June 2, 2011 

Irene Kropp, Deputy Commissioner 

New Jersey Department of 

 Environmental Protection 

401 East State Street 

7th Floor, East Wing 

P.O. Box 420 

Trenton, NJ 08625-0420 

Dear Ms. Kropp: 

On May 9, 2011, the Management Review Board (MRB) met to consider the proposed final 

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

Agreement State Program. The MRB found the New Jersey Agreement State Program 

adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory 

Commission’s (NRC) program. 

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP review 

team=s findings. Based on the results of the current IMPEP review, the next full review of the 

New Jersey Agreement State Program will take place in approximately 4 years. 

During the periodic meeting and at the next IMPEP review, NRC will evaluate the effectiveness 

of the New Jersey’s response to the review team’s recommendations and the overall 

implementation of your Agreement State Program. 

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

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

New Jersey Final IMPEP Report 

cc: Paul Baldauf, Director 

 Environmental Safety & Health
June 2, 2011 

Irene Kropp, Deputy Commissioner 

New Jersey Department of 

 Environmental Protection 

401 East State Street 

7th Floor, East Wing 

P.O. Box 420 

Trenton, NJ 08625-0420 

Dear Ms. Kropp: 

On May 9, 2011, the Management Review Board (MRB) met to consider the proposed final 

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

Agreement State Program. The MRB found the New Jersey Agreement State Program 

adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory 

Commission’s (NRC) program. 

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP review 

team=s findings. Based on the results of the current IMPEP review, the next full review of the 

New Jersey Agreement State Program will take place in approximately 4 years. 

During the periodic meeting and at the next IMPEP review, NRC will evaluate the effectiveness 

of the New Jersey’s response to the review team’s recommendations and the overall 

implementation of your Agreement State Program. 

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

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA/ 

Michael F. Weber 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

New Jersey Final IMPEP Report 

cc: Paul Baldauf, Director 

 Environmental Safety & Health 

DISTRIBUTION: 

See next page 

ADAMS ACCESSION NO.: ML111300226 EDATS: FSME-2011-0070 

OFC FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA TechEd FSME DEDMRT 

NAME LDimmick DWhite MDelligatti TReis CPoland SMoore MFWeber 

DATE 05/18/11 05/20 /11 05/23/11 05/23/11 05/26/11 05/27/11 06/02/11 

OFFICIAL RECORD COPY 
Letter to Irene Kropp from Michael F. Weber dated: June 2, 2011 

SUBJECT: NEW JERSEY FINAL IMPEP REPORT, EDATS: FSME-2011-0070 

DISTRIBUTION: DCD (SP01) 

PUBLIC 

MSSA_Technical_Asst_Resource 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

RErickson,RIV Commissioner Svinicki 

DJanda, RI Commissioner Apostolakis 

SGabriel, RI Commissioner Magwood 

SRodriguez, NM Commissioner Ostendorff 

Robert Gallagher, MA SECY 

Patricia Gardner, NJ 

RLewis, FSME/MSSA 

TReis, FSME/MSSA 

MDelligatti, FSME/MSSA 

DWhite, FSME/MSSA 

MBeardsley, FSME/MSSA 

RLorson, RI 

AHowell, RIV 

KBrock, OEDO 

TRothschild, OGC 

JBiggins, OGC 

JWeil, OCA (2 copies) 

 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NEW JERSEY AGREEMENT STATE PROGRAM 

FEBRUARY 28-MARCH 4, 2011 

FINAL REPORT
New Jersey Final Report 

EXECUTIVE SUMMARY

This report presents the results of the initial IMPEP review of the New Jersey Agreement State 

Program. The review was conducted during the period of February 28 – March 4, 2011, by a 

review team composed of technical staff members from the U.S. Nuclear Regulatory 

Commission (NRC) and the State of Ohio.

Based on the results of this review, the review team found New Jersey’s performance to be 

satisfactory, but needs improvement for two performance indicators, Status of the Materials 

Inspection Program and Technical Quality of Licensing Actions; and found New Jersey’s 

performance to be satisfactory for all other indicators reviewed. The review team made two 

recommendations regarding the performance of the State. The review team recommends that 

the State consistently implement their licensing procedures and NRC’s pre-licensing guidance, 

as well as other administrative licensing procedures found in the NUREG-1556 series; and that 

the State provide additional training to staff members and supervisors regarding technical 

review of licensing actions for uses and technologies that were transferred from the NRC to the 

Bureau’s jurisdiction. 

