the RDS, including scintillation 

solvents such as paradioxane. Cornell currently operates under a broad scope radioactive 

materials license from DOH. 

The RDS has been closed pursuant to a closure plan developed under a Consent Order issued 

by DEC. As part of the conditions of that Consent Order, Cornell operates a groundwater 

treatment system for the non-radioactive contaminants that collects and discharges minute 

amounts of radionuclides incidental to the non-radioactive treatment system. Those radioactive 
New York Final IMPEP Report Page 17 

discharges are regulated by a substantive Part 380 discharge permit. The DEC plans to issue a 

substantive Part 380 permit for ongoing monitoring and maintenance of the RDS before the 

Consent Order is terminated. When the Consent Order is terminated, any substantive permits 

issued under the Order will convert to stand-alone Part 380 permits. 

4.3.1 Status of Low-level Radioactive Waste Disposal Inspection Program 

The review team focused on three factors while reviewing this sub-element. These include the 

inspection frequency, overdue inspections or any deviations from the schedule, and timely 

dispatch of inspection findings to the permittee. The review team’s evaluation was based on the 

DEC’s questionnaire response relative to this indicator, examination of inspection casework, 

and interviews with management and staff. 

The DEC has a one year inspection frequencies at West Valley and the Cornell sites. The 

review team confirmed that DEC inspected both sites annually. They also inspected the West 

Valley site annually for a special inspection which focused on obtaining environmental samples. 

The DEC inspected the West Valley site four times during the review period of June 17, 2011, to 

March 28, 2013. West Valley was inspected November 2011, August 2012, May 2013, and 

November 2013. Cornell was inspected December 2011, November 2012, and January 2014. 

The December 2011 inspection was beyond the year plus 3 months mark as the last inspection 

was performed July 2010. The DEC has maintained the inspection frequency since this 

variance. 

The review team determined that the inspection findings for the LLRW disposal program were 

typically communicated by formal correspondence to the permittee within 30 days following the 

inspection. 

4.3.2 Technical Quality of Inspections 

The review team assessed the quality of LLRW disposal program inspections by evaluating 

inspector performance during the accompaniments and reviewing inspection field notes, 

completed reports, inspection procedures and the staff’s follow-up to previous inspection 

findings, as well as regulatory actions taken and annual supervisory accompaniments. 

On August 13 and 14, 2013, one review team member accompanied two inspectors at the 

West Valley facility, as indicated in Appendix C. The inspectors were well prepared and 

thorough during their limited review of the LLRW disposal site. Under the LLRW permit, site 

security, environmental monitoring, and facility posting were observed. Inspectors conducted 

proper entrance and exit interviews with permittee managers and safety staff. Inspectors also 

conducted interviews with non-supervisory site personnel during the course of the inspection 

to ascertain perspective on permittee commitment to safety and training. During the 

accompaniments, the inspectors demonstrated appropriate performance-based inspection 

techniques and knowledge of the regulations. The inspections were adequate to assess the 

safety and radiological hazards at the LLRW disposal facility. 

Based on an evaluation of five inspection files, the review team determined that the inspection 

reports were thorough, complete, consistent, and had sufficient documentation to ensure that 
New York Final IMPEP Report Page 18 

permittee’s performance with respect to health, safety and security were acceptable. The team 

determined that the inspectors had not been documenting inspection information about most of 

the security requirements on the West Valley site. Through interview, it was determined that the 

inspector had observed security practices but had not documented these observations. The 

inspection findings were well-founded, supported by regulations and were appropriately 

documented. Based on interviews and review of documentation, the review team concluded 

that the inspectors reviewed the previous inspection report and discussed past inspection 

findings with other inspectors and the Radiological Sites Section Chief, in preparation for an 

inspection. Inspectors followed-up on previous inspection findings during the subsequent 

inspection. 

Currently the Cornell inspection responsibility is assigned to an inspector from the Central 

Office. The Radiological Sites Section Chief is performing the inspections at the West Valley 

site until an individual in the Buffalo Office gains the experience at the site and then will perform 

the inspections. The individual is estimated to start independent inspections at the site in 2015 

which will allow the Section Chief to perform inspector accompaniments at West Valley. 

4.3.3 Technical Quality of Licensing Actions 

The team reviewed six permit actions that had been completed during the review period 

including an amendment and a renewal. A listing of the permitting casework reviewed can be 

found in Appendix D. 

The review team determined that the examined permitting actions were thorough, complete, 

consistent, and of acceptable technical quality. The license conditions, including the tie-down 

conditions, were clearly stated and supported by information contained in the file and 

enforceable. Many of the amendments were issued by a Letter Modification to the Permit. 

