November 29, 2011 

Christopher Boyd, Assistant Commissioner 

Office of Radiological Health 

Bureau of Environmental Sciences & Engineering 

New York City Department 

 of Health and Mental Hygiene 

22 Courtlandt Street, 28th Floor, CN 60 

New York, NY 10007 

Dale Desnoyers, Director 

Division of Environmental Remediation 

New York State Department of Environmental Conservation 

625 Broadway 

Albany, NY 12233-7011 

Howard Freed, MD, Director 

Center for Environmental Health 

New York State Health Department 

547 River Street, Room 500 

Troy, NY 12180-2216 

Dear Sirs: 

On October 11, 2011, 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 Agreement State Program 

adequate, but needs improvement, to protect public health and safety, and not compatible with 

the U.S. Nuclear Regulatory Commission’s (NRC) program. Because of the significance of 

the findings, the MRB determined that the New York Program should continue the period of 

Heightened Oversight. Heightened Oversight is an increased monitoring process the NRC 

uses to follow the progress of improvement needed in an Agreement State program. It 

involves preparation of a program improvement plan, bimonthly conference calls, and 

submission of status reports prior to each call with the appropriate New York and NRC 

managers and staff members. 

Section 5.0, page 29, of the enclosed final report contains a summary of the review team’s 

findings and recommendations for the New York Agreement State Program. We request that 

you prepare and submit a program improvement plan as part of your response to the review 

team’s recommendations. I ask that you have your staff discuss the required elements of this 

plan with Mr. Brian McDermott, Director, Division of Materials Safety and State Agreements, 

Office of Federal and State Materials and Environmental Management Programs, to ensure that 

a path forward and measures of success are clearly identified. The plan should be submitted 

within 30 days of receipt of this letter. Upon review of your program improvement plan, NRC 

staff will schedule the first conference call. The initial conference call should be scheduled and 

conducted no later than January 30, 2012. 
C. Boyd, et al. -2- 

Based on the results of the current IMPEP review, a Periodic Meeting will be held within 1 year 

to assess the State’s progress in addressing the open recommendations, and an IMPEP review 

take place approximately 1 year following the Periodic Meeting (2 years from current IMPEP). 

The MRB believes that the performance of an IMPEP at approximately 2 years from the current 

IMPEP will allow the State sufficient time to correct programmatic issues identified during the 

review. The IMPEP review will cover the State’s actions in response to the recommendations in 

the enclosed final report. 

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/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

cc w/ encl: See next page 
C. Boyd, et al. -2- 

Based on the results of the current IMPEP review, a Periodic Meeting will be held within 1 year 

to assess the State’s progress in addressing the open recommendations, and an IMPEP review 

take place approximately 1 year following the Periodic Meeting (2 years from current IMPEP). 

The MRB believes that the performance of an IMPEP at approximately 2 years from the current 

IMPEP will allow the State sufficient time to correct programmatic issues identified during the 

review. The IMPEP review will cover the State’s actions in response to the recommendations in 

the enclosed final report. 

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/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

cc w/ encl: See next page 

DISTRIBUTION: EDATS: FSME-2011-0095 

See next page 

ADAMS Accession Number: ML112920203 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME MBeardsley via email LDimmick DWhite BMcDermott 

DATE 10/25/11 10/24/11 10/27/11 11/16/11 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland MSatorius MWeber 

DATE 11/21/11 11/22/11 11/29/11 

OFFICIAL RECORD COPY 
 

Letter to C. Boyd, et al from Michael F. Weber dated: 

SUBJECT: NEW YORK 2011 FINAL IMPEP REPORT 

cc w/ enclosures: EDATS: FSME-2011-0095

Francis Murray, President and CEO 

NY State Energy Research and Development Authority 

State Liaison Officer 

17 Columbus Circle 

Albany, NY 12223 

Gene Miskin, Director 

Office of Radiological Health 

Bureau of Environmental Sciences & Engineering 

New York City Department 

 of Health and Mental Hygiene 

22 Courtlandt Street, 28th Floor, CN 60 

New York, NY 10007 

Jim Harrington, Director

Remedial Bureau A 

Division of Environmental Remediation 

New York State Department of Environmental Conservation 

625 Broadway 

Albany, NY 12233-7011 

Sandra Hinkel, Chief 

Radiation Control Permits Section, Remedial Bureau A

Division of Environmental Remediation 

New York State Department of Environmental Conservation 

625 Broadway 

Albany, NY 12233-7011 

Timothy Rice, Chief 

Radiological Sites Section, Remedial Bureau A

Division of Environmental Remediation 

New York State Department of Environmental Conservation 

625 Broadway 

Albany, NY 12233-7011 

 

Robert Chinery, M.S., P.E., Assistant Director 

Center for Environmental Health 

New York State Health Department 

547 River Street, Room 500 

Troy, NY 12180-2216 

 
 

Adela Salame-Alfie, Ph.D., Acting Director 

Division of Environmental Health Investigations 

New York State Health Department 

547 River Street, Room 500 

Troy, NY 12180-2216 

Stephen Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

New York State Health Department 

547 River Street, Room 500 

Troy, NY 12180-2216 

Robert Dansereau, Assistant Director 

Bureau of Environmental Radiation Protection 

New York State Health Department 

547 River Street, Room 500 

Troy, NY 12180-2216 

DISTRIBUTION: EDATS: FSME-2011-0095 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

RErickson, RIV/RSAO Commissioner Svinicki 

MOrendi, RI/RSAO Commissioner Apostolakis 

SGabriel, RI Commissioner Magwood 

SXu, FSME Commissioner Ostendorff 

SPoy, FSME SECY 

MHeath, FSME 

JThompson, RIV 

ATroxler, LA 

RCaniano, RIV 

EFordham, WA 

DMerzke, OEDO 

TRothschild, OGC 

JBiggins, OGC 

JKatanic, FSME 

JLuehman, FSME 

JWeil, OCA (2 copies) 

 
Enclosure 

 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NEW YORK AGREEMENT STATE PROGRAM 

JUNE 6-16, 2011 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the New York Agreement State Program. The New York Agreement State 

program is currently administered by three agencies including the New York City Department of 

Health and Mental Hygiene (NYC), the New York State Department of Health (DOH), and the 

New York State Department of Environmental Conservation (DEC). The review was conducted 

during the period of June 6-16, 2011, by a review team composed of technical staff members 

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

Based on the results of this review, the review team recommended, and the Management 

Review Board (MRB) agreed, that New York’s performance be found unsatisfactory for two 

performance indicators reviewed; satisfactory, but needs improvement for two performance 

indicators reviewed; and satisfactory for the four remaining performance indicators reviewed. 

Overall, the review team further recommended, and the MRB agreed, that the New York 

Agreement State Program be found adequate to protect public health and safety, but needs 

improvement, and not compatible with NRC's program. 

 

The review team made five recommendations regarding the performance of the New York 

Agreement State Program. These recommendations, which are briefly described below, 

included areas for improvement to correct identified performance deficiencies and weaknesses 

in New York Agreement State Program. The review team recommended that: (1) DOH develop 

and implement a process to track reciprocity inspections to ensure at least 20 percent of 

candidate licensees for reciprocity are inspected; (2) NYC respond to each incident received in 

accordance with its established Incident Response Procedure; (3) NYC modify its Incident 

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

with the timelines identified in SA-300; (4) NYC evaluate all incident statistical information 

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

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

and (5) 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 SA-300. 

Based on the results of the current review, the review team recommended, and the MRB 

agreed, that the period of Heightened Oversight continue and that the current Program 

Improvement Plan be revised to include those recommendations identified during the 2011 

IMPEP review. The review team further recommended, and the MRB agreed, that a Periodic 

Meeting be held in approximately one year and that the next full IMPEP review take place in 

approximately two 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 June 6-16, 2011, by a review team comprised of 

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

Louisiana. 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 a Final General Statement of Policy” published in the Federal 

Register on October 16, 1997, and the February 26, 2004, NRC Management Directive 5.6, 

“Integrated Materials Performance Evaluation Program (IMPEP).” Preliminary results, which 

covered the period of November 10, 2006, to June 16, 2011, were discussed with New York 

management on the last day of the review. 

A draft of this report was issued to New York for factual comment on July 15, 2011. New York 

responded to the findings and conclusions of the review by letters dated August 10, 2011, from 

Christopher Boyd, Assistant Commissioner, Bureau of Environmental Services and Engineering; 

electronic mail dated August 15, 2011, from Stephen M. Gavitt, Director, Bureau of 

Environmental Radiation Protection; and electronic mail dated August 4 and 8, 2011, from 

Sandra Hinkel, Chief, Radiation Control Permit Section. New York’s response letters are 

attached to this report and can be found in NRC’s Agencywide Document Access and 

Management System (ADAMS) using the Accession Numbers ML11222A252, ML11227A287, 

ML11216A261, and ML112201338. The Management Review Board (MRB) met on October 

11, 2011, to consider the proposed final report. The MRB found the New York Agreement State 

Program adequate to protect public health and safety but needs improvement, and not 

compatible with NRC’s program. 

The New York Agreement State program is currently administered by three agencies: (1) 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; (2) 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; 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 programs are included as 

Appendix B. 

At the time of the review, the combined New York programs regulated approximately 1,500 

specific licenses, including all major types of licenses with the exception of uranium mill tailings. 

The review focused on the radioactive materials program, as implemented 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 non-common 

performance indicators was sent to each of the three agencies on January 20, 2011 

(ML110200486). Each agency provided an electronic response to the questionnaire; DEC on 

May 9, 2011; NYC on May 20, 2011; and DOH on May 23, 2011. A copy of the respective 

questionnaire responses can be found in ADAMS using the Accession Numbers ML111290549, 
New York Final IMPEP Report Page 2 

ML111460424 and ML111460513. An update to the questionnaire response from NYC was 

received by email on June 9, 2011 and can be found under ML111990239. 

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

each agency’s response to the questionnaire; (2) review of applicable New York statutes and 

regulations; (3) analysis of quantitative information from each agency’s licensing and inspection 

database; (4) technical review of selected licensing and inspection actions; (5) field 

accompaniments of 11 State inspectors; and (6) interviews with staff and management to 

answer questions and to clarify issues. The review team evaluated the information gathered 

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

indicator and made a preliminary assessment of the New York Agreement State Program’s 

performance. 

On November 3, 2005, the Management Review Board (MRB) met to consider the findings of a 

Periodic Meeting with the New York Agreement State Program conducted on April 12-13 and 

19, 2005. As a result, the MRB determined that the New York Agreement State Program should 

enter into a period of Heightened Oversight due to a number of overdue NRC amendments 

required for compatibility by each of the agencies that comprise the Agreement State program 

(ML053540394). 

On February 8, 2007, the MRB again met to consider the findings of a full IMPEP review 

conducted on November 1-9, 2006. As a result, the MRB determined that the period of 

Heightened Oversight should be extended due to a lack of progress in eliminating the overdue 

amendments. As a result, each agency continued to have bimonthly calls to discuss their 

progress in adopting regulations, and additional Periodic Meetings were held respectively with 

each agency on November 27, 28 and 29, 2007 and again on July 16, 28 and 29, 2009. 

Following each of the Periodic Meetings, the MRB convened and determined that the period of 

Heightened Oversight should continue. 

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

during the previous IMPEP review. Results of the current review for the common performance 

indicators are presented in Section 3.0. Section 4.0 discusses results of the applicable noncommon performance indicators, and Section 5.0 summarizes the review team’s findings and 

recommendations. The recommendations made by the review team are comments that relate 

directly to performance by the State. A response is requested from the State to all 

recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous review, which concluded on November 9, 2006, two recommendations were 

left open from the prior (2002) review. No new recommendations were opened during the 2006 

review. The review team’s evaluation of the status of these recommendations is as follows: 

1. The review team recommends that DEC transmit inspection findings to their licensees 

within thirty days after the close of the inspection. (Held open from Section 3.2.5 of the 

2002 IMPEP review) 
New York Final IMPEP Report Page 3 

Status: Based on the review of inspection casework and discussions with DEC staff, the 

review team found that DEC is issuing inspection findings in a timely manner. This 

recommendation is closed. 

2. The review team recommends that each New York Agency (NYC, DOH and DEC) 

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

current NRC policy on adequacy and compatibility. (Open from Section 4.1.3 of the 

2002 IMPEP review). 

Status: The review team found that the NYC, DOH, and DEC have each developed and 

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

NRC policy on adequacy and compatibility. Under Heightened Oversight, each 

Program’s overdue regulations, as identified on their current Program Improvement 

Plan, continue to be tracked and monitored. While each Program is still working to 

achieve the ultimate goal of timely adoption of regulations, slight progress has been 

made. This progress, however, has been negated by regulation amendments which 

were not previously overdue for adoption, becoming overdue for adoption, during the 

review period. This recommendation remains open. 

