UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

February 18, 2016 

Benjamin H. Grumbles, Secretary 

Maryland Department of the Environment 

1800 Washington Boulevard 

Baltimore, MD 21230 

Dear Mr. Grumbles: 

On January 21, 2016, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Maryland 

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

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

Section 5.0, page 16, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the Maryland 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for November 2017. 

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/ 

Glenn M. Tracy, 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, Compliance, Administration, 

 and Human Capital Programs 

Office of the Executive Director for Operations 

Enclosure: 

Maryland IMPEP Final Report 

cc: See next page 
 

 

cc w/encl: Roland G. Fletcher, Manager IV 

Radiological Health Program 

Raymond E. Manley, Chief 

Radioactive Materials, Licensing 

and Compliance Division 

Debra Shults, TN 

Organization of Agreement States 

Liaison to the MRB 

Tom Levering, Director 

Emergency Response 

Department of Environment 
February 18, 2016 

Benjamin H. Grumbles, Secretary 

Maryland Department of the Environment 

1800 Washington Boulevard 

Baltimore, MD 21230 

Dear Mr. Grumbles: 

On January 21, 2016, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Maryland 

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

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

Section 5.0, page 15, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the Maryland 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for November 2017. 

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/ 

Glenn M. Tracy, 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, Compliance, Administration, 

 and Human Capital Programs 

Office of the Executive Director for Operations 

Enclosure: 

Maryland IMPEP Final Report 

cc: See next page 

ML16028A314 via email* 

OFC RIV:TL MSTR/ASPB MSTR/ASPB NMSS/MSTR NMSS/Tech 

Editor 

NMSS EDO 

NAME BTharakan* LDimmick: LD PMichalak DCollins WMoore SMoore GTracy 

DATE 02/01/2016 01/ 28 /2016 01/29/2016 02/01/2016 02/02/2016 02/05/2016 02/ 18 /2016

OFFICIAL RECORD COPY 
Letter to B. Grumbles from G. Tracy dated February 18, 2016 

SUBJECT: Maryland FY2016 FINAL IMPEP REPORT 

DISTRIBUTION: 

RidsEdoMailCenter 

RidsOgcMailCenter 

MSampson, OEDO 

MSpencer, OGC 

RidsRgn4MailCenter 

RidsRgn3MailCenter 

RidsRgn1MailCenter 

LRoldan-Otero, NMSS 

KModes, NMSS 

SPoy, NMSS 

DJanda, RI 

BTharakan, RIV 

LHanson, RIV 

SSeeger, TN 

OAS Board 

JWeil, OCA 

RidsSecyCorrespondenceMailCenter 
 

Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MARYLAND AGREEMENT STATE PROGRAM 

NOVEMBER 2-6, 2015 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Maryland Agreement State Program. The review was conducted during 

the period of November 2-6, 2015, by a review team composed of technical staff members from 

the U.S. Nuclear Regulatory Commission (NRC) and the State of Tennessee.

Based on the results of this review, Maryland’s performance was found satisfactory for all seven 

performance indicators reviewed. 

The review team made two recommendations (see Section 5.0) and determined that the four 

recommendations from the 2011 IMPEP review, regarding inspection review of licensee 

non-compliance and corrective actions, performing self-assessments of previous licensing 

actions, reviewing licensee financial assurance requirements and mechanisms, and inactivation 

of obsolete sealed source and device registrations are completed in a timely manner, should be 

closed (see Section 2.0). 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the Maryland Agreement State Program is adequate to protect public health and 

safety and is compatible with the NRC's program. The review team recommended, and the 

MRB agreed, that the next IMPEP review take place in approximately 4 years with a periodic 

meeting mid-cycle. 
Maryland Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the IMPEP review of the Maryland Agreement State 

Program. The review was conducted during the period of November 2-6, 2015, by a 

review team composed of technical staff members from the NRC and the State of 

Tennessee. Review 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 (MD 5.6), “Integrated Materials Performance Evaluation Program (IMPEP),” dated 

February 26, 2004. Preliminary results of the review, which covered the period of 

August 13, 2011, to November 6, 2015, were discussed with Maryland’s managers on 

the last day of the review. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to Maryland on April 23, 2015. Maryland 

provided its response to the questionnaire on October 15, 2015. A copy of the 

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

Management System (ADAMS) (Accession Number ML15341A223). 

A draft of this report was issued to Maryland on December 7, 2015, for factual comment. 

