March 2, 2007

Ms. Jeanine Prud’homme, CIH

Assistant Commissioner

Office of Environmental Sciences & Engineering

New York City Department of Health and Mental Hygiene

2 Lafayette Street, 11th Floor, CN-57

New York, NY 10007

Dear Ms. Prud’homme:

On February 8, 2007, 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

to protect public health and safety and not compatible with the U.S. Nuclear Regulatory

Commission’s (NRC’s) program. The MRB determined the period of Heightened Oversight of

the New York Program should continue.

I request that your program revise and resubmit their Program Improvement Plan as part of the

response to the applicable recommendations in Section 5 of the enclosed final report. The

revised plan should be submitted within 30 days of receipt of this letter. If you have any

questions regarding the expectations of the Program Improvement Plan, please have your staff

contact Janet R. Schlueter, Director, Division of Materials Safety and State Agreements of the

NRC’s Office of Federal and State Materials and Environmental Management Programs. I

request that the bimonthly conference calls between your program and NRC staff continue

during the period of Heightened Oversight. The first call should take place approximately two

weeks after the submittal of your program’s revised Program Improvement Plan. Two weeks

prior to each subsequent call, your program should provide a status report of actions associated

with the Plan to the NRC.

Based on the results of the current IMPEP review, the next full review of the New York

Agreement State Program will take place in approximately four years, with a periodic meeting

tentatively scheduled for November 2007.

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/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: New York Final IMPEP Report

cc: See next page
J. Prud’homme 2

cc: Gene Miskin, Director 

Office of Radiological Health, NYC

Jack Spath, Program Manager

Radioactive Waste Policy & 

 Nuclear Coordinator, NYSERDA

Steve Collins, Illinois

Organization of Agreement States 

 Liaison to the MRB
March 2, 2007

Mr. Edwin Dassati, Director

Bureau of Hazardous Waste & Radiation Management

New York State Department of Environmental Conservation

625 Broadway

Albany, NY 12233-7258

Dear Mr. Dassati:

On February 8, 2007, 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

to protect public health and safety and not compatible with the U.S. Nuclear Regulatory

Commission’s (NRC’s) program. The MRB determined the period of Heightened Oversight of

the New York Program should continue.

I request that your program revise and resubmit their Program Improvement Plan as part of the

response to the applicable recommendations in Section 5 of the enclosed final report. The

revised plan should be submitted within 30 days of receipt of this letter. If you have any

questions regarding the expectations of the Program Improvement Plan, please have your staff

contact Janet R. Schlueter, Director, Division of Materials Safety and State Agreements of the

NRC’s Office of Federal and State Materials and Environmental Management Programs. I

request that the bimonthly conference calls between your program and NRC staff continue

during the period of Heightened Oversight. The first call should take place approximately two

weeks after the submittal of your program’s revised Program Improvement Plan. Two weeks

prior to each subsequent call, your program should provide a status report of actions associated

with the Plan to the NRC.

Based on the results of the current IMPEP review, the next full review of the New York

Agreement State Program will take place in approximately four years, with a periodic meeting

tentatively scheduled for November 2007.

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/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: New York Final IMPEP Report

cc: See next page
E. Dassati 

 

2

cc: Barbara Youngberg, Chief

Radiation Section, DEC

Jack Spath, Program Manager

Radioactive Waste Policy & 

 Nuclear Coordinator, NYSERDA

Steve Collins, Illinois

Organization of Agreement States 

 Liaison to the MRB
March 2, 2007

Adela Salame-Alfie, Ph.D.

Acting Director

Division of Environmental Health Investigations

New York State Health Department

547 River Street

Troy, NY 12180-2216

Dear Dr. Salame-Alfie:

On February 8, 2007, 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

to protect public health and safety and not compatible with the U.S. Nuclear Regulatory

Commission’s (NRC’s) program. The MRB determined the period of Heightened Oversight of

the New York Program should continue.

I request that your program revise and resubmit their Program Improvement Plan as part of the

response to the applicable recommendations in Section 5 of the enclosed final report. The

revised plan should be submitted within 30 days of receipt of this letter and include those

Department of Labor (DOL) regulations required for adoption as a result of the merger with

DOL’s Radiological Health Unit. If you have any questions regarding the expectations of the

Program Improvement Plan, please have your staff contact Janet R. Schlueter, Director,

Division of Materials Safety and State Agreements of the NRC’s Office of Federal and State

Materials and Environmental Management Programs. I request that the bimonthly conference

calls between your program and NRC staff continue during the period of Heightened Oversight. 

The first call should take place approximately two weeks after the submittal of your program’s

revised Program Improvement Plan. Two weeks prior to each subsequent call, your program

should provide a status report of actions associated with the Plan to the NRC.

Based on the results of the current IMPEP review, the next full review of the New York

Agreement State Program will take place in approximately four years, with a periodic meeting

tentatively scheduled for November 2007.

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/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: New York Final IMPEP Report

cc: See next page
A. Salame-Alfie 2

cc: Stephen Gavitt, Director 

Bureau of Environmental Radiation 

 Protection, DOH

Jack Spath, Program Manager

Radioactive Waste Policy & 

 Nuclear Coordinator, NYSERDA

Steve Collins, Illinois 

Organization of Agreement States 

 Liaison to the MRB
March 2, 2007

Ms. Jeanine Prud’homme, CIH

Assistant Commissioner

Office of Environmental Sciences & Engineering

New York City Department of Health and Mental Hygiene

2 Lafayette Street, 11th Floor, CN-57

New York, NY 10007

Dear Ms. Prud’homme:

On February 8, 2007, 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

to protect public health and safety and not compatible with the U.S. Nuclear Regulatory

Commission’s (NRC’s) program. The MRB determined the period of Heightened Oversight of

the New York Program should continue.

I request that your program revise and resubmit their Program Improvement Plan as part of the

response to the applicable recommendations in Section 5 of the enclosed final report. The

revised plan should be submitted within 30 days of receipt of this letter. If you have any

questions regarding the expectations of the Program Improvement Plan, please have your staff

contact Janet R. Schlueter, Director, Division of Materials Safety and State Agreements of the

NRC’s Office of Federal and State Materials and Environmental Management Programs. I

request that the bimonthly conference calls between your program and NRC staff continue

during the period of Heightened Oversight. The first call should take place approximately two

weeks after the submittal of your program’s revised Program Improvement Plan. Two weeks

prior to each subsequent call, your program should provide a status report of actions associated

with the Plan to the NRC.

Based on the results of the current IMPEP review, the next full review of the New York

Agreement State Program will take place in approximately four years, with a periodic meeting

tentatively scheduled for November 2007.

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/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: New York Final IMPEP Report

cc: See next page

Identical letters sent to Jeanine Prud’homme, Edwin Dassati, and Adela Salame-Alfie.

Distribution: DCD (SP01)

Chairman Klein Commissioner McGaffigan Commissioner Merrifield Commissioner Jaczko Commissioner Lyons

FSME RF DMSSA RF KKarcagi, FSME/DMSSA LBolling, FSME/DMSSA DWhite, RI

JTobin, FSME/DILR JRivera, FSME/DMSSA KModes, RI DGilley, FL SMatthews, WA

AKock, OEDO GGrant, RIII JGray, OGC KCyr, OGC FCameron, OGC

RidsFsmeOd DRathbun, FSME/DILR TCombs, OCA (2 copies) RidsSecyCorrespondenceMailCenter

SUNSI Review Complete: : Publicly Available G Non-Publicly Available : Non-Sensitive G Sensitive ML070520165

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA FSME/DMSSA Tech. Ed. FSME DEDMRT

NAME ATMcCraw:gd 

(KSchneider for)

PRathbun

(KSchneider for)

SWMoore JRSchlueter CJPoland 

via Email

CLMiller MJVirgilio

DATE 02/16/07 02/20/07 02/21/07 02/22/07 02/26/07 02/25/07 03/02 /07

OFFICIAL RECORD COPY
J. Prud’homme 2

cc: Gene Miskin, Director 

Office of Radiological Health, NYC

Jack Spath, Program Manager

Radioactive Waste Policy & 

 Nuclear Coordinator, NYSERDA

Steve Collins, Illinois

Organization of Agreement States 

 Liaison to the MRB
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NEW YORK AGREEMENT STATE PROGRAM

NOVEMBER 1-9, 2006

FINAL REPORT

U. S. Nuclear Regulatory Commission

ENCLOSURE
New York Final 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 November 1-9, 2006, by a review team comprised of

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

Florida and Washington. Team members are identified in Appendix A. The review was

conducted in accordance with in 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 July 26, 2002, to November 9, 2006, were discussed with New York

management on the last day of the review. 

At that time, the review team’s preliminary finding was that the State’s performance with respect

to the Non-Common Performance Indicator, Compatibility Requirements, was satisfactory, but

needs improvement. Upon further reflection and consideration of the status of regulations in the

State, the review team determined a finding of unsatisfactory for this indicator was more

appropriate. The team leader notified State officials of this change by telephone on December

20, 2006, prior to issuance of the draft report.

A draft of this report was issued to New York for factual comment on December 21, 2006. The

three agencies that comprise the New York Agreement State program responded separately. 

The New York City Department of Health and Mental Hygiene (NYC) responded via letter, dated

January 16, 2007, from Jeannine Prud’homme, Assistant Commissioner, Environmental

Sciences and Engineering. The New York State Department of Health (DOH) responded via

letter, dated January 22, 2007, from Stephen M. Gavitt, Director, Bureau of Environmental

Radiation Protection. The New York State Department of Environmental Conservation

responsed via letter, dated January 24, 2007, from Barbara Youngberg, Chief, Radiation

Section. The Management Review Board (MRB) met on February 8, 2007, to consider the

proposed final report. The MRB found the New York program adequate to protect public health

and safety and not compatible with NRC’s program. The review team recommended, and the

MRB agreed, that the period of Heightened Oversight of the New York Agreement State

Program continue.

During most of the review period, the New York Agreement State Program was divided among

four separate programs. In July 2006, the New York State Department of Labor’s Radiological

Health Unit (DOL) was merged into DOH. The New York Agreement State program is currently

administered by three agencies: (1) NYC, which has jurisdiction over medical, academic, and

research uses of radioactive materials within the five boroughs of New York City; (2) 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) 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.
New York Final Report Page 2

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 October 10, 2006. Each

agency provided an electronic response to the questionnaire; DEC on October 16, 2006; DOH

on October 19, 2006; and, NYC on October 24, 2006. A copy of the questionnaire responses

can be found in the NRC’s Agencywide Document Access and Management System (ADAMS)

using the Accession Numbers ML063530794, ML063530800, and ML063530801.

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 10 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.

During the review period, New York was placed on Heightened Oversight in November 2005 as

a result of overdue NRC amendments required for compatibility by all of the agencies that

comprise the Agreement State program. The importance of maintaining up-to-date regulations

was stressed during periodic meetings held with each agency in April 2005. NRC

representatives at the periodic meetings recommended that each agency adopt legally binding

requirements to implement the overdue NRC amendments while regulations are being

promulgated.

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 program 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 routine review, which concluded on July 26, 2002, eight recommendations

were made, and the results were transmitted to the respective upper management of the three

New York State Agencies and the New York City Agency on November 12, 2002. The review

team’s evaluation of the current status of these recommendations is as follows:
New York Final Report Page 3

1. The review team recommends that NYC, DOL and DEC perform core inspections in a

timely manner, and that NYC take appropriate actions to improve the tracking mechanisms

necessary to evaluate their own timeliness for initial inspections. (Section 3.1.5)

Current Status: Based on review of the IMPEP questionnaires, discussions with State staff,

and an examination of inspection data, the review team found that all programs were

performing core and initial inspections in a timely manner. This recommendation is closed.

2. The review team recommends that NYC and DEC transmit inspection findings to their

licensees within thirty days after the close of the inspection. (Section 3.1.5)

Current Status: Based on the review of inspection casework and discussions with State

staff, the review team found that NYC is issuing inspection findings in a timely manner. 

DEC, however, continues to experience some delays in their issuance of inspection

findings. The review team recommends that DEC’s actions in response to this

recommendation continue to be tracked. This recommendation remains open for DEC.

3. The review team recommends that NYC review and revise their inspection process,

including report preparation to ensure that the inspection findings are accurately described

in the documentation of the inspection and that cited violations are supported in the

inspection field notes. (Section 3.2.5)

Current Status: The review team noted significant improvement in the quality of NYC’s

inspection reports with respect to documentation and substantiation of inspection findings. 