Overall, the review team recommends that the New Jersey Agreement State Program be found 

adequate to protect public health and safety and compatible with NRC's program. Based on the 

results of the current IMPEP review, the review team recommends that the next full IMPEP 

review take place in approximately 4 years. 
New Jersey Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the New Jersey Agreement State Program. The 

review was conducted during the period of February 28 – March 4, 2011, by a review team 

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

the State of New Mexico. This was the initial review of the program since the Agreement was 

signed in September 2009. 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 Final General Statement of Policy,” published in the 

Federal Register on October 16, 1997, and NRC Management Directive 5.6, “Integrated 

Materials Performance Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary 

results of the review, which covered the period of September 30, 2009, to March 4, 2011, were 

discussed with New Jersey managers on the last day of the review. 

A draft of this report was issued to the State of New Jersey for factual comment on 

March 23, 2011. The State responded by electronic mail dated April 19, 2011, from Patricia 

Gardner, Manager, New Jersey Department of Environmental Protection (NJDEP), Bureau of 

Environmental Protection. A copy of the Bureau’s response is included as the Attachment to 

this report. The Management Review Board (MRB) met on May 9, 2011, to consider the 

proposed final report. The MRB found the New Jersey Agreement State Program adequate to 

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

The New Jersey Agreement State Program is administered by the Bureau of Environmental 

Radiation (the Bureau), in the Division of Environmental Safety and Health (the Division). The 

Division is part of the New Jersey Department of Environmental Protection. Organizational 

charts for the Department, the Division, and the Bureau are included as Appendix B. 

At the time of the review, the New Jersey Agreement State Program regulated approximately 

620 specific licenses authorizing byproduct, source, and certain special nuclear materials. The 

review focused on the radioactive 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 Jersey. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Bureau on October 22, 2010. The Bureau 

provided its response to the questionnaire via email on February 11, 2011. A publicly available 

version of the questionnaire response can be found in NRC’s Agencywide Documents Access 

and Management System (ADAMS) using the Accession Number ML110450005. 

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

the Bureau’s response to the questionnaire; (2) review of applicable New Jersey statutes and 

regulations; (3) analysis of quantitative information from the Bureau’s databases; (4) technical 

review of selected regulatory actions; (5) field accompaniments of five inspectors; and 

(6) interviews with staff and managers. The review team evaluated the information gathered 

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

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

performance. 
New Jersey Final Report Page 2 

Results of the review for the common performance indicators are presented in Section 2.0. 

Section 3.0 details the results of the review of the applicable non-common performance 

indicators, and Section 4.0 summarizes the review team's findings and recommendations. The 

review team’s recommendations are comments that relate directly to Bureau performance by 

the State. 

2.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are: (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

2.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Bureau’s staffing level and staff 

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

these issues, the review team examined the Bureau’s questionnaire response relative to this 

indicator; interviewed managers and staff, reviewed job descriptions and training records, and 

considered any workload backlogs. 

The New Jersey Agreement State Program is composed of a Manager, four supervisors, seven 

technical staff and three administrative support staff. Supervisors and technical staff members 

have at least a bachelor’s degree in a physical or life science and several years of professional 

experience in radiation protection. Supervisors and technical staff conduct inspections, perform 

licensing actions, and respond to incidents and allegations based on individual qualifications. 

Supervisors and technical staff also perform emergency response duties as necessary. Based 

on information provided by the Bureau, the review team estimated that the Bureau expends 

approximately 12.5 full-time equivalents (FTE), including administrative support, to administer 

the Agreement State program. During the review period, no supervisors or technical staff left or 

joined the Bureau. At the time of the review, the Bureau had no vacancies in the Agreement 

State program. 

The Bureau has a documented training plan for technical staff that is consistent with the 

requirements in the NRC/Organization of Agreement States Training Working Group Report and 

NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear 

Material Safety and Safeguards Program Area.” The Bureau uses on-the-job training, such as 

inspector accompaniments, to supplement formal coursework. Staff members are typically 

assigned increasingly complex duties as they progress through the qualification process. Staff 

members are authorized to perform regulatory duties independently after demonstrating 

competency. In the State’s application to become an Agreement State, the State committed to 

using qualification journals for each of its staff members. The review team found that the 

technical staff members have been maintaining their individual qualification journals as they 

complete training classes and licensing and inspection tasks. Technical staff members and 

supervisors also complete individual training plans for each calendar year based on their 

individual and program needs. The team noted one training issue, specific to the technical 

review of licensing actions, which is described in Section 2.4, “Technical Quality of Licensing 

Actions.” 
New Jersey Final Report Page 3 

The review team noted that Bureau managers encourage and support training opportunities, 

based on program needs. The review team concluded that the Bureau’s staffing and training is 

adequate to carry out its regulatory duties. 

