ML20045G292

Staff Rept & Evaluation of MD Radiation Control Program for Period 870130-890217, 17th Regulatory Program Review

ML20045G292
Person / Time
Issue date:	03/13/1990
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
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ML20045G120	List: ML20045G119 ML20045G257 ML20045G265 ML20045G274 ML20045G278 ML20045G283 ML20045G288 ML20045G290 ML20045G292 ML20045G296
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NUDOCS 9307130144
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{{#Wiki_filter:.,. _ ~ .\\ (.- P STAFF REPORT AND EVALUATION OF THE MARYLAND RADIATION CONTROL PROGRAM FOR THE PERIOD JANUARY 30, 1987 TO FEBRUARY 17, 1989 v 17th Regulatory Program Review ( 9307130144 9307o3 PDR .* [] !{i PDR STPRO ESGGEN q)*], ).

f RADIATION CONTROL PRDGRAM: Maryland REVIEW MEETING NUMBER: 17 DATES OF REVIEW: February 13-17, 1989 PERIOD OF REVIEW: January 30, 1987 to February 17, 1989 NRC REPRESENTATIVES: John R. McGrath, RSAO Stewart Ebneter, Director, Division of Radiation Safety and Safeguards RADIATION CONTROL PROGRAM REPRESENTATIVE: Roland Fletcher, Administrator Center for Radiological Health Conclusions The Maryland radiation control program is adequate to protect public health and safety, however, a finding of compatibility had to be deferred due to the fact that the State still has not developed regulations equivalent to NRC's waste classification and manifest rules. These conclusions are based on the review of the technical and administrative aspects of the State's regulatory program for controlling agreement materials. Included in this review were examinations of selected license and inspection fields, the program indicators specified in the NRC " Guide for Evaluation of Agreement State Radiation Control Programs," the review of all licenses issued by the State since January 30, 1987 and our continuing exchange of information i program. Summary Discussion with State Management A summary meeting to present the results of the regulatory program review was held with Mr. Thomas Andrews, Deputy Secretary, Department of the Environment on February 17, 1989. Also present were Dr. Katherine Farrell, Assistant Secretary, Toxics, Environmental Science and Health; Larry Ward, Deputy to Dr. Farrell; and Roland Fletcher, Administrator, Center for Radiological Health. With regard to the review, the following comments were offered: 1. The inclusion of the State's radiation control program in the newly created Department of the Environment has, we believe, been a positive development for the program. The interest that Department management has shown in radiation matters has been reassuring to us. The program has undergone a number of changes since our last review in January 1987, but has managed to accomplish its basic mission regarding protection of the public health and safety. For example, despite the loss of two senior inspectors, the program's inspection backlog has been reduced to essentially zero. 2. During our last two reviews we have commented on the need to revise the State's regulations regarding low-level radioactive waste, specifically the adoption of the waste classification and manifest systems. A draft has been prepared which addresses these and other aspects of low-level waste disposal. Mr. Fletcher has indicated that he will provide a copy of this draft for our review. In the meantime, however, we must defer

e 2 ( a finding of compatibility until such time as these regulations become effective. Status and compatibility of Regulations is a Category I indicator. 3. We were pleased to note that the State has proposed fee legislation. We believe that fee can provide a significant, stable source of funding for a radiation control program and have encouraged all States to adopt some sort of fee system. If we can be of any assistance in moving this issue forward, please call on us. Budget is a Category II indicator. 4. Since the last review, the program has lost two senior inspectors, one for a higher paying but similar position in a State institution. The program has experienced some difficulty in recruiting persons with appropriate training and experience to fill these two positions. One position was filled by a transfer from the X ray program, while the second was filled by an individual with no prior training or experience in radiation protection. The amount of training necessary to bring this individual up to the point where he can begin to contribute to the program's mission is significant. We believe that the State needs to upgrade its salary structure in order to more effectively compete for personnel with qualifications consistent with the duties and responsi-bilities of these positions. Staff continuity is a Category II indicator. 5. Over the past few years the use of radioactive material in the State has t increased significantly. There are now over 500 licenses in the State. Statistical data used to manage the program is still being processed by hand. For Agreement State program the size of Maryland's, we have found that computer capability is necessary to effectively manage the program. The Center has a personal computer available to the staff and we recommend that the staff explore ways of effectively utilizing this Office equipment and support services is a Category II resource. indicator. 6. We were pleased to note that, in most' cases, the Center was diligent in pursuing effective enforcement action when circumstances so required. The State has taken a number of escalated enforcement actions including civil penalties in the period since our last review, however, as noted during previous reviews the Center has no written procedures which address the process by which escalated enforcement actions are taken. We believe that the documentation of these procedures would be of benefit to the program. Enforcement Procedures is a Category I indicator. We noted one significant exception to the program's generally diligent pursuit of timely and effective enforcement action. In June 1988 the State issued an order to Neutron Products, Inc. (NPI) requiring the license to address among other things the deficiencies in monitoring personnel as they leave the limited access area (LAA). This action was the result of an incident in May 1988 in which an employee of NPI was found to be contaminated with cobalt-60 at the Ginna Nuclear Power Plant in New York. Subsequent inspections at NPI in July-August 1988

