November 12, 2002

Ronald Tramontano, Director

Center for Environmental Health

New York State Health Department

547 River Street

Troy, NY 12180-2216

Richard Cucolo, Director

Division of Safety & Health

New York State Department of Labor

State Office Building Campus

Albany, NY 12240

Jeanine Prud’homme

Assistant Commissioner

Office of Environmental Sciences & Engineering

New York City Department of Health

125 Worth Street, Room 613

New York, NY 10013

Stephen Hammond, P.E., Director

Division of Solid & Hazardous Materials

New York State Department of Environmental Conservation

625 Broadway

Albany, NY 12233-7250

Dear Sirs and Madam:

On November 5, 2002, the Management Review Board (MRB) met to consider the proposed

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

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

health and safety and compatible with the Nuclear Regulatory Commission’s program. 

Section 5.0, page 38, of the enclosed final report presents the IMPEP team’s recommendations

for the State of New York. We request your evaluation and response to recommendations

within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review will be in approximately

four years.
Ronald Tramontano - 2 -

Richard Cucolo

Jeanine Prud’homme

Stephen Hammond

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

your support of the Radiation Control Program. I look forward to our agencies continuing to

work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYC

Clayton Bradt, CHP, Principal Radiophysicist

Radiological Health Unit, DOL

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

Bureau of Environmental Radiation Protection, DOH

Paul Merges, Ph.D., Director

Bureau of Radiation, DEC

Jack Spath, Program Manager

Radioactive Waste Policy & Nuclear Coordinator, NYSERDA

William Sinclair, UT

OAS Liaison to the MRB
Ronald Tramontano - 2 -

Richard Cucolo

Jeanine Prud’homme

Stephen Hammond

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

your support of the Radiation Control Program. I look forward to our agencies continuing to

work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYC

Clayton Bradt, CHP, Principal Radiophysicist

Radiological Health Unit, DOL

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

Bureau of Environmental Radiation Protection, DOH

Paul Merges, Ph.D., Director

Bureau of Radiation, DEC

Jack Spath, Program Manager

Radioactive Waste Policy & Nuclear Coordinator, NYSERDA

William Sinclair, UT

OAS Liaison to the MRB

bcc: Chairman Meserve

Commissioner Dicus

Commissioner Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution: See next page

DOCUMENT NAME: G:\IMPEP\ML023100480.wpd

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE RIII STP:DD STP:D DEDMRS

NAME JLynch:gd (LRakovan for) JMPiccone (PHL for) PHLohaus CJPaperiello

DATE 11/6/02 11/6/02 11/6/02 11/ /02

Official Record Copy
Ronald Tramontano - 3 -

Richard Cucolo

Jeanine Prud’homme

Stephen Hammond

Distribution:

DIR RF DCD (SP01) PDR (YES)

EDO RF

KSchneider, STP

LRakovan, STP

AMauer, STP

PLarkins, STP/ASPO FCameron, OGC

DCool, NMSS/IMNS TCombs, OCA (2 copies)

LPsyk, NMSS/IMNS KCyr, OGC

DWhite, RI/RSAO MVirgilio, NMSS

Dave Collins, RII

DPiskura, RIII

AGaines, RIV

BHamrick, California

DFogle, Texas

MAbbaszadeh, Texas

STreby, OGC

JLieberman, OGC

New York File
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NEW YORK AGREEMENT STATE PROGRAM

July 15-26, 2002

FINAL REPORT

U.S. Nuclear Regulatory Commission
New York Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the New York radiation control program. The

review was conducted during the period July 15-26, 2002, by a review team comprised of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement

States of Texas and California. Team members are identified in Appendix A. The review was

conducted in accordance with the "Implementation of the Integrated Materials Performance

Evaluation Program and Rescission of a Final General Statement of Policy," published in the

Federal Register on October 16, 1997, and the November 5, 1999, NRC Management Directive

5.6, "Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of

the review, which covered the period of April 25, 1998 to July 14, 2002, were discussed with

New York management on July 26, 2002.

The team issued a draft report to New York on September 12, 2002 for factual comment. New

York responded to the findings and conclusions of the review by letter dated October 4, 2002

from Stephen Hammond, P.E., Director, Division of Solid & Hazardous Materials, for the State

Department of Environmental Conservation; by letter dated October 21, 2002 from Adela

Salame-Alfie, Ph.D., Director, Bureau of Environmental Radiation Protection, for New York

State Department of Health (DOH); by electronic mail dated October 24, 2002 from Clayton J.

Bradt, CHP, Principal Radiophysicist, for New York State Department of Labor; and by

electronic mail dated October 28, 2002 from Gene Miskin, Director, Bureau of Radiological

Health, for the City Department of Health (Attachments 1-A to 1-D). The review team has

prepared a resolution of comments document to accompany DOH’s comments (Attachment 2). 

The Management Review Board (MRB) met on November 5, 2002 to consider the proposed

final report. The MRB found the New York radiation control program was adequate to protect

public health and safety and compatible with NRC’s program.

The New York Agreement State program is administered by: (1) the New York City Department

of Health and Mental Hygiene, Office of Radiological Health (NYC), which has jurisdiction over

medical, academic, and research uses within the five boroughs of New York City; (2) the New

York State Department of Labor, Radiological Health Unit (DOL), which has jurisdiction over

commercial and industrial uses of radioactive material, including the possession of radioactive

material to be disposed of at a commercial disposal site; (3) the New York State Department of

Health, Bureau of Environmental Radiation Protection (DOH), which has jurisdiction over

medical, academic, and research uses of radioactive material except in New York City; and (4)

the New York State Department of Environmental Conservation, Bureau of Radiation (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 four programs are included as Appendix B. At the time of the

review, the combined New York programs regulated approximately 1,400 specific licenses,

including all types of major licensees except for uranium mill tailings.

The review focused on the material program as it is carried out under the Section 274b

(of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of

New York.

In preparation for the review, a questionnaire addressing the common and non-common

performance indicators was sent to each of the four Agencies on April 29, 2002. Each

Agency provided an electronic response to the questionnaire; NYC, DOL and DEC on July 3,

2002 and DOH on July 5, 2002. A copy of the questionnaire responses can be found on NRC’s

Agencywide Document Access and Management Systems using the Accession Number

ML022470209.
New York Final Report Page 2

During previous reviews of the New York Agreement State program, each New York Agency

was reviewed and evaluated separately for each performance indicator. The on-site review for

each Agency took approximately one week with the entire New York review taking

approximately three months to complete. Each program received ratings for each indicator,

and the overall determination of adequacy and compatibility for the State was based on the

weight of the numerous ratings for each performance indicator. NRC’s rationale for treating the

four New York Agencies separately in the past was that each of the New York Agency’s

radiation control programs is administered independently of each other. Consequently, the

level of review for New York was four times greater than the State of California, which has more

material licensees than New York. For this review, NRC attempted to treat the State more like

a single program, including giving only one rating for the State as a whole for each indicator.

This review was conducted over two consecutive weeks, more in line with other States having

complex organizations. The approach reduced the resources expended on the review by both

the NRC and New York, but still provided sufficient opportunity for the IMPEP review team to

assess New York’s performance and provide more timely feedback. This revised approach was

discussed with management from each of the four New York Agencies and the State

Coordinator, New York State Energy Research and Development Authority (NYSERDA), in a

teleconference on November 29, 2001.

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

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

regulations; (3) analysis of quantitative information from the radiation control program licensing

and inspection data base; (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 or clarify issues. The review team evaluated the information that it gathered

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

performance indicator and made a preliminary assessment of the New York Agreement State

program’s performance.

Section 2 below discusses the State’s actions in response to recommendations made following

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

indicators are presented in Section 3. Section 4 discusses results of the applicable

non-common performance indicators, and Section 5 summarizes the review team's findings. 

Recommendations made by the review team are comments that relate directly to performance

by the State. A response is requested from the State to all recommendations in the final report.
New York Final Report Page 3

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous routine review, which concluded on April 24, 1998, 21 recommendations

were made and the results were transmitted to the respective Commissioners of the three New

York State Agencies and the New York City Agency on November 30, 1998. During the April

1999 follow-up review of the New York City program, five of the eight recommendations for that

Agency were closed. Results of the follow-up review were sent to the New York City

Department of Health Commissioner on July 29, 1999.

The review team’s evaluation of the current status of the remaining 16 open recommendations

is as follows:

NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE (NYC)

1. The review team recommends that NYC inspectors follow the guidance in the NYC

inspection procedures manual which includes the information necessary for properly

documenting violations. (Recommendation 3, Section 3.2.1 of the 1998 report and

Section 3.2 of the 1999 report)

Current Status: Based on casework and interviews with inspectors, the review team

determined that most routine inspection reports neither adequately describe the scope

of the licensees’ activities/radiation protection programs nor indicate observed licensee

activities. This issue is further discussed in Section 3.2.1. This recommendation

remains open.

2. The review team recommends that NYC document its training program to include overall

policy and minimum training requirements to be qualified to conduct the responsibilities

of the program for both the licensing and compliance staff. (Recommendation 5,

Section 3.3.1 of the 1998 report and Section 3.3 of the 1999 report)

Current Status: NYC updated their Procedures Manual and documented their training

program for licensing and compliance staff. This recommendation is closed.

3. The review team recommends that NYC review the staff’s training against their training

requirements, clearly document how the training was achieved, and acquire the

necessary training, as appropriate. (Recommendation 6, Section 3.3.1 of the 1998

report and Section 3.3 of the 1999 report)

Current Status: NYC performed an appropriate review of the staff’s training. This

recommendation is closed.

NEW YORK STATE DEPARTMENT OF LABOR (DOL)

4. The review team recommends that DOL perform initial inspections of licensees within

six months of the licensees’ receipt of licensed material, or commencement of licensed

activities. (Section 3.1.2 of the 1998 report)

Current Status: It is DOL’s policy to conduct initial inspections within six months of

license issuance, or commencement of licensed activities. During this review period

most initial inspections were conducted within these time constraints. The overall

timeliness of DOL’s core inspections was impacted more significantly by the conduct of

Priority 1 inspections on an overdue basis than by the conduct of initial inspections on

an overdue basis. Thus, this recommendation is closed, but a new recommendation
New York Final Report Page 4

regarding the timely performance of all core inspections is made in Section 3.1.2 of this

report.

5. The review team recommends that DOL document its training program to include overall

policy and minimum training requirements for both the licensing and compliance staff. 

(Section 3.3.2 of the 1998 report)

Current Status: DOL created a written procedure documenting their training program for

licensing and compliance staff. This recommendation is closed.

6. The review team recommends that DOL notify NRC of significant reportable events and

provide documentation for all reportable events both in accordance with SA-300

“Reporting Material Events.” (Section 3.5.2 of the 1998 report)

Current Status: During the review period, the team noted that DOL did not notify the

NRC of reportable events and provide documentation in accordance with STP

Procedure SA-300. As discussed in Section 3.5 of this report, this recommendation

remains open.

7. The review team recommends that DOL management take appropriate action to move

the rule package through the rule promulgation process. (Section 4.1.2.2 of the 1998

report)

Current Status: DOL adopted 13 NRC amendments by rulemaking that became

effective on April 15, 1999. This recommendation is closed.

8. The review team recommends that DOL establish and use customized procedures for

conducting sealed source and device (SS&D) reviews based on the guidelines

presented in the SS&D Workshop and tailored to DOL’s types of SS&Ds, specific

policies, requirements, and regulations. (Section 4.2.1 of the 1998 report)

Current Status: DOL developed checklists for conducting SS&D evaluations in

congruence with guidelines presented in NUREG 1556, Volume 3 and the SS&D

Workshop. This recommendation is closed.

9. The review team recommends that DOL establish a clear policy for what constitutes a

concurrence review in accordance with guidelines in Management Directive 5.6 

(Section 4.2.1 of the 1998 report)

Current Status: DOL established a clear policy for conducting concurrence reviews

including the documentation of those reviews. This recommendation is closed.

10. The review team recommends that DOL develop a written formal SS&D training and

qualification program including minimum qualifications for signature authority. (Section

4.2.2 of the 1998 report)

Current Status: DOL established an acceptable written formal SS&D training

qualification program. This recommendation is closed.

11. The review team recommends that DOL explore one of the following options to meet the

qualifications for an SS&D program for New York: (a) immediately before performing

another review, provide additional structured training for the SS&D reviewers or (b) if

DOL determines that maintaining SS&D evaluation authority with a staff that has
New York Final Report Page 5

sufficient qualifications and training to conduct adequate reviews is not viable, return the

SS&D program to NRC. (Section 4.2.2 of the 1998 report)

Current Status: DOL management verified that if DOL received an SS&D evaluation

request that was beyond the scope of staff training, capabilities or experience, DOL

would contact the NRC for technical assistance or for training. This recommendation is

closed.

NEW YORK STATE DEPARTMENT OF HEALTH (DOH)

12. The review team recommends that DOH modify it’s inspection program to ensure that

initial inspections are performed within six months of the licensee’s receipt of licensed

material, within six months after commencement of licensed activities, or within one year

of license issuance, whichever comes first, consistent with NRC Inspection Manual

Chapter (IMC) 2800. (Section 3.1.3 of the 1998 report)

Current Status: The DOH Inspection Procedures Manual was revised consistent with

NRC IMC 2800 for only Priority 1 licenses. However, the vast majority of new licensees

are inspected within six months after license issuance, and extensions are granted on a

case-by-case basis when the licensee has not received material, or, for mobile nuclear

medicine licensees, when the licensee is inspected in conjunction with another

licensee’s activities. Overall, the program is adequately meeting the goals of NRC IMC

2800 with respect to inspection timeliness. This recommendation is closed.

13. The review team recommends that DOH notify NRC of significant reportable events and

provide documentation for all reportable events both in accordance with SA-300. 

(Section 3.5.3 of the 1998 report)

Current Status: It is not DOH’s policy to report events in accordance with STP

Procedure SA-300. DOH management indicated they would review their reporting

obligations and consider reporting to the extent authorized by New York State law. This

issue is discussed further in Section 3.5.3. This recommendation remains open.

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION (DEC)

14. The review team recommends that DEC document its training program to include overall

policy and minimum training requirements for both the permitting and compliance staff. 

(Section 3.3.4 of the 1998 report)

Current Status: DEC provided the review team with a document titled “Recommended

Training for Staff in the Bureau of Radiation,” this document is acceptable to close this

item. This recommendation is closed.

15. The review team recommends that DEC incorporate the handling of incidents and

allegations into their inspection procedures. (Section 3.5.4 of the 1998 report)

Current Status: DEC has drafted changes to their inspection procedures to incorporate

the handling of incidents and allegations, but has not completed the task due to higher

priorities. The team did not note any performance issues related to the handling of

incidents and allegations. This recommendation is closed.

16. The review team recommends that DEC coordinate with the appropriate New York

licensing Agency, the notification to the NRC of significant reportable events and provide
New York Final Report Page 6

documentation for all reportable events both in accordance with SA-300. (Section 3.5.4

of the 1998 report)

Current Status: During a review of incidents over the review period, the team noted that

DEC coordinated with the appropriate New York licensing Agencies with respect to the

incidents. None of the events that DEC responded to required reporting to the NRC. 

This recommendation is closed.

During the 1998 review, 13 suggestions were also made for the State to consider. The team

determined that the State considered the suggestions and took appropriate actions.

3.0 COMMON PERFORMANCE INDICATORS

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

Regional and Agreement State programs. These indicators are: (1) Status of Materials

Inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training;

(4) Technical Quality of Licensing Actions; and (5) Response to Incidents and Allegations. 

3.1 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 independently from each program's licensing and

inspection data tracking system, the examination of completed licensing and inspection

casework, and interviews with management and staff.

In order to compare the performance of the four New York programs with respect to this

indicator, the team limited their review of completed and overdue inspections to the period

beginning after the follow-up review in New York City in April 1999. With this limitation, each

program’s performance could be weighted in accordance with the percentage of core licensee

inspections for which each was responsible during the same period of time. The review team

believes that this approach was sufficient to complete this portion of the review.