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

2.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely issuance of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Bureau's questionnaire response relative to this indicator, data gathered from the 

Bureau’s database, examination of completed inspection casework, and interviews with Bureau 

managers and staff members. 

The review team verified that the Bureau’s inspection priorities were the same as those found in 

NRC’s IMC 2800, “Materials Inspection Program.” Over the review period, the Bureau 

performed 81 Priority 1, 2, and 3 inspections, of which six had been performed overdue (i.e. 

greater than 25% of the assigned inspection frequency). These ranged from 6 months past the 

due date to 11 months past the due date. None were overdue at the time of the review. Initial 

inspections are to be conducted within 12 months of license issuance. The review team noted 

that during the review period four initial inspections had become due, one of these inspections 

had been performed and three were still overdue (from one to five months) at the time of the 

review. Overall, the review team calculated that the Bureau performed 12 percent of its 

inspections overdue during the review period. 

The review team evaluated the Bureau’s timeliness in issuing inspection findings. The Bureau 

is required to follow the NJDEP policy which requires all NJDEP programs to issue inspection 

findings to licensees within 90 days of the final date of the inspection. While this policy differs 

from NRC’s requirement of issuing findings within 30 days, the Bureau typically issues 

inspection findings within 30 days of final completion and often within 1-2 weeks if no findings 

were identified. The review team found that inspection findings from 79 of 81 inspections were 

issued within NRC’s identified 30-day goal. 

During the review period the Bureau received 47 reciprocity requests, of which 31 were 

candidates for inspection based on the criteria in IMC 1220 “Processing of NRC Form 241 and 

Inspection of Agreement State Licensees Operating under 10 CFR 150.20.” The review team 

determined that the Bureau met the 20 percent requirement found in IMC 1220. 

The Bureau had 34 licensees that were subject to the Increased Controls at the time of the 

review. The initial Increased Control (IC) inspections were completed by the NRC prior to this 

review period. The review team noted that follow-up IC inspections as well as National Source 

Tracking System (NSTS) verifications were being conducted during routine inspections of these 

licensees. 

 
New Jersey Final Report Page 4 

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey's performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory, but needs improvement. 

2.3 Technical Quality of Inspections

The review team evaluated 20 inspection reports that included enforcement documentation and 

letters to licensees, and interviewed inspectors who were responsible for radioactive materials 

inspections conducted during the review period. The casework examined included a crosssection of inspections conducted by eight current inspectors and covered a wide variety of 

inspection types involving initial, routine, and special inspections. The casework included 

inspections of various types of programs including: academic, research and development, 

medical institution-written directive required, high dose-rate remote after-loaders, nuclear 

pharmacies, positron emission tomography production facilities, brachytherapy sealed source 

treatments including Sr-90 eye applicator and permanent seed implants used for prostate 

treatments, gamma stereotactic radiosurgery, self-shielded irradiator, and industrial 

radiography. Appendix C lists the inspection casework files reviewed. 

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

thorough, complete, consistent, and of high quality with sufficient documentation to ensure that 

licensees’ performance with respect to health, safety, and security were acceptable. Inspection 

report documentation supported violations, recommendations made to licensees, unresolved 

safety issues, and discussions held with licensees during exit interviews. The review team also 

evaluated the Bureau’s handling and storing of sensitive documents. The review team 

determined that documents containing sensitive and security-related information were 

appropriately protected, and maintained in a manner to limit access. The review team found 

that outgoing correspondence containing sensitive information (licenses, inspection reports, 

etc.) was appropriately marked. 

The Bureau has a policy to accompany all staff performing radioactive materials inspections on 

an annual basis. The review team verified that all qualified inspectors had been accompanied 

prior to the review. Inspectors are accompanied by supervisors. Supervisors who perform 

inspections accompany each other. 

The review team noted that the Bureau maintains an adequate supply of appropriately 

calibrated survey instruments to support the inspection program, as well as to respond to 

radioactive materials incidents and emergency conditions. Each basic kit contains three survey 

instruments for performing surveys under various radiological conditions. Each kit is assigned 

to an individual staff member who is also responsible for ensuring it is properly calibrated. The 

Bureau has a contract with a Pennsylvania calibration lab for calibration services. 