This recommendation is closed.

4. The review team recommends that DOL and DEC perform annual supervisory

accompaniments of all material inspectors. (Section 3.2.5)

Current Status: DEC supervisors have accompanied each inspector annually during the

review period. DOL, now the Industrial Unit of DOH, did not accompany each inspector

annually during the review period; however, the inspectors were accompanied by

supervisors after the on-site review with no performance issues identified. This

recommendation is closed.

5. The review team recommends that NYC review all licenses to ascertain if they require

financial assurance, and take appropriate action on each affected license to ensure that all

licenses meet codified financial assurance requirements. (Section 3.4.5)

Current Status: The review team noted that all licenses identified as requiring financial

assurance, except for two licenses, had financial assurance instruments in place. The

remaining two licensees are currently working with NYC to resolve issues and to complete

their financial assurance packages. This recommendation is closed.

6. The review team recommends that DOH provide prompt, in-depth, documented reviews of

events with the potential for significant health and safety consequences. (Section 3.5.5)

Current Status: The review of incident casework and discussions with staff verified that

DOH, including the Industrial Unit, provides prompt, in-depth, documented reviews of all
New York Final Report Page 4

events. DOH requires their licensees to submit a root cause analysis of any incidents,

which DOH reviews and analyzes to promptly identify any potential generic issues. The

review team verified that the licensees’ root cause analyses and DOH’s reviews are

documented in the appropriate files. This recommendation is closed.

7. The review team recommends that NYC, DOL and DOH draft and implement a method to

ensure timely submittal of information to NRC and the Nuclear Materials Events Database

and implement an effective procedure to identify, track, and review all incident reports. 

(Section 3.5.5)

Current Status: The review of incident casework and discussions with State staff verified

that NYC and DOH, including former DOL, are making timely reports to NRC and NMED

and are utilizing automated systems to identify, track, and review all incident reports. This

recommendation is closed.

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

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

current NRC policy on adequacy and compatibility. (Section 4.1.3)

Current Status: Discussions with NYC revealed that their regulations are up-to-date except

for the 10 CFR Part 35 compatible rule that was due for implementation in October 2005. 

NYC has drafted this rule, but it cannot be implemented until the equivalent rule is adopted

by DOH. DOH, including former DOL, and DEC have drafted a number of regulations and

legally binding requirements; however, none have been sent to the NRC for a compatibility

review. The New York Agreement State Program is currently on Heightened Oversight

based on overdue NRC amendments required for compatibility. 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 eight

technical staff members. There are currently no vacancies in this program. During the review

period, one senior staff member retired and another staff member left the program. These
New York Final Report Page 5

vacancies were filled with three individuals experienced in radiation safety and environmental

health inspections. Two experienced staff members are involved exclusively in radioactive

materials licensing. One of these individuals has a doctorate in physics and is a certified health

physicist. Five staff members are devoted to compliance, which encompasses inspection and

enforcement actions. The Unit Chief is involved in both licensing and compliance activities,

including incident response.

NYC recently added an Emergency Response Unit which is staffed by individuals trained

specifically to respond to radiological incidents. This Unit does not conduct routine compliance

inspections; however, it will augment the routine compliance effort by responding to radiological

incidents. This Unit has the responsibility for conducting NYC’s Increased Controls inspections.

NYC technical positions require a Bachelor’s degree in engineering, physical or biological

sciences. The IMPEP team reviewed job descriptions and the procedure used to qualify new

staff as independent inspectors. The procedure, “Training for New Inspectors,” is

comprehensive and equivalent to the NRC’s Inspection Manual Chapter (IMC)1246. There is

no equivalent procedure for the training and qualification of new license reviewers. The lack of

a documented training plan for license reviewers was discussed with NYC management. 

Currently, no resulting performance issues from the lack of a documented training plan for

license reviewers were identified by the review team; however, the review team encouraged

NYC management to consider developing such a procedure as a succession planning tool.

The program utilizes an “Employee Training Record” to document and track the training

received by individual staff members. This practice is equivalent to a training and qualification

journal. NYC management encourages training and supports out-of-State training opportunities

as they meet program and staff needs.

3.1.2 New York State Department of Health

DOH is managed by the Director, the Assistant Director and six Section Chiefs. DOH utilizes

2.5 full-time equivalents (FTE) for licensing activities and 3.6 FTE for compliance activities. 

DOH currently has one vacancy which is authorized to be filled.

DOH has a comprehensive documented training plan and job descriptions for all current

positions. The review team examined these documents. DOH’s training plan is comparable to

IMC 1246. The review team noted that individual staff qualification journals are kept on an

automated database. The review team noted that DOH management actively supports staff

training through in-house seminars, as well as off-site training.

DOH staff is required to have a Bachelor’s degree in physical and biological sciences, at a

minimum. The review team noted that DOH management actively supports staff training

through in-house seminars, as well as off-site training. The review team determined that DOH

staff is well-qualified, based on education and experience. DOH staff includes several Certified

Health Physicists, a Certified Medical Physicist, and a number of other staff possessing

specialized nuclear training and work experience.
New York Final Report Page 6

3.1.3 New York State Department of Health - Industrial Unit

The Industrial Unit consists of the Section Chief and seven technical staff members. 

Approximately 4.0 FTE are dedicated toward licensing activities, and 3.4 FTE are dedicated

toward compliance activities. During the review period, the Industrial Unit lost two staff

members. One position has been filled and the Industrial Unit is actively recruiting to fill the

remaining vacant position.

The Industrial Unit has a written training qualification program. This program details the core

training. The review team determined that the Industrial Unit’s training qualification program is

consistent with IMC 1246. Individual qualification journals are maintained on an automated

database. The review team queried the database and noted that it contained training course

information, including dates for each course attended by current staff members. The Industrial

Unit has documented position descriptions for each of the current job classifications.

New staff are required to have a Bachelor’s degree in physical or biological sciences, at a

minimum. Most of the staff members have advanced degrees. Two are Certified Health

Physicists and other staff have a variety of nuclear related training and work experience.

3.1.4 New York State Department of Environmental Conservation

DEC is staffed by the Bureau Director, the Section Chief, and nine technical staff members. 

Currently, there are no vacancies in the program. All of the unfilled vacancies noted during the

2002 IMPEP review have been administratively deleted. During the review period, one staff

member was hired and three technical staff left the program. One of the individuals that left the

program intends to resume employment before the end of 2006. The permitting (licensing) and

compliance functions of the program are performed by five members of the staff. The rest of the

staff is dedicated mostly to contaminated sites and events that are not directly covered under

the Agreement. All staff perform duties in incident and emergency response. In addition to the

Section Chief, two individuals have supervisory roles.

All but one of the staff members have a long history with DEC and are thus able to effectively

meet the workload requirements. With the upcoming retirement of a number of key individuals

and the hiring of new personnel, DEC management anticipates that a learning period will be

needed for these potentially inexperienced staff members. To further complicate the situation,

DEC is currently experiencing a hiring freeze, so that staff cannot be added until individuals

leave the program. The Section Chief expressed concern that this system provides limited

opportunity for knowledge transfer to new personnel especially since the general quantity and

complexity of the workload is expected to increase.

DEC will continue to regulate the construction, operation and decommissioning of accelerators. 

In coordination with the other two agencies, the State is intending to continue to regulate certain

accelerator-produced byproduct material, identified in the Energy Policy Act of 2005, by

providing the NRC with the Governor certification letter.

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; however, the high level of qualification required has
New York Final Report Page 7

limited the program’s ability to recruit potential personnel in anticipation of increased staff

turnover and workload increase.

The review team determined that DEC has a minimally acceptable written training policy. 

Historically, DEC has not had much need to develop and document a training program due to

the small number of inspectors and permit reviewers and the low staff turnover. DEC

management stated that new staff will be trained in performing inspections and reviewing permit

applications individually by the permit/inspection unit supervisor. Inspectors-in-training will

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 will move through these

stages based on the assessment of the unit supervisor. The same staff will be trained to review

permit applications by reviewing first minor amendments and routine renewals, then

applications of increasing complexity. All permitting decisions are reviewed by the permit unit

supervisor and the radiation section supervisor. The review team noted that DEC does not

have a consistent method to formally document the training of personnel. After the 2002 IMPEP

review, DEC began to record individuals’ training, but the spreadsheet has not been updated on

a regular basis, because only one new staff member was added during the review period.

3.1.5 Indicator Summary

The review team determined that the New York Agreement State Program is adequately staffed

with qualified personnel. During the review period, staff from the four programs attended a

number of courses sponsored by several organizations, including NRC. Staff from each

program attended the NRC’s Increased Controls course. Staff turnover is low and when a

vacancy does occur it is filled in a timely manner. The review team noted that inspections were

being conducted according to IMPEP criteria and there were no other program deficiencies

linked to staffing level or 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, Technical Staffing and Training, was

satisfactory.

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 restrictive than, those listed in IMC

2800. Inspection frequencies for NYC licensees range from one to three years.
New York Final Report Page 8

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, approximately 6 core inspections

and 13 initial inspections were performed overdue by more than 25 percent of their respective

inspection frequency. Overall, the review team calculated 7 percent of all Priority 1, 2, and 3,

and initial inspections were completed overdue during the review period. This represents a

significant improvement compared to results in the 2002 review where approximately 23 percent

of Priority 1, 2, and 3, and initial inspections were performed overdue. The review team also

noted that the accuracy of information in the inspection database has significantly improved

since the 2002 review, in that newly issued licenses were entered into the database in a timely

manner.

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

inspection casework review. Nearly all letters transmitting inspection findings to licensees were

issued within 30 days after the date of the inspection. Again, this represents a significant

improvement over results of the 2002 review. Since the 2002 review, NYC changed their

process for the preparation and issuance of letters to licensees. The inspector has more

responsibility for the preparation of the transmittal letter. This process change seems to be

directly attributable to the increase in the efficiency of the issuance of inspection findings.

During the review period, NYC received 94 reciprocity notifications from seven different

licensees. NYC performed five inspections during the review period. These five inspections

were performed in 2005 and 2006. In these two years, NYC met the criteria in IMC 1220 of

inspecting 20 percent of candidate reciprocity licensees. No inspections were performed in

2003 and 2004. This issue was discussed with NYC management and they indicated that more

attention has been focused on this area by the new inspector supervisor.

The review team determined that with respect to Commission Staff Requirements Memorandum

(SRM) for COMSECY-05-0028, on Increased Controls, at the time of the on-site review, the

NYC program had inspected 6 of the 27 subject licensees in accordance with the Increased

Controls requirements. The review team evaluated the program’s prioritization methodology

and found it acceptable.

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 restrictive than, those listed in IMC 2800. 

DOH routinely implements their inspection interval extension policy to increase inspection

intervals for licensees demonstrating good prior performance. The latest version of IMC 2800

no longer allows for the extension of inspection frequencies based on good performance. DOH

management was not aware of this change and indicated that they would revise their inspection

procedure to be consistent with IMC 2800.

In their response to the questionnaire, DOH indicated that eight Priority 1, 2, and 3 inspections

were performed overdue during the review period. The review team examined the DOH

inspection database and identified an additional 16 inspections that were performed overdue. 

There were two reasons for the discrepancy. The first reason was the previously mentioned

inspection interval extension policy, and the second was a miscalculation performed by the

program’s inspection database. The review team determined that DOH performed 13 of its 380
New York Final Report Page 9

Priority 1, 2, and 3 inspections overdue, and 1 of the 150 initial inspections was performed

overdue. Overall, the review team calculated that DOH performed 2.6 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. DOH has an effective and efficient process, which ensures that

inspection findings are communicated to licensees in a timely manner. For all the inspection

casework examined, inspection findings were sent to the licensees within 30 days.

During the review period, DOH did not grant any out-of-State licensees reciprocity to work in the

State.

The review team determined that with respect to Commission Staff Requirements Memorandum

(SRM) for COMSECY-05-0028, on Increased Controls, at the time of the on-site review, DOH

had inspected 2 of the 27 subject licensees in accordance with the Increased Controls

requirements. The review team evaluated the program’s prioritization methodology and found it

acceptable.

3.2.3 New York State Department of Health - Industrial Unit

The review team's assessment of the Industrial Unit’s inspection priorities verified that

inspection frequencies for various types of licenses are the same as, or more restrictive than,

those listed in IMC 2800 with one exception. “Storage only pending disposal” licenses are

inspected every five years, as opposed to every three years according to IMC 2800.

