DATED: JULY 6, 1999 SIGNED BY: FRANK J. MIRAGLIA, JR.

Mr. Arthur W. Ray, Deputy Secretary

Maryland Department of Environment

2500 Broening Highway

Baltimore, MD 21224

Dear Mr. Ray:

On June 22, 1999, 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 NRC’s program. 

Section 5.0, page 19, of the enclosed final report presents the IMPEP team’s recommendations. 

The June 3, 1999 letter from Merrylin Zaw-Mon, Director, Air and Radiation Management

Administration, detailed the actions Maryland was taking in response to the recommendations

made by the review team. We request your evaluation and response to Recommendations 4, 6,

7, 8, and 9 within 30 days from receipt of this letter. 

Based on the results of the current IMPEP review, a follow-up IMPEP review focusing on the

State’s licensing and sealed source and device evaluation programs will be completed in one

year and the next full review will be in approximately 4 years.

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

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

cooperatively in the future.

Sincerely, /RA/

Frank J. Miraglia, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Merrylin Zaw-Mon, Director

Air and Radiation Management Administration

Maryland Department of the Environment

Roland G. Fletcher, Manager

Air and Radiation Management Administration

Maryland Department of the Environment

Steven Collins, Organization of Agreement 

 States Representative to MRB

Mr. Arthur W. Ray, Deputy Secretary

Maryland Department of Environment

2500 Broening Highway

Baltimore, MD 21224
Dear Mr. Ray:

On June 22, 1999, 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 NRC’s program. 

Section 5.0, page 19, of the enclosed final report presents the IMPEP team’s recommendations. 

The June 3, 1999 letter from Merrylin Zaw-Mon, Director, Air and Radiation Management

Administration, detailed the actions Maryland was taking in response to the recommendations

made by the review team. We request your evaluation and response to Recommendations 4, 6,

7, 8, and 9 within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, a follow-up IMPEP review focusing on the

State’s licensing and sealed source and device evaluation programs will be completed in one

year and the next full review will be in approximately 4 years.

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

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

cooperatively in the future.

Sincerely,

Frank J. Miraglia, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Merrylin Zaw-Mon, Director bcc: Chairman Dicus

Air and Radiation Management Administration Commissioner Diaz

Maryland Department of the Environment Commissioner McGaffigan

Commissioner Merrifield

Roland G. Fletcher, Manager

Air and Radiation Management Administration

Maryland Department of the Environment

Steven Collins, Organization of Agreement 

 States Representative to MRB

Distribution: See next page.

DOCUMENT NAME: G:\IMPEP\99FINLTR.MD; G:\IMPEP\MDIMP99.FIN

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

OFFICE OSP/RSAO OSP:D DEDR

NAME RLWoodruff:gd:kk PHLohaus FJMiraglia

DATE 07/ /99 07/ /99 07/ /99

OSP FILE CODE: SP-AG-14
Arthur W. Ray - 2 -

Distribution:

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF MARYLAND AGREEMENT STATE PROGRAM

March 22 - 26, 1999

FINAL REPORT

U.S. Nuclear Regulatory Commission
Maryland Final Report Page 1

1.0 INTRODUCTION

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

review was conducted during the period March 22-26, 1999 by a review team comprised of

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

State of Texas. 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 a Final General Statement of Policy," published in the Federal

Register on October 16, 1997, and the November 25, 1998, revised NRC Management Directive

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

review, which covered the period September 27,1996 to March 26, 1999, were discussed with

Maryland management on March 26, 1999

A draft of this report was issued to Maryland for factual comment on April 26, 1999. The State

responded in a letter dated June 3, 1999. The Management Review Board (MRB) met on

June 22, 1999, to consider the proposed final report. The MRB found the Maryland radiation

control program was adequate to protect public health and safety and compatible with NRC’s

program.

The Maryland Department of the Environment (MDE) is the agency within the State of Maryland

that regulates environmental and radiation hazards. The Secretary, MDE, is appointed by and

reports directly to the Governor. The Radiological Health Program (RHP) is organized under the

Air and Radiation Management Administration. The RHP consists of a Radiation Machines

Division and the Radioactive Materials Licensing and Compliance Division. The Radiation

Materials Licensing and Compliance Division includes a supervisor and two Sections, the

Inspection and Enforcement Section with four persons, and the Licensing and Environmental

Radiation Section with three persons. Organization charts for the MDE, the Air and Radiation

Management Administration, and RHP are included as Appendix B. The Maryland program

regulates approximately 592 specific licenses. The review focused on the materials program as

it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended)

Agreement between the NRC and the State of Maryland.

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

performance indicators was sent to the State on January 13, 1999. The State provided a

response to the questionnaire on March 1, 1999. A copy of the questionnaire is included in

Appendix G to the draft report.

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

Maryland's response to the questionnaire; (2) review of applicable Maryland statutes and

regulations; (3) analysis of quantitative information from the RHP licensing and inspection

database; (4) technical review of selected licensing and inspection actions; (5) field

accompaniments of two Maryland inspectors; and (6) interviews with staff and management to

answer questions or clarify issues. The review team evaluated the information that it gathered

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

and made a preliminary assessment of the RHP’s performance. 

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

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

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

performance indicators, and Section 5 summarizes the review team's findings and 
Maryland Final Report Page 2

recommendations. Recommendations made by the review team are comments that relate

directly to program performance by the State. A response is requested from the State to all

recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous IMPEP review of the Maryland radiation control program concluded on 

September 27, 1996. Following the last review, fifteen recommendations and four suggestions

were made in the March 21, 1997 letter and final report to Ms. Merrylin Zaw-Mon, Director, Air

and Radiation Management Administration, MDE. The State initially responded to the issues by

letter dated February 3, 1997, prior to NRC’s issuance of the final report, and also responded to

the March 21, 1997 letter and report in a letter dated April 25, 1997. The status of the

recommendations were discussed during a periodic meeting with the RHP on May 8, 1998. The

team’s review of the current status of the open recommendations is as follows:

1. The review team recommends that the State take action to have the Waste Management

Administration revise the definition of "Person" in the low-level radioactive waste

regulations, Code of Maryland Regulations (COMAR) 26.14.01.02B(28)(e) that was

identified in both the 1993-94 review and the 1995 follow-up review.