3.1.1 New York City Department of Health and Mental Hygiene

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

various types of NYC material licenses are generally the same as, or more restrictive than,

those listed in the NRC IMC 2800, “Materials Inspection Program.” However, due to the

manner in which NYC categorizes licensees, those that are licensed for possession and use of

a high dose-rate remote afterloader (HDR) were inadvertently assigned a Priority 2 as opposed

to a Priority 1. Despite this administrative discrepancy, NYC inspected most HDRs on an

annual basis during the review period. The team discussed the issue with NYC staff, and was

told that they are in the process of compiling a list of licensees possessing and using HDRs, so

that they can adjust the priority to be consistent with NRC IMC 2800.

In their response to the questionnaire, NYC indicated that there was only one currently overdue

core licensee inspection. The examination of the data and inspection files provided by NYC

during the review revealed twelve initial inspections that were currently overdue, as well as the

one Priority 1 inspection currently overdue that was identified by NYC. In addition, during this

review period approximately 16 core inspections were performed on an overdue basis (i.e.,

more than 25% of the inspection frequency beyond the due date for Priority 1, 2, and 3
New York Final Report Page 7

licensees; or, more than six months after license issuance for new licensees). Overall, for this

review period, the team calculated the percentage of core inspections performed on an overdue

basis, or currently overdue, to be 23%, based on a review of all initial inspections performed or

currently overdue, and approximately 32% of the Priority 1, 2, and 3 inspection files.

Two main factors have contributed significantly to the number of overdue inspections. The first

is, as discussed earlier, HDRs were inadvertently assigned a Priority 2, instead of a Priority 1. 

These licenses are in the NYC database as “limited medical” facilities, which includes all nonbroad human-use licensees, except those possessing a gamma knife or teletherapy machine. 

NYC staff is in the process of identifying all of their licensees authorized to possess and use an

HDR, so that they can re-evaluate and revise the inspection frequency, as appropriate. The

second contributing factor is the inability of NYC to accurately and completely identify new

licensees in the inspection database. During the review, NYC provided the review team with

what was intended to be a list of licenses that had recently been issued, however a review of

the list and comparison with the license and inspection files revealed that the list contained a

high proportion of licenses that were in fact, renewed licenses, or re-issued licenses, and not

newly issued licenses. In addition, the list did not contain a significant number of newly issued

licenses that were identified by reviewing hard copies of licensing actions taken during the

review period, copies of which are maintained by the NYC licensing staff. See recommendation

in Section 3.1.5.

The timeliness of the issuance of inspection findings was evaluated during the inspection file

review. The team reviewed 87 letters transmitting inspection findings to licensees. Thirty two

of these letters were issued more than 30 days after the date of the inspection, and in one case

the findings were issued 253 days after the date of the inspection. The responsibility for the

transmission of all inspection findings to the licensee rests with the Materials Inspection Senior

Scientist. The field inspection staff visits the office at least one time per week to deliver raw

field notes to the Senior Scientist, who then prepares the letter transmitting the inspection

findings and the notice of violation, if any. In discussions with the NYC staff, it could not be

clearly ascertained where the delay in the transmission of the findings is occurring. See

recommendation in Section 3.1.5.

During the review period, NYC received 320 reciprocity notifications from six different licensees. 

Two hundred and six of these notifications pertained to HDR source changes or servicing, and

98 involved teletherapy source changes, removals, or servicing. NYC performed two

inspections, one involving a teletherapy source removal, and another involving a teletherapy

source exchange, during the review period. The number of reciprocity inspections performed

by NYC was minimally adequate to meet the revised criteria in NRC IMC 1220, published June

6, 2002. To determine whether a reciprocity licensee requires an inspection, NYC staff

indicated that they review their file on a licensee, but do not review the Nuclear Materials

Events Database (NMED) for events involving the licensee as required by NRC IMC 1220. The

team noted that the files contain only minimal information about the last inspection. The team

discussed the benefits of conducting reciprocity inspections and reviewing the events in the

Nuclear Materials Events Database and the enforcement histories of licensees requesting

reciprocity in New York City in their management of reciprocity inspections.

3.1.2 New York State Department of Labor

The team's review of the DOL inspection priorities verified that inspection frequencies for

various types of DOL material licenses are the same as, or more restrictive than, those listed in

NRC IMC 2800. DOL has approximately 500 active licenses, but only about 140 are Priority 1,

2 or 3 licensees in accordance with NRC IMC 2800. During the review period, DOL issued 394

new licenses, but the vast majority of these were for devices that are generally licensed by the
New York Final Report Page 8

NRC. Only about 80 of the new licenses issued were for Atomic Energy Act (AEA) material

requiring specific licensure. The team limited its review to 10-15% of the approximately 220

licensees that were Priority 1, 2 or 3, or that were newly issued during the review period, and

required specific licensure for AEA material pursuant to NRC’s IMC 2800.

The inspection interval extension/reduction policy has not been used by DOL since 1999. The

team focused on examining the timeliness of DOL’s core inspections relative to the NRC's

priorities except where DOL had extended a routine inspection interval based on the licensee’s

good performance.

In their response to the questionnaire, DOL indicated that there were currently no overdue

inspections of core licensees. This information was verified during the inspection casework

reviews and the review of a listing of all licensees and the date of their last inspection provided

to the team. The review team noted that out of 46 core inspections examined, 6 were 

conducted overdue during the review period; five Priority 1 licensees were inspected four to

nine months past their inspection due dates; and one initial inspection was conducted nine

months after the date of issuance. See recommendation in Section 3.1.5.

The timeliness of the issuance of inspection findings was evaluated during the inspection file

review. DOL has an effective and efficient process, which ensures that inspection findings are

generally communicated to licensees in a timely manner. For the 28 inspection files examined

specifically for timeliness of the communication, only three letters transmitting the inspection

findings were issued more than 30 days after the date of the inspection, and none more than 60

days.

During the review period, DOL granted 50 out-of-state licensees reciprocity to work in New York

State. DOL does not keep a record of the priorities of reciprocity applicants, so the team was

unable to determine how many core licensees had requested reciprocity. DOL conducted 14

reciprocity inspections during the review period. DOL staff stated that they place a priority on

inspecting radiographers versus non-core licensees. In addition, DOL only authorizes

reciprocity for 30 days in a calendar year, thus many out-of-state licensees obtain an DOL

license, and are included in the inspection database. These licensees are contacted at least

annually to determine whether work in New York State is planned, so that an inspection can be

scheduled. It could not be determined whether DOL met the criteria in NRC IMC 1220, as that

document stood during the review period. Based on discussions with DOL staff, and given

DOL’s requirement for specific licensure after 30 days of reciprocity work in a calendar year,

DOL met the revised criteria in NRC IMC 1220, published June 6, 2002.

3.1.3 New York State Department of Health

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

various types of DOH material licenses are generally the same as, or more restrictive than,

those listed in NRC IMC 2800, with two exceptions. These exceptions include the fact that

DOH assigns a Priority 2 to gamma knives (they currently license two facilities with gamma

knives). DOH staff stated that they assigned a Priority 2 to be consistent with their treatment of

teletherapy machines, which they believe pose potential hazards comparable to those

associated with gamma knives. This is consistent with NRC’s Temporary Instruction 2800/033,

and the review team agrees that this approach is adequate to protect public health and safety.

DOH stated in response to the questionnaire that they assign all special nuclear material (SNM)

licensees a Priority 4, rather than use the NRC’s Priorities of 1, 2, 3, or 5, based on quantity

and use of the material. DOH stated that they do not license any facilities solely or primarily for

the use of SNM, and that licensees possessing SNM are actually broad scope licenses, which
New York Final Report Page 9

are Priority 2. The review team confirmed that SNM licensees were inspected at frequencies

consistent with NRC licensees.

DOH routinely implements their inspection interval extension policy to increase inspection

intervals for licensees demonstrating good prior performance. The team focused on examining

the timeliness of DOH’s core inspections relative to the NRC's priorities, except in the cases

discussed in the paragraphs above, or when DOH had extended a routine inspection interval

based on the licensee’s good performance.

DOH has approximately 560 active licenses, but only about 90 are Priority 1, 2, or 3 licensees

based on the priorities defined in the NRC’s IMC 2800. During the review period, DOH issued

approximately 95 new licenses authorizing the possession and use of AEA material. The team

limited its review to 20-25% of the approximately 185 licensees that were Priority 1, 2, or 3, or

that were newly issued during the review period, and authorized the possession and use of AEA

material.

In their response to the questionnaire, DOH indicated that there were currently six core

inspections overdue. These inspections were still overdue during the on-site review, but were

scheduled for inspection before the end of the year. The review team noted that out of 48

inspections examined in a random sample, four were performed on an overdue basis, including

two of the inspections reported by the Agency as overdue at the time of the review. Thus, on

average, approximately 4 out of 48 of the DOH inspections were conducted overdue during the

review period or were currently overdue for inspection at the time of the review.

The timeliness of the issuance of inspection findings was evaluated during the inspection file

review. DOH has an effective and efficient process, which ensures that inspection findings are

communicated to licensees in a timely manner. For the 22 inspection files examined, all

inspection findings were sent to the licensees within 30 days.

During the review period, DOH granted only one out-of-state licensee reciprocity to work in New

York State. They did not inspect this licensee. Based on the fact that DOH only received and

granted one request for reciprocity, DOH met both the criteria in NRC IMC 1220, as that

document stood during the review period, and as revised June 6, 2002.

3.1.4 New York State Department of Environmental Conservation

DEC issues permits to facilities licensed by one of the other three Agencies to release

radioactive effluents to the environment, and inspects only those aspects of each facility’s

program affecting those releases. DEC does not grant reciprocity to out-of-state licensees, so

this element of the indicator was not reviewed for this program. Due to the limited scope of

DEC’s program, they have established a policy of reduced inspection frequency based on

actual and potential releases. For example, nuclear pharmacies are inspected every three

years, rather than annually; and incinerators are inspected every two years, rather than

annually. These reduced frequencies were assessed during the 1998 IMPEP review, and found

to be adequate to protect public health and safety. The assigned frequencies remain the same

as those reviewed during 1998, and the review team finds they are still adequate to protect

public health and safety with respect to DEC's limited-scope inspection program.

DEC staff stated they have extended inspection intervals due to insufficient staff, but that the

permittee's inspection history is reviewed before deciding which inspections may be postponed. 

The team focused on examining the timeliness of DEC’s core inspections relative to their

reduced inspection frequencies, and included all those inspections performed on an overdue

basis, irrespective of the review of the permittees’ performance, because: 1) DEC has already
New York Final Report Page 10

substantially extended the frequency of their inspections based on their limited scope of

inspection, and 2) DEC stated the primary cause of the inspection delay was due to staffing

issues, and not a result of a routinely implemented policy of extension of inspection intervals for

good prior performance.

DEC has 37 active permits, 23 of which are core AEA material. During the review period, DEC

issued four new permits authorizing the release of AEA material to the environment. The team

reviewed inspections for all 23 AEA permittees that were Priority 1, 2 or 3, or that were issued

during the review period.

In their response to the questionnaire, DEC indicated that there were currently two core

inspections of AEA permittees that were overdue. Of these, one involved a permittee that had

only restarted operations in May 2002 after a three-year hiatus, and the team did not consider

this inspection to be overdue. The second inspection reported as overdue by DEC is a Priority

2 permittee pursuant to DEC’s assigned inspection frequencies, and is currently 10 months

overdue for inspection. DEC has committed to performing this inspection before the end of the

calendar year. The review team noted that 4 out of the 23 inspections examined were

performed on an overdue basis or were overdue at the time of the review, based on DEC’s

assigned inspection frequencies. See recommendation in Section 3.1.5.

The timeliness of the issuance of inspection findings was evaluated during the inspection file

review. The team reviewed six letters transmitting the inspection findings to the licensees. 

Four of these letters were issued more than 30 days after the date of the inspection, and in one

case the findings were issued 90 days after the date of the inspection. DEC staff attributed the

delay to a lack of sufficient staff. See recommendation in Section 3.1.5. 

3.1.5 Indicator Summary

Overall, based on the percentage of core licensees for which each program is responsible, New

York State performed approximately 13% of their core inspections on an overdue basis. 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.

The timeliness of the issuance of inspection findings varied significantly from program to

program. Overall, New York State issued approximately 24% of their inspection findings to

licensees more than 30 days after the date of the inspection. The review team recommends

that NYC and DEC transmit inspection findings to their licensees within thirty days after the

close of the inspection.

Based on the information provided in response to the questionnaires and discussions with staff

from each of the New York State programs, New York State met the current criteria in NRC

IMC 1220, as published June 6, 2002.

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

performance with respect to the indicator, Status of Materials Inspection Program, be found

satisfactory with recommendations for improvement.

3.2 Technical Quality of Inspections

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

notes and interviewed select members of the inspection staff. The evaluation included 39

radioactive material inspections conducted during the review period. The casework included 23
New York Final Report Page 11

inspectors (including one former inspector), representing each of the State’s four Agency

Offices, and covered inspections of various types of licensees including hospitals, gamma knife,

industrial radiography, well logging, radiopharmacy, manufacturing and distribution, academic

and medical broad scope institutions, a commercial irradiator, a waste processor, and an

inactive waste burial site. Appendix C lists the inspection casework files reviewed for

completeness and adequacy, with case-specific comments.

The inspection procedures and techniques utilized by all four Agencies were reviewed and

determined to be generally consistent with the inspection guidance provided in NRC 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 Agencies to be comparable with the types of information and data collected under NRC

IMC 2800. Inspections conducted by DOL are generally performed on an announced basis; the

remaining Agencies 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, 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 file reviews and inspector interviews, the team found that routine

inspections covered all aspects of licensee radiation protection programs by all Agencies. The

review team found that for three of the four Agencies, the inspection reports were thorough,

complete, consistent, and of high quality, with sufficient documentation to ensure that licensee’s

performance with respect to health and safety was acceptable. Except as noted below for

NYC, the 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.

Review team members accompanied ten inspectors from all four New York Agencies during the

period of February 26 to June 20, 2002. The accompaniments included inspections of an

industrial radiographer, medical institutions, medical private practice, research and

development, incinerator and burial site. The facilities inspected are identified in Appendix C. 

During the accompaniments, each inspector demonstrated appropriate inspection techniques

and knowledge of the regulations. The inspectors were 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 were adequate to assess radiological health and safety at the licensed

facilities.

The review team noted that all four New York Agencies had adequate numbers of portable

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

emergencies. Each Agency either 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 Agencies have the capability to analyze

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

counting equipment.
New York Final Report Page 12

3.2.1 New York City Department of Health and Mental Hygiene

For NYC, the team reviewed the inspection reports, enforcement documentation, and

inspection field notes and interviewed inspectors for 12 material inspections conducted during

the review period. The 12 inspections selected for review included at least one inspection for

each of NYC’s inspectors, including one former inspector, and one team inspection of a broad

scope licensee. NYC’s inspection procedures are consistent with the inspection guidance

outlined in NRC’s IMC 2800. Inspection reports are in checklist format with space for limited

narrative input that would adequately cover all inspection areas. The NYC has specific

inspection forms for the various types of licensees.

Of the 12 inspections reviewed, six resulted in no violations being identified. For the remaining

six, violations were identified in transmittal letters to licensees. Of those violations, two were

not described in the field notes documenting the results of the inspections. Based on casework

and interviews with select inspectors, the review team determined that the documentation in the

inspection field notes typically did not support the violations transmitted to licensees. None of

the inspection field notes reviewed discussed the relative safety significance or root causes of

the violations identified to licensees. The team found that the wording in the inspection field

notes lacked sufficient detail in the program scope and for the identified violations which may

lead to misinterpretation by the supervisor as he prepares the compliance letter and the

citations. Based on interviews with the NYC staff it appears that the inspections are

performance-based and risk-informed, however, the staff does not document these inspection

efforts, licensee interviews, or observed licensee activities.

The review team noted that five inspection field notes did not include any documentation of

observation of licensed activities or interviews of licensee personnel who performed those

activities. In addition, the documentation in the inspection field notes typically did not support

the violations transmitted to licensees. The team found that violations identified in the casework

were not supported, and in one case contradicted, by information in the inspection report. None

of the inspection field notes discussed the relative safety significance or root causes of the

violations identified to licensees.