The Section receives laboratory and sample analysis support from the State laboratory located 

in Trenton. The State laboratory has a wide array of analytical equipment and is capable of 

detailed radiochemistry analysis. The Bureau also has a total of 13 gamma spectroscopy units 

for on-the-spot radiological determinations should the need arise. 
New Jersey Final Report Page 5 

The review team accompanied five of the Bureau’s inspectors in February 2011. The inspectors 

conducted inspections at two medical brachytherapy licensees and at a Type-A broad scope 

academic licensee. The inspector accompaniments are listed in Appendix C. The inspectors 

demonstrated performance-based inspection techniques and knowledge of the regulations. The 

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

licensees’ radiation safety and security programs. The inspectors focused their efforts 

beginning with the most risk significant activities. The inspectors conducted interviews with 

appropriate personnel, observed licensed operations and appropriately pursued issues noted, 

conducted confirmatory measurements, and utilized good health physics practices. The 

inspectors also held entrance and detailed exit meetings with the appropriate level of licensee 

management. The review team determined that the inspections were adequate to assess 

radiological health, safety, and security at the licensed facilities. 

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey’s performance with respect to the indicator, Technical Quality of Inspections, 

be found satisfactory. 

2.4 Technical Quality of Licensing Actions

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

18 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

proper radioisotopes and quantities, qualifications of authorized users, adequacy of facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for timeliness, use of appropriate deficiency letters and cover 

letters, reference to appropriate regulations, supporting documentation, consideration of 

enforcement history, pre-licensing visits, peer/supervisory review, proper signatures, and 

marking of licenses as Official Use Only-Security Related Information when appropriate. 

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

completed during the initial review period. Licensing actions selected for evaluation included 

5 new licenses, 2 renewals, 3 decommissioning or termination actions, 7 amendments, and 1 

financial assurance action. Files reviewed included a cross-section of license types, including: 

medical diagnosis and therapy, gamma stereotactic radiosurgery, research and development,

nuclear pharmacy, cyclotron production, gauges, industrial radiography, and self-shielded 

irradiators. The casework sample represented work from nine of the ten license reviewers. A 

listing of the licensing casework reviewed is provided in Appendix D. 

On September 30, 2009, NRC transferred 542 specific licenses to New Jersey’s jurisdiction. 

The Bureau merged the NRC licenses with existing Bureau licenses for naturally occurring and 

accelerator-produced radioactive materials. As a result, the Bureau had 620 licenses at the 

time of the review. The majority of the license amendments completed by the Bureau during the 

review period consisted of merging NRC licenses into New Jersey licenses, and reformatting all 

of the NRC licenses into the Bureau’s license template. The Bureau completed approximately 

32 new licenses, 63 license renewals, and 42 termination licensing actions during the review 

period. All licensing actions are initially entered into the Bureau’s computer tracking system 

called the New Jersey Environmental Management System (NJEMS), a database system used 

by all programs in the NJDEP to centrally locate information regarding licenses, inspections, 
New Jersey Final Report Page 6 

enforcement actions, and incidents. In addition to tracking licensing actions, NJEMS is used to 

generate licensing documents in a standardized format. License reviewers use standardized 

sets of conditions specific to the type of licensed program to ensure consistency in licenses. 

Each licensing action is reviewed and signed by a Bureau supervisor. 

Overall, the review team concluded that licensing actions were adequate to protect public health 

and safety; however, based on the evaluation of casework, the review team noted repeated 

examples of issues with thoroughness and adherence to existing licensing procedures and 

guidance. Issues with the technical quality of some reviews were also noted. Specific 

examples included in part, the addition of a complex, new technology to a license without a 

thorough technical review; inconsistent implementation of the Bureau’s licensing procedures; 

and inconsistent implementation of the licensing guidance in the NRC NUREG-1556 series. 

Supervisory reviews did not identify the technical or administrative issues identified by the 

review team. Documentation of licensing actions was often split between the paper license file 

and NJEMS, and in some cases it appeared that records of deficiency calls or e-mails to 

licensees were not retained. 

The Bureau’s procedures require use of NRC’s revised pre-licensing guidance to verify that the 

applicant will use requested radioactive materials as intended. The team identified that these 

procedures were not applied consistently. To determine the extent of the condition, Bureau staff 

then reviewed 20 new licenses and determined that the pre-licensing guidance was either not 

followed or not fully followed for more than half of these. Bureau staff quickly reviewed these 

license files with the review team, and it appeared that each of the licensees either had a 

previous Agreement State or NRC license, had a current State registration for other operations 

within the scope of its licensed activities, and/or State personnel visited the licensee’s site to 

deliver the new license. Following discussion with the review team, the Bureau took immediate 

action to review all new licenses issued from September 30, 2009, through March 4, 2011, to 

complete or verify completion of the pre-licensing checklist and place copies in NJEMS and 

license files; print out e-mails, notes, and phone logs used to make decisions about license 

issuance and place copies in the license file; and confirm that any pre-licensing visit is 

documented in NJEMS and the license file. If completion of the pre-licensing process identified 

that a license was inappropriately issued, the Bureau planned to immediately address this. The 

review team recommends that the Bureau consistently implement their licensing procedures, 

and NRC’s pre-licensing guidance, as well as other administrative licensing procedures found in 

the NUREG-1556 series. 

