DATED: NOVEMBER 30, 1998 SIGNED BY: HUGH L. THOMPSON, JR.

Neal L. Cohen, M.D.

Commissioner

New York City Department of Health

125 Worth Street, Room 329

New York, NY 10013

Mr. James J. McGowan

Commissioner

New York State Department of Labor

State Campus, Building 12

Room 500

Albany, NY 12240

Barbara A. DeBuono, M.D., M.P.H.

Commissioner

New York State Department of Health

Empire State Plaza

Albany, NY 12233

Mr. John P. Cahill

Commissioner

Department of Environmental Conservation

50 Wolf Road

Albany, NY 12233

Dear Commissioners:

On September 1, 1998, the Management Review Board (MRB) met to consider the proposed

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

Department of Labor program that implements a portion of the Agreement with the State of New

York. The other three programs, the New York City Department of Health (NYCH), New York

State Department of Health (NYSH), and New York State Department of Environmental

Conservation (NYDEC), as well as the New York State Energy Research and Development

Authority (NYSERDA), listened in by telephone during this meeting. The MRB made a finding

that the New York program is adequate to protect public health and safety and compatible with

NRC’s program. The revised final report is enclosed. 

The MRB directed the review team to assess the apparent discrepancy between NYCH and

NYDEC’s ratings for the common performance indicator, Technical Staffing and Training. In

response, the team has revised NYCH’s rating for this indicator to “satisfactory.” This matter was

presented to the MRB for final resolution at the September 1, 1998 MRB meeting and the MRB

agreed with the change. The MRB also directed the team to clarify the recommendations on the

reporting of incidents and events to the NRC. The revised recommendation was presented at

the September 1, 1998 MRB meeting and the MRB agreed with the revised recommendation. 

The MRB requested that Section 4.2, Sealed Source and Device Evaluation Program, be revised

prior to the MRB making a decision on the rating for this indicator. The review team revised the

Section and submitted it to the MRB which agreed with the team’s finding of Satisfactory with

Recommendations for Improvement. The revised Section was sent to New York for comment. 

Ms. R. Aldrich’s comments on the revised Section and the review team’s response to the

comments are attached to the revised final report.
Commissioners - 2 -

Section 5, page 44, of the enclosed revised final report presents the IMPEP team’s suggestions,

recommendations, and good practices. We request your evaluation and response to the

recommendations within 30 days from the receipt of the revised final report. NYSH’s letter dated

August 17, 1998 fully responded to the recommendation for NYSH in the report and no further

response is needed from NYSH.

The review team recommended that there be a follow-up review of the New York City

Department of Health program in approximately one year with a full State review in four years. 

The NRC staff will be contacting New York City staff to make arrangements for the follow-up

review. 

I appreciate the courtesy and cooperation extended to the IMPEP teams during the reviews and

your support of the respective New York programs. I look forward to our agencies continuing to

work cooperatively in the future. 

Sincerely, /RA/

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosures:

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYCH

Rita Aldrich, Principal Radiophysicist

Radiological Health Unit, NYDL

Karim Rimawi, Ph.D., Director

Bureau of Environmental Radiation Protection, NYSH

Paul J. Merges, Ph.D., Chief

Bureau of Pesticides and Radiation, NYDEC

John P. Spath, Director

Radioactive Waste Policy and Nuclear Coordination, NYSERDA
Commissioners - 3 -

The NRC staff will be contacting New York City staff to make arrangements for the follow-up

review. 

I appreciate the courtesy and cooperation extended to the IMPEP teams during the reviews and

your support of the respective New York programs. I look forward to our agencies continuing to

work cooperatively in the future. 

Sincerely,

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosures:

As stated

cc: Gene Miskin, Director

Bureau of Radiological Health, NYCH

Rita Aldrich, Principal Radiophysicist

Radiological Health Unit, NYDL

Karim Rimawi, Ph.D., Director

Bureau of Environmental Radiation Protection, NYSH

Paul J. Merges, Ph.D., Chief

Bureau of Pesticides and Radiation, NYDEC

John P. Spath, Director

Radioactive Waste Policy and Nuclear Coordination, NYSERDA

bcc: Chairman Jackson

Commissioner Dicus

Commissioner Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution: See next page

DOCUMENT NAME: G:\IMPEP\98FINLTR.NY2 / G:\IMPEP\NY2IMP.FIN

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 OSP E OSP:DD C OSP:D DEDR

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DATE 11/ /98 01/ /99 01/ /99 08/ /98

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Commissioners - 4 -

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OSP FILE CODE: SP-AG-20; SP-20-1; SP-AG-20-2; SP-AG-20-3; SP-AG-20-4
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NEW YORK AGREEMENT STATE PROGRAM

January 26 - April 24, 1998

REVISED FINAL REPORT

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

1.0 INTRODUCTION

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

New York program is divided into four independent programs which were reviewed separately

with the results of those reviews integrated into this report. The reviews were conducted during

the period January 26 - April 24, 1998, by four separate review teams comprised of technical

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

Alabama, Florida, North Carolina, and Tennessee. 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 25, 1997, revised

NRC Management Directive 5.6, "Integrated Materials Performance Evaluation Program

(IMPEP)." Preliminary results of the review, which covered the period March 31, 1995 to April

24, 1998, were discussed with New York management on May 12, 1998. 

A draft of this report was issued to all four programs in the State of New York for factual

comment on June 24, 1998. The programs responded in letters dated July 15, 1998 by NYCH;

July 27, 1998 by NYDL; July 20, 1998 by NYSH; and July 24, 1998 by NYDEC. The programs’

comments were considered by the team and accommodated in the report. On August 18, 1998,

the Management Review Board (MRB) met to consider the proposed final Integrated Materials

Performance Evaluation Program (IMPEP) report on three of the four programs that implement

the Agreement with the State of New York. The three program represented at the MRB meeting

were the New York City Department of Health (NYCH), New York State Department of Health

(NYSH, and New York State Department of Environmental Conservation (NYDEC). The MRB

made a preliminary finding that the New York program is adequate to protect public health and

safety and compatible with NRC’s program. 

On September 1, 1998, the Management Review Board (MRB) met to consider the proposed

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

Department of Labor program that implements a portion of the Agreement with the State of New

York. The other three programs, the New York City Department of Health (NYCH), New York

State Department of Health (NYSH), and New York State Department of Environmental

Conservation (NYDEC), as well as the New York State Energy Research and Development

Authority (NYSERDA), listened in by telephone during this meeting. The MRB made a finding

that the New York program is adequate to protect public health and safety and compatible with

NRC’s program.

 

The MRB directed the review team to revise NYCH’s rating for the common performance

indicator, Status of the Materials Inspection Program, from “unsatisfactory” to “satisfactory with

recommendations for improvement” based on their actions taken to correct their licensee

database. The review team was directed to assess the apparent discrepancy between NYCH

and NYDEC’s ratings for the common performance indicator, Technical Staffing and Training. In

response, the team has revised NYCH’s rating for this indicator to “satisfactory.” This matter was

presented to the MRB for final resolution at the September 1, 1998 MRB meeting and the MRB

agreed with the change. The MRB also directed the team to clarify the recommendations on the

reporting of incidents and events to the NRC. The revised recommendation was presented at

the September 1, 1998 MRB meeting and the MRB agreed with the revised recommendation. 

The MRB requested that Section 4.2, Sealed Source and Device Evaluation Program, be revised

prior to the MRB making a decision on the rating for this indicator. The review team revised the
New York Revised Final Report Page 2

Section and submitted it to the MRB which agreed with the team’s finding of Satisfactory with

Recommendations for Improvement. The revised Section was sent to New York for comment. 

Ms. R. Aldrich’s comments on the revised Section and the review team’s response to the

comments are attached to the revised final report.

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

of Health, Bureau of Radiological Health (NYCH), 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 (NYDL), which has jurisdiction over commercial and industrial

uses of radioactive materials, including the possession of radioactive material to be disposed of

at a commercial disposal site; (3) the New York State Department of Health (NYSH), which has

jurisdiction over medical, academic, and research uses of radioactive materials except in New

York City; and (4) the New York State Department of Environmental Conservation, Bureau of

Pesticides and Radiation (NYDEC), 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 1500 specific

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

The review focused on the materials program as it is carried out under the Section 274b (of the

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

York.

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

performance indicators was sent to: (1) NYCH, November 21, 1997; (2) NYDL, December 15,

1997; (3) NYSH, February 6, 1998; and (4) NYDEC, February 12, 1998. Each New York program

provided a response to the questionnaire on: (1) NYCH, January 14, 1998; (2) NYDL,

January 27, 1998; (3) NYSH, March 13, 1998; and (4) NYDEC, March 27, 1998. During the

review, discussions with each program’s staff resulted in the responses being further developed. 

A copy of these final responses are included in Appendix G to the proposed final report issued

August 7, 1998.

The teams’ general approach for conduct of these reviews consisted of: (1) examination of New

York programs’ responses to the questionnaire; (2) review of applicable New York State and City

statutes and regulations; (3) analysis of quantitative information from the radiation control

programs’ licensing and inspection data bases; (4) technical review of selected licensing and

inspection actions; (5) field accompaniments of at least one inspector from each program;

and (6) interviews with staff and management to answer questions or clarify issues. The teams

evaluated the information that they gathered against the IMPEP performance criteria for each

common and non-common performance indicator as applicable to each program and made a

preliminary assessment of each radiation control program’s performance for each indicator.

Section 2 below discusses each programs’s actions in response to recommendations made

following the previous 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 and

recommendations. Recommendations made by the team are comments that relate directly to

each program’s performance. A response is requested from each program to all

recommendations in the revised final report. Suggestions are comments that the team believes
New York Revised Final Report Page 3

could enhance each of the individual programs. Each program is requested to consider

suggestions, but no response is requested.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous routine review, which concluded on March 30, 1995, ten recommendations

were made and the results were transmitted to the respective Secretaries/Commissioners of the

three New York State agencies and the New York City agency on March 18, 1996. The team’s

review of the current status of these recommendations is as follows:

NEW YORK CITY DEPARTMENT OF HEALTH (NYCH)

(1) Status and Compatibility of Regulations. NYCH needed to revise its QM rule definitions

by December 6, 1996 in order to maintain compatibility with the NRC. 

Current Status: The NRC reinitiated an evaluation of whether the QM rule should be

used as a basis for the determination of an Agreement State program’s compatibility. It

was decided that pending the completion of the re-evaluation, the absence of a

compatible QM rule would not be used as a basis for withholding of a finding for

compatibility. The compatibility category of the QM rule under the new Commission policy

on Adequacy and Compatibility, which became effective on September 6, 1997, has been

set as “D” with paragraphs (a), (b), and (c) of the rule identified as having provisions

important to Health and Safety. Based on the above, and because Part 35 is being

amended in its entirety, the team determined that this recommendation should be closed.

(2) Inspection Procedures. It was recommended that NYCH develop a formal written policy

on conducting unannounced inspections.

Current Status: As part of the review of the indicator “Technical Quality of Inspections”

(see Section 3.2.1), the team examined NYCH’s inspection procedures manual. In

Section 5.C.3.a. of the manual, there is a discussion regarding NYCH’s policy regarding

announced versus unannounced inspections. This section of the manual clearly states it

is the general policy of NYCH to perform routine inspections on an unannounced basis. 

The review team also determined that NYCH inspectors were following the City’s policy

regarding the conduct of routine inspections on an unannounced basis. Based on these

findings, the team determined that this recommendation should be closed.
New York Revised Final Report Page 4

NEW YORK STATE DEPARTMENT OF LABOR (NYDL)

(1) Status and Compatibility of Regulations. It was recommended during the last review that

NYDL reconsider its decision not to adopt the amendments to 10 CFR Part 36, “Licenses

and Radiation Safety Requirements for Irradiators” that became effective on July 1, 1993.

Current Status: During this review, the team determined that NYDL has prepared a

package of regulations, including those for Part 36, which is currently in legal review (see

Section 4.1.2.2). As part of the team’s review of the indicators “Technical Quality of

Licensing” and “Technical Quality of Inspections,” the team noted that NYDL was

implementing the requirements of Part 36 through the use of checklists during the

licensing and inspection of the only commercial irradiator facility under NYDL’s

jurisdiction. Use of the checklist ensures that the licensee has committed to all the

requirements in 10 CFR Part 36 even though not required to by regulation. The

licensee’s commitments are incorporated into the licenses. Based on the team’s finding 

that NYDL is implementing Part 36 through licensing and inspection until the adoption of

the rule, the team determined that this recommendation should be closed.

NEW YORK STATE DEPARTMENT OF HEALTH (NYSH)

(1) Status and Compatibility of Regulations.

a. It was recommended that NYSH adopt the Decommissioning Rule as soon as

possible to maintain compatibility with the NRC.

Current Status: The NYSH has implemented the rule through license conditions. The

team reviewed the list of licensees that are subject to the financial assurance

requirements and reviewed the application of these license conditions. The team found

that the licensees requiring financial assurance either had license conditions in place or

had been issued letters requesting additional information prior to issuance of license

conditions. The NYSH also implements other decommissioning provisions through

regulations and other decommissioning license conditions (see Section 4.1.2.2). The

team considers this approach to implementing the financial assurance and

decommissioning requirements to be acceptable, and determined that this

recommendation should be closed. 

b. The NYSH needed to revise its QM rule definitions by December 6, 1996 in order

to maintain compatibility with the NRC. 

Current Status: The NRC reinitiated an evaluation of whether the QM rule should be

used as a basis for the determination of an Agreement State program’s compatibility. It

was decided that, pending the completion of the re-evaluation, the absence of a

compatible QM rule would not be used as a basis for withholding of a finding for

compatibility. The compatibility category of the QM rule under the new Commission policy

on Adequacy and Compatibility, which became effective on September 6, 1997, has been

set as “D” with paragraphs (a), (b), and (c) of the rule identified as having provisions

important to Health and Safety. Based on the above, and because Part 35 is being

amended in its entirety, the team determined that this recommendation should be closed.
New York Revised Final Report Page 5

c. The NYSH should perform a review of its licensees based on the requirements of

the emergency planning (EP) rule, document the review, and if any licensees

meet the requirements of the rule, incorporate applicable section of the rule into

licenses until the rule can be promulgated.

Current Status: The team reviewed NYSH’s evaluation of its licensees against the

requirements of the EP rule and concurred with NYSH’s conclusion that the possession

limits of all licensees were below that requiring an EP plan. The team determined that

this recommendation should be closed.

(2) Responses to Incidents and Allegations. It was recommended that NYSH perform timely

and on-site investigations to independently assess allegations based on health and safety

considerations; develop criteria to determine which allegations can be referred to

licensees; assess licensee’s evaluation of allegations; and maintain complete files.

Current Status: During the review of the common indicator “Response to Incidents and

Allegations” (see Section 3.5.3), the team evaluated NYSH’s response to these

recommendations. Based on the findings detailed in Section 3.5.3 of this report, the

team determined that this recommendation should be closed.

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION (NYDEC)

(1) Technical Quality of Licensing Actions. It was recommended that NYDEC expeditiously

complete the inspection of NYCH licensees to determine if any where subject to NYDEC

permitting requirements.

Current Status: The team evaluated NYDEC’s response to this recommendation during

its review of the common indicators “Technical Quality of Licensing” and “Technical

Quality of Inspections.” The team concluded that NYDEC staff took prompt action to

identify those NYCH licensees requiring NYDEC permits. Periodic memoranda to

NYDEC management documenting the progress of this evaluation were prepared by staff. 

Based on the team’s findings during this review, the team determined that this

recommendation should be closed.

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 team focused on four factors in reviewing this indicator: inspection frequency, overdue

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

licensees. This evaluation is based on the individual programs’ questionnaire responses relative

to this indicator, data gathered independently from each program's licensing and inspection data
New York Revised Final Report Page 6

tracking system, the examination of completed licensing and inspection casework, and interviews

with managers and staff.

3.1.1 New York City Department of Health (NYCH) - Status of Materials Inspection Program

NYCH’s inspection priority system closely matches NRC’s system. The team’s assessment of

the current inspection priorities verified that inspection frequencies for various types or groups of

licensees are equivalent to or more frequent than those listed in NRC Inspection Manual Chapter

2800 (IMC 2800) frequency schedule. In reviewing NYCH’s priority schedule, the team noted

that NYCH continues to have priority categories which are inspected more frequently than those

of the NRC. The NYCH has only five categories of licensees, with a total of three priorities. The

NYCH priorities are either Priority 1 for once every 12 months, Priority 2 for once every 24

months, or Priority 3 for once every 36 months.

In their response to the questionnaire, NYCH indicated that as of January 1998, six licenses

identified as core inspections in IMC 2800 were overdue by more than 25 percent of NRC’s

frequency. The NYCH’s current inspection schedule identified 21 Priority 1 licenses; however,

the team discovered that the software-based system did not identify approximately 19 additional

Priority 1 licenses for inspection purposes. Tracking of those, five were overdue at the time of

the review and were not scheduled for inspection. Overall, NYCH’s inspection scheduling

system tracked only 243 of the 440 active licenses. The team estimates that NYCH would need

to perform approximately 220 inspections each year in order to keep pace with its due

inspections (the estimate assumes that all Priority 1 licenses, one-half of all Priority 2 licenses,

and one-third of all Priority 3 licenses were inspected each year). Each year of the review period,

NYCH budgeted approximately 266 inspections for completion. In fiscal years (July to June)

1995, 1996 and 1997, NYCH completed 127, 263, and 154 inspections, respectively. Due to

difficulties in obtaining information from NYCH’s inspection tracking system, the true status of the

materials inspection program could not be accurately assessed.

Since there was not an adequate database to evaluate the status of inspections, the team did a

sampling by examining the inspection histories of 25 out of the 40 total NYCH Priority 1 licenses. 

Since the last review, 33 inspections of those licenses have been completed. Of those

inspections (33 percent), 19 inspections (58 percent) were overdue based on NYCH’s priority at

the time that the NYCH conducted them; however, only 11 inspections were overdue (33

percent) based on IMC 2800 priorities (8 of the 19 were teletherapy). The review team

recommends that the NYCH correct the software anomalies that limit NYCH’s ability to effectively

track licenses for inspection, set and adhere to yearly inspection goals, and communicate NYCH

management’s expectations with regard to inspection goals, such that NYCH is able to eliminate

all overdue inspections. 

With respect to initial inspections of new licenses, the team reviewed the inspection tracking

system and found that initial inspections were usually entered into the system together with

existing licenses. The NYCH’s inspection supervisor assigns all inspections, and is able to

identify new licenses by the license number. NYCH currently has a six month inspection

frequency for all initial inspections, which is consistent with NRC’s initial inspection requirement

in IMC 2800.

From the review of the inspection database and examination of license files, NYCH was not

consistently implementing its six month initial inspection policy. The team examined 22 new

licenses issued since February 1995. Of those new licenses, NYCH conducted initial inspections
New York Revised Final Report Page 7

within six months of issuance for nine licenses (41%). The inspections that did not meet the six

month inspection goal ranged from 8 to 22 months after the licenses were issued. The review

team recommends that all initial inspections of licensees be performed within six months of

license issuance or within six months of the licensee’s receipt of material and commencement of

operations, consistent with IMC 2800 and NYCH policy.

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

review. Of the 15 files examined, in 11 cases the inspection correspondence was sent to the

licensee within 30 days of the inspection date. Correspondence from three of the remaining

inspections was sent between 32 and 39 days. In the fourth case, Brooklyn Hospital Center,

License No. 91-2924-01, NYCH completed its inspection on June 21, 1996, but did not transmit

the inspection findings until November 1, 1996 (134 days).

Based on the sampling done by the team, it appears that NYCH is not conducting its inspection

program for core licensees in accordance with IMC 2800. The lack of an adequate tracking

system significantly contributed to this finding which was presented at the exit meeting with

NYCH on January 30, 1998. In response to the teams’s findings presented at the exit meeting

on January 30, 1998, Mr. Kenneth R. Daniel, Jr., Deputy Director, Bureau of Radiological Health,

Department of Health, submitted a letter dated February 17, 1998 (Attachment 1), providing

additional information regarding this indicator. The letter indicated that the software anomaly had

been corrected and that NYCH was able to effectively track all of its licenses for inspection. The

team’s review of the inspection due list for the following 12 months ending in February 1999

appeared to indicate that all licenses were now captured in the scheduling system. However, the

team could not reconcile the inspection dates in the updated list with the last known inspection

dates identified during the review. Through further discussions with NYCH, some of these

discrepancies have been cleared up; however, the database needs additional quality control that

will occur over time with the use of the database. The NYCH’s February 17, 1998, letter did not

address the team’s findings with regard to the conduct of initial inspections. The NYCH will need

to continue to address the tracking, the timely scheduling and completion of inspections for all

current licenses, and initial inspections for new licenses.

Based on the IMPEP evaluation criteria, the review team initially recommended that NYCH’s

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

unsatisfactory. Based on the actions taken by NYCH since the review to correct their database

and schedule inspections to meet the criteria, the MRB directed that NYCH’s performance with

respect to this indicator be changed to satisfactory with recommendations for improvement.

3.1.2 New York State Department of Labor (NYDL) - Status Materials of Inspection Program

The team’s review verified that NYDL’s inspection priorities are at least as frequent as similar

license types or groups listed in NRC IMC 2800. Of particular note is the greater number of

inspections completed by NYDL choosing to designate its 110 Moisture/Density Gauge licenses

as inspection Priority 2, while the NRC frequency for a similar licensee is Priority 5. Designating

such a large number of licensees under such a high priority requires NYDL to perform more

frequent inspections of such licensees, while allowing some flexibility in inspection frequency in

comparison to IMC 2800.

Similar to IMC 2800, NYDL management has the ability to extend the interval between

inspections for licensees on the basis of good licensee performance. In 1997, NYDL extended

37 license inspections by approximately one year due to good compliance histories. 
New York Revised Final Report Page 8

As noted in their response to the questionnaire, no routine inspections completed by NYDL

during the review period were overdue by more than 25% of the scheduled frequency set out in

IMC 2800. 

