UNITED STATES 

 NUCLEAR REGULATORY COMMISSION 

 REGION I 

 2100 RENAISSANCE BOULEVARD, SUITE 100 

 KING OF PRUSSIA, PENNSYLVANIA 19406-2713

October 1, 2013 

Roland G. Fletcher, Manager 

Radiological Health Program 

Air & Radiation Management Administration 

Maryland Department of the Environment 

1800 Washington Boulevard, Suite 750 

Baltimore, MD 21230-1718 

Dear Mr. Fletcher: 

A periodic meeting was held with you and your staff on August 28, 2013. The purpose of the 

meeting was to review and discuss the status of the Maryland Department of the Environment’s 

Agreement State Program. The NRC was represented by Daniel Collins, Duncan White, Sophie 

Holiday and me. 

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

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

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

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

comments. 

Sincerely, 

 /RA M. L. Ford for/ 

Donna M. Janda 

Regional State Agreements Officer 

Division of Nuclear Materials Safety 

Enclosure: As stated 

 
October 1, 2013 

Roland G. Fletcher, Manager 

Radiological Health Program 

Air & Radiation Management Administration 

Maryland Department of the Environment 

1800 Washington Boulevard, Suite 750 

Baltimore, MD 21230-1718 

Dear Mr. Fletcher: 

A periodic meeting was held with you and your staff on August 28, 2013. The purpose of the 

meeting was to review and discuss the status of the Maryland Department of the Environment’s 

Agreement State Program. The NRC was represented by Daniel Collins, Duncan White, Sophie 

Holiday and me. 

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

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

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

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

comments. 

Sincerely, 

 /RA M. L. Ford for/

Donna M. Janda 

Regional State Agreements Officer 

Division of Nuclear Materials Safety 

Enclosure: As stated 

Distribution: 

D. White, FSME 

M. Beardsley, FSME 

L. Dimmick, FSME 

K. Meyer, FSME 

S. Holiday 

J. Clifford, RI 

D. Collins, RI 

SUNSI Review Complete: DMJ (Reviewer=s Initials) 

DOCUMENT NAME: S:\State Agreement Files\Maryland\MARYLAND PERIODIC MEETING SUMMARY final 8-28-13.docx 

After declaring this document “An Official Agency Record” it will be released to the Public. 

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

attachment/enclosure "N" = No copy ML13274A302 

OFFICE DNMS/RI E 

NAME Janda/mlf f/ 

DATE 10/01/13 

OFFICIAL RECORD COPY
Enclosure 

 

AGREEMENT STATE PERIODIC MEETING SUMMARY FOR MARYLAND 

 DEPARTMENT OF THE ENVIRONMENT (MDE) 

DATE OF MEETING: August 28, 2013 

NRC Attendees Maryland Radiological Health Program (RHP) 

Donna Janda, RSAO, Region I Roland, Fletcher, Manager, Radiological Health 

Program 

Daniel Collins, Deputy Director, Division 

of Nuclear Materials Safety, Region I 

Raymond Manley, Chief, Radioactive Materials 

Licensing & Compliance Division 

Duncan White, Branch Chief, Agreement 

State Program Branch, FSME 

Barbara, Park, Supervisor, Radioactive Materials 

Licensing Section 

Sophie Holiday, Health Physicist, FSME Alan Jacobson, Supervisor, Radioactive Materials 

Inspection Section 

 

DISCUSSION: 

During the 2011 Integrated Materials Performance Evaluation Program (IMPEP) review of the 

Maryland Agreement State Program (the Program), the review team found the State’s 

performance satisfactory for six performance indicators: Technical Staffing and Training, Status 

of Materials Inspection Program, Technical Quality of Inspections, Technical Quality of 

Incidents and Allegations, Compatibility Requirements, and Sealed Source and Device 

Evaluation Program. The review team found the State’s performance satisfactory, but needs 

improvement, for the performance indicator, Technical Quality of Licensing Actions. Four 

recommendations regarding Program performance were made by the IMPEP review team. On 

November 3, 2011, the Management Review Board (MRB) met to consider the proposed final 

IMPEP report on the Maryland Agreement State Program. The MRB found the Program 

adequate to protect public health and safety and compatible with NRC’s program. The MRB 

directed that the next full IMPEP review take place in approximately four years. 