Current Status: The team found that MDE’s Waste Management Administration has

taken action to revise the definition of “person” in COMAR 26.14.01.02B(28)(e) to clearly

exclude the regulation of Federal agencies located in Maryland. The team reviewed the

revised definition and found it compatible with NRC regulations, however, the steps

outlined in OSP Procedure SA-201, Review of State Regulations, should be completed

before any rule is adopted as final. The revised definition was published on April 9, 1999

for comment with final adoption expected by July 1999. This recommendation will remain

open until a final rule is adopted.

2. The review team recommends that the State of Maryland inform NRC when the referring

physician/patient notification requirements has been completed by Sacred Heart Hospital.

Current Status: The State received a progress report on July 18, 1997, regarding the

1987-1988 therapeutic misadministrations at Sacred Heart Hospital. The progress report

indicated that the hospital had received location confirmation from 14 of the 19 physicians

involved in the care of 26 of the 33 misadministered patients. Since that time, the

hospital has changed ownership and gone through a consolidation. The new owners

continued to pursue information regarding patient notification from the 14 physicians with

little success. Interviews were conducted with ten of the 20 physicians, and one

physician is deceased. Most physicians did not recall the exact circumstances or

notification actions. Based on the efforts put forth by the Maryland program and the

hospital, as well as the period of time that has elapsed since the misadministrations, this

recommendation is closed.

3. The review team recommends that the State incorporate the April 1995 revisions to NRC

Inspection Manual Chapter 2800 into their Inspection Procedures Manual. 

Current Status: The State updated their inspection frequencies. This recommendation is

closed.
Maryland Final Report Page 3

4. The review team recommends that management provide a corrective action plan to

address the issue of qualifying staff. The team also recommends that management

provide a training and qualification plan for new staff that includes an appropriate

education background, and a requalification plan for staff that do not meet the initial

qualifications, and staff who are reassigned from another technical area, and continued

training for long-term staff. 

Current Status: The State added a chapter to their Radiological Health Inspection Manual

that adequately addressed this recommendation. This recommendation is closed.

5. The review team recommends that the State assess the adequacy of the program staff to

ensure the long-term ability of the program to complete the pending rules and

amendments for adoption to remain compatible. 

Current Status: The State formed a special team to develop regulations needed for

compatibility and to assure that Maryland's regulations remain compatible. This issue

was also highlighted at the Division level as a priority task. Additional details are provided

under Section 4.1. This recommendation is closed.

6. The review team recommends that the State adhere to the policy of annual supervisory

accompaniments of all inspectors. 

Current Status: The State is adhering to the policy of conducting annual

accompaniments of inspectors. This recommendation is closed.

7. To ensure consistency in performance among inspection staff, the review team

recommends that the State develop a program outlining the necessary steps to be

followed by compliance staff for full inspector qualification. 

Current Status: The State created a program outlining the necessary steps for full

inspector qualification. This recommendation is closed.

8. The review team recommends that the State begin voluntary reporting of all reportable

events to the NRC Operations Center and begin participating in the NMED database

system collection of material events by providing event information directly into the NMED

system electronically or providing compatible information in written form in accordance

with guidance contained in the "Handbook on Nuclear Material Event Reporting in the

Agreement States," Draft Report, March 1995. 

Current Status: The State's corrective actions were fully implemented by November

1998, and the State is currently adhering to the recommended policy. This

recommendation is closed.

9. The team recommends that the State provide event information for three events identified

by the State in response to the Questionnaire, as follows: (1) 1/23/95 Maryland State

Highway event, (2) 5/26/95 Soil Safe Inc. event, and (3) 5/30/96 Aerosol Monitoring

event. 

Current Status: The information on the named events has been provided to the NMED

data system. This recommendation is closed.
Maryland Final Report Page 4

10. The review team recommends that the State improve the effectiveness of the Regulation

Adoption Management Plan by providing a realistic schedule of milestones for

development and adoption of the 10 rules currently identified in the plan for adoption by

the end of 1997. 

Current Status: The State completed this task with the formation of the regulation

reviews committee and the progress is discussed in Section 4.1. This recommendation is

closed.

11. The review team recommends that the State address the process for handling multiple

rulemakings to ensure that they are completed within three years of the effective date. 

Current Status: The State's process is currently working as discussed in Section 4.1. 

This recommendation is closed.

12. The team recommends that the State address the staff's comments relating to Maryland's

COMAR final rules that were transmitted to the State. 

Current Status: The State addressed the comments from the 1996 report during

subsequent rule revision correspondence. The status of the Maryland regulations is

discussed under Section 4.1. This recommendation is closed.

13. The review team recommends that the State implement a plan to review all registration

sheets, based on the risk associated with the device, especially detailed QA/QC program

information. 

Current Status: The original recommendation was made in 1993 but was never closed. 

The State did not review all registration certificates for missing information or against

existing guidance. The State requested QA/QC programs be submitted for the more

significant devices, except for Neutron Products, Inc. (NPI). The State wanted NPI to

address other more significant issues. This recommendation is closed and will be carried

forth as a repeat recommendation in Section 4.2.

14. The review team recommends that the State adopt regulations compatible with 10 CFR

30.32 (g) and 10 CFR 32.210. (Section 4.2)

Current: The State has adopted these regulations. This recommendation is closed.

15. The review team recommends that an additional senior staff member should be trained to

perform the SS&D evaluations to supplement the program as it matures. 

Current Status: The State is training one of its license reviewers to perform SS&D

reviews. He has performed one review and has attended an NRC SS&D workshop. He

currently does not meet the qualification guidance in Management Directive 5.6. This

recommendation remains open and will be carried forth as a repeat recommendation in

Section 4.2.

During the 1996 review, four suggestions were made concerning: (1) the development of a

formal training plan; (2) the assessment of certain inspections performed by a previous

employee; (3) the development of guidance documents for license terminations; and (4) the
Maryland Final Report Page 5

implementation of an allegation tracking system. The team determined that the State considered

the suggestions and took appropriate actions. However, with regard to the allegation tracking

system, the RHP managers related that they did not plan to establish a tracking system for

allegations since no allegations were received during the review period except those referred to

Maryland by the NRC.

