UNITED STATES 

 NUCLEAR REGULATORY COMMISSION 

 REGION I 

 2100 RENAISSANCE BOULEVARD, SUITE 100 

 KING OF PRUSSIA, PENNSYLVANIA 19406-2713

November 20, 2012 

Gene Miskin, Director 

Office of Radiological Health 

Division of Environmental Remediation 

New York City Department of Health and Mental Hygiene 

22 Cortlandt Street, 34th Floor 

New York, NY 10007 

Dear Mr. Miskin: 

A periodic meeting was held with you and your staff on September 27, 2012. The purpose of 

the meeting was to review and discuss the status of the New York City Department of Health 

and Mental Hygiene’s Agreement State Program. The NRC was represented by Raymond 

Lorson, Michelle Beardsley and me. 

I have completed and enclosed a general meeting summary, including any specific actions that 

will be taken as a result of this meeting. If you feel that our conclusions do not accurately 

summarize the meeting discussion, or have any additional remarks about the meeting in 

general, please contact me at (610) 337-5371, or email to Donna.Janda@nrc.gov to discuss 

your comments. 

Sincerely, 

 /RA/ 

Donna M. Janda 

Regional State Agreements Officer 

Division of Nuclear Materials Safety 

Enclosure: As stated 

 
November 20, 2012 

Gene Miskin, Director 

Office of Radiological Health 

Division of Environmental Remediation 

New York City Department of Health and Mental Hygiene 

22 Cortlandt Street, 34th Floor 

New York, NY 10007 

Dear Mr. Miskin: 

A periodic meeting was held with you and your staff on September 27, 2012. The purpose of 

the meeting was to review and discuss the status of the New York City Department of Health 

and Mental Hygiene’s Agreement State Program. The NRC was represented by Raymond 

Lorson, Michelle Beardsley and me. 

I have completed and enclosed a general meeting summary, including any specific actions that 

will be taken as a result of the meeting. If you feel that our conclusions do not accurately 

summarize the meeting discussion, or have any additional remarks about the meeting in 

general, please contact me at (610) 337-5371, or email to Donna.Janda@nrc.gov to discuss 

your comments. 

Sincerely, 

 /RA/ 

Donna M. Janda 

Regional State Agreements Officer 

Division of Nuclear Materials Safety 

Enclosure: As stated 

Distribution: 

M. Beardsley, FSME 

L. Dimmick, FSME 

K. Meyer, FSME 

R. Lorson, RI 

D. Collins, RI 

SUNSI Review Complete: DMJ (Reviewer=s Initials) 

DOCUMENT NAME: S:\State Agreement Files\New York\City\PERIODIC MEETING SUMMARY FOR NYC 9-27-12.docx 

After declaring this document AAn Official Agency Record@ it will be released to the Public. 

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with 

attachment/enclosure "N" = No copy ML12328A050 

OFFICE DNMS/RI E 

NAME DJanda/dmj 

DATE 11/20/12 

OFFICIAL RECORD COPY

 
Enclosure 

AGREEMENT STATE PERIODIC MEETING SUMMARY FOR NEW YORK CITY 

DEPARTMENT OF HEALTH AND MENTAL HYGIENE (NYC) 

DATE OF MEETING: September 27, 2012 

NRC Attendees New York City Department of Health and Mental 

Hygiene Attendees 

Donna Janda, RSAO, Region I Gene Miskin, Director, Office of Radiological Health 

Michelle Beardsley, FSME Tobias Lickerman, Unit Chief, Materials Program 

Raymond Lorson, Director, 

DNMS, Region I 

DISCUSSION: 

The Integrated Materials Performance Evaluation Program (IMPEP) review of the New York 

Agreement State Program (the Program) was conducted on June 6-16, 2011. On October 11, 

2011, the Management Review Board (MRB) met to consider the proposed final IMPEP report 

on the Program and found the Program adequate, but needs improvement, to protect public 

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

program. The agencies which comprise the New York Agreement State program are the New 

York State Department of Health (NYS DOH), New York State Department of Environmental 

Conservation (NYS DEC), and New York City Department of Health and Mental Hygiene (NYC). 