Maryland responded to the findings and conclusions of the review by letter dated 

January 8, 2016. A copy of Maryland’s response can be found in ADAMS (Accession 

Number ML16012A168), and the review team’s resolution of comments using 

ML16014A108. The MRB met on January 21, 2016, to consider the proposed final 

report. The MRB found the Maryland Agreement State Program adequate to protect 

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

The Maryland Agreement State Program is administered by the Radioactive Materials 

Licensing and Compliance Division (the Division) of the Radiological Health Program 

(the Program). The Radiological Health Program is located within the Air and Radiation 

Management Administration (the Administration) of the Department of the Environment 

(the Department). Organizational charts for Maryland can be found in ADAMS 

(Accession Number ML15299A193). 

At the time of the review, the Maryland Agreement State Program regulated 539 specific 

licenses authorizing possession and use of radioactive 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 Maryland. 

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 Maryland Agreement State Program’s performance. 
Maryland Final IMPEP Report Page 2 

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS 

The previous IMPEP review concluded on August 12, 2011. The final report is available 

in ADAMS (Accession Number ML113180028). The results of the previous review and 

the status of the 2011 recommendations are as follows: 

Technical Staffing and Training: Satisfactory 

Recommendation: None 

Status of Materials Inspection Program: Satisfactory 

Recommendation: None 

Technical Quality of Inspections: Satisfactory 

Recommendation: The review team recommends that the State take measures to 

ensure that sufficient information pertaining to the inspection review of items of 

non-compliance as well as the effectiveness of licensee corrective actions is adequately 

documented in inspection records (Section 3.3 of the 2011 IMPEP report). 

Status: The review team identified four inspection casework files which contained 

documentation related to items of non-compliance, including the notice of violation 

issued by the Program; the licensee’s response to the notice of violation, including the 

licensee’s corrective actions to address the violation(s); the Program’s 

acknowledgement of the licensee’s response; and the documentation in the Program’s 

inspection report closing out the violation. Based on a review of these files, the review 

team determined that Maryland is adequately documenting the inspection review of 

items of non-compliance and the effectiveness of licensee corrective actions. The 

review team recommended, and the MRB agreed, that this recommendation be closed. 

Technical Quality of Licensing Actions: Satisfactory but Needs Improvement 

Recommendation: The review team recommends that Maryland perform a 

self-assessment of selected licensing actions issued during the review period, and on a 

routine basis in the future, to ensure that the Program’s review of licensing actions are 

adequately documented and that licensing actions are thorough and consistent with the 

regulations and appropriate licensing guidance (Section 3.4 of the 2011 IMPEP report). 

Status: Maryland reviewed 37 licensing actions and found 25 of 37 licensing actions to 

be acceptable. Twelve licensing actions were found deficient and needed a deficiency 

letter, an amendment, a corrected copy of the license, or a re-evaluation of a renewal 

action. Of the 12 deficient licensing actions 4 were completed by a former license 

reviewer and 8 were completed by one of the current license reviewers. Maryland has 

corrected all 12 of the deficient licensing actions. The current licensing supervisor started 

with Maryland in March 2015 and has performed a root cause evaluation of these 

deficient licensing actions from the self-assessments. The supervisor identified the 

improper use of checklists and the carryover of errors from one licensing action to the 

next as the root causes. Maryland will continue to perform self-assessments of 

completed licensing actions. The review team recommended, and the MRB agreed, that 
Maryland Final IMPEP Report Page 3 

this recommendation be closed. The review and MRB note that this recommendation 

called for a retrospective review of issued licensing actions. The MRB determined that 

Maryland met the intent of the recommendation. However, to assure quality before a 

licensing action is issued, the MRB supported a new recommendation for a quality 

assurance program that reviews licensing actions before they are issued (Section 3.4.c.). 

Recommendation: The review team recommends that the State: (1) take measures to 

ensure that the financial assurance requirements are reviewed as part of significant 

license actions and during renewals; (2) evaluate the need for financial assurance 

related to radionuclide production (cyclotron) licensees; and (3) perform a review of the 

adequacy and validity of financial assurance mechanisms on file with the program 

(Section 3.4 of the 2011 IMPEP report). 

Status: Maryland has a procedure in place that follows NUREG-1757 Volume 3, 

Revision 1 “Consolidated NMSS Decommissioning Guidance – Financial Assurance, 

Recordkeeping, and Timeliness.” License reviews included an evaluation for the need 

for financial assurance. Maryland currently has 25 licensees that require financial 

assurance. The financial assurance mechanisms for these actions are properly 

organized in a locked cabinet. Maryland maintains an up-to-date financial assurance 

database of these licensees. In terms of the 2011 IMPEP, one of the two cyclotron 

licenses has a limiting condition for financial assurance and the other cyclotron licensee 

provided its revised decommissioning funding plan and a new financial assurance 

mechanism on November 16, 2015, subsequent to the onsite review. The review team 

recommended, and the MRB agreed, that this recommendation be closed. 