The NYC inspectors typically conduct inspections Monday-Thursday. The inspectors return to

the office on Fridays and document the week’s inspections and prepare for the following week’s

inspections. Upon return from the field, the inspector debriefs the supervisor and provides the

inspection field notes for review and approval. The supervisor prepares the compliance letter

and writes up the citations. Based on the findings described above, there appears to be a

“disconnect” between the staff and the supervision of the inspection program. Specifically, the

team found that the wording in the inspection field notes lacks sufficient detail in the program

scope and for the identified violations which may lead to misinterpretation by the supervisor as

he prepares the compliance letter and the citations. See recommendation in Section 3.2.5.

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

to the questionnaire, NYC reported, and the team confirmed, that each inspector was

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

inspections, the supervisor provided feedback to the inspector.

3.2.2 New York State Department of Labor

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

database information for 11 material inspections conducted during the review period. The

casework included five material inspectors.
New York Final Report Page 13

The inspection procedures and techniques utilized by DOL are generally consistent with the

inspection guidance provided in NRC IMC 2800. Specific guidance for certain classes of

licensees or facilities are also included in the procedures manual. The team reviewed

inspection reports and found them to be comparable with the types of information and data

collected under NRC IMC 2800. The inspection field notes provided adequate, consistent

documentation of inspection findings.

The review team noted that DOL’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 team found that peer review of the inspection documentation and

correspondence resulted in their consistent excellent 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 the

Program Manager prior to issuing the inspection findings to the licensee. When significant

commitments are made in response to violations, DOL 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 typically limited to the issuance of Orders. The review team noted a considerable

coordination effort between DOL and DOH on an escalated enforcement case involving a

teletherapy service vendor who failed to file for reciprocity and was not licensed to perform the

proposed licensed activities. DOL issued an order to the company, prohibited the firm from

conducting licensed activities within the State of New York for a period of one year.

The DOL Program Manager has not performed annual supervisory accompaniments of the

material inspectors since 2000. The manager stated that competing demands on his time and

the fact that most inspectors are located in the Manhattan office have not allowed him to

perform the accompaniments. See the review team recommendation in Section 3.2.5.

3.2.3 New York State Department of Health

The inspection procedures and techniques utilized by DOH were reviewed and determined to

be generally consistent with the inspection guidance provided in NRC IMC 2800. The review

team evaluated inspection reports and found them to be comparable with the types of

information and data collected under NRC IMC 2800 and DOH procedures.

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. Both individuals sign a memo-sized paper documenting their review. This

form is maintained in the inspection file folder. Overall, the 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.
New York Final Report Page 14

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 thorough review of all Administrative Tribunals (Hearing

Boards) revealed that this process is very effective in obtaining eventual compliance whether

the end result is a fine, an American College of Radiology audit commitment, or other

compliance commitment.

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

response to the questionnaire, DOH reported, and the team confirmed, that all inspectors had

accompaniments in 2001.

3.2.4 New York State Department of Environmental Conservation

A representative cross-section of completed inspection reports was reviewed and found 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 in a very prompt time frame. Escalated enforcement procedures are

in place and followed, as needed. The escalated actions include referral to the General

Counsel in preparation for an enforcement conference which may result in a fine and/or a

Consent Order. This process is used approximately once a year.

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 NRC IMC 2800.

With one exception, supervisory accompaniments of DEC inspectors are conducted at least

once a year. The inspector responsible for inspecting the activities at an inactive radioactive

waste site, has not been accompanied by a supervisor since 1998. See the team’s

recommendation in Section 3.2.5.

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 October 2001. 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. 

Since the last review, warning letters were sent to 40 generators who shipped regulated

medical waste contaminated with radioactive material to the landfills.

3.2.5 Indicator Summary

Accompaniments of inspectors from all four Agencies identified competent, thorough, safetyoriented inspections. The inspection processes for DOL, DOH and DEC proved to be well
New York Final Report Page 15

designed and implemented. The NYC inspection process, however, is in need of revision. A

disconnect exists between the inspectors and the supervision of the inspection program.

Inspection reports and notices of violation are incomplete, inconsistent and of marginal quality. 

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.

DOL inspectors have not been accompanied by a supervisor since 2000. As indicated in

Section 4.3.2, a DEC inspector has not been accompanied since 1998. The review team

recommends that DOL and DEC perform annual supervisory accompaniments of all material

inspectors.

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

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

satisfactory.

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive material program

staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate these

issues, the team examined each program's questionnaire responses relative to this indicator,

interviewed program management and staff, and considered any possible workload backlogs in

licensing or compliance actions, as well as the status of regulation development and other

program activities.

3.3.1 New York City Department of Health and Mental Hygiene

NYC’s radioactive material program is staffed by the Director and a Chief of Radioactive

Materials Division who supervise a licensing section with two staff and an inspection section

with a supervisor and five staff. The program currently has two vacancies in the compliance

section. The Director indicated that they currently do not have the approval to fill either vacancy

due to a hiring freeze.

During 2000 and 2001, the program lost six experienced individuals due to a City staff reduction

buyout. Four new technical staff where hired, leaving two vacancies in the inspection section

and reducing the number of license reviewers from four to two. There is currently a new buyout

available to four technical staff, and the backfilling of those vacancies may be curtailed if those

staff choose to accept the buyout.

The review team determined that NYC staffing is currently adequate. However, if any of the

current staff that are eligible for the buyouts leave and their vacancies are not filled, this could

adversely effect the program.

NYC technical staff are required to have a Bachelor’s degree in science and at least one year

of experience. From the review of the technical qualifications of the current staff, the review

team concluded that NYC has been able to hire qualified individuals. NYC has one Certified

Health Physicist on staff.

The review team’s evaluation of NYC’s training records and interviews with the staff indicated

that new and current staff had appropriate training. In discussions with senior management,

they pointed out that getting approval for out-of-city travel was difficult and that they would seek

as much training as they could from institutions within New York City. They have been utilizing
New York Final Report Page 16

several one-day seminars in the appropriate training areas. In response to a recommendation

from the previous IMPEP review, NYC updated their procedure manual that documents the

licensing and inspection training program.

3.3.2 New York State Department of Labor

DOL’s radioactive material program is staffed by the Program Manager and eight associate

radiophysicists. All six of the inspection staff, and two of the licensing staff were with the

program for the entire review period. During the review period, two staff members, an

associate radiophysicist and a principal radiophysicist retired from State employment. The

principal radiophysicist position was filled by promoting an associate radiophysicist leaving two

associate vacancies. These vacancies were filled during this review period by hiring three new

associate radiophysicists. The review team found that the current staffing level is adequate for

the workload.

The licensing and inspection functions of the program are segregated with all of the licensing

conducted in Albany and nearly all of the inspections conducted out of the Manhattan office. 

Licensing duties are performed by the Program Manager and four associate radiophysicists

(one of the associate radiophysicist also conducts some inspections). Inspection duties are

performed by four associate radiophysicists. All staff perform duties in incident and emergency

response.

Associate radiophysicist staff are required to have a Bachelor’s degree in science and at least

three years of experience. Twenty-four graduate credit hours in radiological science may be

substituted for up to one year of experience. To be considered for a position, an individual

must successfully complete a technical examination to be placed on the registry from which

individuals are selected. From the review of the technical qualifications of the current staff, the

team concluded that the State has been able to hire qualified individuals. DOL has three

Certified Health Physicists on staff.

The team determined that there was an appropriate written training policy. All formal training is

documented in a computer database. On-the-job training is documented in signature cards

signed by the mentoring staff person. A review of training records and interviews with the staff

hired since the last review identified that they met the training requirements for licensing and

inspection staff. 

3.3.3 New York State Department of Health

The DOH radioactive material program is staffed by the Director, the Section Chief, the Field

Supervisor, and ten staff. There are currently two vacancies for Radiological Health Specialists,

however, there is a freeze on new hires. The Director indicated that waiver requests have been

submitted to fill these vacancies. The review team found the current staffing level to be

adequate.

The staff of the material program is positioned in four field offices and the main office in Albany. 

The field staff perform only compliance activities including compliance work for the x-ray and

other radiation programs. The Albany staff conduct all of the licensing and a portion of the

compliance activities. Licensing duties are performed by the supervisors and three staff. All

staff perform duties in incident and emergency response.

All but two DOH technical staff were with the program for the entire review period. One

individual is a license reviewer in the Albany office and the other is a compliance inspector in

the Buffalo office. Both of the staff attended required training courses and had appropriate on-
New York Final Report Page 17

the-job training. The license reviewer is not yet fully qualified, so all of his work is reviewed by

qualified staff prior to issuance. The inspector is considered by the field supervisor to be fully

qualified to perform independent inspections. This inspector was accompanied by the review

team. Details of this accompaniment can be found in Section 3.2.3.

DOH Radiological Health Specialists are required to have a Bachelor’s degree in science and at

least two years of experience. A Masters or Doctorate degree in health physics can be

substituted for one or two years experience, respectively. To be considered for a position, an

individual must successfully complete a technical examination to be placed on the registry from

which individuals are selected. From the review of the technical qualifications of the current

staff, the review team concluded that the State has been able to hire qualified individuals. 

There are four certified health physicists in the DOH program.

The review team evaluated the DOH written training policy and requirements and found them

acceptable. Previously, DOH successfully used a training matrix to track training courses

required for technical staff. Due to other priorities and personnel changes, the matrix has not

been maintained over the last several years. The use of a training matrix is considered to be a

beneficial tool in helping to keep track of required training and DOH management indicated that

it would be instituted again. Monthly video conferences are held between regional and Albany

staff. These sessions cover current health physics topics and other programmatic matters, as

needed.

3.3.4 New York State Department of Environmental Conservation

DEC’s radioactive material program is staffed by the Bureau Director, Section Chief, and ten

staff. There are currently two vacancies in the radiation section. One position is in the

contaminated sites section and the other is in the permits and inspections section. The

permitting (licensing) and compliance functions of the program are performed by three staff

members. The rest of the staff is dedicated mostly to contaminated sites and events that are

not directly covered under the Agreement with the NRC. All staff perform duties in incident and

emergency response.

At the time of the review, the three staff members who performed permitting and compliance

functions had been with the program for the entire review period. The team noted that there

was an upswing in cyclotron inspection and permitting during this review period that has

effectively reduced the staff available for the program from three to two. This was recognized

and a vacancy is currently shown on the permitting and inspection section organization chart. 

The Bureau Director indicated that the State currently has a freeze on hiring and that the vacant

position could not be filled unless a waiver is granted for need.

DEC recently received two new applications for accelerators and have had numerous inquiries

regarding possible accelerator construction. Thus, the staff needed for inspection and

permitting of accelerators will most likely increase over time, further reducing the staffing

available for the Agreement State program inspection and permitting. During the review period,

the staffing was adequate, however, with the increased workload due to accelerators and the

current vacancy, the program could be adversely effected.

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 of the current staff, the team concluded that DEC has been able to hire

qualified individuals.
New York Final Report Page 18

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

has not completed the training policy due to the small number of inspectors and permit

reviewers, as well as low turnover. DEC management stated that new staff will be trained in

performing inspections and reviewing permit applications individually by the Permit 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.

3.3.5 Indicator Summary

Technical staffing and training for all four Agencies is adequate for the Agreement State

program workload. As indicated above, hiring freezes and increased responsibilities in other

program areas have stretched some program staffs.

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

performance with respect to the indicator, Technical Staffing and Training, be found

satisfactory.

3.4 Technical Quality of Licensing Actions

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

specific licenses as specified for each of the four New York programs. A total of 33 licensing

actions were examined, including five new license issuances, five terminations, 10

amendments, and 15 renewals, encompassing the work of 12 license reviewers. Licensing

actions were evaluated for completeness, consistency, proper isotopes and quantities used,

qualifications of 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 files were checked for retention of necessary documents and supporting data.

3.4.1 New York City Department of Health and Mental Hygiene

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

which had been completed in the review period and to include work by three reviewers. The

cross-section sampling included all but three of NYC’s major licenses as defined by NYC in the

questionnaire, and included the following types: broad scope medical; broad scope academic;

gamma knife; hospital nuclear medicine; private practice physicians; teletherapy; HDR remote

afterloaders; and intravascular brachytherapy. Twelve license files were evaluated by the

review team. Licensing actions included one new license, five renewals, five amendments, and

one termination. A list of these licenses with case-specific comments may be found in

Appendix D.

The review team found that the licensing actions were thorough, complete, consistent, of good

technical quality, and with health and safety issues properly addressed. The licensee’s

compliance history appeared to be taken into account when reviewing renewal applications as

determined from discussion with license reviewers.

All licensing actions are peer reviewed by license reviewers for grammar and format. The

Director does a second complete review prior to signing license documents. Individual license
New York Final Report Page 19

reviewers sign letters of deficiency that are mostly well written and used at the proper time. 

Because of the experience level of license reviewers, checklists are not used. The team found

that termination licensing actions were adequately documented. No potentially significant

health and safety issues were identified.

NYC defines backlog as licensing actions not addressed, either by letter of deficiency or

completed license document, within 100 days of receipt. At the time of the review, NYC had no

actions on backlog. License conditions, including tie-down conditions, are usually stated clearly

and are inspectable/enforceable. Applicable guidance documents are available to license

reviewers and are generally followed. All team members experienced numerous delays in

casework reviews due to the condition of files, missing documentation subsequently discovered

in staff offices, and misfiled documents.

The review team discussed with NYC staff the process for obtaining financial assurance for

decommissioning from those licensees required to provide it. Four of the 12 licenses evaluated

were authorized for quantities of radioactive material which met the NYC criteria for financial

assurance. The review team discussed with NYC staff how they addressed the financial

assurance requirements contained within their rule. License reviewers indicated that

determinations of financial assurance were not being conducted when renewing licenses or

writing new licenses. NYC management indicated that due to the long existence and financial

ties to government of many of the licensees that would require financial assurance for

decommissioning, it was decided to no longer make financial assurance determinations or

require licensees and applicants to submit either a decommissioning funding plan or

certification of financial assurance. Further, during evaluations of affected licensees, the team

discovered that the table used to assess the need for financial assurance contained in the NYC

regulations is inaccurate (see Section 4.1.2). See recommendation in Section 3.4.5.

In discussions with NYC management, it was noted that there are no major decommissioning

efforts underway with regard to byproduct material in New York City. NYC indicated that no

exemptions were issued during the report period.

3.4.2 New York State Department of Labor

The team examined completed licenses and casework for six license actions, representing the

work of three license reviewers. The license reviewers and program manager were interviewed

to supply additional information regarding licensing decisions or file contents. The license

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

completed in the review period. The sampling included most of DOL’s major byproduct material

licenses as defined by DOL in the questionnaire including the following types: broad scope

research and development; panoramic irradiator; industrial radiography; portable gauge; and

nuclear pharmacy. Licensing actions reviewed included two new licenses, two renewals, and

two amendments (one including a use area/building decommissioning). A list of these six

licenses with case specific comments may be found in Appendix D.

The review team found that the licensing actions were very thorough, complete, consistent, of

high technical quality, and with health and safety issues properly addressed. The licensee’s

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

from discussions with the license reviewers. 

The casework review indicated that DOL staff follows their, or NRC, licensing guides during the

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

request. The team found that termination licensing actions were adequately documented. No
New York Final Report Page 20

potentially significant health and safety issues were identified. License conditions, including tiedown conditions, are usually stated clearly and are inspectable/enforceable. Deficiency letters

clearly state regulatory positions and are used at the proper time.

During the assessment of appropriate financial assurance for decommissioning for one

licensee, an error was found in the table in the regulations used to determine the amount of

financial assurance. The result is that instead of accepting financial assurance in the amount of

$750,000, the licensee should be required to submit a decommissioning funding plan. See

Section 4.1.2 for additional information.

DOL indicated that one exemption to their regulations, pertaining to a variance from filing an

application for a DOL license for manufacturers of generally licensed devices operating in the

State, was issued during the report period. The variance allowed these manufacturers to work

under existing NRC or Agreement State radioactive material licenses in the State under

reciprocity. The DOL regulation requiring a specific license for generally licensed device

manufacturers is more restrictive than NRC regulation. The granting of this variance brings the

State into congruence with NRC and other Agreement State policies.