3.0 COMMON PERFORMANCE INDICATORS

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

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

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

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

3.1 Status of Materials Inspection Program

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

overdue inspections, initial inspections of new licenses, and timely dispatch of inspection

findings. The team reviewed Maryland’s response to the questionnaire responses relative to this

indicator, data gathered from the State’s licensing and inspection database and tracking

systems, examination of completed inspection casework and interviews with staff members.

Half of Maryland’s 52 licensee categories have more aggressive inspection intervals than

specified in Inspection Manual Chapter (IMC) 2800. There are no categories with inspection

intervals longer than that required by the IMC. Although the inspection manual indicates that

inspection intervals can be lengthened or shortened based on the licensee’s performance, the

present practice is only to shorten intervals when needed. 

The State’s response to the questionnaire indicated that it had no backlog or overdue

inspections. The team confirmed this by reviewing 49 examples of casework. All inspections

were performed well within the required frequency due to the tighter inspection intervals and the

inspection scheduling system used. The State performs initial inspections within the first six

months of license issuance. The State also conducts a site visit prior to issuing a license to

discuss aspects of the license and verify the readiness of the future licensee to receive

radioactive material. 

Reciprocity inspections are performed at the proper frequency in accordance with IMC 1220,

except for source exchange licensees. Since the last IMPEP review, one of four licensees was

missed in 1998, three of four missed in 1997, and two of two missed in 1996. RHP management

agreed that additional effort should be made to inspect all source exchange licenses due to the

high potential hazard.

The team noted that inspection correspondence was generally sent within 30 days of inspection

to the licensee. Notices of violation are dispatched well within the 30-day requirement, with only

occasional longer time periods. Of the 49 casework reviewed, 45 inspection reports were issued

within 30 days or less and two reports were issued within 35 days. Two reports were issued at

69 and 82 days.

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

performance, with respect to the indicator, Status of Materials Inspection, be found satisfactory.
Maryland Final Report Page 6

3.2 Technical Quality of Inspections

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

documentation, and interviewed inspectors for 22 material inspections conducted during the

review period. The casework included inspections by all four material license inspectors. The

casework covered inspections of various license types, including: portable gauge, nuclear

pharmacy, private nuclear medicine, mobile nuclear medicine, institutional medicine, blood

irradiator, teletherapy, academic, broad academic, industrial radiography, well logging, and

service companies. Appendix C lists the inspection casework reviewed for completeness and

adequacy including the case-specific comments.

The RHP has developed computerized inspection field notes that are based on NRC field notes

and inspection guidance. Based upon the inspector accompaniments and the casework reports

reviewed, the team verified that the inspection procedures are consistent with NRC procedures

and that inspections are being performed unannounced. The RHP has computerized the

licensing/inspection data and a print out of inspections due is available on the computer system. 

The Supervisor, Radioactive Materials Licensing and Compliance Division, makes the inspection

assignments. The inspector prepares for the inspection by obtaining the appropriate inspection

forms and notes from the computer and reviewing the license/inspection file for open compliance

issues, incidents, and allegations. 

Based on casework, the review team noted that routine inspections covered all aspects of the

licensees’ radiation programs. The review team found that inspection reports were thorough,

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

performance with respect to health and safety was acceptable. The documentation supported

violations, recommendations made to the licensee, unresolved safety issues, and discussions

held with the licensee during exit interviews. Team inspections were performed when

appropriate and for training purposes. The casework documentation shows that inspectors are

utilizing the appropriate inspection notes and addressing both open items from previous

inspections and any incidents that have occurred since the previous inspection. The casework

also shows that the inspection forms and notes are used consistently by inspectors to assure

uniform and complete inspection practices.

Following an inspection, the inspector debriefs with the Supervisor to discuss the inspection

results and appropriate enforcement action as needed. The field notes are then completed along

with an inspection report and a draft enforcement letter is prepared as appropriate. The team

noted that a narrative inspection report is prepared for all facilities with a one year inspection

frequency and for all escalated enforcement cases. According to the State’s procedure, the draft

report and draft enforcement letter are reviewed by the Supervisor within 10 days, and prior to

any enforcement documents being prepared in final form. All final enforcement correspondence

is signed by the RHP Manager. Enforcement practices allow for a Maryland Form E-1 to be

issued by the inspector on site at the time of the inspection if there are no items or only minor

items of noncompliance. RHP also utilizes a Form E-2 which is similar to the NRC Form 592. 

The team found that approximately two thirds of the casework reviewed resulted in no items of

noncompliance. As noted above, the Supervisor is required to review all field notes and

inspection reports within 10 days following the inspection. The team found that in 10 cases, the

Supervisor had not reviewed the field notes or inspection reports within the 10-day period

following the inspection, as required by the inspection procedure, and that the Supervisor’s

review was often performed after the Notice of Violation had been issued. The review team
Maryland Final Report Page 7

recommends that all inspection documentation be reviewed and signed by RHP management

before the inspection correspondence is issued to the licensee.

Licensing and inspection information is combined in one file and maintained by both inspection

and licensing staff. The review team discussed with RHP the difficulty in locating reports and

correspondence in the State’s files. However, in all cases, the technical staff were able to locate

the missing documents. After consideration, the team considers this to be an administrative

issue rather than a performance issue.

During the week of February 1, 1999, a review team member performed accompaniments of the

two State inspectors on separate inspections of licensed activities (see Appendix C). The

inspections were of a medical institution and field industrial radiography licensee. During the

accompaniments, inspectors demonstrated appropriate inspection skills and knowledge of the

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

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

of both inspectors was outstanding. The inspections were adequate to assess radiological

health and safety of the licensed activities. 

The review team found that Maryland maintains a sufficient number of portable radiation

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

and emergencies. Included in the inventory are ion chambers, micro R meters, high range

detectors, Geiger Mueller tubes, ratemeters, scintillation detectors, high and low range pocket

dosimeters, alpha meters, calibration check sources, and air sampling equipment. The review

team examined instrumentation and observed that the survey instruments available during the

IMPEP review were calibrated and operable. The RHP has an arrangement with Baltimore Gas

and Electric Company which assists the RHP by providing a database for the instrument

calibration and can provide additional instrumentation for emergencies if needed. The RHP also

contracts with a commercial radiological service company to provide calibrations and repairs. 