The following is a status summary of the four recommendations that were identified in the 2011 

Maryland final IMPEP report: 

1. The review team recommended 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. 

Status: The Division Chief stated that inspectors have been trained and reminded to 

ensure that documentation of the effectiveness of licensee corrective actions is 

included in inspection records. Each inspection report is reviewed by the inspection 

supervisor to ensure the documentation is in the report. In addition, the Program is 

now documenting inspection reports in a manner similar to the reports in NRC 

Manual Chapter 2800, “Materials Inspection Program.” Also, during the license 
Enclosure 

2 

renewal process, the license reviewer determines, from a review of the most recent 

inspection report, if the licensee’s response to a Notice of Violation is adequate. The 

reviewer then takes action based on the adequacy of the licensee’s response. 

2. The review team recommended that the State 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. 

Status: According to the Division Chief, the Program has performed several 

activities to address this recommendation. Since September 2012, a total of 25 

licensing actions were reviewed by the Program’s licensing team during staff 

meetings. Overall, the reviewers confirmed that licensing practices were thorough 

and consistent with regulations and licensing guidance. In addition, after a review of 

financial assurance actions, the Program implemented changes to the review 

process for decommissioning funding plans and followed up with applicable 

licensees. 

After the 2011 IMPEP review, the Program conducted an initial review of their 

licenses and determined, at that time, that no emergency plans were required. 

However, in subsequent follow up activities, the Program determined that the 

licensing process could be further strengthened for those licensees that have the 

inclusive possession condition of “any radioactive material between atomic numbers 

3 and 83.” The Program is having these licensees submit written documentation 

confirming their exemption from the requirement for an emergency plan as defined 

under COMAR 26.12.01.01 C.23(b). 

Since the 2011 IMPEP review, the Program developed procedures and letters to 

address emergency plans for applicable licensees. In addition, the Program has 

changed the amendment review process for licensees who request to terminate their 

license. The Division Chief stated that the Program staff has carefully reviewed the 

efficacy and completeness of their licensing checklist and how license reviewers 

apply the checklist. The staff believes that discussions of the process were very 

helpful in ensuring consistency in the licensing process. 

The Program has implemented an ongoing review of licensing actions. During each 

calendar quarter, all license reviewers and the Licensing Supervisor are each 

assigned a licensing action for quality review that was completed within the previous 

six months. 

3. The review team recommended that the State: (1) take measures to ensure that 

financial assurance requirements are reviewed as part of significant licensing actions 

and during licensing renewals; (2) evaluate the need for financial assurance related 

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

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

Program. 
Enclosure 

3 

Status: The Division Chief stated that this issue was identified by the Program prior 

to the 2011 IMPEP review. Since the review, the Program reviewed all financial 

assurance instruments and conducted training for all staff. The Program loaded the 

financial assurance instruments into a database to maintain an ongoing record. The 

Program staff reviewed the licensing procedures to determine where the process 

could be strengthened in relation to financial assurance matters. The Program is in 

the process of developing a new procedure for addressing decommissioning funding 

plans and has now incorporated by reference most of NRC’s regulations in their 

proposed regulations. In addition, the Program is working with the State of Maryland 

Attorney General’s Office to have a Financial Advisor assist with the financial 

assurance review process in the future. 

The Division Chief stated that the Program has addressed the comment in the 

IMPEP report regarding the financial assurance considerations associated with 

cyclotron activities at a broad scope licensee. The licensee now has financial 

assurance for their cyclotron activities. The Program also revised the license 

condition that was being used for financial assurance commitments to adequately 

reflect all factors associated with financial assurance obligations. Licenses with the 

new license condition were reissued to affected licensees. 