Technical Quality of Incident and Allegation Activities: Satisfactory 

Recommendation: None 

Compatibility Requirements: Satisfactory 

Recommendation: None 

Sealed Source and Device Evaluation Program: Satisfactory 

Recommendation: The review team recommends that, for the 25 obsolete Sealed 

Source and Device (SS&D) registrations identified in Appendix G, the Program take 

actions to submit the status of those registrations for inclusion in the National SSD 

Registry, to include transfer of each registration to inactive status as recommended in 

Section 13.4 of NUREG 1556, Volume 3, Revision 1, “Applications for Sealed Source 

and Device Evaluation and Registration,” and to take measures to ensure that future 

registrations that become obsolete are inactivated in a timely manner (Section 4.2.2 of 

the 2011 IMPEP report). 

Status: The Program inactivated the 25 obsolete SS&D registrations identified in 

Appendix G of the 2011 IMPEP report. All of the issues raised during the last IMPEP 

review have been adequately resolved. The review team recommended, and the MRB 

agreed, that this recommendation be closed. 

Overall finding: Adequate and Compatible 
Maryland Final IMPEP Report Page 4 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review the NRC regional and 

Agreement State radioactive materials programs. These indicators are (1) Technical 

Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality 

of Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of 

Incident and Allegation Activities. 

3.1 Technical Staffing and Training 

The ability to conduct effective licensing and inspection programs is largely dependent 

on having a sufficient number of experienced, knowledgeable, well-trained technical 

personnel. Under certain conditions, staff turnover could have an adverse effect on the 

implementation of these programs, and thus could affect public health and safety. 

Apparent trends in staffing must be explored. Review of staffing also requires a 

consideration and evaluation of the levels of training and qualification. The evaluation 

standard measures the overall quality of training available to, and taken by, materials 

program personnel. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-103, “Reviewing 

the Common Performance Indicator: Technical Staffing and Training,” and evaluated 

Maryland’s performance with respect to the following performance indicator objectives: 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Agreement State training and qualification program is equivalent to NRC’s Inspection 

Manual Chapter (IMC) 1248, “Formal Qualifications Program for Federal and State 

Materials and Environmental Management Programs.” 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies, especially senior-level positions, are filled in a timely manner. 

• There is a balance in staffing of the licensing and inspection programs. 

• Management is committed to training and staff qualification. 

• Individuals performing materials licensing and inspection activities are adequately 

qualified and trained to perform their duties. 

• License reviewers and inspectors are trained and qualified in a reasonable period of 

time. 

b. Discussion 

The Maryland Agreement State Program is composed of 6 technical staff members (3 

each in the licensing and inspection sections), 2 supervisors, 1 administrative staff 

person, and 1 manager which equals 10 full-time equivalents for the radioactive 

materials program, including vacancies. Currently, there are two vacancies, one each in 

 
Maryland Final IMPEP Report Page 5 

the licensing and inspection sections. At the time of the review, these positions were 

vacant for 7 and 8 months, respectively, and Maryland had just begun the interview 

process for the vacant inspector position. The licensing position was on hold pending 

the outcome of an internal human resource audit. During the review period, four staff 

members (two inspectors, one license reviewer, and the licensing supervisor) left the 

program. One license reviewer position was vacant at the beginning of the review 

period. That position was vacant for approximately 17 months until it was filled in 

February 2012. Excluding the current vacancies, the other vacant positions during the 

review period were vacant from 8 to 9 months before they were filled. During the review 

period, Maryland hired one inspector, one license reviewer, and the licensing supervisor. 

Maryland’s training and qualification program is not compatible with the NRC’s IMC 

1248. Maryland should have adopted the essential elements of IMC 1248 within 6 

months after it was published on April 19, 2013. The IMC 1248 describes the activities 

and training that license reviewers and inspectors must complete to become fully 

qualified to perform the duties of the job. The IMC 1248 identifies formal training 

classes, including required and specialized training, individual study activities, and onthe-job training activities. The IMC 1248 also added specific refresher training 

requirements for qualified staff to maintain qualifications. The Program’s current staff is 

fully qualified, however, new staff hired by the Maryland Program must complete a 

qualification program that is compatible with IMC 1248. 

c. Evaluation 

The review team determined that during the review period the Maryland program met 

most of performance indicator objectives listed in Section 3.1.a. However, vacancies 

were not always filled in a timely manner, and the Program’s training and qualification 

manuals were not compatible with IMC 1248. 