3.4.3 New York State Department of Health

The cross-section sampling of licensing casework included DOH’s major licenses as defined by

DOH in the questionnaire, including the following types: broad scope medical; broad scope

academic; gamma knife; hospital nuclear medicine; brachytherapy; HDR remote afterloaders;

research and development, and self-shielded irradiator. The licensing casework was selected

to provide a representative sample of licensing actions which had been completed in the review

period and to include work by five reviewers. Nine license files were reviewed. Licensing

actions included five renewals, three amendments, and one termination. A list of these licenses

with case-specific comments may be found in Appendix D.

The review team found that the licensing actions were very thorough, complete, consistent, of

high quality, and 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 inspectable. Deficiency letters are well written, clearly

indicating regulatory position and used at the appropriate times. The licensee's compliance

history was taken into account when reviewing renewal applications. License reviewers

appropriately used the Department’s licensing guides and standard license conditions. The

team found that the terminated licensing action was well documented, showing appropriate

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

the cases they review. No significant health and safety issues were identified.

The 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.

3.4.4 New York State Department of Environmental Conservation

The team examined completed permits (licenses) and casework for six permitting actions in six

permit files, representing the work of three permit reviewers. The permit reviewers and Section

Chief were interviewed, when needed, to supply additional information regarding permitting

decisions or file contents. The permit casework was selected to provide a representative
New York Final Report Page 21

sample of permitting actions which had been completed in the review period and to include 

work by all reviewers. The sampling included the following types of permits issued under Part

380 of the New York State Code of Regulations: air effluents, incinerators, and water

discharge. Permitting actions reviewed included two new permits, one renewal, one

modification (amendment), and two cancellations (terminations). A list of the six permits

reviewed with case specific comments may be found in Appendix D.

The review team found that the permitting actions were thorough, complete, consistent, of high

technical quality, and 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 upper 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 holder’s compliance history appeared to be always taken into account when reviewing

renewal applications as determined from documentation in the permit files and discussions with

the permit reviewers.

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

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

support the permit. The 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

applications. Permit tie-down conditions were stated clearly, backed by information contained

in the file, and inspectable. Each permitting action receives a supervisory chain review. Letters

of deficiency clearly state regulatory positions, are used at appropriate times and are signed by

upper management. Permit documents are signed by various Regional Directors throughout

the State. 

3.4.5 Indicator Summary

The review team found that the licensing (and permitting) actions for all four Agencies were

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

properly addressed.

NYC is not requiring licensees to submit financial assurance instruments as required by New

York regulations. 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.

The review team identified errors in the NYC and DOL financial assurance regulation tables. 

Program management indicated that they would ensure that corrections were made to the

regulations. Specific information on the errors in these tables can be found in Section 4.1.2.

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

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

satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the State’s actions in responding to incidents, the review team

examined the responses to the questionnaire relative to this indicator, reviewed the incident
New York Final Report Page 22

reports for New York in the National Materials Event Database (NMED) against those contained

in the Agency files, and evaluated reports and supporting documentation for 26 incidents. A list

of the incident casework examined with case-specific comments is included in Appendix E. The

review team also reviewed the Agencies’ response to 19 allegations involving radioactive

material, 12 of which were referred to New York by the NRC during the review period. The

incidents selected for review included the following categories: misadministrations, lost and

stolen radioactive material, contaminated waste, personnel contamination and exposure,

leaking source, equipment damage, and equipment failure.

3.5.1 New York City Department of Health and Mental Hygiene

The review team examined NYC’s response to the questionnaire relative to this indicator,

reviewed the incident reports for NYC in NMED against those contained in NYC’s files, and

evaluated reports and supporting documentation for seven incidents and one allegation.

NYC treats radioactive material incidents and allegations similarly and does not maintain a

database to track them. The incident reports are filed in chronological order, without a

comprehensive index. The team physically combed through the incident files for the period

covered by this review, and selected seven incidents that were potentially reportable. 

Incident response was prompt and generally thorough with emphasis placed on licensee

performance. As with inspection reports (see Section 3.2.1) documentation of incident

response was lacking in completeness and depth. The method of logging incidents,

dispatching inspectors, and recording the results was inconsistent, ranging from no apparent

supervisory review through on-site visits by an inspector and the supervisor. Not all incidents

were copied to the inspection/licensing files for follow-up at the next inspection. See

recommendation in Section 3.5.5.

A total of 15 incidents were forwarded to the NRC during the review period. Little consistency

was identified in reporting information to the NMED database. An incident in February 2002,

requiring 24-hour notification, was not reported to NRC until July 2002. NYC personnel stated

that information was transmitted to the NRC via State and Tribal Programs (STP), and they

depended upon that office to evaluate and provide information to the NMED contractor. The

review team discussed with NYC management the requirement to report incidents to the NRC

Operations Center rather than STP. NYC management stated that they would institute a

procedure to report incidents to the NRC for inclusion in NMED and would use the current

version of STP Procedure SA-300 “Reporting Material Events.” They also stated that a

procedure would be drawn up and used to track incidents.

Evaluation of one allegation file, that was referred by the NRC, indicated that NYC took prompt

and appropriate action in response to the alleger’s concerns. These actions included detailed

interviews with the alleger, prompt investigation and routine follow-up at the next inspection. 

The alleger’s identity was protected from disclosure. The review of the casework and

interviews of staff determined that NYC staff provided appropriate feedback to the alleger

regarding NYC’s investigation into the allegation. NYC management did not specifically

distinguish any other allegations received during the review period. The review team searched

incident/allegation files, but did not identify any other allegations reported to the program.

3.5.2 New York State Department of Labor

The review team evaluated DOL’s handling of 10 incidents and six allegations. Five of the six

allegations were either referred by NRC or involved a licensee common to both the State and

NRC. The review team found that DOL’s responses to incidents and allegations were complete
New York Final Report Page 23

and comprehensive. Initial responses were prompt and well-coordinated. The level of effort

was commensurate with the health and safety significance of the event. Inspectors were

dispatched for on-site investigations when appropriate and DOL took suitable enforcement

action when indicated. Allegers’ identities were adequately protected from disclosure and

feedback was provided to the allegers, as warranted.

The review team’s evaluation of the incident casework revealed a lack of consistent reporting

incidents to the NRC for inclusion in NMED. Three of the incidents reviewed that required

reporting to the NRC were not reported and another was reported 20 months late. The team

assessed DOL’s process for reporting significant incidents (immediate or 24-hour notification). 

DOL was inconsistent in reporting significant events to NRC, mainly due to philosophical

differences with NRC policy. The Program Manager does not feel an obligation to promptly

report incidents to the NRC that do not directly impact NRC licensees or licensees from other

Agreement States. As identified in Appendix E, the three incidents not reported to the NRC

(Appendix E, DOL Files 1, 2, and 8) were a stolen moisture-density gauge, a damaged

moisture-density gauge, and a coronary afterloader brachytherapy source which became stuck

during a source exchange. The Program Manager stated, that if an incident involved an NRC

or other State licensee or was generic in nature, prompt notifications would be made. In April

2001, DOL provided a summary report of nine incidents for inclusion in the NMED system at the

request of the NRC. See recommendation in Section 3.5.5.

3.5.3 New York State Department of Health

In evaluating the effectiveness of DOH's actions in responding to incidents, the review team

examined DOH’s response to five incidents and 10 allegations. The incident and allegation

reports are filed in chronological order, without a comprehensive index. The review team

selected for review five incidents that were potentially reportable to the NRC. The vast majority

of incidents reported to DOH involved alarms at non-radioactive waste or recycling facilities,

caused in most cases by naturally-occurring radioactive material or patient waste. 

The review team found that DOH has a procedure requiring the prompt, in-depth, and

documented review of incidents reportable to DOH within 30 days. In all of the five cases

reviewed, documentation of DOH's response was either missing or incomplete. Of the three

cases examined that required a report to DOH within 30 days, DOH determined that one of the

incidents required a prompt visit by DOH staff. In that case, the inspector's report contained

only scant information about the incident, which involved two therapeutic misadministrations on

the same day. Another case file for an event that required reporting did not show if a site visit

was required or if one was performed. Subsequent to the on-site review, DOH located

documentation that indicated that an on-site review was not necessary. The documentation for

the other two cases reviewed by the team indicated that investigations failed to adequately

address certain issues. Specifically, the team was unable to determine if the incident had been

investigated and how DOH intended to ensure follow-up during the next routine inspection, as

there was no reference to this event in the licensing/inspection file, nor any cross-reference to

the investigation file. See Appendix E for specific details.

In three of the five cases reviewed, the licensee provided appropriate corrective actions. DOH

staff reviewed those actions, and the investigations were closed on that basis. DOH does not

perform a formal supervisory review of closed investigations, but DOH staff stated that

supervisors are generally kept aware of the progress of investigations, and discuss when

closure of the investigations is appropriate. The lack of formality in 1) the tracking of these

incidents, 2) the documentation of these incidents, 3) the cross-referencing of these incidents

with the license files, and 4) the supervisory review of the investigation documentation all
New York Final Report Page 24

appear to contribute to the overaII lack of rigor in the depth, quality, timeliness, and

documentation of investigations. See recommendation in Section 3.5.5. 

The reporting of incidents to the NRC by DOH was inconsistent. Fifteen incidents were

reported to the NRC for inclusion in NMED during the review period. For the five incidents

reviewed by the team, three clearly required reporting, but only one was reported to the NRC,

some six months after the event was reported to DOH by the licensee. The other two incidents’

reporting status could not be clearly ascertained from information in the files. DOH staff stated

that they provide quarterly reports to STP and that they presumed these reports met their

reporting obligations. The team explained that incident reporting responsibilities are outlined in

STP Procedure SA-300 and require reporting to the NRC Operations Center. DOH indicated

they would re-evaluate their reporting procedures, and consider complying with STP Procedure

SA-300, however they expressed concerns that New York State law may prohibit them from

providing certain information, such as licensee names or other identifying information. See

recommendation in Section 3.5.5. 

The review team evaluated 10 DOH allegations, five of which were referred from the NRC.

Allegations are handled in the same manner as incidents. In general, based on staff

discussions and file evaluation, the team determined that DOH took prompt and appropriate

action in response to allegers’ concerns. Alleger identities were protected from disclosure. Staff

indicated that feedback is provided to allegers regarding DOH’s investigations. 

3.5.4 New York State Department of Environmental Conservation

The review team evaluated the response to four incidents to which DEC responded. DEC’s

response to incidents was generally complete and comprehensive. Initial responses were

prompt and well-coordinated, and the level of effort was commensurate with the health and

safety significance. DEC dispatched inspectors for on-site investigations when appropriate, and

took suitable enforcement and follow-up actions. DEC did not have any incidents reportable to

NMED.

Evaluation of two allegation files (one referred by NRC) indicated that DEC took prompt and

appropriate action in response to the allegers’ concerns. These actions included detailed

interviews with the allegers, prompt investigation and routine follow-up at the next inspection. 

The allegers’ identities were protected from disclosure. The evaluation of the casework and

interviews of staff determined that DEC staff provided appropriate feedback to the allegers

regarding their investigations.

3.5.5 Indicator Summary

Overall, New York's response to incidents was adequate and prompt. As discussed above,

however, the review team identified deficiencies in the DOH’s documentation of their

investigations into incidents. The review team recommends that DOH provide prompt, in-depth,

documented reviews of events with the potential for significant health and safety consequences. 

For the national NMED system to effectively identify any security concerns or generic problems

with equipment or procedures in a timely manner, all States, including New York, should

routinely submit the vital information on the incidents that occur in their jurisdiction to the NMED

system. Since 1997, when the Commission policy on Adequacy and Compatibility was

published in the Federal Register, Agreement State participation in the NMED system became

mandatory. In 1998, STP issued an implementing procedure (STP Procedure SA-300) for

Agreement State reporting of material events to comply with this policy change.
New York Final Report Page 25

The review team recommends that NYC, DOL, and DOH 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. 

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

performance with respect to the indicator, Response to Incidents and Allegations, be found

satisfactory with recommendations for improvement.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing Agreement

State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program;

and (4) Uranium Recovery Program. The New York Agreement does not cover the uranium

recovery program, so only the first three non-common performance indicators were applicable

to this review. Note: due to the nature of the non-common performance indicators, the

information presented has not been divided into sub-sections by Agency as was done with the

common performance indicators.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation

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’s radiation program is delegated

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

delegation to local governments when covering greater than two million individuals. DOL’s

legislative authority to administer its portion of the Agreement State program is granted in

Section 27 of the Labor Law and Article 28-D of the General Business Law. 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. 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. There has been no legislation passed since the last

IMPEP review that affected any of the four Agencies responsible for the Agreement State

program in New York.

4.1.2 Program Elements Required for Compatibility 

NYC regulations are found in Article 175 of the New York City Health Code - Radiation Control,

and apply to all ionizing radiation, whether emitted from radionuclides or devices. New York

City requires a license for possession, and use, of all radioactive material including naturally

occurring radioactive material, such as radium, and accelerator-produced radionuclides. New

York City also requires registration of all equipment designed to produce x-rays or other ionizing

radiations. The City’s regulatory adoption process is a six-step process that takes between six

months to a year to complete depending on the complexity of the rule change.

DOL 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) that apply to all commercial and

industrial uses of radioactive material. DOL requires a license for possession and use of all

radioactive material for commercial and industrial purposes including naturally occurring

radioactive material, such as radium, and accelerator-produced radionuclides. DOL's

regulatory adoption process is a seven-step process that takes at least 12 months to complete.
New York Final Report Page 26

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 that apply to 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 naturally

occurring radioactive material, such as radium, and accelerator-produced radionuclides for

medical, academic, or research and development. DOH also requires registration of all

equipment designed to produce x-rays or other ionizing radiations. DOH’s regulatory adoption

process is a ten-step process that takes approximately 12 to 18 months, depending on the

complexity of the action.

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

Rule, and Regulations that apply to environmental releases and the disposal of radioactive

material. DEC requires a permit for release of radioactive material to the environment including

the disposal of radioactive material, including naturally occurring radioactive material, 

such as radium, and accelerator-produced radionuclides. DEC’s regulatory adoption process is

a ten-step process that takes approximately 18 to 24 months.

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

the regulatory adoption process. The regulations for all four Agencies are not subject to sunset

provisions. The regulatory adoption process for the three state-wide Agencies (DOL, DOH and

DEC) include a review of proposed regulations by the Governor’s Office for Regulatory Reform. 

This office evaluates proposed regulations for impact on the State’s business community.

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

Agency responses 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 STP 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.

Since the previous IMPEP review, NYC adopted 1 regulation amendment that became effective

in April 1999 and adopted 2 additional amendments by legally binding requirements. Since the

previous IMPEP review, DOL adopted 13 NRC amendments in a rule package that became

effective in April 1999. In addition, DOL indicated that the following NRC amendment is met by

existing language in Section 38.15 of their regulations. The team reviewed the relevant section

of the regulation and concluded that the essential elements of the NRC amendment have been

met. However, DOL needs to submit the legally binding requirement for NRC review per STP

Procedure SA-201, Review of State Regulations.

 “Recognition of Agreement State Licensees in Areas Under Exclusive Federal

Jurisdiction Within an Agreement State,” 10 CFR 150 amendment (62 FR 1662) that

became effective February 27, 1997.

During the review period, DOH adopted 4 amendments through legally binding requirements. 

They also indicated that Article 12-b of the New York Public Health Law addressed another

requirement. DEC adopted one amendment by legally binding requirements, and a proposed

regulation has also been drafted and is currently undergoing review. Legally binding

requirements should be submitted to the NRC for review per STP Procedure SA-201.

The review team determined that the following regulations were not adopted and were overdue

at the time of the review. They have not been incorporated in license conditions or other legally
New York Final Report Page 27

binding requirements.

NYC has neither drafted nor adopted:

 “Timeliness in Decommissioning Material Facilities,” 10 CFR Part 30, 40 and 70

amendments (59 FR 36026) that became effective August 15, 1994. 

 “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR

Parts 19 and 20 (60 FR 36038) that became effective August 14, 1995. 

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

and 70 (60 FR 38235) that became effective November 24, 1995. 