The review team discussed licensing training received by Bureau staff prior to initial 

implementation of the Agreement. The Bureau Manager stated that in March of 2009 the 

Bureau hosted the licensing course and the majority of the technical staff had attended the 

course. The review team also noted that a team of Bureau staff had traveled to the NRC 

Region I office for one day to look at the space requirements for docket files and to review the 

administrative aspects of the licensing program. Additionally, one Bureau staff member spent a 

week in the Region I office observing the licensing process and reviewed NRC’s Licensing 

Tracking System (LTS) as it relates to the administrative licensing process. The review team 

then discussed the licensing deficiencies noted with the Bureau Manager and in part, suggested 

additional technical licensing training for the staff as an adjunct to any licensing training already 

received. The Bureau Manager acknowledged that the issues noted regarding licensing would 

likely be improved with additional technical training. The review team recommends that the 
New Jersey Final Report Page 7 

Bureau provide additional training to staff members and supervisors regarding technical review 

of licensing actions for new uses and technologies that were transferred from the NRC to the 

Bureau’s jurisdiction. 

The review team examined the Bureau’s licensing practices regarding IC and Fingerprinting 

Orders. The review team noted that the Bureau uses license conditions for IC and 

Fingerprinting, as appropriate. Requirements for NSTS are included in the State’s regulations. 

The review team analyzed the Bureau’s methodology for identifying those licenses and found 

the rationale was thorough and accurate. The Bureau requires full implementation of the IC 

prior to issuance of a new license or license amendment that meets the established criteria. 

The review team found that files containing IC licenses are kept in a locked room and the 

licenses and corresponding cover letters were marked as containing sensitive information. 

The Bureau had initiated the process to address maximum possession limits on radioactive 

materials licenses as requested by RCPD-10-007 letter dated June 21, 2010. The Bureau had 

identified the licenses affected and had sent letters to the respective licensees requesting 

information for the maximum possession limit authorization.

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory, but needs improvement. 

2.5 Technical Quality of Incident and Allegation Activities

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

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

this indicator, evaluated selected incidents reported for New Jersey in the Nuclear Material 

Events Database (NMED) against those contained in the Bureau’s files, and evaluated the 

casework for 4 reported radioactive materials incidents. A listing of the casework examined, 

with case-specific comments, can be found in Appendix E. The review team also evaluated the 

Bureau’s response to 3 allegations involving radioactive materials. The NRC did not refer any 

allegations to the Bureau during the review period. 

When notified of an incident or an allegation, the Bureau Manager and staff discuss the initial 

response and the need for an on-site investigation, based on the safety significance. If the 

incident meets the reportability thresholds, as established in the Office of Federal and State 

Materials and Environmental Management Programs (FSME) Procedure SA-300 “Reporting 

Material Events,” the Bureau notifies the NRC Headquarters Operations Center and enters the 

information into NMED in a prompt manner. 

The incidents selected for review included personnel and equipment contamination, lost and/or 

stolen radioactive material, and damaged equipment. The review team determined that the 

Bureau’s responses to incidents were thorough, complete, and comprehensive in all instances. 

Initial responses were prompt and well coordinated, and the level of effort was commensurate 

with the health and safety significance of the event. When no immediate threat was present and 

the Bureau determined that the licensee had qualified, competent individuals investigating the 

incident, the Bureau generally responded telephonically with an on-site follow-up inspection at a 

later date when appropriate. 
New Jersey Final Report Page 8 

 

In evaluating the effectiveness of the Bureau's response to allegations, the review team 

evaluated the casework for 3 allegations. The review team concluded that the Bureau took 

prompt and appropriate action in response to concerns raised. The review team noted that the 

Bureau thoroughly documented the investigation and retained all necessary documentation to 

appropriately close the allegation. The Bureau notified the alleger of the conclusion of the 

investigation. The review team determined that the Bureau adequately protected the identity of 

allegers. 

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

3.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State Programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) Lowlevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRC’s 

Agreement with the State of New Jersey does not relinquish authority to regulate a sealed 

source and device evaluation program, a low-level radioactive waste disposal program, or a 

uranium recovery program, so only the first non-common performance indicator was applicable 

to this review. 