The review team was concerned about the length of time that vacancies were open and 

the extended period of time that the Program has been operating with reduced staffing 

levels. During the review period, the Program lost an experienced fully-qualified 

inspector to a position outside of State government, and an experienced fully-qualified 

license reviewer and the licensing supervisor retired from State government. The 

Program currently has two positions that have been vacant for over 7 months. 

Additionally, the licensing supervisor position was vacant for approximately 9 months 

during the review period. These vacancies and operating with less than a full staff for a 

significant portion of the review period have impacted the Program’s ability to complete 

licensing actions and inspections in a timely manner. 

The workload generated from the licensing and inspection activities associated with 539 

licensees, in addition to unplanned incident response and allegation activities, is 

significant, even at full staffing levels. However, at reduced staffing levels, the review 

team noted the following impacts to Maryland’s administration of the licensing and 

inspection programs. 
Maryland Final IMPEP Report Page 6 

In the licensing program, there are currently more licensing actions open and for a 

longer period of time than during the same period in 2014. Also, the average time to 

complete a licensing action has increased from 176 days to 206 days in that same 

period of time. 

In the inspection program, Maryland’s management made a decision to postpone 

inspections of lower risk significant activities (e.g., nuclear gauge inspections) to focus 

the Program’s available inspection resources on completing initial inspections of new 

licensees and higher risk significant priority 1, 2, and 3 licensees, at the required 

frequency. As documented in Section 3.2 of this report, the Program has an overdue 

rate of 5 percent for priority 1, 2, 3, and initial inspections. The review team determined 

that, while 5 percent overdue is still satisfactory, when compared to the 2011 IMPEP 

overdue rate of 1 percent, there is a declining trend in performing inspections for higher 

risk significant activities on time. 

Maryland has separate training and qualification programs for inspectors and license 

reviewers, which did not contain the essential elements of IMC 1248. Maryland’s 

inspector qualification program incorporated significantly more of the essential elements 

than the license reviewer qualification program. In September 2015, both the inspector 

and license reviewer qualification programs adopted the new refresher training 

requirements for qualified staff. However, neither program has completely adopted the 

required and specialized training, individual study activities, or on-the-job training to be 

considered compatible with IMC 1248. Although, there have not been any new 

inspectors or license reviewers participating in the qualification program since IMC 1248 

was published in April 2013, Maryland is set to hire new staff that will start the training 

and qualification program. Therefore, the review team recommended, and the MRB 

agreed, that Maryland develop, update, and implement a training and qualification 

program that meets the essential elements of IMC 1248 to ensure that new staff are 

properly trained to license and inspect all Maryland radioactive material license types. 

d. Results 

The review team strongly considered recommending a Satisfactory but Needs 

Improvement rating for this indicator because of Maryland’s delay in addressing the 

staffing vacancies. However, the current staff is fully qualified, and the Program’s 

managers addressed resource shortfalls during the review period without sacrificing the 

technical quality of licensing, inspection, and incident response activities. Therefore, the 

review team concluded that Maryland demonstrated satisfactory performance during the 

review period. 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Technical 

Staffing and Training, be found satisfactory. 

3.2 Status of the Materials Inspection Program 

Periodic inspections of licensed operations are essential to ensure that activities are 

being conducted in compliance with regulatory requirements and consistent with good 
Maryland Final IMPEP Report Page 7 

safety practices. The frequency of inspections is specified in NRC IMC 2800 “Materials 

Inspection Program” dated November 15, 2010, and is dependent on the amount and 

kind of material, the type of operation licensed, and the results of previous inspections. 

There must be a capability for maintaining and retrieving statistical data on the status of 

the inspection program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-101, “Reviewing 

the Common Performance Indicator: Status of the Materials Inspection Program,” and 

evaluated Maryland’s performance with respect to the following performance indicator 

objectives: 

• Initial inspections and inspections of Priority 1, 2, and 3, licensees are performed at 

the frequency prescribed in IMC 2800. 

• Candidate licensees working under reciprocity are inspected in accordance with the 

criteria prescribed in IMC 1220, “Processing of NRC Form 241, Report of Proposed 

Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and 

Offshore Waters, and Inspection of Agreement State Licensees Operating Under 

10 CFR 150.20.” 

• Deviations from inspection schedules are normally coordinated between technical 

staff and management. 

• There is a plan to perform any overdue inspections and reschedule any missed or 

deferred inspections; or a basis has been established for not performing any overdue 

inspections or rescheduling any missed or deferred inspections. 