The Environmental Laboratory was not visited during the review; however, the RHP managers

and technical staff related that the laboratory provides good support in performing quantitative

analyses of samples collected during inspections or incidents in a timely manner.

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

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

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive materials program 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 State's questionnaire responses relative

to this indicator, interviewed RHP management and staff, and considered any possible workload

backlogs.

At the time of the review, eight staff members were directly involved with the Agreement State

radioactive material program, including management. There are currently no unfilled vacancies. 

The Licensing and Environmental Section has three individuals and the Inspection and

Enforcement Section has four individuals currently assigned. During the review period, one

inspector left, and an individual was hired within nine months to refill that position. The new staff

member possesses a bachelor’s degree and several years experience in nuclear medicine. 
Maryland Final Report Page 8

Although RHP has the ability to hire an individual at an entry level (health physicist trainee), RHP

does not have any trainees on the staff. All staff are at least at a Health Physicist II level.

License reviewers and inspectors have all been through the core courses listed in IMC 1246, and

the management’s commitment to staff training is evident in the quickness that the new staff

member has been the given opportunity and funds to complete the core course offered by the

NRC. The RHP staff has also had training from other agency training programs, including the

Department of Energy and the Federal Emergency Management Agency, commercial vendors

and local educational institutes. A 1996 IMPEP recommendation advocated the creation of a

corrective action plan for the qualification of staff. The Radiological Health Inspection Manual

now contains a chapter on training and qualifications procedures, utilizing previous training, core

and specialized training, inspection accompaniments, and evaluation by management to qualify

individual staff.

The review team expressed concern that future demands and workload on the present staff may

impact the long-term ability of the RHP to maintain a full level of proficiency in all areas of the

program. This concern is based upon the projected retirement of the individual responsible for

oversight of the RHP’s adoption of regulations (Section 4.1), the processing of enforcement

actions (Section 3.1), the performance in the licensing area (Section 3.4), and performance in the

sealed source and device area (Section 4.2). The staffing level should be closely monitored

given the possible retirement and need to improve overall performance of the program,

particularly in the licensing and sealed source and device evaluation program areas. The review

team recommends that the State evaluate present and future staffing needs of the RHP and

develop a strategy that will assure RHP’s continued adequacy and compatibility.

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

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

3.4 Technical Quality of Licensing

The review team examined completed licenses and casework for 25 licensing actions,

representing the work of four license reviewers. The license reviewers and RHP management

were interviewed to supply additional information regarding licensing decisions or file contents.

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

used, qualifications of authorized users, adequate facilities and equipment, and operating and

emergency procedures sufficient to establish the basis for licensing actions. Licenses were

reviewed for accuracy, appropriateness of the license and its tie-down conditions, and overall

technical quality. Casework was evaluated for adherence to good health physics practices,

reference to appropriate regulations, supporting documents, peer or supervisory review, and

proper signature authorities. The files were checked for retention of necessary documents and

supporting data.

The licensing actions reviewed included the following types of licenses: academic; medical (both

broad scope and specific); industrial radiography; radiopharmacy; panoramic and self-shielded

irradiator; portable and fixed gauge; High Dose Rate (HDR) afterloader; brachytherapy;

manufacturing and distribution; waste broker; incinerator; and service. Licensing actions

included 2 new licenses, 13 amendments, 7 renewals, and 3 terminations. A list of these

licenses with case-specific comments may be found in Appendix D.
Maryland Final Report Page 9

The program processed 1158 licensing actions during the review period, or an average of 460

actions per year. These consisted of 52 terminations, 81 new license applications, 172

renewals, and 853 amendments. Monthly tracking reports are generated and reviewed by RHP

management.

All incoming licensing actions are briefly reviewed by the Supervisor and then logged into a

computer tracking system by the licensing staff. There are currently two individuals who perform

license reviews full time and have signature authority. A third individual recently started

performing reviews. A majority of the licensing actions are performed by the most experienced

license reviewer. This staff member also assigns each action. If a deficiency letter is required,

the license reviewer prepares the letter using standard deficiency paragraphs for the signature of

the Supervisor. After the review is completed, each licensing action, including the cover letter, is

reviewed by the Supervisor. 

The Supervisor’s review is initialed on both the license and letter, and then sent to the RHP

Manager for signature. The Administrative Assistant confirms the proper review, prints the final

copy for signature, and mails the license to the licensee. Boilerplate licenses as well as standard

conditions for each type of amendment are used to generate all new and renewed licenses thus

ensuring a standard license. If the licensing action is an amendment request, RHP will issue the

completed amendment on a supplement sheet indicating only those license conditions that were

changed. 

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

and with health and safety issues properly addressed. Tie-down conditions are backed by

information contained in the file, and are inspectable. Deficiency letters clearly state regulatory

positions, are used when appropriate, and identify deficiencies in the licensees' documents. 

Terminated licensing actions are well-documented, showing appropriate transfer and survey

records. The program uses a combination of NRC and State regulatory guides. In addition, a

number of additional guidance documents are used. Checklists for most categories of licenses

are used for new or renewal actions and maintained with the license file. The licensing staff

conducts a pre-licensing visit to all new applicants prior to issuing the license to review the

conditions of the licenses, COMAR regulations, and RHP policies. These visits are documented

with a checklist maintained in the appropriate docket file. The review team noted that RHP has

initiated the practice within the last year of routinely amending licenses to incorporate licensees’

commitments made in response to notices of violations issued from inspection findings. 