3.1 Compatibility Requirements

3.1.1 Legislation

New Jersey became an Agreement State on September 30, 2009. Legislative authority to 

create the Bureau and enter into an Agreement with NRC is granted in the Radiation Protection 

Act (N.J.S.A 26:2D-1), the Administrative Procedures Act (N.J.S.A. 52:14B-1 et seq.), and the 

Atlantic Interstate Low-Level Radioactive Waste Compact Implementation Act. 

The State’s rulemaking process automatically adopts NRC requirements by reference with the 

exception of Subpart E of 10 CFR Part 20. When NRC amends requirements, the amendments 

are automatically incorporated into New Jersey’s rules without further proposal or publication. 

However, because New Jersey specifically substitutes some New Jersey titles, addresses and 

language, there are times when the State may be required to amend its rules to make 

administrative changes which are then sent to NRC for review. These administrative changes 

do not alter the substantive portions of the regulation. 

New Jersey regulations are subject to sunset review and recently came due for review in 2010. 

A one year extension was granted and the State is currently working to complete the review. 

Once approved, the next sunset review will take place in 2015. 

3.1.2 Program Elements Required for Compatibility 

New Jersey’s regulations for control of radiation are located in the New Jersey Administrative 
New Jersey Final Report Page 9 

Code, Title 7, Chapter 28, and apply to all persons who receive, possess, use, transfer, own, or 

acquire any source of radiation. New Jersey requires a license for the receipt, possession, use, 

transfer, ownership, or acquisition, of radioactive material. New Jersey also requires the 

registration of ionizing radiation machine facilities. 

The review team evaluated the Bureau’s response to the questionnaire, reviewed the status of 

regulations required to be adopted by the State under the Commission’s adequacy and 

compatibility policy, and verified the adoption of regulations with data obtained from the State 

Regulation Status Sheet that FSME maintains. 

Current NRC policy requires that Agreement States adopt certain equivalent regulations or 

legally binding requirements no later than 3 years after the effective date of NRC’s regulations. 

At the time of this review, New Jersey had no overdue regulations and has completed all 

outstanding regulation changes through the last NRC final rulemaking which was issued in 

2009. 

The State adopts most NRC regulations by reference and uses legally binding requirements 

such as license conditions when necessary. New Jersey regulations that are adopted by 

reference indicate a “pointer” to the appropriate NRC regulations, so that if the NRC modifies a 

regulation, the change is automatic for the State’s regulations. If the NRC develops a new 

regulation section, such as the upcoming 10 CFR Part 37 security requirements rule, or updates 

regulations that the State does not adopt by reference, the State must create a new section in 

their regulations or update their regulations accordingly. The State’s regulatory process 

typically takes approximately two years to complete, which includes time for public comment. 

Based on the IMPEP evaluation criteria, the review team recommends, and the MRB agreed, 

that New Jersey’s performance with respect to the indicator, Compatibility Requirements, be 

found satisfactory. 

4.0 SUMMARY 

As noted in Sections 2.0 and 3.0 above, the review team found New Jersey’s performance to be 

satisfactory, but needs improvement for two performance indicators: Status of the Materials 

Inspection Program and Technical Quality of Licensing Actions. The review team found New 

Jersey’s performance to be satisfactory for all other indicators reviewed. The review team made 

two recommendations regarding the performance of the State. Overall, the review team 

recommends, and the MRB agreed, that the New Jersey Agreement State Program be found 

adequate to protect public health and safety and compatible with NRC's program. Based on the 

results of the current IMPEP review, the review team recommends, and the MRB agreed, that 

the next full IMPEP review take place in approximately 4 years. 

Below are the review team’s recommendations, as mentioned in an earlier section of the report, 

for evaluation and implementation by the State: 

1. The review team recommends that the Bureau consistently implement their licensing 

procedures and NRC’s pre-licensing guidance, as well as other administrative licensing 

procedures found in the NUREG-1556 series. (Section 2.4) 
New Jersey Final Report Page 10 

2. The review team recommends that the Bureau provide additional training to staff 

members and supervisors regarding technical review of licensing actions for uses and 

technologies that were transferred from the NRC to the Bureau’s jurisdiction. 