• Inspection findings are communicated to licensees in a timely manner (30 calendar 

days, or 45 days for a team inspection, as specified in IMC 0610, “Nuclear Material 

Safety and Safeguards Inspection Reports”). 

b. Discussion 

Maryland conducted 302 priority 1, 2, and 3, and initial inspections during the review 

period. Five percent of those inspections (1 initial inspection and 14 priority 1, 2, or 3 

inspections) were conducted overdue. A satisfactory performance rating is warranted 

when less than 10 percent of inspections are conducted overdue. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 3.2.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Status of the 

Materials Inspection Program, be found satisfactory. 
Maryland Final IMPEP Report Page 8 

3.3 Technical Quality of Inspections 

Inspections, both routine and reactive, provide assurance that licensee activities are 

carried out in a safe and secure manner. Accompaniments of inspectors performing 

inspections, and the critical evaluation of inspection records are used to assess the 

technical quality of a program’s inspection capability. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-102, “Reviewing 

the Common Performance Indicator: Technical Quality of Inspections,” and evaluated 

Maryland’s performance with respect to the following performance indicator objectives: 

• Inspections of licensed activities focus on health, safety, and security. 

• Inspection findings are well-founded and properly documented in reports. 

• Management promptly reviews inspection results. 

• Procedures are in place and used to help identify root causes and poor licensee 

performance. 

• Inspections address previously identified open items and violations. 

• Inspection findings lead to appropriate and prompt regulatory action. 

• Supervisors conduct annual accompaniments of each inspector to assess 

performance and assure consistent application of inspection policies. 

• For programs with separate licensing and inspection staffs, to verify that procedures 

are established and followed to provide feedback information to license reviewers. 

• For Agreement States, to determine if inspection guides are consistent with NRC 

guidance. 

• An adequate supply of calibrated survey instruments is available to support the 

inspection program. 

b. Discussion 

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

interviewed inspectors for 25 materials inspections conducted during the review period. 

The casework reviewed included inspections conducted by six (current and former) of 

Maryland’s inspectors and covered medical, industrial, commercial, academic, research, 

and service provider licenses. 

Review team members accompanied four program inspectors during September and 

October 2015. The inspector accompaniments are identified in Appendix B. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 3.3.a. 

 
Maryland Final IMPEP Report Page 9 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Technical 

Quality of Inspections, be found satisfactory. 

3.4 Technical Quality of Licensing Actions 

The quality, thoroughness, and timeliness of licensing actions can have a direct bearing 

on public health and safety, and security. An assessment of licensing procedures, 

actual implementation of these procedures, and documentation of communications and 

associated actions between the Maryland licensing staff and the regulated community 

will be a significant indicator of the overall quality of the program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-104, “Reviewing 

the Common Performance Indicator: Technical Quality of Licensing Actions,” and 

evaluated Maryland’s performance with respect to the following performance indicator 

objectives: 

• Licensing action reviews are thorough, complete, consistent, and of acceptable 

technical quality with health, safety, and security issues properly addressed. 

• Essential elements of license applications have been submitted and elements meet 

current regulatory guidance (e.g., financial assurance, increased controls, prelicensing guidance). 

• License reviewers, if applicable, have the proper signature authority for the cases 

they review independently. 

• License conditions are stated clearly and are inspectable. 

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

• Reviews of renewal applications demonstrate a thorough analysis of a licensee’s 

inspection and enforcement history. 

• Applicable guidance documents are available to reviewers and are followed (e.g., 

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.). 

• Licensing practices for risk significant radioactive materials are appropriately 

implemented including increased controls and fingerprinting orders (Part 37 

equivalent). 

• Documents containing sensitive security information are properly marked, handled, 

controlled and secured. 

b. Discussion 

During the review period, Maryland performed 1,754 radioactive material licensing 

actions. Maryland receives over 400 licensing actions each year and currently has 539 

active specific licenses. The review team evaluated 25 radioactive material licensing 

actions, which included casework for one former license reviewer, two current license 

reviewers, and the current licensing supervisor. The licensing actions selected included 
Maryland Final IMPEP Report Page 10 

1 new application, 14 amendments, 4 renewals, 2 terminations, 1 bankruptcy, and 

3 financial assurance actions. The review team evaluated casework for several license 

types and actions: broad-scope, medical diagnostic and therapy, cyclotron, 

manufacturer and distributor, industrial radiography, research and development, 

academic, nuclear pharmacy, portable and fixed gauges, panoramic irradiators, service 

providers, and waste brokers. 