In their response to the questionnaire, the Industrial Unit indicated that their database only

tracked currently due inspections. At the time of the on-site review, the Industrial Unit’s

inspection database was not available for review. The review team examined information in the

inspection files for most Priority 1, 2, and 3 licenses and initial licenses to compile information

on the timeliness of inspections. The review team determined that 7 of 112 Priority 1, 2, and 3

inspections were performed overdue and, of the 148 new licenses issued during the review

period, 9 were performed overdue, 126 performed in one year or less, and 13 that are currently

due. Overall, the review team calculated that the Industrial Unit performed 6.5 percent of its

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 Industrial Unit has an effective and efficient process, which

ensures that inspection findings are generally communicated to licensees in a timely manner. 

For the inspection casework examined by the review team specifically for timeliness of the

communication, nearly all letters with inspection findings were transmitted within 30 days after

the date of the inspection.

During the review period, the Industrial Unit granted 117 out-of-State reciprocity approvals to

work in the State, of which 37 were candidate licensees. The Industrial Unit conducted 29

reciprocity inspections during the review period which met the criteria in IMC 1220. The

Industrial Unit only authorizes reciprocity for 30 days in a calendar year, thus many out-of-State

licensees obtain a specific license. These out-of-State specific licensees are contacted at least

annually to determine whether work in New York State is planned.
New York Final Report Page 10

The review team determined that with respect to Commission Staff Requirements Memorandum

(SRM) for COMSECY-05-0028, on Increased Controls, at the time of the on-site review, The

Industrial Unit had inspected 4 of the 21 subject licensees in accordance with the Increased

Controls requirements. The review team evaluated the program’s prioritization methodology

and found it acceptable.

3.2.4 New York State Department of Environmental Conservation

DEC issues permits to facilities licensed by one of the other agencies 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 permitees based on the actual releases to the environment. 

Since the 35 permitees are required to report their effluents releases to DEC annually, the

Program may adjust their inspections frequency accordingly as releases to the environment

change. The assigned frequencies for permitees can range from one to four years. Most

permitees are inspected at three or four year intervals. The review team determined that these

frequencies are adequate to protect public health and safety.

The review team confirmed that one inspection identified in the questionnaire was performed

overdue and that one initial inspection is currently overdue. DEC has not performed the initial

inspection of this facility since the permitee has not used radioactive materials requiring

emissions. The review team calculated that DEC performed 4 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 evaluated eight letters transmitting the inspection

findings to the licensees. Six of these letters were issued more than 30 days after the date of

the inspection with the longest being issued 59 days after the date of the inspection. The DEC

attributed the delay to the need to prioritize work and inefficiencies in the process to issue

reports. In the 2002 IMPEP report, that review team noted that timely issuance of inspection

findings was also an issue and made a recommendation. The current review team

recommends that the 2002 review team’s recommendation regarding the timely dispatch of

inspection findings remain open for DEC. See recommendation in Section 3.2.5.

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

was not reviewed for this program.

3.2.5 Indicator Summary

Overall, based on the percentage of licenses for which each program is responsible, the State

performed approximately 6.8 percent of their Priority 1, 2, and 3, and initial inspections overdue. 

For individual programs, the range of overdue inspections ranged from approximately 3 to 7

percent.

The issuance of inspection findings to licensees for NYC, DOH, and the Industrial Unit was

found to be timely. DEC was generally not timely in this issuance of inspection results, as

discussed in Section 3.2.4. The review team recommends that DEC transmit inspection

findings to their licensees within 30 days after the close of the inspection. This is a repeat

recommendation from the 2002 IMPEP report.
New York Final Report Page 11

Based on the information provided in the responses to the questionnaires, gathered during the

evaluation of casework by the review team, and obtained during discussions with staff from

NYC and the Industrial Unit, the review team determined that the State met the criteria in IMC

1220 for reciprocity inspections.

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, was satisfactory.

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, and inspection

field notes and interviewed select members of the inspection staff for 47 radioactive material

inspections conducted during the review period. The casework reviewed included 27

inspections, representing each of the State’s four programs, and covered inspections of various

types of licenses including hospitals, private practices, high dose-rate remote afterloaders,

gamma knife, brachytherapy, industrial radiography, radiopharmacy, manufacturing and

distribution, academic and medical broad scope institutions, a commercial irradiator, and a

waste processor. Appendix C lists the inspection casework files 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 certain classes of licensees or facilities are also

included in the respective procedures manuals. The review team’s evaluation of inspection

reports identified three of the four programs have comparable inspection reports in regard to the

types of information and data collected under IMC 2800. Inspections conducted by the

Industrial Unit are generally performed on an announced basis; the remaining programs

generally performed unannounced inspections.

Inspection reports were reviewed to determine if the reports adequately documented the scope

of the licensed program, licensee organization, personnel protection, posting and labeling,

control of material, equipment, use of material, transfer, increased controls and disposal. The

reports were also checked to determine if they adequately documented operations observed,

interview of workers, independent measurements, status of previous violations, substantiation of

violations, and the substance of discussions during exit interviews with management. Based on

the casework reviews and inspector interviews, the review team found that routine inspections

covered all aspects of licensees’ radiation protection programs by all programs. The review

team found that for all four programs, the inspection reports were thorough, complete,

consistent, and of high quality, with sufficient documentation 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 for training purposes.

A review team member accompanied ten inspectors from all four programs during the period of

November 8, 2005, to October 26, 2006. The accompaniments included inspections of medical

institutions, medical private practice, research and development, and a waste broker. The

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

demonstrated appropriate inspection techniques and knowledge of the regulations. The
New York Final Report Page 12

inspectors were trained, well-prepared for the inspection, and thorough in their audits of the

licensees’ radiation safety programs. Each inspector conducted confirmatory measurements

and utilized good health physics practices. Their inspections adequately assessed radiological

health and safety at the licensed facilities.

The review team noted that all four 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,

requires the inspector to perform instrument calibrations, or has a dedicated person who

performs the instrument calibrations. The portable instruments used during the inspector

accompaniments were operational and calibrated. All programs have the capability to analyze

alpha, beta, and gamma contamination samples and maintain their respective laboratory

counting equipment.

3.3.1 New York City Department of Health and Mental Hygiene

During the previous IMPEP reviews in 1998 and 2002, the review teams determined that the

documentation in the inspection field notes typically did not support the violations transmitted to

licensees. Previous review teams also noted that inspection field notes did not review or

discuss the relative safety significance or root causes of the violations identified to licensees. 

The 2002 review team found that the wording in the inspection field notes lacked sufficient detail

in the program scope and for the identified violations, which apparently led to misinterpretation

by the inspector supervisor as he prepared the compliance letter and the citations. During this

review, the review team noted significant improvement in this area. As noted in Section 3.2.1,

NYC changed their process for the preparation and issuance of letters to licensees. The

inspector has more responsibility for the preparation of the transmittal letter. The review team

found that the wording in the inspection field notes had sufficient detail in the program scope

and for the identified violations, which lead to accurate compliance letters and the citations.

The review team noted a number of inspection files where the inspector’s radiation survey

instruments information was not included in field notes. Based on the discussions with NYC

staff, the review team determined that the previous inspector supervisor did not require this

information, and consequently, the inspectors did not provide it. Under the current inspector

supervisor, the review team noted that this information is being provided more consistently.

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.

In addition to implementing Commission Staff Requirements Memorandum (SRM) for

COMSECY-05-0028, on Increased Controls, the NYC Program is working with a DOE national

laboratory and a contractor to perform individual security assessments of approximately 30

medical facilities. The assessment will make specific recommendations regarding each facility’s

overall security (not just radiological) and develop a generic security checklist. In a separate

initiative, the New York City Police Department (NYPD) is also visiting radioactive materials

users in the City. Although NYPD will make recommendations regarding the facility’s security

and will outline the usefulness of developing a local facility security plan, an important aspect of

this initiative is outreach. NYC also indicated that NYPD has supported their Increased Control

inspection efforts. A review team member observed a NYPD visit during an inspector

accompaniment.
New York Final Report Page 13

3.3.2 New York State Department of Health

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

DOH uses the same field note format “Inspection of Radionuclide Installations” for different

types of inspections covering the areas of academic, research and development, medical, and

teletherapy licenses.

To assure consistency and quality of reports, the Field Supervisor and Section Chief provide

thorough reviews. Overall, the review team found that the inspection reports showed excellent

quality and attention to detail. Reports contained no major discrepancies from standard

practices or established DOH procedures.

When a licensee responds to a notice of violation, an inspector evaluates the response and, in

all cases, a reply was sent to the licensee within 30 days of receipt. For the casework reviewed,

documented inspection findings led to proper regulatory actions and appropriate enforcement. 

Inspection results showed licensee compliance was acceptable during the review period. For

escalated enforcement, a review of select Administrative Tribunals (Hearing Boards) revealed

that this process is very effective in obtaining compliance, whether the end result is a fine or

other compliance commitment.

DOH has a policy of performing annual supervisory accompaniments of inspectors. In response

to the questionnaire, DOH reported, and the review team confirmed, that all inspectors were

accompanied by a supervisor annually during the review period.

3.3.3 New York State Department of Health - Industrial Unit

The inspection field notes evaluated by the review team exhibited adequate, consistent

documentation of inspection findings. The review team noted that the Industrial Unit’s

inspection field notes and inspection correspondence are peer reviewed by one of the senior

inspectors to ensure consistency, thoroughness, and quality of reports. Overall, the review

team found that peer review of the inspection documentation and correspondence resulted in

their consistent high quality.

Routine enforcement letters were drafted and issued to licensees by the inspector. When the

licensee responds to a notice of violation, the inspector evaluates the licensee's submittal and

prepares a response. Once the inspector determines that the licensee has satisfactorily

responded to the violations and has acknowledged their response, the inspection field notes

and correspondence are given to another senior inspector for review. The inspectors informed

the review team that they discuss any unusual issues regarding the inspection findings with

management prior to issuing the inspection findings to the licensee. When significant

commitments are made in response to violations, Industrial Unit staff performed a follow-up

inspection to confirm that the commitments made in the licensee's correspondence were

implemented.

For the casework reviewed, documented inspection findings led to proper regulatory actions

and appropriate enforcement. Escalated enforcement action beyond the issuance of Notices of

Violation was limited to the issuance of Orders.
New York Final Report Page 14

Industrial Unit management has performed one supervisory accompaniment of a material

inspector since the 2002 review. The manager stated that competing demands on his time and

the extensive experience of the inspectors led him to not perform the accompaniments. 

However, two additional accompaniments were completed after the on-site reviews. In the 2002

report, the review team noted that Industrial Unit inspector accompaniments were an issue and

made a recommendation. The review team considers this matter closed based on the inspector

accompaniments performed by the review team and the subsequent accompaniments by DOH

supervisors after the on-site review. 

3.3.4 New York State Department of Environmental Conservation

The review team evaluated nine 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, the Permit Unit Supervisor, and the Section Chief to discuss the

inspection. Unresolved issues, recent changes to the permit, and specific concerns of the

inspector are 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.

DEC also regulates the low-level radioactive waste (LLRW) transportation into, within, and

through New York State via issuance of permits under the authority of 6 NYCRR 381 "LowLevel Radioactive Waste Transporter Permit and Manifest Regulations.” Currently, one DEC

technical staff member is specifically assigned to transportation issues. An annual report on

LLRW waste transportation is prepared by DEC; the latest dated June 2005. A list of authorized

treatment, storage, and disposal facilities was maintained on file. Verification of authorized

facilities is done through the NRC or another Agreement State.

Enforcement actions are taken against generators for shipment of regulated medical waste

contaminated with radioactive material to the landfills. Warning letters are sent to the waste

generators for improper handling and shipment of regulated medical waste to the landfills.

3.3.5 Indicator Summary

Accompaniments of inspectors from all four programs demonstrated competent, thorough,

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

programs proved to be well designed and 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, was

satisfactory.
New York Final Report Page 15

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 59 licensing actions were

examined, including 5 new license issuances, 7 terminations, 29 amendments (including

financial assurance and Increased Controls amendments), 3 modifications, 14 renewals, and 1

notification, encompassing the work of 18 license reviewers. The licensing casework was

selected to provide a representative sample of licensing actions which had been completed

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.