The review team reviewed the 2012 Annual Report Cornell University Radiation Disposal 

Site – Chemical Disposal Site of March 2013, which is a requirement of the permit. The team 

reviewed the Quarterly Report for the State-licensed Disposal Area and the 

NYSERDA – Maintained Areas of the Western New York, Nuclear Service Center (WNYNSC) 

dated July 1-Sepember 30, 2013, and the NYSERDA SDA at West Valley 2011 Annual Report, 

both are required by the permit. The review team found that health and safety issues were 

properly addressed as part of the licensing action. 

The review team concluded that the New York’s permitting process was thorough, complete, 

consistent, and of acceptable quality. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB 

agreed, that New York’s performance with respect to the indicator, Low-level Radioactive 

Waste Disposal Program, be found satisfactory. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, New York’s performance was found satisfactory for the 

indicators, Status of the Materials Inspection Program, Technical Quality of Inspections, 

Technical Quality of Licensing Actions, Technical Quality of Incidents and Allegations, SS&D 
New York Final IMPEP Report Page 19 

Evaluation Program, and LLRW Disposal Program. The indicator, Technical Staffing and 

Training, was found satisfactory, but needs improvement. The indicator, Compatibility 

Requirements was found unsatisfactory. These indicators remain unchanged from the previous 

IMPEP review. Progress has been made on the indicator, Compatibility Requirements, but the 

State has not yet addressed a number of outstanding NRC comments regarding earlier 

regulation packages. In addition, there are nine regulation amendments overdue for adoption 

by the Program. The indicator, Technical Quality of Incidents and Allegations Activities, 

improved from the last review. The IMPEP team recommended that Technical Quality of 

Licensing Actions be found satisfactory, but needs improvement. The MRB directed this 

indicator be found satisfactory since the issues were central to one agency and not reflective of 

overall program performance. Additionally, some of the examples of licensing weaknesses 

were resolved during the MRB meeting. 

The review team made three recommendations regarding program performance in technical 

staffing, quality of licensing, and compatibility requirements. The review team determined that 

the recommendations from the 2011 IMPEP review, regarding reciprocity inspections, 

development of an action plan to adopt NRC regulations, and incident reporting and incident 

procedures should be closed. 

Accordingly, the review team recommended, and the MRB agreed, that that the New York 

Agreement State Program is adequate to protect public health and safety and is not compatible 

with the NRC's program. Considering the progress the Program made under the indicator 

Technical Quality of Incident and Allegations Activities, where performance was improved from 

unsatisfactory to satisfactory during the review period, and the progress made in adopting 

several overdue rules, the review team recommended, and the MRB agreed, that the period of 

Heightened Oversight be discontinued and a period of Monitoring be initiated. The review team 

recommended, and the MRB agreed, that the next IMPEP review take place in approximately 4 

years. 

RECOMMENDATIONS 

1. 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 staff’s qualifications. 

(Section 3.1) 

2. 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 NYC’s equivalent to 10 

CFR Parts 30, 33, and 35, and applicable licensing guidance documents and license 

conditions, and (2) take measures to ensure that the NYC’s review of licensing actions 

are complete and well-documented. (Section 3.4) 

3. 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) 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B New York Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Regulation Status Review 

Appendix G Sealed Source and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Lisa Dimmick, FSME Team Leader, Compatibility (DOH, DEC, NYC) 

Donna Janda, RI Technical Quality Incidents and Allegations (DOH, 

DEC, NYC) 

 Inspector Accompaniments (DEC) 

Ken Lambert, RIII Technical Quality of Inspection Program (DOH and 

NYC) 

Lizette Roldan-Otero, RIV Technical Quality of Licensing (DOH and NYC) 

Joe O’Hara, FSME Staffing and Training (DOH, DEC, NYC) 

Jerry Bai, State of Florida Status of the Materials Inspection Program (DOH & 

NYC) 

Maria-Arribas-Colon, FSME Sealed Source & Device Program, (DOH) 

Dennis Lawyer, RI Low Level Waste Program (DEC) 

Anthony Gaines, RIV Inspector Accompaniments (DOH, NYC) 
APPENDIX B 

NEW YORK ORGANIZATION CHARTS 

ADAMS ACCESSION NO(S).: 

ML14119A153 – New York DOH 

ML14119A158 – New York City DHMH 

ML14070A270 – New York DEC 
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

New York City Department of Health and Mental Hygiene

File No.: 1 

Licensee: Rockefeller University License No.: 74-2989-02 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 8/20/12 Inspector: JL 

 Comment: The licensee’s response to the violations was not in the file. 