3.0 COMMON PERFORMANCE INDICATORS 

IMPEP identifies five common performance indicators to be used in reviewing both 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

Evaluation of this performance indicator included a review of each agency’s staffing level and 

staff turnover, as well as the technical qualifications and training histories of the staff. To 

evaluate these issues, the review team examined the respective program’s response to the 

IMPEP questionnaire relative to this indicator, interviewed management and staff, reviewed job 

descriptions and training records, and considered any possible workload backlogs. 

3.1.1 New York City Department of Health and Mental Hygiene

NYC is staffed by the Office Director, the Unit Chief for the Materials Program, and seven 

technical staff members totaling of 4.7 full-time equivalents (FTE). There are currently no 

vacancies in this program. During the review period, one staff member transferred from the 

materials program to the Emergency Response Unit (ERU) and another individual was hired as 

a replacement. 

Originally the ERU was an integral part of the NYC program and as part of the NYC program 

conducted Increased Controls (IC) inspections for the City of New York. However, when the 

ERU expanded and became an independent Bureau, they no longer assisted in conducting IC 

inspections. Now the NYC program conducts all IC inspections within the five boroughs of New 

York. With the advent of the Lower Manhattan Security Initiative, NYC inspectors in conjunction 
New York Final IMPEP Report Page 4 

with the New York City Police Department conduct joint IC inspections. 

NYC requires a Bachelor’s degree in engineering, physical or biological sciences for all 

technical positions. The review team reviewed the job descriptions as presented by the Office 

Director, for NYC Scientist I-III staff positions. The job descriptions identify the individual 

categories and describe typical tasks required for the position. The review team found that the 

job descriptions are consistent with requirements for equivalent NRC positions. The review 

team also reviewed a portion of the NYC Policy and Procedure Manual dated 2004 as 

presented by the Unit Chief. This document describes, in part, the requirements for training for 

new members of the field staff. New inspectors are required to attend the five week Applied 

Health Physics course offered by Oak Ridge Associated Universities (ORAU) or a similar series 

of courses unless the individual’s background is such that they already have similar training and 

experience. 

The Unit Chief provided the team with a breakdown of training that each inspector has 

completed. The review team noted that, with the exception of attending NRC’s S-201, 

“Material’s Control and Security Course” (IC training course), no member of the staff had 

attended any materials specific technical training courses in several years. The review team 

noted that NYC, through a cross-training initiative, has provided X-ray related training. 

During interviews with two NYC inspectors, the inspectors indicated that they had not been to 

any materials training outside of the IC training course. However, the inspectors were 

considered fully qualified to perform all types of inspections independently. The review team 

found that in the case of the two newest inspectors, who upon their hire dates did not have 

technical backgrounds sufficient to exempt them from initial technical training, NYC did not 

follow its own training procedures and send the inspectors to the five-week health physics 

training course as required by their procedures. Based on the documentation provided to the 

review team by the Unit Chief, only two individuals have attended the five-week health physics 

training course, one with nearly 20 years experience and one with nearly 15 years experience. 

No other individuals have attended this training. 

NRC staff conveyed concerns related to inspector training to the NYC Office Director and Unit 

Chief via email on May 12, 2011 (ML111990264). Subsequently, on May 25, 2011, NYC filed 

an application with the NRC Agreement State Training Coordinator to have three NYC 

inspectors attend three separate basic training courses (ML111990259). 

The review team found that NYC staff has made requests for additional technical training which 

have, for the most part, not been acted upon until recently. As noted in Section 3.5.1 of this 

report, the review team identified additional training concerns, specifically regarding incident 

reporting requirements. The review team believes that NYC could benefit from SA-300 training 

(reporting requirements) as the team had concerns about the ability of NYC to accurately apply 

the reporting requirements to incidents that occur within their jurisdiction. 

3.1.2 New York State Department of Health

DOH is managed by the Director, the Assistant Director, and four Section Chiefs. DOH has a 

total of 11.5 FTE in the materials program. There are currently no vacancies in this program. 

During the review period, one senior staff member was reassigned to the Laboratory and 10 
New York Final IMPEP Report Page 5 

other staff members left the program. These positions were permanently eliminated and 

represented an overall reduction of 6.2 FTE for the materials program. The review team noted 

that over the course of the review most, if not all, of the deficiencies (timeliness and resources 

for program improvements) found within the Program were related to a diminished staffing level, 

or loss of staff during the review period. 

The Program has 36 total staff members who are responsible for licensing and inspection of 

approximately 1200 materials licensees, registration and inspection of approximately 11,000 

X-Ray facilities, licensing and review of continuing education for approximately 20,000 licensed 

X-Ray technologists, supporting emergency response activities for three power reactor sites, 

environmental monitoring, and management of the Radon program. The Director and Assistant 

Director primarily conduct administrative activities. Program managers stated that they have 

been forced to take staff from the X-Ray program to maintain the materials program. They 

added that this movement of staff has reduced the effectiveness of the X-Ray program and 

some work remains uncompleted. The strain of the permanent staff losses has begun to erode 

the overall effectiveness of the Program and has resulted in reduced performance in some 

areas. While the review team did not note any performance issues where health, safety, and 

security was directly involved, the review team did note several areas within the Program where 

staff losses have resulted in deficiencies as noted throughout this report. 

DOH staff is required to have a Bachelor’s degree in physical or biological sciences. DOH 

reported that it does have a general training policy but not a formalized training process. While 

individual qualification type journals are maintained for the staff, they only attend training 

classes on an “as needed” basis. The Assistant Director stated that not all staff needs to attend 

all the training classes, and added that DOH evaluates the need for materials specific training 

based on the program’s needs, an individual’s prior training and experience, and the individual’s 

assignments, and then tailors training to those needs. DOH also hosts training classes when 

the need arises or a class becomes available. DOH also utilizes a mentorship type program 

where new staff are trained one-on-one directly with senior staff. The review team determined 

that DOH staff is well-qualified, based on education and experience. 

DOH also faces the possibility of more staff losses in the future due to retirements, and 

anticipates that these positions may also be eliminated. Further, DOH is currently operating 

under a hard hiring freeze, no staff can be added and no exceptions to the freeze are allowed. 

Additionally, the State recently announced the possibility of another 10,000 statewide layoffs. 

How these additional reductions in staff might affect the Program is unclear at this time. 

3.1.3 New York State Department of Environmental Conservation

DEC is managed by the Bureau Director and two Section Chiefs. DEC has a total of 5.75 FTE. 

There have been two vacancies in the program since 2008: an Environmental Radiation 

Specialist 2 position (West Valley Environmental Monitor) and an Environmental Program 

Specialist 2 position (LLRW Transporter Program). The Department has not yet requested 

waivers to fill those positions due to budget constraints. During the review period, the 

Radiological Sites Section Chief and a staff member in charge of low-level radioactive waste 

and regulatory development left the program. The staff member who previously filled the West 

Valley Environmental Monitor position was promoted to Section Chief, and that vacated position 

currently remains open. Also during the review period DEC hired three new staff members. 
New York Final IMPEP Report Page 6 

The permitting and inspection activities of the program are performed by six staff members, with 

the rest of the staff dedicated primarily to contaminated sites as well as other activities not 

directly covered under the Agreement. All staff is involved in incident and emergency response 

activities. 

DEC technical positions are required to have a Bachelor’s degree in science or engineering and 

at least two years of experience in the environmental radiation field. From the review of the 

technical qualifications and discussions with current staff, the review team concluded that DEC 

has been able to hire qualified individuals. 

Because of the small number of inspectors and permit reviewers, DEC has not developed a 

formal qualification program. DEC does have a documented training policy. Staff in the 

Radiation Control Permit Section must complete, at a minimum, the following courses: Applied 

Health Physics, Licensing Practices and Procedures, Inspection Procedures, and Air Sampling 

courses, as well as the 40-hour HAZWOPER course. All permit section staff have completed 

those minimum required courses. In addition, new Radiation Control Permit Section staff is 

trained individually by their supervisors in performing inspections and reviewing permit 

applications. Inspectors in training move through the following stages: (1) accompanying 

experienced inspectors, as observers; (2) assisting experienced inspectors; (3) taking the lead 

in inspections, assisted by experienced inspectors; and (4) performing inspections 

independently. Inspectors move through these stages based on the assessment of the Section 

Chief. The same staff is trained to review permit applications by first reviewing minor permit 

modifications and routine renewals, then applications of increasing complexity. All permitting 

decisions are reviewed by the Section Chief. The review team noted that DEC monitors training 

of personnel with a spreadsheet that is updated on a regular basis. 

Environmental Radiation Specialist staff in the Radiological Sites Section must also complete 

courses in Applied Health Physics and 40-hour HAZWOPER, and additional courses in 

Environmental Monitoring, MARSSIM, and RESRAD, as appropriate for assignments. 

DEC also faces the possibility of more staff losses in the future due to retirements and 

anticipates that these positions may also be eliminated. Further, DEC is currently operating 

under a hard hiring freeze, no staff can be added and no exceptions to the freeze are allowed. 

Additionally, the State recently announced the possibility of another 10,000 statewide layoffs. 

How these additional reductions in staff might affect the Program is unclear at this time. 

3.1.4 Indicator Summary

The review team determined that the only Program that was fully staffed during the review 

period was the NYC Program. DOH has experienced several permanent staff losses in many 

key areas which has started to affect the program’s effectiveness and efficiency. While DEC is 

not fully staffed, they have been less affected by the staff losses. Regardless of the number of 

staff losses noted, the review team found no specific performance issues at this time where 

health, safety and security are concerned. 

NYC has a documented training program; however, the review team determined that this 

procedure was not being implemented in all cases. Some NYC staff members interviewed have 

educational backgrounds in fields unrelated to the work performed and admit to being deficient 
New York Final IMPEP Report Page 7 

in knowledge of the license types/activities they inspect. Staff requests for training have only 

recently been approved by management. 

Additionally, NYC staff has not demonstrated the ability to apply reporting criteria to incidents 

they have received. A serious event which was determined by the review team to meet the 

reporting criteria had been previously evaluated by NYC staff and found to not be reportable. 

The review team believes that NYC staff would benefit from training on NRC reporting 

requirements. 

A balance in staffing for licensing and inspection, qualification criteria for technical staff, and 

management commitment to training are key features for a satisfactory performance in technical 

staffing and training. For one of the three agencies, the review team determined that permanent 

staff losses could adversely upset the balance in staffing and licensing. In another agency, 

training and qualification standards are not being followed and a commitment to materials 

training by management was not evident. 

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 Staffing and Training, be 

found satisfactory, but needs improvement. 

3.2 Status of Materials Inspection Program

The review team focused on five factors in reviewing the status of the material inspection 

program: inspection frequency, overdue inspections, initial inspections of new licensees, timely 

dispatch of inspection findings to licensees, and the performance of reciprocity inspections. The 

review team’s evaluation is based on the individual programs' questionnaire responses relative 

to this indicator, data gathered from each program's licensing and inspection database, the 

examination of completed licensing and inspection casework, and interviews with management 

and staff. 

3.2.1 New York City Department of Health and Mental Hygiene

The review team's assessment of NYC inspection priorities verified that inspection frequencies 

for various types of licenses are either the same as, or more frequent than, those listed in 

Inspection Manual Chapter (IMC) 2800. 

In their response to the questionnaire, NYC indicated that there were no Priority 1, 2, or 3 

inspections overdue by more than 25 percent of their respective inspection frequency. The 

examination of the data and inspection files provided by NYC during the review confirmed that 

there were no overdue inspections. During the review period no Priority 1,2, and 3 inspections, 

and no initial inspections were performed overdue by more than 25 percent of their respective 

inspection frequency. 

The timeliness of the issuance of inspection findings to licensees was evaluated during the 

inspection casework review. The team found that NYC does not actively track the timeliness of 

its issuance of inspection findings to licensees. Two of the forty inspections files reviewed 

contained inspection findings letters issued greater than 30 days. 
New York Final IMPEP Report Page 8 

NYC does not grant reciprocity to out-of-State licensees; therefore, this element of the indicator 

was not reviewed for this program. 

3.2.2 New York State Department of Health

The review team's assessment of DOH inspection priorities verified that inspection frequencies 

for various types of licenses are the same as, or more frequent than, those listed in IMC 2800. 