 

License reviewers and the licensing supervisor perform license reviews following the 

guidance in the NRC’s NUREG-1556 series, “Consolidated Guidance About Materials 

Licenses.” All licenses are signed by the program manager. Licenses are issued for a 

7-year period under a timely renewal system. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 3.4.a. 

Since the last IMPEP review, Maryland has improved the technical quality of its licensing 

actions. License reviewers use the NUREG-1556 series as a guide for completing all 

licensing actions, perform self-assessments on completed licensing actions, review 

licenses for financial assurance, and ensure that financial assurance documents are 

organized and secured in a locked location. 

The review team determined that licensing actions were generally thorough, complete, 

consistent, and of acceptable technical quality with health, safety, and security issues 

properly addressed. The review team identified missing license components in 7 of the 

25 licensing case files reviewed, which were subsequently corrected by the Program. 

Two licenses were missing both the maximum possession limits for some radionuclides 

and the standard license condition for transportation. Two additional licenses were 

missing the maximum possession limits for some radionuclides. One additional license 

was missing the standard license condition for transportation. One license was missing 

the standard license condition for incineration of radioactive waste. One license listed a 

Radiation Safety Officer on a broad-scope license, but the file was missing 

documentation of the individual’s radioactive material training and experience. 

In addition, 163 of Maryland’s 539 licenses included a license condition that licensed 

material may be used at temporary job sites throughout the State of Maryland without 

specifying that, for work at a federal facility, the jurisdictional status of the temporary job 

site must be determined by the licensee. Although Maryland’s regulations in Part A 

Section A-1 of the Annotated Code of Maryland, Environmental Article, differentiates 

between NRC jurisdiction and Maryland jurisdiction, the review team determined that the 

license condition needed clarification. The review team shared a license condition with 

Maryland that would provide clarity on the jurisdictional status at temporary job sites. 

Maryland plans to modify the temporary job site license condition at the next amendment 

or renewal of the license. 

Because of the above findings identified by the review team in some of the case files, 

the review team recommended, and the MRB agreed, that Maryland develop and 
Maryland Final IMPEP Report Page 11 

implement a quality assurance program to ensure that licenses are reviewed for 

completeness and accuracy prior to issuance by the State. The quality assurance 

program may include, for example, checklists, peer checks, independent reviews, 

periodic training, and/or other error prevention techniques. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Technical 

Quality of Licensing Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities 

The quality, thoroughness, and timeliness of response to incidents and allegations of 

safety concerns can have a direct bearing on public health and safety. An assessment 

of incident response and allegation investigation procedures, actual implementation of 

these procedures, internal and external coordination, and investigative and follow-up 

procedures and actions will be a significant indicator of the overall quality of the 

program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-105, “Reviewing 

the Common Performance Indicator: Technical Quality of Incident and Allegation 

Activities,” and evaluated Maryland’s performance with respect to the following 

performance indicator objectives: 

• Incident response, investigation, and allegation procedures are in place and 

followed. 

• Response actions are appropriate, well-coordinated, and timely. 

• On-site responses are performed when incidents have potential health, safety or 

security significance. 

• Appropriate follow-up actions are taken to ensure prompt compliance by licensees. 

• Follow-up inspections are scheduled and completed, as necessary. 

• Notifications are made to the NRC Headquarters Operations Center for incidents 

requiring a 24-hour or immediate notification to the Agreement State or NRC. 

• Incidents are reported to the Nuclear Material Events Database. 

• Allegations are investigated in a prompt, appropriate manner. 

• Concerned individuals are notified of investigation conclusions. 

• Concerned individuals’ identities are protected, as allowed by law. 

b. Discussion 

During the review period, 43 incidents were reported to Maryland. The review team 

evaluated 14 radioactive materials incidents which included 5 lost/stolen/abandoned 

radioactive materials, 2 potential overexposures, 3 medical events, 3 damaged 
Maryland Final IMPEP Report Page 12 

equipment, and 1 leaking sources. Maryland dispatched inspectors for onsite 

follow-up for 12 of the cases reviewed. 

During the review period, 13 allegations were received by Maryland. The review team 

evaluated 11 allegations, including 8 allegations that the NRC referred to the State, 

during the review period. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 3.5.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Technical 

Quality of Incident and Allegation Activities, be found satisfactory. 

4.0 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) Low-Level Radioactive Waste Disposal Program, and (4) Uranium 

Recovery Program. The NRC’s Agreement with Maryland does not relinquish regulatory 

authority for a uranium recovery program; therefore, only three non-common 

performance indicators applied to this review. 