File No.: 2 

Licensee: Rentrop, K. Peter - M.D. License No.: 91-3262-01 

Inspection Type: Routine, unannounced Priority: 5 

Inspection Date: 3/14/13 Inspector: MR 

File No.: 3 

Licensee: Bergmann, Steven - M.D. License No.: 91-3379-01 

Inspection Type: Routine, unannounced Priority: 5 

Inspection Date: 1/4/13 Inspector: JL 

File No.: 4 

Licensee: Memorial Sloan Kettering License No.: 75-2968-01 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 6/19/13 Inspector: OA 

File No.: 5 

Licensee: Columbia Presbyterian Medical Center License No.: 75-2878-01 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 8/2/11 Inspector: EC 

 Comment: Inspection documentation issued to the licensee 48 days after the inspection. 

 

File No.: 6 

Licensee: New York Presbyterian Hospital License No.: 75-2960-04 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 7/16/12 Inspector: JL 

File No.: 7 

Licensee: Columbia Presbyterian Medical Center License No.: 93-2878-05 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 8/29/12 Inspector: OA 

 
File No.: 8 

Licensee: NYCHCC North Central Bronx Hospital License No.: 91-3211-01 

Inspection Type: Routine, unannounced Priority: 3 

Inspection Date: 2/21/12 Inspector: MR 

File No.: 9 

Licensee: Stevens, Ronald – M.D. License No.: 91-3467-01 

Inspection Type: Routine, unannounced Priority: 5 

Inspection Date: 1/10/14 Inspector: JL 

File No.: 10 

Licensee: University Hospital of Brooklyn at LICH License No.: 91-3501-01 

Inspection Type: Routine, unannounced Priority: 3 

Inspection Date: 8/18/11 Inspector: EC 

File No.: 11 

Licensee: Wyckoff Heights Hospital License No.: 91-2846-01 

Inspection Type: Routine, unannounced Priority: 3 

Inspection Date: 5/2/11 Inspector: JH 

File No.: 12 

Licensee: Rockefeller University License No.: 75-2989-01 

Inspection Type: Increased Controls, unannounced Priority: 2 

Inspection Date: 10/11/12 Inspector: MR 

File No.: 13 

Licensee: Memorial Sloan-Kettering Cancer Research Center License No.: 74-2968-01 and 02 

Inspection Type: Increased Controls, unannounced Priority: 2/3 

Inspection Date: 8/13/13 and 9/18/13 Inspector: MR 

New York State Department of Health

File No.: 14 

Licensee: North Shore University Hospital License No.: 1016 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 12/16-18/13 Inspector: CB 

File No.: 15 

Licensee: Columbia University License No.: 537-2 

Inspection Type: Routine, announced Priority: 3 

Inspection Date: 4/17/13 Inspector: CB 

File No.: 16 

Licensee: Entec Consultants, Inc. License No.: C2630 

Inspection Type: Routine, unannounced Priority: 1 

Inspection Date: 1/17 and 23 /13 Inspector: AC 

File No.: 17 

Licensee: Corning Hospital License No.: 421 
Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 12/7/11 Inspector: SK 

 Comment: Inspection documentation issued to the licensee 179 days after the 

inspection. 

File No.: 18 

Licensee: Westchester Medical Center License No.: 586 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 11/21/13 Inspector: JK 

File No.: 19 

Licensee: Steris Isomedix Services, Inc. License No.: C2583 

Inspection Type: Routine, unannounced Priority: 1 

Inspection Date: 12/16/11 Inspector: BK 

 Comment: Letter to licensee and inspection checklist were not in the file. 

File No.: 20 

Licensee: Cardinal Health License No.: C2364 

Inspection Type: Routine, unannounced Priority: 2 

Inspection Date: 12/13/13 Inspector: DG 

 Comment: Inspection documentation issued to the licensee 63 days after the inspection. 

File No.: 21 

Licensee: Rolex Watch USA, Inc. License No.: C0263 

Inspection Type: Routine, announced Priority: 2 

Inspection Date: 10/11/12 Inspector: BK 

File No.: 22 

Licensee: Dobbs Ferry Pavilion License No.: 2960 

Inspection Type: Routine, unannounced Priority: 1 

Inspection Date: 11/30/12 Inspector: DS 

File No.: 23 

Licensee: North Shore University Hospital at Plainview License No.: 1153 

Inspection Type: Routine, unannounced Priority: 3 

Inspection Date: 11/28/12 Inspector: MK 

 
File No.: 24 

Licensee: Eastern Testing & Inspection, Inc. License No.: C2438 

Inspection Type: Routine, unannounced Priority: 1 

Inspection Date: 12/15 and 22/11 Inspector: AB 

 Comment: Inspection documentation issued to the licensee 34 days after the inspection. 

File No.: 25 

Licensee: NYSERDA, West Valley License No.: C0382 

Inspection Type: Routine, announced Priority: 5 

Inspection Date: 06/15/11 Inspector: SK 

 Comment: Inspection documentation issued to the licensee 56 days after the inspection. 