In their response to the questionnaire, DOH indicated and the review team verified that seven 

Priority 1, 2, and 3 inspections were overdue at the time of the review. The review team 

determined that during the review period DOH performed 19 of its 556 Priority 1, 2, and 3 

inspections overdue. All 25 initial inspections were performed within one year of license 

issuance. Overall, the review team calculated that DOH performed 4.3 percent of the Priority 1, 

2, and 3, and initial inspections overdue. 

The timeliness of the issuance of inspection findings to licensees was evaluated during the 

inspection casework review. The review team determined that 20 percent of all inspection 

findings letters to licensees were sent out greater than 30 days. The review team determined 

through discussions with Program staff, that issuance of inspection findings is not routinely 

tracked by the Program. 

DOH only authorizes reciprocity for 30 days in a calendar year; as a result, many out-of-State 

licensees obtain a specific license. During the review period, DOH granted 101 out-of-State 

reciprocity approvals. The review team determined that DOH does not track the reciprocity 

inspections performed by its staff. When the review team requested reciprocity inspection files 

for the review period, DOH could only produce files for reciprocity inspections completed in 

calendar year 2010. Therefore, the review team could not determine the percentage of 

candidate reciprocity licensees that were inspected in 2007, 2008 and 2009. Upon examining 

the files for 2010, the review team found that two of seven candidate reciprocity licensees were 

inspected or 28 percent of candidate reciprocity licensees, which meets the 20 percent required 

by NRC Inspection Manual Chapter (IMC) 1220. The review team recommends that DOH 

develop and implement a process to track reciprocity inspections to ensure at least 20 percent 

of candidate licensees for reciprocity are inspected. 

3.2.3 New York State Department of Environmental Conservation

DEC issues permits to facilities licensed by DOH to release radioactive effluents to the 

environment and inspects only those aspects of each facility’s program affecting those releases. 

Due to the limited scope of DEC’s program, they have established a policy of setting inspection 

frequencies for permittees based on the actual releases to the environment. Since the 

permittees are required to report their effluent releases to DEC annually, the Program may 

adjust their inspection frequency accordingly as releases to the environment change. The 

assigned frequencies for permittees can range from one to four years with most being inspected 

at three to four year intervals. The review team determined that these frequencies are adequate 

to protect public health and safety. 
New York Final IMPEP Report Page 9 

The review team confirmed that 5 of 72 inspections identified in the questionnaire were 

performed overdue and none of the three initial inspections were conducted overdue. The 

review team calculated that DEC performed six percent of its inspections overdue. 

The timeliness of the issuance of inspection findings to licensees was evaluated during the 

inspection casework review. The review team discussed issuance of inspection findings with 

Program management and staff and found that the Program was mistakenly informed that 

inspection findings should be issued within 30 business days. The review team clarified that 

inspection findings should be issued within 30 calendar days. The review team evaluated 

letters transmitting the inspection findings to the licensees and found that all inspection letters 

reviewed were transmitted within 30 business days from the date of the inspection. The 

Program manager acknowledged the discrepancy and committed to ensuring that inspection 

findings are issued within 30 calendar days from this point forward. 

DEC does not grant reciprocity to out-of-State licensees; therefore, this element of the indicator 

was not reviewed for this program. 

3.2.4 Indicator Summary

Overall, the review team found that the State performed less than 10 percent of Priority 1, 2, 

and 3, and initial inspections overdue. 

The issuance of inspection findings to licensees for NYC was found to be timely. DOH issued 

approximately 20 percent of its inspection findings letters past 30 days. DEC was found to be 

timely with issuance of inspection findings; however there was a misconception with regards to 

30 business days versus 30 calendar days. 

For reciprocity performance, the review team determined that DOH met the criteria in IMC 2800 

for calendar year 2010, but was unable to make determinations for calendar years 2007, 2008 

and 2009. As indicated in Section 3.2.2, the review team recommends that DOH develop and 

implement a process to track reciprocity inspections to ensure that at least 20 percent of 

candidate licensees for reciprocity are inspected. 

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 48 inspection files, including enforcement documentation and letters 

to licensees, and interviewed inspectors who were responsible for radioactive material 

inspections conducted during the review period. The casework reviewed included inspections 

performed by each of the State’s three programs, and covered inspections of various types of 

licenses including medical institutions-with/without written directives required, high dose-rate 

remote afterloaders, gamma knife, brachytherapy, gauges, industrial radiography, 

radiopharmacy, manufacturing and distribution, research and development, academic and 

medical broad scope institutions, and irradiators. Appendix C lists the inspection casework files 
New York Final IMPEP Report Page 10 

reviewed, with case-specific comments, as well as the results of the review team’s inspector 

accompaniments. 

The inspection procedures and techniques utilized by all programs were evaluated by the 

review team and were determined to be generally consistent with the inspection guidance 

provided in IMC 2800. Specific guidance for the various license types/activities is also included 

in the respective procedures manuals and/or checklists. 

Based on the evaluation of the casework, the review team determined that inspection 

documentation for each of the three programs was sufficient to ensure that licensees’ 

performance with respect to health and safety and security was acceptable. Documentation 

adequately supported the cited violations, recommendations made to the licensee, unresolved 

safety issues, and discussions held with the licensee during exit interviews. Team inspections 

were performed when appropriate and were also utilized for training purposes. 

Review team members accompanied 11 inspectors from all three programs during the period of 

May 2 through June 3, 2011. The accompaniments included inspections of medical institutions, 

medical broad scope, industrial radiography, gauges, open air irradiators, effluent monitoring, 

Increased Controls and an accompaniment of an inspector during a waste site inspection. The 

facilities inspected are identified in Appendix C. During the accompaniments, each inspector 

demonstrated appropriate inspection techniques and knowledge of the regulations. The 

inspectors were prepared for the inspections, and thorough in their reviews of the licensees’ 

radiation safety programs. Each inspector conducted confirmatory measurements and utilized 

good health physics practices. The inspections adequately assessed radiological health, safety 

and security at the licensed facilities. 

The review team noted that all three programs had an adequate supply of portable radiation 

detection instruments for use during routine inspections and response to incidents and 

emergencies. Each program uses an outside vendor for instrument service and calibration, 

and/or has in-house capability to perform instrument calibrations. The portable instruments 

used during the inspector accompaniments were operational and calibrated. All three programs 

have the capability to analyze alpha, beta, and gamma contamination samples. 

3.3.1 New York City Department of Health and Mental Hygiene

The NYC inspection staff consists of four staff members plus a supervisor. Three of these 

individuals are being cross-trained to perform machine source (X-Ray) inspections. The 

inspectors are typically in the field Monday through Thursday of each week and in the office on 

Fridays. 

The inspection field notes contained adequate, consistent documentation of inspection findings. 

NYC divides its licenses into seven categories (limited non-human use, broad non-human use, 

broad human use, limited human use, teletherapy, and gamma knife). There are separate 

inspection field notes and checklist forms for each category except gamma knife, as well as a 

form for Increased Controls security inspections. NYC management noted that they are 

considering a change to performance-based inspections and agreed that inspection field notes 

forms will be updated, as needed, to correspond to the ongoing regulation revisions. 
New York Final IMPEP Report Page 11 

To ensure consistency of inspection documentation and findings, the inspection supervisor 

conducts reviews of the staff member’s field notes. Although the inspection supervisor 

independently performed inspections, his work was not consistently reviewed by another 

supervisor or manager. 

NYC has a policy of performing annual supervisory accompaniments of each inspector. Based 

on a review of records provided by NYC, the review team concluded that each inspector was 

accompanied by the supervisor at least once a year during the review period. Although the 

inspection supervisor independently performed inspections, he was not consistently 

accompanied each year by another supervisor or manager. NYC management agreed that, in 

the future, annual accompaniments will be performed for the inspection supervisor. 

The review team determined that inspection files for Increased Controls security inspections are 

stored in a secure location. The review team noted that these file folders are not marked as 

containing security-related information. In addition, letters to licensees containing securityrelated inspection information are not marked to indicate this. NYC management agreed to 

develop a system to distinguish file folders containing security-related inspection information 

and to begin marking letters to licensees containing security-related information. 

3.3.2 New York State Department of Health

The DOH inspection staff is split between the central office and field offices. A field supervisor 

and 11 staff members are based in the central office, with 50 percent of the field supervisor’s 

time and no more than 25 percent of each staff member’s time assigned to radioactive materials 

compliance. Seven staff members are based in field offices, with four individuals assigned to 

devote at least 50 percent of their time to radioactive materials. 

The inspection field notes contained adequate and consistent documentation of inspection 

findings. DOH uses a series of forms to record field notes for different types of inspections, 

including medical, laboratory, PET cyclotron, nuclear pharmacy, other unsealed source, 

irradiator, fixed radioactive material device, portable radioactive material device, and Increased 

Controls. The review team determined that there are no formal inspection procedures; staff 

stated that the field note forms serve as inspection procedures and inspectors use NRC 

inspection procedures as references. 

To ensure consistency and quality of inspection documentation and findings, the field supervisor 

conducts reviews of the staff members’ inspection documentation. For central office staff, the 

field supervisor reviews the inspection field notes. For field office staff, the inspectors call the 

supervisor to discuss issues identified during inspections. The supervisor reviews a faxed copy 

of inspection letters sent by field office staff to licensees; however, this is somewhat inconsistent 

for inspections in which no violations are identified. The supervisor agreed to develop a system 

to review inspection field notes for field office staff. 

DOH has a policy of performing annual supervisory accompaniments of inspectors; however, 

these have been inconsistently performed. In the year preceding the on-site IMPEP review, 10 

of 18 active inspectors were accompanied by a supervisor. 

 
New York Final IMPEP Report Page 12 

3.3.3 New York State Department of Environmental Conservation

The DEC inspection staff is split between two Sections, the Radiological Sites Section and the 

Radiation Control Permits Section. At the time of the review, the Radiological Sites Section had 

a Chief and six staff members. The Radiation Control Permits Section had a Chief and four 

staff members. 

During the review period, 72 inspections were conducted; 3 of those were initial inspections of 

new permits. The review team evaluated 10 completed inspection reports and found the reports 

to be very thorough with inspection findings well documented. Inspection findings were 

consistently compared to the permit and regulatory requirements. Prior to the inspection, a full 

briefing is held between the inspectors and the Section Chief to discuss the inspection. The 

review team found that unresolved issues, recent changes to the permit, and specific concerns 

of the inspector were well documented in the inspection reports. The completed reports were 

reviewed by supervisory personnel. Escalated enforcement procedures are in place and 

followed, as needed. 

The review team evaluated the latest version of DEC’s permit inspection and enforcement 

procedures and all current inspection forms. In general, all procedures and forms appear to be 

consistent with the applicable guidance found in IMC 2800. 

The review team determined that supervisory accompaniments of DEC inspectors 

are conducted on an annual basis. 

3.3.4 Indicator Summary

Team accompaniments of inspectors from the three programs demonstrated competent, 

thorough, safety-oriented inspections. The inspection processes and documentation for all 

programs were well implemented. 

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 Inspections, be 

found satisfactory. 

3.4 Technical Quality of Licensing Actions

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

specific licenses for each of the New York programs. A total of 48 licensing actions were 

examined, including new license issuances, terminations, amendments (including financial 

assurance and Increased Controls amendments), renewals, and modifications to permits (DEC). 

The actions reviewed encompassed the work of license reviewers currently with each Program 

as well as those who have left each Program during the review period. The sample included a 

variety of license types, including broad scope academic, broad scope medical, broad scope 

research and development, gamma knife, high dose-rate remote afterloaders, industrial 

radiography, irradiators, nuclear pharmacy, portable gauge, radioactive waste brokers, and 

veterinary teletherapy. A listing of the licensing casework reviewed, with case-specific 

comments, may be found in Appendix D. 
New York Final IMPEP Report Page 13 

Licensing actions were evaluated for completeness, consistency, proper radioisotopes and 

quantities used, qualifications of radiation safety officers and authorized users, adequate 

facilities and equipment, sufficient operating and emergency procedures, consideration of 

enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, 

proper signature authorities, and overall technical quality. The casework was also checked for 

retention of necessary documents and supporting data. 

3.4.1 New York City Department of Health and Mental Hygiene

The review team examined a random sample of completed casework and interviewed license 

reviewers for 758 licensing actions performed by NYC over the review period. 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, security requirements, operating and emergency 

procedures, appropriateness of license conditions, and overall technical quality. The casework 

was also reviewed for use of appropriate correspondence, reference to appropriate regulations, 

supporting documentation, consideration of enforcement history, pre-licensing visits, peer and 

supervisory review, and proper signatures. These items were generally found to be adequately 

performed unless specifically noted below. 