4. The review team recommended that, for the 25 obsolete SS&D registrations 

identified in Appendix G, the Program take actions to submit the status of those 

registrations for inclusion in the national Sealed Source and Device 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. 

Status: In addition to the 25 obsolete SS&D registrations identified during the 2011 

IMPEP review, the Program identified an additional 8 obsolete SS&D registrations 

that needed to be addressed. Since the 2011 IMPEP review, the Program has 

inactivated all 33 sheets. In addition, the Program reviewed the licensing procedure 

and developed an inactivation checklist to capture all necessary information which 

would be needed to complete the inactivation process. 

OTHER TOPICS COVERED DURING THE MEETING INCLUDED:

Program Strengths

The Program has an experienced and well-trained licensing and inspection staff which 

maintains operational efficiency in times of staff shortages. In addition, the Division Chief noted 

that a strength of the Program is having a Regulations Committee which meets at least once per 

month and has a dedicated staff member to ensure that the Program is current with their 

regulations. 

Program Weaknesses

The Program identified the following challenges currently being faced by managers and staff: 

finding a mechanical engineer for SS&D reviews; getting work done when short staffed (using 
Enclosure 

4 

supervisors and licensing staff perform inspections in order to avoid overdue inspections); and 

knowledge management concerns with many supervisors approaching retirement. 

Agreement State Program Staffing and Training

The Program staff currently consists of six full-time and two part-time technical staff members 

and three managers. Since the 2011 IMPEP review, the Program lost one inspector and hired 

one inspector and one license reviewer. Both new staff members are currently in the 

qualification process. There are currently no vacancies in the Program. 

Organization

The Maryland Agreement State Program is administered by the Radiological Health Program 

under the Air and Radiation Management Administration of the Maryland Department of the 

Environment. There have been no reorganizations since the 2011 IMPEP review. 

Program Budget/Funding

The Program is fully funded by licensing fees which are placed into a dedicated account. The 

Division Chief stated that approximately five years ago the Maryland legislature passed a rule 

that provided the legislature access to the dedicated fund. Funding for equipment purchases is 

provided through a U.S. Department of Energy Southern States Energy Grant. 

Inspection and Licensing Programs

The Program’s inspection frequencies are at least as frequent as NRC’s. Since the 2011 

IMPEP review, the Program began using a new database for all inspection data. The Program 

reported that 3 out of 120 routine inspections were completed overdue since the 2011 IMPEP 

review. No Priority 1, 2, or 3 inspections are currently overdue. Due to previous staffing 

shortages, the Program has a backlog of Priority 5 inspections. Now that the Program is fully 

staffed, the backlog is being addressed. In the past year, the Division Chief performed 9 

inspections during times of staffing shortages. The Program is conducting security inspections 

at two-year frequencies with the exception of industrial radiography, which is performed at oneyear intervals. 

The Program currently has approximately 535 specific licenses. Maryland licensees are subject 

to a seven-year license renewal term. The Program will be promulgating regulations to require 

licensees to submit renewal applications seven months prior to the license expiration date. The 

Program has to meet certain metrics for their licensing actions, including a requirement for 

greater than 90 percent of the license amendments must be completed within 45 days of 

submission and license renewals must be completed within seven months of submission. 

Regulations and Legislative Changes

There have not been any legislative changes or proposals that have affected the Program since 

the 2011 IMPEP review. The State has promulgated three supplements incorporating three 

amendments since the 2011 IMPEP review. The Program anticipates submitting three 

additional supplements, which will incorporate five amendments for promulgation by the end of 

calendar year 2014. The Program currently has no overdue regulations. 
Enclosure 

5 

The RHP Regulations Committee has placed the new 10 CFR Part 37 regulations on their 

agenda as an important upcoming item to be addressed. The Program managers noted that 

addressing new regulations is challenging at times and having the Regulations Committee and 

adopting some regulations by reference is very helpful. 