Licensing actions were evaluated for completeness, consistency, proper isotopes 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 found that NYC’s licensing actions were thorough, complete, consistent, and

of good technical quality with health and safety issues properly addressed. All licensing actions

are peer reviewed by license reviewers for content, grammar, and format. License conditions,

including tie-down conditions, are usually stated clearly and are enforceable. Because of the

experience level of the license reviewers, checklists, review plans, and standard procedures are

not used.

The license reviewers have a longstanding working relationship with the licensees; such that

license deficiencies are handled by undocumented telephone calls and e-mail. The review

team determined that this practice does not lead to any significant health and safety issues, but

it could hinder new reviewers’ ability to follow and understand the licensing process. The review

team discussed the importance of documenting licensee information requests in response to

license application deficiencies with NYC management and staff.

The review team discussed with NYC staff the efforts they have made in terms of acquiring

financial assurance for decommissioning from those licensees required to provide it. NYC

determined that 14 of their licensees require financial assurance. Four of the 14 have actual

possession limits below that requiring financial assurance; however, their authorized possession

limits on their license may not have been reduced and therefore the licensee may be able to

acquire radioactive material in quantities requiring financial assurance without the need to

provide for financial assurance. The review team discussed the benefits of limiting possession

limits in these cases with NYC. Eight of the 14 provided financial assurance. In cases where a

Standby Trust Agreement (STA) was used, the bank revised the standard language and the

reviewer accepted the new wording without a legal review. The review team discussed with

NYC the necessity to perform a legal review in order to ensure that the STA meets the intent of

the financial assurance requirement. The remaining two licensees have not submitted financial

assurance even though the reviewers have provided all of the required information. In
New York Final Report Page 16

discussions with NYC management, they committed to work with the two remaining licensees to

obtain the required financial assurance.

The review team noted that financial assurance mechanisms (e.g., bonds) are kept in a filing

cabinet in an unlocked room. NYC committed to moving all financial assurance to the license

reviewer’s office, and the room or the cabinet will be locked.

In discussions with NYC management, the review team noted that there are no major

decommissioning efforts underway with regard to byproduct material within the City. NYC

indicated that no exemptions were issued during the review period.

The review team examined the licensees that NYC determined met the criteria for the Increased

Controls, per COMSECY-05-0028. The review team determined that NYC had correctly

identified the licensees that require Increased Controls based on this criteria, and will continue

to issue Increased Controls to any additional licensees, as appropriate. Each licensee was

issued a NYC Commissioner’s Order requiring the Increased Controls in accordance with the

timeline established by the NRC in the SRM for COMSECY-05-0028.

3.4.2 New York State Department of Health

The review team found that DOH’s licensing actions 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, as determined from

documentation in the license files and/or discussions with the license reviewers.

License conditions, including tie-down conditions, are almost always stated clearly, backed by

information contained in the file, and 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. No significant health and safety issues were identified.

The review team noted that financial assurance for decommissioning is required for private

universities during the initial application or renewal process. Public institutions do not require

financial assurance for decommissioning because State institutions are self-insured.

The review team examined the licensees that DOH determined met the criteria for the Increased

Controls, per COMSECY-05-0028. The review team determined that DOH had correctly

identified the licensees that require Increased Controls based on this criteria, and will continue

to issue Increased Controls to any additional licensees, as appropriate. Each license was

amended to include the Increased Controls requirements as license conditions. DOH issued

the Increased Controls in accordance with the timeline established by the NRC in the SRM for

COMSECY-05-0028.

3.4.3 New York State Department of Health - Industrial Unit

The review team found that the Industrial Unit’s licensing actions were thorough, complete,

consistent, and of high quality with health and safety issues properly addressed. The licensee’s
New York Final Report Page 17

compliance history is taken into account when reviewing renewal applications, as determined

from discussions with the license reviewers.

The casework review indicated that the Industrial Unit’s staff follow their licensing guides during

the review process to ensure that licensees submit the information necessary to support the

request. License conditions, including tie-down conditions, are usually stated clearly and are

enforceable. Deficiency letters clearly stated regulatory positions.

The review team noted that there are 33 licenses that have been in timely renewal for more than

one year. They range in age from 1996 to 2005. In speaking with the Industrial Unit manager,

he indicated that these licenses were not completed because of the loss of experienced

personal and the reorganization. In some cases, licensed operations have not significantly

changed and the facilities are inspected periodically. The Industrial Unit has inspected these

licensees at intervals shorter than those prescribed for similar license types in IMC 2800. The

review team noted that even though the renewals have not been completed, any potential

health and safety issues should have been identified during the inspection process. Industrial

Unit management is aware of this licensing backlog and will prioritize the oldest renewals. With

the recent merger, there is additional qualified personnel to distribute the workload and

minimize or eliminate the licensing backlog.

The review team examined the licensees that the Industrial Unit determined met the criteria for

the Increased Controls, per COMSECY-05-0028. The review team determined that the

Industrial Unit had correctly identified the licensees that require increased controls based on this

criteria, and will continue to issue increased controls to any additional licensees, as appropriate. 

Each license was amended to include the Increased Controls requirements in a license tiedown document. The Industrial Unit issued the Increased Controls in accordance with the

timeline established by the NRC in the SRM for COMSECY-05-0028.

3.4.4 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

permit holders 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 issued six exemptions of 6 NYCRR Part 381 mostly to broad-scope academic

licensees who transport Class A LLRW between their various complexes, facilities, and

buildings, using registered vehicles for consolidation of waste prior to final transport. These

exemption permits are renewed every two years.

The review team found that cancellation permitting 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 guides

during the review process to enure that the permit holders submit the information necessary to
New York Final Report Page 18

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. Currently this process at the permit

administrator level may take as long as several months. This delay in the issuance of permits

could impact permitees. The permit unit supervisor 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 followup action.

3.4.5 Indicator Summary

The review team found that the licensing and/or permitting actions for all New York programs

were thorough, complete, consistent, and of good technical quality with health and safety issues

properly addressed.

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, was satisfactory.

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 NMED against those

contained in the respective program’s files, and evaluated the casework and supporting

documentation for 22 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 seven 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 with the Program Managers and selected staff. The

incidents included: lost/stolen materials, equipments failures/disconnects, contamination/spills,

damaged devices and packages, and medical events.

3.5.1 New York City Department of Health and Mental Hygiene

NYC staff investigated a total of 72 incidents during the review period. The review team

evaluated reports and supporting documentation for seven radioactive materials incidents for

NYC. The majority of these incidents were not reportable to NRC, based on the guidance in
New York Final Report Page 19

NRC’s Office of Federal and State Materials and Environmental Management Programs (FSME)

Procedure SA-300, “Reporting Materials Incidents.” NYC’s response to incidents was welldocumented, 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 on during the course of

the incident’s investigation and prior to closure. The licensees’ responses were reviewed by

Program staff for adequacy. Copies of incident investigations are placed in licensee’s

license/inspection file. Incident cases were filed according to year and date of occurrence. Any

pending actions are considered before new licensing actions are taken and are also followed up

on during the next routine inspection. Individual incident files did not always include an incident

log number, during the 2002 to 2005 time frame. NYC does not utilize an automated tracking

database for incidents and allegations; however, case files are easily retrieved from folders filed

in chronological order.

The review team assessed NYC’s response to four allegations involving radioactive material,

including two allegations referred to NYC by the NRC. In both NRC cases 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 followup,

notification, and close-out were made. The review team identified two additional allegations,

which were properly handled including appropriate notification.

3.5.2 New York State Department of Health

During the review period, DOH investigated 37 incidents. The review team evaluated all seven

incidents requiring reporting to the NRC and one allegation. DOH utilizes a newly established

automated incident/event tracking systems 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 and

NMED, 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 followup action, as appropriate.

Incidents and allegations are investigated based on their radiological health and safety

significance. On-site investigations are prompt, thorough and well-documented. Significant

improvement was noted in DOH’s reporting of incidents to NRC and NMED in accordance with

FSME Procedure SA-300. A comparison of reportable incidents on file in NMED to those

contained in the “Incident” database proved that the required incidents were captured.

3.5.3 New York State Department of Health - Industrial Unit

During the review period the Industrial Unit investigated 41 incidents. The review team

evaluated all six incidents requiring reporting to the NRC and three allegations, one of which

was referred to the Industrial Unit by NRC. The review team found the Industrial Unit’s

response to incidents and allegations to be comprehensive and complete. Initial responses

were prompt and well-coordinated. The level of investigative effort was commensurate with the

health and safety significance. Inspectors dispatched to conduct on-site investigations

employed appropriate enforcement tools to achieve regulatory compliance. Allegers’ identities

are protected from disclosure and feedback to allegers was made as appropriate.
New York Final Report Page 20

Licensees are required to review each incident from a root cause analysis perspective and to

develop measures to prevent recurrence. The Industrial Unit’s staff reviews the adequacy of

the licensees’ responses and provides feedback to the respective licensee.

3.5.4 New York State Department of Environmental Conservation

The review team evaluated DEC’s response to two radioactive materials 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 significance of

the incident. DEC dispatched inspectors for on-site investigations, as appropriate, and took

enforcement and followup action, as needed. DEC did not have any incidents that met the

criteria for reporting to NMED. DEC received no allegations during the review period.

3.5.5 Indicator Summary

New York’s performance for this indicator was adequate and prompt. The review team noted an

improvement in NYC’s cataloging of incidents since 2005. DOH’s automated “Incident”

database is a significant improvement in identifying, tracking, and trending incident and

allegation information.

The New York programs have procedures in-place and are, when appropriate, reporting

incidents to the NRC and to NMED.

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, was satisfactory.

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, DOL, and

DEC. Now, there are only three; 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. 
New York Final Report Page 21

 Accommodations were made to transfer authority in a manner that minimizes the impact on

licensee activities. All rules, regulations, and acts in effect at the time of the transfer will remain

in effect until duly modified or abrogated by the Commissioner of Health. Due to the short

amount of time between the merge and the IMPEP review, DOH has kept the programs

separate (functionally operating as units) until plans can be made to fully integrate personnel,

responsibilities, and regulations of the two units. New York State Environmental Conservation

Law Articles 1, 3, 17, 19, 27 and 29 are the bases to create DEC and implement a portion of the

Agreement with the NRC.

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, particularly

in the case of the Increased Controls license condition. On licenses in which Increased

Controls apply, DOH and the Industrial Unit implement the Order in different fashions; DOH

listed all six Increased Controls conditions on the licenses, whereas the Industrial Unit used tiedown conditions. These methods will be aligned as the programs become fully integrated.

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. The regulatory adoption processes for the State-wide programs (DOH, including the

Industrial Unit, and DEC) include a review of proposed regulations by the Governor’s Office for

Regulatory Reform (GORR). This Office evaluates proposed regulations for impact on the

State’s small business community.

NYC regulations are found in Article 175 of the New York City Health Code and apply to all

ionizing radiation, whether emitted from radionuclides or devices. NYC requires a license for

possession and use of all radioactive material, including naturally occurring and acceleratorproduced radioactive material (NARM). NYC also requires registration of all equipment

designed to produce x-rays or other ionizing radiation. NYC’s regulatory adoption process is a

six-step process that takes between six months and one year to complete, depending on the

complexity of the rule change.

Since the 2002 IMPEP review, NYC has adopted the Increased Controls license condition and

ten NRC amendments. Some of the amendments cannot be implemented until DOH has

adopted similar requirements to ensure consistent regulation of licensees throughout the State

and to prevent transboundary issues when licensees cross jurisdictions.

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

! “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.
New York Final Report Page 22

! “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.

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

or by adopting alternate legally binding requirements:

! “Compatibility with IAEA Transportation Safety Standards and other Transportation Safety

Amendments,” 10 CFR Part 71 amendment (69 FR 3697), that became effective on

October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

! “Medical Use of Byproduct Material - Recognition of Specialty Boards,” 10 CFR 35 Part

amendment (70 FR 16336; 71 FR 1926), that became effective on April 29, 2005, and is

due for Agreement State adoption by April 29, 2008.

! “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.

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 and apply to all ionizing radiation, whether emitted from

radionuclides or devices used for medical, academic, or research and development. DOH

requires a license for possession and use of all radioactive material, including NARM. DOH

also requires registration of all equipment designed to produce x-rays or other ionizing radiation. 

DOH’s regulatory adoption process is a ten-step process that takes approximately 12 to 18

months, depending on the complexity of the action.