The review team noted that NYC does not use licensing check-lists designed to ensure 

consistency in licensing actions, and that licensing guidance documents used by NYC were 

developed in 1991. The review team discussed the advantages of using the most current 

guidance including the NUREG 1556 series of licensing guidance. However, no inconsistencies 

were noted by the review team. Licenses are being amended by using the previous license 

issued and incorporating the requested changes. 

The review team found that noted deficiencies in licensee submissions are often handled by 

undocumented telephone calls and e-mail. The review team discussed the importance of fully 

documenting licensee requests in response to license application deficiencies with NYC 

management and staff, noting that a complete and well documented licensing action assists the 

inspectors and demonstrates the steps taken by the license writer and the licensee, in order to 

issue an amended license. 

The review team assessed NYC’s implementation of NRC’s pre-licensing guidance issued on 

September 22, 2008, and transmitted to the Agreement States via RCPD-08-020, “Requesting 

Implementation of the Checklist to Provide a Basis for Confidence That Radioactive Material 

Will Be Used as Specified on a License and the Checklist for Risk-Significant Radioactive 

Material.” States were given 6 months from the date of the letter to incorporate the essential 

objectives of the revised pre-licensing guidance into their respective licensing programs. 

Based on the licensing casework reviewed, the review team found that NYC had not 

implemented the essential elements of the pre-licensing guidance for any licensing actions 

initiated during the review period. Furthermore, NYC had not performed any pre-licensing visits. 

Since NYC failed to apply the guidance as required, NYC had no indication what licensees 

might require a pre-licensing visit. The review team suggested that NYC audit those licensing 

actions performed between the implementation dates of the guidance through the last date of 

the review and apply the guidance to determine if any licensing actions had been 

inappropriately issued. The review team also discussed the need to apply the pre-licensing 
New York Final IMPEP Report Page 14 

guidance to all future licensing actions to determine and document the basis for confidence, that 

radioactive materials will be used as intended and as described in the application or amendment 

request, prior to authorizing the material on the license. On June 30, 2011, the review team 

received notification from NYC indicating they had retroactively applied the pre-licensing criteria 

to all new licenses issued since the November 2006 IMPEP review and found that none had 

met the threshold requirements requiring a pre-licensing site visit. NYC committed to using the 

pre-licensing guidance in the future. 

The review team observed that NYC did not typically review the enforcement history during the 

license renewal process. The review team expressed to the reviewer that license renewals are 

opportunities for the staff to review the licensee’s history and to evaluate the historical licensing 

and inspection documentation and perform a quality assurance assessment of the license file. 

The review team reviewed the license files for those licensees subject to the ICs. In 2005, in 

order to meet compatibility requirements, NYC submitted to the NRC, a proposed license 

condition and letter to implement the ICs. NRC approved the submitted license condition and 

letter; however, NYC chose not to implement the ICs by license condition but through the 

issuance of a Commissioner’s Order to their IC licensees requiring them to implement the 

provisions of the IC Order. This Commissioner’s order was never submitted to NRC for 

compatibility purposes. The team discussed the importance of this matter with Program 

management and presented two options to either add the originally approved license condition 

to the IC licenses referencing the Commissioner’s Order or submit the Commissioner’s Order to 

NRC for a compatibility review. In an email dated June 16, 2011, the NYC AC stated that these 

IC license amendments were completed on June 17, 2011 (ML111990186). 

3.4.2 New York State Department of Health

The review team found that a random sampling of DOH’s 1,094 licensing actions completed 

during the review period were thorough, complete, consistent, and of high quality with health 

and safety issues properly addressed. The licensee’s compliance history is taken into 

account when reviewing renewal applications. 

The review team noted that license conditions, including tie-down conditions, are stated clearly, 

backed by information contained in the file, and they appear enforceable. Deficiency letters are 

well-written, clearly indicate DOH’s regulatory position, and are used at the appropriate times. 

License reviewers appropriately used DOH’s licensing guides and standard license conditions. 

The review team found that the terminated licensing actions were well-documented, showing 

appropriate transfer and survey records. License reviewers have the proper signature authority 

for the cases they review. All licensing actions are peer reviewed by license reviewers for 

content, grammar, and format. Pre-licensing guidance is applied and pre-licensing visits are 

being performed where necessary. 

The review team examined the licensees that DOH determined met the criteria for the ICs, per 

COMSECY-05-0028. The review team determined that DOH had correctly identified the 

licensees that require ICs based on these criteria, and will continue to issue ICs to any 

additional licensees, as appropriate. Each license was amended to include the IC requirements 

as license conditions. DOH issued the ICs in accordance with the timeline established by the 

NRC in the SRM for COMSECY-05-0028. 
New York Final IMPEP Report Page 15 

The review team noted that DOH currently has a total of 73 licenses that have been under 

timely renewal for more than one year. One license has been under timely renewal for the past 

21 years, and 10 have been under timely renewal for more than 5 years. This issue was 

discussed with DOH managers who stated they will get the renewals completed. DOH 

attributed this backlog to a staffing issue. DOH added that this is an area where they have been 

forced to choose how to apply their limited resources and that they will try to finish them as soon 

as they can. 

 3.4.3 New York State Department of Environmental Conservation

The review team found that DEC’s permitting actions were thorough, complete, consistent, and 

of high technical quality with health and safety issues properly addressed. Permit files contain 

extensive documentation of the permitting process, including memorandum and electronic mail 

messages between permit reviewers and senior management. Permit reviewers routinely 

conduct confirmatory inspections and calculations to verify permit holder status, commitments, 

and findings presented by permit holders during the permitting process. Permits issued by DEC 

often incorporate references and conditions related to other permits required by DEC. The 

review team determined that the permit holder’s compliance history appeared to always be 

taken into account when reviewing renewal applications, as determined from documentation in 

the permit files and discussion with the permit reviewers. 

The review team found that permit cancellation actions were well-documented, showing either 

survey findings or documentation that the permit holder’s effluents did not exceed the 10 

percent exemption limit. The casework review indicated that permitting staff follow their 

guidance during the review process to ensure that the permit holders submit the information 

necessary to support a permit. The review team found the checklists and the worksheets for 

each type of permit to be comprehensive and incorporated excellent notes to reviewers to 

assist in the review of the applications. Permit tie-down conditions were stated clearly, backed 

by information contained in the file, and enforceable. Each permitting action receives a 

supervisory chain review. Letters of deficiency clearly stated regulatory positions, are used at 

appropriate times, and are signed by upper management. 

Once DEC completes the permit review and drafts the permit document, DEC forwards the draft 

permit to one of nine permit administrators located throughout the State. The actual permit is 

then signed and issued by the permit administrator. The Section Chief monitors the status of 

permits sent to the regional permit administrator for issuance, documents the status in monthly 

reports, and maintains contact with the regional permit administrator until the permit is issued. 

In the case of an excessive delay, metrics for the outstanding permit are communicated to 

DEC’s Chief Permit Administrator for follow-up action. 

3.4.4 Indicator Summary

The review team identified the following performance concerns related to licensing that were 

discussed in the Sections for the individual Programs. 

The review team found that NYC had not implemented the pre-licensing guidance to determine 

if any licensing actions had been issued inappropriately, nor have they performed any prelicensing visits. The team also noted that NYC did not review past enforcement history during 
New York Final IMPEP Report Page 16 

the license renewal process as a means of performing quality assurance on the license file. 

The review team found follow-up questions to licensing actions are often performed via 

undocumented telephone calls and email. 

In the case of DOH, the review team found that DOH consistently applies the most current 

guidance, uses checklists to ensure consistency, and has implemented the pre-licensing 

guidance. However, the review team noted that licensing was another area within the DOH 

materials program where the lack of staff has affected or diminished the Program’s 

performance. At the time of the 2006 review DOH had 33 licenses under timely renewal for 

more than one year. During the 2011 review, DOH now had 73 licenses under timely renewal 

for more than one year. Ten licenses have been under timely renewal for more than 5 years 

with one of those being under timely renewal for 21 years. 

In the case of DEC, the review team found the unit to be producing high quality work with little 

difficulty. While DEC is slightly down on staff, it has been able to keep up with the workload. 

Reviews of inspection and enforcement history, application of guidance documents, and 

consideration of health and safety issues are key features for a satisfactory performance in 

technical quality of licensing. For one of the three agencies, the review team noted repeated 

examples where licensing actions did not apply required guidance and documentation 

supporting licensing actions was not complete. 

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 Licensing 

Actions, be found satisfactory, but needs improvement. 

3.5 Technical Quality of Incident and Allegation Activities

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

allegations, the review team examined each program’s response to the questionnaire relative to 

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

Events Database (NMED) against those contained in the respective program’s files, and 

evaluated the casework and supporting documentation for 18 radioactive materials incidents. A 

listing of the incident casework examined, with case-specific comments, may be found in 

Appendix E. The review team also assessed the responsible program’s response to three 

allegations involving radioactive materials, including three allegations referred to the responsible 

program by the NRC during the review period. 

The review team discussed incident and allegation procedures, file documentation, each 

program’s event and allegation tracking system, NMED, and notification of incidents to the 

NRC’s Headquarters Operations Center based on the guidance in NRC’s Office of Federal and 

State Materials and Environmental Management Programs (FSME) Procedure SA-300, 

“Reporting Materials Incidents”, with the Program Managers and selected staff. The incidents 

included: lost/stolen materials, equipment failures/disconnects, contamination/spills, damaged 

devices and packages, and medical events. 
New York Final IMPEP Report Page 17 

3.5.1 New York City Department of Health and Mental Hygiene

The review team noted that NYC’s questionnaire response indicated that no reportable 

incidents were received during the review period. Following discussions of this indicator with 

NYC staff and review of files, the team found that this was not correct. 

NYC staff informed the review team that in 2009, NYC Department of Health and Mental 

Hygiene issued an Information Notice (2009-03) to remind Licensees and Certified 

Registrants of the requirements specified in Article 175 of the NYC Health Code for reporting 

medical events involving radiation. The reporting requirements apply to all radiation 

equipment and radioactive material use. Subsequent to the Information Notice, NYC sent 

Orders to licensees in 2009 and 2010, requesting information on the total number of 

treatments performed, and the number of recordable and reportable errors between the 

years 2006 and 2009, as required by Health Code 175. Approximately 90 licensees 

responded. The review team reviewed the file of responses and identified two incidents that 

were reportable under NRC regulations: one report of a dose to an embryo/fetus and one 

medical event. The review team also noted that NYC had not identified these two incidents 

as being reportable to NRC. NYC staff reported that they had performed follow-up by e-mail 

to one of the two incidents and no follow-up to the other incident. Following discussion with 

the IMPEP team, NYC reported these incidents to the NRC Operations Center on June 15, 

2011, during the IMPEP review. 

Based on the response to the request for information from their licensees, NYC staff developed 

a summary document entitled “Summary of Misadministrations for NYC 2006-2009”. This 

document included statistical information from 14 licensees of reportable/recordable incidents 

between 2006 and 2009 and included both radiation equipment and radioactive materials 

incidents. While on site, the review team made several requests for documentation to 

determine how NYC evaluated the statistical information received from licensees, what type of 

follow-up they performed, and if any follow-up was performed in accordance with their Policy 

and Procedure Manual for Incident Response. 

On June 28, 2011, NYC submitted, in retrospect, a tabular summary of “Institutions with 

Confirmed Incident Reports for NYC 2006-2009.” This table showed a total of 14 reported 

events with seven of them being subject to reporting. The summary did not contain any 

information as to whether additional reports will be made to the NRC or if NYC performed any 

follow-up investigations/inspections in accordance with NYC incident follow-up procedures. On 

August 8, 2011, NYC provided the review team with an updated table reflecting 13 reportable 

events with 2 of them being subject to reporting. 

Based on the above noted issues related to incident identification and follow-up, the review 

team is recommending the following: 

• NYC respond to each incident received in accordance with its established Incident 

Response Procedure. 

• NYC modify its Incident Response Procedure to add timely notifications to the NRC 

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

 
New York Final IMPEP Report Page 18 

• 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. 

Additionally, the review team assessed NYC’s response to one allegation involving 

radioactive material during the review period. The review team noted that NYC performed a 

prompt and appropriate on-site investigation. The alleged radiation safety concerns were 

not substantiated, and proper follow-up, notification and close-out were made. 