 “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20

and 35 amendments (60 FR 48623) that became effective October 25, 1995. 

 “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,”

10 CFR Parts 20, 30, 40, 61 and 70 amendments (61 FR 24669) that became

effective June 17, 1996. 

 “Recognition of Agreement State Licensees in Areas Under Exclusive Federal

Jurisdiction Within an Agreement State,” 10 CFR 150 amendment (62 FR 1662) that

became effective February 27, 1997. 

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

amendments (62 FR 39057) that became effective August 20, 1997. 

 “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 63 FR 13773) that became effective February 12, 1998. 

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

35 and 36 amendments (63 FR 39477 and 45393) that became effective October 26,

1998. 

DOL has not adopted:

 “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,”

10 CFR Parts 20, 30, 40, 61 and 70 amendments (61 FR 24669) that became

effective June 17, 1996. DOL has not drafted this amendment.

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

amendments (62 FR 39057) that became effective August 20, 1997. DOL has not

drafted this amendment but has implemented this regulation and associated guidance

by legally binding requirement.

 “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 63 FR 13773) that became effective February 12, 1998. 

DOL's legal counsel has reviewed this amendment and determined that its beyond the

scope of DOL's regulatory authority which is limited to licensees and registrants. The

Program Director indicated that in the case of a sub-contractor or other third party

whose deliberate misconduct resulted in a licensee violating DOL regulations, the DOL’s

recourse would be the pursuit of enforcement action against the licensee. The team
New York Final Report Page 28

considers this an acceptable alternative to meet the essential elements of this NRC

amendment."

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

35 and 36 amendments (63 FR 39477 and 45393) that became effective October 26,

1998. DOL has not drafted this amendment.

DOH has drafted, but has not yet adopted:

 “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR

Parts 19 and 20 (60 FR 36038) that became effective August 14, 1995. 

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

amendments (62 FR 39057) that became effective August 20, 1997. 

 “Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14

Urea,” 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2,

1998. 

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

35 and 36 amendments (63 FR 39477 and 45393) that became effective October 26,

1998. 

DEC has not adopted:

 “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR

Parts 19 and 20 (60 FR 36038) that became effective August 14, 1995. A proposed

regulation has been drafted and is currently undergoing review.

 “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,” 10

CFR Parts 20, 30, 40, 61 and 70 amendments (61 FR 24669) that became effective

June 17, 1996. A proposed regulation has been drafted and is currently undergoing

review.

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

amendments (62 FR 39057) that became effective August 20, 1997. A proposed

regulation has been drafted and is currently undergoing review.

 “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 63 FR 13773) that became effective February 12, 1998. 

DEC has not drafted this amendment.

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

35 and 36 amendments (63 FR 39477 and 45393) that became effective October 26,

1998. A proposed regulation has been drafted and is currently undergoing review.

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

CFR Part 20 amendment (63 FR50127) that became effective November 20, 1998. 

DEC has not drafted this amendment.

All four Agencies will need to address the following regulations in upcoming rulemakings or by
New York Final Report Page 29

adopting alternate legally binding requirements within three years of the date adopted by the NRC.

NYC will need to adopt the following NRC amendments:

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

amendment (64 FR 54543; 64 FR 55524) that became effective February 2, 2000.

 “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective April 5, 2002.

 “Medical Use of Byproduct Material,” 10 CFR 20, 32, and 35 amendments

(67 FR 20249) that became effective October 24, 2002.

DOL will need to adopt the following NRC amendments:

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

amendment (64 FR 54543; 64 FR 55524) that became effective February 2, 2000.

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

10 CFR Part 39 amendment (65 FR 20337) that became effective May 17, 2000.

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

that became effective January 8, 2001.

 “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

Material,” 10 CFR Part 32 amendments (65 FR 79162) that became effective

February 16, 2001.

 “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective April 5, 2002.

 “Medical Use of Byproduct Material,” 10 CFR 20, 32, and 35 amendments

(67 FR 20249) that became effective October 24, 2002. DOL will need to adopt

only those changes to the pharmacy requirements.

DOH will need to adopt the following NRC amendments:

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

amendment (64 FR 54543; 64 FR 55524) that became effective February 2, 2000.

 “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective April 5, 2002.

 “Medical Use of Byproduct Material,” 10 CFR 20, 32, and 35 amendments (67 FR

20249) that became effective October 24, 2002.

DEC will need to adopt the following NRC amendment:

 “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective April 5, 2002.

4.1.3 Indicator Summary
New York Final Report Page 30

The review team noted that all four Agencies have at least four NRC amendments that are

overdue and will be adopted in a time frame greater than three years after the effective date of

their adoption by the NRC. 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

programmatic issues. The review team recommends that each New York Agency (NYC, DOH,

DEC and DOL) adopt NRC regulations in accordance with the current NRC policy on adequacy

and compatibility.

As discussed in Section 3.4, the team identified errors in NYC and DOL regulations which affect

the amount of surety required to be addressed by licensees. Article 175.101(n) contains the

NYC requirement for financial assurance. The section references 175.101 Appendix B (Exempt

Quantities) to determine appropriate financial assurance. This table does not include

americium or plutonium. A more appropriate table for NYC to use would be in Article 175.03,

Appendix C (Quantities of Licensed or Registered Material Requiring Labeling).

In Section 12 NYCRR Part 38.41, Table 4 (Quantities of Licensed Materials) of DOL

regulations, which is also used for financial assurance, the quantity for carbon-14 is listed as

1000 microcuries whereas the equivalent NRC table (10 CFR 30, Appendix B) has a carbon-14

value of 100 microcuries. This table has a compatibility category of B, requiring essentially

identical quantities. Program management indicated that they would ensure that corrections

were made to the regulations.

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

performance with respect to the indicator, Legislation and Program Elements Required for

Compatibility, be found satisfactory with recommendations for improvement.

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

Only DOL performs this portion of the Agreement for the State of New York. Three

sub-indicators were used to evaluate DOL’s performance regarding their SS&D Evaluation

Program. These sub-indicators are: (1) Technical Quality of the Product Evaluation Program;

(2) Technical Staffing and Training; and (3) Evaluation of Defects and Incidents Regarding

SS&Ds.

In assessing DOL’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, DOL indicated that no SS&D reviews had been performed since the

previous IMPEP. During the on-site review, the review team and DOL staff identified one SS&D

evaluation that was performed in 2001. The team observed the staff's use of various

appropriate guidance documents and procedures, and interviewed the staff and Program

Manager involved in SS&D evaluations.

4.2.1 Technical Quality of the Product Evaluation Program

DOL processed one new SS&D application since the last review and performed no

amendments to existing SS&D evaluations. The casework review indicated that DOL staff

follows their, or NRC, guidance during the review process to ensure that licensees submit the

information necessary to support the product. DOL demonstrated that they have modified

guidance from the NRC for their specific use. The tie-down condition is stated clearly and is

inspectable/enforceable. Deficiency letters clearly stated regulatory positions and were used at

the proper time. A concurrent review was accomplished by a second SS&D evaluation-qualified

reviewer. Additional specific comments are listed in Appendix F.
New York Final Report Page 31

The review team interviewed the staff and supervisor responsible for SS&D evaluations, and

examined the staff’s use of new guidance documents and procedures. DOL staff has improved

in following NRC guidance and conferring with NRC or other experienced DOL staff. The team

found no health and safety issues relative to the SS&D evaluation which was reviewed.

In 2000, another Agreement State requested that New York update a Registry sheet to identify

device changes approved by DOL since the sheet was last issued in 1976. NRC also

requested that DOL update the sheet to maintain a viable national registry. DOL indicated that

a proper review of the device was performed and it was found acceptable for distribution to

general licensees. Instead of updating the Registry, DOL offered the State and NRC a copy of

the license amendment which was issued to the device manufacturer. In 2001, NRC again

requested an updated Registry sheet from New York, but since then, the manufacturer sold that

portion of their business to a company in another Agreement State. The review team contacted

that State and was informed that the successor company had filed an SS&D Registry request

with them. DOL has terminated the manufacturer’s possession and distribution license.

The review team identified the need to inactivate several registrations (only one contains

byproduct material authorization) formerly held by a company no longer in business. DOL

management’s agreed to address the inactivations as time and resources permit.

4.2.2 Technical Staffing and Training

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

safety evaluations of SS&D applications in accordance with the NRC/OAS Training Work Group

recommendations. Specific procedures for documenting training requirements for qualification

as a SS&D reviewer were created. 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. The team determined that the reviewers meet

the technical training required for SS&D reviews as described under the guidance. Similarly,

the team determined that the staffing level of qualified reviewers is sufficient in view of the

relatively low number of licensees who need registration certificates in New York.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

DOL staff were not aware of any defects or incidents involving devices reviewed by their

program. The review team conducted a search of the NMED system and DOL files to

determine whether incidents might have taken place that were not known to DOL staff. No

incidents were identified related to devices considered during the review.

4.2.4 Indicator Summary

Only one SS&D review was performed since the last IMPEP review. The evaluation was

adequately performed, however, the DOL Program Manager is aware, with this limited number

of device reviews performed by New York, that expertise is difficult to maintain. He committed

to conferring with NRC or other Agreement State SS&D programs if a complex device

evaluation is required which surpasses DOL expertise.

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

performance with respect to the indicator, Sealed Source and Device Evaluation Program, be

found satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program
New York Final Report Page 32

New York has two former radioactive waste disposal sites: the State Licensed Disposal Area at

West Valley (West Valley), and the University of Cornell Radiation Disposal Site at Lansing

(Cornell).

West Valley was operated as a commercial low-level radioactive waste disposal facility

authorized by DOL and DOH from 1963 to 1975. The site ceased operations in 1975, and has

since been under State ownership and control. Nuclear Fuel Services (NFS), Inc., was the

commercial operator of the site. The wastes, approximately 2.4 million cubic feet, that were

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

waste brokers, and decontamination companies, were placed in 14 parallel trenches. The

trenches range from approximately 450 to 650 feet in length and are approximately 20 feet

deep. In addition to the trenches, West Valley contains three lagoons which were excavated

and used to hold water pumped from the trenches during disposal operations. In 1974

regulatory responsibility for West Valley was transferred from DOH to DEC. NYSERDA

assumed responsibility for West Valley in 1983.

Currently, NYSERDA holds two permits from DEC for West Valley. DEC is responsible for all

environmental releases and the permitting of the disposal units. One of the permits authorizes

the emission of radionuclides from the vent system of the West Valley leachate storage tank 

and the other permit 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. NYSERDA also holds a radioactive material license from DOL which

covers the on-site radiation control program, occupational exposure of individuals, and control

of radioactive material as it affects occupational exposures.

Disposal operations at Cornell occurred between 1956 and 1978. The disposal site is about

290 by 300 feet in size. Wastes were buried in trenches excavated 6 to 12 feet deep. 

Low-level radioactive laboratory material were buried at Cornell, as were solvents such as

paradioxane. Cornell currently operates under a broad scope radioactive material license from

DOH.

Cornell is being remediated through a substantive permit under a consent order. DEC issued a

permit in April 2002 which includes the requirements imposed by the consent order. The team

reviewed the permit which authorizes discharge of water containing radioactive material from a

groundwater treatment system located at the site. It was noted on the permit that the treatment

system is for a non-radiological contaminant, paradioxane, and that the radionuclide discharge

is incidental to this treatment process. Upon completion of all activities under the consent

order, DEC will issue a permit for the monitoring activities at this site.

4.3.1 Status of Low-Level Radioactive Waste Inspection

The review team found that DEC and DOL inspect West Valley at the required annual

frequency and that DEC inspects Cornell at the required annual frequency as well. 

Regarding the timeliness of the DEC inspection reports, the review team noted that for an

inspection conducted on September 18, 2001, the report was completed on December 3, 2001. 

This exceeded the 15-working day requirement for report completion specified in the inspection

procedure document. The report was reviewed by the inspector’s supervisor on December 11,

2001, and the formal inspection letter, signed by the inspector notifying the licensee of the

inspection findings was sent to the licensee on December 11, 2001. The team found that DOL

issued their inspection findings to NYSERDA within 15 days of completion of the inspection.
New York Final Report Page 33

4.3.2 Technical Quality of Inspections

The review team evaluated the latest DEC and DOL inspection reports and found the scope

and quality of the reports to be complete and thorough, and emphasized public health and

safety, as well as protection of the environment. DEC inspects the burial sites on an annual

basis 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 annual

inspection, pre-operational and follow-up inspections are conducted by the DEC staff.

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

measurements using 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 are

collected from the three creeks.

The DEC inspector was accompanied by his supervisor in June 1998, but has not been

accompanied since. The review team recommends that DEC perform annual supervisory

accompaniments of the inspector (See recommendation in Section 3.2.5 of this report). The

supervisory accompaniments of DOL inspectors is discussed in Section 3.2.2.

On July 19, 2002, a site visit at West Valley was conducted by a review team member

accompanied by the DEC inspector. Prior to and during the site visit, the inspector provided the

team a detailed explanation of the site background, site description, storage facilities, and

current activities, including environmental monitoring by DEC at West Valley. Another team

member accompanied the DEC inspector to Cornell on May 29, 2002, during a pre-operational

inspection of the radiation treatment system. A discussion of inspector accompaniments can

be found in Section 3.2.

4.3.3 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. The training, experience, and the

educational qualifications for the inspector were evaluated and were found to be adequate. The

review team commented on the need for a back-up inspector trained to inspect the West Valley

facility. The comment was noted and acknowledged by DEC management.

Qualifications of DOL inspectors were reviewed by the team and found to be adequate. See

Section 3.3.2 for additional detail.

4.3.4 Technical Quality of Licensing

DOL 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 team reviewed one of the licensing actions issued by DOL for this

license and found the review thorough, complete, and of excellent quality.

A separate file is maintained for each licensing action. All correspondence related to the

issuance of the license was well documented. Technical reviews and issuance of the licenses
New York Final Report Page 34

are conducted by the DOL staff in the Albany office. The licenses are issued for three years

unless renewed, suspended, revoked, or terminated by DOL. Three months prior to license

expiration, DOL notifies the licensee of the expiration date. A tracking system is maintained for

all actions.

DEC has issued two permits to NYSERDA. One of the permits authorizes the emission of

radionuclides from the vent system of the West Valley leachate storage tank and the other

permit 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. Renewal of the maintenance and monitoring permit is in process. The air permit

will soon be terminated and relevant provisions will be combined with the maintenance and

monitoring permit upon renewal. The team reviewed licensing actions completed by DEC and

found the reviews thorough, complete, and of excellent quality.

A separate file is maintained for each permit. All correspondence and telephone calls related to

the issuance/termination of the permits were well documented. Guidance documents for

terminating permits were maintained on file. Technical reviews for the permits are conducted

by the DEC staff in the Albany office. A draft is sent to the DEC regional offices for

issuance/final action. The permits are issued for five years unless renewed, suspended,

revoked or terminated by DEC. A tracking system is maintained for all permitting actions. 

4.3.5 Response to Incidents and Allegations

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

Valley or Cornell since the last review.

4.3.6 Indicator Summary

Oversight of the two former radioactive waste disposal sites by DEC and DOL is suitable and

thorough.

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

performance with respect to the indicator, Low-level Radioactive Waste Disposal Program, be

found satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found New York’s performance to be

satisfactory for five performance indicators, and satisfactory with recommendations for

improvement for the indicators: 1) Status of Materials Inspection Program; 2) Response to

Incidents and Allegations; and 3) Legislation and Program Elements Required for Compatibility. 

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

health and safety and compatible with NRC's program. Based on the results of the current

IMPEP review, the review team recommended, and the MRB agreed, that the next full review

should be in approximately four years.