During the review period, DOH adopted the Increased Controls license condition and one NRC

amendment. DOH submitted three final regulations to the NRC for a compatibility review. NRC

staff identified comments on the regulations that will need to be addressed in order for the

regulations to be compatible with Federal requirements. DOH has drafted a number of legally

binding requirements to address NRC amendments while regulations are being promulgated. 

The review team informed DOH management and staff of the process, as detailed in FSME

Procedure SA-201, “Review of State Regulatory Requirements,” for submitting legally binding

requirements, such as license conditions, to the NRC for a compatibility review.

DOH has drafted legally binding requirements for the following NRC amendments; however,

none of them have been submitted to the NRC for a compatibility review:

! “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.

! “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 Report Page 23

! “Frequency of Medical Examinations for Use of Respiratory Protection Equipment,” 10 CFR

Part 20 amendment (60 FR 7900), that became effective on March 13, 1995, and was due

for Agreement State adoption by March 13, 1998.

! “Clarification of Decommissioning Funding Requirements,” 10 CFR Parts 30, 40, and 70

amendments (60 FR 38235), that became effective on November 24, 1995, and was due

for Agreement State adoption by November 24, 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 on August 20, 1997, and was due for

Agreement State adoption by August 20, 2000.

! “Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea,”

10 CFR Part 30 amendment (62 FR 63634), that became effective on January 2, 1998, and

was due for Agreement State adoption by January 2, 2001.

! “Respiratory Protection and Controls to Restrict Internal Exposure,” 10 CFR Part 20

amendment (64 FR 54543, 64 FR 55524), that became effective on February 2, 2000, and

was due for Agreement State adoption by February 2, 2003.

! “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 - Recognition of Specialty Boards,” 10 CFR 35 Part

amendment (70 FR 16336; 71 FR 1926), that became effective on April 29, 2005, and is

due for Agreement State adoption by April 29, 2008.

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

! “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.

! “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.

! "Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment

(60 FR 50248 and 61 FR 28724), that became effective on April 1, 1996, and was due for

Agreement State adoption on April 1, 1999.

! “Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

With an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662), that became

effective on February 27, 1997, and was due for Agreement State adoption by February 27,

2000.
New York Final Report Page 24

! “Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts

20 and 35 amendments (62 FR 4120), that became effective on May 29, 1997, and was

due for Agreement State adoption by May 29, 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.

! “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.

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

or by adopting alternate legally binding requirements:

! “Compatibility with IAEA Transportation Safety Standards and other Transportation Safety

Amendments,” 10 CFR Part 71 amendment (69 FR 3697), that became effective on

October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

! “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.

The Industrial Unit’s regulations are found in Part 38 of Title 12 of the Official Compilation of

Codes, Rules and Regulations of the State of New York (12 NYCRR Part 38) and apply to all

commercial and industrial uses of radioactive material. The Industrial Unit requires a license for

possession and use of all radioactive material for commercial and industrial purposes, including

NARM. The Industrial Unit’s regulatory adoption process used to be a seven-step process that

took at least 12 months to complete. Since the merger with DOH, the Industrial Unit’s

regulatory adoption process is now consistent with DOH’s regulatory adoption process.

Since the previous IMPEP review, the Industrial Unit adopted the Increased Controls license

condition and a legally binding requirement for one overdue amendment. The review team

discussed with Industrial Unit staff the use of legally binding requirements to use in interim while

GORR considers proposed regulations. Industrial Unit staff started meeting weekly to

promulgate legally binding requirements to address outstanding NRC amendments and to

discuss necessary accommodations to the regulations for the DOH/DOL merge. Industrial Unit

regulations shall be amended to include the new NRC amendments in conjunction with the

incorporation of these requirements into DOH regulations. DOH Industrial Unit staff are

exploring the legality of adopting regulations by reference to Federal regulations, which may

shorten the adoption period.
New York Final Report Page 25

For the Industrial Unit, the following NRC amendments are overdue for adoption:

! “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.

! “Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

With an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662), that became

effective on February 27, 1997, and was due for Agreement State adoption by February 27,

2000.

! “Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiography Operations,” 10 CFR Parts 30, 34, 71, and 150 amendments (62 FR 28947),

that became effective on June 27, 1997, and was due for Agreement State adoption by

June 27, 2000.

! “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.

! “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.

! “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,” 10

CFR Part 39 amendment (65 FR 20337), that became effective on May 17, 2000, and was

due for Agreement State adoption by May 17, 2003.

! “New Dosimetry Technology,” 10 CFR Parts 34, 36, and 39 amendments (65 FR 63749),

that became effective on January 8, 2001, and was due for Agreement State adoption by

January 8, 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 April 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.
New York Final Report Page 26

For the Industrial Unit, the following NRC amendments will need to be addressed in upcoming

rulemakings or by adopting alternate legally binding requirements:

! “Compatibility with IAEA Transportation Safety Standards and other Transportation Safety

Amendments,” 10 CFR Part 71 amendment (69 FR 3697), that became effective on

October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

! “Security Requirements for Portable Gauges Containing Byproduct Material,” 10 CFR Part

30 amendment (70 FR 2001), that became effective on July 11, 2005, and is due for

Agreement State adoption by July 11, 2008.

! “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.

DEC regulations are found in Title 6, Parts 380, 381, 382, and 383 of the New York Codes,

Rule, and Regulations 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 is a ten-step process that takes approximately 18 to 24

months to complete.

Since the previous review, DEC has drafted regulations to address seven NRC amendments

and is in the process of writing the supporting documentation (e.g. Regulatory Analysis,

Environmental Assessment, etc.) for submission to GORR. The rulemaking package is

estimated to be completed in early 2009. DEC is currently addressing parts of the NRC

amendment, “Radiological Criteria for License Termination,” through legally binding

requirements.

For DEC, the following 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.

! “Decommissioning Record keeping 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.

! “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.

! “Termination or Transfer of Licensed Activities: Record keeping 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.
New York Final Report Page 27

! “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.

The State-wide programs (DOH, including the Industrial Unit, and DEC) are not able to

completely adopt the NRC’s “Deliberate Misconduct by Unlicensed Persons” amendment due to

legal constraints. The Industrial Unit’s legal counsel’s review of this amendment determined

that it is beyond the scope of the State’s regulatory authority. New York’s regulatory authority is

limited to licensees and registrants. Industrial Unit management indicated that, in the case of a

subcontractor or other third party whose deliberate misconduct resulted in a licensee violating

DOL regulations, the program’s recourse would be the pursuit of enforcement action against the

licensee. Despite this limitation of regulatory authority, the New York programs still must

include the other requirements of the deliberate misconduct amendment in the State’s

regulations and implement those requirements effectively.

The review team noted that since the last IMPEP review, DEC adopted the following

amendments:

! “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment,” 10 CFR

Part 20 Amendment (63 FR 50127) that became effective November 20, 1998, and was

due for Agreement State adoption by November 20, 2001. 

! “Compatibility with IAEA Transportation Safety Standards and other Transportation Safety

Amendments,” 10 CFR Part 71 amendment (69 FR 3697), that became effective on

October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

In response to the requirements of 651(e) of the Energy Policy Act of 2005 (EPAct), the State of

New York intends to submit a letter to the NRC to indicate that the State intends to continue to

regulate all radioactive materials which includes naturally occurring radioactive material, such

as radium, and accelerator-produced radionuclides. Rather than officially amending the New

York’s Agreement with the NRC, the Governor-appointed State Liaison Officer expects to

coordinate with all the programs and obtain the Governor’s certification, defined in the EPAct, to

continue regulatory authority for the newly-defined byproduct material (NARM).

4.1.3 Indicator Summary

The review team noted that all programs continue have a number of overdue NRC

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

timely matter was caused in part by the need to address higher priority issues that may affect

public health and safety and in part due to the state’s lengthy promulgation process. The review

team recommends that the three State Agencies (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. 
New York Final Report Page 28

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,

was unsatisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Program

The Industrial Unit has sole responsibility for performing SS&D evaluations in the State of New

York. Three sub-indicators were used to evaluate the Industrial Unit’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.

In assessing the Industrial Unit’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 Industrial Unit indicated that two SS&D evaluations

had been performed since the previous IMPEP. During the on-site review, the review team did

not identify any additional SS&D evaluations completed since the previous IMPEP. The review

team assessed the documentation for the two SS&D evaluations performed and interviewed

staff and management involved in SS&D evaluations.

4.2.1 Technical Staffing and Training

The Program Manager and two radiophysicists are the reviewers qualified to conduct and sign

safety evaluations of SS&D applications. The Program Manager documented specific training

courses required and taken by all reviewers. The two radiophysicists have taken all required

training. The Program Manager has taken all required training, except NRC’s Inspection

Procedures course; however, the Program Manager’s years of experience in inspections

reasonably satisfies qualification requirements. Only the Program Manager and one of the

radiophysicists performed SS&D evaluations since the previous IMPEP. The review team

interviewed these individuals and found them familiar with the SS&D evaluation process. They

are also familiar with and have access to applicable guidance and reference documents. Due

to the very low number of evaluations performed over the years, the Industrial Unit does not

have a formal qualification board, nor a minimum number of evaluations needed to become a

qualified SS&D reviewer. Signature authority is granted after successfully completing required

training classes. The review team determined that the reviewers are qualified to review and

sign SS&D evaluations and that the Industrial Unit has a sufficient staffing level of qualified

reviewers to adequately handle their workload.

4.2.2 Technical Quality of the Product Evaluation Program

The Industrial Unit processed two 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 Industrial Unit staff follow 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 Report Page 29

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Industrial Unit staff were not aware of any defects or incidents involving sources and devices

evaluated by their program. The review team conducted a search of NMED and Industrial Unit

files to determine whether incidents outside of the knowledge of Industrial Unit staff existed. 

The review team did not identify any incidents involving sources or devices evaluated by the

Industrial Unit.

4.2.4 Indicator Summary

The Industrial Unit performed two 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, was 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. The wastes, approximately 2.4 million cubic

feet, that were 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.
New York Final Report Page 30

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

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 West Valley and inspections at Cornell. At times, staff from DEC regional offices accompany

the inspector to observe and to assist with sampling. As indicated in Section 3.1.4, the training,

experience, and the educational qualifications for this inspector were evaluated and were found

to be adequate. Qualifications of the three Industrial Unit inspectors that may inspect the facility

were reviewed by the team and found to be adequate. See Section 3.1.2 for additional details.

4.3.2 Status of Low-Level Radioactive Waste Disposal Inspections

Both DEC and the Industrial Unit have one year inspection frequencies at West Valley. DEC

has a one year frequency for the Cornell site. The review team confirmed that the Industrial

Unit inspected the West Valley license annually.

DEC inspected the West Valley site three times during the review period in November 2002,

August 2004, and April 2005. The Cornell site was inspected by DEC in October 2002, June

2003, and July 2004. DEC management attributed the delay in conducting the annual

inspections to a lack of sufficient staff and higher priority work. The Program Manager indicated

that DEC staff has been to both sites a number of times since the last inspections in 2004 and

2005 for site tours and meetings. During these visits, staff has had the opportunity to observe

the condition of the sites. The review team concluded that despite the lack of a formal

inspection by DEC of these closed sites for the last two to three years, the on-site visits are

adequate to ensure that the sites have not changed significantly and that health and safety

continues to be adequately protected. The Program completed inspections of both sites

following the on-site review.

Regarding the timeliness of inspection reports, the review team noted that six of the seven DEC

inspection reports issued were greater than 30 days after the completion of the inspection. This

matter is discussed in detail in Section 3.2.4 and the recommendation made in Section 3.2.5

also applies for inspection reports for LLRW facilities. The team found that the Industrial Unit

issued their inspection findings to NYSERDA within 30 days of completion of the inspection.

4.3.3 Technical Quality of Inspections

The review team evaluated all the DEC reports and the latest Industrial Unit inspection report

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 inspections

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
New York Final Report Page 31

conducted by DEC staff. The listing of inspection casework reviewed in Appendix C includes

the casework reviewed in evaluating this indicator.

DEC conducts environmental monitoring at the burial sites, which includes gamma radiation

measurements using thermoluminescent dosimeters (TLDs), as well as surface water and

sediment sampling. At West Valley, TLDs are placed along the boundary fence line, at each of

the three off-site creeks, at the nearest residence, at Sardinia, and at Rock Spring Road. 

Surface water and sediment samples are collected from the three creeks.