3.5.2 New York State Department of Health

During the review period, DOH investigated 279 incidents. The review team evaluated 13 

incidents requiring reporting to the NRC and three allegations. DOH utilizes an automated 

incident/event tracking system called “Incident.” This database is tied directly to DOH’s 

licensing/inspection database and prompts the user to investigate the root cause or 

contributing factors surrounding each incident. There is also a reminder to notify NRC, as 

appropriate. The “Incident” database permits the staff to identify incidents and to follow trends. 

Incidents and allegations are posted to the individual licensing and inspection files for follow-up 

action, as appropriate. DOH’s response to incidents and allegations are investigated based on 

their radiological health and safety significance. On-site investigations are well-documented, 

prompt, and comprehensive. Initial responses were coordinated and complete, and the level of 

effort was commensurate with the health and safety significance. Inspectors were promptly 

dispatched for on-site investigations, when appropriate, and took suitable enforcement action. 

Corrective actions were appropriately followed up during the course of the incident’s 

investigation and prior to closure. 

The review team reviewed the files for approximately half of all incidents (414) that were 

reported to DOH during the review period. These include both material and non-material 

incidents. During the review period, DOH reported 26 incidents (not including Wal-Mart Exit 

Signs) to the NRC Operation Center. Of those 26 reported incidents, only three were reported 

in accordance with the timeliness requirements found in SA-300. Of approximately 200 incident 

files reviewed, the review team identified eight incidents that should have been reported to the 

NRC but were not. The review team notified DOH of the eight unreported incidents and before 

the review was completed, DOH was already working on reporting these incidents. The review 

team also informed DOH that they needed to perform a review of the additional 200 incident 

files to determine if additional incidents should be reported to NRC. DOH agreed to begin that 

review and notify NRC when it was completed. In reviewing incident and allegation response 

procedures, the team found that DOH does not have a documented incident response 

procedure, nor does DOH have a documented allegation response procedure. The review team 

recommends 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 SA-300. 

3.5.3 New York State Department of Environmental Conservation

The review team evaluated DEC’s response to two radioactive material incidents. DEC’s 

response to incidents was complete and comprehensive. The staff’s initial responses were 

prompt, well-coordinated and at a level commensurate with the health and safety 
New York Final IMPEP Report Page 19 

significance of the incident. DEC dispatched inspectors for on-site investigations, as 

appropriate, and took enforcement and follow-up action, as needed. DEC did not have any 

incidents that met the criteria for reporting to NMED. The review team assessed DEC’s 

response to one allegation involving radioactive material. Prompt and appropriate 

investigations were conducted through on-site and telephone contact with the allegers. The 

alleged radiation safety concerns were not substantiated and proper follow-up, notification, 

and close-out were made. 

3.5.4 Indicator Summary

The review team found several issues related to incident identification, application of reporting 

regulations, and timeliness in reporting that were discussed with the individual Programs. 

In 2009, NYC issued Information Notice 2009-03 reminding its licensees of the regulatory 

requirement to report incidents. Subsequently, NYC issued Orders to its licensees to get them 

to report statistical incident information. Once the information was received, NYC did not 

promptly perform a review to determine whether these incidents were reportable. For events 

they were aware of, staff was unable to accurately apply the reporting criteria as they failed to 

report events that were reportable. Additionally, subsequent to the review, NYC again 

demonstrated its inability to apply the reporting criteria by reporting an incident that was not 

reportable. 

While DOH is able to apply the reporting criteria to incidents under its jurisdiction, DOH 

experienced difficulties in timely reporting. During the review period, DOH reported 26 incidents 

of which 23 were not reported in a timely manner. DOH attributes this issue to the lack of staff. 

Additionally, DOH has also experienced difficulty in identifying reportable events. Of 

approximately 200 incident files reviewed by the review team, eight reportable incidents were 

found to have not been reported. DOH has another 200 files to review to determine if any 

additional incidents should have been reported. 

While DEC has far fewer incidents to respond to, DEC responded in a timely and efficient 

manner. The team found no issues with DEC’s incident response or allegation processes. 

The team is making the following recommendations: NYC: 1) NYC respond to each incident 

received in accordance with their established Incident Response Procedure; 2) NYC modify 

their Incident Response Procedure to add timely notifications to the NRC Operations Center in 

accordance with the timelines identified in SA-300; 3) NYC evaluate all incident statistical 

information received from licensees, both past and future, and follow-up in a manner to ensure 

that each incident is properly evaluated for health, safety, and security implications; and 4) 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 SA-300. 

Identification of corrective actions, timely incident response, follow-up inspections, and event 

notifications of the NRC are key features for a satisfactory performance in technical quality of 

incidents and allegations. One of the three agencies demonstrated response to incidents to be 

incomplete, inappropriate, and poorly coordinated. Another agency was delinquent with several 

notifications. 
New York Final IMPEP Report Page 20 

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 unsatisfactory 

4.0 NON-COMMON PERFORMANCE INDICATORS 

IMPEP identifies four non-common performance indicators to be used in reviewing 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. New York State does not currently have a Uranium Recovery Program, therefore, 

only the first three non-common performance indicators were applicable to this review. 

4.1 Compatibility Requirements

4.1.1 Legislation

New York became an Agreement State on October 15, 1962. Historically, there have been four 

separate programs regulating ionizing radiation in the State of New York; NYC, DOH, New York 

State Department of Labor (DOL), and DEC. Due to the merging of DOH and DOL in 2006 

there are now only three programs; NYC, DOH, and DEC. 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). 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. DOH’s legislative authority to administer its portion 

of the Agreement with the NRC is granted in New York Public Health Law, Article 2, Title II, 

Sections 201 and 225. Effective July 1, 2006, Part B of Chapter 58 of the Laws of 2006 

(S6458/A9558-B) merged the radioactive materials program of DOL with DOH. Articles 1, 3, 17, 

19, 29, and 37 of the Environmental Conservation Law provide DEC with the authority to 

implement its radiation program. 

4.1.2 Program Elements Required for Compatibility

The review team assessed the status of the regulations required for adoption, evaluated each 

program’s response to the questionnaire, 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 NRC’s State Regulation Status Data 

Sheet. Interviews were conducted with the staff and files were reviewed to confirm the use of 

license conditions when regulations were not adopted within the 3-year time frame. 

The review team found that all programs provide the opportunity for public comment during the 

regulatory adoption process. The regulations for all programs are not subject to sunset 

provisions. 

NYC regulations are found in Article 175 of the New York City Health Code. NYC’s regulatory 

adoption process can take upwards of two years to complete, depending on the complexity of 

the rule change. 

Since the 2006 IMPEP review, NYC has adopted thirteen NRC amendments. 
New York Final IMPEP Report Page 21 

For NYC, the following eight NRC amendments are overdue for adoption: 

• “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. 

• “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. 

• “Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for 

Medical Use,” 10 CFR Parts 30, 32, and 35 amendments (59 FR 61767; 59 FR 65243; 60 

FR 322), that became effective on January 1, 1995 and was due for Agreement State 

adoption by January 1, 1998. 

• “Minor Corrections, Clarifying Changes, and a Minor Policy Change,” 10 CFR Parts 20, 35, 

and 36 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. 

• “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. 

• “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. 

• “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. 

• “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. 

For NYC, the following NRC amendment will need to be addressed in upcoming rulemakings or 

by adopting alternate legally binding requirements: 

• “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 regulations are found in 10 NYCRR Chapter 1, Part 16 (Ionizing Radiation), Part 76 

(Public Health Administrative Tribunal), and Part 405 (Hospitals-Minimum Standards) of the 

New York State Public Health Code. DOH’s regulatory adoption process takes approximately 

two years, dependent on the complexity of the rule change. 
New York Final IMPEP Report Page 22 

Since the 2006 IMPEP, DOH adopted eleven NRC amendments. 

For DOH, the following 16 NRC amendments are overdue for adoption: 

• “Quality Management Program and Misadministrations,” 10 CFR Part 35 amendment (56 FR 

34104), that became effective on January 27, 1992 and was due for Agreement State 

adoption by January 27, 1995. 

• “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. 

• “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. 

• “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70 

amendments (62 FR 39057), that became effective August 20, 1997 and was due for 

Agreement State adoption on August 20, 2000. 

• “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. 

• “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. 

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct 

Material,” 10 CFR Parts 30, 31, and 32 amendments (65 FR 79162), that became effective 

on February 16, 2001 and was due for Agreement State adoption on February 16, 2004. 

• “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. 

• “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. 

• “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40, and 70 amendments 

(68 FR 57327), that became effective on December 3, 2003, and was due for Agreement 

State adoption by December 3, 2006. 

• “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 April 24, 2005. 
New York Final IMPEP Report Page 23 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendments (71 FR 15005), 

that became effective on March 27, 2006, and is due for Agreement State adoption by 

March 27, 2009. 

• “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. 

• “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. 

• “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. 

• “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. 

For DOH, the following NRC amendment will need to be addressed in upcoming rulemakings or 

by adopting alternate legally binding requirements: 

• “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. 

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. 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 LLRW shipments into, within, and through New York State. DEC’s 

regulatory adoption process takes approximately two years to complete if there are no mitigating 

factors. 

Since the 2006 IMPEP, DEC adopted two NRC amendments. 

For DEC, the following eight NRC amendments are overdue for adoption: 

• “Notification of Incidents,” 10 CFR Parts 20, 30, 31, 34, 39, 40, and 70 amendments (58 FR 

64980), that became effective on October 15, 1991, and was due for Agreement State 

adoption by August 15, 1994. 

• “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. 
New York Final IMPEP Report Page 24 

• “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. 

• “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. 

• “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. 

• “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. 

• “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. 

• “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. 

4.1.3 Indicator Summary

The review team noted that all programs continue to have an extensive number of overdue NRC 

amendments. The review team concluded that the delay in the promulgation of regulations was 

caused in part by the need to address higher priority issues that may affect public health and 

safety, and the State’s lengthy promulgation process. All three Programs currently have in 

place a performance improvement plan (PIP) that addresses each Program’s plan for adopting 

overdue NRC regulations. The team reviewed these plans and noted that some overdue 

regulations were not incorporated into the current PIPs. The PIP for each Program should be 

revised to incorporate any missing overdue NRC amendments and to incorporate each 

Program’s plan for adoption. 

Based upon 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 (SS&D) Evaluation Program

The New York State Department of Health has sole responsibility for performing SS&D 

evaluations in the State of New York. Three sub-indicators were used to evaluate the 

Department’s performance regarding the SS&D Evaluation Program. These sub-indicators are: 

(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 25 

In assessing the Department’s SS&D Evaluation Program, the review team examined 

information gathered from data contained in the National Sealed Source and Device Registry. 

In the IMPEP questionnaire response, the Department indicated that three SS&D evaluations 

had been performed since the previous IMPEP. However, during the review, the team 

determined that actually four SS&D evaluations had been performed since the previous IMPEP. 

The review team assessed the documentation for the four SS&D evaluations performed and 

interviewed staff and management involved in SS&D evaluations. 

4.2.1 Technical Staffing and Training

The team found that DOH currently has two reviewers who are considered qualified by the 

Program to conduct and sign safety evaluations of SS&D applications. Both have attended 

training the Program requires for qualification. The team also noted that the current manager 

responsible for oversight of the SS&D program is not a qualified reviewer and is therefore not 

qualified to perform secondary reviews. The team noted that for each of the reviews conducted 

during the review period, secondary reviews had been performed by a former Program Manager 

who had been qualified to perform the reviews. 

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

SS&D evaluation process, as well as available guidance and reference documents. While the 

team did not note any performance issues associated with the Program’s SS&D reviews, the 

review team found that DOH does not have a formal qualification program. They also do not 

have a set number of reviews to be conducted by each individual prior to being considered 

qualified to independently perform SS&D reviews. This is mainly due to the low number of 

evaluations performed annually. Program management authorizes signature authority after the 

individual has completed required training classes. 

 

DOH provided the training policy used by the Program for SS&D reviewers in training. The 

review team determined, based on Program requirements for qualification, that the reviewers 

appear qualified to review and sign SS&D evaluations, and that the DOH appears to have a 

sufficient number of qualified reviewers to adequately handle their workload. DOH noted that 

they have one additional individual qualified to perform SS&D reviews. This individual now 

works for another part of DOH, but can be called upon to assist if needed. 

4.2.2 Technical Quality of the Product Evaluation Program

DOH processed four new SS&D applications since the last review and performed no 

amendments to existing SS&D evaluations. A listing of the SS&D certificates evaluated by the 

review team, with case specific comments, can be found in Appendix F. The casework review 

indicated that DOH 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 evaluation-qualified reviewer. The review team found no health 

and safety issues relative to the SS&D evaluations. 