Event Reporting

The Program has reported five radioactive materials events to the NRC since the 2011 IMPEP 

review. The Division Chief stated that three additional events were submitted to the NRC 

Nuclear Material Events Database (NMED) this week, including one event involving a leak in a 

pump in the main pool of a panoramic irradiator. This event did not require reporting to the NRC 

Operations Center. The Program continues to close out events in NMED as appropriate. 

Response to Incidents and Allegations

The Program continues to be sensitive to notifications of incidents and allegations. Incidents 

are quickly reviewed for their effect on public health and safety. Staff is dispatched to perform 

onsite investigations when necessary. The Program is aware of the need to maintain an 

effective response to incidents and allegations. Since the 2011 IMPEP review, six allegations 

which were initially received by the NRC were transferred to the Program for follow up action. 

Sealed Source and Device (SS&D) Evaluation Program

The Program currently has five active SS&D registration sheets, including one new sheet under 

review for a new medical device (GammaPod). The Program currently does not have a contract 

for an engineer to conduct the engineering review for this new device and is working with NRC 

to have the engineering portion of the device review completed by NRC. 

At the time of this meeting, the State was still licensing the distribution of high dose rate remote 

afterloader devices for a manufacturer who had moved their operations to Georgia in 2012. The 

State of Maryland could not terminate the license until such time as the State of Georgia issued 

a new license to this manufacturer for distribution of these devices. Since the periodic meeting, 

the State of Georgia issued the new distribution license and the State of Maryland could move 

forward with terminating the distribution license held by Maryland. 

Current State Initiatives

The Program managers noted that the MDE is in the process of changing their requirements for 

license renewal submissions. Once enacted, licensees will be required to submit renewal 

applications seven months prior to the license expiration date. 

Each year the Air and Radiation Management Administration submits a list of priorities to the 

Governor. One of the priorities submitted this year was regarding a State of Maryland 

radioactive materials licensee who has been under court order for several years for numerous 

violations of Maryland regulations. The Program noted that there has been some progress with 

this licensee regarding waste shipments and security measures. 

The Program staff provides support to the Preventive Radiological Nuclear Detection Program 

activities and participates in nuclear power plant exercises. The Program is currently changing 
Enclosure 

6 

certain general licenses to specific licenses. In addition, the Program is interested in using webbased licensing. 

Emerging Technologies

The Program noted the following emerging technologies: the use of smartphones being 

implemented as a tool for materials inspectors; licensing of the new GammaPod medical 

treatment device; and moving toward a paperless system (reciprocity, inspection database). 

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

The Program managers noted that they are currently licensing a new medical device which will 

be used for the treatment of breast cancer. The Program is reviewing service provider and 

manufacturing/distribution licenses for this device. In addition, the Program and NRC are 

reviewing the SS&D registration sheet for this new device. 

State’s Mechanisms to Evaluate Performance

The Program provides major inspection and licensing data on a monthly basis and enforcement 

data on a quarterly basis to MDEStat, which is a tool used by MDE for an annual report which is 

posted as a public record on the MDE website. The State of Maryland audits the Program every 

three years. Supervisors perform reviews of inspection reports and licensing actions. The 

inspection supervisor conducts supervisory accompaniments of inspectors on an annual basis. 

The Program inspection and licensing staffs hold one to two staff meetings per month. 

CONCLUSIONS: 

The State of Maryland Radiological Health Program has an experienced and well-trained staff 

which continues to address the recommendations that were made during the 2011 IMPEP 

review. The Program is experiencing some backlog in Priority 5 inspections but now that it is 

fully staffed, the Program is working off the backlog. NRC staff recommends that the next 

IMPEP review should be conducted as scheduled in FY 2015 (tentatively August 2015).