4.1 Compatibility Requirements 

State statutes should authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory responsibility 

under the agreement. The statutes must authorize the State to promulgate regulatory 

requirements necessary to provide reasonable assurance of protection of public health, 

safety, and security. The State must be authorized through its legal authority to license, 

inspect, and enforce legally binding requirements, such as regulations and licenses. 

NRC regulations that should be adopted by an Agreement State for purposes of 

compatibility or health and safety should be adopted in a time frame so that the effective 

date of the State requirement is not later than 3 years after the effective date of NRC's 

final rule. Other program elements, as defined in Appendix A of State Agreements 

procedure SA-200, “Compatibility Categories and Health and Safety Identification for 

NRC Regulations and Other Program Elements,” that have been designated as 

necessary for maintenance of an adequate and compatible program should be adopted 

and implemented by an Agreement State within 6 months following NRC designation. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-107, “Reviewing 

the Non-Common Performance Indicator: Compatibility Requirements,” and evaluated 
Maryland Final IMPEP Report Page 13 

Maryland’s performance with respect to the following performance indicator objectives. 

A complete list of regulation amendments can be found on the NRC Web site at the 

following address: https://scp.nrc.gov/rss_regamendents.html. 

• The Agreement State program does not create conflicts, duplications, gaps, or other 

conditions that jeopardize an orderly pattern in the regulation of radioactive materials 

under the Atomic Energy Act, as amended. 

• Regulations adopted by the Agreement State for purposes of compatibility or health 

and safety were adopted no later than 3 years after the effective date of the NRC 

regulation. 

• Other program elements, as defined in SA-200 that have been designated as 

necessary for maintenance of an adequate and compatible program have been 

adopted and implemented within 6 months of NRC designation. 

• The State statutes authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory 

responsibility under the agreement. 

• The State is authorized through its legal authority to license, inspect, and enforce 

legally binding requirements such as regulations and licenses. 

• Impact of sunset requirements, if any, on the State’s regulations. 

b. Discussion 

Maryland became an Agreement State on January 1, 1971. The Maryland Agreement 

State Program’s current effective statutory authority is contained in the Annotated Code 

of Maryland, Environmental Article, Title 8, “Radiation,” and Title 7, “Hazardous Materials 

and Hazardous Substances.” The Department is designated as the State’s radiation 

control agency. Maryland’s statutory authority is sufficiently broad for the regulation of 

byproduct, source, special nuclear materials, and other radioactive materials. Seven 

supplements of State regulations affecting the radiation control program were passed 

during the review period. 

Maryland’s administrative rulemaking process takes approximately 7 months from 

drafting to finalizing a rule. The public, the NRC, other agencies, and potentially 

impacted licensees and registrants are offered an opportunity to comment during the 

process. Comments are considered and incorporated, as appropriate, before the 

regulations are finalized and approved by the Secretary of the Environment. The review 

team noted that the State’s rules and regulations are not subject to “sunset” laws. 

During the review period, Maryland submitted 11 final regulation amendments and 4 

proposed regulation amendments to the NRC for a compatibility review. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 3.4.1.a. 
Maryland Final IMPEP Report Page 14 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Compatibility 

Requirements, be found satisfactory. 

4.2 SS&D Evaluation Program 

Adequate technical evaluations of SS&D designs are essential to ensure that SS&D’s 

will maintain their integrity and that the design is adequate to protect public health and 

safety. NUREG-1556, Volume 3, “Consolidated Guidance about Materials Licenses: 

Applications for Sealed Source and Device Evaluation and Registration,” provides 

information on conducting SS&D reviews and establishes useful guidance for review 

teams. Three sub elements; technical staffing and training, technical quality of the 

product evaluation program, and evaluation of defects and incidents regarding SS&D’s, 

will be evaluated to determine if the SS&D program is satisfactory. Agreement States 

with authority for SS&D evaluation programs who are not performing SS&D reviews are 

required to commit in writing to having an SS&D evaluation program in place before 

performing evaluations. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-108, “Reviewing 

the Non-Common Performance Indicator: Sealed Source and Device Evaluation 

Program,” and evaluated Maryland’s performance with respect to the following 

performance indicator objectives: 

Technical Staffing and Training 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies are filled in a timely manner. 

• Management is committed to training and staff qualification. 

• Individuals performing SS&D evaluation activities are adequately qualified and 

trained to perform their duties. 

• SS&D reviewers are trained and qualified in a reasonable period of time. 

Technical Quality of the Product Evaluation Program 

• SS&D evaluations are adequate, accurate, complete, clear, specific, and consistent 

with NUREG 1556, Volume 3. 
Maryland Final IMPEP Report Page 15 

Evaluation of Defects and Incidents 

• SS&D incidents are reviewed to detect possible manufacturing defects and the root 

causes of these incidents. 