 
New York Final IMPEP Report Page 26 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

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

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

and DOH files. 

 

4.2.4 Indicator Summary

DOH performed four SS&D evaluations since the last IMPEP review. These evaluations 

adequately addressed health and safety issues and were of sufficient technical 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, Sealed Source and Device 

Evaluation Program, be found satisfactory. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

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. 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 permit for the SDA from the DEC, which regulates monitoring 

and maintenance of the facility. NYSERDA also holds a radioactive materials license from the 

Industrial Unit for the West Valley Site. 

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. Low-level 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. The review team reviewed a 
New York Final IMPEP Report Page 27 

substantive permit issued by DEC in April 2002 authorizing discharges of radioactive materials, 

the presence of which is incidental to discharges of the groundwater treatment system. When 

remedial activities required by the Consent Order have ended, DEC will issue a permit through 

the radiation program for monitoring and maintenance activities at the RDS. 

4.3.1 Technical Staffing and Training

Currently, one DEC inspector is assigned to conduct inspections and environmental monitoring 

at the West Valley site, and inspections at Cornell disposal site. At times, the staff from DEC 

regional offices accompanies the inspector to observe and to assist with inspections and 

sampling. The review team evaluated the training, experience, and the educational 

qualifications for this inspector. DEC uses a mentor approach for training inspectors. The 

Section Chief will accompany the inspector and verify that inspection procedures and protocol 

are followed on the inspection. The DEC inspectors have the proper education qualifications 

and experience and take the necessary courses to prepare them for the job. While the review 

team noted no performance issues, they did note that DEC had no formal training program to 

document and track staff training. While DEC inspectors were well qualified and well trained, 

DEC managers determined their program could benefit from formally documenting training 

within the Program and immediately began developing a process to document and track training 

for DEC inspectors. 

DOH’s low-level waste inspectors are also trained in a manner similar to DEC inspectors. While 

the review team again noted no performance issues, they noted that DOH also had no formal 

training program to document and track staff training. While DOH inspectors are also well 

qualified and well trained, DOH management believes that the current manner in which they 

develop staff is sufficient and did not see a need to make any changes at this time. 

4.3.2 Status of Low-Level Radioactive Waste Disposal Inspections

Both DEC and DOH have one year inspection frequencies at West Valley. DEC has a one year 

frequency for the Cornell site as well. The review team confirmed that DOH inspected the West 

Valley license annually. 

DEC inspected the West Valley site four times during the review period of November 2006 to 

June 2011. West Valley was inspected October 2006, September 2009, October 2010 and 

June 2011. DEC did not have a documented inspection of the West Valley site in 2007 or 2008. 

The DEC staff admitted they did not have an official site inspection for a 25 month period. They 

explained that most efforts were involved with participating in a DOE, NRC and EPA working 

group focused on the development of an Environmental Impact Statement for West Valley. In 

2007, the West Valley environmental monitor position was occupied with an individual who was 

responsible for both the West Valley and Cornell sites. In 2007, DEC hired an additional 

inspector who, in 2008, was assigned to assist the West Valley environmental monitor. In 2009, 

the West Valley monitor position became vacant and since that time, the inspector hired in 2007 

has continued to work both the West Valley and Cornell sites until the West Valley position is 

filled. 
New York Final IMPEP Report Page 28 

DEC acknowledged that it missed two inspections and has taken actions to correct its program 

with yearly inspections being performed as required in 2009, 2010 and 2011. Regarding the 

timeliness of inspection reports, the review team noted that three of the inspection reports were 

issued greater than 30 days after the completion of the inspection. It was noted that DEC was 

issuing its inspection reports within 30 business days rather than 30 calendar days as required 

due to a miscommunication. The review team clarified the requirement and DEC has made the 

necessary change. 

The review team also reviewed DOH’s inspections for its Radiological Environmental Monitoring 

Program at West Valley. The inspections were completed on time throughout the review period. 

The team found that DOH issued its inspection reports to NYSERDA within 30 business days of 

completion of the inspection. DOH expressed interest in changing the frequency of its 

inspection or asking for assistance from DEC. However with any change to its program, DOH 

will need to develop a technical justification and update its inspection procedures. 

4.3.3 Technical Quality of Inspections

The review team evaluated all DEC and DOH inspection reports and found the scope and 

quality of the reports to be complete and thorough and emphasized public health and safety, as 

well as protection of the environment. Overall, the inspection reports were of high technical 

quality. DEC inspects the burial sites for fence and trench cover integrity. Drainage basins, 

storage buildings, surrounding land surfaces, and surface water drainage pathways are also 

inspected. In addition to the routine inspections, pre-operational and follow-up inspections, as 

well as site visits in conjunction with various stakeholders, are conducted by DEC staff. 

DEC conducts environmental monitoring at the burial sites, including surface water and 

sediment sampling. In 2005 DEC discontinued deployment of thermoluminescent dosimeters 

(TLDs) at the West Valley site. Since that time, the site operator NYSERDA has deployed TLDs 

at West Valley. TLDs are placed along the boundary fence line, at each of the three off-site 

creeks, the nearest residence, Sardinia and Rock Spring Road. Surface water and sediment 

samples are collected from the three creeks. Cornell University has always deployed TLDs at 

the Cornell site. 

The DEC inspector has been accompanied by a supervisor annually during the last three field 

inspections. The review team found this frequency acceptable given the small number of 

inspections performed by the DEC staff. 

4.3.4 Technical Quality of Licensing

DOH has issued a radioactive material license to NYSERDA authorizing possession of the 

wastes previously disposed of at West Valley, management and maintenance of West Valley, 

and possession and treatment of radioactive solids and liquids generated as a result of 

management and maintenance activities. The license covers the on-site radiation control 

program, occupational exposure of individuals, and control of radioactive material as it affects 

occupational exposures. The review team evaluated a Radioactive Materials License renewal 

issued by the DOH for this license and found all associated licensing actions thorough, 

complete, and of high technical quality. 
New York Final IMPEP Report Page 29 

DEC has issued one permit to NYSERDA that authorizes the maintenance and monitoring of 

West Valley and the operation of the West Valley facilities for the purpose of controlling 

discharges of radionuclides to the environment. The permit was issued in 2009 in accordance 

with applicable provisions of the Environmental Conservation Law. The review team evaluated 

the permit and found all associated actions thorough, complete and of high technical quality. 

4.3.5 Technical Quality of Incidents and Allegations

DEC had one incident at the West Valley disposal site during the review period. West Valley’s 

trench 5, 6 and 7 suffered a tear in the geomembrane that covers the disposal cells. The review 

team evaluated the procedures and protocols for reporting incidents as well as the follow-up 

actions. 

The licensee, NYSERDA, notified DEC of the incident shortly after the problem was discovered. 

DEC followed up with communication to their regional office, DOH, DOE West Valley and all 

necessary entities that have any authority at West Valley. The review team noted that DEC 

conducted an inspection of the trenches, met with the licensee to develop a strategic plan and 

was present during repairs. DEC was very timely with their documentation, communication, and 

associated inspections and follow-up. The review team found that DEC procedures and 

protocol in handling incidents to be very thorough, complete and of high quality. 

4.3.6 Indicator Summary

The review team found that oversight of the two former radioactive waste disposal sites by DEC 

and the DOH is suitable and thorough. 

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 

Overall, the review team recommended, and the MRB agreed, that the New York Agreement 

State Program be found adequate to protect public health and safety, but needs improvement, 

and not compatible with NRC's program. As noted in Sections 2.0, 3.0, and 4.0 above, the 

review team recommended, and the MRB agreed, that New York’s performance be found 

unsatisfactory for the performance indicators, Technical Quality of Incident and Allegation 

Activities and Compatibility Requirements; and satisfactory, but needs improvement for the 

performance indicators, Technical Staffing and Training and Technical Quality of Licensing 

Actions. The review team found, and the MRB agreed, New York’s performance to be 

satisfactory for the other indicators reviewed. The review team made five recommendations 

regarding the performance of the State. 

Based on the results of the current IMPEP review, and in accordance with the criteria in NRC 

Management Directive 5.6, the review team recommended, and the MRB agreed, that the 

period of Heightened Oversight continue for the State of New York. The review team further 

recommended, and the MRB agreed, that a Periodic Meeting be held within 1 year to assess 

the State’s progress in addressing the open recommendations and that the next IMPEP review 
New York Final IMPEP Report Page 30 

be performed in approximately two years. 

One recommendation from the 2006 IMPEP remains open. The recommendation concerns the 

development and implementation of an action plan by NYC, DOH and DEC to adopt NRC 

regulations in accordance with the current NRC policy on adequacy and compatibility. (Section 

2.0) 

Below are the review team’s recommendations, as mentioned in the report, for evaluation and 

implementation by the State: 

RECOMMENDATIONS 

1. The review team recommends 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 3.2.2) 

2. The review team recommends that NYC respond to each incident received in 

accordance with its established Incident Response Procedure. (Section 3.5.1) 

3. The review team recommends that NYC modify the Incident Response Procedure to add 

timely notifications to the NRC Operations Center in accordance with the timelines 

identified in SA-300. (Section 3.5.1) 

4. The review team recommends that NYC evaluate all incident statistical information 

received from licensees, both retrospectively and prospectivley, and follow-up in a 

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

implications. (Section 3.5.1) 

5. The review team recommends 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 SA-300. (Section 3.5.2)
 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 Sealed Source and Device Casework Reviews 
 APPENDIX A 

 IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Randy Erickson, Region IV Team Leader 

 Technical Staffing and Training (NYC) 

 Inspector Accompaniments (DOH and NYC) 

Monica Orendi, Region I Status of Materials Inspection Program 

 Compatibility Requirements 

Sandra Gabriel, Region I Technical Quality of Inspections (DOH and NYC) 

Shirley, Xu, FSME Technical Quality of Licensing Actions (DEC) 

Technical Quality of Inspections (DEC) 

Technical Quality of Incident and Allegation 

Activities 

Stephen Poy, FSME Technical Staffing and Training (DOH and DEC) 

 Sealed Source and Device Evaluation Program 

Maurice Heath, FSME Low-Level Radioactive Waste Disposal Program 

James Thompson, Region IV Inspector Accompaniments (DOH and DEC) 

Ann Troxler, Louisiana Technical Quality of Licensing Actions 

 (DOH and NYC) 
APPENDIX B 

NEW YORK ORGANIZATION CHARTS 

ADAMS ACCESSION NOs.: 

ML111460433 – New York City Department of Health and Mental Hygiene 

ML111460503 – New York State Department of Health 

ML111290559 – New York State Department of Environmental Conservation 
 APPENDIX C 

 INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS 

ONLY. 

 New York City Department of Health and Mental Hygiene

File No.: 1 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/13/10 Inspector: OA 

File No.: 2 

Licensee: Weill Medical College of Cornell University License No.: 91-3197-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/23/08 Inspector: EC 

File No.: 3 

Licensee: Columbia-Presbyterian Medical Center License No.: 52-2878-04 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 12/14/06 Inspector: JH 

File No.: 4 

Licensee: Lenox Hill Hospital License Nos.: 91-2926-01 

Inspection Type: Special, Announced 92-2926-02 

Inspection Date: 5/11/11 Priority: 2 

Inspector: MR 

File No.: 5 

Licensee: Columbia-Presbyterian Medical Center License Nos.: 74-2878-03 

Inspection Type: Special, Announced 75-2878-01 

Inspection Date: 1/26/10 93-2878-05 

Priority: 2 

Inspector: MR 

File No.: 6 

Licensee: The Museum of Modern Art License No.: 52-2851-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/22/08 Inspector: JL 

Comment: 

No supervisory review. 

File No.: 7 

Licensee: George Varsos, M.D. License No.: 91-3126-01 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 6/11/09 Inspector: JH 
New York Final IMPEP Report Page C.2 

Inspection Casework Reviews 

File No.: 8 

Licensee: Frederick Feuerbach, M.D. License No.: 91-3231-01 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 12/12/06 Inspector: HT 

File No.: 9 

Licensee: New York City Veterinary Specialists License No.: 52-3334-01 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 5/3/07 Inspector: HT 

Comment: 

Report states inspection performed on 5/3/07. Letter to licensee refers to inspection 

performed on 5/10/07. 