(Section 2.4) 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B New Jersey Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Randy Erickson, Region IV Team Leader 

 Technical Quality of Inspections 

 Compatibility Requirements 

 Inspector Accompaniments 

Donna Janda, Region I Technical Staffing and Training 

 Technical Quality of Incident and 

 Allegation Activities 

Sandra Gabriel, Region I Technical Quality of Licensing Actions 

Santiago Rodriguez, New Mexico Status of Materials Inspection Program 
APPENDIX B 

NEW JERSEY ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML110450003
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Janx Integrity Group License No.: 507152 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 1/27/10 Inspectors: CB 

File No.: 2 

Licensee: Certified Testing Labs License No.: 507161 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 10/7-8/10 Inspector: CB 

File No.: 3 

Licensee: Branch Radiographic Labs, Inc. License No.: 507051 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 6/4/10 and 6/29/10 Inspectors: CB 

File No.: 4 

Licensee: Jersey Shore Medical Center License No.: 331191 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 7/14/09 Inspector: JM 

File No.: 5 

Licensee: IBA Molecular North America, Inc. License No.: 439619 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/21/10 Inspector: DZ, CB 

File No.: 6 

Licensee: Mountainside Hospital License No.: 332177 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/7/10 Inspector: NS, RP 

File No.: 7 

Licensee: Newark Beth Israel Medical Center License No.: 455336 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 12/1-2/10 Inspector: JT, JM 

File No.: 8 

Licensee: Memorial Sloan Kettering Cancer Center License No.: 332593 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 11/9/10 Inspectors: ET, RP 
New Jersey Draft Report Page C.2 

Inspection Casework Reviews 

File No.: 9 

Licensee: Somerset Medical Center License No.: 450635 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 11/1/10 Inspector: ET, RP 

File No.: 10 

Licensee: Ocean Medical Center License No.: 457842 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/14/10 Inspector: JT 

File No.: 11 

Licensee: Petnet Solutions, Inc. License No.: 459066 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/13/10 and 11/17/10 Inspectors: DZ, CB 

File No.: 12 

Licensee: Riverview Medical Center License No.: 297846 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 10/6/10 Inspector: JT 

File No.: 13 

Licensee: Robert Wood Johnson University Hospital License No.: 450729 

Inspection Type: Special, Announced Priority: 2 

Inspection Dates: 6/16/10 Inspectors: JM, BC, RP 

File No.: 14 

Licensee: Centrastate Health Care System, Inc. License No.: 444567 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/3/10 Inspectors: NS, JM 

File No.: 15 

Licensee: Monmouth Medical Center License No.: 332041 

Inspection Type: Special, Announced Priority: 2 

Inspection Date: 3/10/10 Inspectors: JM 

File No.: 16 

Licensee: JFK Medical Center License No.: 441325 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 2/17/10 Inspector: JM, RP, JT 

File No.: 17 

Licensee: Robert Wood Johnson Medical Center @ Rahway License No.: 425392 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/24/10 Inspectors: NS, RP 
New Jersey Draft Report Page C.3 

Inspection Casework Reviews 

File No.: 18 

Licensee: Johnson & Johnson Pharmaceutical R&D License No.: 507685 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 10/21/10 Inspector: CB, JT 

File No.: 19 

Licensee: Chilton Memorial Hospital License No.: 332052 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/24/10 Inspector: RP 

File No.: 20 

Licensee: Trinitas Hospital License No.: 540-137-1 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/14-15/11 Inspectors: RP, JM 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: Trinitas Hospital License No.: 332163 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/14-15/11 Inspector: RP, JM 

Accompaniment No.: 2 

Licensee: Rutgers, The State University of New Jersey License No.: 29-05218-28 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 2/16-17/11 Inspector: BC, CB 

Accompaniment No.: 3 

Licensee: Kennedy Health System License No.: 454375 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/18/11 Inspector: JT 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Central New Jersey Blood Center License No.: 508156 

Type of Action: Amendment Amendment No.: 090001 

Date Issued: 11/17/09 License Reviewer: CB 

File No.: 2 

Licensee: Central New Jersey Blood Center License No: 508156 

Type of Action: Amendment Amendment No.: 100001 

Date Issued: 9/22/10 License Reviewer: BC 

File No.: 3 

Licensee: Monmouth Medical Center License No.: 332041 

Type of Action: Amendment Amendment No.: 100004 

Date Issued: 2/7/11 License Reviewer: JM, RP 

Comment: 

a) Reviewer did not address technical issues such as licensee commitments that were 

inappropriate for the requested device or inconsistent with current regulations. 

b) Reviewer described communications with licensee regarding technical issues; however, 

there was no record in the license file. 

File No.: 4 

Licensee: Consultants in Cardiology License No.: 448385 

Type of Action: Renewal Amendment No.: 100001 

Date Issued: 2/24/10 License Reviewer: ET 

Comment: 

 Technical review was not performed in accordance with NUREG-1556 guidance. 

File No.: 5 

Licensee: Duffield Associates Inc. License No.: 518330 

Type of Action: New Amendment No.: 100001 

Date Issued: 3/7/10 License Reviewer: AW 

Comment: 

 Pre-licensing review was not performed in accordance with RCPD-08-020. 
New Jersey Draft Report Page D.2 

License Casework Reviews 

File No.: 6 

Licensee: EMSL Analytical Inc. License No.: 535776 

Type of Action: New Amendment No.: 100001 

Date Issued: 11/30/10 License Reviewer: JG and CB 

Comment: 

 License did not include decay-in-storage license condition. 