The DEC inspector is accompanied by his supervisor every two years. The review team found

this frequency acceptable given the small number of inspections performed by the DEC staff

member assigned to these sites.

4.3.4 Technical Quality of Licensing Actions

The Industrial Unit 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 renewal and a subsequent

amendment issued by the Industrial Unit for this license and found the licensing actions

thorough, complete, and of high technical quality. These casework reviews are included in

Appendix D.

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 expired on October 1, 2002;

however, it was extended under the State’s Administrative Procedures Act. NYSERDA

submitted a sufficient application before the expiration date, and DEC staff had initiated

reviewing the application and discussing revisions with NYSERDA. NYSERDA and DEC staff

were also committed to working with US Department of Energy on the Environmental Impact

Statement for the entire West Valley site. This activity took priority over the permit renewal. 

Renewal of the maintenance and monitoring permit is currently in process. The renewal will

include updating or replacing all of the tie-down documents.

An air permit issued to NYSERDA was terminated early in the review period, and relevant

provisions were combined with the maintenance and monitoring permit. The review team

evaluated licensing actions completed by DEC and found them to be thorough, complete, and of

high technical quality.

4.3.5 Technical Quality of Incident and Allegation Activities

There were no incidents, allegations, operational errors, damage, or accidents related to the

West Valley or the Cornell sites since the last review.

4.3.6 Indicator Summary

Oversight of the two former radioactive waste disposal sites by DEC and the Industrial Unit is

suitable and thorough.
New York Final Report Page 32

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, was satisfactory.

5.0 SUMMARY

New York’s performance was found satisfactory for all performance indicators with the

exception of Compatibility Requirements, which was found unsatisfactory. Accordingly, the

review team recommended, and the MRB agreed, that the New York Agreement State Program

is adequate to protect public health and safety and not compatible with NRC’s program. The

compatibility determination was based on significant delays in the adoption of required

regulations. The review team recommended, and the MRB agreed, that the period of

Heightened Oversight of the New York Agreement State Program continue until required

regulations or legally binding requirements are adopted by New York and reviewed and

determined to be compatible by the NRC. The review team recommended, and the MRB

agreed, that a periodic meeting will be conducted in approximately one year and that the next

full IMPEP review of the New York Agreement State Program will take place in approximately

four years.

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

evaluation and implementation, as appropriate, by the State.

RECOMMENDATIONS:

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

within 30 days after the close of the inspection. (Section 3.2.5) (Open recommendation

from the 2002 IMPEP Review)

2. The review team recommends that the three State Agencies (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. (Section 4.1.3) (Open recommendation

from the 2002 IMPEP Report)
LIST OF APPENDIXES AND ATTACHMENT

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

Attachment Letters from Jeannine Prud’homme, Stephen Gavitt,

 and Barbara Youngberg

New York’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Lloyd Bolling, FSME Team Leader

Technical Staffing and Training

Technical Quality of Incident and Allegation

 Activities

Compatibility Requirements

Duncan White, Region I Status of Materials Inspection Program

Technical Quality of Inspections

Inspector Accompaniments

Kathy Modes, Region I Technical Quality of Licensing Actions

Deborah Gilley, Florida Technical Quality of Licensing Actions

Jennifer Tobin, FSME Technical Staffing and Training

Technical Quality of Incident and Allegation

 Activities

Compatibility Requirements

Jonathan Rivera, FSME Sealed Source and Device Evaluation Program

Stephen Matthews, Washington Status of Materials Inspection Program 

Technical Quality of Inspections

Low-Level Radioactive Waste Disposal Program
APPENDIX B

NEW YORK ORGANIZATION CHARTS

ADAMS ASSESSION NOS.

ML063530794, ML063530800, ML063530801
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: MDS Nordion License No.: 2087-0793

Inspection Type: Reciprocity Priority: N/A

Inspection Date: 6/29/06 Inspector: HT

File No.: 2

Licensee: Our Lady of Mercy License No.: 91-2900-01

Inspection Type: Routine, Announced Priority: 5

Inspection Date: 7/25/06 Inspector: JH

Comment:

Inspection file contained personnel information.

File No.: 3

Licensee: Our Lady of Mercy License No.: 91-2900-01

Inspection Type: Increased Controls Priority: N/A

Inspection Date: 7/25/06 Inspectors: JD/TL

File No.: 4

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

Inspection Type: Initial, Unannounced Priority: 2

Inspection Date: 8/15/06 Inspector: JH

File No.: 5

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

Inspection Type: Increased Controls Priority: N/A

Inspection Date: 8/15/06 Inspector: JD

File No.: 6

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

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 1/25/06 Inspector: EC

Comments

a) Violation was issued identifying the incorrect procedure number.

b) Inspector’s radiation survey instruments information not included in field notes.

File No.: 7

Licensee: Herry Gunarta License No.: 91-3294-01

Inspection Type: Routine, Announced Priority: 5

Inspection Date: 9/7/06 Inspector: OC
New York Final Report Page C.2

Inspection Casework Reviews

File No.: 8

Licensee: Columbia Unversity License No.: 74-3030-01

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 4/6/06 Inspector: JH

Comment:

Inspector’s radiation survey instruments information not included in field notes.

File No.: 9

Licensee: New York University Medical Center License No.: 93-2955-05

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 11/6/05 Inspector: EC

File No.: 10

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

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 3/30/06 Inspector: HT

Comment:

Inspector’s radiation survey instruments information not included in field notes.

File No.: 11

Licensee: Coney Island Hospital License No.: 91-2902-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/15/06 Inspector: OC

New York State Department of Health

File No.: 12

Licensee: Community General Hospital License No.: 1099

Inspection Type: Routine, Announced Priority: 3

Inspection Date: 11/10/05 Inspector: WK

File No.: 13

Licensee: Canton-Potsdam Hospital License No.: 1097-2

Inspection Type: Routine, Announced Priority: 5

Inspection Date: 10/17/05 Inspector: VG

File No.: 14

Licensee: SUNY Upstate Medical University License No.: 0047

Inspection Type: Routine, Announced Priority: 2

Inspection Dates: 12/8-19/03 Inspectors: GB, JC, HS

Comment:

Inspectors reviewed licensee’s gamma knife program but did not document due to lack of

specific inspection field notes for this modality.
New York Final Report Page C.3

Inspection Casework Reviews

File No.: 15

Licensee: Geneva General Hospital License No.: 1766

Inspection Type: Routine, Announced Priority: 5

Inspection Date: 8/24/04 Inspector: WK

File No.: 16

Licensee: SUNY Albany License No.: 0459-01

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 11/2/04 Inspectors: AD, JC

File No.: 17

Licensee: New York United Hospital Medical Center License No.: 1005

Inspection Type: Routine, Unannounced Priority: 2

Inspection Dates: 3/9/03 and 7/25/03 Inspector: OO

File No.: 18

Licensee: Kaleida Health- DeGraff Memorial Hospital License No.: 0548

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 9/21/05 Inspector: BI

Comment:

Inspector’s radiation survey instruments information not complete.

File No.: 19

Licensee: Columbia University License No.: 0537-3

Inspection Type: Routine, Unannounced Priority: 3

Inspection Dates: 5/13-14/05 Inspector: GB

Comment:

Inspector’s radiation survey instrument information not complete.

File No.: 20

Licensee: Good Samaritan Hospital License No.: 0575

Inspection Type: Routine, Unannounced Priority: 2

Inspection Dates: 8/17-18/06 Inspector: CB

File No.: 21

Licensee: Amsterdam Associates in Cardiology License No.: 5051

Inspection Type: Routine, Unannounced Priority: 5

Inspection Date: 3/6/06 Inspector: JC

Comment:

Inspection file contained personnel information.

File No.: 22

Licensee: John T. Mather Memorial Hospital License No.: 0495

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 12/15/05 Inspector: AB
New York Final Report Page C.4

Inspection Casework Reviews

File No.: 23

Licensee: Cold Spring Harbor Laboratory License No.: 0574

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 12/12/03 Inspector: AB

Comment:

Inspector’s radiation survey instrument information not complete.

File No.: 24

Licensee: Good Samaritan Hospital License No.: 0490

Inspection Type: Routine, Unannounced Priority: 2

Inspection Dates: 6/13/06 and 6/21/06 Inspector: JK

File No.: 25

Licensee: Cornell University License No.: 0005-3A

Inspection Type: Routine, Announced Priority: 2

Inspection Dates: 5/20-23/03 Inspectors: SK, OO, GB

File No.: 26

Licensee: Orange Regional Medical Center License No.: 0563

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 7/11/06 Inspector: JK

Comment:

Inspector’s radiation survey instrument information not complete.

File No.: 27

Licensee: Inter-Community License No.: 3191

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/22/06 Inspector: SK

File No.: 28

Licensee: Mount Vernon Hospital License No.: 1006

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 4/21/06 Inspector: OO

Comment:

Inspector’s radiation survey instrument information not complete.

File No.: 29

Licensee: Sisters of Charity Hospital License No.: 2911

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 5/31/06 Inspector: SK
New York Final Report Page C.5

Inspection Casework Reviews

New York State Department of Health - Industrial Unit

File No.: 30

Licensee: Buffalo X-Ray Company License No.: 0286-0511

Inspection Type: Increased Controls Priority: N/A

Inspection Dates: 9/7/06 and 10/20/06 Inspector: BK

File No.: 31

Licensee: Cardinal Health License No.: 2449-3500

Inspection Type: Routine, Unannounced Priority: 2

Inspection Dates: 6/28-29/05 Inspector: RP

File No.: 32

Licensee: CoPhysics Corporation License No.: 2691-3949

Inspection Type: Routine, Announced Priority: 3

Inspection Date: 12/21/05 Inspector: RP

File No.: 33

Licensee: General Electric Company License No.: 0794-0220

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 1/10/05 Inspector: RP

File No.: 34

Licensee: General Electric Company License No.: 0794-0220

Inspection Type: Routine, Announced Priority: 2

Inspection Dates: 1/5-6/05 Inspector: JM

File No.: 35

Licensee: Municipal Testing Laboratory, Inc. License No.: 2072-1988

Inspection Type: Routine, Unannounced Priority: 1

 and Increased Controls

Inspection Dates: 9/1/06 and 9/28/06 Inspector: BK

File No.: 36

Licensee: NYSERDA License No.: 0382-1139

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 12/1/04 Inspector: JM

File No.: 37

Licensee: Radiac Research Corporation License No.: 1944-1879

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 12/19/05 Inspector: RP

File No.: 38

Licensee: Pall RAI Manufacturing Company License No.: 1935-1921

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 2/7/06 Inspector: BK

Comment:

Inspection file contained personnel information.
New York Final Report Page C.6

Inspection Casework Reviews

New York State Department of Environmental Conservation

File No.: 39

Permitee: Eastman Kodak Company Permit Nos.: 8-2614-00205/01177 & /01826

Inspection Type: Routine, Unannounced Priority: 4

Inspection Date: 10/2/06 Inspector: SH

Comment:

Letter to permitee issued 47 days after completion of inspection.

File No.: 40

Permitee: Proctor & Gamble Pharmaceuticals Permit Nos.: 7-0842-00013/00007 & /00009

Inspection Type: Routine, Announced Priority: 4

Inspection Date: 7/18/06 Inspectors: AG, JF

Comment:

Letter to permitee issued 44 days after completion of inspection.

File No.: 41

Permitee: Cardinal Health Permit No.: 9-1430-00175/00001

Inspection Type: Routine, Unannounced Priority: 4

Inspection Date: 8/27/03 Inspectors: AG, MS

Comments:

Letter to permitee issued 39 days after completion of inspection.

File No.: 42

Permitee: NRD, Inc. Permit No.: 9-1446-00018/00001

Inspection Type: Special, Announced Priority: 3

Inspection Date: 7/14/05 Inspectors: BY, JF

Comment:

Letter to permitee issued 59 days after completion of inspection.

File No.: 43

Permitee: NYS Health Department - Wadsworth Center Permit No.: 4-0130-00034/0001

Inspection Type: Routine, Announced Priority: 4

Inspection Date: 1/11/06 Inspectors: JF, AG

Comment:

Letter to permitee issued 42 days after completion of inspection.