1 ( .4 i 3 ( and October-November 1988 revealed that adequate corrective action has not yet been achieved.- We encourage the State to pursue this case to the fullest extent of the enforcement options available and we pledge the cooperation and assistance of the NRC staff in addressing this case and pursuing it to a satisfactory conclusion. ASSESSMENTS I. LEGISLATION AND REGULATIONS A. Legal Authority (Category I) On July 1,1987 the RCP became a part of the new Maryland Department of the Environment (MDI). This has been a very positive development for th'e program. RCP management has increased access to MDE manage-ment, which has shown a high degree of interest in the RCP. Since the time of the review, the State legislature has passed fee legis-lation for the RCP. This should have a very positive impact on the-program. The State satisfies the NRC guidelines for this program indicator. B. Status and Compatibility of Regulations (Category I) The State does not have regulations equivalent to NRC's waste classification and manifest regulations. A finding of compatibility was not offered for this reason. Low-level waste regulations are the responsibility of the Waste Management Administration. The State is a member of the Appalachian Compact and had been waiting for the host State, Pennsylvania, to establish regulations. Since the Pennsylvania process is now essentially complete, Maryland plans to move forward. II. ORGANIZATION A. Location of the RCP within the State Organization (Category II) As indicated earlier, the RCP is now in the Department of the Environment. This has had a positive effect on the program as a whole. The Program Director has access to appropriate levels of state management. The State satisfies the NRC guidelines for this program indicator. B. Internal Organization of the RCP (Category II) The State satisfies the NRC guidelines for this program indicator. The organization is now titled Center for Radiological Health, however, there have been no significant changes since the last review. k i

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i C. Legal Assistance (Category II) The State satisfies the NRC guidelines for this program indicator. The RCP has been receiving excellent support from the Attorney General's Office staff. D. Technical Advisory Committees (Category II) The State satisfies the NRC guidelines for this program indicator. Under the State reorganization, appointments are now made by the Secretary, MDE. III. MANAGEMENT A. Quality.of Emergency Planning (Category I) The State satisfies the NRC guidelines for this program indicator. The Maryland Emergency Management and Civil Defense Agency is currently in the process of completely revising the Maryland Disaster Assistance Plan. It is not known at this time if the radiological portion of the plan will be modified substantively. CRH is tracking this activity. B. Budget (Category II) { The State satisfies the NRC guidelines for this program indicator. CRH staff does not feel the current budget is adequate. Of particular concern is the current salary levels and the lack of training funds. Subsequent to the review, the legislature passed fee authorization which should significantly augment resources. C. Laboratory Support (Category II) The State satisfies the NRC guidelines for this program indicator. Laboratory services are being provided by the Department of Health and Mental Hygiene. Under the reorganization, this program remained under DHMH. Since the lab only services MDE, no problems have arisen as a result cf the current arrangement. D. Administrative Procedures (Category II) The State satisfies the NRC guidelines for this program indicator. E. Management (Category II) The State satisfies the NRC guidelines for this program indicator. (