Below are the recommendations, as mentioned earlier in the report, for evaluation and

implementation, as appropriate, by the State.
New York Final Report Page 35

RECOMMENDATIONS:

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)

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)

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)

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

accompaniments of all material inspectors. (Section 3.2.5)

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)

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)

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)

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)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B B-1 NYC Organization Charts

B-2 DOL Organizational Chart

B-3 DOH Organizational Charts

B-4 DEC Organizational Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source and Device Reviews

Attachment 1 Responses to Draft Report

1-A October 28, 2002 Electronic mail from Gene Miskin New York

City Health Response to Draft IMPEP Report

1-B October 24, 2002 Electronic mail from Clayton J. Bradt 

NYS Dept of Labor Response to Draft IMPEP Report

1-C October 21, 2002 Letter from Adela Salame-Alfie

NYS Dept of Health Response to Draft IMPEP Report 

1-D October 4, 2002 Letter from Stephen Hammond

NYS Dept of Environmental Conservation Response to Draft 

IMPEP Report 

Attachment 2 New York State Department of Health Response to Draft IMPEP

Report; Resolution of Comments Document
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

James Lynch, Region III Team Leader

Response to Incidents and Allegations

Inspector Accompaniments

Duncan White, Region I Legislation and Program Elements Required for

Compatibility

Response to Incidents and Allegations

Technical Quality of Licensing Actions 

Inspector Accompaniments

David Fogle, Texas Technical Quality of Licensing Actions

Sealed Source and Device Evaluation Program

Deborah Piskura, Region III Technical Quality of Inspections

Response to Incidents and Allegations

Barbara Hamrick, California Status of Materials Inspection Program

Response to Incidents and Allegations

Tony Gaines, Region IV Technical Staffing and Training

Response to Incidents and Allegations

David Collins, Region II Response to Incidents and Allegations

Muhammadali Abbaszadeh, Texas Low-Level Radioactive Waste Disposal Program
APPENDIX B-1

New York City Department of Health & Mental Hygiene

Office of Radiological Health

ORGANIZATION CHARTS

ML022490410
APPENDIX B-2

New York State Department of Labor

Radiological Health Unit

ORGANIZATION CHART

ML022490413
APPENDIX B-3

New York State Department of Health

Bureau of Environmental Radiation Protection

ORGANIZATION CHARTS

ML022490414
APPENDIX B-4

New York State Department of Environmental Conservation

Division of Solid and Hazardous Materials

Bureau of Radiation

ORGANIZATION CHARTS

ML022490415
 APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE

File No.: 1

Licensee: The Animal Medical Center License No.: 92-2899-01

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Teletherapy; Non-Human Use Priority: 1

Inspection Date: 8/6/01 Inspector: EC

Comments:

a) No indication that the inspector contacted licensee management or the RSO.

b) No description of any observed activities.

c) Limited description of the program scope.

File No.: 2

Licensee: Rafael Cavero, M.D. License No.: 91-1634-01

Location: New York, NY Inspection Type: Routine, announced

License Type: Medical, Private Practice (brachytherapy) Priority: 2

Inspection Date: 6/28/01 Inspector: JH

Comments:

a) Compliance letter issued 8 days late.

b) No description of the root cause of the violation in the field notes.

c) Licensee apparently did not respond to the compliance letter.

File No.: 3

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

Location: New York, NY Inspection Type: Routine, unannounced 

License Type: Broad Scope; R&D Priority: 1

Inspection Date: 6/26/01 Inspector: EC

Comments:

a) No description of the root cause of the violations in the field notes.

b) Compliance letter issued 223 days late.

c) One violation not supported/described in the inspection field notes.

d) Licensee apparently did not respond to the compliance letter.

File No.: 4

Licensee: Memorial Sloan-Kettering Cancer Center License No.: 92-2968-02

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Teletherapy Priority: 3

Inspection Date: 11/27/01 Inspector: AA
New York Final Report Page C.2

Inspection Casework Reviews

Comments:

a) Date of inspection not indicated in inspection field notes.

b) No description of any observed activities.

File No.: 5

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

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Broad Scope-Medical (w/ HDR) Priority: 1

Inspection Date: 6/6/01 Inspector: EC

Comments:

a) Inspection date not specified in the field notes.

b) No indication in inspection field notes that inspectors performed independent surveys or

observed licensee activities.

File No.: 6

Licensee: Mt. Sinai School of Medicine License No.: 74-2909-05

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Broad Scope-Academic Priority: 2

Inspection Date: 3/6/00 Inspectors: EC, TK

Comments:

a) No indication in inspection field notes that inspectors performed independent surveys or

observed licensee activities.

b) One violation for failure to provide periodic retraining was cited, however the inspection

report indicated that periodic retraining was not required.

c) No description of the root cause of the violations (7 cited in compliance letter) in the field

notes.

d) Compliance letter issued 42 days late.

e) No information regarding individuals (RSO and management) present at exit meeting.

File No.: 7

Licensee: NYCHHC-Coney Island Hospital License No.: 91-2902-01

Location: Brooklyn, NY Inspection Type: Routine, unannounced

License Type: Limited Medical Priority: 3

Inspection Date: 1/6/99 Inspectors: EC, AA

Comments:

a) Violation in compliance letter not documented in field notes.

b) Limited description of the program scope.

File No.: 8

Licensee: NYCHHC-Harlem Hospital Center License No.: 91-2904-01

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Limited Medical Priority: 3

Inspection Date: 5/16/02 Inspector: JH

File No.: 9

Licensee: New York University Medical Center License No.: 93-2955-05

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Gamma Knife Priority: 1
New York Final Report Page C.3

Inspection Casework Reviews

Inspection Date: 6/21/01 Inspector: RB

Comment:

a) Personal privacy information (patient name, ID No., and treatment record) placed in the

license file as an attachment to the inspection field notes.

File No.: 10

Licensee: John E. Strobeck, M.D. License No.: 91-3103-01

Location: New York, NY Inspection Type: Initial, unannounced

License Type: Medical Private Practice Priority: 5

Inspection Date: 12/13/99 Inspector: TK

Comment:

a) The inspector indicated that he could not locate licensee personnel and found the facility

locked. No further follow-up was apparent based on the review of the file, discussions

with staff, or review of the computer database.

File No.: 11

Licensee: Tribeca Pharmaceuticals License No.: 52-3141-01

Location: New York, NY Inspection Type: Initial, announced

License Type: R&D Priority: 3

Inspection Date: 4/28/02 Inspector: JH

Comments:

a) Initial inspection performed 15 months after license issuance.

b) No indication the licensee management or the RSO were contacted during the

inspection.

c) No indication of any observed licensee activities.

d) Limited description of the program scope.

File No.: 12

Licensee: Andrew Van Tosh, M.D. License No.: 91-3109-01

Location: New York, NY Inspection Type: Initial, announced

License Type: Medical Private Practice Priority: 3

Inspection Date: 1/12/00 Inspector: TK

Comments:

a) Limited description of the program scope.

b) Root cause of the violations not described in the field notes.

c) Licensee apparently did not respond to the compliance letter.

NEW YORK STATE DEPARTMENT OF LABOR

File No.: 1

Licensee: Branch Radiographic Labs License No.: 29-03405-02

Location: Orangebury, NY Inspection Type: Routine, announced

License Type: Industrial Radiography Priority: 1

Inspection Date: 1/4/02 Inspector: BK

File No.: 2

Licensee: Certified Testing Labs License No.: 1920-1836
New York Final Report Page C.4

Inspection Casework Reviews

Location: Bronx, NY Inspection Type: Routine, announced

License Type: Industrial Radiography Priority: 1

Inspection Date: 1/22/01 Inspector: RP

File No.: 3

Licensee: Isomedix Operations License No.: 2583-3814

Location: Chester, NY Inspection Type: Routine, announced 

License Type: Pool Irradiator Priority: 1

Inspection Date: 11/09/00 Inspectors: JM, CB

Comments:

a) Inspection overdue; previous inspection performed 2/99.

b) Error in notice of violation wording.

File No.: 4

Licensee: Monofrax, Inc. License No.: 92-2968-02

Location: Falconer, NY Inspection Type: Routine, unannounced

License Type: Source Material Processor Priority: 3

Inspection Date: 4/25/02 Inspector: AA

File No.: 5

Licensee: NYSERDA License No.: 0382-1139

Location: West Valley, NY Inspection Type: Routine, announced

License Type: Waste Disposal Site Priority: 1

Inspection Date: 3/14/00 Inspector: BK

File No.: 6

Licensee: Radiac Research Corporation License No.: 1944-1879

Location: Brooklyn, NY Inspection Type: Routine, announced

License Type: Waste Broker Priority: 1

Inspection Date: 11/20/01 Inspector: RMP

File No.: 7

Licensee: Rolex Watch USA, Inc. License No.: 0263-1074

Location: New York, NY Inspection Type: Routine, announced

License Type: Manufacturing & Distribution Priority: 1

Inspection Date: 4/6/01 Inspector: BK

File No.: 8

Licensee: Schlumberger Technology Corporation License No.: 2091-0491

Location: Sugarland, TX Inspection Type: Routine, announced

License Type: Well Logging Priority: 2

Inspection Date: 12/11/01 Inspector: JM

File No.: 9

Licensee: Syncor International Corporation License No.: 2613-3868

Location: Newburgh, NY Inspection Type: Routine, unannounced

License Type: Nuclear Pharmacy Priority: 1

Inspection Date: 9/20/00 Inspector: CB

Comment:
New York Final Report Page C.5

Inspection Casework Reviews

a) Inspection overdue; last inspection performed 4/99.

File No.: 10

Licensee: Syncor International Corporation License No.: 2449-3500

Location: Syracuse, NY Inspection Type: Routine, unannounced 

License Type: Nuclear Pharmacy Priority: 1

Inspection Dates: 9/12-13/00 Inspectors: JM, CB

Comment:

a) Inspection overdue; last inspection performed 5/99.

File No.: 11

Licensee: Wyeth-Ayerst Research License No.: 0716-0007

Location: Pearl River, NY Inspection Type: Routine, announced

License Type: Broad Scope R&D Priority: 1

Inspection Date: 7/12-14/00 Inspector: BK

NEW YORK STATE DEPARTMENT OF HEALTH

File No.: 1

Licensee: Buffalo General Hospital License No.: 0039-2

Location: Buffalo, NY Inspection Type: Routine, unannounced

License Type: Teletherapy Priority: 2

Inspection Date: 12/19/01 Inspector: BI

File No.: 2

Licensee: Central Radiopharmaceutical Services, Inc. License No.: 2950

Location: Buffalo, NY Inspection Type: Routine, unannounced

License Type: Nuclear Pharmacy Priority: 1

Inspection Date: 11/18/98 Inspector: RD

File No.: 3

Licensee: Columbia Memorial Hospital License No.: 1120-2

Location: New York, NY Inspection Type: Routine, unannounced

License Type: Medical Priority: 2

Inspection Date: 3/21/02 Inspector: CC

Comment:

a) Compliance letter addressed to the wrong individual.

File No.: 4

Licensee: E. J. Noble License No.: 3124

Location: Gouveneur, NY Inspection Type: Routine, unannounced

License Type: Mobile Nuclear Medicine Priority: 2

Inspection Date: 8/1/00 Inspector: GB

File No.: 5

Licensee: Foss Therapy Services License No.: N/A

Location: Alta Loma, CA Inspection Type: Special, unannounced

License Type: Service (reciprocity) Priority: 1

Inspection Date: 2001 Inspectors: CB, SG
New York Final Report Page C.6

Inspection Casework Reviews

Comment:

a) Inspection date not specified in the field notes.

File No.: 6

Licensee: Hypurrcat, Inc. License No.: 5043

Location: Bedford Hills, NY Inspection Type: Initial, unannounced

License Type: Veterinary Priority: 2

Inspection Date: 1/22/02 Inspector: AB

File No.: 7

Licensee: Rensselaer Polytechnic Institute License No.: 1035

Location: Troy, NY Inspection Type: Routine, unannounced

License Type: Broad Scope-Academic Priority: 2

Inspection Date: 9/18/00 Inspector: CC

File No.: 8

Licensee: St. Joseph’s Hospital Health Center License No.: 0487

Location: Syracuse, NY Inspection Type: Routine, unannounced

License Type: Limited Medical Priority: 2

Inspection Date: 7/26/00 Inspector: VG

File No.: 9

Licensee: SUNY Upstate Medical University License No.: 0047-3

Location: Syracuse, NY Inspection Type: Routine, unannounced

License Type: Gamma Knife Priority: 2

Inspection Date: 12/5/00 Inspector: GB

File No.: 10

Licensee: SUNY Upstate Medical University License No.: 0047

Location: New York, NY Inspection Type: Routine, announced

License Type: Broad Scope-Medical Priority: 1

Inspection Date: 12/5/00 Inspector: TK

Comment:

a) Inspection currently overdue; previous inspection 12/00.

File No.: 11

Licensee: University at Albany, SUNY License No.: 0459-1

Location: Albany, NY Inspection Type: Routine, announced

License Type: Broad Scope-Academic Priority: 2

Inspection Dates: 12/10-11/01 Inspectors: OO, CC

Comment:

a) Inspection report indicated “non-compliance.” The compliance letter indicated only

recommendations.

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION

File No.: 1

Licensee: ICN East, Inc. Permit No.: 5-3
New York Final Report Page C.7

Inspection Casework Reviews

Location: Orangeburg, NY Inspection Type: Routine, unannounced

License Type: Manufacturing and Distribution Priority: 3

Inspection Date: 6/1/00 Inspector: MS

File No.: 2

Licensee: NRD, L.L.C. Permit No.: 53-3

Location: Grand Island, NY Inspection Type: Routine, unannounced

License Type: Manufacturing and Distribution Priority: 3

Inspection Date: 7/30/99 Inspector: BY

Comment:

a) Compliance letter issued 61 days late.

File No.: 3

Licensee: PharmaLogic Syracuse, L.L.C. Permit No.: 180-3

Location: Syracuse, NY Inspection Type: Initial, unannounced

License Type: Nuclear Pharmacy Priority: 3

Inspection Date: 1/10/02 Inspectors: AMG & SH

Comment:

a) Compliance letter issued 12 days late.

File No.: 4

Licensee: Trudeau Institute Permit No.: 96-01

Location: Saranac Lake, NY Inspection Type: Routine, unannounced

License Type: R&D with incineration Priority: 2

Inspection Date: 9/2/99 Inspectors: AMG & RE

Comments:

a) Compliance letter issued 10 days late.

b) Inspection currently overdue; last inspection performed 9/99.

File No.: 5

Licensee: Wyeth-Ayerst Research Permit No.: 147-3

Location: Pearl River, NY Inspection Type: Routine, unannounced

License Type: R&D Priority: 3

Inspection Date: 8/1/01 Inspector: AMG

Comments:

a) Inspection overdue; last inspection 1/97.

b) Compliance letter issued 27 days late.
New York Final Report Page C.8

Inspection Casework Reviews

INSPECTOR ACCOMPANIMENTS

The following inspection accompaniments were performed as part of the IMPEP review.

Accompaniment No.: 1

Licensee: NYS DOH-Griffin Laboratory DEC Permit No.: 4-0130-00034/00001

Location: Guilderland, NY Inspection Type: Announced, Routine

Type: Incinerator Priority: 1

Inspection Date: 2/26/02 Inspector: AMG

Accompaniment No.: 2

Licensee: Ellis Hospital DOH License No.: 0484

Location: Schenectady, NY Inspection Type: Announced, Routine

Type: Medical Institution - QMP required Priority: 2

Inspection Date: 2/27/02 Inspector: MV

Accompaniment No.: 3

Licensee: Rye Radiological Associates, LLP DOH License No.: 1032

Location: Rye Brook, NY Inspection Type: Unannounced, Routine

Type: Medical Private - QMP required Priority: 3

Inspection Date: 5/2/02 Inspector: AB

Accompaniment No.: 4

Licensee: Harlem Medical Center NYC License No.: 91-2904-01

Location: New York, NY Inspection Type: Announced, Routine

License Type: Medical Institution - QMP required Priority: 3

Inspection Date: 5/16/02 Inspector: JH

Accompaniment No.: 5

Licensee: Mount St. Mary’s Hospital DOH License No.: 1018

Location: Lewiston, NY Inspection Type: Unannounced, Routine

Type: Medical Institution - QMP required Priority: 2

Inspection Date: 5/21/02 Inspector: SK

Accompaniment No.: 6

Licensee: Buffalo General Hospital DOH License No.: 2914

Location: Buffalo, NY Inspection Type: Unannounced, Routine

Type: Medical Institution - QMP required Priority: 2

Inspection Date: 5/22/02 Inspector: BI

Accompaniment No.: 7

Licensee: Cornell University DEC Permit No.: 7-5032-00102/00001

Location: Lansing, NY Inspection Type: Announced, Special

License Type: Burial Site Priority: 1

Inspection Date: 5/29/02 Inspector: TR

Accompaniment No.: 8

Licensee: Entec Consultants, Inc. DOL License No.: 2630-3897

Location: Schenectady, NY Inspection Type: Announced, Routine

License Type: Industrial Radiography Priority: 1
New York Final Report Page C.9

Inspection Casework Reviews

Inspection Date: 6/11/02 Inspector: BK

Accompaniment No.: 9

Licensee: Cortland Memorial Hospital DOH License No.: 427-1

Location: Cortland, NY Inspection Type: Unannounced, Routine

License Type: Medical Institution - QMP required Priority: 3

Inspection Date: 6/17/02 Inspector: VG

Accompaniment No.: 10

Licensee: Proctor and Gamble Pharmaceuticals, Inc. DOL License No.: 0720-0619

Location: Norwich, NY Inspection Type: Announced, Routine

License Type: Research and Development Priority: 3

Inspection Date: 6/19-20/02 Inspector: JM
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE

File No.: 1

Licensee: Memory Pharmaceuticals License No.: 52-3089-01

Location: New York, NY Amendment No.: 5

License Type: Limited Non-Human Use Type of Action: Termination

Date Issued: 11/2/00 License Reviewer: RF

Comment:

a) No date was provided on the facility close-out radiation survey.