In June 1994, the NYDL reciprocity limit was changed to thirty days in a calendar year. As a

result, companies that perform work in New York with any frequency are required to apply for and

receive a license from NYDL. This resulted in the issuance of licenses to 47 out-of-state

companies. These licensees are scheduled for inspections at the same priority interval as instate licensees.

Fifty-four companies requested reciprocity during 1997 and 10 were inspected while performing

licensed activities in the State. The NYDL does not keep records of the types or the priorities of

reciprocity licensees. Thus, NYDL does not schedule reciprocity inspections consistent with a

priority schedule. It is the decision of NYDL management to focus resources on NYDL licensee

inspections, and thus complete reciprocity inspections only as resources allow. 

The team also examined NYDL’s performance in completing initial inspections of new licensees,

and noted that in general, initial inspections are not always completed within six months of the

commencement of licensed activities. The team sampled 10 newly issued licenses during the

review period, and found that three received an initial inspection within the six month guideline. 

Of the remaining seven, five of them received an initial inspection within seven months of the

commencement of licensed activities. The two remaining initial inspections were performed 56

days and 314 days beyond the six month guideline. The review team recommends that NYDL

perform initial inspections of licensees within six months of the licensees’ receipt of licensed

material, or commencement of licensed activities. 

Contrary to IMC 2800, NYDL does not complete an initial inspection of a licensee within one year

of the issuance of the license if the licensee does not receive licensed material. If no material is

received by a licensee within six months of license issuance, NYDL begins correspondence with

the licensee to ensure knowledge of the receipt of licensed material. At the same time, NYDL

attempts to persuade the licensee to cancel their license if the licensee believes no radioactive

material will be received. The team recognizes this policy as an acceptable alternative to the

guidelines established in IMC 2800.

The timely dispatch of inspection findings was also evaluated during the inspection file review. 

Of 20 inspection findings examined, the correspondence for 17 inspections was sent to the

licensee within 30 days of the inspection date. For the other two inspections, the

correspondence was sent to the licensee from 1 and 35 days beyond the 30 day guideline. The

team does not believe that the issuance of inspection findings is a problem for this program.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL’s performance

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

3.1.3 New York State Department of Health (NYSH) - Status of Materials Inspection Program

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

various types or groups of licenses are at least as frequent as similar license types or groups

listed in the NRC IMC 2800 frequency schedule. Fourteen program codes are scheduled for

more frequent inspections by NYSH than similar NRC licensees.
New York Revised Final Report Page 9

With respect to initial inspections of new licenses, the team evaluated the inspection tracking

data system and verified that initial inspections were entered into the computerized tracking

system together with existing licenses. A review of the inspection tracking system showed that

initial inspections are differentiated from routine inspections by including the issuance date of the

license in bold in the column listing the last inspection. Although new licenses are clearly marked

in the tracking system and scheduled within six months of issuance, a significant number (12 of

27) of the initial inspections were not completed within six months as suggested by IMC 2800.

A review of the database identified 67 new licenses issued since the 1995 review of NYSH. The

team selected 27 of these licenses in which the initial inspection was due. Of these 27, 11

licenses were inspected within the six month window, four were inspected one month late, seven

were inspected two to six months late, and five were inspected over six months late. The team

determined that NYSH policy is that initial inspections are to be scheduled for inspection within

six months of issuance. The NYSH management assigns inspections to inspectors twice a year

and monitors the progress of inspections completed on a monthly basis. However, inspectors

are not required by management to complete new inspections within six months. The review

team recommends that NYSH modify its 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 IMC 2800.

In their response to the questionnaire, NYSH indicated that three inspections were overdue by

more than 25% of the scheduled frequency. At the time of the on-site review, these inspections

had been performed. The timeliness of inspection of core licensees at regular intervals in

accordance with IMC 2800 was evaluated during the inspection file review. The team selected

31 inspections for review and determined that three of the inspections were performed at

intervals that exceeded IMC 2800 inspection frequencies by more than 25%. These three

inspections were overdue by one, two and three months when next inspected.

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

review. Of 16 inspection findings examined, the correspondence for all of these inspections was

sent to the licensee within 30 days of the inspection date. This total included five escalated

enforcement actions that required more documentation to be prepared and reviewed by NYSH

staff and management.

Based on the IMPEP evaluation criteria, the review team recommends that NYSH’s performance

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

with recommendations for improvement.

3.1.4 New York State Department of Environmental Conservation (NYDEC) - Status of

Materials Inspection Program

The team’s review of NYDEC’s inspection priorities showed that inspection frequencies are

based primarily on the magnitude of the permitted discharge of radioactive material to the

environment (i.e., the maximum average annual concentration of the effluent that may be

discharged to the environment) instead of IMC 2800. The inspection priorities range from one to

four years. Based on the limited scope of NYDEC’s regulatory oversight for facilities (i.e.,

discharges to environment only) and the priorities of the inspections, the team concluded that

these frequencies were adequate to protect public health and safety and to assure permittee

(licensee) compliance.
New York Revised Final Report Page 10

In their response to the questionnaire, NYDEC indicated that it had no overdue inspections. The

team confirmed this by reviewing the current permittee list which indicates the last inspection of

the permittee and by file review. Since the NYDEC only regulates environmental discharges, low

level radioactive waste and transportation, reciprocity does not apply to this portion of the New

York program.

It was noticed by the team that the procedures for inspection priorities utilized by NYDEC states

that “new permittees will continue to receive pre-permit inspection whenever possible, and will

always receive an initial inspection within the first year of operation.” The IMC 2800 states that

the initial inspection be done within six months. The NYDEC has been inspecting almost all

initial permittees within six months and performs a pre-permit inspection of the facilities. In order

to make NYDEC’s initial inspection policy consistent with NRC policy and practice, the Program

Director stated that the wording of the inspection priority memo would be revised to require an

initial inspection within six months instead of within one year. In response to the draft IMPEP

report, NYDEC indicated that the inspection priority memo has been revised to require initial

inspections within six months.

For initial inspection of new licensees, the team reviewed the inspection schedules for the review

period. For the seven new permits that were issued, inspections were conducted at six facilities

within six months, and the other was done at eight months. In addition to the initial inspection,

the permittees also receive a pre-permitting inspection.

During inspection file reviews, the team evaluated NYDEC’s timeliness in issuing inspection

findings. The team found that inspection findings were generally sent well within the 30 day time

frame with two of ten inspections exceeding the 30 day guideline (one at 49 days and one at 335

days).

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

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

satisfactory. 

3.2 Technical Quality of Inspections

3.2.1 New York City Department of Health (NYCH) - Technical Quality of Inspections

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

notes and interviewed inspectors for 15 materials inspections conducted during the review

period. The 15 inspections selected for review included at least one inspection for each of the

NYCH’s inspectors and two team inspections of major broad scope licenses. The inspections

included four medical broad scope licenses, two academic broad scope licenses, two teletherapy

licenses, five limited medical use licenses, and two private practice physicians. Appendix C-1

lists the inspection files reviewed in depth with case-specific comments.

Of the 15 inspections reviewed, seven resulted in no violations being identified. For the

remaining eight, violations were identified in transmittal letters to licensees. Of those violations,

13 were not described in the field notes documenting the results of the inspections. In a majority

of the cases reviewed, the inspections identified technically valid violations; however, neither the

techniques employed nor the manner in which inspections were documented provided many

insights into the performance of NYCH’s licensees, other than the status of the licensees’

compliance with NYCH regulations. The review team recommends that NYCH inspectors follow
New York Revised Final Report Page 11

the guidance in the NYCH inspection procedure manual which includes the information

necessary for properly documenting violations. In NYCH’s letter dated February 17, 1998, the

NYCH responded to this recommendation by stating that a copy of the student manual for the

Inspecting for Performance course has been obtained and they plan to conduct an in-house

training course in the near future for their materials inspectors.

For 14 of the violations issued in the inspections reviewed, the licensees provided information in

their responses that appeared to dispute the violation. When a licensee disputes a Notice of

Violation (NOV), the licensee must take the dispute to the Tribunal. If the licensee does not

appear, the NOV stands and the fine must be paid. In none of these cases, did NYCH’s files

indicate whether the violations were upheld or retracted. The team could not determine the

status of these violations and their final disposition. The review team suggests that NYCH

establish a policy that the results of all Tribunal’s be placed in the appropriate inspection files.

The NYCH has a policy of performing annual supervisory accompaniments of inspectors. In

response to the questionnaire, NYCH reported that each inspector was accompanied by the

supervisor at least once a year during the review period. Interviews of NYCH inspectors

determined that the supervisor accompanies the inspectors more frequently, but in those other

occasions, the supervisor acted as the lead inspector. Following those inspections, the

supervisor provided feedback to the inspector.

Four inspection accompaniments identified in Appendix C were performed by two team

members. During the week of October 28 - 31, 1997, a team member performed

accompaniments of three inspectors on an inspection of an academic broad scope licensee. A

second team member performed accompaniments of four inspectors during an inspection of a

medical broad scope licensee that included the source loading of a gamma knife unit, during the

week of December 1 - 5, 1997. Two additional inspection accompaniments were performed on

January 20 and 21, 1998 with each of newest inspectors in the program. These

accompaniments were performed at licensees that these inspectors were qualified to

independently inspect.

The team determined that the performances of the inspectors during team inspections were

compliance, rather than performance, oriented. For example, during the December 1997

inspection exit meeting attended by the team member, the reviewer was not able to determine

whether the inspection findings discussed were violations, concerns, or recommendations. The

NYCH’s exit did not reference specific regulatory requirements that were violated, or distinguish

poor practices from violations. In a few cases, the inspectors appeared to impose their personal

preference in the conduct of some operations rather than limit themselves to the enforcement of

NYCH’s regulations. The review team recommends that NYCH inspectors follow the guidance in

NYCH inspection procedure manual which emphasizes the use of performance-based inspection

techniques rather than compliance-based techniques and 

provide training to its inspectors through NRC’s Inspecting for Performance Materials Course or

similar course.

During the inspection accompaniments performed in January 1998, the two inspectors

demonstrated appropriate inspection skills and knowledge of the regulations. The inspectors

were thorough in their review of the licensee’s radiation safety program. Inspection techniques

were observed to be generally performance oriented. These inspections were adequate to

assess the licensee’s radiological health and safety performance.
New York Revised Final Report Page 12

The team noted that the NYCH has an adequate number of portable radiation detection

instruments for use during routine inspections and response to incidents and emergencies. The

NYCH uses an outside vendor for instrument service and calibration. The portable instruments

used during the inspector accompaniments were operational and calibrated.

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

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

with recommendations for improvement.

3.2.2 New York State Department of Labor (NYDL) - Technical Quality of Inspections

The team reviewed the inspection reports, enforcement documentation, and the data base

information for 21 materials inspections conducted during the review period. The casework

included NYDL's three materials inspectors and covered a sampling of different license types as

follows: two broad scope commercial; one research and development; three portable gauges;

two fixed gauges; three industrial radiography; three nuclear pharmacies; two service; one

manufacturer; one waste broker; one gas chromatograph; one storage; and one commercial

irradiator. Appendix C-2 provides a list of the inspection cases reviewed in-depth with casespecific comments. 

The inspection procedures and techniques utilized by NYDL were reviewed and determined to be

generally consistent with the inspection guidance provided in IMC 2800. Specific guidance for

certain classes of licensees or facilities are also included in the procedures manual maintained in

the Manhattan office where all inspectors are based. The team reviewed inspection reports and

found them to be comparable with the types of information and data collected under NRC

Inspection Procedure 87100. Inspections are generally performed on an announced basis.

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

The NYDL uses supplementary field notes for different types of inspections covering the areas of 

manufacturing (quality assurance), industrial radiography, fixed gauge, and gas chromatograph

licenses. 

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 materials, equipment, use of materials, transfer, and disposal. The reports were also checked

to determine if the reports adequately documented operations observed, interview of workers,

independent measurements, status of previous noncompliance items, substantiation of all items

of noncompliance, and the substance of discussions during exit interviews with management. 

The reviewer completes an inspection review form which becomes part of the inspection file. 

Overall, the team found that peer review of the inspection documentation and correspondence

resulted in their consistent excellent quality. The review team noted a good practice in that

NYDL’s inspection field notes and inspection correspondence are peer reviewed by one of the

senior inspectors to ensure consistency, thoroughness, and quality of reports. 

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

licensee responds to a NOV, the inspector evaluates the licensee's submittal and prepares a

response. Once the inspector determines that the licensee has satisfactorily responded to the

NOV and has acknowledged their response, the inspection field notes and correspondence is

given to another senior inspector for review. The inspectors told the team that they discuss any

atypical issues regarding the inspection findings with the program manager prior to issuing the
New York Revised Final Report Page 13

inspection findings to the licensee. When significant commitments are made in response to

NOVs, NYDL 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. The program manager stated that escalated enforcement action

beyond the issuance of NOVs was limited to the issuance of orders. The NYDL held four

enforcement conferences which resulted in the issuance of orders. The team discussed with

NYDL management at the exit meeting that the incorporation of a wider range of enforcement

tools into the enforcement policy such as severity levels and civil penalties would provide NYDL

with alternative methods to emphasize the importance of prompt, comprehensive identification

and correction of conditions important to safety.

One inspector accompaniment identified in Appendix C-2 was performed by a team member on

December 11 and 12, 1997 at an industrial radiography storage location and a temporary job site

of the licensee. The remaining two inspectors were accompanied during the previous review. 

During the accompaniment, the inspector demonstrated appropriate inspection skills and

knowledge of the regulations. The inspector was well prepared and thorough in the review of the

licensee’s radiation safety program and performance of licensed activities in the public domain. 

Inspection techniques were observed to be performance oriented, and the technical performance

of the inspector was at a high level. The inspection was adequate to assess the licensee’s

radiological health and safety performance.

The NYDL program manager performs annual supervisory accompaniments of all inspectors and

documents each evaluation on an inspection accompaniment form. 

The team noted that NYDL has an ample number of portable radiation detection instruments for

use during routine inspections and response to incidents and emergencies. Instrument

calibration is performed by NYDL inspectors at the Manhattan office using NIST traceable alpha,

beta, and gamma sources. The NYDL procedures also include laboratory and instrument

calibration procedures. The NYDL uses an outside vendor for instrument service. The portable

instruments used during the inspector accompaniment was observed to be operational and

calibrated. The instrument storage area is co-located with the radiation counting laboratory and

storage area for emergency response kits. A sampling of portable instruments maintained were

found to be within calibration. The NYDL’s radiation counting laboratory includes a low

background alpha and beta proportional counter, liquid scintillation counter, and a sodium iodide

detector coupled to a multichannel analyzer. The program’s germanium lithium detector is no

longer functional and has not yet been replaced. The inspection staff is responsible for analyzing

their own samples and maintaining the laboratory counting equipment.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance

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

3.2.3 New York State Department of Health (NYSH) - Technical Quality of Inspections

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

notes and interviewed inspectors for 16 materials inspections conducted during the review

period. The casework included 11 of the NYSH's materials license inspectors, and covered

inspections of various types including medical, academic, teletherapy and pharmacy. Appendix

C-3 lists the inspection files reviewed in depth with case-specific comments. During the week of
New York Revised Final Report Page 14

February 23, 1998, a team member performed accompaniments of four NYSH inspectors on

separate inspections of licensed facilities. 

During the 1995 review of NYSH, there was a preliminary recommendation to modify the

inspection report format to include sections to identify how previous items of noncompliance

were addressed by the licensee and to document findings presented to licensee management

during exit meetings. The NYSH has modified its field note format to include both of these

topics. The NYSH now documents whether or not previous items of noncompliance were

resolved and there is now an area to document the exit meeting and subsequent discussions. 

During this review, the team noted that there was a lack of documentation of the substance of

discussions at the exit meetings. The review team suggests that the NYSH's inspection

documentation of exit meetings should contain substantive discussions of issues with the

Radiation Safety Officer (RSO) and/or licensee management. 

The inspection procedures and techniques utilized by NYSH were reviewed and determined to be

generally consistent with the inspection guidance provided in IMC 2800. The team reviewed

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

collected under NRC Inspection Procedure 87100 and NYSH procedures. Thirteen of the 16

inspections reviewed were performed on an unannounced basis.

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

NYSH 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. 

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 materials, equipment, use of materials, transfer, and disposal. The reports were also checked

to determine if the reports adequately documented operations observed, interview of workers,

independent measurements, status of previous noncompliance items, substantiation of all items

of noncompliance, and the substance of discussions during exit interviews with management. 

Although it is evident that some workers were interviewed, it is rarely documented that ancillary

personnel, authorized users, or the RSO were involved in this process. Of the 16 inspections

reviewed, not one documented interviewing ancillary personnel. The review team suggests that

NYSH incorporate a field for documentation of interviewing ancillary personnel, authorized users,

technicians, and RSOs into their field notes. 

To assure consistency and quality of reports, it was evident the Radioactive Material Section

Field Supervisor and Section Chief provided thorough reviews but until recently did not document

this review. Six out of the 16 inspections reviewed did not have documented supervisor review. 

Also, the inspection correspondence and field notes are not signed by supervision. Only the

inspector's signature is available on this paperwork. The NYSH has initiated a new process to

have the field supervisor and/or the section chief sign a separate memo sized paper

documenting their review. This piece of paper 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 NYSH

procedures. 

When the licensee responded to a NOV, the response was given to the inspector to evaluate the

licensee's response and, in each case, a response was sent to the licensee within 30 days of
New York Revised Final Report Page 15

receipt. The team, as noted previously, identified a concern related to the documentation of

supervisory review of enforcement letters and licensee responses.

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 and that escalated enforcement action in the process of Administrative

Tribunals (Hearing Board) occurred only five times. A thorough review of all Administrative

Tribunals 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. Four of the five cases reviewed were dealt with expeditiously through negotiation

with NYSH which is a preliminary step in the Tribunal process. All five cases have been

inspected or have been scheduled to be inspected within the next 6 to 12 months. 

Four inspector accompaniments identified in Appendix C-3 were performed by a team member. 

During the accompaniments, inspectors demonstrated appropriate inspection skills and

knowledge of the regulations. The inspectors were well prepared and thorough in the review of

licensee radiation safety programs. The technical performance of the inspectors was at a high

level. During these accompaniments, the reviewer observed that the inspectors focused on

records reviews and checking off the field notes instead of observing the licensees operations;

therefore, the reviewer identified that the inspectors would benefit from more training in

inspecting for performance. The inspections were adequate to assess radiological health and

safety at the licensed facilities. The review team suggests that the NYSH inspectors attend

additional training in inspecting for performance techniques.

The NYSH has a policy of performing annual supervisory accompaniments of inspectors. In

response to the questionnaire, NYSH reported that 10 out of the 12 inspectors had

accompaniments in 1997. The two inspectors that did not have accompaniments were a field

supervisor and another inspector not assigned inspections for 1997. 

The team noted that NYSH has an ample number of portable radiation detection instruments for

use during routine inspections and response to incidents and emergencies. The NYSH has a

dedicated person in the Department for assuring and performing all instrument calibrations. The

portable instruments used during the inspector accompaniments were observed to be operational

and calibrated. The instrument storage area is located within the Department and at each field

office. A sampling of portable instruments maintained at each location was available and found

to be within calibration. 

Based on the IMPEP evaluation criteria, the review team recommends that NYSH’s performance

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

3.2.4 New York State Department of Environmental Conservation (NYDEC) - Technical Quality

of Inspections

The team reviewed the inspection reports, enforcement documentation, and interviewed

inspectors for 10 materials inspections conducted during the review period. The casework

included seven of the NYDEC’s materials license inspectors, and covered inspections of various

types including air, water, and incinerator permits. Appendix C-4 lists the inspection files

reviewed in depth with case-specific comments. 
New York Revised Final Report Page 16

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

among the inspector, their supervisor, and the Radiation Section Supervisor 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 team reviewed the latest version of Part 380 Permit Inspection Procedures, revised

September 1996, Enforcement Guidance Memorandum Radiation dated May 17, 1995, and all

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

applicable guidance found in IMC 2800 and IP 87100.

Supervisory accompaniments of inspectors are conducted on a routine basis. All of the

inspectors have been accompanied at least once a year and most of the supervisors have been

accompanied during the review period.

Two inspector accompaniments identified in Appendix C-4 were performed by a team member on

April 7, 1998. Of the remaining three inspectors, two were accompanied during previous reviews

and the other was re-assigned to other work within NYDEC. During the accompaniments, the

inspectors demonstrated appropriate inspection skills and knowledge of the regulations. The

inspectors were well prepared and thorough in the review of licensee radiation safety programs. 

Inspection techniques were observed to be performance oriented, and the technical performance

of the inspectors was at a high level. The inspections were adequate to assess radiological

health and safety of the licensee’s effluent monitoring program.

The team found that NYDEC has a variety of survey instruments. The instruments include a

good mix of microroentgen meters, GM meters, ion chambers, velometers, and other portable

survey meters. The meters are calibrated annually using an outside vendor. The NYDEC also

has available a high purity germanium detector, tritium monitor, TLD reader/irradiator, and a

neutron detector. Samples are also sent to an outside laboratory for analysis.

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

performance with respect to the indicator, Technical Quality of Inspection, be found satisfactory.

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive materials 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 - Technical Staffing and Training

At the time of the review, NYCH’s radioactive materials program was staffed by the Deputy

Bureau Chief, licensing section with a supervisor and four staff, and compliance section with a
New York Revised Final Report Page 17

section supervisor, scientist, and five staff. The Bureau Chief position had been vacant for 18

months, filled for four months, and then vacant again as of the week after the review. In general,

the team found that the current staffing level is adequate except the team noted that the vacancy

at the Bureau Chief position was affecting several aspects of the program as identified in this

report. At the August 18, 1998 MRB meeting, Mr. Miskin announced that he has been selected

as the Bureau Chief effective August 10, 1998.

At the time of the review, all staff had been with the program for the majority of the review period. 