5 ( F. Office Equipment and Support Services (Category II) All licensing and inspection data are now being kept by hand. With well over 500 licenses, the CRH should be utilizing computer capabilities. CRH has an IBM PC-AT-but is not being used for the radioactive materials program. The CRH staff intends to obtain PC training in order to begin using this system. G. Public Information (Category II) The State satisfies the NRC guidelines for this program indicator. IV. PERSONNEL A. Qualifications of Technical Staff (Category II) The State satisfies the NRC guidelines for this program indicator. B. Staffing Level (Category II) The State satisfies the NRC guidelines for this program indicator. C. Staff Supervision (Category II) The State satisfies the NRC guidelines for this program indicator. i D. Training (Category II) The State satisfies the NRC guidelines for this program indicator. CRH management would like to take advantage of short courses, workshops, etc. other than those sponsored by NRC, but due to limit budget resources have not been able to. E. Staff Continuity (Category II) The State's two most senior inspectors left the program since the last review. One individual left the profession while the other obtained a higher paying HP position in another State institution. One position was filled by shifting an individual from the x-ray program while the other was recruited from outside the RCP. Salary levels continue to be a problem for the program. The RCP has been unable to compete with the private sector or with other State insti-tutions such as the University of Maryland. The second individual recruited by the program has no radiological experience and the program must expend considerable time and effort to get this individual to a level where he can contribute to the RCP mission. It was recommended that the State seriously consider upgraded staff

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..~ ( 6 { V. LICENSING A. Technical Quality of Licensing Actions (Category I) The State satisfies the NRC guidelines for this program indicator. Seventeen license files were reviewed. Details of the reviews can be found in Appendix B-1. A number of minor deficiencies were noted, however, for the most part the licensing staff is doing high quality work. The only case which will require some work on the part of the staff is the Terumo irradiator. Because of the volume of material submitted (some of which was prior to the formal application), it is difficult to determine what s;.ecific procedures and other commitments the licensee is tied to. The " tie-down" condition needs to be reevaluated to assure that all important commitments are referenced. B. Adequacy of Product Evaluations (Category I) i No new sealed sources or devices were evaluated during the review period. C. Licensing procedures (Category II) The State satisfies the NRC guidelines for this program indicator. VI. COMPLIANCE A. Status of Inspection program (Category I) The State satisfies the NRC guidelines for this program indicator. Against all odds (such as the loss of their two most senior inspectors) the CRH managed to eliminate its inspection backlog since the last review. B. Inspection Frequency (Category I) The State satisfies the NRC guidelines for this program indicator. C. Inspectors' Performance and Capability (Category I) 1 The State satisfies the NRC guidelines for this program indicator. The inspection supervisor has made six supervisory accompaniments, at least one with each inspector. An NRC inspection accompaniment was proposed for an inspection at a broad license, however, due to the developments at NPI this has not yet been scheduled. D. Responses to Incidents and Alleged Incidents (Category I) The State continues to respond to a significant number of events, f 53 since the last review. The great majority of these " events" \\ turn out to have no radiological significance. The State, however, I I

~ 7 continues to consider on-site response to each and every possible event to be of high priority. A summary of the recent events has been forwarded to SLITP and AEOD. E. Enforcement Procedures (Category I) CRH is very diligent in pursuing escalated enforcement actions. CRH has taken a number of such actions during the review period including the issuance of civil penalties. As noted during previous reviews the State has no written procedures which address the process by which escalated enforcement actions are taken. Obviously, this has not hindered the program to any degree, but nonetheless, it was a recommended that the documentation of such procedures would be useful to the program and the CRH staff agreed. One exception to the State's general diligence in pursuing enforcement action was in the case of NPI. In June 1988, the State issued an order to NPI requiring the licensee to address, among other things, the deficiencies in monitoring personnel as they leave the limited access area (LAA). This action was the result of an incident in May 1988 in which an employee of NPI was found to be contaminated with cobalt-60 at the Ginna Nuclear Power Plant in New York. Subse-quent inspections were conducted at NPI in July-August 1988 and October-November 1988. Inspection reports did not document the 4 status of NPI's actions as a result of the order. This issue came to our attention again when, subsequent to our program review, we were notified by Ginna Reactor staff on February 24, 1989, that the same individual from NPI was found to have cobalt-60 contamination again at the Ginna site. Since the February 198' e mt, NRC has worked very closely with the State staff in addr.ssing the NPI situation. The State issued an order on March 3, 1989, essentially closing down the licensee's operation. The State has taken a cautious approach in evaluating NPI's proposed corrective actions, including obtaining NRC technical assistance in evaluating the NPI program. Although some problems did arise, both on the part of the State and NRC, particularly in the area of :ommunication, the State has generally handled this difficult case in an admirable manner. F. Inspection Procedures (Category II) The State satisfies the NRC guidelines for the program indicator. G. Inspection Reports (Category II) Seventeen compliance files were reviewed during the meeting. Details on the reviews can be found in Appendix B-2. There were a number of minor deficiencies in inspection reports which I believe reflect the inexperience of the inspection staff and will probably be corrected as they gain experience. The most significant deficiency, however, g concerned recent inspections at NPI. In June 1988, the State issued \\ an order to NPI requiring the licensee to, among other things, modify