File No.: 44

Permitee: MP Biomedicals East, Inc. Permit No.: 3-3924-00003/00002

Inspection Type: Termination Priority: 4

Inspection Date: 10/20/05 Inspector: SH
New York Final Report Page C.7

Inspection Casework Reviews

File No.: 45

Permitee: MP Biomedicals East, Inc. Permit No.: 3-3924-00003/00002

Inspection Type: Routine, Announced Priority: 4

Inspection Date: 8/3/04 Inspector: MS

File No.: 46

Permitee: Wyeth Research Permit No.: 3-3924-00025/386-0

Inspection Type: Routine, Unannounced Priority: 4

Inspection Date: 6/6/06 Inspector: SH

File No.: 47

Permitee: Nuclear Diagnostics Products Permit No.: 1-2824-02390/2

Inspection Type: Initial, Announced Priority: 4

Inspection Date: 7/26/05 Inspectors: AG, SH

Comment:

Letter to permitee issued 51 days after completion of inspection.

File No.: 48

Permitee: Cornell University Permit No.: 7-5032-00102/00001

Inspection Type: Routine, Announced Priority: 1

Inspection Dates: 10/22/02, 6/12/03, 12/4/03, 7/28/04 Inspector: TR

Comment:

Letters to permitee issued at 40, 145, 46 and 20 days after completion of inspections.

File No.: 49

Permitee: NYSERDA - West Valley State Disposal Area Permit No.: 9-0422-00011/00011

Inspection Type: Routine, Announced Priority: 1

Inspection Dates: 11/12-13/02, 8/18-19/04, 4/25-27/05 Inspector: TR

Comment:

Letters to permitee issued at 35, 149 and 54 days after completion of inspections.

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: Long Island College Hospital License No.: 91-2843-01

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 10/24/06 Inspector: EC

Accompaniment No.: 2

Licensee: St. Vincent’s Midtown Hospital License No.: 91-2882-01

Inspection Type: Routine, Unannounced Priority: 5

Inspection Date: 10/26/06 Inspector: JH
New York Final Report Page C.8

Inspection Casework Reviews

New York State Department of Health

Accompaniment No.: 3

Licensee: Hudson Valley Heart Center License No.: 3036

Inspection Type: Routine, Unannounced Priority: 5

Inspection Date: 11/8/05 Inspector: JC

Accompaniment No.: 4

Licensee: Glen Falls Hospital License No.: 0481

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 11/9/05 Inspector: AD

Accompaniment No.: 5

Licensee: Community General Hospital License No.: 1099

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 11/10/05 Inspector: WK

Accompaniment No.: 6

Licensee: Southside Hospital License No.: 0405-2

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/8/06 Inspector: CB

Accompaniment No.: 7

Licensee: Good Samaritan Hospital License No.: 0490

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 6/13/06 Inspector: JK

Accompaniment No.: 8

Licensee: White Plains Medical Center License No.: 1059

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/14/06 Inspector: OO

New York State Department of Health - Industrial Unit

Accompaniment No.: 9

Licensee: Radiac Research Corporation License No.: 1944-1879

Inspection Type: Routine, Announced Priority: 2

Inspection Date: 12/19/05 Inspector: RP

New York State Department of Environmental Conservation

Accompaniment No.: 10

Permitee: Wyeth Ayerst Research Permit No.: 3-3924-00025/386-0

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/6/06 Inspector: SH
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: Herry Gunarta, M.D. License No.: 91-3294-01

Type of Action: Termination Amendment No.: 2

Date Issued: 10/10/06 License Reviewer: DH

File No.: 2

Licensee: Mt. Sinai School of Medicine License No.: 74-2909-05

Type of Action: Financial Assurance Amendment No.: 3

Date Issued: 9/20/06 License Reviewer: DH

Comment:

Upon review, by NYC, it was determined that financial assurance is required. Discussions

with the licensee over an extended period of time have not resolved several issues. NYC

staff is referring this case to upper management for resolution.

File No.: 3

Licensee: NYU Hospitals Center License Nos.: 75-2955-01,

92-2955-03, 93-2955-05

Type of Action: Financial Assurance Amendment No.: N/A

Date Issued: N/A License Reviewer: DH

Comment:

A revised Standby Trust Agreement was accepted without a legal review.

File No.: 4

Licensee: NYU School of Medicine License No.: 74-2955-02

Type of Action: Financial Assurance Amendment No.: N/A

Date Issued: N/A License Reviewer: DH

Comment:

Upon review, by NYC, it was determined that financial assurance is required. Discussions

with the licensee over an extended period of time have not resolved several issues. NYC

staff is referring this case to upper management for resolution.

File No.: 5

Licensee: SUNY Health Sciences Center License No.: 74-2934-02

Type of Action: Financial Assurance Amendment No.: 2

Date Issued: 10/24/06 License Reviewer: DH
New York Final Report Page D.2

License Casework Reviews

File No.: 6

Licensee: St Vincent’s Hospital License No.: 75-3009-01

Type of Action: Notification Amendment No.: 11

Date Issued: 2/13/03 License Reviewer: DH

Comment:

Licensee is currently in Chapter 11 bankruptcy. NYC is receiving copies of the court

documents and is monitoring the situation. The licensee is still in operation.

File No.: 7

Licensee: City College (CUNY) License No.: 74-3042-01

Type of Action: Renewal Amendment No.: 5

Date Issued: 3/28/06 License Reviewer: DH

File No.: 8

Licensee: New York Blood Center License No.: 74-2946-01

Type of Action: Amendment Amendment No.: 7

Date Issued: 9/26/06 License Reviewer: DH

File No.: 9

Licensee: Columbia University License No.: 74-3030-01

Type of Action: Amendment Amendment No.: 8

Date Issued: 2/9/05 License Reviewer: RF

File No.: 10

Licensee: NYU Medical Center License No.: 74-2955-02

Type of Action: Renewal Amendment No.: 6

Date Issued: 9/20/06 License Reviewer: RF

File No.: 11

Licensee: Manhattan College License No.: 52-2974-01

Type of Action: Renewal Amendment No.: 4

Date Issued: 10/12/06 License Reviewer: RF

Comment:

Radiation Safety Officer approved with no prior, hands-on experience.

File No.: 12

Licensee: NYCHHC-Kings County Hospital Center License No.: 91-3310-01

Type of Action: New Amendment No.: 0

Date Issued: 5/25/06 License Reviewer: RF

Comments:

a) Complex review encompassed the separation of Kings County from SUNY. A review of the

file did not show the many communications that took place between NYC and the licensee. 

Telephone calls were made, but not documented.

b) Social security numbers were visible on the Landauer exposure reports which were

included in the file.
New York Final Report Page D.3

License Casework Reviews

File No.: 13

Licensee: NYCHHC-Kings County Hospital Center License No.: 92-3287-02

Type of Action: New Amendment No.: 0

Date Issued: 9/15/06 License Reviewer: RF

Comment:

Complex review encompassed the separation of Kings County from SUNY. A review of the

file did not show the many communications that took place between NYC and the licensee. 

Telephone calls were made, but not documented. It appears that the experienced license

reviewers were very familiar with the license activities of Kings County.

File No.: 14

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

Type of Action: Renewal Amendment No.: 3

Date Issued: 1/14/03 License Reviewer: DH

File No.: 15

Licensee: Long Island Jewish Medical Center License No.: 75-2986-01

Type of Action: Amendment Amendment No.: 16

Date Issued: 5/26/06 License Reviewer: RF

Comments:

a) Financial assurance was based on actual inventory rather than license possession limits. 

License was not amended, nor was a limiting license condition.

b) An amendment request dated December 29, 2005 was reviewed. An invoice was sent on

February 23, 2006. The licensee has not paid the fee and therefore the amendment has

not been issued. No documentation in the file to indicate that the licensee has been

contacted since the invoice was issued.

File No.: 16

Licensee: St. Luke’s Roosevelt Medical Center License No.: 75-2898-01

Type of Action: Amendment Amendment No.: 18

Date Issued: 8/4/06 License Reviewer: DH

Comment:

Financial Assurance evaluation was based on actual inventory and not possession limits. 

NYC will amend the license to reduce possession limits to a level in which Financial

Assurance is not required.

File No.: 17

Licensee: Memorial Sloan Kettering License No.: 75-2968-02

Type of Action: Financial Assurance Amendment No.: 6

Date Issued: 7/29/05 License Reviewer: RF

File No.: 18

Licensee: Beth Israel Medical Center/Kings Highway Division License No.: 91-3022-01

Type of Action: Amendment Amendment No.: 7

Date Issued: 5/17/05 License Reviewer: DH
New York Final Report Page D.4

License Casework Reviews

New York State Department of Health

File No.: 19

Licensee: AVC Services License No.: 5074

Type of Action: Amendment Amendment No.: 4

Date Issued: 11/25/05 License Reviewers: CC, CB

File No.: 20

Licensee: Bertrand-Chaffee Memorial Hospital License No.: 5084

Type of Action: Amendment Amendment No.: 3

Date Issued: 4/27/05 License Reviewer: RD

File No.: 21

Licensee: Cold Springs Harbor Laboratory License No.: 574

Type of Action: Amendments Amendment No.: 39

Dates Issued: 10/23/05, 10/3/06, 10/21/06 License Reviewer: CB

File No.: 22

Licensee: Good Samaritan Hospital License No.: 490

Type of Action: Amendment Amendment No.: 49

Date Issued: 7/21/03 License Reviewer: WV

File No.: 23

Licensee: Good Samaritan Hospital Medical Center License No.: 575

Type of Action: Renewal Amendment No.: 58

Date Issued: 4/27/05 License Reviewer: CC

Comments:

a) Facility diagram for HDR and brachytherapy source location was not in license file. DOH

sent letter on November 8, 2006, to acquire facility diagram.

b) Specific procedures give an orderly authority to perform contamination control procedures.

c) License file did not contain a checklist of the evaluation of HDR devices.

File No.: 24

Licensee: North Westchester Hospital Center License No.: 585

Type of Action: Amendment Amendment No.: 53

Date Issued: 9/8/06 License Reviewer: CB

File No.: 25

Licensee: University of Albany License No.: 459-1

Type of Action: Amendment Amendment No.: 57

Date Issued: 4/27/05 License Reviewer: CB

File No.: 26

Licensee: John T. Mather Memorial Hospital License No.: 495

Type of Action: Amendment Amendment No.: 21

Date Issued: 11/23/05 License Reviewer: RD

File No.: 27
New York Final Report Page D.5

License Casework Reviews

Licensee: Kaleida Health License No.: 548

Type of Action: Amendment Amendment No.: 24

Date Issued: 7/13/04 License Reviewer: JC

Comment:

Review was of limited scope.

File No.: 28

Licensee: Charles H. Albrecht Radiation Oncology, P.C. License No.: 2823

Type of Action: Amendment Amendment No.: 7

Date Issued: 4/27/05 License Reviewer: OAO

Comment:

Review was of limited scope.

File No.: 29

Licensee: Good Samaritan Hospital License No.: 575

Type of Action: Amendment Amendment No.: 68

Date Issued: 10/3/06 License Reviewer: JK

File No.: 30

Licensee: New York United Hospital Medical Center License No.: 1005

Type of Action: Termination Amendment No.: 40

Date Issued: 4/10/06 License Reviewer: CJB

File No.: 31

Licensee: Inter-Community Memorial Hospital License No.: 3191

Type of Action: Renewal Amendment No.: 4

Date Issued: 11/29/02 License Reviewer: CC

File No.: 32

Licensee: Orange Regional Medical Center License No.: 563

Type of Action: Renewal Amendment No.: 82

Date Issued: 10/3/06 License Reviewer: AD

File No.: 33

Licensee: Institute for Cancer Prevention License No.: 1799

Type of Action: Termination Amendment No.: 32

Date Issued: 9/16/05 License Reviewer: CB

File No.: 34

Licensee: NYSERDA - West Valley Site Management Program License No.: C-0382

Type of Action: Amendment Amendment No.: 1

Date Issued: 9/22/06 License Reviewer: WV

New York State Department of Health - Industrial Unit

File No.: 35

Licensee: Imaging and Sensing Technology Corporation License No.: 0387-0058
New York Final Report Page D.6

License Casework Reviews

Type of Action: Amendment Amendment No.: 2

Date Issued: 4/27/05 License Reviewer: WV

File No.: 36

Licensee: Imaging and Sensing Technology Corporation License No.: 0754-0058

Type of Action: Amendment Amendment No.: 3

Date Issued: 11/21/05 License Reviewer: WV

File No.: 37

Licensee: Cardinal Health License No.: 2593-3842

Type of Action: Amendment Amendment No.: 6

Date Issued: 1/12/06 License Reviewer: DS

Comment:

Amendment completed on an expired license. License expired January 31, 2003. 