File No.: 2

Licensee: SUNY-HSC at Brooklyn/Kings County Hospital License No.: 75-2934-01

Location: Brooklyn, NY Amendment No.: 7

License Type: Broad Scope Medical, Brachytherapy Type of Action: Amendment

Date Issued: 6/10/02 License Reviewer: RF

File No.: 3

Licensee: Singal Sanjiv, MD License No.: 91-3177-01

Location: New York, NY Amendment No.: N/A

License Type: Limited Medical - Cardiologist Type of Action: New

Date Issued: 4/2/02 License Reviewer: DH

Comment:

a) Posting and security issues not addressed.

File No.: 4

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

Location: New York, NY Amendment No.: 2

License Type: Gamma Knife Type of Action: Amendment

Date Issued: 3/8/00 License Reviewer: DH
New York Final Report Page D.2

Licensing Casework Reviews

File No.: 5

Licensee: Beth Israel Medical Center License No.: 91-2897-01

Location: New York, NY Amendment No.: Not applicable

License Type: Limited Medical Type of Action: Amendment/Variance

Date Issued: 3/12/02 License Reviewer: TL

Comments:

a) Variance from license authorization granted by letter, but specific variance information

not included (i.e., no citation of what the variance is from.....e.g., “you are hereby

exempted from item 6.A. of License number”....)

b) Telephone contact with licensee seeking clarification was not documented.

c) Radioactive source strength to be used during the patient procedure was not addressed

during the licensing process or in the letter granting variance.

File No.: 6

Licensee: New York University Medical Center License No.: 92-2955-03

Location: New York, NY Amendment No.: 11

License Type: Teletherapy Type of Action: Renewal

Date Issued: 10/19/01 License Reviewer: DH

File No.: 7

Licensee: Lenox Hill Hospital License No.: 91-2926-01

Location: New York, NY Amendment No.: 15

License Type: Limited Medical - Intravascular Brachytherapy Type of Action: Amendment

Date Issued: 3/13/01 License Reviewer: DH

File No.: 8

Licensee: St. Luke’s - Roosevelt License No.: 75-2898-01

Location: New York, NY Amendment No.: 11

License Type: Broad Human Use Type of Action: Renewal

Date Issued: 8/9/01 License Reviewer: RF

Comment:

a) Financial assurance required but not addressed.

File No.: 9

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

Location: New York, NY Amendment No.: 4

License Type: Broad Human Use Type of Action: Renewal

Date Issued: 2/18/02 License Reviewer: DH

Comments:

a) Financial assurance required but not addressed.

b) Several standard license conditions for iodine-131 and tritium not included on renewed

license.

c) The renewed license had not yet been signed and transmitted to the licensee.

File No.: 10

Licensee: The New York Blood Center, Inc. License No.: 74-2946-01

Location: New York, NY Amendment No.: 4

License Type: Broad Non-Human Use Type of Action: Amendment
New York Final Report Page D.3

Licensing Casework Reviews

Date Issued: 4/23/02 License Reviewer: DH

Comment:

a) Financial assurance required but not addressed.

File No.: 11

Licensee: Columbia-Presbyterian Medical Center License No.: 74-2878-03

Location: New York, NY Amendment No.: 10

License Type: Broad Non-Human Use Type of Action: Renewal

Date Issued: 4/26/02 License Reviewer: DH

Comment:

a) Financial assurance required but not addressed.

File No.: 12

Licensee: NY Hospital Division - New York Presbyterian Hospital License No.: 91-2960-01

Location: New York, NY Amendment No.: 9

License Type: Limited Medical Type of Action: Renewal

Date Issued: 2/22/01 License Reviewer: DH

Comment:

a) Supervisory review failed to correct errors in the renewed license document that later

required the generation of a corrected license amendment.

b)

NEW YORK STATE DEPARTMENT OF LABOR

File No.: 1

Licensee: Imaging and Sensing Technology License Nos.: 0317-0058, 0387-0058, 0754-0058

Location: Horseheads, NY Amendment No.: 5

License Type: Broad Research and Development Type of Action: Amendment

Date Issued: 8/3/01 License Reviewer: DS

File No.: 2

Licensee: Steris Isomedix Services License No.: 2583-3814

Location: Chester, NY Amendment No.: 4

License Type: Panoramic wet-source-storage irradiator Type of Action: Amendment

Date Issued: 6/7/02 License Reviewer: CB

File No.: 3

Licensee: Proctor & Gamble Pharmaceuticals, Inc. License No.: 0720-0619

Location: Norwich, NY Amendment No.: 5

License Type: Broad Research and Development Type of Action: Renewal

Date Issued: 3/22/02 License Reviewer: CB

Comment:

a) Financial assurance for decommissioning was received from this license, however, due

to an error in the regulations, the applicable limit for carbon-14 is off by one order of
New York Final Report Page D.4

Licensing Casework Reviews

magnitude. The result is that instead of accepting financial assurance in the amount of

$750,000, the licensee should be required to submit a decommissioning funding plan.

File No.: 4

Licensee: Prime NDT Services, Inc. License No.: 2998-4232

Location: Whitehall, PA Amendment No.: N/A

License Type: Industrial Radiography Type of Action: New

Date Issued: 5/24/02 License Reviewer: DS

File No.: 5

Licensee: Materials Testing Lab, Inc. License No.: 2274-3075

Location: New Hyde Park, NY Amendment No.: 2

License Type: Portable Gauge Type of Action: Renewal

Date Issued: 6/23/99 License Reviewer: DG

File No.: 6

Licensee: PharmaLogic Syracuse, LLC License No.: 2935-4169

Location: Syracuse, NY Amendment No.: N/A

License Type: Radiopharmacy Type of Action: New

Date Issued: 5/16/00 License Reviewer: CB

 NEW YORK STATE DEPARTMENT OF HEALTH

File No.: 1

Licensee: Albany Medical Center License No.: 590

Location: Albany, NY Amendment No.: 67

License Type: Broad Medical Type of Action: Renewal

Date Issued: 12/18/00 License Reviewer: CC

File No.: 2

Licensee: Regeneron Pharmaceuticals, Inc. License No.: 2904

Location: Tarrytown, NY Amendment No.: 10

License Type: Research & Development, Self-Shielded Irradiator Type of Action: Amendment

Date Issued: 5/16/01 License Reviewer: MV

File No.: 3

Licensee: St. James Mercy Hospital License No.: 1790

Location: Hornell, NY Amendment No.: 28

License Type: Medical Institution - Brachytherapy Type of Action: Renewal

Date Issued: 8/7/00 License Reviewer: MV

File No.: 4

Licensee: Westchester Medical Center License No.: 586

Location: Valhalla, NY Amendment No.: 70

License Type: Medical Institution - HDR Type of Action: Amendment

Date Issued: 11/30/01 License Reviewer: OO
New York Final Report Page D.5

Licensing Casework Reviews

File No.: 5

Licensee: Lockport Memorial Hospital License No.: 2905

Location: Lockport, NY Amendment No.: 7

License Type: Medical Institution - Brachytherapy Type of Action: Renewal

Date Issued: 4/25/00 License Reviewer: BD

File No.: 6

Licensee: Cornell University License No.: 5-3A

Location: Ithaca, NY Amendment No.: 98

License Type: Broad Academic Type of Action: Renewal

Date Issued: 12/5/00 License Reviewers: CC&CB

Comment:

a) License file does not include decommissioning cost estimates or audit report required

for self-guarantee.

File No.: 7

Licensee: Rochester General Hospital / Pluta Family Cancer Center License No.: 26

Location: Rochester, NY Amendment No.: 118

License Type: Medical Institution -HDR Type of Action: Termination

Date Issued: 2/13/02 License Reviewer: CC

File No.: 8

Licensee: State University of New York at Stony Brook License No.: 455

Location: Stony Brook, NY Amendment No.: 55

License Type: Broad Medical - HDR Type of Action: Renewal

Date Issued: 2/5/02 License Reviewer: CC

Comment:

a) Financial assurance required but not addressed.

File No.: 9

Licensee: Memorial Sloan-Kettering CC at Mercy Medical Center License No.: 1038-1

Location: Rockville Centre, NY Amendment No.: 29

License Type: Gamma Knife Type of Action: Amendment

Date Issued: 5/24/02 License Reviewer: MV

Comment:

a) Telephone contact to the licensee to clarify request for amendment was not

documented.

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION

File No.: 1

Licensee: Pharmalogic Syracuse, Inc. Permit No.: 180-3

Location: Syracuse, NY Modification No.: N/A

License Type: Radiopharmacy, Air Permit Type of Action: New

Date Issued: 7/27/01 Permit Reviewer: SH
New York Final Report Page D.6

Licensing Casework Reviews

File No.: 2

Licensee: University of Rochester Permit No.: 129-1

Location: Rochester, NY Modification No.: Unknown

License Type: Broad Academic, Incinerator Permit Type of Action: Termination

Date Issued: 9/25/00 Permit Reviewer: SH

Comment:

a) Readings were provided by permittee in close-out radiation survey, however there is no

identification of equipment used to take readings.

File No.: 3

Licensee: State University of New York - Health Science Center Permit No.: 166-3

Location: Syracuse, NY Modification No.: Unknown

License Type: Broad Medical, Air Permit Type of Action: Termination

Date Issued: 7/10/00 Permit Reviewer: SH

File No.: 4

Licensee: Eastman Kodak Company Permit No.: 184-3

Location: Rochester, NY Modification No.: N/A

License Type: Manufacturing and Distribution, Air Permit Type of Action: New

Date Issued: 9/28/01 Permit Reviewer: MS

Comment:

a) Tie-down condition includes incorrect letter date.

File No.: 5

Licensee: Proctor and Gamble Pharmaceuticals Permit No.: 56-2

Location: Norwich, NY Modification No.: Unknown

License Type: Broad Research and Development, Water Permit Type of Action: Amendment

Date Issued: 4/13/99 Permit Reviewer: AG

File No.: 6

Licensee: Self Powered Lighting Permit No.: 164-3

Location: West Nyack, NY Modification No.: Unknown

License Type: Manufacture and Distribution, Air Permit Type of Action: Renewal

Date Issued: 12/4/01 Permit Reviewer: SH
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE

File No.: 1

Licensee: Columbia Presbyterian Medical Center License No.: 92-02878-02

Site of Incident: New York, NY Incident Log No.: NMED #020100

Date of Incident: 3/11/01 Type of Incident: Misadministration

Investigation Date: 3/12/01 Type of Investigation: On-site

Summary of Incident and Final Disposition: A resident physician in Oncology used an outdated

treatment program. The current program was available, but the resident used a program

available on the network which had been placed there by the system administrator without the

knowledge of the authorized individuals. The treatment resulted in 460 centiGray instead of the

200 centiGray ordered. NYC staff verified the licensee’s actions, no violation was identified.

Comment:

a) Report not in license file for follow-up at next inspection.

File No.: 2

Licensee: Columbia University License No.: 74-3030-01

Site of Incident: New York, NY Incident Log No.: NMED #000147

Date of Incident: 1/9/00 Type of Incident: Personnel Contamination

Investigation Date: 2/22/00 Type of Investigation: Review Licensee Report

Summary of the Incident and Final Disposition: A graduate student reported contamination in

an apartment. Investigation by the licensee could not conclusively prove who was responsible.

Individuals were suspended from the University. The NYC report states that individuals acted

outside the control of the University, individually responsible for their own acts. No violation

issued for individual or licensee.

Comment:

a) Report not updated to NMED after review.

File No.: 3

Licensee: Beth Israel Medical Center. License No.: 92-2897-01

Site of Incident: New York, NY Incident Log No.: NMED #020697

Date of Incident: 8/9/01 Type of Incident: Misadministration

Investigation Date: 8/9/01 Type of Investigation: On-site

Summary of the Incident and Final Disposition: Teletherapy technician failed to include wedge

in treatment set-up, discovered after treatment completed. Licensee now requires two

individuals to review plan and verify set-up.

Comment:

a) This report was not found in the license file for follow-up.
New York Final Report Page E.2

Licensing Casework Reviews

File No.: 4

Licensee: Brooklyn Hospital. License No.: 91-2924

Site of Incident: New York, NY Incident Log No.: NMED #020694

Date of Incident: 1/17/02 Type of Incident: Misadministration

Investigation Date: 2/1/02 Type of Investigation: On-site

Summary of the incident and Final Disposition: Physician failed to follow procedure to identify

patient and implanted iodine-125 seeds to the prostate of the wrong patient. Licensee reports

that individual will probably suffer some functional, permanent damage to prostate. NYC issued

violation for failure to follow procedure. Inspection file contains report for follow-up at next

inspection.

Comments:

a) Licensee failed to notify NYC in timely manner. NYC did not notify NRC until July 15,

2002.

b) No estimate of dose to patient prostate.

File No.: 5

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

Site of Incident: New York, NY Incident Log No.: NMED #010441

Date of Incident: 1/26/01 Type of Incident: Lost Radioactive Material

Investigation Date: 1/26/01 Type of Investigation: On-site

Summary of the incident and final disposition: Upon completion of a temporary implant

procedure, five seeds were unaccounted for. NYC staff responded, and participated in survey

of patient, operating room, and waste. NYC staff contacted a separate licensee which provides

laundry service to this hospital. The seeds were found in laundry and storage was arranged. 

Licensee stated that future soiled laundry would be moved past the same radiation monitors as

the hospital waste containers. No violation identified.

File No.: 6

Licensee: Private Individual License No.: Non-licensee

Site of Incident: Private residence Incident Log No.: None

Date of Incident: 1/15/02 Type of Incident: Potential Contamination

Investigation Date: 1/16/02 Type of Investigation: On-site

Summary of the incident and final disposition: Individual complained of radiation from adjoining

residence. Staff responded, found no elevated radiation levels. No cause for action.

File No.: 7

Licensee: Private individual License No.: Non-licensee

Site of Incident: Private residence Incident Log No.: None

Date of Incident: 1/26/00 Type of Incident: Potential Contamination

Investigation Date: 1/26/00 Type of Investigation: On-site

Summary of the incident and final disposition: Survey of private residence in response to

complaint, with negative results. Letter sent to individual about results of survey.

NEW YORK STATE DEPARTMENT OF LABOR
New York Final Report Page E.3

Licensing Casework Reviews

File No.: 1

Licensee: Testwell Laboratories Licensee No.: 2406-3328

Site of Incident: Ozone Park, NY Incident Log No.: 01-16

Date of Incident: 10/10/01 Type of Incident: Stolen RAM

Investigation Date: 11/7/01 Type of Investigation: Telephone

Summary of Incident and Final Disposition: Car stolen from the front of employee’s home with

a Troxler Model 3430 gauge. Licensee filed report. Gauge never recovered.