Because of the significance of the findings, the MRB determined that the Program should 

continue the period of heightened oversight, which was initiated in November 2005. The MRB 

also directed each of the agencies that comprise the Agreement State program to revise their 

Program Improvement Plans (PIP) as part of their response to the final IMPEP report. The NRC 

reviewed the agencies’ initial PIPs and concluded that each PIP contained a reasonable and 

realistic approach to addressing the recommendations made in the final IMPEP report. The 

MRB also directed that bimonthly calls be conducted between the New York and NRC staffs. 

As part of the heightened oversight process, each agency submits an updated PIP prior to each 

bimonthly call. In addition, the MRB determined that a periodic meeting should be held within 

one year of the MRB to assess the State’s progress in addressing the open recommendations. 

This summary describes the periodic meeting with the NYC. 

The status of NYC’s actions to address the open recommendation from the 2006 IMPEP review 

follows: 

Recommendation 1: The 2006 IMPEP review team recommended that NYC develop 

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

NRC policy on adequacy and compatibility. 

Status: Since the June 2011 IMPEP, NYC has updated their PIP to address their 

overdue regulation amendments. The adoption process for the eight overdue 

amendments has slipped six to nine months due to managing other Program priorities, 

including amending the regulations to address a new proton beam facility being built in 

New York City. 
NYC Periodic Meeting 2 

Summary 

Enclosure 

The status of NYC’s actions to address the open recommendations from the 2011 IMPEP 

review follows: 

Recommendation 2: The review team recommended that NYC respond to each 

incident received in accordance with its established Incident Response Procedure. 

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

and has trained the staff on the contents of the revised procedure. Program managers 

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

and to follow the proper sequence of events to close out all incidents reported to NYC. 

Recommendation 3: The review team recommended that NYC modify its Incident 

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

accordance with the timelines identified in SA-300. 

Status: The Office Director stated that program staff was made aware of and instructed 

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

Procedure was modified to add the requirement for timely notifications. 

Recommendation 4: The review team recommended that NYC evaluate all incident 

statistical information received from licensees, both retrospectively and prospectively, 

and follow up in a manner to ensure that each incident is properly evaluated for health, 

safety, and security implications. 

Status: The Office Director stated that this evaluation continues to be the standard 

practice of NYC. The inspection staff has been reminded to follow the medical event 

protocol for all events received (whether voluntarily reported or identified through an 

Order.) The inspection staff was also reminded to review the quality assurance records 

during inspections at licensee facilities to determine if any reportable events occurred 

which were not reported to NYC. 

OTHER TOPICS COVERED DURING THE MEETING INCLUDED:

Program Strengths and Weaknesses

The Office Director stated that having a well-trained, experienced staff is a major strength of 

NYC’s radioactive materials program. In addition, the Office Director stated that he has good 

management support. He meets with the Assistant Commissioner on a weekly basis to discuss 

the status of the radioactive materials program. NYC has adequate equipment to support the 

program. 

The Office Director noted that training needs are being addressed and will continue to be 

addressed as they are identified. Several staff members are approaching retirement age so the 

Office Director is evaluating potential areas for addressing knowledge management issues. 

 
NYC Periodic Meeting 3 

Summary 

Enclosure 

Feedback on the NRC’s Program

The Office Director offered his opinion that recently the IMPEP process has become more 

subjective and is not as helpful as previous IMPEP reviews. This opinion is consistent with 

concerns previously raised by the New York Agreement State program related to the IMPEP 

process. NYC is appreciative of NRC-funded qualification training courses. 

Agreement State Program Staffing and Training

Since the 2011 IMPEP review, NYC has lost one technical staff member due to retirement. 

According to the Office Director, this position is being posted. Currently the NYC program is 

allotted 4.7 full-time equivalents (FTE) which is adequate to implement the radioactive materials 

program. 

Support for staff training exists in NYC. Staff members have attended NRC-funded training 

courses as part of their training process. Staff members need a 30–day lead time for approval 

for out-of-state travel. 

Inspection and Licensing Programs

The Office Director and Unit Chief noted that since the 2011 IMPEP review, there have been no 

backlogs in either licensing or inspection activities. NYC currently has approximately 350 

radioactive materials licenses. License reviewers are using the pre-licensing guidance. Three 

pre-licensing visits have been completed since the 2011 IMPEP review. 