Two staff members joined the program shortly after the last review in 1995. Both performed well

on their inspection accompaniments. The Bureau Chief resigned in July 1996 with a successor

hired in October 1997. The new Bureau Chief resigned in January 1998, effective February 6,

1998. In addition, the Assistant Commissioner that oversees the Bureau was dismissed in midJanuary 1998 with the Deputy Commissioner being dismissed in February 1998. In an additional

organizational change, the Departments of Health and Mental Health are being combined into

one department. The final organizational chart for this new Department will not be available until

the City Council approves the reorganization. At the time of the review, it appears that the NYCH

will remain intact. 

From supervisor interviews and a review of the position descriptions, the team determined that

successful candidates for technical positions 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 the NYCH has been able to hire qualified individuals. The

NYCH has one Certified Health Physicist (CHP) and one individual that has passed Part 1 of the

CHP examination. 

In interviews with the staff and a review of documents, the team determined that there was no

written training policy or qualifications criteria. The review team recommends that NYCH

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. In NYCH’s letter dated February 17, 1998, the NYCH responded to this recommendation

by indicating that although their Policy and Procedures Manual contains a written policy for staff

training, the manual is currently being updated and will include these recommendations.

The team’s review of NYCH’s training records and interviews with the staff identified that several

staff members should attend at least one course to fully address their training needs. 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 several one day seminars in the appropriate training areas. 

The review team recommends that NYCH review the staff’s training against their training

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

training, as appropriate. 

Based on the IMPEP evaluation criteria, the review team initially recommended that NYCH's

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

with recommendations for improvement. At the August 18, 1998 MRB meeting, the MRB

requested that the team reassess its basis for the recommendation stated above. The team’s

reassessment concluded that the personnel performance is addressed in the indicator, Technical

Quality of Inspections, and that the recommendation for this indicator should be changed to

satisfactory. The MRB agreed with this change at the September 1, 1998 meeting.
New York Revised Final Report Page 18

3.3.2 New York State Department of Labor - Technical Staffing and Training

At the time of the review, NYDL’s radioactive materials program was staffed by the principal

radiophysicist and seven associate radiophysicists. In general, the team found that the current

staffing level is adequate, except that the team noted that the inspection staff has a very heavy

workload attributed to the fact that one of the four inspectors was restricted to office duties only. 

The principal radiophysicist also carries a very heavy licensing caseload that may have affected

the status of regulatory development. The staffing and training will be impacted by the

recommendations in the SS&D section (4.2) with the recommendation for significant additional

training for both of the SS&D staff. The review team suggests that NYDL management consider

whether additional staffing is warranted when considering the impacts of the licensing and

inspection workloads, the regulation development needs, and the SS&D program improvement

needs. 

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

conducted in Albany and inspections conducted out of the Manhattan office. Licensing duties are

performed by the principal radiophysicist and three associate radiophysicists. Inspection duties

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

emergency response. At the time of the review, all staff had been with the program for the entire

review period. 

From supervisor interviews and a review of the position descriptions, the team determined that

successful candidates for technical positions 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. The NYDL

program has one CHP with one other person working on their certification. 

In interviews with the staff and review of documents, the team determined that there was no

written training policy. The principal radiophysicist committed in a memo to upper management

to follow the recommendations in the NRC/OAS Training Working Group report as the program’s

overall training plan. They also are required to submit annual training plans to upper

management. All formal training is documented complete in a computer database. On-the-job

training is documented in signature cards signed by the mentoring staff person. The review of

their training records and interviews with the staff identified that one staff member should attend

the industrial radiography course and that most staff desired additional training in internal

dosimetry and decommissioning. The review team recommends that NYDL document its training

program to include overall policy and minimum training requirements for both the licensing and

compliance staff. 

Based on the IMPEP evaluation criteria, the review team recommends that NYDL’s performance

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

3.3.3 New York State Department of Health (NYSH) - Technical Staffing and Training

At the time of the review, the NYSH radioactive materials program was staffed by the Director,

two supervisors, and eleven staff. The team found that the current staffing level appeared

adequate. 
New York Revised Final Report Page 19

The staff of the materials program is segregated into four field offices and the main office in

Albany. Compliance duties are performed by both supervisors and the eleven staff. The field

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

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

activities. Licensing duties are performed by the supervisor and four staff. All Albany staff

perform duties in incident and emergency response. 

At the time of the review, all staff, except one, had been with the program for the entire review

period. The new individual was transferred from the laboratory to the licensing/compliance staff

in Albany. The individual has attended several training courses and is a senior staff member

based on his 20 plus years working as a radiochemist in the laboratory. All work, by this

individual both inspections and licensing actions, is reviewed by qualified staff prior to issuance.

From supervisor interviews and a review of the position descriptions, the team determined that

successful candidates for technical positions are required to have a Bachelor’s degree in science

and at least 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 review team

concluded that the State has been able to hire qualified individuals. There is one certified health

physicist (CHP) in the NYSH program with six others that have passed Part I of the CHP

examination.

The NYSH has a written training policy and requirements. The team reviewed the policy and

requirements and found them acceptable. The NYSH has a training matrix where they enter the

courses that have been completed. The review of this matrix identified several courses which

are needed for individual staff. These were: two for inspection procedures, one for licensing

practices and procedures, most of the staff for teletherapy/brachytherapy, three for transportation

of radioactive materials, and, as recommended in Section 3.2.3, additional training in inspecting

for performance for the inspection staff. Although these individuals have not attended specific

courses, they have had some on-the-job training and short seminars to cover these areas. The

team considered that in every training area the program had multiple qualified individuals that

have been provided the on-the-job training, therefore, from a programmatic standpoint, the

program has sufficiently trained staff. Through management review, all staff, except for the

recent transfers, have been qualified to perform independent work. NYSH’s program conducts

monthly TeleVideo conferences with its regional and Albany staff. These sessions cover current

health physics topics and other programmatic matters, as needed. The review team considers

the TeleVideo conferences to be a good practice to bring and keep their staff current on health

physics and program issues. 

Based on the IMPEP evaluation criteria, the review team recommends that NYSH's performance

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

3.3.4 New York State Department of Environmental Conservation (NYDEC) - Technical Staffing

and Training

At the time of the review, NYDEC’s radioactive materials program was staffed by the Bureau

Chief, Radiation Section Leader, and ten staff. There are currently two vacancies in the radiation

section. Both positions are for contaminated sites and environmental analysis to support

contaminated site evaluations. In response to the draft IMPEP report, NYDEC indicated that,

subsequent to the team visit, they have filled both of these positions. About half of the staff time
New York Revised Final Report Page 20

is spent on contaminated sites and events that are not directly covered under the agreement with

NRC. The permitting (licensing) and compliance functions of the program are integrated with six

staff performing both functions part of the time. All staff perform duties in incident and

emergency response. 

At the time of the review, all staff had been with the program for the entire review period. Two

staff left the program in 1997, and one staff member was assigned work outside the Bureau

which amounted to half of his time. 

From supervisor interviews and a review of the position descriptions, the team determined that

successful candidates for 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 the State has

been able to hire qualified individuals. 

In interviews with the staff and a review of documents, the team determined that there was no

written training policy. Because of the small number of inspectors and permit reviewers, NYDEC

does not have a formal qualification program. New staff have been trained in performing

inspections and reviewing permit applications individually by the permit unit supervisor. 

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

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

assisted by experienced inspectors; and (4) performing inspections independently. Inspectors

move through these stages based on the assessment of the unit supervisor. The same staff are

trained to review permit applications by reviewing first minor amendments and routine renewals,

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

unit supervisor and the radiation section supervisor. The review team recommends that NYDEC

document its training program to include overall policy and minimum training requirements for

both the permitting and compliance staff. 

Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's

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

3.4 Technical Quality of Licensing Actions

The teams examined completed licensing casework and interviewed the reviewers for specific

licenses as specified for each of the four New York programs. Licensing actions were evaluated

for completeness, consistency, proper isotopes and quantities used, qualifications of authorized

users, adequate facilities and equipment, and operating and emergency procedures sufficient to

establish the basis for licensing actions. Licenses were reviewed for accuracy, appropriateness

of the license and of its conditions and tie-down conditions, and overall technical quality. 

Casework was evaluated for timeliness, adherence to good health physics practices, reference to

appropriate regulations, documentation of safety evaluation reports, product certifications or

other supporting documents, consideration of enforcement history on renewals, pre-licensing

visits, peer or supervisory review as indicated, and proper signature authorities. The files were

checked for retention of necessary documents and supporting data.

3.4.1 New York City Department of Health (NYCH) - Technical Quality of Licensing Actions

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 all reviewers. The cross-
New York Revised Final Report Page 21

section sampling included all of NYCH’s major licenses as defined by NYCH in the questionnaire,

and included the following types: broad scope medical; broad scope academic; gamma knife;

hospital nuclear medicine; private practice physicians nuclear medicine; teletherapy; high dose

remote afterloaders; blood irradiators; bone mineral analyzers; and in vitro laboratories. Nineteen

license files were reviewed. Licensing actions included three new licenses, nine renewals, 28

amendments, two terminations, and one license rescinded. A list of these licenses with casespecific comments can be found in Appendix D-1. In discussions with NYCH management, it

was noted that there are no major decommissioning efforts underway with regard to agreement

material in New York City. Also, there are no identified sites with potential decommissioning

difficulties equivalent to those sites in NRC's Site Decommissioning Management Plan. The only

exemptions issued were to physicians requesting the carbon 14 urea breath test recently

approved by NRC.

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

documentation in the license files or discussion with license reviewers. The review of the two

gamma knife licenses indicates license reviewers should pay close attention to the conditions of

use listed in the SS&D registry for these type of devices. The team discussed with NYCH staff

how they addressed these conditions since there was limited documentation in the file. Several

of the conditions were individually considered by NYCH staff and others were not because NYCH

staff considered them as being covered through the manufacturer operating procedures and/or

training program. The review team suggests that NYCH consider documenting how the SS&D

conditions of use were addressed for the two gamma knife licenses and will be addressed in

future SS&D licensee’s actions. In NYCH’s letter dated February 17, 1998, the NYCH responded

to this suggestion by adding a memo to the license reviewer’s handbook that instructs reviewers

to include as license conditions the specific language from the SS&D Registry dealing with the

restrictions of use or recommendations concerning safety matters as appropriate.

The team found that terminated licensing actions and the license rescinded were well

documented, showing appropriate transfer records and survey records. For the case that the

license was rescinded, NYCH took possession of licensed material for proper disposal.

Licenses are renewed on a 5-year frequency. Licenses that are under timely renewal are

amended as necessary to assure public health and safety issues are addressed during the

period that the license is in the renewal process. Each licensing action receives management

review before the action is finalized and issued. Interviews with the licensing staff indicate that

there is discussion between reviewers and management on complex licensing actions completed

by management. The license reviewers submit all deficiency letter replies and a date stamped

final licensing action to management for review and management signature. If approved,

management signs the action, then the license is held for license fee payment. The date of

payment is the issuance date of the license action. The difference between these two dates may

cause initial inspection scheduling difficulties. The review team suggests that NYCH list the date

the licensing action is issued (date of fee payment) on the license and in their database, instead

of the date of management signature. In NYCH’s letter dated February 17, 1998, the NYCH

responded to this suggestion by upgrading their radiation database to trigger an inspection due

date based on the actual date of issuance of the new license rather than the date the license

was signed.
New York Revised Final Report Page 22

The casework was reviewed for adequacy and consistency with the NYCH procedures. The

casework review also indicated that the NYCH reviewers follow their licensing guides during the

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

The licensing guides are similar to NRC guides.

Based on the IMPEP evaluation criteria, the review team recommends that NYCH’s performance

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

3.4.2 New York State Department of Labor (NYDL) - Technical Quality of Licensing Actions

The team examined completed licenses and casework for 16 license actions, representing the

work of four 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, and to include work by all reviewers. The sampling

included the following types: research and development; manufacturing and distribution;

industrial radiography; portable gauges; fixed gauges; gas chromatograph; commercial broad

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

renewals, six amendments, and two terminations. A list of these 16 licenses with case specific

comments can be found in Appendix D-2. In discussions with NYDL staff, the team noted that

NYDL is currently performing confirmatory measurements at the decommissioning of the

Cintichem facility with regard to agreement material in New York. 

The 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. Generic notices were issued to

specific classes of licensees to address particular safety concerns, such as, a notice on bumpers

for Amersham 660 radiography cameras.

One of the licensing actions examined by the team required the licensee to submit financial

assurance. The originals of financial documents could not be located. Based on discussions

with the program manager and a review of the original financial assurance documents

maintained in NYDL’s Manhattan office, the team determined that some licensees: (1) are no

longer required to have financial assurance; (2) were inconsistent in designating the obligee; and

(3) did not have a trust agreement with each financial mechanism. Prior to this review, NYDL

sent a letter to its licensees requesting them to review their financial assurance and update their

financial mechanism. The review team suggests that NYDL continue to audit their financial

assurance files to ensure that they contain all required information and are current with NYDL

requirements.

The team found that terminated licensing actions were well documented, showing appropriate

transfer records and survey records. A review of the licensing actions over the period showed

that most terminations were for licensees possessing sealed sources. These files showed that

documentation of proper disposal or transfer was available.

Licenses are renewed on a 3-year frequency. The NYDL performs a complete review during

every other 3-year cycle to ensure that the license’s radiation safety program is adequate and
New York Revised Final Report Page 23

meets current NYDL requirements. Licenses that are under timely renewal are amended as

necessary to assure that public health and safety issues are addressed during the period that the

license is in the renewal process. Unless reviewed by the two individuals with signature

authority, each licensing action receives a supervisory chain review.

At the time of the review, there were 57 renewals greater than a year old, and 27 amendments

and two new applications greater than 6 months old. Based on discussions with NYDL program

manager, the program receives approximately 300 licensing actions a year and the total number

of pending actions is approximately 200 actions. The total number of pending actions has been

reduced in half compared to the last review period. 

The team found that the current staff is well trained and experienced in a broad range of

licensing activities. The casework was reviewed for adequacy and consistency with NYDL

procedures. The casework review indicated that NYDL staff follows their licensing guides during

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

license. The licensing guides are similar to NRC guides. The NYDL has developed simplified

licenses for fixed gauges and gas chromatograph licenses that do not require a license tie-down

condition. The NYDL also issues notices to its licensees to alert them to changes in regulatory

requirements or to emphasize a particular area of concern identified by NYDL or another agency.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL’s performance

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

3.4.3 New York State Department of Health (NYSH) - Technical Quality of Licensing Actions

The team examined completed licensing casework and interviewed the reviewers for 21 specific

licenses. 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 all reviewers. The

cross-section sampling included all of NYSH's major licenses as defined by NYSH in the

questionnaire and included the following types: academic-broad; research and developmentspecific; research and development-broad; irradiator; medical (broad with high dose remote

afterloader, private practice, hospital, nuclear cardiology, mobile nuclear medicine site,

brachytherapy, teletherapy, and high dose remote afterloader); and clinical laboratory. Licensing

actions included six new licenses, seven renewals, one amendment, and seven terminations. A

list of these licenses with case-specific comments can be found in Appendix D-3. 

The 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. Generic notices were issued to

specific classes of licensees to address particular safety concerns, such as, a notice on HDR

issues.

In discussions with NYSH management, it was noted that there were no major decommissioning

efforts underway with regard to agreement material in the NYSH program. Also, there were no

identified sites with potential decommissioning difficulties equivalent to those sites in NRC's Site

Decommissioning Management Plan. The team found that terminated licensing actions were

well documented, showing appropriate transfer records and survey records. 
New York Revised Final Report Page 24

Based on the IMPEP evaluation criteria, the review team recommends that NYSH’s performance

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

3.4.4 New York State Department of Environmental Conservation (NYDEC) - Technical Quality

of Licensing Actions

The team examined completed licenses and casework for 14 license actions in 14 specific

license files, representing the work of six license reviewers. The license reviewers and the

Section Chief were interviewed when needed 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 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, water discharge, and environmental study. Licensing

actions reviewed included three new licenses, three renewals, two amendments, three

terminations, and three inquiries. Inquiries are permit applications or facility evaluations initiated

by the radiation staff to determine if licensees discharging radioactive materials to the

environment in their effluent exceed the 10% exemption threshold. A licensee is required to

have a permit if the annual average effluent concentration of the licensee’s discharge exceeds

10% of the NYDEC’s regulatory limit in Table II of Part 380. If the licensee’s discharge is less

than 10% of NYDEC limits, then a permit is not needed; however, the licensee is still required to

survey and maintain appropriate records to demonstrate compliance with Part 380. A list of the

14 permits and inquiries reviewed with case specific comments can be found in Appendix D-4.

The 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

appeared to be taken into account when reviewing renewal applications as determined from

documentation in the license files and/or discussions with the license reviewers. No exemptions

were issued by NYDEC during this review period.

The team found that terminated licensing actions were well documented, showing either

appropriate survey records or documentation that the licensee’s effluents did not exceed the 10%

exemption limit. A review of the licensing actions over the period showed that a majority of

terminations were for permittees whose effluents were reduced to less than the 10% exemption

limit.

Permits are issued or renewed with a 5-year expiration period. The radiation staff occasionally

issues a permit for a shorter period, but this is done to coincide expiration dates with other

NYDEC permits issued to the facility. Permits that are under renewal are amended as necessary

to assure that public health and safety issues are addressed during the period that the permit is

undergoing the renewal process. Each licensing action receives a supervisory chain review.

The team found that the current staff is well trained and experienced in licensing activities related

to discharge of radioactive material into the environment. The casework was reviewed for

adequacy and consistency with the NYDEC procedures. The casework review indicated that the

radiation staff follow their licensing guides during the review process to ensure that licensees

submit the information necessary to support the license. 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.
New York Revised Final Report Page 25

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

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

satisfactory.

3.5 Response to Incidents and Allegations

3.5.1 New York City Department of Health (NYCH) - Response to Incidents and Allegations

In evaluating the effectiveness of NYCH's actions in responding to incidents and allegations, the

team examined NYCH’s response to the questionnaire relative to this indicator, reviewed the

incidents reported for NYCH in the "Nuclear Material Events Database (NMED)", and those

contained in the City’s casework and license files, and supporting documentation, as appropriate

for eight incidents. A list of the incident casework with comments is included in Appendix E-1. 

The team reviewed NYCH’s response to six allegations received during the review period. 

The eight incidents selected for review included two misadministrations, one lost package of

radioactive material, two loss of control of radioactive material, two overexposures, and one

procedural failure. Of the six allegations reviewed in detail, the NRC Region I office referred one

to NYCH and the others came directly from allegers. During the review period, NRC referred 10

allegations to NYCH. All of these allegations have been closed out.

Responsibility for initial response and follow-up actions to material incidents and allegations 

rests with NYCH staff. When NYCH is notified of either an incident or an allegation (also referred

to as “complaints”) during working hours, an inspector takes the incoming notification and briefs

the materials inspection supervisor or the Director of NYCH to determine the approach to be

taken. Incoming complaints are considered either immediate or non-immediate based on their

apparent safety significance. The supervisor assigns the complaint to one of the inspectors who

will respond the same day or next if the complaint is immediate, or a longer period if nonimmediate. The NYCH provides a 24-hour emergency number for anyone to report emergencies

involving hazardous materials. The NYCH can also receive notification through the State

Warning Point (State operated emergency line). When a radiological incident is reported after

work hours, NYCH staff is contacted at home.

The review of incident casework, licensing casework, and interviews with staff revealed that

incidents are promptly evaluated for the need for on-site investigations. For those incidents not

requiring on-site investigations, copies of letters to licensees were in the incident and licensing

files indicating that the incident would be investigated during the next scheduled inspection. In

response to incidents, NYCH took prompt, appropriate action. The review of casework indicated

that incident reports were thorough and well-documented. The team found that NYCH’s

complaint file is maintained manually with a copy in the appropriate specific license file. 

Documentation on incidents or allegations involving non-licensees are maintained solely in the

complaint file. These reports included sections on the background, findings, conclusions/

recommendations, instruments used, and signatures. The team noted that some of the nonimmediate complaints were documented on a preprinted two sided “complaint control record”

form. The incident reports were reviewed and signed by the inspection supervisor. The team did

note that follow up to incidents at the next inspection was not always documented in the field

notes. The review team suggests that NYCH investigated incidents be clearly documented in the

field notes at the next inspection. 
New York Revised Final Report Page 26

The team reviewed NYCH’s process for reporting significant events immediately or 24 hour

notification. The team determined that NYCH was inconsistent in reporting significant events to

the NRC Operations Center, but was consistent in reporting to other NRC offices. The team also

queried the incident information reported on the NMED system for NYCH which identified 11

reported material incidents. These incidents were not based on reports submitted by NYCH, but

through other notification mechanisms such as preliminary notification or calls to the NRC

Operations Center. Although NYCH staff has been provided training on the NMED system, they

have not been providing periodic reports on reportable events. During the exit meeting on

January 30, 1998, and their letter dated February 17, 1998, NYCH and Department management

committed to providing information on reportable events to NMED including those reportable

events that occurred during fiscal years 1996 and 1997. As of September 3, 1997 when the

Commission policy on Adequacy and Compatibility was published in the Federal Register, the

Agreement State participation in the NMED system became mandatory. On February 25, 1998,

OSP issued an implementing procedure (SA-300) for Agreement State reporting of materials

events to comply with this policy change. The review team recommends that NYCH notify NRC

of significant reportable events and provide documentation for all reportable events both in

accordance with SA-300.

The review of the allegation files indicated that NYCH took prompt and appropriate action in

response to allegers’ concerns. These actions included detailed interviews with the allegers,

prompt investigation and routine follow up at the next inspection, when warranted. The NYCH

protects the identity of the alleger if requested. The review of the casework and interviews of

staff determined, however, that NYCH staff did not document any feedback to the alleger on

NYCH’s investigation into the allegation and NYCH’s findings. The review team suggests that

NYCH include written documentation that the alleger has been contacted regarding the results of

NYCH’s findings into the alleger’s concerns. In NYCH’s letter dated February 17, 1998, the

NYCH responded to this suggestion by confirming that documentation to file will indicate that

allegers were notified of the results of investigations.