File No.: 26 

Licensee: A.M.P. Radiation Oncology License No.: 5556 

Inspection Type: Initial, announced Priority: 5 

Inspection Date: 08/14/13 Inspector: CB 

File No.: 27 

Licensee: NCM USA Bronx, LLC License No.: C5496 

Inspection Type: Reactive, announced Priority: 2 

Inspection Date: 08/12 and 15/13 Inspector: MS 

New York State Department of Environmental Conservation

File No.: 28 

Permitee: New York State Energy Research and Permit No.: 9-0422-00011/00011 

 Development Authority (NYSERDA) 

Inspection Type: Special and Announced Priority: 1 

Inspection Date: 5/21-22/13 Inspector: DO 

File No.: 29 

Permitee: NYSERDA Permit No.: 9-0422-00011/00011 

Inspection Type: Routine and Announced Priority: 1 

Inspection Date: 8/13-14/13 Inspector: DO 

File No.: 30 

Permitee: NYSERDA Permit No.: 9-0422-00011/00011 

Inspection Type: Special and Announced Priority: 1 

Inspection Date: 11/20/13 Inspector: TR 

File No.: 31 

Permitee: Cornell University Permit No.: NA 

Inspection Type: Routine and Announced Priority: 1 

Inspection Date: 12/22/11 Inspector: DO 

File No.: 32 

Permitee: Cornell University Permit No.: NA 
Inspection Type: Routine and Announced Priority: 1 

Inspection Date: 10/27-28/12 Inspector: DO 

File No.: 33 

Permitee: Cardinal Health Nuclear Pharmacy Services Permit No.: 1-282402219/00001 

Inspection Type: Routine and Unannounced Priority: 3 

Inspection Date: 4/20/12 Inspector: AG 

File No.: 34 

Permitee: SUNY at Buffalo Permit No.: 9-1402-00680/00029 

Inspection Type: Routine and Unannounced Priority: 3 

Inspection Date: 8/28-29/13 Inspector: AG 

File No.: 35 

Permitee: NRD LLC Permit No.: 9-1446-0018/00001 

Inspection Type: Routine and Announced Priority: 3 

Inspection Date: 12/18-19/13 Inspector: JF 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

New York State Department of Health

Accompaniment No.: 1 

Licensee: Adirondack Diagnostic Imaging License No.: 3290 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/19/13 Inspector: DS 

Accompaniment No.: 2 

Licensee: St. Peter’s Health Partners, Medical Associates, P.C. License No.: 5565 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 8/20/13 Inspector: RS 

Accompaniment No.: 3 

Licensee: Cardiology Consultants of Rockland, P.C. License No.: 3287 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 8/21/13 Inspector: AC 

Accompaniment No.: 4 

Licensee: Able Testing and Inspection, Inc. License No.: C2555 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 8/22/13 Inspector: DG 

Accompaniment No.: 5 

Licensee: St. Peter’s Hospital License No.: 1073-2 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/23/13 Inspector: CB 
Accompaniment No.: 6 

Licensee: Island Diagnostic Imaging Associates, PLLC License No.: 5114 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 08/27/13 Inspector: MK 

New York City Department of Health and Mental Hygiene

Accompaniment No.: 7 

Licensee: The New York Community Hospital License No.: 91-2991-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 08/28/13 Inspector: MR 

Accompaniment No.: 8 

Licensee: Columbia-Presbyterian Medical Center License No.: 93-2878-05 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 08/29/13 Inspector: OA 

Accompaniment No.: 9 

Licensee: Staten Island University Hospital License No.: 91-2840-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 08/30/13 Inspector: JL 

New York State Department of Environmental Conservation

Accompaniment No.: 10 

Licensee: University of Rochester Lab for Laser Energetics Permit No.: 8-2699-00059/00003 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 7/16/13 Inspector: TF 

Accompaniment No.: 11 

Licensee: NYSERDA SDA Permit No.: 9-0422-00011/00011 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 8/13 and 14/13 Inspector: DO 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Daniel Amen, M.D./Amen Clinics Inc. License No.: 91-3475-01 

Type of Action: New Amendment No.: NA 

Date Issued: 09/27/12 License Reviewer: IS/DH 

File No.: 2 

Licensee: Daniel Amen, M.D./Amen Clinics Inc. License No: 91-3475-01 

Type of Action: Amendment Amendment No.: 01 

Date Issued: License Reviewer: IS 

 Comment: The reviewer improperly added an individual as a RSO to the license. The 

proposed RSO did not meet the qualification requirements in accordance 

with 175.103(j)(5), and 175.103(j)(1), respectively. 