l 8 ( their portal monitoring system. Two subsequent inspections were conducted and the inspection reports did not document the status of NPI's actions per the order. H. Confirmatory Measurements (Category II) The State satisfies the NRC guidelines for this program indicator. VII. OTHER ASPECTS OF THE STATE'S RADIATION CONTROL PROGRAM A. Non-Agreement Sources of Radiation NARM is licensed the same as agreement materials. B. Environmental Monitoring System No reviewer comments. C. Other Areas No reviewer comments. 1 j ( 1

/ I APPENDICES A. Review Indicators and State Responses to Questionnaire B. Casework Reviews C. Present Review Comment Letter e 0

1 ( EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM STATE REVIEW GUIDELINES, QUESTIONS AND ASSESSMENTS Name of State Program: Maryland Date of HRC Review: February 1989 I. LEGISLATION AND REGULATIONS NRC Guidelines: Clear statutory authority should exist, designating a state radiation control agency and providing for promulgation of J regulations, licensing, inspection and enforcement. States regulating uranium or thorium recovery and associated wastes pursuant to the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) must have statutes enacted to establish clear authority for the State to carry out the requirements of UMTRCA. Where regulatory responsibilities are divided between Stati agencies, clear understandings should exist as to division of responsibilities and requirements for coordination. A. Legal Authority Questions: 1. Please list all currently effective legislation that impacts the State's radiation control program. Annotated Code of Maryland Environmental Title 8 - Radiation Section 8-101 601 Title 7 Hazardous Materials and Hazardous Substances Sections 7-201, 7-208, 7-225 7-226, 7-227, 7-228 7-232, 7-223, 7-234 7-235, 7-236, 7-237 7-238, 7-239, 7-240 7-241, 7-242, 7-243 7-244, 7-245, 7-249 7-250, 7-251, 7-252 7-257 2. What changes have been made to the statutory authority of the Radiation Control Program (RCP) to license, inspect, and other-wise regulate agreement materials since the last review? i Effective July 1, 1987 the Radiation Control Program became a part of the newly formed Department of the Environment. The i I authority to license, inspect, etc. is not delegated from the i Secretary of the Environment.

2 3. If your State regulates uranium or thorium recovery operations l and associated wastes pursuant to an amended agreement and UMTRCA, explain any changes to the statutory authority for these functions. N.A. 4. Are copies of the current enabling act and other statutes (e.g., Administrative Procedures Act, Sunshine Act., etc.) which govern the conduct of the agreement materials program on file in the RCP office and with the NRC? If revisions have occurred since the last review, the changes should be included. Yes 5. If the State's regulatory authorities are divided between agencies, what procedures and memoranda are in effect to provide clear understanding of the divisions of responsibilities and requirements for coordination? None 6. Does the State have the authority to: a. apply civil penalties? If so, cite legislation. Yes, Section 8-501(b), HE Article b, collect fees? If so, cite legislation. Not at this time. Legislation is pending. c. require performance bonds or sureties for decommissioning licensed facilities? If so, cite legislation. No d. require performance bonds or sureties for clean-up of licensed facilities after a contamination accident? If so, cite legislation. No e. require long-term care funds for uranium mill or low-level waste facilities? If so cite legislation. No 7. If any responses to the above question are negative, explain any plans the State may have regarding those issues. Other than for fees, there are currently no plans to address these issues. Ii

3 B. Status of Regulations (Category I) k NRC Guidelines: The State should have regulations essentially identi-cal to 10 CFR Part 19, Part 20 (radiation dose standards and effluent limits), and those required by UMTRCA, as implemented by Part 40. lhe State should adopt other regulations to maintain a high degree of uniformity with NRC regulations. Questions: 1. When did the RCP last amend regulations in order to maintain compatibility and when did the revisions become effective? Adopted: September 2, 1986. Effective: September 21, 1986 2. Referring to the enclosed NRC chronology of amendments (Attach-ment A) note the effective date of the NRC changes last adopted by the RCP. June 28, 1983. 3.a. Were there any compatibility items that were not adopted by the RCP? Yes

b. If so, please identify and explain why they were not adopted.