Based on the IMPEP evaluation criteria, the review team recommends that NYCH’s performance

with respect to the indicator, Response to Incidents and Allegations, be found satisfactory.

3.5.2 New York State Department of Labor (NYDL) - Response to Incidents and Allegations

In evaluating the effectiveness of NYDL's actions in responding to incidents, the team examined 

NYDL's response to the questionnaire relative to this indicator, NYDL’s written procedures for 

incident response, and the incidents reported for NYDL in the "Nuclear Material Events Database

(NMED).” The team examined NYDL’s incident and license files and supporting documentation

for 13 incidents. In all cases reviewed, once notification was received, NYDL promptly

responded and adequately protected public health and safety. Incidents were adequately

documented in the files and when they involved a licensee of NYDL, the incident was also

reviewed at the next routine inspection. Issues and concerns arriving out of these incidents that

involved other regulatory agencies were referred to the appropriate agency by NYDL. A list of

the incident casework with comments is included in Appendix E-2.

The team reviewed NYDL’s process for reporting significant NYDL events (immediate or 24-hour

notification). The team determined that NYDL was inconsistent in reporting significant events to

the NRC Operations Center but was consistent in reporting them to other NRC offices. During

the review period, NYDL had made only one summary report of incidents for inclusion in the

NMED system. For the NMED system to effectively identify in a timely manner any generic
New York Revised Final Report Page 27

problems with equipment or procedures, NYDL must routinely submit the vital information on the

incidents that occur in their jurisdiction to the NMED system. As of September 3, 1997 when the

Commission policy on Adequacy and Compatibility was published in the Federal Register, the

Agreement State participation in the NMED system became mandatory. On February 25, 1998,

OSP issued an implementing procedure (SA-300) for Agreement State reporting of materials

events to comply with this policy change. The review team recommends that NYDL notify NRC

of significant reportable events and provide documentation for all reportable events both in

accordance with SA-300.

In evaluating the effectiveness of NYDL's actions in responding to allegations, the team

examined NYDL's response to the questionnaire relative to this indicator and NYDL’s written

procedures for response to allegations. The team reviewed NYDL's response to seven

allegations, including the allegation referred to NYDL by NRC. NRC referred a total of three

allegations to NYDL. All of them have been closed out. All possible allegations are evaluated by

NYDL’s Director to determine the level of investigation they may merit. Not all allegations

referred to NYDL by the NRC were considered allegations by NYDL. Two of the NRC referred

allegations selected for review were not in NYDL’s allegation files but had been answered by

letters to NRC from the Director, because in her evaluation they should not be included as NYDL

investigated allegations. Based on the information provided by NYDL, NRC closed these

allegations. The NYDL responded promptly with on-site investigations to the four allegations

reviewed with potential ongoing conditions that could lead to excessive exposures. The NYDL’s

response to allegations was timely and appropriate for the significance of the allegation. NYDL

protects the identify of the alleger, when requested. In two of the seven files reviewed, NYDL’s

allegation tracking system did not document that a closed investigation had in fact been closed

out. The NYDL’s tracking system does not indicate if the alleger was informed of the results of

the investigation nor is this required by the NYDL’s allegation procedures. The review team

suggests that, when each allegation is completed and closed out, NYDL update their allegation

tracking systems accordingly to reflect the actual status for all allegations.

Based on the IMPEP evaluation criteria, the review team recommends that NYDL's performance

with respect to the indicator, Response to Incidents and Allegations, be found satisfactory.

3.5.3 New York State Department of Health (NYSH) - Response to Incidents and Allegations

In evaluating the effectiveness of NYSH’s actions in responding to incidents and allegations, the

team examined NYSH’s response to the questionnaire relative to this indicator, the incidents

reported for New York in the "Nuclear Material Events Database (NMED)," those incidents

contained in NYSH’s casework and license files, and supporting documentation, as appropriate

for 12 incidents. A list of the incident casework with comments is included in Appendix E-3. The

team reviewed NYSH’s response to five allegations received during the review period. 

The 12 incidents selected for review included three misadministrations, one leaking source, two

loss of control of radioactive material, one overexposure, two equipment failures, two releases of

radioactive material, and one contamination event. Of the five allegations reviewed, the NRC

Region I office referred one to NYSH and the others came directly from allegers.

The NYSH use the same process for handling incidents and allegations. Responsibility for initial

response and follow-up actions to material incidents and allegations rests with the staff. When

NYSH is notified of either an incident or an allegation during working hours, an inspector takes

the incoming notification and briefs the Section Chief in Albany or the field supervisor in Syracuse
New York Revised Final Report Page 28

to determine the approach to be taken. Either supervisor will evaluate the potential safety

significance of the incident/allegation to determine the type of response that NYSH will take. 

Although staff and supervisors are located in five different offices around the State, the team

noted effective use of NYSH’s e-mail system to communicate and document actions taken for

any of the events. The NYSH has a 24-hour number to report radiological emergencies through

the State Warning Point. The notification list includes after work hours phone numbers for NYSH

staff.

The review of incident and licensing casework, and interviews with staff revealed that incidents

are promptly evaluated for the need for on-site investigations. For those incidents not requiring

on-site investigations, copies of letters to licensees were in the incident and licensing files

indicating that the incident would be investigated during the next scheduled inspection. In

response to incidents, NYSH had taken prompt, appropriate action. The review of casework

indicated that incident reports were thorough and well-documented. The team found that

incident and allegations events are tracked on a computerized system and filed on monthly basis. 

Each event is classified by the type of accident/incident (including a category for allegations) and

includes a summary sheet with an event description, contact person, site name and responsible

party, follow up, outcome, and if the event has been closed out. Detailed information on each

event such as telephone conversations and close out memorandums are maintained in the

incident file and, if a specific licensee is involved, in the appropriate docket file. Documentation

on incidents or allegations involving non-licensees are maintained solely in the incident file. The

event reports are reviewed and signed by the Bureau Chief on a monthly basis. The team did

note that incidents were generally followed up at the next inspection.

The team reviewed NYSH’s process for reporting significant (immediate or 24-hour notification)

events. The team determined that NYSH was inconsistent in reporting significant events to the

NRC Operations Center but was consistent in reporting to other NRC offices. The team also

queried the incident information reported on the NMED system for NYSH which identified six

reported material incidents plus one abnormal occurrence. Although NYSH staff has been

provided training on the NMED system, they have not been providing periodic reports on

reportable events. The team determined that NYSH last reported incidents to the NMED system

in April 1997. The NMED system does not include NYSH reports since that time. During the exit

meeting on April 3, 1998, NYSH staff and management indicated that a new tracking system was

under development to track incidents and allegations, and that NYSH would explore interfacing

their software to allow transfer of reportable events to NMED. As of September 3, 1997 when

the Commission policy on Adequacy and Compatibility was published in the Federal Register, the

Agreement State participation in the NMED system became mandatory. On February 25, 1998,

OSP issued an implementing procedure (SA-300) for Agreement State reporting of materials

events to comply with this policy change. The review team recommends that NYSH notify NRC

of significant reportable events and provide documentation for all reportable events both in

accordance with SA-300.

The review of the allegation files indicated that NYSH has taken prompt and appropriate action in

response to the allegers’ concerns. The review of casework and interviews of staff determined

staff provided feedback on the follow-up findings to the alleger. The identity of the alleger is

protected by NYSH.

Based on the IMPEP evaluation criteria, the review team recommends that NYSH’s performance

with respect to the indicator, Response to Incidents and Allegations, be found satisfactory.
New York Revised Final Report Page 29

3.5.4 New York State Department of Environmental Conservation (NYDEC) - Response to

Incidents and Allegations

In evaluating the effectiveness of NYDEC’s actions in responding to incidents and allegations,

the team examined NYDEC's response to the questionnaire regarding this indicator, the incidents

reported for State of New York in the NMED against those contained in the NYDEC files, and the

casework and supporting documentation for four material incidents and five allegations. 

The four incidents selected for review included two releases of radioactive material, one damage

to equipment and one release of material resulting from equipment and procedural failure and

are listed in Appendix E-4. Of the five allegations reviewed, NRC Region I office referred four to

NYDEC and the other one came directly to NYDEC from an alleger. The team noted during file

reviews and confirmed during discussions with staff that a majority of the incidents received by

the Radiation Section are radiation alarms at solid waste and regulated medical waste facilities

involving patient excreta, exempt material, or NARM material.

Responsibility for initial response and follow-up actions to material incidents and allegations 

rests with Radiation Section staff. When the NYDEC is notified of an incident during working

hours, either the Section Chief or the Program Director is consulted to evaluate the safety

significance of the event and determine the course of action to be taken. For incidents during

non-work hours, NYDEC’s radiation management can be contacted through the New York’s State

Warning Point. Radiation Section management also indicated that NYDEC sometimes

coordinates the response to an incident with one of the State licensing agencies (NYCH, NYSH,

and NYDL) which have staff in regional offices in the vicinity of the incident.

The review of incident and licensing casework, and interviews with staff revealed that incidents

are promptly evaluated for the need for on-site investigations. For those incidents not requiring

on-site investigations, copies of letters to licensees were in the licensing files indicating that the

incident would be investigated during the next scheduled inspection. The team noted that the

Radiation Section is currently evaluating the radiation detection systems at solid waste and

regulated medical waste facilities in an effort to prepare guidance for setting a radiation level for

rejecting a shipment of waste containing radioactive material. Solid waste and regulated medical

waste facilities are required by permit to monitor incoming waste for radioactivity, store the

radioactive material in shielded areas, and report an alarm to NYDEC.

In responding to incidents and allegations, NYDEC took prompt, appropriate actions. The review

of casework indicated that incident reports are thorough and well-documented. The incident

reports were reviewed and signed by the section supervisor. The team noted that documentation

relating to the follow up to allegations pertaining to licensed material or operations is maintained

in the licensing files. The other allegations are in the incident/ allegation file. It was also noted

that the Radiation Section’s procedural manual does not address the handling of incidents and

allegations. The review team recommends that NYDEC incorporate the handling of incidents

and allegations into their inspection procedures. 

The team reviewed NYDEC’s process for reporting significant (immediate or 24-hour notification)

events. The team determined that NYDEC was inconsistent in reporting significant events to the

NRC Operations Center. The NYDEC’s response to the questionnaire indicated that reporting of

events to NMED is not their responsibility. During the team’s discussions with NYDEC

management, they indicated that the licensing agency (NYDEC issues permits) would be

responsible for reporting events to NMED and to NRC. A review of the information reported on
New York Revised Final Report Page 30

an NMED system printout for the State of New York indicated one event reported to NMED by

NYDL that NYDEC also treated as an incident. As of September 3, 1997 when the Commission

policy on Adequacy and Compatibility was published in the Federal Register, the Agreement

State participation in the NMED system became mandatory. On February 25, 1998, OSP issued

an implementing procedure (SA-300) for Agreement State reporting of materials events to

comply with this policy change. The review team recommends that NYDEC coordinate with the

appropriate New York licensing agency, the notification to the NRC of significant reportable

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

NYDEC maintains a chronological file of radiation alarms at solid waste and regulated medical

waste facilities. Other incidents reported to the Radiation Section are maintained in the

appropriate licensing file, but there is no corresponding incident file for these events. The review

team suggests that NYDEC maintain one file for all types of incidents involving radioactive

material.

Based on the IMPEP evaluation criteria, the review team recommends that NYDEC's

performance with respect to the indicator, Response to Incidents and Allegations, be found

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

The 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.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 New York City Department of Health (NYCH) - Legislation and Program Elements

 Required for Compatibility

4.1.1.1 Legislation

Along with their response to the questionnaire, NYCH provided the team with the opportunity to

review copies of legislation that affect the radiation control program. Legislative authority for

NYCH’s portion of the Agreement State program is granted in Chapter 22 of the New York City

Charter (specifically Section 556(s)). NYCH’s radiation program is delegated from the NYSH

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. The team noted that the

legislation and delegation has not changed since being found adequate during the previous

review, and found that the City Charter is adequate. 

4.1.1.2 Program Elements Required for Compatibility

The NYCH Regulations for Control of Radiation, found in Article 175 of the New York City Health

Code - Radiation Control, 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
New York Revised Final Report Page 31

including naturally occurring materials, 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 team examined the procedures used in NYCH's regulatory process and found that it is a six

step process that takes between six months to a year to complete depending on the complexity

of the rule change. 

The team evaluated NYCH’s responses to the questionnaire and reviewed the regulations

adopted by NYCH since the 1995 review to determine the status of the NYCH regulations under

the Commission’s new adequacy and compatibility policy. The team found that the NYCH did not

promulgate any new regulations since the last review. 

NYCH has not adopted the following regulations within the 3-year time frame: 

! “Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70

amendments (59 FR 36026) that became effective August 15, 1994. The rule is being

evaluated by NYCH’s Office of General Counsel with an expected date for adoption of

September 1998. 

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

CFR Part 20 amendment (60 FR 7900) that became effective March 13, 1995. The

NYCH has decided to not proceed with a rulemaking and will retain the more stringent

requirement of annual medical examinations. At this time, NYCH does not have any

licensees that use respiratory protection equipment.

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and

61 amendments (60 FR 15649 and 25983) that became effective March 1, 1998. The

Agreement States are to promulgate their regulations no later than March 1,1998 so that

NRC and the State would require this national system to be effective at the same time. 

NYCH has this rule under review with their General Counsel to determine whether any

additional rulemaking is needed, since NYDEC has this rule in place and it applies to all

NYCH licensees. 

NYCH has not yet adopted the following regulations that are applicable to the NYCH program,

but intends to address them in timely rulemakings or by adopting alternate generic legally binding

requirements: 

! “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR Parts 19

and 20 amendments (60 FR 36038) that became effective August 14, 1995. 

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

amendments (60 FR 38235) that became effective November 24, 1995. 

! “10 CFR Part 71: Compatibility with the International Atomic Energy Agency,” 10 CFR

Part 71 amendment (60 FR 50248 and 61 FR 28724) that became effective April 1, 1996. 

! “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 35

amendments (60 FR 48623) that became effective October 20, 1995. 
New York Revised Final Report Page 32

! “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,” 10 CFR

Parts 20, 30, 40, 61, and 70 amendments (61 FR 24669) that became effective May 16,

1996. 

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

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

effective January 13, 1997. 

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

20 and 35 amendments (62 FR 1662) that became effective May 29, 1997.

! “Radiological Criteria for License Termination,” 10 CFR Part 20, 30, 40, and 70

amendments (62 FR 39058) that became effective August 20, 1997. 

The review team recommends that NYCH place the regulatory changes agenda and establish

specific schedules to address the regulatory changes in Section 4.1.1.2 within three years of the

regulations becoming effective NRC rules. 

Based on the IMPEP evaluation criteria, the review team recommends that NYCH’s performance

with respect to the indicator, Legislation and Program Elements Required for Compatibility, be

found satisfactory. 

4.1.2 New York State Department of Labor (NYDL) - Legislation and Program Elements

 Required for Compatibility

4.1.2.1 Legislation

Along with their response to the questionnaire, NYDL provided the team with the opportunity to

review copies of legislation that affect the radiation control program. Legislative authority for

NYDL 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. The NYDL is designated as the

radiation control agency for industrial and commercial uses of radioactive materials. The team

noted that the legislation has not changed since being found adequate during the previous

review and found that the State legislation is adequate. 

4.1.2.2 Program Elements Required for Compatibility

The NYDL Regulations for Control of Radiation, 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)

apply to all commercial and industrial uses of radioactive materials. The NYDL requires a license

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

including naturally occurring materials, such as radium, and accelerator-produced radionuclides. 

The team examined the procedures used in NYDL's regulatory process and found that it is a

6-step process that takes between six to 12 months to complete. 

The team evaluated NYDL’s responses to the questionnaire and reviewed the regulations

adopted by the State since the 1995 review to determine the status of the NYDL regulations

under the Commission’s new adequacy and compatibility policy. The team found that the NYDL
New York Revised Final Report Page 33

addressed the following NRC regulation amendments; however, they have not been finalized

and, therefore, they have not been adopted within the 3-year time frame:

! “Licensing and Radiation Safety Requirements for Irradiators,” 10 CFR Part 36 (58 FR

7715) that became effective July 1, 1993. See Section 2.0 for interim actions being taken

by NYDL to implement this rule on a case-by-case basis.

! “Decommissioning Recordkeeping: Documentation Additions,” 10 CFR Parts 30, 40, and

70 amendments (58 FR 39628) that became effective October 25, 1993. 

! “Self-Guarantee as an Additional Financial Mechanism,” 10 CFR Parts 30, 40, and 70

amendments (59 FR 1618) that became effective January 28, 1994. 

! “Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70

amendments (59 FR 36026) that became effective August 15, 1994. 

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

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

became effective January 1, 1995. 

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and

61 amendments (60 FR 15649 and 25983) that became effective March 1, 1998. Note:

The Commission delayed the effective date to March 1, 1998 so that the Agreement

States could promulgate and implement these requirements at the same time. 

These rule changes, as well as others, are in a package that has been under review by NYDL’s

General Counsel’s office for approximately a year. The requirements in these rules are being

implemented through license conditions as an interim measure. The review team recommends

that NYDL management take appropriate action to move the rule package through the rule

promulgation process. At the State exit meeting on May 12, 1998, the team was informed that

this rule package was released from the General Counsel’s office and should be final by the end

of 1998. 

The NYDL has not yet adopted the following regulations, but intends to address them in timely

rulemakings or by adopting alternate generic legally binding requirements:

! “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR Parts 19

and 20 amendments (60 FR 36038) that became effective August 14, 1995. 

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

amendments (60 FR 38235) that became effective November 24, 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 May 16,

1996. 

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

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

effective January 13, 1997. 
New York Revised Final Report Page 34

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

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

that became effective June 27, 1997. 

! “Radiological Criteria for License Termination,” 10 CFR Part 20, 30, 40 and 70

amendments (62 FR 39058) that became effective August 20, 1997. 

Based on the IMPEP evaluation criteria, the review team recommends that NYDL’s performance

with respect to the indicator, Legislation and Program Elements Required for Compatibility, be

found satisfactory. 

4.1.3 New York State Department of Health (NYSH) - Legislation and Program Elements 

Required for Compatibility

4.1.3.1 Legislation

Along with their response to the questionnaire, the NYSH provided the team with the opportunity

to review copies of legislation that affect the radiation control program. Legislative authority for

NYSH’s portion of the agreement with the NRC is granted in New York Public Health Law, Article

2, Title II, Sections 201 and 225. NYSH is responsible for regulating the medical, academic and

research uses of radioactive materials. The review team noted that the legislation has not

changed since being found adequate during the previous review, and found that the State

legislation is adequate. 

4.1.3.2 Program Elements Required for Compatibility

The NYSH Regulations for Control of Radiation, 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 apply to ionizing radiation, whether emitted

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

requires a license for possession and use of all radioactive material, including naturally occurring

radioactive materials, such as radium, and accelerator-produced radionuclides for medical,

academic, or research and development. NYSH also requires registration of all equipment

designed to produce x-rays or other ionizing radiations.

The team examined the procedures used in NYSH's regulatory process and found that it is a ten

step process that takes approximately 12 to 18 months, depending on the complexity of the

action. 

The team evaluated NYSH’s responses to the questionnaire and reviewed the regulations

adopted by the State since the 1995 review to determine the status of the NYSH regulations

under the Commission’s new adequacy and compatibility policy. The team noted that NYSH

addressed the following NRC regulation amendments:

! “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,” 10 CFR

Parts 20, 30, 40, 61 and 70 amendments (61 FR 24669) that became effective on

May 16, 1996. 
New York Revised Final Report Page 35

The NYSH has decided to address the above decommissioning and financial assurance

regulations with the use of license conditions. The NYSH identified nine licensees that

are subject to the financial assurance requirements. NYSH has imposed license

conditions on five of these licensees and has requested information from the others so

that appropriate conditions can be developed. The team reviewed the license conditions

and verified that they are being used. Additional license conditions addressed the

timeliness and records retention requirements in that the licensees must submit a

decontamination plan to NYSH for approval 90 days prior to ceasing operations and must

keep all records of spills and incidents until the license is terminated. The team

considers these license conditions adequate implementation of the intent of the

decommissioning and financial assurance rules. 

! “Emergency Preparedness for Fuel Cycle and Other Radioactive Materials Licensees,” 10

CFR Parts 30, 40 and 70 amendments (54 FR 14051) that became effective April 7,

1990. The team reviewed the assessment done by NYSH and agree that they do not

have any licensees that are subject to this requirement. Therefore, they have not

adopted this rule. 

! “Licensing and Radiation Safety Requirements for Irradiators,” 10 CFR Part 36 (58 FR

7715) that became effective July 1, 1993. The NYSH authority in this area would only

apply to large research irradiators not commercial operations. Therefore, NYSH has not

adopted 10 CFR Part 36 equivalent regulations, but has licensed a facility using the

safety requirements in their Part 16.12(f), which are equivalent to the requirements

moved from 10 CFR Part 20 to Part 36 when it was promulgated. In addition to these

safety requirements, NYSH has imposed the other Part 36 requirements through license

conditions. The team found this approach acceptable. 

! “Notification of Incidents,” 10 CFR Parts 20, 30, 31, 34, 39, 40 and 70 amendments

(56 FR 64980) that became effective October 15, 1991. The team reviewed the

requirements in Part 16.15 and identified that they do not fully address the notification

requirements in this rulemaking. The NYSH indicated that they would review this issue

further. 

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

CFR Part 20 amendment (60 FR 7900) that became effective March 13, 1995. At this

time, the NYSH does not have any licensees that use respiratory protection equipment. 

They are considering this rule in the next rule amendment package. 

! “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 35

amendments (60 FR 48623) that became effective October 20, 1995. The team reviewed

the requirements in Parts 16.123 and 16.7 and found that the objectives of the rule had

been adopted.