Renewal application and timely filed letter issued December 20, 2002 and January 12,

2006, respectively.

File No.: 38

Licensee: Mallinckrodt Medical Inc. License No.: 2312-3141

Type of Action: Amendment Amendment No.: 5

Date Issued: 7/31/97 License Reviewer: DS

Comment:

License has not been renewed since July 31, 1997. Renewal and timely filed letters

available for October 20, 2000 and August 27, 2003.

File No.: 39

Licensee: Cardinal Health License No.: 2364-3250

Type of Action: Amendment Amendment No.: 13

Date Issued: N/A License Reviewers: DS, CB

Comment:

License expired October 31, 2002. Five amendments were issued since expiration date

and prior to renewal. Industrial Unit employees could not locate the 2002 renewal

application and timely filed letter.

File No.: 40

Licensee: Able Testing Inspection, Inc. License No.: 2555-3760

Type of Action: Amendment Amendment No.: 2

Date Issued: 11/21/05 License Reviewer: CB

File No.: 41

Licensee: Meade Testing Laboratories License No.: 2697-3954

Type of Action: Renewal Amendment No.: 0

Date Issued: 4/15/03 License Reviewer: WV

File No.: 42

Licensee: Meade Testing Laboratories License No.: 2697-3954 
New York Final Report Page D.7

License Casework Reviews

Type of Action: Amendment Amendment No.: 1

Date Issued: 2/13/06 License Reviewer: CB

File No.: 43

Licensee: VITS America Inc. License No.: 3188-4421

Type of Action: New Amendment No.: N/A

Date Issued: 6/16/06 License Reviewer: DS

File No.: 44

Licensee: INFICON License No.: 3113-4348

Type of Action: New Amendment No.: N/A

Date Issued: 6/4/04 License Reviewer: CB

File No.: 45

Licensee: Eustance & Horowitz, P.C. License No.: 2338-3186

Type of Action: Termination Amendment No.: 1

Date Issued: 7/21/04 License Reviewer: AC

File No.: 46

Licensee: Integrated Technologies License No.: 3051-4286

Type of Action: Termination Amendment No.: 1

Date Issued: 4/18/05 License Reviewer: DG

Comment:

Reviewer did not obtain leak test, but did verify that gauge was transferred to authorized

recipient.

File No.: 47

Licensee: Bristol-Myers Squibb Company License No.: 0931-0311

Type of Action: Amendment Amendment No.: 3

Date Issued: 4/20/06 License Reviewer: WV

File No.: 48

Licensee: General Electric Company License No.: 0794-0220

Type of Action: Renewal Amendment No.: 2

Date Issued: 5/13/04 License Reviewer: DS

Comment:

Licensee submitted a surety bond for more money than previously submitted. Reviewer

accepted bond for the licensee’s financial assurance without obtaining a revised cost

estimate. The revised cost estimate would have described how the new cost figure was

calculated.

File No.: 49

Licensee: Radiac Environmental Services License No.: 1944-1879

Type of Action: Renewal Amendment No.: 1

Date Issued: 9/13/05 License Reviewer: DS

Comment:
New York Final Report Page D.8

License Casework Reviews

Limited renewal review completed.

File No.: 50

Licensee: Pall Corporation License No.: 1935-1921

Type of Action: Renewal Reference/Amendment No.: N/A

Date Issued: N/A License Reviewers: CB, WV

Comment:

This license was last renewed in 1993 and expired in 1996. In the last 10 years, the

license was amended twice. This renewal application has been re-assigned and is

estimated for completion by June 2007.

New York State Department of Environmental Conservation

File No.: 51

Licensee: University of Rochester Permit No.: 8-2699-00059/00003

Type of Action: Modification Facility/Program No.: 170-3

Date Issued: 7/27/06 License Reviewer: JF

File No.: 52

Licensee: University of Rochester Permit No.: 8-2699-00059/00003

Type of Action: Renewal Facility/Program No.: 170-3

Date Issued: 1/21/03 License Reviewer: SH

File No.: 53

Licensee: NRD, LLC Permit No.: 9-1446-00018/00001

Type of Action: Modification Facility/Program No.: 53-3

Date Issued: 12/6/05 License Reviewer: BY

File No.: 54

Licensee: SP Lighting Corp. Permit No.: 3-3920-00277/00003

Type of Action: Termination Facility/Program No.: 164-3

Date Issued: 3/4/05 License Reviewer: SH

File No.: 55

Licensee: Phillips Lighting Co. Permit No.: 8-4624-00022/00018

Type of Action: Renewal Facility/Program No.: 172-3

Date Issued: 10/16/03 License Reviewer: AG

File No.: 56

Licensee: Cornell University Permit No.: 7-5007-00037/00001

Type of Action: Renewal Facility/Program No.: 155-3

Date Issued: 12/2/03 License Reviewer: AG

Comment:

The renewal application was received on January 28, 2003. There was a delay in the

review due to staffing shortage - additional information received October 21, 2003; permit

drafted November 17, 2003 and issued December 2, 2003.
New York Final Report Page D.9

License Casework Reviews

File No.: 57

Licensee: Trudeau Institute Permit No.: 5-1646-00014/00002

Type of Action: Termination Facility/Program No.: 96-1

Date Issued: 3/24/05 License Reviewer: SH

File No.: 58

Licensee: Cardinal Health 414 Permit No.: 8-2614-00812/00002

Type of Action: Modification Facility/Program No.: 191-3

Date Issued: 7/27/05 License Reviewer: SH

File No.: 59

Licensee: Nuclear Diagnostic Products Permit No.: 1-2824-02390/00002

Type of Action: New Facility/Program No.: 190-3

Date Issued: 7/27/06 License Reviewer: AG, SH
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: U. S. Customs License No.: N/A

Date of Incident: 6/3/04 Incident Log No.: 040498

Investigation Date: 7/2/04 Type of Investigation: On-Site

File No.: 2

Licensee: Redacted License No.: N/A

Date of Incident: 4/13/05 Incident Log No.: 050276

Investigation Date: 4/19/05 Type of Investigation: Phone

File No.: 3

Licensee: Redacted License No.: N/A

Date of Incident: 4/18/05 Incident Log No.: 050398

Investigation Date: 4/18/05 Type of Investigation: Phone

File No.: 4

Licensee: Non-Licensee License No.: N/A

Date of Incident: 4/30/04 Incident Log No.: N/A

Investigation Date: 4/30/04 Type of Investigation: On-Site

Comment:

File lacks incident log number.

File No.: 5

Licensee: U. S. Customs License No.: N/A

Date of Incident: 4/21/04 Incident Log No.: 040356

Investigation Date: 4/21/04 Type of Investigation: On-Site

File No.: 6

Licensee: Material Testing Labs License No.: N/A

Date of Incident: 11/27/02 Incident Log No.: 9

Investigation Date: 11/27/02 Type of Investigation: On-Site

File No.: 7

Licensee: U. S. Post Office License No.: N/A

Date of Incident: 8/30/04 Incident Log No.: 2004-8-29

Investigation Date: 8/30/04 Type of Investigation: On-Site
New York Final Report Page E.2

Incident Casework Reviews

New York State Department of Health

File No.: 8

Licensee: Redacted License No.: N/A

Date of Incident: 4/16/03 Incident Log No.: 86

Investigation Date: 4/17/03 Type of Investigation: Phone

Comment:

Date of patient followup call not recorded.

File No.: 9

Licensee: Redacted License No.: N/A

Date of Incident: 5/12/03 Incident Log No.: 13

Investigation Date: 5/27/03 Type of Investigation: Phone

File No.: 10

Licensee: Redacted License No.: N/A

Date of Incident: 5/19/05 Incident Log No.: 9

Investigation Date: 5/20/05 Type of Investigation: Phone

File No.: 11

Licensee: Redacted License No.: N/A

Date of Incident: 5/17/06 Incident Log No.: 455

Investigation Date: 7/21/06 Type of Investigation: On-Site

File No.: 12

Licensee: Redacted License No.: N/A

Date of Incident: 10/21/03 Incident Log No.: 131

Investigation Date: 10/22/03 Type of Investigation: Phone

File No.: 13

Licensee: Redacted License No.: N/A

Date of Incident: 4/13/05 Incident Log No.: 344

Investigation Date: 4/19/05 Type of Investigation: On-Site

Comment:

Written response from non-licensed transport company received 5-months late.

File No.: 14

Licensee: Vassar College License No.: RML-410

Date of Incident: 12/13/04 Incident Log No.: NY-06-004

Investigation Date: 12/13/04 Type of Investigation: Phone
New York Final Report Page E.3

Incident Casework Reviews

New York State Department of Health - Industrial Unit

File No.: 15

Licensee: Materials Testing License No.: 2274-3075

Date of Incident: 11/22/02 Incident Log No.: 3-10

Investigation Date: 11/27/02 Type of Investigation: On-Site

File No.: 16

Licensee: Testwell Laboratories License No.: 2406-3328

Date of Incident: 10/30/03 Incident Log No.: 3-20

Investigation Date: 10/31/03 Type of Investigation: Phone

Comment:

Lost gauging device, case remains open.

File No.: 17

Licensee: SJB Services, Inc. License No.: 2574-3792

Date of Incident: 7/26/04 Incident Log No.: 4-25

Investigation Date: 7/26/04 Type of Investigation: Phone

File No.: 18

Licensee: Testwell Laboratories License No.: 2930

Date of Incident: 8/29/04 Incident Log No.: 4-34

Investigation Date: 8/29/04 Type of Investigation: On-Site

File No.: 19

Licensee: Pall Corp. License No.: 1935-1921

Date of Incident: 8/31/05 Incident Log No.: 5-23

Investigation Date: 8/31/05 Type of Investigation: Phone

File No.: 20

Licensee: Steris Isomedix Services, Inc. License No.: 2583-3814

Date of Incident: 5/26/06 Incident Log No.: 6-14

Investigation Date: 7/10/06 Type of Investigation: On-Site

New York State Department of Environmental Conservation

File No.: 21

Licensee: QIS, Inc. License No.: N/A

Date of Incident: 4/10/06 Incident Log No.: C09-20060804-13

Investigation Date: 4/10/06 Type of Investigation: On-Site

File No.: 22

Licensee: Syncor - Rochester Permit No.: 8-2646-00001/00001

Date of Incident: 6/25/03 Incident Log No.: N/A

Investigation Date: 6/25/03 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-1210-D-101-B SS&D Type: Ion generators, Chromatography

Manufacturer: Inficon, Inc. Model Nos.: Scanex ESD-450, Scanex I,

Date Issued: 6/4/04 Scentograph Series, Aquaprobe

SS&D Reviewers: DS, CB

Comments:

a) The drawings and operator’s manual submitted by the applicant were marked “preliminary.” 

The SS&D reviewer indicated that these documents were tied-down in the References

section of the certificate, requiring the applicant to submit an amendment request if

changes are made to them.

b) A letter from the applicant, dated May 5, 2004, was not included as a tie-down condition

under the References section of the certificate. This letter requested minor typographical

corrections to the certificate and a minor request to change the color of the device label for

better clarity. The SS&D reviewer indicated that, because of no health and safety

significance, these minor corrections and request would not normally be tied down to the

certificate. The requested change in the device label did not affect the information present

on the certificate.

c) The file did not specify overall dimensions in the drawings/illustrations in the attachments to

certificates, nor in the text of the certificates, to describe the overall size of the device.

File No.: 2

Registry No.: NY-1260-D-101-G SS&D Type: Beta Gauge

Manufacturer: VITS America, Inc. Model Nos.: 721X Series (7210, 7211, 7212, 7213)

Date Issued: 6/16/06 SS&D Reviewers: DS, CB

Comments:

a) The radiation profiles had essentially the same reading for the shutter in both the open and

closed positions. The SS&D reviewer indicated that due to the small size of the air gap

between the detector and source housing, there would not be much change in the readings

between the shutter in the open and closed positions.

b) The file did not specify overall dimensions in the drawings/illustrations in the attachments to

certificates, nor in the text of the certificates, to describe the overall size of the device.
ATTACHMENT

Letters from Jeannine Prud’homme,Stephen Gavitt,

and Barbara Youngberg

New York’s Response to Draft IMPEP Report

ADAMS: ML070300584