The State has not adopted any regulations equivalent to the NRC LLW classification and manifest rules. C. Updating of Regulations (Category II) NRC Guidelines: The RCP should establish procedures for effecting appropriate amendments to State regulations in a timely manner, normally within 3 years of adoption by NRC. For those regulations deemed a matter of compatibility by NRC, State regulations should be amended as soon as practicable but no later than 3 years. Opportunity should be provided for the public to comment on proposed regulation changes. (Required by UMTRCA for. uranium mill regulation.) Pursuant to the-terms of the Agreement, opportunity should be provided for the NRC to comment on draft changes in State regulations. 1. Does the RCP have a schedule or program for revising and adopting changes to regulations within three years of adoption by the NRC? Not a written program or schedule but we understand the need for this and act accordingly. (

~ 4 2. Has the RCP adopted all regulations deemed a matter of ( compatibility by NRC within three years? (Refer to NRC chronology). '..>). No. The State does not have a written draft or regulations r~ equivalent to NRC's waste classification and manifest regulations. 3. What are the RCP's procedures for adopting new regulations? Briefly describe each step in the procedure. A copy of new procedures are available in Region I files. 4. How is the public involved in the process? Proposed regulations are published in the Maryland Register for comment. A public hearing is also held. 5. a. Does the NRC have the opportunity to comment on draft changes to RCP regulations? Yes. b. If so, does the RCP respond to the comments? Yes. II. ORGANIZATION A. Location of the Radiation Control Program Within the State Organization (Category II) NRC Guidelines: The RCP should be located in a State organization parallel with comparable health and safety programs. The Program Director should have access to appropriate levels of State management. 1. Attach a dated organization chart (s) showing the RCP and its location within the department and State organization. Organization Charts are attached as Appendix A. 2. Is the RCP on a comparable level within the State organization with other health and safety programs so as to r.ompete effectively for funds and staff? ' es. 3. Does the program director have access to appropriate levels of State management? Yes. (

w 5 B. Internal Organiiation of the RCP (Category II) k NRC Guidelines: The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. Where regional offices are utilized, the lines of communication and administrative control between the regions and the central office (Program Director) should be clearly drawn to provide uniformity in inspection policy, procedures and supervision. Questions: 1. Attach dated copies of your 1r.te:nal RCP organization charts. 3 Organization Chart ettsched as Appendix B. 2. Ho'w is the RCP organized so as to provide specific lines of supervision from program management for executing program policy? Divided in Sections with Section Heads in Charge. 3. If regional offices are used: No regional office used. To whom do regional personnel report administratively? a. b. To whom do regional personnel report technically? 4. If the RCP contracts with other agencies to administer the program: RCP does not contract with other agencies to administer the program. Identify the contracting agencies and indicate their a. responsibilities. b. To whom do contract personnel report administratively? To whom do contract personnel report technically? c. C. Legal Assistance (Category II) NRC Guidelines: Legal staff should be assigned to assist the RCP, or procedures should exist to obtain legal assistance expeditiously. Legal staff should be knowledgeable regarding the RCP program, statutes, and regulations. f

y 6 Questions: ( 1. Are legal staff members assigned to assist the RCP or do pro-cedures exist to obtain legal assistance expeditiously? 1 Toxics, Environmental Science and Health (TESH) has legal assistance specifically assigned from the State Attorney 1 General's office. 2. Is the legal staff knowledgeable regarding the RCP, statutes, regulations and needs? %) l The acting TESH attorney has been on board about six months and j has been involved in all RCP enforcement actions regulatory and legislative interpretations. 3. If legal assistance was utilized since last review, provide a summary of the circumstances. See response to Question 2. D. Technical Advisory Committees (Category II) NRC Guidelines: Technical Committees, Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically complex problems. A State Medical Advisory Committee should be used to provide broad guidance on the uses of radioactive cirugs in or on humans. The Committee should represent a wide spectrum of medical disciplines. The Committee should advise the RCP on policy matters and regulations related to use of radio-isotopes in or on humans. Procedures should be developed to avoid conflict of interest, even though Committees are advisory. This does not mean that representatives of the regulated community should not serve on advisory committees or not be used as consultants. Questions: 1. Discuss practices followed for obtaining technical assistance when needed (e.g., consultants, technical and medical advisory committees, licensees, the NRC and other State and Federal Agencies). The law provides for a Radiation Control Advisory Board (RCAB); we have a Medical Advisory Committee (MAC). Regular meetings of the RCAB are held. Assistance from the MAC is either by mail or a meeting. Consultants are used on a case by case basis. If we need assistance from a licensee we request it, the same for the NRC and other State and Federal agencies. 2. What steps are taken to avoid conflicts of interest? Attention is given to avoiding conflicts of interest by not ( requesting advice from committee members in cases involving a i licensee with whom they are associated. Legal guidance is also obtained.