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

20 and 35 amendments (62 FR 1662) that became effective May 29, 1997. The team

reviewed the requirements in Parts 16.123 and 16.7 and found that the objectives of the

rule had been adopted.

The NYSH has not yet adopted the following regulations, but intends to address them in timely

rulemakings or by adopting alternate generic legally binding requirements:
New York Revised Final Report Page 36

! “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR Parts 19

and 20 amendments (60 FR 36038) that became effective August 14, 1995. 

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

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

effective January 13, 1997. 

! “Radiological Criteria for License Termination,” 10 CFR Part 20, 30, 40, and 70

amendments (62 FR 39058) that became effective August 20, 1997. 

Based on the IMPEP evaluation criteria, the review team recommends that NYSH’s performance

with respect to the indicator, Legislation and Program Elements Required for Compatibility, be

found satisfactory. 

4.1.4 New York State Department of Environmental Conservation (NYDEC) - Legislation and 

Program Elements Required for Compatibility

4.1.4.1 Legislation

Along with their response to the questionnaire, the NYDEC provided the review team with the

opportunity to review copies of legislation that affect the radiation control program. Legislative

authority to create an agency and implement a portion of the agreement with the NRC is granted

in New York State Environmental Conservation Law Articles 1, 3, 17, 19, 27, and 29. The

NYDEC is designated as the agency responsible for effluents from licensed facilities and

environmental contamination as its portion of the State's radiation control program. The review

team noted that the legislation has not changed since being found adequate during the previous

review, and found that the State legislation is adequate.

4.1.4.2 Program Elements Required for Compatibility 

The NYDEC Regulations for Control of Radiation, found in Title 6, Parts 380, 381, 382, and 383

of the New York Codes, Rule, and Regulations (NYCRR) apply to environmental releases and

the disposal of radioactive materials. The NYDEC requires a permit for release of radioactive

materials to the environment including the disposal of radioactive materials, including naturally

occurring materials, such as radium, and accelerator-produced radionuclides. 

The team examined the procedures used in NYDEC's regulatory process and found that it is a

eight step process that takes approximately 12 to 18 months. The team evaluated NYDEC’s

responses to the questionnaire and reviewed the regulations adopted by the State since the 1995

review to determine the status of the NYDEC regulations under the Commission’s new adequacy

and compatibility policy. The team found that the State addressed the following NRC regulation

amendments:

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and

61 amendments (60 FR 15649 and 25983) that became effective March 1, 1998. The

NYDEC adopted this rule by reference on July 9, 1997. The team noted that the

reference listed in Section 381.18 was as of January 1, 1996. Subsequent changes were

made to the regulation that are not incorporated by reference. The NYDEC will adopt the

more recent regulation by reference at the next opportunity to change the rule.
New York Revised Final Report Page 37

! “10 CFR Part 71: Compatibility with the International Atomic Energy Agency,” 10 CFR

Part 71 amendments (60 FR 50248 and 61 FR 28724) that became effective April 1,

1996. The NYDEC has adopted the DOT and NRC transportation regulations by

reference on July 9, 1997; therefore, no further action is required to make this regulation

effective on NYDEC permittees. The team noted that the incorporation by reference was

as of January 1, 1996 which does not include the corrected tables which were published

in 1996. In addition, NYDEC reference includes those items that are limited to NRC

implementation. The NYDEC is reviewing these issues and will address them in a future

rulemaking, if necessary. 

The NYDEC has not yet adopted the following regulations, but intends to address them in timely

rulemakings or by adopting alternate generic legally binding requirements:

! “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR Parts 19

and 20 amendments (60 FR 36038) that became effective August 14, 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 May 16,

1996. 

! “Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air

Act,” 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9, 1997. 

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

20 and 35 amendments (62 FR 1662) that became effective May 29, 1997. 

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

amendments (62 FR 39058) that became on effective August 20, 1997. 

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

performance with respect to the indicator, Legislation and Program Elements Required for

Compatibility, be found satisfactory. 

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

The NYDL has the responsibility for commercial and industrial use of radioactive materials;

therefore, NYDL is the only New York program that has responsibility for SS&D evaluations and

is the only program reviewed under this indicator. In assessing NYDL’s SS&D evaluation

program, the team examined information provided by the NYDL in response to the IMPEP

questionnaire on this indicator. A review of all completed SS&D evaluations and supporting

documents covering the review period was conducted. The team interviewed the staff and

supervisor responsible for SS&D evaluations, and examined the staff's use of new guidance

documents and procedures.

Since the last program review, NYDL completed one SS&D evaluation in 1997, which involved a

static eliminator. NYDL has performed few SS&D reviews due to the limited number of

manufacturers (currently 3 licensees) in New York. The previous SS&D review was performed

over 6 years ago. Due to the infrequent number of SS&D reviews and types of designs of the 

SS&Ds manufactured in the State (static eliminators, small beta gauges, and tritium signs),

NYDL indicated that their SS&D program efforts are at a level that is consistent with the number
New York Revised Final Report Page 38

and types of designs of the SS&Ds manufactured by their licensees. Since only one action was

processed by the State during the review period, the team’s basis for assessing the adequacy of

the overall SS&D program was limited. 

The NYDL identified a number of guidance documents to assist in the review of SS&Ds. These

include NRC’s NUREG-1550, “Standard Review Plan for Applications for Sealed Source and

Device Evaluations and Registrations;” Regulatory Guide 6.9, “Establishing Quality Assurance

Programs for the Manufacture and Distribution of Sealed Sources and Devices Containing

Byproduct Material;” Policy & Guidance Directive 84-22, Revision 1, “What Source and Device

Designs Require an Evaluation;” and a February 2, 1996 memorandum, containing draft

regulations covering the licensing of manufacturers or initial transfers of products containing

sealed sources to general licensees, issued as standard reviewer guidance. Staff uses the

checklist from NUREG-1550 in the review of SS&Ds to determine completeness of the review. 

Also, the NYDL has available a number of additional guidance documents including national and

international standards, various regulatory guides, and SS&D workshop manuals. NYDL also

has recently received NUREG-1556, Volume 3, “Applications for Sealed Source and Device

Evaluation and Registration,” and indicated that they will incorporate it into their review

procedures. 

4.2.1 Technical Quality of the Product Evaluation Program

The team examined the one new SS&D registration certificate action and a “custom” product

evaluation along with their supporting documentation. Case-specific comments for the one

SS&D registration certificate issued by the NYDL are listed in Appendix F. The review team

suggests that NYDL consider the comments identified in Appendix F and take action as NYDL

deems appropriate.

Staff interviews indicated that the current NYDL SS&D policies and procedures were not always

used or followed during the SS&D review. The team noted three items in particular, based on

the interviews with staff:

 C The SS&D reviewers were aware that requirements existed for persons who manufacture

or initially transfer products to persons generally licensed and were aware of the February

2, 1996, memorandum. However, the SS&D reviewers did not follow this guidance and

use the draft regulations during their review.

 C Not all staff were aware of, or completely understood, the policy for reviewing Quality

Assurance and Quality Control (QA/QC) programs for manufacturers and distributors of

SS&Ds as part of licensing and during inspections using the SS&D QA/QC guide. 

 C Both reviewers placed primary emphasis on the use of the checklist in NUREG-1550 as

an all inclusive review document and placed less emphasis on its use as a guide to

identify areas requiring additional detailed review. 

The team recognized that the NYDL program has a small subset of the types of sources and

devices covered by the NRC guidance documents and procedures. The development of custom

procedures based on the NYDL regulatory needs and practices would clarify the review process. 

The review team recommends NYDL establish and use customized procedures for conducting

SS&D reviews based on the guidelines presented in the SS&D Workshop and tailored to NYDL’s

types of SS&Ds, specific policies, requirements, and regulations. The guidelines should also
New York Revised Final Report Page 39

identify what actions NYDL would take in the event they receive an SS&D request that is outside

of those covered by the customized procedures.

There was not a consensus among the NYDL reviewers and management as to what constitutes

a concurrence review and none of them indicated an understanding consistent with MD 5.6. The

concurrence review performed for the registration certificate relied heavily on the work of the first

reviewer and the completeness of his review (as indicated by the checklist). The NYDL’s

practice of allowing the reviewers to work closely and jointly on the safety evaluations tends to

preclude the independence of the concurrence reviews. The review team recommends that

NYDL establish a clear policy for what constitutes a concurrence review in accordance with

guidelines in Management Directive 5.6.

4.2.2 Technical Staffing and Training

The NYDL reported that two staff members currently have authority to conduct and sign SS&D

evaluations. The Supervisor is responsible for oversight of the SS&D evaluation program, but

does not perform technical evaluations of SS&D actions. However, it is standard practice for the

Supervisor to review all documents (including SS&D certificates) prior to issuance. Both

reviewers have science degrees at either the bachelors or masters level with additional training

in health physics. Both reviewers have attended NRC’s SS&D Workshop and staff are well

trained in health physics principles. Neither staff member, however, has previous on-the-job

experience performing safety evaluations of products and through interviews, the team learned

that neither staff member has formal training or prior design analysis experience in all areas

listed in MD 5.6. To address this issue, the Supervisor indicated that the use of qualified

engineering staff in another division has been proposed and was under consideration. This

option was used with limited success during the “custom” review. The Supervisor indicated that

the process for requesting additional technical assistance with engineering subjects was also

under review and possible revision. In addition, NYDL indicated that hiring additional reviewers

who already have demonstrated qualifications to perform SS&D reviews would not be cost

effective given NYDL’s current budget and workload. 

The team identified that there is no formal written process for authorizing reviewers to perform

safety evaluations and sign completed SS&D registration certificates, nor for a formal

determination of a reviewer’s qualifications to perform all areas of an evaluation prior to obtaining

signature authority. The NYDL practice for granting signature authority is to assign signature

authority to persons who both meet the minimum criteria for a materials licensing reviewer and

have also attended an NRC SS&D Workshop. No further evaluation of the reviewers’

qualifications is performed to ensure they meet the criteria in MD 5.6. The team noted the

purpose of the criteria in MD 5.6 is to ensure that the initial evaluation, and concurrence review,

are performed by two qualified individuals. The team also discussed the importance of having a

formal, qualification program in the SS&D area.

The review team recommends that NYDL develop a written formal SS&D training and

qualification program including minimum qualifications for signature authority. The program

should ensure that reviewers meet the qualifications listed in MD 5.6, as applicable to their

program and commensurate with the scope and complexity of the SS&Ds manufactured by their

licensees. As appropriate for the complexity of the SS&Ds manufactured by NYDL’s licensees,

SS&D reviewer training should include the following subject areas as a minimum:

-- engineering materials and their properties and uses
New York Revised Final Report Page 40

-- reading and understanding engineering drawings and blueprints

-- understanding the interrelationship of conditions of use and prototype testing, and

-- interpreting test results (e.g., prototype and performance testing)

The program should also include a demonstration by reviewers of their ability to apply these

qualifications and use applicable requirements and review guidance appropriately during SS&D

evaluation. Because NYDL receives so few SS&D evaluation requests, the team concluded it

does not have sufficient casework to conduct such a demonstration for the existing staff through

an in-house program. 

The review team recommends that NYDL 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 in the areas listed in Section 4.2.2. This training should provide the

reviewers with sufficient knowledge and understanding of these areas to perform

adequate SS&D safety reviews commensurate with the types, complexity, and radiation

hazards associated with the SS&Ds. The team indicated that on-the-job training, which

includes review critiques by more experienced SS&D reviewers, could be used to gain

additional experience in conducting reviews. The team indicated that this training would

be offered by the Branch within NRC responsible for performing SS&D reviews;

experience indicates that two weeks per reviewer is necessary. This type training could

provide the reviewers additional understanding and experience in applying SS&D

procedures and applicable regulations, and additional understanding of the application of

basic engineering principles as they apply to SS&D reviews. Alternatively, NYDL could

obtain additional needed expertise from other appropriately qualified organizations on a

case-by-case basis. The option of requesting engineering technical assistance from NRC

or other Agreement States was also discussed during the MRB meeting. 

b. If NYDL determines that maintaining SS&D evaluation authority with a staff that has

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

SS&D program to NRC.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The NYDL reported one incident involving a product failure. This incident involved a Troxler

portable moisture density gauge. A user reported that the tip of the source rod fell off following a

measurement. The manufacturer was made aware of the incident and conducted an

investigation. The manufacturer concluded that the failure was caused by abuse and lack of

maintenance and was not a generic issue. The incident file did not indicate whether the NYDL

agreed with this determination, but the NYDL took actions against the licensee to emphasize the

importance of following appropriate use and maintenance instructions. In addition, the NYDL

sent a notice to all of its portable moisture density gauge licensees also emphasizing this 

importance and modified NYDL’s inspection procedures to add a review of maintenance records

for inspections of portable moisture density gauge licensees. The team examined the NYDL’s

evaluation of this incident, and determined that relevant issues were addressed.

The IMPEP team members were unable to reach consensus on the rating for this indicator. 

Based on the IMPEP evaluation criteria in MD 5.6, the reviewer of this indicator recommended

NYDL’s performance be found unsatisfactory and the team leader recommended the
New York Revised Final Report Page 41

performance rating be found satisfactory with recommendations for improvement. When IMPEP

team consensus on an indicator rating is not achievable, the team leader recommendation is

used as the rating of record. During the MRB meeting on September 1, 1998, the MRB

requested that the team revise appropriate portions of the SS&D section to reflect the meeting

discussions. Much of those MRB discussions were directed at understanding NYDL’s position

that the rating for the SS&D non-common indicator should be satisfactory because of their

performance in the one review that was completed. The review team considered the additional

information presented at the MRB and, while there was some support for adopting the NYDL’s

position, the majority recommends, based on MD 5.6, that the rating of satisfactory with

recommendations for improvement be retained. Additionally, the MRB concurred with the NRC’s

staff initiative to review the guidance in MD 5.6 for the SS&D non-common indicator, after the

Organization of Agreement States completes its planned IMPEP-like assessment of NRC’s

SS&D program. The NYDL should consider this revision to MD 5.6 prior to developing any of the

guidance recommended by the review team. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

The New York State Department of Labor (NYDL) and the New York State Department of

Environmental Conservation (NYDEC) split responsibilities for the low-level radioactive waste

program in the State of New York. NYDL is responsible for the occupational exposure of

individuals and control of radioactive material as it affects occupational exposures. This includes

the on-site radiation control program. NYDEC is responsible for all environmental releases and

the permitting of the disposal units (design, construction, and operation of the disposal facility). 

This includes waste package receipt and inspection and temporary storage of waste prior to

emplacement in waste disposal units.

The State of New York has stopped activities for siting a commercial low-level waste disposal

site. Therefore, the programs are not staffed nor prepared to process a new license application. 

The team finds this acceptable given the status of the LLRW siting process. The State does

have two former radioactive waste disposal sites: The State Licensed Disposal Area (SDA) at

West Valley, and the Radiation Disposal Site (RDS) at Cornell University. 

The SDA is a portion of the West Valley Nuclear Services Center site and was operated as a

commercial radioactive waste disposal site. The site ceased operations in 1975, and has been

under State ownership and control. The New York State Energy, Research, and Development

Authority (NYSERDA) is the State agency responsible for the site and is permitted by NYDEC

and licensed by NYDL. NYDEC has issued three permits to NYSERDA for this site. One air

emissions permit, one Research and Development (R&D) permit for the cover design study, and

the disposal permit that limits the discharges from the disposal area itself. Now that the testing

phase of the cover study is completed, the R&D permit will soon be combined with the disposal

permit. NYDEC inspects the site on an annual basis with NYDEC staff and visits the site on a

much more frequent basis. The team reviewed the latest inspection report (June 4, 1997, see D4) and found the inspection thorough and timely. The disposal area has been covered with the

R&D cover or a synthetic membrane cover. The State is monitoring the water levels in the

trenches to determine the effect of the covers. The NYDL is responsible for the occupational

activities at the site due to a storage building with a small amount of LLRW being stored. The

NYDL inspects the site on an annual basis to determine if the materials are properly stored and if

the licensee has maintained an acceptable radiation protection program. The NYDL has

conducted these inspections during the review period. 
New York Revised Final Report Page 42

The Cornell disposal site dates back to the early radiation programs through the mid-1970's. The

NYDL has no responsibility at this site since it was not a commercial disposal site, Cornell holds

a radioactive materials license from the NYSH. The site is being remediated through a consent

order with a sister Bureau within the NYDEC other than the Bureau of Pesticides and Radiation

(BPR). The consent order includes the requirements that would be imposed by a permit from

BPR. Upon completion of all activities under the consent order, BPR will issue a permit for the

ongoing monitoring activities for this site. The site has been partially remediated by covering the

waste disposal area with a synthetic cover and a layer of soil to protect the synthetic cover. 

There is still ground water remediation needed for non-radiological contamination at the site. 

The Cornell site is inspected on an annual basis. The team reviewed the last inspection and

determined that the scope and quality of inspection was appropriate. 

Based on the IMPEP evaluation criteria, the review team recommends that NYDL’s and

NYDEC’s performances with respect to the indicator, Low-level Radioactive Waste Disposal

Program, both be found satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team, following review by the MRB for three of

the programs, found that the performance of the four New York agreement programs with

respect to each of the performance indicators to be mixed with 23 satisfactory, and 4 satisfactory

with recommendations for improvement. The most significant concerns were associated with the

NYCH program. Accordingly, the review teams original recommended finding for the New York

program, adequate, but needs improvement, and compatible with NRC’s program, was changed

by the MRB to a preliminary finding of adequate to protect public health and safety and

compatible with NRC’s program. This preliminary finding was re-evaluated at the September 1,

1998 MRB meeting for the fourth program (NYDL) and the MRB finalized the overall finding to be

adequate to protect public health and safety and compatible with the NRC’s program. The

review team recommends that a follow-up review be scheduled in one year for the NYCH

program to assess the progress of the program in implementing their responses to the

recommendations in this report. At the September 1998 MRB meeting, the MRB did not object to

the follow-up review for the NYCH program. The review team recommended that the next

IMPEP review for the New York agreement program be in four years. The MRB agreed with this

recommendation.

Below is a summary list of suggestions and recommendations, as mentioned in earlier sections

of the report, for evaluation and implementation, as appropriate, by the individual programs.

NEW YORK CITY DEPARTMENT OF HEALTH (NYCH)

RECOMMENDATIONS:

1. The review team recommends that the NYCH correct the software anomalies that limit

NYCH’s ability to effectively track licenses for inspection, set and adhere to yearly

inspection goals, and communicate NYCH management’s expectations with regard to

inspection goals, such that NYCH is able to eliminate all overdue inspections. 

(Section 3.1.1)

2. The review team recommends that all initial inspections of licensees be performed within

six months of license issuance or within six months of the licensee’s receipt of material
New York Revised Final Report Page 43

and commencement of operations, consistent with IMC 2800 and NYCH policy. (Section

3.1.1)

3. The review team recommends that NYCH inspectors follow the guidance in the NYCH

inspection procedure manual which includes the information necessary for properly

documenting violations. (Section 3.2.1)

4. The review team recommends that NYCH inspectors follow the guidance in NYCH

inspection procedure manual which emphasizes the use of performance-based inspection

techniques rather than compliance-based techniques and provide training to its

inspectors through NRC’s Inspecting for Performance Materials Course or similar course. 

(Section 3.2.1)

5. The review team recommends that NYCH 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. 

(Section 3.3.1) 

6. The review team recommends that NYCH review the staff’s training against their training

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

necessary training, as appropriate. (Section 3.3.1)

7. The review team recommends that NYCH notify NRC of significant reportable events and

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

(Section 3.5.1)

8. The review team recommends that NYCH place the regulatory changes agenda and

establish specific schedules to address the regulatory changes in Section 4.1.1.2 within

three years of the regulations becoming effective NRC rules. (Section 4.1.1.2)

SUGGESTIONS:

1. The review team suggests that NYCH establish a policy that the results of all Tribunals

for their licensees be placed in the appropriate inspection files. (Section 3.2.1)

2. The review team suggests that NYCH consider documenting how the SS&D conditions of

use were addressed for the two gamma knife licenses and will be addressed in future

licensing action. (Section 3.4.1) 

3. The review team suggests that NYCH list the date the licensing action is issued (date of

fee payment) on the license and in their database, instead of the date of management

signature. (Section 3.4.1)

4. The review team suggests that NYCH investigated incidents be clearly documented in the

field notes at the next inspection. (Section 3.5.1)

5. The review team suggests that NYCH include written documentation that the alleger has

been contacted regarding the results of NYCH’s findings into the alleger’s concerns. 

(Section 3.5.1)
New York Revised Final Report Page 44

NEW YORK STATE DEPARTMENT OF LABOR (NYDL)

RECOMMENDATIONS:

1. The review team recommends that NYDL perform initial inspections of licensees within

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

activities. (Section 3.1.2)

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

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

(Section 3.3.2)

3. The review team recommends that NYDL notify NRC of significant reportable events and

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

(Section 3.5.2)

4. The review team recommends that NYDL management take appropriate action to move

the rule package through the rule promulgation process. (Section 4.1.2.2)

5. The review team recommends NYDL establish and use customized procedures for

conducting SS&D reviews based on the guidelines presented in the SS&D Workshop and

tailored to NYDL’s types of SS&Ds, specific policies, requirements, and regulations. The

guidelines should also identify what actions NYDL would take in the event they received

an SS&D request that is outside of those covered by the customized procedures. 

(Section 4.2.1)

6. The review team recommends that NYDL establish a clear policy for what constitutes a

concurrence review in accordance with guidelines in Management Directive 5.6. 

(Section 4.2.1)

7. The review team recommends that the NYDL develop a written formal SS&D training and

qualification program including minimum qualifications for signature authority. 