The review team noted that 8 of the 25 licensing actions reviewed either did not authorize the

licensed material requested by the licensee, did not authorize the correct isotope form or

possession limit, named the wrong Radiation Safety Officer (RSO), did not address an aspect of

the radiation protection program, authorized distribution of licensed material not included on the

device’s Sealed Source & Device (SS&D) registration’s sheet, or did not include tie-down

conditions committing the licensee to follow submitted procedures. For example, the team noted

that one of the omitted tie-downs included the operational procedures for the use of an HDR

source in a coronary afterloader in an Investigative Device Evaluation study. There were also

two cases where license amendments were issued out of sequence instead of incorporating the

action with the pending renewal or new application. In the case of the new application, the

applicant submitted additional information which was issued as an amendment prior to the

issuance of the new license. Although there is a potential health and safety consequence as a

result of these license deficiencies, none have been observed by RHP or reported by the

licensee.
Maryland Final Report Page 10

The review team noted that at the time of the review, 50 license renewals have been in timely

renewal for one year or more, or approximately 10% of all materials licenses. A majority of the

overdue renewals (65%) have been in timely renewal between one and two years, a significant

number (27%) have been pending for more than three years. Two of the actions have been in

timely renewal for more than 10 years with the oldest action in renewal for over 12 years for one

of the State’s largest medical broad scope licenses. A number of these actions have been

pending for extended periods needing either a written response from the licensee to a deficiency

letter, review of the licensee’s application, or review of the licensee’s response to a deficiency

letter by the program.

The review team discussed the licensing backlog and the accuracy and technical quality of

licenses with RHP management who indicated their awareness of the situation and discussed

with the review team the need to provide additional staffing and oversight of the licensing staff. 

The review team recommends that RHP management implement an action plan to reduce the

number of backlogged licensing actions and set goals to improve the accuracy and overall

technical quality of licenses.

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

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

with recommendations for improvement.

3.5 Response to Incidents and Allegations

To evaluate the effectiveness of the State’s actions in responding to incidents, the review team

examined the State’s response to the questionnaire regarding this indicator, evaluated selected

incidents reported for Maryland in the “Nuclear Material Events Database” (NMED) against those

contained in the Maryland files, and evaluated the casework and supporting documentation for

eight radioactive material incidents. A list of incident casework examined along with case

specific comments is contained in Appendix E. The team also evaluated the State’s response to

six radioactive materials allegations which were referred to the State by NRC during the review

period.

The review team discussed the State's incident and allegation processes, file documentation, the

State’s equivalent to the Freedom of Information Act, NMED, and notification of incidents to the

NRC Operations Center with the program managers and selected staff. In addition, the State’s

understanding and use of the NMED system was verified by a team member during a

demonstration of data entry into the system, and through the generation of specific reports

requested during the review. 

When notification of an incident is received, the managers and staff discuss the health and

safety risk associated with the incident, the information needed, the need for an on-site

investigation, and coordination with other Agencies. The actions taken in response to the event

are documented in a report, filed, and the data entered into the NMED system. Enforcement

actions or other regulatory actions were taken as appropriate. The team confirmed that the State

has the most recent NRC guidance for reporting incidents. The key program staff were all aware

of the guidance and had general knowledge about the use of the NMED database system. 

The State had 18 radioactive materials incidents during the review period. Eight incidents were

selected for casework review, including a stolen portable gauge, two misadministrations, one

occupational overexposure, two damaged portable gauge incidents, one industrial radiography
Maryland Final Report Page 11

accident, a leaking source, and a stuck teletherapy source incident. The review team found that

the State’s responses to incidents were complete and comprehensive. Initial responses were

prompt and well-coordinated. The level of effort was commensurate with the health and safety

significance. Inspectors were dispatched for on-site investigations when appropriate and the

State took suitable enforcement action including coordination with the license reviewers and

follow up, as appropriate. There were no performance issues identified during the incident

casework reviews. 

During the review period, there were no materials allegations received by the State directly, and

six materials allegations were referred to the State by the NRC. All six were examined in detail

by the review team. The review of the casework and the State’s files indicates that the State

took prompt and appropriate action in response to the concerns raised. All of the allegations

reviewed were appropriately closed and the team noted that allegations were treated and

documented internally in the same manner as incidents. There were no performance issues

identified from the review of the casework documentation, except for one allegation report that

was filed in a non-confidential file that contained the identity of the alleger. 

The State has allegation procedures, “Radioactive Materials Procedure for Handling Allegations,

Revision 0, dated September 18, 1996, which were assessed in accordance with IMPEP criteria,

draft OSP Procedure SA-105, “Response to Incidents and Allegations,” and the NRC

Management Directive 8.8, “Management of Allegations,” revised February 4, 1999. Copies of

the NRC documents were provided to the State during the review. The team’s assessment

shows that the State's procedure does not adequately address the following: (1) the definition of

“allegation;” (2) the protection of the allegers identity; (3) allegations received during inspections;

(4) the referral of allegations not under RHP jurisdiction (except for criminal cases); and (5)

documentation for closing out the concern(s) with the alleger, except for cases where an

inspection or investigation is not warranted. The review team recommends that the State revise

their allegation procedure to incorporate appropriate elements following NRC guidance

documents.

The team also determined during the review that Maryland can protect the identity and

confidentially of individuals and related information. The RHP Manger provided specific

“excerpts” from a “Public Information Act Manual” prepared by the Attorney General’s office. This

information was referenced as Public Information Statue, 10-618(f)(2)(iv).

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

performance with respect to the indicator, Response to Incidents and Allegations, be found

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing Agreement

State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program;

and (4) Uranium Recovery Program. Maryland’s Agreement does not cover a uranium recovery

program, so only the first three non-common performance indicators were applicable to this

review.
Maryland Final Report Page 12

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation 

Along with their response to the questionnaire, the State provided the review team with the

opportunity to review copies of legislation that affect the radiation control program. The 

currently effective statutory authority is contained in Annotated Code of Maryland, Environmental

Article, Title 8, “Radiation,” and Title 7, “Hazardous Materials and Hazardous Substances.” The

RHP, Air and Radiation Management Administration, MDE implements the radiation control

program.

4.1.2 Program Elements Required for Compatibility

The statutes are contained in COMAR 26.12.01.01 “Regulations for the Control of Ionizing

Radiation” (1994) that applies to all ionizing radiation. COMAR 26.15 “Disposal of Controlled

Hazardous Substances-Radioactive Hazardous Substances” contains statues specific to lowlevel radioactive waste issues. Maryland requires a license for the possession and use of all

radioactive material including naturally occurring materials, such as radium, and acceleratorproduced radionuclides. Maryland also requires registration of all equipment designed to

produce x-rays or other ionizing radiation.