7 3. Are any committees involved in setting policies? If so, f explain. No. 4. Attach a list showing the membership, specialties and affiliations of the Medical and/or Technical Advisory Committees. ) Lists are available in Region I files. 5. Indicate whether the advisory committees are established by statute, by appointment of the Governor, by appointment of the Board of Health, by appointment of the Agency, or by other means. RCAB established by statute. Appointments made by Sec., MDE. MAC was establ.ished in 1971 by the Department upon becoming Agreement State. Membership appointed by Secretary; still same as originated. 6. What is the formal meeting frequency of each committee, and are minutes of committee meetings prepared? j The RCAB meets four times per year. Minutes are prepared. 7. What was the date of the last formal meeting of each committee? g RCAB - November 9, 1988. 8. Are individual committee members contacted for consultation? No. 9. Discuss how each committee is used, the average workload placed on the committee, and the remuneration, if any. The RCAB is asked to give advice as needed at time of the meetings. Members are provided with drafts of regulations, etc. to review and comment on. The average workload would probably not exceed 10 hours each 6 months. The law stipulates that members are to receive no remuneration, but provides for reimbursement of expenses. The PAC is consulted by mailing each member a letter of request for advice supported by the necessary backup material. Members then respond by mail giving their recommendations. No remuneration is provided. Estimated average workload - 8 hrs. per year. III. MANAGEMENT AND ADMINISTRATION A. Quality of Emergency Planning (Category I) / NRC Guidelines: The State RCP should have a written plan for \\ response to such incidents as spills, overexpost es, transportation accidents, fire or explosion, theft, etc.

j .l l 8 The Plan should define the responsibilities and actions to be taken ( by State agencies. The Plan should be specific as to persons res-ponsible for initiating response actions, conducting operations and cleanup. Emergency communication procedures should be adequately established with appropriate local, county and State agencies. Plans should be distributed to appropriate persons and agencies. NRC should be provided the opportunity to comment on the Plan while in draft form. The plan should be reviewed annually by Program staff for adequacy and to determine that content is current. Periodic drills should be performed to test the plan. l Questions: 1. Is the RCP responsible for its own emergency plan or are acci-dents involving radioactive materials incorporated into a com-prehensive State plan developed and administered by another St' ate agency? Please provide copies of all applicable plans for review. Radiation response plan is incorporated into the Maryland Disaster Assistance Plan (MDAP). The MDAP is a comprehensive State plan. Excerpts applicable to radiation incidents are available in Region I files. 2. What written procedures or plans does the RCP use for responding to incidents involving radioactive materials? For materials incidents, the general plan applies. For fixed nuclear facilities Annex Q of the plan applies. CRH rarely i refers to the MDAP in #1 above. 3. If the plan covers major accidents at nuclear facilities, how does it cover non-catastrophic incidents such as those involving transportation of materials? It instructs all persons (or agencies) requesting assistance for radiological incidents to notify CRH, the Maryland State 'l Police (MSP) and the Maryland Emergency Management & Civil Defense Agency (MEM & CDA). 4. How does the plan define responsibilities and actions to be taken by all State Agencies (initiating response actions, operations, cleanup,etc.)? Secretary, MDE is primarily responsible for directing radio-i logical assistance and recovery operations. Other State i agencies will provide appropriate assistance to MDE. 5. How does the plan provide for notification of and communications with appropriate government agencies? ( i