File No.: 7 

Licensee: URS Corporation License No.: 507141 

Type of Action: Amendment Amendment No.: 110001 

Date Issued: 2/22/11 License Reviewer: JT 

File No.: 8 

Licensee: Branch Radiographic Laboratories, Inc. License No.:507051 

Type of Action: Amendment Amendment No.: 100001 

Date Issued: 3/9/10 License Reviewer: AW 

File No.: 9 

Licensee: IBA Molecular North America Inc. License No.: 452369 

Type of Action: Amendment Amendment No.: 100002 

Date Issued: 9/21/10 License Reviewer: AW 

File No.: 10 

Licensee: IBA Molecular North America Inc. License No.: 439619 

Types of Action: Amendment Amendment Nos.: 100001 

Date Issued: 12/28/10 License Reviewer: CB

File No.: 11 

Licensee: The Heart Specialists Group LLC License No.: 514223 

Types of Action: New Amendment No.: 090001 

Date Issued: 2/24/10 License Reviewer: NS 

Comment: 

a) Pre-licensing review was not performed in accordance with RCPD-08-020. 

b) Technical review was not performed in accordance with NUREG-1556 guidance. 

File No.: 12 

Licensee: Integral PET Associates License No.: 526648 

Type of Action: New Amendment No.: 110001 

Date Issued: 1/31/11 License Reviewer: NS 

Comment: 

 Technical review was not performed in accordance with NUREG-1556 guidance. 
New Jersey Draft Report Page D.3 

License Casework Reviews 

File No.: 13 

Licensee: Hackensack University Medical Center of Westwood License No.: 542561 

Type of Action: New Amendment No.: 100001 

Date Issued: 11/17/10 License Reviewer: NS 

Comment: 

a) Pre-licensing review was not performed in accordance with RCPD-08-020. 

b) Technical review was not performed in accordance with NUREG-1556 guidance. 

File No.: 14 

Licensee: Roxbury Open MRI & Surgical Center License No.: 436770 

Type of Action: Termination Amendment No.: N/A 

Date Issued: 1/20/11 License Reviewer: JG 

File No.: 15 

Licensee: Ligand Pharmaceuticals License No.: 507506 

Type of Action: Termination Amendment No.: N/A 

Date Issued: 2/10/11 License Reviewer: JG 

File No.: 16 

Licensee: Wyeth Pharmaceuticals Inc. DBA Wyeth Research License No.: 330948 

Type of Action: Termination Amendment No.: N/A 

Date Issued: 1/21/11 License Reviewer: JG 

File No.: 17 

Licensee: Xenobiotics Laboratories, Inc. License No.: 507356 

Type of Action: Financial Assurance Amendment No.: N/A 

Date Issued: 8/18/10 License Reviewer: DZ 

File No.: 18 

Licensee: Hopewell Radiology Group (Jamesburg Facility) License No.: 453815 

Type of Action: Renewal Amendment No.: 100003 

Date Issued: 11/29/10 License Reviewer: ET 

Comment: 

 Technical review was not performed in accordance with NUREG-1556 guidance. 
New Jersey Draft Report Page E.1 

Incident Casework Reviews 

APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Cardinal Health Nuclear Pharmacy License No.: 440735 

Date of Incident: 3/11/10 NMED Log No.: 100128 

Investigation Date: 3/11/10, 5/25/10 Type of Incident: Contamination Event 

 Type of Investigation: Telephone, Site 

File No.: 2 

Licensee: Bed, Bath and Beyond License No.: General 

Date of Incident: 10/1/09 NMED Log No.: 100229 

Investigation Date: 4/12/210 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 

Comment: 

The general licensee identified the damaged exit sign on 3/14/10 and reported it to the 

Bureau on 4/12/10. 

File No.: 3 

Licensee: SOR Testing Laboratories License No.: 507162 

Date of Incident: 10/8/10 NMED Log No.: 100505 

Investigation Date: 10/9/10 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

File No.: 4 

Licensee: Bed, Bath and Beyond License No.: General 

Date of Incident: 8/26/10 NMED Log No.: 100535 

Investigation Date: 9/17/10 Type of Incident: Lost RAM 

 Type of Investigation: Telephone 
ATTACHMENT 

April 19, 2011 Email from Patricia Gardner 

New Jersey’s Response to the Draft Report 

ADAMS Accession No.: ML111100390