The review team examined the State’s administrative rulemaking process and found that the

process takes six months from the development stage to the final approval by the Secretary of

the Environment, after which the rule becomes effective in 10 days. The regulation adoption

process is provided in Title 10, “Government Procedures,” Subtitle 1, “Administrative Procedures

Acts - Regulations.” The public, 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 State can adopt other agency regulations by reference which

has been done with respect to transportation regulations adopted by the U.S. Department of

Transportation and the U.S. Postal Service regulations that were in effect on May 15, 1996. The

State also has the authority to issue legally binding requirements (e.g., license conditions) in lieu

of regulations until compatible regulations become effective.

The team evaluated Maryland’s response to the questionnaire and reviewed the status of

regulations under the Commission’s new adequacy and compatibility policy. The review team

noted that regulations were updated on December 6, 1996 (Supplement 1), November 3, 1997

(Supplement 2), June 29, 1998 (Supplement 3) and December 28, 1998 (Supplement 4). The

team found that the State addressed the following NRC regulation amendments since the last

IMPEP review:

! “Licensing and Radiation Safety Requirements for Irradiators,” 10 CFR Part 36

(58 FR 7715) that became effective July 1, 1993.

! “Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70

amendments (59 FR 36026) that became effective August 15, 1994.

! “Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for

Medical Use,” 10 CFR Parts 30, 32, and 35 amendments (59 FR 61767 and 65243)

that became effective January 1, 1995.
Maryland Final Report Page 13

! “Frequency of Medical Examinations for Use of Respiratory Protection Equipment,”

10 CFR Part 20 amendment (60 FR 7900) that became effective March 13, 1995.

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and

61 amendments (60 FR 15649 and 25983) that became effective March 1, 1998. The

Agreement States are to promulgate their regulations no later than March 1,1998 so that

NRC and the State would require this national system to be effective at the same time.

The State has not yet adopted the following regulations, but intends to address them in timely

rulemaking, or by adopting alternate generic legally binding requirements:

! The definition of “person” in the low-level radioactive waste regulations

COMAR 26.14. 01.02B(28)(e) as it relates to Federal agencies. As noted in Section 2,

this was identified in both the 1993-94 review, 1995 follow-up review, and the 1996

IMPEP review. The team reviewed the revised definition and found it compatible with

NRC regulations, however, the steps outlined in OSP Procedure SA-201, Review of State

Regulations, should be completed before any rule is adopted as final. The revised

definition was published on April 9, 1999 for comment with final adoption expected by July

1999. 

! “Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment

(60 FR 28323) that became effective June 30, 1995.

! “Radiation Protection Requirement: Amended Definitions and Criteria,” 10 CFR Parts 19

and 20 amendments (60 CFR 36038) that became effective August 14, 1995.

! “Clarification of Decommissioning Funding Requirements,” 10 CFR Parts 30, 40, and 70

amendments (60 FR 38235) that became effective November 24, 1995.

! “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 35

amendments (60 FR 48623) that became effective October 20, 1995.

! “10 CFR Part 71: Compatibility with the International Atomic Energy Agency,”

10 CFR Part 71 amendments (60 FR 50248) that became effective April 1, 1996.

! “Termination or Transfer of Licensed Activities: Recordkeeping Requirements,” 10 CFR

Parts 20, 30, 40, 61, and 70 amendments (61 FR 24669) that became effective June 17,

1996.

! “Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air

Act,” 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9, 1997.

! “Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

Within an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662) that became

effective February 27, 1997.

! “Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts

20 and 35 amendments (62 FR 4120) that became effective May 29, 1997.
Maryland Final Report Page 14

! “Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial

Radiography Operations,” 10 CFR Parts 30, 34, 71, and 150 amendments (62 FR 28948)

that became effective June 27, 1997.

! “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70

amendments (62 FR 39057) that became effective August 20, 1997.

! “Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14

Urea,” 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2,

1998.

! “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 13773) that became effective February 12, 1998.

! “License for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiographic Operations; Clarifying Amendments and Corrections,” 10 CFR Part 34

amendment (63 FR 37059) that became effective July 9, 1998.

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

32, 35, 36, and 39 amendments (63 FR 393477 and 63 FR 45393) that became effective

October 26, 1998.

! “Transfer for Disposal and Manifest; Minor Technical Conforming Amendments,”

10 CFR Parts 20, 35, 36, and 39 amendment (63 FR 50127) that became effective

November 20, 1998.

During the review, the State related that seven of the above regulations required for compatibility

are combined in two packages (Supplements 5 and 6) and are in the process of being adopted. 

Both supplements have been reviewed by NRC and the State expects them to be adopted by

August 1999. Four additional regulations required for compatibility by September 2000 are

currently being developed by RHP staff for incorporation into COMAR (Supplement 7).

The team noted that the RHP staff member responsible for oversight of the adoption of NRC

regulations required for compatibility is scheduled to retire by end of this year. In light of this

pending retirement, the State’s past difficulties in adopting NRC regulations for compatibility, and

the need for the State to adopt a number of significant regulations currently under development

by the NRC over the next few years, the team discussed the importance of maintaining the level

of performance for this indicator with MDE management.

It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(III) provides that regulations

required prior to September 3, 1997, should be adopted by the State as expeditiously as

possible, but not later than three years after the September 3, 1997 effective date of the

Commission Policy Statement on Adequacy and Compatibility, i.e., September 3, 2000.

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

performance with respect to the indicator, Legislation and Program Elements Required for

Compatibility, be found satisfactory.
Maryland Final Report Page 15

4.2 Sealed Source and Device (SS&D) Evaluation Program

In assessing the State's Sealed Source & Device (SS&D) evaluation program, the review team

examined information provided by the State in response to the IMPEP questionnaire on this

indicator. A review of selected new and amended SS&D evaluations and supporting documents

covering the review period was conducted. The team observed the RHP’s use of guidance

documents and procedures, and interviewed the staff, RHP Manager, and Supervisor involved in

SS&D evaluations.