• Incidents are evaluated to determine if other products may be affected by similar 

problems. Appropriate action and notifications to the NRC, Agreement States, and 

others, as appropriate, should occur in a timely manner. 

b. Discussion 

Technical Staffing and Training 

At the time of the review, Maryland had three staff members qualified to perform SS&D 

reviews. The program plans to train another staff member to be fully qualified to perform 

SS&D evaluations, and hire another person who may be trained to perform SS&D 

evaluations. During the review period two SS&D staff members left the program and 

one staff member was hired. The team noted that the license reviewer position, which 

would also be one of the SS&D reviewer positions, has been vacant since April 1, 2015. 

Maryland has a training program equivalent to NRC training requirements listed in IMC 

1248, Appendix D. 

Technical Quality of the Product Evaluation 

Maryland has five SS&D licensees. The review team evaluated 23 of 49 SS&D actions 

processed during the review period. These actions included a new evaluation and 48 

inactivations. 

Evaluation of Defects and Incidents Regarding SS&D’s 

No incidents involving SS&D registered products were reported to the Program during 

the review period. Consequently, the review team did not evaluate incidents related to 

the SS&D program. The review team confirmed that procedures are in place should an 

SS&D-related incident occur. The Program is aware of the need to review such 

incidents as potentially generic in nature with possible wide-ranging effects. 

c. Evaluation 

The review team determined that during the review period Maryland met the 

performance indicator objectives listed in Section 4.2.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Maryland’s performance with respect to the indicator, Sealed 

Source and Device Evaluation Program, be found satisfactory. 
Maryland Final IMPEP Report Page 16 

4.3 Low Level Radioactive Waste (LLRW) Disposal Program 

In 1981, the NRC amended its Policy Statement, “Criteria for Guidance of States and 

NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through 

Agreement,” to allow a State to seek an amendment for the regulation of LLRW. 

Although Maryland has the authority to regulate LLRW, there are no plans for a 

commercial LLRW disposal facility in Maryland. Accordingly, the review team did not 

review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, Maryland’s performance was found satisfactory 

for all seven performance indicators reviewed. The review team made two 

recommendations regarding the performance of the State and determined that the four 

recommendations from the 2011 IMPEP review should be closed. 

Accordingly, the review team recommended, and the MRB agreed, that the Maryland 

Agreement State Program be found adequate to protect public health and safety and 

compatible with the NRC's program. Based on the results of the current IMPEP review, 

the review team recommended, and the MRB agreed, that the next full IMPEP review 

take place in approximately 4 years with a periodic meeting mid-cycle. 

Below are the review team’s recommendations, as mentioned in the report, for 

evaluation and implementation by Maryland: 

1. The review team recommends that Maryland develop, update, and implement a 

training and qualification program that meets the essential elements of IMC 1248 to 

ensure that new staff are properly trained to license and inspect all Maryland 

radioactive material license types. 

2. The review team recommends that Maryland develop and implement a quality 

assurance program to ensure that licenses are reviewed for completeness and 

accuracy prior to issuance by the State. The quality assurance program may 

include, for example, checklists, peer checks, independent reviews, periodic training, 

and/or other error prevention techniques. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Inspection Accompaniments 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Binesh Tharakan, Region IV Team Leader 

 Technical Staffing and Training 

Steve Seeger, Tennessee Status of Materials Inspections 

Donna Janda, Region I Technical Quality of Inspections 

 Inspector Accompaniments 

Kathy Modes, NMSS Technical Quality of Licensing Actions 

Latischa Hanson, Region IV Technical Quality of Incident and 

 Allegation Activities 

 Inspector Accompaniments 

Stephen Poy, NMSS Compatibility Requirements 

 Sealed Source and Device Evaluation Program 
APPENDIX B 

INSPECTION ACCOMPANIMENTS 

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

Accompaniment No.: 1 License No.: 05-002-04 

License Type: High Dose Rate Remote Afterloader Priority: 2 

Inspection Date: 09/22/15 Inspector: RM 

Accompaniment No.: 2 License No.: 03-001-03 

License Type: Medical Institution, Written Directive Required Priority: 3 

Inspection Date: 09/29/15 Inspector: KB 

Accompaniment No.: 3 License No.: 27-014-01 

License Type: Self-Shielded Irradiator Priority: 5 

Inspection Date: 09/30/15 Inspector: AJ 

Accompaniment No.: 4 License No.: 25-022-01 

License Type: Industrial Radiography Priority: 1 

Inspection Date: 10/29/15 Inspector: AG