Regulations 

During the 2011 IMPEP review, the review team identified eight NRC amendments that were 

overdue for adoption by NYC. Since the IMPEP review and prior to submission of the updated 

PIP, NYC submitted two final amendments to NRC for review. In addition, NRC determined that 

one amendment which was listed as overdue in the 2011 IMPEP report was not applicable to 

NYC’s program. The NYC submitted the latest version of their PIP to the NRC in August 2012 

(ML12235A438). Since the 2011 IMPEP review, one additional amendment has become 

overdue and will need to be addressed by NYC. 

The following six NRC amendments are overdue for adoption by NYC: 

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

30, 40, and 70 amendments (63 FR 39477, 63 FR 45393), that became effective on 

October 26, 1998, and was due for Agreement State adoption by October 26, 2001. 

(RATS ID 1998-5) 

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

Part 20 amendment (63 FR 50127), that became effective on November 20, 1998, and 

was due for Agreement State adoption by November 20, 2001. (RATS ID 1998-6) 

• “Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32, and 150 amendments 

(72 FR 58473), that became effective on December 17, 2007, and were due for 

Agreement State adoption by December 17, 2010. (RATS ID 2007-2) 
NYC Periodic Meeting 4 

Summary 

Enclosure 

• “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 35, 61, and 150 amendments (72 FR 55864), that became effective on 

November 30, 2007, and were due for Agreement State adoption by 

November 30, 2012. (RATS ID 2007-3) 

• “Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent,” 

10 CFR Parts 19 and 20 amendments (72 FR 68043), that became effective on 

February 15, 2008, and were due for Agreement State adoption by February 15, 2011. 

(RATS ID 2008-1) 

• “Medical Use of Byproduct Material – Authorized user Clarification,” 10 CFR Part 35 

amendment (74 FR 33901), that became effective on September 28, 2009, and was due 

for Agreement State adoption by September 28, 2012. (RATS ID 2009-1) 

Organization

The radioactive materials program is administered by the Materials Unit in the Office of 

Radiological Health. The Office is located in the Department of Health and Mental Hygiene 

(Department). The Office Director stated that NYC has had no legislative changes or 

organization changes to their program since the 2011 IMPEP review. 

Program Budget/Funding

The Office Director stated that there have been across-the-board reductions in funding within 

the Department. License fees are placed into a general fund and have not been changed in the 

last 18 years. The program is not experiencing any problems with travel for inspections or for 

out-of-state activities. 

Event Reporting

NYC has reported two events to NRC since the 2011 IMPEP review. NYC inspectors 

responded to both events in a timely manner. 

Response to Incidents and Allegations

NYC continues to be sensitive to notifications of incidents and allegations. The Office Director 

stated that there have been no significant events or events with generic implications in NYC’s 

jurisdiction since the 2011 IMPEP review. One misdirected call was referred to NYC from NRC 

since the IMPEP. 

Current NYC Initiatives

NYC has received an application for a proton therapy facility. Significant effort has been utilized 

to ensure regulations and guidance documents are in place prior to this facility being 

operational. 

 
NYC Periodic Meeting 5 

Summary 

Enclosure 

Large, Complicated, or Unusual Authorizations for Use of Radioactive Materials

NYC received a request for authorization of radium-223 for medical use. The Office Director 

and Unit Chief are interested in guidance on licensing this type of material and use. After this 

meeting, Ms. Beardsley was informed by the FSME Team Leader, Medical Radiation Safety 

Team, an update on this topic will be provided at the November 2012 NRC/OAS/CRCPD 

conference call. 

State’s Mechanisms to Evaluate Performance

Supervisors accompany all inspectors on an annual basis. All inspection and licensing work 

receive supervisory reviews. License reviewers conduct peer reviews of licensing actions. 

Periodic staff meetings are held to discuss issues. 

SUMMARY: 

NYC has experienced some delay in moving regulation amendments through the adoption 

process due to other Office priorities. NYC does not have a backlog in either licensing or 

inspections. NYC is addressing the recommendations made in the 2011 IMPEP review. 

 

NRC staff recommends that the next IMPEP review should be conducted as scheduled in 

FY 2013 (tentatively September 2013).