(Section 4.2.2)

8. The review team recommends that NYDL 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 in the areas listed in Section 4.2.2. This training

should provide the reviewers with sufficient knowledge and understanding of

these areas to perform adequate SS&D safety reviews commensurate with the

types, complexity, and radiation hazards associated with the SS&Ds. The team

indicated that on-the-job training, which includes review critiques by more

experienced SS&D reviewers, could be used to gain additional experience in

conducting reviews. The team indicated that this training would be offered by the

Branch within NRC responsible for performing SS&D reviews; experience

indicates that two weeks per reviewer is necessary. This type training could

provide the reviewers additional understanding and experience in applying SS&D

procedures and applicable regulations, and additional understanding of the

application of basic engineering principles as they apply to SS&D reviews. 
New York Revised Final Report Page 45

Alternatively, NYDL could obtain additional needed expertise from other

appropriately qualified organizations on a case-by-case basis. The option of

requesting engineering technical assistance from NRC or other Agreement States

was also discussed during the MRB meeting. 

b. If NYDL determines that maintaining SS&D evaluation authority with a staff that

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

return the SS&D program to NRC.

SUGGESTIONS:

1. The review team suggests that the NYDL management consider whether additional

staffing is warranted when considering the impacts of the licensing and inspection

workloads, the regulation development needs, and the SS&D program improvement

needs. (Section 3.3.2)

2. The review team suggests that NYDL continue to audit their financial assurance files to

ensure that they contain all required information and are current with NYDL requirements. 

(Section 3.4.2)

3. The review team suggests that, when each allegation is completed and closed out, 

NYDL update their allegation tracking system accordingly to reflect the actual status for

all allegations. (Section 3.5.2)

4. The review team suggests that NYDL consider the comments identified in Appendix F,

and take action as NYDL deems appropriate. (Section 4.2.1)

GOOD PRACTICES:

1. The review team noted a good practice in that NYDL’s inspection field notes and

inspection correspondence are peer reviewed by one of the senior inspectors to assure

consistency, thoroughness, and quality of reports. (Section 3.2.2)

NEW YORK STATE DEPARTMENT OF HEALTH (NYSH)

RECOMMENDATIONS:

1. The review team recommends that NYSH modify to its 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 IMC 2800. (Section 3.1.3)

2. The review team recommends that NYSH notify NRC of significant reportable events and

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

3.5.3)
New York Revised Final Report Page 46

SUGGESTIONS:

1. The review team suggests that NYSH’s inspection documentation of exit meetings should

contain substantive discussions of issues with the Radiation Safety Officer (RSO) and/or

licensee management. (Section 3.2.3)

2. The review team suggests that NYSH incorporate a field for documentation of

interviewing ancillary personnel, authorized users, technicians, and RSOs into their

field notes. (Section 3.2.3)

3. The review team suggests that the NYSH inspectors attend additional training in

inspecting for performance techniques. (Section 3.2.3)

GOOD PRACTICES:

1. The review team considers monthly TeleVideo conferences to be a good practice to bring

and keep their staff current on health physics and program issues. (Section 3.3.3)

NEW YORK STATE DEPARTMENT OF ENVIRONMENTAL CONSERVATION (NYDEC)

RECOMMENDATIONS:

1. The review team recommends that NYDEC document its training program to include

overall policy and minimum training requirements for both the permitting and compliance

staff. (Section 3.3.4)

2. The review team recommends that NYDEC incorporate the handling of incidents and

allegations into their inspection procedures. (Section 3.5.4)

3. The review team recommends that NYDEC coordinate with the appropriate New York

licensing agency, the notification to the NRC of significant reportable events and provide

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

SUGGESTIONS:

1. The review team suggests that NYDEC maintain one file for all types of incidents

involving radioactive material. (Section 3.5.4)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B B-1 NYCH’s Organization Charts

B-2 NYDL’s Organizational Charts

B-3 NYSH’s Organizational Charts

B-4 NYDEC’s Organizational Charts

Appendix C C-1 NYCH Inspection File Reviews

C-2 NYDL Inspection File Reviews

C-3 NYSH Inspection File Reviews

C-4 NYDEC Inspection File Reviews

Appendix D D-1 NYCH License File Reviews

D-2 NYDL License File Reviews

D-3 NYSH License File Reviews

D-4 NYDEC License File Reviews

Appendix E E-1 NYCH Incident File Reviews

E-2 NYDL Incident File Reviews

E-3 NYSH Incident File Reviews

E-4 NYDEC Incident File Reviews

Appendix F NYDL Sealed Source and Device Reviews

Attachment 1 February 17, 1998 letter from Mr. K. Daniel, Jr., NYCH

Attachment 2 New York Programs’ Comments on the Draft IMPEP Report

Attachment 3 NYDL Comment Letter on Revised SS&D Section and NRC

Comment Analysis
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

New York City Department of Health, Bureau of Radiological Health (NYCH)

Name Area of Responsibility

Dennis Sollenberger, OSP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for 

 Compatibility

Duncan White, RSAO, Region I Response to Incidents and Allegations

Technical Quality of Inspections

Michael Stephens, Florida Technical Quality of Licensing Actions

Jamnes Cameron, Region III Status of Materials Inspection Program

Technical Quality of Inspections

New York State Department of Labor, Radiological Health Unit (NYDL)

Name Area of Responsibility

Dennis Sollenberger, OSP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for 

 Compatibility

Low-Level Radioactive Waste Disposal Program

Duncan White, RSAO, Region I Technical Quality of Licensing Actions

Technical Quality of Inspections

James McNees, Alabama Response to Incidents and Allegations

Technical Quality of Inspections

Douglas Broaddus, NMSS Sealed Source and Device Evaluation Program

Lance Rakovan, OSP Status of Materials Inspection Program
New York Final Report Page A.2

IMPEP Review Team Members

New York State Department of Health, Bureau of Environmental Radiation Protection

(NYSH)

Name Area of Responsibility

Dennis Sollenberger, OSP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for 

 Compatibility

Duncan White, RSAO, Region I Status of Materials Inspection Program

Response to Incidents and Allegations

Lee Cox, North Carolina Technical Quality of Inspections

Jacqueline Cook, Region IV Technical Quality of Licensing Actions

New York State Department of Environmental Conservation, Bureau of Pesticides and

Radiation (NYDEC)

Name Area of Responsibility

Dennis Sollenberger, OSP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for 

 Compatibility

Low-Level Radioactive Waste Disposal Program

Duncan White, RSAO, Region I Technical Quality of Licensing Actions

Response to Incidents and Allegations

Inspector Accompaniments

Allen Grewe, Tennessee Status of Materials Inspection Program

Technical Quality of Inspections












Attachment 2

New York Programs’ Comments on the Draft IMPEP Report
Mr. Richard L. Bangart -22- July 15‘1998

(Section 3.3.1)

5. The Bureau has had documentation of overall policy and minimum training

requirements for its professional staff since the inception of the scientist

titles. (See enclosure)

6. The Bureau maintains an ongoing Training Log for each Assistant Scientist,

Scientist and Senior Scientist. This log includes all NRC courses, DOT

courses, FEMA courses, seminars and in-house training these individuals

participated in.

Please note that there is an error on page 16 of the draft team report in section

3.3.1, first paragraph. The compliance section supervisor is the senior

scientist and the field supervisor is a scientist.

(Section 3.5.1)

7. The Bureau is unaware of any instance when a significant event occurring

within New York City was not reported to NRC within 24 hours. Follow up

documentation has been provided to Region 1 and/or Headquarters as

appropriate. The NMED software has been installed in the Bureau’s standalone PC connected to the Internet.

(Section 4.1 .I -2)

8. Bureau management and NYCDOH Office of General Counsel have been

meeting to discuss upcoming rule-making requirements so that the three

year time limits for adoption can be met.

We appreciate the effort that went into issuing this complicated draft team report in

such a timely manner. If you or the review team members have any questions,

please contact Mr. Kenneth Daniel, Deputy Director, at 212/676-1558.

Sincerely,

Neal 1. Cohen, M.D.

Commissioner

enc. “Assistant Scientist (Radiation Control) Notice of Examination 11124i82”

cc: B. Mojica, M.D,

A. Goldberg

G. Miskin

R. Borri

STATE OF NEW YORK

DEPARTMENT OF LABOR

DIVISION OF SAFETY AND HEALTH

Radiological Health Unit

Building # 12, Room 134-A

State Office Building Campus

Albany, NY 12240

July 27, 1998

Richard L. Bangart

U.S. Nuclear Regulatory Commission

11555 Rockville Pike

Rockville, Maryland 20852-2738

Dear Mr. Bangart,

We have received the June 24, 1998 draft report on the recent NRC evaluation of

our program and have reviewed it for factual correctness, as requested.

Our comments regarding the factual accuracy of specific sections of the report are

attached. However, we feel that it is also both appropriate and necessary to comment on

a procedural problem that was evident during the evaluation, and which figures

prominently in the draft report.

We found the Team Leader, Dennis Sollenberger, and his associate, Duncan

White, to be highly professional in their conduct of our evaluation. They related to

myself and my staff on a peer basis, and seemed quite comfortable with the concept that

our policies and procedures need not be the same as NRC’s in order for us to achieve

equivalent or better performance outcomes: i.e., they placed primary emphasis on

performance, in keeping with the new IMPEP process philosophy.

However, there was one area of the evaluation where this philosophy was

conspicuously lacking, and this was in the review of our sealed source and device

(SS&D) evaluation program by a .member of NRC’s SS&D evaluation unit. For some

reason, this part of the review was not only not performance-based; it seemed to

deliberately ignore performance. To begin with, we were told at all three levels of exit

. meetings for this review that the SS&D registration certificate for the only SS&D

evaluation performed during the review period by our program was satisfactory, that

applicable health and safety issues had been properly addressed and that our staff are

capable, but could use more experience. In other words, our actual performance in this

area during the review period had been satisfactory. However, we were also told that the

NRC reviewer for this *‘performance” indicator who had spent the entire week analyzing

Telephone: 518-457- 1202 FAX: 5184857406

1
-2- July 27, 1998

how our staff had approached this one evaluation, their first, wanted to find us

unsatisfactory!

The reasons for his findings were incomprehensible to us at the time and remain

incomprehensible. Although the draft report modifies his findings, as a result of the team

leader’s overriding opinion, it still asserts deficiencies in our SS&D program which are

not supported by the facts or by the specific guidelines in Management Directive (MD)

5.6, and which are inconsistent with our actual performance.

For example: the draft report posits as an “issue” that neither of our SS&D

reviewers “has a strong background, through formal training and prior experience, in the

area of engineering design analysis.” However, nowhere in MD 5.6 is this criterion given

as a requirement or even as a guideline. MD 5.6 states only that evaluation of SS&D

review staffing and training should be conducted in the same manner and as part of the

Common Performance Indicator 3, except with a focus on training commensurate with

the conduct of the SS&D reviews. It then goes on to state that staff should have a

bachelor’s degree or equivalent training in the physical and/or life sciences; should be

able to understand and interpret prototype tests and results, to read and understand

blueprints and drawings, and to understand and utilize basic knowledge of engineering

materials and their properties - training and abilities which both of our reviewers have.

MD 5.6 does not specify the means by which these abilities should be acquired, nor

should it, and it most certainly does not require “formal training and prior experience, in

the area of engineering design analysis.” It is evident to us that a person who has had

such specific “formal training and prior experience” will almost certainly be a graduate of

an engineering program. It was equally evident during our IMPEP review that the NRC

reviewer was using this criterion as his personal standard for judging our staffs technical

training and experience. However, such personal preferences have no place in an

objective evaluation of a program’s performance. Nothing in the draft report supports a

factual finding that our staff do not meet the criteria listed in MD 5.6 for SS&D review

staffing and training, and we also note that our performance with regard to Common

Performance Indicator 3 was found to be satisfactory.

We are also at a loss to understand the statement made in the draft report that

“NYDL management has not put forth the effort to bring the SS&D program in line with

the specific guidelines in management Directive (MD) 5.6.” We meet every single one of

the indicators for satisfactory performance that are listed in MD 5.6, as evidenced by our

actual satisfactory performance, and this is a result of significant effort on our part.

We also disagree wholeheartedly with the report’s statements that “The NYDL

management does not feel that it is an efficient use of its resources to qualify and

maintain qualification for staff in a discipline that is infrequently needed”, and that

“Neither staff member has any previous experience performing safety evaluations of

products or similar types of evaluations, nor has worked in a related field.” As stated

above, our staff are “qualified” to perform the reviews in question, and they need not be - -

engineers in order to competently perform such reviews. Also, radioactive materials
-3- July 27, 1998

licensing, and health physics in general, is most definitely a “related field.” Both

reviewers are experienced licensing staff who have attended NRC’s training on the

conduct of SS&D evaluations, and who frequently review and critique SS&D certificates

in the process of licensing companies to use sources and devices. Contrary to NRC’s

concept of these certificates as “approvals”, we consider them simply to be sources of

information, and can and do require additional safeguards during licensing if we consider

it appropriate, as do the other NYS radioactive materials licensing agencies. In one case,

the three NYS agencies required a device to be retrofitted with an additional safety

feature before we even allowed NYS licensees to acquire and use it. Evaluating

radioactive sources and devices is not a separate and unique discipline; it is, and has

always been, a part of radioactive materials licensing and should not be a separate and

“non-common” performance indicator for IMPEP reviews.

The current IMPEP approach fails to recognize that all states and, we assume,

NRC regional offices perform “custom” SS&D evaluations, and they all respond to

incidents and accidents involving source and device product failures. Yet only state

programs that conduct non-custom SS&D evaluations have their “custom” evaluations

reviewed under IMPEP, and only they are required to evaluate the root causes of defects

and incidents regarding SS&D’s under IMPEP (including SS&D’s that they didn’t

evaluate). This is true regardless of the relative numbers of custom or non-custom

evaluations performed by a state or region, or the number of product failures involving

SS&D’s that they may have investigated. Therefore, a state or region that may have

performed a large number of custom SS&D evaluations (but no non-custom evaluations),

and may have responded to a number of incidents involving SS&D product failures,

during the IMPEP review period will not have its performance in these areas reviewed.

However, the NYDL which performed one custom and one non-custom SS&D evaluation

and responded to one SS&D product failure incident during the review period, had each

of these three actions reviewed in exhaustive detail. This is neither fair nor equitable, and

it does not promote the kind of uniform evaluation of state and regional programs, which

is one of the stated purposes of the IMPEP process.

In summary, it appears that the SS&D portion of our program evaluation was

conducted under the “old” rules for NRC evaluations, not the IMPEP approach; and that

conclusions were based on how closely our way of achieving satisfactory performance

paralleled NRC’s way, rather than on the satisfactory performance outcome itself. It also

appears that the current IMPEP approach of treating a program’s competence to perform

source and device evaluations as a non-common performance indicator is invalid, and

unfairly fails to hold all programs to the same standards.

The attachment to this letter contains our specific factual objections to statements

made in the draft report. However, we strongly urge that NRC management review the

manner in which the SS&D component of IMPEP evaluations is being addressed by NRC

staff; and especially whether staff are placing “primary emphasis on performance” as

directed. Conversations with other Agreements State programs indicate that our

experience is not unique, and that the approach being used for this one performance
-4- July 27, 1998

indicator during IMPEP reviews is not performance-based. NRC management should

also review and reevaluate the practice of treating evaluations of radioactive sources and

devices, and investigation of source and device product failures as a performance

indicator only for states that perform non-custom SS&D evaluations. This performance

indicator clearly should apply to all Agreement States and NRC regional offices.

Sincerely,

Rita Aldrich

Principal Radiophysicist

Wfdh

Enc.

cc: Peter Chiefari
-5- July 27, 1998

NYDL Comments on June 24,1998

Draft IMPEP Report

Section 3.1.2:

This section discusses the reciprocity inspections performed by the NYDL, and it

states that we do not schedule reciprocity inspections consistent with any priority

schedule, and goes on to say that we are focusing resources on inspection of our own

licensees.

However, we should have brought to the reviewers’ attention the fact that in June,

1994 we reduced our reciprocity limit to thirty days in a calendar year. As a result, the

companies that performed work in NYS with any frequency were required to apply for

and receive a license from NYS. This resulted in the issuance of 47 out-of-state licenses,

and these licensees are scheduled for inspection at the same priority interval as our instate licensees. Therefore, the companies we would be most concerned about, due to the

scope of their operations in NYS, no longer operate under reciprocity and are inspected

by this agency on a regular basis.

We would also like to make a comment on the draft report’s statement that

“reciprocity licensees should be inspected to assure the health and safety of both radiation

workers as well as the public.” Since any member of the public reading this statement

might find it alarming, the statement should be deleted or appropriately qualified.

“Reciprocity licensees” are inspected -by the agency that issued their license. We give

reciprocity based on the understanding that such licensees are regulated by their licensing

authorities as stringently as we regulate our licensees, including regular inspections by

those authorities to assure that these companies operate in a manner that assures the

health and safety of radiation workers and the public. Indeed, one of the purposes of the

Agreement State Program is to provide a basis for confidence in granting reciprocity. We

require advance notification by companies wishing to enter the state under reciprocity, to

afford us the opportunity to inspect their operations if we so choose. This is a matter of

discretion on our part - not a responsibility. Our first obligation is the inspection of

companies licensed by this agency.

NRC should also consider the resource implications of their position on

inspection of reciprocity licensees. If an industrial radiography licensee is inspected

annually by a state that issued their license, and in the course of a year does work under

reciprocity in three other Agreement States and in NRC jurisdiction, is it an intelligent

use of limited resources to have them inspected four additional times in that year? The

performance of reciprocity inspections is a matter that must be left to the judgment of the

authority that grants reciprocity, and each authority must have the latitude to make its

judgements based on its own priorities and the availability of resources.
-6- July 27, 1998

Section 3.3.2:

This section states that our staffing and training will be impacted by ’

recommendations made further on in the draft report for “significant additional training”

of our SS&D staff. Since, as stated in our cover letter, our staff are already appropriately

trained, we do not expect routine ongoing training in this area to impact on staffing

resources.

The section also states that to be considered for a position in this program, an

individual must have a bachelor’s degree in science and at least one year of experience.

This is incorrect in that a candidate must have three years of specific qualifying

professional experience. Also, twenty-four graduate credit hours in radiological science

may be substituted for up to one year of the experience.

The section also states that there is no written training policy although the

program had committed in a memo to upper management to follow the recommendations

of the NRUOAS Training Working Group Report, and goes on to state that one staff

member should attend an industrial radiography course and that other staff desired

additional training in internal dosimetry and the conduct of decommissioning surveys.

The program is located in the NYDL’s Division of Occupational Safety and

Health, and all programs in the Division prepare overall training plans, annual training

plans and annual training and conference timelines. The report of the NRCIOAS

Working Group was submitted to Division management as our program’s overall training

plan, and we have also submitted annual plans and timelines which are specific to the

training planned for a particular year and also contain topical meetings and conferences

we plan to attend. All formal training completed by program staff is documented in a

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

mentoring staff person. These documents constitute our written training policies and

plans.

Section 3.4.2:

This section comments on an NRC review of financial assurance documents

submitted by licensees, especially one case in which a document was a copy rather than

the original. We have since been advised by our finance office and by counsel, that we

do not need original documents but do need original signatures and that a standby trust is

not required by the State of New York for surety bonds. We are continuing our review of

financial assurance documents on file, but our policy on licensees that no longer need

financial assurance, due to changes in operations or changes made in our regulations in

1994, is to advise them of this during license renewals.
-7- July 27, 1998

Section 3.5.2:

This section discusses our reporting of incidents requiring immediate or 24-hour

reporting to us by licensees, to NRC. It also states that during the review period we made

only one “summary report” of incidents to NRC, and describes our reporting as

“inconsistent.”

However, of the thirteen incident files reviewed by NRC during this IMPEP, only

four required immediate or 24-hour notification to our program by licensees under current

regulations. In spite of this, five of the thirteen incidents were reported to NRC, and four

of the thirteen were reported to other Agreement States having a regulatory involvement.

We consider that quite consistent.

The “summary report” referred to was not a report of “immediate or 24-hour

incidents”, it was simply a printout of our computer database for all of the incidents

(reportable or not) that occurred during a one year period. Periodically we receive a

request from NRC for this data and are happy to provide it.

We will continue to share information on incidents of concern to NRC and the

states to these agencies.

Section 4.1.2:

This section discusses regulations that NRC desires the state to adopt or to enforce

by alternate legally binding requirements. However, it focuses on a rulemaking package

that had been under review by counsel at the time of the IMPEP as the only means to

accomplish this. The package has since been approved by counsel’s office, which had

been otherwise tied up with the review of a number of emergency rulemakings.

This section should be modified to acknowledge that the NYDL is effectively

implementing the requirements in question, during the licensing and inspection of

relevant facilities through the use of licensing guides, license conditions and inspection

reports and checklists. This would also make the draft report internally consistent, since

Section 2.0 closes out a recommendation from the previous review through a finding that

we are implementing one of the regulations in question through licensing and inspection

protocols.

Section 4.2:

This section is a four-page discussion of our SS&D evaluation program and the

one SS&D evaluation performed since the current program manager took over the

program in 1993. The staff member who had previously performed these evaluations

retired early in 1994, and this unit began petitioning NRC to provide training in the

conduct of these evaluations since NRC was the sole arbiter of what a satisfactory

evaluation was. In September 1995, NRC did hold a training workshop on the evaluation
-8- July 27, 1998

of SS&D’s and two of our staff attended. In a follow-up letter to our Commissioner

dated October 27, 1995, the Director of the Office of State Programs, Richard Bangart,

stated that as a result of the workshop “we believe that sufficient instruction and reference

information was provided to Agreement State staff to enable them to conduct adequate

SS&D evaluations.” This was a reasonable statement, especially if the staff in question

had good health physics backgrounds and solid radioactive materials licensing

experience, which our staff did. Therefore, this combination of training, knowledge and

experience constituted our qualification program for staff who would perform SS&D

evaluations.

We are now being told that we must establish an elaborate program for “signature

authority” for these evaluations, in a qualification program in which reviewers are to

“complete a sufficient number of cases which are critiqued by a qualified SS&D

reviewer.”