File No.: 3 

Licensee: Hari Ashamalla, M.D./All City Ambulatory Surgery Ctr. License No.: 91-3402-01 

Type of Action: Termination Amendment No.: 03 

Date Issued: 02/11/14 License Reviewer: IS 

File No.: 4 

Licensee: Columbia Presbyterian Medical Center License No.: 75-2878-01 

Type of Action: Amendment Amendment No.: 38 

Date Issued: 03/07/14 License Reviewer: IS 

File No.: 5 

Licensee: Van-Hong Nguyen, M.D./Marathon Medical, PC License No.: 91-3457-01 

Type of Action: Termination/Change of Ownership Amendment No.: 1 

Date Issued: 01/15/14 License Reviewer: IS 

File No.: 6 

Licensee: Van-Hong Nguyen, M.D./ License No.: 91-5399-01 

Mount Sinai Marathon Medical, PC 

Type of Action: New/Change of Ownership Amendment No.: NA 

Date Issued: 01/15/14 License Reviewer: IS 

File No.: 7 

Licensee: Memorial Sloan Kettering License No.: 75-2968-01 

Type of Action: Amendment Amendment No.: 17 

Date Issued: 08/16/13 License Reviewer: DH 

 
New York Final IMPEP Report D. 2 

License Casework Reviews 

File No.: 8 

Licensee: Montefiore Medical Center License No.: 75-2885-01 

Type of Action: Amendment Amendment No.: 38 & 39 

Date Issued: in 2012 License Reviewer: DH 

File No.: 9 

Licensee: Montefiore Medical Center License No.: 75-2885-01 

Type of Action: Amendment Amendment No.: 45 

Date Issued: 03/12/14 License Reviewer: IS 

File No.: 10 

Licensee: NY Presbyterian Hospital/ License No.: 93-2878-05 

Columbia University Med Center 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 03/03/14 License Reviewer: IS 

 Comment: The reviewer improperly added an individual as an RSO to the license. 

There was no supporting documentation to show the RSO had received or 

was going to receive training regarding the radiation safety aspects of the 

gamma knife. 

File No.: 11 

Licensee: Bhumi, Sarat License No.: 91-3342-01 

Type of Action: Renewal Amendment No.: 3 

Date Issued: 07/03/12 License Reviewer: DH 

 Comment: Review did not demonstrate a thorough analysis of the licensee’s inspection 

and enforcement history. The license reviewer did not adhere to the 

applicable and current guidance for this review. 

File No.: 12 

Licensee: Bhumi, Sarat License No.: 91-3342-01 

Type of Action: Termination Amendment No.: 4 

Date Issued: License Reviewer: DH 

 Comment: Team member could not evaluate the termination because the file lacked the 

supporting documentation for the termination request. 

File No.: 13 

Licensee: The Animal Medical Center License No.: 52-2899-02 

Type of Action: Renewal Amendment No.: 10 

Date Issued: 01/15/14 License Reviewer: IS 

 Comment: The license reviewer did not adhere to the applicable and current guidance 

for this review. Review did not demonstrate a thorough analysis of the 

licensee’s inspection and enforcement history. The review was not thorough, 

complete, clear, and of poor technical quality. 
New York Final IMPEP Report D. 3 

License Casework Reviews 

File No.: 14 

Licensee: Sheehan Memorial Hospital License No.: 1847 

Type of Action: Termination Amendment No.: 18 

Date Issued: 06/25/12 License Reviewer: MH 

File No.: 15 

Licensee: Adelphi University License No.: 45 

Type of Action: Renewal Amendment No.: 22 

Date Issued: 02/09/12 License Reviewer: AC 

File No.: 16 

Licensee: Syracuse University License No.: 40 

Type of Action: Amendment/Decommission Amendment No.: 29 

Date Issued: 02/20/13 License Reviewer: DS 

File No.: 17 

Licensee: Cardinal Health License No.: C2613 

Type of Action: Termination Amendment No.: 16 

Date Issued: 09/03/13 License Reviewer: MS 

File No.: 18 

Licensee: TEI Analytical Services, Inc. License No.: C5547 

Type of Action: New Amendment No.: 

Date Issued: 02/21/13 License Reviewer: DG 

File No.: 19 

Licensee: Windsong Radiology Group, P.C. License No.: 3051 

Type of Action: Amendment Amendment No.: 37 

Date Issued: 03/08/13 License Reviewer: JK 

File No.: 20 

Licensee: WIndsong Radiology Group, P.C. License No.: 3051 

Type of Action: Amendment Amendment No.: 35 

Date Issued: License Reviewer: JK 

File No.: 21 

Licensee: AMP Radiation Oncology License No.: 5584 

Type of Action: New Amendment No.: 