Since the last review, the State has instituted a policy that the RHP Manager and Supervisor 

review and sign all registration certificates prior to issuance in addition to the two reviews

conducted by the technical staff. These reviews are not technical in nature, but are to ensure the

technical soundness, readability, and understandability of the registration certificates.

4.2.1 Technical Quality of the Product Evaluation Program

Since the last IMPEP review, the State has issued three new SS&D certificates, seven

amendments, and three corrections. The review team examined five new or amended SS&D

registration certificates and their supporting documentation. The registration certificates

reviewed covered the period since the last IMPEP review and represented cases completed by

three reviewers. In addition, one registration certificate from the previous IMPEP review was

reviewed for resolution of previously identified items. The review team identified additional

significant technical issues that need to be addressed in this registration certificate. It was noted

that previous comments on all casework reviewed during the 1996 IMPEP were not addressed. 

The registration certificates issued by the State and evaluated by the review team are listed with

case-specific comments in Appendix F.

The review team found that some SS&D evaluations do not fully address important health and

safety concerns. For two of the registration certificates reviewed, MD-1003-D-101-G and MD1003-D-102-G, the review team identified significant deficiencies common to both. These

deficiencies include inadequate description of the device and safety features in the description

section of the registration certificate; inadequate engineering drawings; inadequate dose

estimates; inadequate engineering analyses performed by the applicant; and improper

instructions in the device’s user’s manual.

The review team was unable to make a determination that the above devices could be used

safely under the expected conditions of use due to the above deficiencies. These findings are

significant since both of these devices are distributed as generally licensed, where it is assumed

that the user is able to use the device safely without being trained in radiation safety. The review

team recommends that the State promptly review registration certificates MD-1003-D-101-G and

MD-1003-D-102-G, taking into consideration the deficiencies listed in Appendix F for each

registration certificate, and amend the registration certificates accordingly. 

The review team also identified repeated examples of deficiencies with respect to thoroughness,

completeness, consistency, clarity, technical quality, and adherence to existing guidance. 

Adequate engineering drawings were not provided in most cases. The engineering drawings

should contain safety critical components, such as the shutter, pneumatics, source holders,

shielding, etc., with materials of construction, methods of construction, and dimensions and

tolerances. Four of the registration certificates had attachments listed as proprietary or

confidential, contrary to the State’s policy on proprietary information. Several deficiency letters

issued by the State and responses from the applicants could not be located in the supporting
Maryland Final Report Page 16

files. Several documents submitted by the applicants should have been referenced in the

registration certificates. Finally, there was a lack of documentation (e.g., staff reviewers stated

that they had discussed deficiencies and received information from applicants over the telephone

and there was no information in the supporting files documenting these calls).

During the 1993 review, NRC recommended that the State and vendors should replace missing

information and review outdated registration sheets in accordance with the standard format and

content guidance. The 1993 review recommended that the State obtain and maintain sufficient

documentation on file to establish a complete health and safety basis for the integrity of the

product designs. This item was closed out based on the State's response to the 1993 review.

With the assignment of new staff to the program in 1995, the review team requested the

documentation of the State's actions to this previous comment. The staff present in 1996 was

not aware of this commitment and management was not able to produce documentation of

actions taken by Maryland in response to the 1993 review.

Based on the above, the 1996 IMPEP review team recommended that the State implement a

plan to review all registration certificates, based on the risk associated with the device, especially

detailed quality assurance/quality control (QA/QC) program information. The State requested

QA/QC programs be submitted by their registration certificate holders for the more significant

devices, except for Neutron Products, Inc. (NPI). The State wanted NPI to address other more

significant issues. These QA/QC programs were reviewed and incorporated into the distribution

licenses of the registration certificate holders. The State did not review all registration

certificates for missing information or against existing guidance. The team is concerned about

the magnitude of the issues identified in this review, and the fact that similar issues raised in the

1996 IMPEP review were not fully addressed. The team recommends that the State, using

NUREG-1556 guidance and following the description of a “concurrence review” in Management

Directive 5.6, complete a secondary review of all registration certificates issued by the State to

identify any missing information and with priority of the actions based on the risk associated with

the device.

The State’s reviewers stated that they currently follow the NRC’s guidance in NUREG-1556, Vol.

3, “Consolidated Guidance on Materials Licensees: Applications for Sealed Source and Device

Evaluation and Registration,” when reviewing applications and drafting registration certificates. 

Prior to this document’s issuance in July 1998, the State’s reviewers followed the NRC’s

guidance in NUREG-1550, “Standard Review Plan for Applications for Sealed Source and Device

Evaluations and Registrations,” and Regulatory Guide 10.10, “Guide for the Preparation of

Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct

Material.” NUREG-1556, Vol. 3, combined and superseded the guidance provided in these

documents. Review of the five registration certificates and interviews with the staff indicates that

staff is not adequately following the prescribed guidance. Section 4.2.2 contains a

recommendation that addresses this issue.

4.2.2 Technical Staffing and Training

During this IMPEP period, all reviews were performed by three staff members. All three staff

members are health physicists, two are qualified license reviewers, and the third is a senior

inspector. All three have attended at least one of the NRC’s sealed source and device

evaluation workshops. Only one reviewer worked with a qualified SS&D reviewer (the former

SS&D reviewer who retired in June 1995) prior to independently reviewing and signing

registration certificates. The other two staff members had no experience reviewing applications
Maryland Final Report Page 17

or drafting registration certificates prior to being assigned cases as the primary reviewer for

formal review. 