We have already commented in our cover letter that the NRC reviewer for this

indicator seemed to be comparing our program to his personal preferences rather than to

something reasonably approximating the contents of MD 5.6 for this and similar

indicators. We have never been asked for a similar elaborate program for “signature

authority” for licensing in general (and SS&D evaluations are a part of licensing), or for

inspection correspondence; nor does the phrase “signature authority” have any meaning

in our program. The NYDL is responsible for the actions of all Department staff while

they are acting in their official capacities. It is the responsibility of the program manager

to authorize staff to perform specific functions, and at what level of independence they

may operate. For example: all current inspection staff are authorized to sign final

inspection letters, only myself and one staff member are authorized to sign licenses and

only two staff members are authorized to perform SS&D evaluations. Licensing actions

and SS&D evaluations also require a concurrence review and sign off by designated staff.

These concurrence reviews include an independent technical review of the materials

submitted by the applicant, and the documents prepared by the initial reviewer (but not to

the same level of detail as the initial review and do not involve a review of every page of

the applicant’s submittal) and address each area addressed in the initial review.

Concurrent reviewers must make an independent determination that the documents

prepared by the initial reviewer address all relevant health and safety issues, are wellsupported by the material submitted by the applicant, that all regulatory requirements are

met, that the draft documents are clear and complete and that it is safe and appropriate to

issue them in final form. Typically, a checklist is used to assist in ensuring that all

necessary topics are covered and to document the consistency of reviews. However, we

have no prohibition against collaboration between the initial and concurrence reviewers,

and this is true for both licensing and SS&D actions. In the case of unusual or infrequent

actions I encourage as much dialogue and collaboration as possible since we find that this

helps to surface issues and improve our final product, as well as to provide maximum

experience benefit to the reviewers. In the case of this first SS&D evaluation, the two

reviewers approached it as a team effort, with the concurrence reviewer fully involved as

the work progressed. However, a full concurrence review was performed; the reviewer
-9- July 27, 1998

evaluated each area addressed during the initial review, following the same checklist and

referring back to the applicant’s submittal; the reviewer focused on ensuring that the

SS&D met all requirements, would not pose health or safety concerns and that the draft

registration certificate provided an adequate basis for licensing. This meets all the criteria

in MD 5.6.

Appendix F of the draft report contains specific comments by the review team on

the one non-custom SS&D evaluation reviewed. Our response to each of these comments

is contained in the attached memo from Clayton Bradt to myself, which itself includes

attachments.

There are also three particular items raised in the draft report that are based on an

hours-long question and answer session conducted separately with each of our two

reviewers by the NRC SS&D team member. One item faults the reviewers for not

reviewing our draft regulations for GL manufacture and distribution duiing the SS&D

evaluation, although it is also stated that the reviewers were aware of the relevant

requirements and no specific deficiency is alleged to have resulted. Another item faults

the concurrence reviewer because he “was not aware of the policy to review QA/QC

programs during the licensing review, and assumed that the first reviewer adequately

reviewed the QA/QC program.” This was a matter of memory. The concurrence review

was conducted several months before this interview and the reviewer did not recall that it

was noted on the review checklist that the QA/QC program review was done as part of

the license renewal, and he himself had not done a renewal of one of our three

manufacturing licenses. The third item faults both reviewers because they “relied heavily

on the checklist in NUREG- 1550 to identify specific items that should be

reviewed.. .rather than using it as a guide to help identify areas that should be evaluated”,

and goes on to say that additional guidance documents and regulations should have been

consulted “to identify specific items that must be evaluated” or addressed. We disagree

with the NRC reviewer’s concept of a checklist and can find no items or areas that we

failed to evaluate as a result of its use. We like the checklist, believe that it served our

needs and are working on modifying it to make it even more useful. As stated earlier, we

use checklists in all of our licensing activities, including SS&D evaluations, and find

them very useful. We would also quote from the third paragraph of Section 4.2 of the

draft report, which states “Staff uses the checklist from NUREG- 1550 to assist in the

review of SS&D’s, and help ensure that all pertinent issues are addressed.” That is

correct.
‘THE CITY OF NEW YORK

DEPARTMENT OF HEALTH

O-ICE OF THE COMMISSIONER

125 WORTH STREET July 15,1998

NEW YORK, NY 10013

Richard L. Bangart, Director

Office of State Programs

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001

Dear Mr. Bangart:

Ntit & CQkEN, ti0.

COMWISSIONER

TEL (2 12) 766.b26 1

FAX (2 12) 964-0472

The following responses are being made by the New York City Bureau of

Radiological Health to the IMPEP draft team report dated June 24,1998.

(Section 3,1 .l)

1. The software anomalies of our RAD database have been cleared up.

Management can now call up inspections due on a weekly, monthly and yearly

basis, in addition to being able to ascertain which licenses have been

inspected for these periods.

2. The initial inspection is now being scheduled when the new license is mailed

out. This is accomplished through the RAD database with a “Need

Inspection” activation button or code. The new license is then included in the

inspections due list that is reviewed on a monthly basis by the radioactive

materials field supervisor in charge of scheduling.

(Section 32.1)

3. As pointed out, the procedures for properly documenting violations are

included in our inspection procedure manual. In-services, in addition to

supervisory review, are being stepped up to ensure that inspectors are fully

aware of these procedures. A radioactive materials inspection log has been

developed as an addition to the inspection forms that includes NOV # and

date of hearing and results of the hearing.

4. The in-services mentioned above will include emphasis on performancebased rather than compliance- based inspections. The Bureau has obtained

the “Inspecting for Performance Materials” student manual from NRC which

will be used as a classroom resource for the in-services. The Bureau is also

pursuing the feasibility of incorporating projected training fund requirements

for professional staff in upcoming fee schedule revisions.

-
0 STATE OF NEW YORK . ‘I, DEPARTMENT OF HEALTH

II University Place

Barbara A. DeBuono, M.D., M.P.H.

Commissioner

Albany, New York X2203-3399

Dennis P. Whalen

Executive Deputy Commissioner _ .

Dennis Sollenberger, Ph.D.

Mail Stop 0-3-H-20

Office of State Programs

US Nuclear Regulatory Commission

Washington, DC. 20555

July 20,1998

Dear Dr. Sollenberger:

Enclosed are our comments on the draft report ‘Integrated Materials Performance

Evaluation Program, Review of New York Agreement State Program, January 26-April24,

1998.” These comments address editorial changes that we feel should be made to the report.

We also plan to submit a separate response to the recommendations made by the team in the

report.

I would like to emphasize the point that is included in the attached comments, on the need

to maintain confidentiality of facilities reporting medical misadministrations to our department.

This confidentiality is required by New York State Public Health Law, and therefore, we ask that

all identifiers to licensees that reported such misadministrations to us be removed from the

IMPEP report, as well as from all other NRC reports or documents available to the public.

If you have any questions, or need additional information, contact Steve Gavitt at

5I8/458-6485.

Sincerely,

Karim Rimawi, Ph.D., Director

Bureau of Environmental Radiation Protection

CC: Stephen Gavin
NYS Department of Health

Comments on draft IMPEP report

The following comments concern only those portions of the draft IMPEP report relating to New

York State Health Department program:

Page 8 The report indicates that there are 24 overdue inspections of new licensees (out of

34 reviewed), however there is no mention of the significance of these findings.

For example, seven of these overdue inspections are former General Licensees

(which are not inspected by NRC) which we decided to convert to specific

licensees for tracking purposes; one is a depleted uranium licensee; three licensees

where not overdue since the facilities did not have materials on-site until

sometime after the license issuance date (this information is contained in the

license file); and two licenses were inspected previously but a change in

ownership initiated a new license to the new owners but the facilities and

equipment remained unchanged.

Page 24 The report notes that certain standard conditions are in some licenses but not

others. It then goes on to indicate a potential problem - “a license reviewer

informed the team that this standard condition should be put on all licenses.” But

it is then resolved - “As this issue was pursued, the team was then informed that

this standard condition is now in the regulations.” It is unclear as to the

significance of the above. When a standard license condition is made into a

regulation it is taken off the licenses as they are renewed. Therefore licenses that

have not been renewed will have the condition until their renewal. We do not

believe this is a problem.

In the same paragraph there is a focus on our “list of standard license conditions.”

This list is just a compilation of all various license conditions. We do not use this

list to generate licenses. Licenses are not created from a blank document. Each

category of license has its own “boilerplate” that is kept up to date with all

applicable license conditions. When a new license condition is created, it is

added to the appropriate “boilerplate” and to our list of standard license

conditions. When a license condition becomes obsolete it is deleted from the

boilerplate but not from the “list”. So while it is true our list of standard license

conditions contains outdated conditions - this does not affect our licensing process

and has no significance.

Page 36 We did adopt the “Criteria for Release of Individuals Administered Radioactive

Materials” see section 16.123 of Part 16.

Appendix E-3 Please note that NYS law prohibits the disclosure of the name of any facility that
I - -

provides reports pursuant to Part 405. Therefore you cannot print the name,

location and license # for files nos. 6,7,8, and 9 in Appendix E-3 and we ask that

these be removed from all copies of the reports and any other public documents

NRC issues or maintains. File no. 1 is allowed since we took an enforcement

action against this licensee and that information is available for public review.

Page 18 There are 4 field offices (Buffalo, Rochester, Syracuse and New Rochelle) and the

main office.

Page 19 We do have a written training policy which was provided to the IMPEP team

(copy attached).

Page 19 We only have one CHP in the program. Six others passed Part I of the

certification exam last year, four of whom were eligible and took Part II this year.
BERP INSPECTOR QUALIFICATION PROCEDURE

-01 PURPOSE

01.01 To provide training guidelines for personnel to achieve

initial qualification as an inspector through local, formal

classroom, and on-the-job training.

01.02 To identify mandatory and optional requirements for

inspectors after achieving initial inspector qualification status.

01.03 To provide additional training opportunities for the

experienced inspector in identified specialty areas.

-02 OBJECTIVES

02.01 To ensure that inspectors meet minimum knowledge and

qualification standard.

02.02 To provide a standardized methodology for determining that

an inspector has met the minimum training requirements.

-03 POLICY

Inspector personnel must understand the facilities, processes, and

activities for those areas they inspect in addition to the

criteria, techniques, and mechanics of inspection. They must also

be keenly aware of the potential for negative impact on safety if

the inspection process is allowed to become overly intrusive in

areas of operation where problems are not occurring. In addition,

the inspector must be sensitized to the potential for negative

regulatory impact. Newly hired personnel seldom possess all of

these required qualifications. Therefore, formal classroom, selfstudy, and on-the-job training are needed to ensure that the newly

hired inspector obtains the required knowledge and understanding

necessary to be considered qualified to implement the inspection

program.

Each inspector must complete the appropriate required training

outlined in Appendix A of this procedure or verify, through

successful completion of a written equivalency examination, that

the desired level of knowledge in a particular specialty area has

been obtained. Training requirements for new inspectors will be

documented by the Bureau of Environmental Radiation Protection in

a Qualification Journal which is identified in Appendix B of this

chapter. Completion of the Training and Qualification Journa'l

constitutes the minimum inspector qualification requirements, and

encompasses regulatory, administrative, and technical practices

pertinent to each area of inspection. Other requirements such as
Page 2

local training may be used to supplement or enhance training. The

passing grade for each course examination or equivalency

examination is 70%.

Once an inspector has completed the training identified in Appendix

A, that inspector will be evaluated by the appropriate Section

Chief or Field Supervisor to determine that the minimum

requirements are met.

In a situation where qualification is delayed as a result of an

inspector not being able to schedule certain formal training

courses, or for other time restraint consideration, the appropriate

Section Chief,.the BERP Field Supervisor or Bureau Director (or his

delegate) may provide interim qualification for those areas where

the inspector is considered qualified.

Inspectors who are receiving on-the-job training in preparation for

meeting qualification requirements, can perform inspection

activities under the direction of an inspector. With the exception

of inspectors who are receiving on-the-job training, an inspector

is expected to be qualified for the area being inspected. In some

cases where an inspector has taken most but not all of the required

training, this may require the issuance of interim qualification.

An inspector who changes disciplines or is assigned to perform

inspections in additional areas of discipline, must meet the

training and qualifications requirements for the new discipline.

It is expected that similar training requirements between

disciplines will not have to be repeated, and credit for the

previous similar training will be indicated in the current

qualificatfon journal.

This procedure and qualification journal are periodically revised

to reflect the training needs of inspectors as determined by

changes to the inspection procedures. An inspector that is

qualified prior to the time any revisions are made to th'is

procedure will continue to remain 'qualified. The supervisor of a

qualified inspector will determine whether or not the inspector

should take new courses added to this procedure as they are

offered. This determination is based on the inspector's prior

work experience and current inspection activities.

Special circumstances (e.g., training opportunities) may make it

impossible to provide employees with required formal classroom

training within the time frames specified in Appendix A. When this

occurs, the appropriate Section Chief will issue a memorandum

indicating the affected training courses, circumstances involved,

and reinstatement dates. If a new or proposed course listed in

the procedure is not available at the time an inspector. has

satisfied all other requirements, and the course is not critical

to performing fnspectfons as a qualified inspector, certfficatfon
I

I

.

may be given with the condition that the remaining course

requirement be satisfied when the course is “next available. ”
Page 3

Temporary instructions (TIs) that focus on speciffc "Area of

Emphasis" may require special training requirements for Inspectors

prior to their performing the inspection. These special training

requirements will be identified by the appropriate Section Chief,

The schedule for preparation of any special training should allow

enough lead time to prepare the required training course and

implement it prior to inspection being performed using the TI.

-04 DEFINITIONS

COURSE SERIES. A progressive sequence of courses in a particular

technology.

Equivalency Examination. An Examination administered in lieu of

specific course attendance.

On-Site Training. Required training for inspectors designed to

thoroughly acquaint the inspector with specific site systems,

structures, and management organization.

Required Training. Formal classroom and on-the-job training

representing the minimum acceptable level of knowledge in a given

field.

Supplemental Training. Additional training courses beyond those

identified for "Required Training.' The additional courses will

be determined by the inspector's supervisor and will depend on the

inspector's previous work experience and planned inspection

activities in specific area.

Refresher Training. Required training designed to update and

maintain qualification.

Training and Qualification Journal. A document that establishes

the minimum training requfrements for formal classroom instruction,

on-the-job training, local training sessions, and self-study. This

document establishes the basic generic training requirements for

inspector types identified in Appendix A, and lists the

qualification journals in Appendix B.

Interim Qualfffcation. Qualification of an inspector by the

Bureau Director or Section Chief or Field Supervisor (or his

delegate) to conduct independent inspections in specified areas of

the inspection program before that inspector completes all required

training.
Page 4

-05 RESPONSIBILITIES AND AUTHORITIES

05.01 Director, Bureau of Environmental Radiation Protection

establishes the training requirements for inspector positions

listed in Appendix A.

05.02 Section Chiefs/Field Supervisor, Bureau of Environmental

Radiation Protection, ensure that inspectors achieve and maintain

qualifications in accordance with the guidelines provided in this

procedures.

-06 TRAINING ACTIVITIES

06.01 All staff whose principal job assignment is to perform

inspections in their assigned areqs of expertise, must successfully

complete the training requirements for their individual inspection

areas as listed in Appendix A.

a. Written examinations may be used to determine whether

inspectors have obtained the 70% level of knowledge and

understanding.

b. Inspectors who fail courses may be given the opportunity to

acquire the knowledge level required through self-study and

re-examination or to repeat the course.

C . Program management assumes that inspectors possess the

necessary motivation and ability to achieve such a level of

knowledge and understanding. In the rare situation where

such is not the case, program management will decide what

action to take on an individual basis.

06.02 classroom and simulator training are designed to supplement

the inspector's education, experience, and on-the-job training by

providing basic theory and knowledge as well as job related

techniques.

-07 BERP TRAINING AND QUALIFICATION JOURNAL

07.01 The BERP is responsible for developing and maintaining the

Training Qualification Journal. The use of the Journal is

described in Appendix B of this chapter.

07.02 The BERP Journal provides the minimum training

requirements to develop Training and Qualification Journals. Newly

hired inspectors, except those in the intern program, will have a

detailed series of activities and study areas to be completed in

a specific period, usually within the first 2 years of employment.

I

1 .

PAGE 6

-10 INTERIM INSPECTOR QUALIFICATION

In general, only those inspectors who have successfully completed

the required training will be allowed to independently perform

inspections. However, if responsible management evaluates the

background and performance of an individual inspector and concludes

that the inspector has demonstrated an ability to perform

inspections in specific areas, even though the required training

has not been completed, the Section Chief, the BERP Field

Supervisor or Bureau Director, or designee as appropriate, can

authorize the individual to perform inspections in those areas.

When this approach is used, the successful completion of the

training is still required to be completed within the time limits

specified.

It is not the intent of this procedure to require persons to

participate in each of the defined training activitfes if they

already possess the type and level of knowledge that would be

achieved by completing the prescribed training. If inspectors,

when hired, through previous work experience and training, are

deemed to possess the appropriate knowledge level for a prescribed

training area, then equivalency examination(s) may be taken and

thereby satisfy the training requirements. However, if work

experience or previous training is determined to be equivalent to

a given course, that course may be waived by appropriate management

(Section Chief or Bureau Director) and a justification entered in

the trainee's qualification journal.

10.01 An inspector who has not completed all requirements for

final certification in one of the areas listed in A may obtain

interim qualification to independently perform inspections in

specified areas for which prescribed training has been completed.

10.02 To establish an interim certification, the inspector's

supervisor will evaluate the inspector's qualifications and

identify the portions of the inspection program for which interim

qualification is appropriate.

30.03 Interim qualification will be approved by the the BERP

Field Supervisor, the appropriate Section Chief or the Bureau

Director, or his designee for interim qualification in the

identified areas.

10.04 Approval of the interim qualification will be documented

and record kept in the individual's training file.
Page 7

-11 EXCEPTIONS

11.01 Inspectors, who through prior experience and education,

possess sufficient knowledge to meet minimum requirements, may

validate a course though satisfactory completion of an equivalency

examination.

11.02 At the discretion of the Section Chief or Field Supervisor,

inspectors may be qualified for certain types of inspections before

they complete all of the training requirements for certification.

For example, an inspector may be qualified to perform inspections

of academic materials licensees before completing the specialized

courses and becoming qualified for inspecting medical licenses.

11.03 The Bureau Director has the authority to waive any

requirement listed for an inspector in this procedure.

Justification for the waiver will be documented, and entered into

the inspector's training file.

1245-12 POST QUALIFICATION TRAINING

This procedure identifies training requirements beyond those that

are required for initial qualification for the experienced

inspector. For the inspector who has received certification of

initial qualification, mandatory and optional training requirements

are identified in the sections entitled "Trafnfng Required Within

Two Years of Certification," "Supplemental Training Courses, ' and

"Refresher Training." These sections are listed for purpose in

Appendix A to this procedure. The purpose of this additional

training is to recognize that inspector training does not stop with

initial qualification; that training should be made available for

the experienced inspector on the basis of need, special

circumstances, and to keep current with the inspection program.

In particular, the Fundamentals of Inspection Refresher Course (G102) provides the inspector current views on regulatory policy and

philosophy as it relates to the inspection program and the

Principles of Good Regulation.

END

Appendices

: :

Appendix A, Training Activities

Appendix 8, NRC Training and Qualification Journals
I

.

.

x

APPENDIX A

TRAINING ACTIVITIES

A . PURPOSE

To ensure that inspectors are qualified to:

1. Know their role and mission.

2 . Understand the responsfbilftfes and legal authority of an

inspector.

3. Know inspection techniques and procedures and are capable of

performing the inspector function.

4. Have the type and level of technical knowledge needed to

adequately perform inspection activities.

5. Understand the inspection program.

B. TRAINING REQUIREMENTS

Each section of this appendix provides the inspector training

requirements for a partfcular inspection activity as indicated

below.

Section Area of inspection

I-A

I-B

Radiation Producing Equipment Inspector

HCFA Mammography Inspector

I-C Radioactive Materials Inspector

II-A Next Inspector

II-B FDA Compliance Testing Inspectar
SECTION I-A

TRAINING REQUIREMENTS FOR

RADIATION PRODUCING EQUIPMENT INSPECTOR

A. APPLICABILITY

The training described below is required for all radiation

producing equipment inspectors assigned to perform radiological

safety inspection activities at radiation equipment registrant

facilities.

B. TRAINING

1. Required initial training. This training is required for

initial certification of the radiation equipment inspector.

a. Required local on-the-job training.

(1) Orientation

(2) Code of Federal Regulations (21 CFR 1000)

(3) NYSDGH Regulations (10 NYCRR 16, 76, 89)

(4) NY Public Health Law

(5) NCRP Reports No. 66, 85, 99, 100, 102, 104, 105, 107

(6) DOH Memorandums

(7) NYS Guides on Radiation Safety/Quality Assurance

Programs

(8) FDA Inspection Manual

(9) Sndustry Codes and NIST Standards

(10) Radiological Safety Inspection Accompaniments.

These include at a minimum accompaniment inspections

at least two hospitals including or supplemented by

at least four surveys of each of the following

units: fluoroscopic, mammographic, radiographic,

dental, Computerized Tomographic (CT), and nonhuman use other than veterinary.

(11) NYSDOH Inspection Procedures

b. Required Formal Training Courses. This training is

provided in formal classroom or workshop environments and

is conducted by the BERP or FDA staff or contractors.

(I) Basic Radiation Protection/Health Physics

(2) Medical X-ray Protection

2. Training Required Within Two Years of Certification. This

training is required within two years of initial formal

certification and is conducted by Eastman Kodak Corporation.

a. Kodak Moore 2

I

.

.

I SECTION I-B

TRAINING REQUIREMENTS FOR

HCFA MAMMOGRAPHY SURVEYOR

A. APPLICABILITY

The training described below is requfred for all HCFA mammography

program inspectors assigned to perform radiological safety

inspection activities at HCFA mammographic facilities.

B. TRAINING

1. Required initial training. This training is required for

initial certification of the radiation equipment inspector.

a. Required local on-the-job training.