Date Issued: 7/25/13 License Reviewer: RD 

File No.: 22 

Licensee: AMP Radiation Oncology License No.: 5584 

Type of Action: Amendment Amendment No.: 01 

Date Issued: 9/10/13 License Reviewer: RD 

 
New York Final IMPEP Report D. 4 

License Casework Reviews 

File No.: 23 

Licensee: AMP Radiation Oncology License No.: 5584 

Type of Action: Amendment Amendment No.: 02 

Date Issued: 12/26/13 License Reviewer: DS 

File No.: 24 

Licensee: Northern Westchester Hospital Center License No.: 585 

Type of Action: Amendment Amendment No.: 81 

Date Issued: 02/26/14 License Reviewer: JK 

 Comment: The preceptor dates were not correct. The NRC Form had dates that were 

longer than the time the preceptor was at the hospital. Clarification on the 

dates should have been requested. 

File No.: 25 

Licensee: Mount Sinai North Shore Medical Group License No.: 5539 

Type of Action: Amendment Amendment No.: 4 

Date Issued: 03/14/14 License Reviewer: MH 

File No.: 26 

Licensee: Steris Isomedix Services, Inc. License No.: C2583 

Type of Action: Financial Assurance Amendment No.: 4 

Date Issued: 03/22/12 License Reviewer: MH 

File No.: 27 

Permitee: NYSERDA Permit No.: 9-0422-00011/00011 

Type of Action: Amendment Amendment No.: NA 

Date Issued: Letter of Modification to the Permit written on 

10/11/2013, 12/14/2013, 12/19/2013 and 1/13/2014. Permit Reviewer: DO 

File No.: 28 

Permitee: Cornell University Permit No: NA (Under Consent Order) 

Type of Action: Renewal Amendment No.: NA 

Date Issued: Currently Pending Issue Permit Reviewer: DO 

File No.: 29 

Permitee: NRD LLC Permit No.: 9-1446-00018 

Type of Action: Renewal Amendment No.: NA 

Date Issued: 5/23/2013 Permit Reviewer: JF 

File No.: 30 

Permitee: SUNY at Buffalo Permit No.: 9-1402-00680/00029 

Type of Action: Amendment Amendment No.: NA 

Date Issued: 11/18/2013 Permit Reviewer: AG 

 

 
New York Final IMPEP Report D. 5 

License Casework Reviews 

File No.: 31 

Permitee: Cardinal Health Permit No.: 1-2824-02719/00001 

Type of Action: Renewal Amendment No.: NA 

Date Issued: 10/1/12013 Permit Reviewer: AG 

 

File No.: 32 

Permitee: University of Rochester Permit No.: 8-2699-00059/00003 

Type of Action: Renewal Amendment No.: NA 

Date Issued: 12/21/2012 Permit Reviewer: TF 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Memorial Sloan Kettering Cancer Center License No.: 75-2968-01 

Date of Incident: 06/29/11 NMED No.: 120588 

Investigation Date: 09/21/11 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 2 

Licensee: Mount Sinai Medical Center License No.: 75-2909-04 

Date of Incident: 09/20/12 NMED No.: 120588 

Investigation Date: 09/25/12 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 3 

Licensee: Montefiore Medical Center License No.: 75-2885-01 

Date of Incident: 03/22/13 NMED No.: 130384 

Investigation Date: 7/8/13 Type of Incident: Overexposure 

 Type of Investigation: Site 

File No.: 4 

Licensee: Memorial Sloan Kettering Cancer Center License No.: 75-2968-01 

Date of Incident: 11/21/13 NMED No.: 140003 

Investigation Date: 12/13/13 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 5 

Licensee: Integrated Medical Professionals License No.: 5335 

Date of Incident: 02/14/14 NMED No.: 140109 

Investigation Date: 03/07/14 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Site 

File No.: 6 

Licensee: Materials Testing Lab, Inc. License No.: C2274 

Date of Incident: 10/23/12 NMED No.: 120634 

Investigation Date: 10/24/12 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Phone 
New York Final IMPEP Report E. 2 

Incident Casework Reviews 

File No.: 7 

Licensee: Redacted License No.: Redacted 

Date of Incident: 10/13/11 NMED No.: 110574 

Investigation Date: 10/14/11 Type of Incident: Medical Event 

 Type of Investigation: Phone/Email 

File No.: 8 

Licensee: Callanan Industries License No.: G14553 

Date of Incident: 05/09/12 NMED No.: 120302 

Investigation Date: 05/09/12 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Phone 

File No.: 9 

Licensee: Steris Isomedix Services, Inc. License No.: C2583 

Date of Incident: 12/27/13 NMED No.: 140017 

Investigation Date: 12/30/13 & 02/06/14 Type of Incident: Equipment Failure 

 Type of Investigation: Phone/Letter 

File No.: 10 

Licensee: Eastman Kodak Company License No.: C1347 

Date of Incident: 10/27/07 NMED No.: 110330 

Investigation Date: 10/29/07 & 11/28/11 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Phone/Email 