Based on interviews and discussions with the staff and the extensive deficiencies, findings,

comments, and issues identified in the registration certificates reviewed, the team determined

that the RHP staff do not fully meet the qualification guidance in Management Directive 5.6 and

need additional training and experience in the review of applications and drafting of registration

certificates. Specifically, the staff needs additional training and experience in the following areas: 

understanding and interpreting the appropriate prototype tests that ensure the integrity of the

products under normal and likely accidental conditions of use; reading and understanding

blueprints and drawings (including the types and contents of blueprints and drawings that

applicants are required to submit); understanding the conditions of use; and understanding and

utilizing basic knowledge of engineering materials and their properties. During the 1996 IMPEP

review, an offer was extended to the State for a reviewer to work with the Sealed Source Safety

Section at NRC Headquarters. No reviewer from the State of Maryland has worked with staff at

NRC Headquarters. This review team has made the same offer to the State. The 1996 IMPEP

team recommended that an additional senior staff member be trained to perform the sealed

source and device evaluations to supplement the program as it matures. The State had

assigned an additional individual to the program who has completed one review to date and

would also benefit from additional training and experience. The review team recommends that

the State provide the staff additional training and experience in the review of sealed source and

device applications and the drafting of registration certificates (including the guidance contained

in NUREG 1556, Vol. 3). This should include training and experience which will meet the

qualification guidance found in Management Directive 5.6. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The review team reviewed the State’s response to two events requiring the evaluation of defects

and incidents regarding sealed sources and devices. The State responded satisfactorily to both

events.

4.2.4 Summary

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

performance with respect to the indicator, Sealed Source and Device Evaluation Program, be

found satisfactory with recommendations for improvement. During the MRB meeting on June 22,

1999, the MRB requested that the team revise appropriate portions of the SS&D section to reflect

meeting discussions. Many of those MRB discussions were directed at understanding the review

team’s decision to recommend a satisfactory with recommendations for improvement rating as

opposed to an unsatisfactory rating for this indicator. The MRB commented that based on the

criteria in Management Directive 5.6, an unsatisfactory rating for this indicator appeared to be a

possibility and questioned each team member concerning the satisfactory with recommendations

for improvement rating. Given the significance of the comments made on the SS&D casework

reviewed by the team, the MRB recommends that the State respond to all of the review team’s

comments in Appendix F of the final report, and the MRB directed that a follow-up review of the

State’s SS&D program be completed in one year. Due to the findings involving the common

performance indicator, Technical Quality of Licensing Actions, the MRB also directed that the

follow-up review include the State’s licensing program. The MRB accepted the team’s

recommendation that Maryland’s performance with respect to this indicator be found satisfactory

with recommendations for improvement.
Maryland Final Report Page 18

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 as a separate category. Those

States with existing Agreements prior to 1981 were determined to have continued LLRW

disposal authority without the need of an amendment. Although Maryland has LLRW disposal

authority, NRC has not required States to have a program for licensing a LLRW disposal facility

until such time as the State has been designated as a host State for a LLRW disposal facility. 

When an Agreement State has been notified or becomes aware of the need to regulate a LLRW

disposal facility, they are expected to put in place a regulatory program which will meet the

criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW

disposal facility in Maryland. Accordingly, the review team did not review this indicator.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found Maryland's performance to be

satisfactory in all but two indicators. The indicators, Technical Quality of Licensing Actions and

SS&D Evaluation Program were found to be satisfactory with recommendations for improvement. 

However, in view of the State’s performance demonstrated in the Status of Inspection Program

and the Technical Quality of Inspections indicators, the review team recommended and the MRB

concurred in finding the Maryland Agreement State program to be adequate to protect public

health and safety and compatible with NRC's program. A follow-up review focusing on the

State’s licensing and SS&D programs will be completed in approximately one year.

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

implementation and evaluation, as appropriate, by the State. 

RECOMMENDATIONS:

1. The review team recommends that the State take action to have the Waste Management

Administration revise the definition of "Person" in the low-level radioactive waste

regulations, Code of Maryland Regulations (COMAR) 26.14.01.02B(28)(e) that was

identified in both the 1993-94 review and the 1995 follow-up review. (Section 2.0)

2. The review team recommends that all inspection documentation be reviewed and signed

by RHP management before the inspection correspondence is issued to the licensee.

(Section 3.2)

3. The review team recommends that the State evaluate present and future staffing needs

of the RHP and develop a strategy that will assure RHP’s continued adequacy and

compatibility. (Section 3.3)

4. The review team recommends that RHP management implement an action plan to

reduce the number of backlogged licensing actions and set goals to improve the accuracy

and overall technical quality of licenses. (Section 3.4)

5. The review team recommends that the State revise their allegation procedure to

incorporate appropriate elements following NRC guidance documents. (Section 3.5)
Maryland Final Report Page 19

6. The review team recommends that the State promptly review registration certificates MD1003-D-101-G and MD-1003-D-102-G, taking into consideration the deficiencies listed in

Appendix F for each registration certificate, and amend the registration certificates

accordingly. (Section 4.2.1)

7. The team recommends that the State, using NUREG-1556 guidance and following the

description of a “concurrence review” in Management Directive 5.6, complete a

secondary review of all registration certificates issued by the State to identify any missing

information and with priority of the actions based on the risk associated with the device. 

(Section 4.2.1)

8. The 1996 IMPEP team recommended that an additional senior staff member be trained to

perform the sealed source and device evaluations to supplement the program as it

matures. The State had assigned an additional individual to the program who has

completed one review to date and would also benefit from additional training and

experience. The review team recommends that the State provide the staff additional

training and experience in the review of sealed source and device applications and the

drafting of registration certificates (including the guidance contained in NUREG 1556, Vol.

3). This should include training and experience which will meet the qualification

guidance found in Management Directive 5.6. (Section 4.2.2)

9. The MRB recommends that the State respond to all of the review team’s comments in

Appendix F of the final report. (Section 4.2.4)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Maryland’s Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source and Device Casework Reviews

Attachment Maryland’s Response to Draft IMPEP Report

 Dated June 3, 1999
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Richard Woodruff, Region II Team Leader

Response to Incidents and Allegations

Duncan White, Region I Technical Quality of Licensing Actions

Legislation and Program Elements Required for

Compatibility

Inspector Accompaniments

Joseph DeCicco, NMSS Status of Materials Inspection Program

Technical Staffing and Training

William Silva, Texas Technical Quality of Inspections

Brian Smith, NMSS Sealed Source and Device Evaluation Program
APPENDIX B

STATE OF MARYLAND

DEPARTMENT OF ENVIRONMENT

AND

AIR AND RADIATION MANAGEMENT ADMINISTRATION

AND

RADIOLOGICAL HEALTH PROGRAM

ORGANIZATION CHARTS