(1) Orientation -

(2) Code of Federal Regulations (42 CFR 494.50 to

494.64)

(3) NYSDOH Regulations (10 NYCRR 16, 76, 89)

(4) NY Public Health Law

(5) NCRP Reports No. 66, 85, 99, 100, 102, 104, 105, 107

(6) DOH Memorandums

(7) NYS Guides on Radiation Safety/Quality Assurance

Programs

(8) HCFA Inspection Manual

(9) Industry Codes and NIST Standards

(10) HCFA Mammographic Survey Accompaniments. These must

include at a minimum accompaniment inspections at

least five HCFA mammographic surveys.

(11) NYSDOH Inspection Procedures

(12) ASPEN

b. Required Formal Training Courses. This training is

provided in formal classroom or workshop environments and

is conducted by the BERP or FDA staff or contractors.

(1) HCFA Mammography Certification Course

2. Training Required Within Two Years of Certification. This

training is required within two years of initial formal

certification and is conducted by Eastman Kodak Corporation.

a. Kodak Moore 2

3 . Supplemental Training Courses. Depending on the inspector's

previous work experience and planned inspection activities,

additional courses may be required in order to gain knowledge

necessary for specialized inspection activities. Program

management will make this determination on an individual basis.
I .

.

4. Refresher Training. Refresher training will be conducted

as needed and as determined by management.
1 .

.

% SECTION I-C

TRAINING REQUIREMENTS FOR

RADIOACTIVE MATERIALS INSPECTOR

A. APPLICABILITY

The training described below is required for all radioactfve

materials inspectors assigned to perform radiological safety

inspection activities at material licensee facilities.

B. TRAINING

1. REQUIRED INITIAL TRAINING. This training is required for

initial certification of the materials inspector.

a. Required Local Training. - This training is conducted

in the local office using the appropriate Training and

Qualification Journal.

(1) Orientation

(2) Code of Federal Regulations

(3) NYSDOH Regulations

(4) NY Public Health Law

(5) NYS DEC Regulations

(6) Updated Safety Analysis Report (if applicable)

(7) Regulatory Gu+dance

(8) NRC Inspection Manual

(9) Industry Codes and Standards

(10) Radiological Safety Inspection Accompaniments

(11) NRC Manual

(12) NYSDOH Inspection Procedures

b . Required Formal Training Courses. This training is

provided in formal classroom or workshop environments and

is conducted by USNRC staff and USNRC contractors.

(1) Health Physics (&NRC)

(2) Medical use of Radionuclides Nuclear Medicine

Course (USNRC)

(3) Teletherapy (USNRC) for teletherapy inspections

(4) Inspection Procedures Course (GPA/SP) or

Fundamentals of Inspection Course (G-101)

2. Training Required Within Two Years of Certification. This

training is required within two years of initial formal

certification and is conducted or arranged by NRC staff.

a. OSHA Orientation Course

b. Transportation of Radioactive Materials Course (H-308)

c. Internal Dosimetry & Whole Body Counting Course'

d. Effective Communications for NRC Inspectors

I

. l

* : SECTION II-A

TRAINXNG REQUIREMENTS FOR

NEXT SURVEYOR

A. APPLICABILITY

The training described below is required for all NEXT program

inspectors assIgned to perform radiological safety inspection

activities at NEXT facilities.

B. TRAINING

1. Required initial training. This training is required for

initial certification of the NEXT surveyor.

a . Required local training.

(1) Orientation

(2) Code of Federal Regulations (21 CFR 1000)

(3) NYSDQH Regulations (10 NYCRR 16, 76, 89)

(4) NY Public Health Law

(5) NCRP Reports No. 66, 85, 99, 100, 102, 104, 105, 107

(6) DOH Memorandums

(7) NYS Guides on Radiation Safety/Quality Assurance

Programs

(8). NEXT Survey Procedures Manual

(9) Industry Codes and NIST Standards

(10) BERP Inspection Procedures

b. Required Formal Training Courses. This training is

provided in formal classroom or workshop environments and

is conducted by the BERP or FDA staff or contractors.

(1) NEXT Surveyor Training Course

2. Training Required Within Two Years of Certification. Not

applicable.

3. Supplemental Training Courses. Each year, NEXT surveyors are

expected to complete the Next Surveyor Training Course for that

year since changes in inspection procedures and areas of coverage

usually occur.

4. Refresher Training. Refresher training will be conducted each

year as needed.
1 APPENDIX B

EERP INSPECTOR TRAINING AND QUALIFICATION JOURNAL

A. PURPOSE

To establish a method of conducting and documenting successful

completion of the training requirements set forth in this

procedure.

6. BACKGROUND

The BERP Training and Qualification 3ournal is designed to ensure

that a uniform method of conducting and documenting training is

being followed for all inspectors.

The Journal establishes the minimum training requirements that must

be met for all required general and formal training courses listed

in Appendix A and serves as a guide for development of other

training and qualification journals (i.e., local and vendor

journals).

C. BASIC REQUIREMENTS

The BERP Journal must be used to conduct and document training

activities for all inspectors.

The BERP is responsible for developing and maintaining the Training

and Qualification Journals. The Training and Qualification

Journals included as part of this Appendix 6 establish the minimum

requirements for a Training and Qualification Journal that must be

completed for each inspector type listed in this and defined in

Appendix A.
New York State Department of Environmental Conservation

Division of Solid & Hazardous Materials

Bureau of Pesticides & Radiation

50 Wolf Road, Albany, New York 12233-7255

518-485-8981 FAX 518-485-8390

July 24,1998

John P. Cahill

Commissioners

We have reviewed the Draft Report of the Integrated Materials Performance Evaluation

Program Review of the New York Agreement State Program (January 26- April 24,1998), which

was transmitted to this Department by a June 24,1998 letter from Richard Bangart. For the

most part, we found the sections of the report addressing this Department’s radiation control

program to be factually correct. Our suggested corrections are enclosed.

We appreciate the suggestions and recommendations offered by IMPEP team, both

during their visit and in the draft report. We are reviewing them, and will respond when the final

report is issued.

Thank you for the opportunity to review the draft report. If you have any questions,

please contact me or Barbara Youngberg.

Sincerely,

Paul J. Merges, Ph.D.

Director, Bureau of Pesticides & Radiation

Division of Solid & Hazardous Materials

Enc.

cc: D. White, USNRC, Region 1

R. Aldrich, NYSDOL

G. Miskin, NYCDOH

K. Rimawi, NYSDOH

J. Spath NYSERDA
New York State Department of Environmental Conservation

Division of Solid & Hazardous Materials

Bureau of Pesticides & Radiation

Comments on Draft Report

Integrated Materials Performance Evaluation Program

Review of New York Agreement State Program

January 26 - April 24,1998

1. Page 9, Section 3.1.4 Status of Materials Inspection Program

The draft report notes that although initial inspections are usually performed within six

months of permit issuance, our inspection policy memorandum called for initial inspections to be

performed witt one year ofthe date the permit is issued. This was inconsistent with IMC

2800, which requires initial inspections within six months. The draft report also states that the

Program Director committed to revising the policy memorandum accordingly. This has been

done.

2. Page 19, Section 3.3.4 NYDEC - Technical Staffing and Training

The two vacancies noted in the draft report have been filled.

3. Pages 42 - 43, Section 4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

The draft report states, “NYDL is responsible for the occupational exposure of

individuals and control of radioactive material up to the point of placement in the disposal unit or

release from the site.” This is not completely accurate. The Department of Labor does have

responsibility for occupational exposures and therefore, has authority over the radioactive

material as it affects occupational exposures; however, DEC has authority, under Articles 17

and 29 of the Environmental Conservation Law, over most aspects of the design, construction,

and operation of the disposal facility. This includes waste package receipt and inspection and

temporary storage of waste prior to emplacement in waste disposal units. DEC’s authority is

reflected in our regulations for LLRW Disposal Facilities, 6 NYCRR Parts 382 and 383.

In the second paragraph of this section, the last sentence would be more consistent with

commonly used acronyms if it read, “The State does have two former radioactive waste disposal

sites: the State Licensed Disposal Area (SDA) at West Valley, and the Radiation Disposal Site

(RDS) at Cornell University.”

We suggest changing the first sentence of the third paragraph of this section to read, “The

SDA is a portion of the West Valley Nuclear Services Center site and was operated as a

commercial radioactive waste disposal site.” The operation of the SDA predates the adoption of

the radioactive waste classification system. Some of the waste placed in the SDA would vary

Page 1 of 2
from the criteria for classification as LLRW pursuant to 10 CFR Part 61. The reference to

LLRW in the fourth sentence should also be deleted.

In the first complete paragraph on page 43, the second sentence should be changed to

read, “The NYDL has no responsibility at this site since it was not a commercial disposal site.

Cornell holds a radioactive materials license from the NYS Department of Health.”

4. Appendix D-4 NYDEC License File Reviews, Page D-4.1, File No. 2

We suggest revising the comment to read, “Since emissions at two release points exceed

the effluent concentration values in Table II, permit limits were set to limit the potential dose to

the maximally exposed member of the public.”

5. Appendix D-4 NYDEC License File Reviews, Page D-4.3, File No. 13

The comment states that the termination application and licensee’s closeout survey were

not in the file. This is true, and as was explained to the IMPEP reviewer at the time, it was due

to the fact that the documents were large and therefore not stored in the file drawer. At that time,

only the SPL project manager, who was not in the office when the question was posed, knew

where the documents were. The documents were always in the office. We have since made

room in the file drawer for them, and they are stored with the rest of the SPL file.

Page 2 of 2
Attachment 3

New York Department of Labor Comment Letter

on Revised SS&D Section and

NRC Comment Analysis
STATE OF NEW YORK

DEPARTMENT OF LABOR

DMSION OF SAFETY AND HEALaTH

Radiological Health Unit

Building #12, Room 134-A

State Office Building Campus

Albany, NY 12240

October 13, 1998

TO: Hugh Thompson, USNRC

Richard Bangart, USNRC

Karen Cyr, USNRC

Carl Paperiello, USNRC

Thomas Martin, USNRC

.

Roland Fletcher, State of Maryland

FROM: Rita Aldrich

We have received and reviewed Richard Bangart’s letter of October 2, 1998, and the enclosed revision of

the Sealed Source & Device (SS&D) section of the New York IMPEP report on our February, 1998

review. We note that although some of the language has been modified the findings are unchanged.

We have also polled other Agreement States on what SS&D reviewer’s checklist(s) they were using, if

any. Responses indicate that they are under the impression that NRC wants them to use the checklist in

NUREG 1550 (or 1556), as is, since this is what was used in the NRC SS&D workshops. One state

reported that conversations with NRC staff had convinced them that NRC had “no tolerance for

customized or improved checklists.”

We have also obtained a copy of the “IMPEP Regulatory Review Sealed Source & Device Reviewer

Guidance.” Strangely enough the guidance includes a checklist that parallels the NUREG checklist,

indicating clearly that the NUREG checklist is the model expected to be in use by the states during

IMPEPS.

Yet we continue to be criticized for placing “primary emphasis on the use of the checklist . . . as an all

inclusive review document,” even though it was used for the review of an ultimately simple device and

nothing was overlooked as a result of its use. Curious.

We have also reviewed the Texas (June, 1997) and Illinois (March, 1997) IMPEP report sections on their

SS&D evaluation programs. Based on the issues raised, criticisms made and responses accepted by their

IMPEP teams, and the fact that both programs were found to be satisfactory, our program should clearly

be found satisfactory. We would be happy to present a point-by-point comparison between what was

accepted by the Texas and Illinois IMPEP teams as justifying a finding of fully “satisfactory” for those

states, versus what was found insufficient to support such a finding for our program. However, in the

interest of brevity, I would like to point out the following inconsistencies:

1. We were criticized for perceived shortcomings in our concurrence review for the one SS&D

evaluation performed (which criticism we categorically disagree with).

ED0 -- G980621

Telephone: 516-457-l 202 FAX: 516-465-7406
-2-

Texas was judged to have overlooked a serious discrepancy in an applicant’s submission that

would probably have been caught by a concurrence review. The product involved was a

radiographic exposure device. The IMPEP team recommended that “the state review the issue of

concurrence reviews for SS&D safety evaluations and implement procedures that require an

independent review for all future evaluations.”

Conclusion:

Texas did not perform a concurrence review of a high hazard device evaluation in which the

IMPEP team reported a significant discrepancy in the applicant’s submission.

We did perform a concurrence review of a low hazard device evaluation in which no significant

discrepancies were found, but were criticized for not having “a clear policy for what constitutes a

concurrence review.”

Texas was found satisfactory but we need improvement.

2. We were criticized because staff did not refer to draft regulations before allowing use of a leak test

interval of 13 months, even though the rationale for the 13 month interval was explained to the

reviewer during the IMPEP.

Illinois allowed a 36 month leak test interval for a device based on a comparison with similar

model devices. The IMPEP report merely “suggested” that the basis for the decision be

documented in the registry file.

Conclusion:

We aIlowed a 13 month leak test interval for a device because the source used was approved for a

13 month interval, and were criticized for staffs not being “aware of the specific requirements

contained in the draft regulations” and not consulting them during the review.

Illinois allowed a 36 month interval, has the same regulations in place that we have in draft, and

was not criticized for not consulting them.

The two programs made decisions based on very similar reasoning. It was acceptable in one case

but not in the other. Illinois was found satisfactory but we need improvement.

3. The Illinois SS&D staff have college and graduate school degrees similar to our staffs , and a

statement is made in their report that “all members are trained in health physics principles and

have attended at least one SS&D workshop.” It is also stated that if needed, the program can

obtain engineering assistance from professional engineers who work in other programs. It is also

stated that the head reviewer demonstrated to the IMPEP team “an ability to understand and

interpret the information submitted by applicants as described in the performance criteria,

including engineering-related issues.” (emphasis added)
-3-

Everything stated above concerning the Illinois staff is true of our staff. The section could have

been used verbatim in our report, but it was not. Instead we were criticized for our staff not

having “formal training or prior design analysis experience in all areas listed in MD5.6,” and were

told that we should develop an elaborate training program.

Conclusion:

Illinois staff were evaluated against the criteria in MD5.6 and found satisfactory.

We were not evaluated against the criteria in MD5.6, which is limited to staff having specified

basic “abilities,” but apparently against the IMPEP reviewer’s personal criteria which require

“formal training or prior design analysis experience.” We have qualifications identical to those of

Illinois program staff, who are satisfactory, but we are being told that we need improvement.

4. Neither the Texas nor the Illinois report used the term “signature authority,” nor made any

reference to a “formal qualification program” for granting such authority. This is not surprising,

however, because the terminology does not appear in MD5.6, although reference is made to states

having a program for training and qualification of personnel. Yet our IMPEP report contains a

discussion of our need for an elaborate “qualification program” and “formal written process” for

“signature authority” to ensure that “reviewers meet the qualifications listed in MD5.6.”

Our program has adopted the recommendations of the Nuclear Regulatory CommissionOAS

Training Working Group on Training requirements, and all of our staff have had the “basic”

training specified on page 3 of the report (I mis-referenced this as “core” training during our MRB

discussion), as well as extensive additional training. All of this training is documented in our

consolidated computer training file which was shown to the IMPEP team.

In addition to this training, our two SS&D reviewers have attended the Nuclear Regulatory

Commission’s workshop on the performance of SS&D evaluations. Following this, I authorized

them to perform and sign SS&D evaluations; one as the lead reviewer and the other as the

concurrence reviewer. These constitute our qualifying procedures for the staff who perform

SS&D evaluations. I would draw your attention to page 1 of the Training Working Group Report,

which states that “the number of inspector or license reviewer positions in an individual

Agreement State may not warrant the development of extremely detailed qualifying procedures.”

The report goes on to recommend that states develop lists of positions and basic training

requirements for them, and have some method to sign off on completed areas of training, although

some of the requirements may be included in hiring requirements. We believe we have done that,

as I explained during the MRB meeting.

Conclusion:

The Texas and Illinois programs were found satisfactory by their IMPEP teams under the direction

of Richard Woodruff, with no discussion of formal qualification programs for signature authority.
-4-

Neither MD5.6 nor the Nuclear Regulatory CommissionOAS Working Group Report requires

such a program.

We conduct our program in the same manner as Texas and Illinois; our staff have similar

qualifications; their training is documented; and I have authorized them to perform and sign

SS&D evaluations. Texas and Illinois were found satisfactory but we are being told that we need

improvement.

We have also reviewed the SS&D section of the proposed IMPEP Report for Rhode Island; a program

very similar to our own in size and scope.

For example, Rhode Island performed one SS&D evaluation during the review period, and has two staff

involved in the program - neither of which has an engineering background or other formal training, other

than attendance at an NRC SS&D workshop.

The SS&D section of the Rhode Island report is one page in length, which is remarkable to begin with,

compared to four pages for our report. Comments included in the Rhode Island report include the

following:

- “The SS&D review checklist received at the NRC SS&D workshop was used to assure all

relevant materials had been submitted and reviewed,” and “The team determined that the staff will

use the guidance in NUREG-1556, Vol. 3, for any future reviews.”

- “The team found that the two reviewers work together closely when conducting a review and

discuss issues and concerns they have identified in an application.”

- “The ORH also indicated that they would draw upon resources outside of their office if

necessary. Outside resources could include State engineers or the local University engineering

department, the NRC SS&D Section or another Agreement State,” and that the ORH “would, if

necessary, send their reviewers for additional training.”

Rhode Island’s SS&D Program was found satisfactory. If the members of the MRB will review the

comparable paragraphs in the New York State report, we believe that the inconsistencies with the

approach used in Rhode Island’s review will be quite obvious.

The situation that New York finds itself in defies logic. If we had not adopted all of NRC’s guidance

documents in the SS&D area; had not used a reviewer’s checklist or used one very different from the

NUREG model; had not performed a concurrence review; had not sent our SS&D reviewers to NRC’s

SS&D workshop; did not have additional engineering expertise at our disposal; and had not produced a

satisfactory SS&D evaluation sheet, we could make some sense out of the criticisms in this report.

However, having done all of the above, and having demonstrated in our previous comments on this -

section of the IMPEP report that we meet all of the criteria in MD5.6 for a finding of satisfactory, we do

not intend to waste any more of our program’s time and resources on this issue.

NRC Staff Analysis of the New York State Department of Labor Comments on 

Revised Draft Section 4.2, Sealed Source and Device Evaluation Program

The IMPEP review team evaluation of the NYDL comments on the revised SS&D Section of the

1998 program review and the recommendations to the MRB follow: 

General Comment:

The recommendations in the SS&D Section are programmatic issues that should be addressed

regardless of the number of case reviews conducted during the review period. Comment No. 2

below is a case-specific comment that demonstrates that additional experience conducting

reviews would enhance the thoroughness of the NYDL reviews. 

Specific Comments:

1. Concurrence review: As stated in the report, the team identified inconsistent

understanding of what constitutes a concurrence review. The team’s recommendation is

that this be corrected through the program establishing a definition, in writing, for

concurrence review. The team continues to support this recommendation. 

2. Leak test frequency extension: The staff reviewed NYDL’s comment about the source

SS&D registration sheet allowing a 13 month leak test frequency. The source SS&D

sheet does allow extension of the frequency to up to 13 months when it is justified based

on the device in which the source is being placed. Since the case-specific review did not

discuss a rationale for this extension, the team made the case-specific comment that such

a rationale should have been documented in the device evaluation file. The team

continues to support the case-specific comment. 

3. Qualifications of NYDL staff to perform SS&D reviews: The comparisons to other

programs is not an accurate comparison. The NYDL staff are not as well qualified, based

mainly on experience conducting SS&D reviews, as the other programs mentioned in the

NYDL response. In addition, the TX and IL programs have staff conducting SS&D reviews

that have had formal engineering training and have other engineering resources within the

RCP that are consulted on a regular basis. The RI primary reviewer has been conducting

SS&D reviews for 18 years although at a similarly low frequency of reviews per year. The

review team continues to support its recommendation for experience based training for the

SS&D reviewers prior to conducting an SS&D review of a more complex device. 

4. Signature authority or formal qualification program: NYDL stated that they have adopted

the recommendations of the NRC/OAS Training Working Group report, however, on page

3 of the report it states, “The Agreement States should document a training program that,

at a minimum, contains a statement of policy, minimum qualifications for staff training, and

supervisory responsibility for ensuring this policy is implemented....” The sample policy

statement in Appendix D of the report also states, “When an individual has demonstrated

competency in a particular training area to management, the training chart will be

completed by that member of management.” The review team was reflecting these

statements when it made the recommendation that NYDL clearly define its requirements

for staff to independently perform SS&D evaluation including a demonstration of

competency and for management to “grant signature authority” or what ever term the state

wants to use to signify that the individual has made such a demonstration to management. 

This process is what is expected for the licensing and inspection programs also and is not
2

something unique to the SS&D evaluation program. The review team continues to support

its recommendation that the training requirements and management approval (signature

authority) to conduct independent work in the SS&D evaluation area be documented. 

The NYDL response referred frequently to other program review reports and there were

comparisons made to each of the other programs as they may compare to the NYDL. The TX

and IL programs are significantly larger than the NYDL program and similar issues were raised in

the IL and TX reviews but were limited to case-specific and individual reviewer issues. 

The objective of the review team’s recommendations was to improve the documentation of the

NYDL program that would, at a minimum, have procedures that would address the sources and

devices that are manufactured in the State. The response from NYDL appears to state that they

do not wish to define the scope of their program by developing procedures specific to the sources

and devices currently manufacture in the State. Such documentation would focus future SS&D

casework reviews and IMPEP reviews of the program. The review team continues to support

clarification in the NYDL program and continues to support is recommendations in this area. 

Conclusion:

The review team concluded, after consideration of the comments presented at the September 1,

1998 MRB meeting and in the October 13, 1998 letter, that the NYDL SS&D program did not fully

meet the criteria in MD 5.6 for a satisfactory rating. Therefore, the review team recommends that

NYDL’s performance with respect to the SS&D evaluation program be found satisfactory with

recommendations for improvement based on the criteria in MD 5.6.