 Comment: Event occurred during previous IMPEP review period and identified during 

2011 IMPEP as not reported to NRC. Event reported to NRC on 07/01/11. 

File No.: 11 

Licensee: Redacted License No.: Redacted 

Date of Incident: 03/25/13 NMED No.: 130176 

Investigation Date: 04/05/13 & 06/06/13 Type of Incident: Medical Event 

 Type of Investigation: Phone 

File No.: 12 

Licensee: Roswell Park Cancer Institute License No.: 2923 

Date of Incident: 07/12/13 NMED No.: 130470 

Investigation Date: 09/20/13 Type of Incident: Lost/Stolen RAM 

 Type of Investigation: Letter/Next Inspection 

File No.: 13 

Licensee: NCM USA Bronx, LLC License No.: C5496 

Date of Incident: 07/15/13 NMED No.: 130353 

Investigation Date: 08/12 & 8/15/13 Type of Incident: Overexposure 

 Type of Investigation: Site 
APPENDIX F 

REGULATION STATUS REVIEW 

RATS ID Description Agency State Status

1991-4 Notification of Incidents,” 10 CFR Parts 20, 

30, 31, 34, 39, 40, and 70 amendments (56 

FR 64980), that became effective on 

October 15, 1991 and was due for 

Agreement State adoption by October 15, 

1994.

DOH 1/28/2000 Open 

Regulations 

adopted but 

unresolved 

comments. 

NYC 12/5/2011 

comments 

DEC NA 

1993-1 Decommissioning Recordkeeping and 

License Termination: Documentation 

Additions,” 10 CFR Parts 30 and 40 

amendments (58 FR 39628), that became 

effective on October 25, 1993 and was due 

for Agreement State adoption by October 

25, 1996.

DOH 1/28/2000 Closed 

NYC 9/22/2011 

DEC NA 

1996-3 Termination or Transfer of Licensed 

Activities: Recordkeeping Requirements,” 

10 CFR Parts 20, 30, 40, 61, and 70 

amendments (61 FR 24669), that became 

effective on June 17, 1996 and was due for 

Agreement State adoption by June 17, 

1999.

DOH 2/20/14 (LC) Closed 

NYC 6/12/2006 

DEC NA 

1995-7 Medical Administration of Radiation and 

Radioactive Materials,” 10 CFR Parts 20 

and 35 amendments (60 FR 48623), that 

became effective on October 20, 1995, and 

was due for Agreement State adoption by 

October 20, 1998. Only Part 20 

provisions need to be adopted. 

DOH Open 

NYC 10/20/1998 

DEC NA 

1994-3 Timeliness in Decommissioning Material 

Facilities,” 10 CFR Parts 30, 40, and 70 

amendments (59 FR 36026), that became 

effective on August 15, 1994 and was due 

for Agreement State adoption by August 

15, 1997.

DOH 1/28/2000 Open 

NYC 6/12/2006 

DEC 

1995-5 Radiation Protection Requirements: 

Amended Definitions and Criteria,” 10 CFR 

Parts 19 and 20 amendments (60 FR 

36038), that became effective on August 

14, 1995, and was due for Agreement 

State adoption by August 14, 1998. 

DOH Open 

NYC 2/23/2007 

DEC 
New York Final IMPEP Report F. 2 

Regulation Status Review 

1997-6 Radiological Criteria for License 

Termination,” 10 CFR Parts 20, 30, 40, and 

70 amendments (62 FR 39057), that 

became effective on August 20, 1997, and 

was due for Agreement State adoption by 

August 20, 2000.

DOH 2/20/2014 

(LC) 

Open 

NYC 2/23/2007 

DEC 

1998-5 Minor Corrections, Clarifying Changes, and 

a Minor Policy Change,” 10 CFR Parts 20, 

30, 40, and 70 amendments (63 FR 39477, 

63 FR 45393), that became effective on 

October 26, 1998, and was due for 

Agreement State adoption by October 26, 

2001.

DOH Open 

NYC 6/12/2014 

DEC 

1998-6 Transfer for Disposal and Manifests: Minor 

Technical Conforming Amendment,” 10 

CFR Part 20 amendment (63 FR 50127), 

that became effective on November 20, 

1998 and was due for Agreement State 

adoption by November 20, 2001.

DOH NA Closed 

NYC 6/12/2014 

DEC 2/28/2006 

1998-1 Deliberate Misconduct by Unlicensed 

Persons,” 10 CFR Parts 30, 40, and 70 

amendments (63 FR 1890, 63 FR 13773), 

that became effective on February 12, 

1998, and was due for Agreement State 

adoption by February 12, 2001.