File No.: 10 

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

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/10/09 Inspector: JH 

File No.: 11 

Licensee: Long Island Jewish Medical Center License No.: 75-2986-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/10/09 to 3/23/09 Inspector: JH 

File No.: 12 

Licensee: Shirish Thanawala, M.D. License No.: 91-2866-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/10/09 Inspector: OA 

File No.: 13 

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

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 12/21/06 Inspector: EC 

File No.: 14 

Licensee: Beth Israel Medical Center License No.: 91-2897-01 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 2/5/08 Inspector: OA 

File No.: 15 

Licensee: The New York Hospital Medical Center of Queens License No.: 91-2894-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/24/07 Inspector: JH 

File No.: 16 

Licensee: Lenox Hill Hospital License No.: 91-2926-01 

Inspection Type: Follow-up, Unannounced Priority: 2 

Inspection Date: 3/22/07 Inspector: JL 
New York Final IMPEP Report Page C.3 

Inspection Casework Reviews 

Comment: 

 No supervisory review. 

File No.: 17 

Licensee: Lenox Hill Hospital License No.: 92-2926-02 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/3/10 Inspector: JH 

 New York State Department of Health

File No.: 18 

Licensee: Massena Memorial Hospital License No.: 3248 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 10/30/07 Inspector: SG 

File No.: 19 

Licensee: William Bradley, DVM License No.: 3114 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/13/08 Inspector: AD 

File No.: 20 

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

Inspection Type: Routine, Special, Announced Priority: 1 

Inspection Date: 12/21/09 Inspector: DG 

Comment: 

Inspection performed 44 days overdue. Inspection documentation issued to licensee 

59 days after inspection. 

File No.: 21 

Licensee: Utica College License No.: 1143 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 12/10/09 Inspector: WV 

File No.: 22 

Licensee: Northern Westchester Hospital Center License No.: 0585 

Inspection Type: Routine, Special, Unannounced Priority: 2 

Inspection Date: 5/22-5/23/07 Inspector: AB 

File No.: 23 

Licensee: Buffalo Cancer Center License No.: 5041 

Inspection Type: Routine, Special, Unannounced Priority: 2 

Inspection Date: 6/11/10 Inspector: CB/SK 

File No.: 24 

Licensee: SJB Services, Inc. License No.: C2542 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 9/11/08 Inspector: BK 
New York Final IMPEP Report Page C.4 

Inspection Casework Reviews 

File No.: 25 

Licensee: Newburgh SPECT Imaging License No.: 5088 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 3/13/07 Inspector: CB 

File No.: 26 

Licensee: SUNY College at Geneseo License No.: 1042 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 10/8/09 Inspector: MT 

Comment: 

No supervisory review. 

File No.: 27 

Licensee: New York Oncology Hematology License No.: 5107 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 12/17/10 Inspector: MS 

File No.: 28 

Licensee: PB Americas, Inc. License No.: C3235 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 12/2/09 Inspector: AC 

File No.: 29 

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

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/17/10 Inspectors: RS,CB 

File No.: 30 

Licensee: St. Elizabeth Medical Center License No.: 457-1 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 3/8/07 Inspector: OO 

File No.: 31 

Licensee: Faxton St. Luke’s Healthcare License No.: 0462 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/4/11 Inspector: VG 

Comment: 

No supervisory review. 

File No.: 32 

Licensee: Cornell University License No.: 0005-3A 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 8/11-8/14/09 Inspector: WK 
New York Final IMPEP Report Page C.5 

Inspection Casework Reviews 

File No.: 33 

Licensee: Regenron Pharmaceuticals License No.: 2904 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 3/25/11 Inspector: JM 

File No.: 34 

Licensee: SUNY at Stony Brook License No.: 0455 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/14, 5/28, and 6/10/09 Inspectors: AB/JM 

File No.: 35 

Licensee: Saint-Gobain Performance Plastics Corporation License No.: C2889 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/21/09 Inspector: MH 

File No.: 36 

Licensee: Pharmalogic Syracuse, LLC License No.: C3231 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/26/11 Inspector: AC 

File No.: 37 

Licensee: W.M. Burke Medical Research Institute License No.: 1859 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 2/27/08 Inspector: CB 

File No.: 38 

Licensee: Eastman Kodak Company License No.: C1347 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 11/3-11/4/09 Inspector: WV 

File No.: 39 

Licensee: NRD, LLC License No.: C1391, C1429 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 1/23-1/24/07 Inspector: WV 

Comment: 

a) Inspection documentation issued to licensee 43 days after inspection. 

b) No supervisory review. 

File No.: 40 

Licensee: Reviss Services, Inc. License No.: IL-0205801 

Inspection Type: Reciprocity Priority: N/A 

Inspection Date: 4/9/10 Inspector: JM 
New York Final IMPEP Report Page C.6 

Inspection Casework Reviews 

 New York State Department of Environmental Conservation

File No.: 41 

Permitee: Triad Isotope, Inc. Permit Nos.: 1-2824-00545/00001 

Inspection Type: Announced, Special Priority: 4 

Inspection Date: 8/30/2010 Inspector: AG 

File No.: 42 

Licensee: PharmaLogic, Syracuse Permit No.: 4-0126-00642/00002 

Inspection Type: Routine, Unannounced Priority: 4 

Inspection Date: 2/15/2008 Inspector: AG 

File No.: 43 

Permitee: IBA Molecular North America, Inc. Permit Nos.: 4-0126-00502/00007 & /00001 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/29/2010 Inspectors: TF, MS 

 

File No.: 44 

Permitee: PETNET Solutions, Inc. Permit Nos.: 4-0126-00501/00001 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 5/25/2007 Inspector: MS 

 

File No.: 45 

Permitee: North American Philips Lighting Permit Nos.: 8-4624-00022/00018 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 11/17/2010 Inspectors: JF, AG 

Comment: 

Inspection documentation issued to licensee 6 days late. 

File No.: 46 

Permitee: University of Rochester Permit Nos.: 8-2699-00059/00003 

Inspection Type: Routine, Announced Priority: 4 

Inspection Date: 10/07/2009 Inspectors: AG, TF 

Comment: 

Inspection documentation issued to licensee 14 days late. 

File No.: 47 

Permitee: Cardinal Health 420, LLC Permit No.: 8-2614-00811/00001 

Inspection Type: Announced, Special Priority: 3 

Inspection Date: 11/4/2008 Inspectors: AG, MS 

Comment: 

Inspection documentation issued to licensee 13 days late. 
New York Final IMPEP Report Page C.7 

Inspection Casework Reviews 

File No.: 48 

Permitee: NRD, Inc. Permit No.: 9-1446-00018/00001 

Inspection Type: Special, Announced Priority: 4 

Inspection Date: 4/8/2009 Inspectors: SH, JF 

INSPECTOR ACCOMPANIMENTS 

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

 New York City Department of Health and Mental Hygiene

Accompaniment No.: 1 

Licensee: New York University Hospital Center License No.: 75-2955-01 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 5/5/11 Inspector: EC 

Accompaniment No.: 2 

Licensee: New York University Hospital Center License No.: 75-2955-01 

Inspection Type: Special, Announced 75-2955-02 

Inspection Date: 5/6/11 92-2955-03 

93-2955-05 

Priority: 2 

Inspector: MR 

 New York State Department of Health

Accompaniment No.: 3 

Licensee: Good Samaritan Hospital License No.: 0575 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 5/2/11 Inspector: AB 

Accompaniment No.: 4 

Licensee: Pall Hauppauge License No.: C1935 

Inspection Type: Routine/Special, Unannounced Priority: 2 

Inspection Date: 5/3/11 Inspector: BK 

Accompaniment No.: 5 

Licensee: Meade Testing Labs License No.: C2697 

Inspection Type: Routine/Special, Unannounced Priority: 1 

Inspection Date: 5/4/11 Inspector: JM 

Accompaniment No.: 6 

Licensee: Noyes Memorial Hospital License No.: 1831 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/16/11 Inspector: MT 
New York Final IMPEP Report Page C.8 

Inspection Casework Reviews 

Accompaniment No.: 7 

Licensee: Quality Inspection Services License No.: C2700 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 5/17/11 Inspector: SK 

Accompaniment No.: 8 

Licensee: Radiotherapy Associates, LLC License No.: 3111 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/18/11 Inspector: VG 

Accompaniment No.: 9 

Licensee: Clough, Harbor & Associates License No.: C2844 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 5/19/11 Inspector: MH 

 New York State Department of Environmental Conservation

Accompaniment No.: 10 

Permitee: Albany Medical Center Permit No.: 4-0101-00036/00006 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/20/11 Inspector: JF 

Accompaniment No.: 11 

Permitee: NYS Energy Research & Development Authority Permit No.: 9-0422-00011/00011 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/1/11 Inspector: DO 
 APPENDIX D 

 LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

 New York City Department of Health and Mental Hygiene

File No.: 1 

Licensee: Centenary Hospital License No.: 92-2848-01 

Type of Action: Termination Amendment No.: 9 

Date Issued: 10/22/08 License Reviewer: DH 

File No.: 2 

Licensee: Cabrini Medical Center License No.: 92-2922-02 

Types of Action: Termination Amendment No.: 9 

Date Issued: 4/01/09 License Reviewer: DH 

File No.: 3 

Licensee: Lenox Hill Hospital License No.: 91-2926-01 

Type of Action: Amendment Amendment No.: 25 

Date Issued: 6/22/10 License Reviewer: DH 

File No.: 4 

Licensee: Albert Einstein College of Medicine. License No.: 91-2919-01 

Type of Action: Amendment Amendment No.: 3 

Dates Issued: 6/4/08 License Reviewer: DH 

File No.: 5 

Licensee: Fordham University License No.: 52-2964-01 

Type of Action: Amendment Amendment No.: 7 

Date Issued: 3/02/09 License Reviewer: DH 

File No.: 6 

Licensee: Keith Tobin, M D License No.: 91-2979-01 

Type of Action: Amendment Amendment No.: 8 

Date Issued: 3/9/11 License Reviewer: DH 

File No.: 7 

Licensee: SUNY Health Service Center License No.: 74-2934-02 

Type of Action: Renewal Amendment No.: 4 

Date Issued: 11/15/10 License Reviewer: DH 

File No.: 8 

Licensee: Polytechnic Institute of New York University License No.: 52-2903-01 

Type of Action: Renewal Amendment No.: 6 

Date Issued: 9/24/08 License Reviewer: DH 
New York Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 9 

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

Type of Action: New Amendment No.: 0 

Date Issued: 2/17/11 License Reviewer: DH 

Comments 

a) License issued without the required security license condition. 

b) No pre-licensing determination performed. 

File No.: 10 

Licensee: New York Eye & Ear Infirmary License No.: 91-2936-01 

Type of Action: Amendment Amendment No.: 6 

Dates Issued: 11/03/10 License Reviewer: DH 

File No.: 11 

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

Type of Action: Amendment Amendment No.: 8 

Dates Issued: 10/26/10 License Reviewer: DH 

File No.: 12 

Licensee: Albert Einstein College of Medicine License No.: 74-2919-02 

Type of Action: Amendment Amendment No.: 11 

Dates Issued: 5/21/08 License Reviewer: DH 

Comments: 

 License issued without the required security license condition. 

File No.: 13 

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

Type of Action: Amendment Amendment No.: 13 

Date Issued: 5/02/11 License Reviewer: DH 

Comment: 

 License issued without the required security license condition. 