Comment:

a) Event not reported to NRC.

File No.: 2

Licensee: Product Development and Technologies Licensee No.: 2453-3511

Site of Incident: Amsterdam, NY Incident Log No.: 01-001

Date of Incident: 1/19/01 Type of Incident: Lost RAM

Investigation Date: 1/23/01 Type of Investigation: On-site

Summary of Incident and Final Disposition: Troxler Model 3430 gauge fell off back of truck. 

Recovered by a member of the public. The individual contacted local police when he heard

local media reports. Site inspection revealed that shutter was not completely closed. Corrected

by licensee and sent to Troxler for inspection.

Comment:

a) Event not reported to NRC.

File No.: 3

Licensee: Anheuser-Busch Inc. Licensee No.: 2879-4113

Site of Incident: Baldwinsville, NY Incident Log No.: 01-025

Date of Incident: 12/26/01 Type of Incident: Contamination Event

Investigation Date: 12/26/01 Type of Investigation: Telephone

Summary of Incident and Final Disposition: Tritium exit sign fell off wall. One letter appeared

not to glow and licensee assumed sign was cracked (loss of approximately 2 curies). Safety

manager removed sign from the area and bagged it. A radiation consultant was hired by the

licensee to take wipes and bioassays. Wipes taken revealed minimal contamination. Urine

samples of workers in area were background. Damaged sign returned to vendor on 1/14/02 for

disposal.

File No.: 4

Licensee: Wyeth-Ayerst Licensee No.: 0716-0007

Site of Incident: Pearl River, NY Incident Log No.: 01-022

Date of Incident: 12/11/01 Type of Incident: Leaking source

Investigation Date: 12/11/01 Type of Investigation: Next Inspection

Summary of Incident and Final Disposition: Routine leak test of Hewlett Packard electron

capture detector (nickel-63) measured removable contamination. Source removed from service

and returned to manufacturer.

File No.: 5

Licensee: Syncor International Licensee No.: 2449-3500
New York Final Report Page E.4

Licensing Casework Reviews

Site of Incident: Syracuse, NY Incident Log No.: 98-047

Date of Incident: 11/24/98 Type of Incident: Misadministration

Investigation Date: 12/1/98 Type of Investigation: On-site and follow-up inspection

Summary of Incident and Final Disposition: Nuclear pharmacy used a spent cardiolite vial to

prepare six new unit doses (8 and 30 millicuries of technetium-99m). The dispensed doses

(unlabeled technetium-99m) resulted in the two hospitals who received the doses reporting

imaging problems. Subsequent DOL inspection determined a procedural problem and lack of

licensee attention as cause of the improperly dispensed doses. Licensee’s corrective actions

were confirmed during follow-up inspection.

File No.: 6

Licensee: Cryovac Licensee No.: 2884-4118

Site of Incident: Rochester, NY Incident Log No.: 99-003

Date of Incident: 9/17/99 Type of Incident: Exposure

Investigation Date: 1/25/99 Type of Investigation: Telephone and follow-up inspection

Summary of Incident and Final Disposition: Maintenance worker spent approximately 30

minutes in the beam of an NDC Model 104 backscatter gauge containing approximately 150

millicuries of americium-241. Shutter closed when discovered. Licensee’s dose evaluation

estimated a worst case dose of 13 millirem. Licensee’s report also included re-training and

procedural changes that were confirmed during follow-up inspection.

File No.: 7

Licensee: General Electric Co. Licensee No.: 0794-0220

Site of Incident: Schenectady, NY Incident Log No.: 99-039

Date of Incident: 7/15/99 Type of Incident: Lost RAM

Investigation Date: 7/28/99 Type of Investigation: Telephone

Summary of Incident and Final Disposition: Varian electron capture detector containing 15

millicuries of nickel-63 was lost and presumed to be commercially incinerated with other

construction and demolition waste. DOL issued a notice of violation and licensee took

appropriate corrective actions.

Comment:

a) Event reported to NRC 20 months late.

File No.: 8

Licensee: Nucletron Corporation Licensee No.: 2674-3822

Site of Incident: Roslyn, NY Incident Log No.: 99-051

Date of Incident: 10/14/99 Type of Incident: Equipment failure

Investigation Date: 10/15/99 Type of Investigation: Next inspection

Summary of Incident and Final Disposition: Coronary afterloader using 150 millicuries of

phosphorus-32 became stuck during source exchange at hospital. Nucletron technician was

able to retract source. Source returned to Nucletron’s Maryland facility. DOH was notified of

incident. Nucletron was not authorized by DOL to work with phosphorus-32 source and notice

of violation was issued. Nucletron amended license.

Comment:

a) Event not reported to NRC.
New York Final Report Page E.5

Licensing Casework Reviews

File No.: 9

Licensee: Atlantic Testing Laboratories Licensee No.: 2863-4097

Site of Incident: Adams, NY Incident Log No.: 02-007

Date of Incident: 1/23/02 Type of Incident: Equipment damage

Investigation Date: 1/24/02 Type of Investigation: On-site

Summary of Incident and Final Disposition: Troxler model 3411B gauge run over by bulldozer. 

Source rod was bent and sliding block was partially open. Source itself was not damaged. 

Gauge returned to manufacturer for disposal.

File No.: 10

Licensee: Washington Group International Licensee No.: 2978-4212

Site of Incident: Buchanan, NY Incident Log No.: 00-057

Date of Incident: 8/19/00 Type of Incident: Equipment failure

Investigation Date: 8/21/00 Type of Investigation: Telephone

Summary of Incident and Final Disposition: Amersham model 660B radiography exposure

device with a source containing 35 curies of iridium-192 failed to retract and posilock

mechanism failed to engage. Source finally retracted by cranking source back and forth several

times. Maximum dosimeter reading was five millirem. Licensee working in State under

reciprocity.

NEW YORK STATE DEPARTMENT OF HEALTH

NOTE: BLANKS ARE INFORMATION THAT HAS BEEN OMITTED IN COMPLIANCE WITH

STATE LAW

File No.: 1

Licensee: Licensee No.: 

Site of Incident: Incident Log No.: None

Date of Incident: 10/18/00 Type of Incident: Potential Misadministration

Investigation Date: 12/13/00 Type of Investigation: On-site

Summary of Incident and Final Disposition: A patient undergoing an iridium-192 brachytherapy

treatment climbed out of bed and fell, dislodging one of the treatment sources, and dislocating

others. The Radiation Safety Officer responded within one and a half hours, but there was no

response by the radiation oncologist until 6 hours after the event was discovered, at which time

it was determined that the "needles were bent and the distribution of sources was no longer

deemed appropriate,” according to DOH’s report. The licensee provided an estimate that the

patient had received only 33% of the prescribed treatment. The licensee provided a corrective

action plan to ensure a timely response by the appropriate medical staff in the future.

Comments: 

a) There was conflicting information as to the dislocation of the sources. The written DOH

documentation indicates that one of the sources became dislodged and was found on

the floor and that the “distribution of the [remaining] sources was no longer deemed

appropriate,” thus the treatment was terminated. Subsequent to the on-site IMPEP

review, DOH reported that the oncologist “carefully noted the position of the ends of the

needles with respect to the template and noted that the 11 remaining needles were in
New York Final Report Page E.6

Licensing Casework Reviews

the proper position, although one needle was observed loose and he removed it.” This

discrepancy has not been resolved.

b) There was only minimal documentation as to the exposure to hospital personnel due to

the dislodged source (i.e., the licensee's report stated, "five millirem per hour at one

meter" but did not identify one meter from what, nor whether this measurement was

taken before or after the dislodged source was recovered and shielded). 

c) There was no assessment made as to the dose to unintended tissue as a result of the

dislocation of the sources during the six hours between the time the event was

discovered and the arrival of the radiation oncologist. The failure of the licensee to

respond to the event in a timely manner may have resulted in a misadministration

depending on the unintended dose to tissue outside the treatment area.

File No.: 2

Licensee: Licensee No.: 

Site of Incident: Incident Log No.: None

Date of Incident: 3/2/01 Type of Incident: Misadministration

Investigation Date: 3/27/01 Type of Investigation: On-site

Summary of Incident and Final Disposition: The licensee reported two misadministrations of

phosphorus-32, resulting in underdoses to the patients of approximately 50% and 88% less

than the prescribed doses. In addition, and in conjunction, the licensee experienced

contamination of the positioning equipment, linens, a sink, and other items in the vicinity of the

mishap. According to the inspector's report, back pressure caused phosphorus-32 to come out

of the needle when the syringe was changed. The licensee's corrective actions included

utilizing a stopcock and using plastic-backed absorbent paper to cover the floor in the injection

area. 

Comments: 

a) There as no discussion as to result to the patients involved (i.e., whether the treatment

was completed at a later time or abandoned altogether). 

b) There as no discussion as to why the first injection failed. The licensee did not evaluate

the problem before attempting the second injection. 

c) There was no discussion as to whether any personnel were contaminated in this event.

d) The event was not identified in NMED. 

File No.: 3

Licensee: Cornell University Licensee No.: 0005-3A

Site of Incident: Ithaca, NY Incident Log No.: None

Date of Incident: Unknown Type of Incident: Contaminated waste

Investigation Date: 1/16/02 Type of Investigation: Telephone

Summary of Incident and Final Disposition: The licensee advised DOH that they found elevated

radiation levels in some drainage pipes sent to a scrap metal dealer. The licensee borrowed

DOH’s gamma spectroscopy equipment and identified the contamination as cesium-137. DOH

staff provided a DOT exemption to the licensee to return the material to the licensee' facility for

proper disposal. 

Comments: 

a) There was no documented assessment if the contamination was removable or fixed,

and whether there was contamination in the areas where the pipes had been removed. 
New York Final Report Page E.7

Licensing Casework Reviews

b) There was no determination as to whether or not this event was reportable. This event

was not identified in NMED. 

c) DOH staff indicated they would normally follow up on such an incident during the next

inspection, although a review of the licensing/inspection file revealed there was no

information in the file that would trigger the inspector to ask about the event. 

File No.: 4

Licensee: Clifton Springs Hospital and Clinic Licensee No.: 1873

Site of Incident: Clifton Springs, NY Incident Log No.: None

Date of Incident: 7/5/00 Type of Incident: Lost source

Investigation Date: 1/10/01 Type of Investigation: Next inspection

Summary of Incident and Final Disposition: Licensee lost an iodine-125 seed {approximately

0.3 millicuries). The licensee was preparing 57 seeds for a patient treatment when the

treatment was postponed. The licensee did not perform a survey after the cancellation of the

treatment to ensure they had retrieved all the seeds from the treatment needles, because they

did not have a survey instrument available. When the treatment was re-scheduled, the licensee

discovered that a seed was missing, and made a report to DOH. DOH investigate the incident

during a routine inspection six months later.

Comments:

a) Documentation of the investigation of this incident consisted of approximately two lines

in the routine inspection report. The report indicated the event had occurred, contained

a minimal description of the event, and noted that the licensee had revised procedures

for the proper removal of seeds from the needles. 

b) Subsequent to the on-site IMPEP review, DOH stated that they had reviewed the

licensee’s report and determined that a review during the next routine inspection was

more appropriate and efficient than a reactive inspection. The licensee’s report was not

available during the on-site IMPEP review in either the investigation file or the

licensing/inspection file.

File No.: 5

Licensee: Licensee No.: 

Site of Incident: Incident Log No.: None

Date of Incident: 8/21/01 Type of Incident: Misadministration

Investigation Date: None Type of Investigation: None

Summary of Incident and Final Disposition: The licensee reported a therapeutic

misadministration to DOH. The physician had prescribed 75% of the "normal dose" delivered for

the treatment of prostate cancer using implanted iodine-125 seeds, but at the time of treatment

the licensee administered 100% of the "normal dose," resulting in an overdose of 25% to the

patient.

Comments:

a) This event was not identified in NMED.

b) There was no indication in the file that the event was closed. During the on-site IMPEP

review, DOH staff stated they believed someone did visit the site, but there was no

evidence in the file and they were unable to confirm a site visit. Subsequent to the

IMPEP review, DOH stated that they found that they actually had reviewed the

licensee’s report and determined that no on-site response was necessary. The
New York Final Report Page E.8

Licensing Casework Reviews

licensee’s report was not in the investigation file, nor the licensing/inspection file during

the on-site IMPEP review. 

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION

File No.: 1

Licensee: Karta Industries DEC Permit No.: none

Site of Incident: Peekskill, NY Incident Log No.: none

Date of Incident: 5/16/01 Type of Incident: Contaminated trash

Investigation Date: 5/7/01 Type of Investigation: Telephone

Summary of Incident and Final Disposition: Bales of waste set off radiation alarms at an Ohio

landfill and were returned to Peekskill facility. Indian Point 2 nuclear power plant radiation

safety personnel helped determine that waste was kitty litter contaminated with iodine-131. 

Waste was allowed to decay and sent to landfill. DEC provided results of the investigation to

DOH for follow-up.

File No.: 2

Licensee: T.A. Predel Co. DEC Permit No.: none

Site of Incident: Schenectady, NY Incident Log No.: none

Date of Incident: 4/16/01 Type of Incident: Abandoned RAM

Investigation Date: 4/16/01 Type of Investigation: On-site

Summary of Incident and Final Disposition: Radiation alarm of refuse container was caused by

two military aircraft cockpit instruments (bank and turn indicators) containing thorium-232.

Instruments were returned to Army personnel at Watervliet Arsenal on 4/20/01 for disposal.

File No.: 3

Licensee: Samaritan Hospital DEC Permit No.: none

Site of Incident: Troy, NY Incident Log No.: none

Date of Incident: 4/11/00 Type of Incident: Lost RAM

Investigation Date: 4/27/00 Type of Investigation: None

Summary of Incident and Final Disposition: Lost three iodine-125 brachytherapy seeds (0.87

millicurie) to sanitary sewers. Originally reported to DOH and referred to DEC due to discharge

into sewers. DEC evaluated discharge and determined that no further enforcement action was

needed.

File No.: 4

Licensee: New York Medical College DEC Permit No.: none

Site of Incident: Valhalla, NY Incident Log No.: none

Date of Incident: 3/11-12/98 Type of Incident: Release of RAM

Investigation Date: 4/22/98 Type of Investigation: On-site

Summary of Incident and Final Disposition: During an inspection, a DOH inspector discovered

the discharge of large amounts of tritium were made into the sanitary sewer by a user for an

unauthorized commercial operation at licensee. On-site inspection determined that releases

did not exceed discharge concentration limits. Dose to member of public was well below

applicable limit. Licensee issued civil penalty by DEC.
APPENDIX F

SEALED SOURCE AND DEVICE (SS&D) CASEWORK REVIEWS

NEW YORK STATE DEPARTMENT OF LABOR

Registry No.: NY-1132-D-101-G SS&D Type: Ion generators, Chromatography

Manufacturer: Vacuum Instrument Corporation Model Nos.: 961-200 / 961-300

Date Issued: 2/8/01 SS&D Reviewer: CB

Comments:

a) The device is designed with forward-facing handles for insertion into an electronics

cabinet. With the device inserted into a electronics cabinet, the label on the exterior of

the device housing would not be readily visible.

b) Expected life of device was not addressed.

c) Quality assurance for device assembly requested in the deficiency letter by reviewer, but

response did not contain device assembly methods, tolerances or documentation

related to quality assurance.
ATTACHMENT 1

INCOMING RESPONSE TO DRAFT REPORT

Attachment 1-A October 28, 2002 Electronic mail from Gene Miskin 

New York City Department of Health 

Response to Draft IMPEP Report - ML02302436

Attachment 1-B October 24, 2002 Electronic mail from Clayton J. Bradt 

New York State Department of Labor 

Response to Draft IMPEP Report - ML023020290

Attachment 1-C October 21, 2002 Letter from Adela Salame-Alfie 

New York State Department of Health 

Response to Draft IMPEP Report - ML023020674

Attachment 1-D October 4, 2002 Letter from Stephen Hammond 

New York State Department of Environmental Conservation 

Response to Draft IMPEP Report - ML022910079
ATTACHMENT 2

New York State Department of Health Response to Draft IMPEP Report; 

Resolution of Comments Document - ML023026072