DOH 6/19/2013 

(LC) 

comments 

Open 

Legally 

binding 

requirement

s adopted 

but 

unresolved 

comments.

NYC 6/12/2006 

DEC 4/25/2006 

2002-1 Revision of the Skin Dose Limit,” 10 CFR 

Part 20 amendment (67 FR 16298), that 

became effective on April 5, 2002, and was 

due for Agreement State adoption by April 

5, 2005. 

DOH Open 

NYC 6/1/2006 

DEC NA 

2002-2 Medical Use of Byproduct Material,” 10 

CFR Parts 20, 32, and 35 amendments (67 

FR 20249), that became effective on April 

24, 2002, and was due for Agreement 

State adoption by October 24, 2005.

DOH 8/8/2013 

Comments 

Part 35 only 

Open 

Regulations 

adopted but 

unresolved 

comments 

and partial 

rule 

adoption. 

NYC 6/12/2014 

DEC NA 

2005-2 Medical Use of Byproduct MaterialRecognition of Specialty Boards,” 10 CFR 

Part 35 amendment (70 FR 16336, 71 FR 

1926), that became effective on April 29, 

DOH 8/8/2013 Closed 

NYC 6/12/2014 
New York Final IMPEP Report F. 3 

Regulation Status Review 

2005, and was due for Agreement State 

adoption by April 29, 2008

DEC NA 

2006-1 “Minor Amendments,” 10 CFR Parts 20, 

30, 32, 35, 40, and 70 amendments (71 FR 

15005), that became effective on March 

27, 2006, and was due for Agreement 

State adoption by March 27, 2009. 

DOH 8/8/2013 

Comments 

Part 35 only 

Open 

Regulations 

adopted but 

unresolved 

comments 

and partial 

rule 

adoption. 

NYC 7/7/2011 

Comments 

DEC NA 

2007-1 “Medical Use of Byproduct Material – Minor 

Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendments (72 FR 

45147, 72 FR 54207), that became 

effective on October 29, 2007 and were 

due for Agreement State adoption on 

October 29, 2010

DOH 8/8/2013 

Part 35 only 

Open 

Regulations 

adopted but 

unresolved 

comments 

and partial 

rule 

adoption 

NYC 7/7/2011 

Comments 

DEC NA 

2007-2 Exemptions From Licensing, General 

Licenses, and Distribution of Byproduct 

Material: Licensing and Reporting 

Requirements,” 10 CFR Parts 30, 31, 32, 

and 150 amendments (72 FR 58473), that 

became effective on December 17, 2007 

and was due for Agreement State adoption 

by December 17, 2010.

DOH Open 

NYC 6/12/2014 

Comments 

DEC NA 

2007-3 Requirements for Expanded Definition of 

Byproduct Material,” Parts 20, 30, 31, 32, 

33, 35, 61, and 150 amendments (72 FR 

55864), that became effective on 

November 30, 2007 and was due for 

Agreement State adoption by November 

30, 2010. 

DOH 8/8/2013 

Part 35 only 

Open 

NYC 6/12/2014 

Comments 

DEC 

2008-1 Occupational Dose Records, Labeling 

Containers, and Total Effective Dose 

Equivalent,” 10 CFR Parts 19 and 20 

amendments (72 FR 68043), that became 

effective February 15, 2008 and was due 

for Agreement State adoption by February 

15, 2011.

DOH Open 

NYC 6/12/2014 

DEC 

2009-1 Medical Use of Byproduct Material – 

Authorized User Clarification,” 10 CFR Part 

35 amendment (74 FR 33901), that 

became effective on September 28, 2009 

and is due for Agreement State adoption 

by September 28, 2012.

DOH 8/8/2013 Open 

Regulations 

adopted but 

unresolved 

comments 

NYC 4/24/2013 

Comments 

DEC NA 
APPENDIX G 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registry No.: NY-1210-D-103-B SS&D Type: ECD 

Applicant Name: Inficon, Inc. Type of Action: Ownership change and new ECD Model 

Date Issued: 7/13/2012 SS&D Reviewers: DS, DG 
 

ATTACHMENT(S) 

May 14, 2014 Letter from Sandra Hinkle 

New York DEC Response to the Draft Report 

ADAMS Accession No.: ML14136A386 

June 3, 2014 Email from Stephen Gavitt 

New York DOH Response to the Draft Report 

ADAMS Accession No.: ML14157A217 

June 4, 2014 Letter from Christopher Boyd 

New York City DHMH Response to the Draft Report 

ADAMS Accession No.: ML14161A566 

NRC Comment Resolution - REVISED 

ADAMS Accession No.: ML14266A285