File No.: 14 

Licensee: New York Blood Center License No.: 74-2946-01 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 3/04/09 License Reviewer: DH 

Comment: 

 License issued without the required security license condition. 
New York Final IMPEP Report Page D.3 

License Casework Reviews 

 New York State Department of Health

File No.: 15 

Licensee: Good Samaritan Hospital License No.: 490 

Type of Action: Amendment Amendment No.: 53 

Date Issued: 5/04/06 License Reviewer: OO 

File No.: 16 

Licensee: Roswell Park License No.: 2923 

Types of Action: Amendment Amendment No.: 28 

Date Issued: 12/05/07 License Reviewer: CB 

File No.: 17 

Licensee: Regeneron Pharmaceuticals License No.: 2904 

Type of Action: Amendment Amendment No.: 16 

Date Issued: 1/17/08 License Reviewer: CB 

File No.: 18 

Licensee: Northshore Radiology at Glen Cove License No.: 5307 

Type of Action: New Amendment Nos.: 0 

Dates Issued: 2/13/08 License Reviewer: CB 

File No.: 19 

Licensee: Comprehensive Cardiology of Long Island License No.: 5330 

Type of Action: New Amendment No.: 0 

Date Issued: 2/24/09 License Reviewer: AC 

File No.: 20 

Licensee: Melville Surgery Center License No.: 5361 

Type of Action: Termination Amendment No.: 1 

Date Issued: 3/19/09 License Reviewer: CB 

File No.: 21 

Licensee: Quality Inspection Services License No.: C2514 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 1/21/09 License Reviewer: VD 

File No.: 22 

Licensee: Corning Hospital License No.: 0421 

Type of Action: Amendment Amendment No.: 53 

Date Issued: 2/23/10 License Reviewer: AC 

File No.: 23 

Licensee: Westchester PET and Medical License No.: 5081 

Type of Action: Amendment Amendment Nos.: 12 

Dates Issued: 3/7/11 License Reviewer: AC 
New York Final IMPEP Report Page D.4 

License Casework Reviews 

File No.: 24 

Licensee: Arnot Health License No.: 5182 

Type of Action: Amendment Amendment No.: 6 

Dates Issued: 9/28/08 License Reviewer: AD 

File No.: 25 

Licensee: SUNY College License No.: 1064 

Type of Action: Amendment Amendment No.: NA 

Dates Issued: Pending License Reviewers: RD/CB 

 

File No.: 26 

Licensee: Benedictine Hospital License No.: 1181 

Type of Action: Amendment Amendment No.: 42 

Date Issued: 3/30/07 License Reviewer: RD 

File No.: 27 

Licensee: Pepsi Cola License No.: C3078 

Type of Action: Renewal Amendment No.: 2 

Date Issued: 12/26/06 License Reviewer: DG 

File No.: 28 

Licensee: Eastman Kodak License No.: C1347 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 9/9/09 License Reviewer: DG 

File No.: 29 

Licensee: Warren & Panzer Engineering License No.: C2631 

Type of Action: Renewal Amendment No.: 2 

Date Issued: 8/7/09 License Reviewer: DG 

File No.: 30 

Licensee: Medical Arts Radiology License No.: 5291 

Types of Action: New Amendment No.: 0 

Date Issued: 6/13/07 License Reviewer: MH 

File No.: 31 

Licensee: Glen Falls Hospital License No.: 0481 

Type of Action: Amendment Amendment No.: 74 

Date Issued: 12/5/08 License Reviewer: MH 

File No.: 32 

Licensee: Sheehan Memorial Hospital License No.: 1847 

Type of Action: Renewal Amendment No.: N/A 

Dates Issued: Pending License Reviewer: MH 

File No.: 33 

Licensee: Glen Falls Hospital License No.: 0481 

Type of Action: Amendment Amendment No.: 72 

Date Issued: 1/14/08 License Reviewer: JK 
New York Final IMPEP Report Page D.5 

License Casework Reviews 

File No.: 34 

Licensee: Buffalo Medical Group License No.: 2902 

Type of Action: Renewal Amendment No.: 18 

Date Issued: 7/8/11 License Reviewer: AC 

File No.: 35 

Licensee: Sky Testing Services License No.: 

Type of Action: Amendment Amendment No.: 2 

Date Issued: 7/02/10 License Reviewer: WV 

File No.: 36 

Licensee: Roswell Park Cancer Institute License No.: 2923 

Type of Action: Renewal Amendment No.: N/A 

Date Issued: Pending License Reviewers: RD/CB 

Comments: 

 Under timely renewal for 6075 days. 

File No.: 37 

Licensee: Ciba Specialty Chemicals License No.: C2730 

Types of Action: Termination Amendment No.: 3 

Dates Issued: 7/17/07 License Reviewer: DH 

File No.: 38 

Licensee: American Red Cross License No.: 1761 

Type of Action: Renewal Amendment Nos.: 24 

Dates Issued: 3/10/10 License Reviewer: AC 

 

 New York State Department of Environmental Conservation

File No.: 39 

Permittee: North American Philips Lighting Permit No.: 8-4624-00022/00018 

Type of Action: Modification Facility/Program No.: 

Date Issued: 7/27/06 Permit Reviewer: JF 

File No.: 40 

Permittee: PETNET Solutions, Inc. Permit No.: 4-0126-00501/00001 

Type of Action: Modification Facility/Program No.: 

Date Issued: 8/6/08 Permit Reviewer: TF 

File No.: 41 

Permittee: Mirion Technologies Permit No.: 8-0724-00139/00003 

Type of Action: New Facility/Program No.: Not used since 2008 

Date Issued: 1/24/07 Permit Reviewer: TF 

File No.: 42 

Permittee: University of Rochester Permit No.: 8-2699-00059/00003 

Type of Action: Modification Facility/Program No.: 170-3 

Date Issued: 1/12/10 Permit Reviewer: TF 
New York Final IMPEP Report Page D.6 

License Casework Reviews 

File No.: 43 

Permittee: University of Rochester Permit No.: 8-2699-00059/00003 

Type of Action: Renewal Facility/Program No.: 170-3 

Date Issued: 2/21/08 Permit Reviewer: TF 

File No.: 44 

Permittee: NRD, LLC Permit No.: 9-1446-00018/00001 

Type of Action: Modification Facility/Program No.: 53-3 

Date Issued: 11/10/09 Permit Reviewer: JF 

File No.: 45 

Permittee: Cardinal Health 420 Permit No.: 8-2614-00811/00001 

Type of Action: Modification Facility/Program No.: 188-3 

Date Issued: 2/17/08 Permit Reviewer: AG 

File No.: 46 

Permittee: IBA Molecular North America, Inc. Permit Nos.: 4-0126-00502 /00001 

Type of Action: Facility/Program No.: 182-3 

Date Issued: 2/7/10 Permit Reviewer: TF 

File No.: 47 

Permittee: PharmaLogic Syracuse Permit No.: 4-0126-00642-00002 

Type of Action: New Facility/Program No.: 192-3 

Date Issued: 12/10/07 Permit Reviewer: AG 

File No.: 48 

Permittee: Triad Isotopes, Inc. Permit No.: 1-2824-00545/00001 

Type of Action: Modification Facility/Program No.: 131-3 

Date Issued: 7/23/09 Permit Reviewer: AG 
 APPENDIX E 

 INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

 New York City Department of Health and Mental Hygiene

File No.: 1 

Licensee: Redacted 

Date of Incident: 9/22/06 

Investigation Date: 6/16/11 

Comments: 

a) Licensee reported event to NYC on January 3, 2007 and in 2009. NYC took no followup action.

b) Event met requirements for an Abnormal Occurrence.

c) This incident was reported to NRC on June 15, 2011. 

File No.: 2 

Licensee: Redacted 

Date of Incident: 10/6/09 

Investigation Date: N/A 

Comments: 

a) Licensee reported event to NYC on October 9, 2009 . NYC took no follow-up action. 

b) This incident was reported to NRC on June 15, 2011. 

File No.: 3 

Licensee: Redacted 

Date of Incident: 6/24/09 

Investigation Date: 7/16/09 

Comment: 

a) Licensee reported event to NYC on June 24, 2009 

b) NYC conducted a follow-up on July 16, 2009. No inspection report available. 

c) Event was non-reportable but reported to NRC on June 24, 2011.. 

 New York State Department of Health

File No.: 4 

Licensee: Redacted License No.: N/A 

Date of Incident: 3/6/07 Incident Log No.: 520 

Investigation Date: 3/9/07 Type of Investigation: On-Site 

File No.: 5 

Licensee: Redacted License No.: N/A 

Date of Incident: 6/19/07 Incident Log No.: 548 

Investigation Date: 6/20/07 Type of Investigation: On-Site 
New York Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 6 

Licensee: Redacted License No.: N/A 

Date of Incident: 6/21/07 Incident Log No.: 550 

Investigation Date: 6/22/07 Type of Investigation: On-Site 

File No.: 7 

Licensee: Redacted License No.: N/A 

Date of Incident: 5/23/07 Incident Log No.: 522 

Investigation Date: 6/8/07 Type of Investigation: On-Site 

File No.: 8 

Licensee: Redacted License No.: N/A 

Date of Incident: 7/2/07 Incident Log No.: 553 

Investigation Date: 7/2/07 Type of Investigation: On-Site 

File No.: 9 

Licensee: Redacted License No.: N/A 

Date of Incident: 10/2/07 Incident Log No.: 566 

Investigation Date: 10/3/07 Type of Investigation: On-Site 

File No.: 10 

Licensee: SJB Services, Inc. License No.: C2500 

Date of Incident: 11/1/07 Incident Log No.: 572 

Investigation Date: 11/2/07 Type of Investigation: Phone 

File No.: 11 

Licensee: Xerox Corporation License No.: C3155 

Date of Incident: 3/1/08 Incident Log No.: 662 

Investigation Date: 11/17/08 Type of Investigation: On-Site

File No.: 12 

Licensee: Redacted License No.: N/A 

Date of Incident: 7/31/09 Incident Log No.: 740 

Investigation Date: 7/31/09 Type of Investigation: Phone 

File No.: 13 

Licensee: Redacted License No.: N/A 

Date of Incident: 5/26/10 Incident Log No.: 837 

Investigation Date: 5/28/10 Type of Investigation: Phone 

File No.: 14 

Licensee: Certified Testing Laboratory License No.: C2639 

Date of Incident: 8/30/09 Incident Log No.: 749 

Investigation Date: 8/31/09 Type of Investigation: On-Site 

File No.: 15 

Licensee: Dominion Resources, Inc. License No.: N/A 

Date of Incident: 4/19/10 Incident Log No.: 822 

Investigation Date: 4/19/10 Type of Investigation: Phone 
New York Final IMPEP Report Page E.3 

Incident Casework Reviews 

File No.: 16 

Licensee: Cole Consulting Corporation License No.: C2937 

Date of Incident: 2/25/08 Incident Log No.: 590 

Investigation Date: 2/25/08 Type of Investigation: On-Site 

 New York State Department of Environmental Conservation

File No.: 17 

Permittee: Cardinal Health 41 Permit No.: 8-2614-00812/2 

Date of Incident: 12/6/06 Incident Log No.: N/A 

Investigation Date: 12/7/06 Type of Investigation: Phone 

File No.: 18 

Permittee: SUNY Buffalo Permit No.: 9-1402-00680/29 

Date of Incident: 12/1/06 Incident Log No.: N/A 

Investigation Date: 12/14/06 Type of Investigation: Phone 
APPENDIX F 

 SEALED SOURCE AND DEVICE REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: NY-1271-S-101-S SS&D Type: Gaseous Light Source 

Manufacturer: mb-microtec ag Model Nos.: 400/1, 400/2, 400/3, 400/4, 400/5, and 400/6 

Date Issued: 12/14/06 

Type of Action: New Registration 

SS&D Reviewers: DS, CB 

File No.: 2 

Registry No.: NY-1210-D-102-G SS&D Type: Ion Generators, Chromatography 

Manufacturer: Inficon, Inc. Model Nos.: CMS5000 

Date Issued: 03/02/10 

Type of Action: New Registration 

SS&D Reviewers: DS, CB 

Comments: 

a) Information regarding radiation profiles, leak testing, prototype testing, conditions of use, 

quality control/quality assurance can be found in case file for SSD NY-1210-D-101-B. 

Model CMS5000 is very similar to Model CMS500 found in SSD NY-1210-D-101-B. 

b) Drawings used in the registration did not specify overall dimensions to describe the 

overall size of the device. 

File No.: 3 

Registry No.: NY-0502-D-112-G SS&D Type: Static Eliminator 

Manufacturer: NRD, LLC Model Nos.: Nuclecel Ionizer Model P-2035 

Date Issued: 12/30/2009 

Type of Action: New Registration 

SS&D Reviewers: DS, CB 

Comment: 

 Drawings used in the registration did not specify overall dimensions to describe the overall 

size of the device. 

File No.: 4 

Registry No.: NY-0502-D-111-G SS&D Type: Static Eliminator 

Manufacturer: NRD, Inc. Model Nos.: Nuclecel Ionizer Model 

Date Issued: 11/23/2009 P-2060 and Model P-2062 

Type of Action: New Registration 

SS&D Reviewers: DS, CB 

Comment: 

Drawings used in the registration did not specify overall dimensions to describe the overall 

size of the device. 
ATTACHMENT 

August 4, 2011 Letter from Sandra Hinkel 

DEC’s Response to the Draft Report 

ADAMS Accession No.: ML11216A261 

August 8, 2011 Letter from Sandra Hinkel 

DEC’s Follow-up Response to the Draft Report 

ADAMS Accession No.: ML112201338 

August 10, 2011 Letter from Christopher Boyd 

NYC’s Response to the Draft Report 

ADAMS Accession No.: ML11222A252 

August 15, 2011 Letter from Stephen Gavitt 

DOH’s Response to the Draft Report 

ADAMS Accession No.: ML11227A287 

and 

NRC’s Comment Resolution Document 

ADAMS Accession No.: ML112450318