9 Communications are primarily by public telephone systems. ( Individual agencies may also utilize two-way radio or beepers for internal notification. Some interface exists on two-way radio frequencies. 6. How is the response program organized so that qualified indi-viduals are readily available through identifiable channels of communication? Any and all of the CRH staff can be called on to respond in a radiation emergency. Priority of response goes to RAM enforcement section due to their day-to-day experience. No formalized "on-call" schedule exists, nor is it considered necessary based on past experience. CRH personnel can be reached by call-out lists maintained by the following: a. MSP b. MEM & COA c. DHMH Emergency Operator d. Management Staff 7. Has the plan been distributed to all participating agencies? I Yes. 8. Has the NRC had opportunity to comment on the plan in draft form? No, the plan was originally approved by Governor's Executive Order on September 26, 1975. Updates are issued as necessary by MEM & CDA. 9. Is the plan reviewed annually by the RCp for adequacy and to assure the content is current? Yes, but changes are not currently being published as " updates". MEM & CDA is working on a completely revised MDAP.

10. Are drills performed periodically to test the plan for radio-active materials emergencies? Explain, for example, how non-routine office hours communications are checked.

Not specifically for non-reactor emergencies. Since the call-outs to CRH and MDE are identical for reactor and non-reactor emergencies, one drill will suffice for both possibilities. Off-hours notification drills are conducted to test the notification system. B. Budget (Category II) NRC Guidelines: Operating funds should be sufficient to support program needs such as: staff travel necessary to conduct an effec-tive compliance program, including routine inspections, followup or special inspections (including pre-licensing visits) and responses to

^ 10 incidents and other emergencies; instrumentation and other equipment {'- to support the RCP; administrative costs in operating the program including rental charges, printing costs, laboratory services, com-puter and/or word processing support, preparation of correspondence, office equipment, hearing costs, etc. as appropriate. Principal operating funds should be from sources which provide continuity and reliability, i.e., general tax, license fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc. Questions: 1. What fiscal year is used by your State? July 1 to June 30. 2. Indicate the amount for funds obtained from each source (fees, State General funds, HHS, NRC environmental monitoring or trans-portation surveillance contracts, EPA, FDA and others). Source of Funds FY 88 Fees 0 State General Funds $714,313 NRC Environmental Monitoring Contract 13,500 HHS/PHS/FDA, X-Ray Inspections Contract 12,443 MD Department of Natural Resources, Power Plant Siting Program Contract 9,478 Nuclear Power Agreement (BG&E) Partial Funding for Two People in Emergency Planning 68,594 $818,328 3. Show the total amounts assigned to: 1 Amounts assigned: a. the total radiation control program Total radiation control program: $818,328 b. the radioactive materials program. Total radioactive materials program: $467,616 (57% of total) 4. What is the change in budget from the previous year and what is the reason for the change (new programs, change in emphasis, statewide reduction, etc.)? Change from previous year: $ 35,475 ( Increase due primarily to salary reviews. 1

~ f. j i 11 {, 5. Describe your fee system, if you have one, and give the percen-tage of cost recovery. Enclose a copy of the fee schedule. Legislation submitted, awaiting outcome. i 6. Does the RCP administer the fee system? NA 7. What recourse does the RCP have in the event of non payment? NA 8. Overall, is the funding sufficient to support all o.f the program needs? If not, specify the problem areas. No, current funding is not sufficient for increased RAM usage statewide and the budget includes no training funds. MDE has submitted legislation for user fees that, if passed, will augment the budget by 5400,000. I C. Laboratory Support (Category II) NRC Guidelines: The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc., on a priority established by the RCP. Questions: 1. Are laboratory services readily available in-house or through other departments within the State organization? Yes. 2. If services are provided by other departments, discuss the arrangements, supervision, charges and interdepartmental com-munications. The Radiation Chemistry laboratory is under DHMH but supports MDE almost exclusively. 3. If laboratory services must be provided by a non-State agency: NA a. Discuss the contractual arrangements. b. Is the party providing the service an RCP licensee? If a State licensee provides the service or equipment, what c. are the costs?

12 4. Describe the capability of the laboratory as follows: I a. Can it qualitatively and quantitatively analyze low-energy beta emitters? Yes. b. Can it qualitatively and quantitatively analyze alpha emitters? Yes. c. Can it selectively determine the presence and quantity of gamma emitters? Yes. d. Can it handle samples in any physical form - wipes, liquids, solids, gaseous? Yes e. Does the lab participate in a periodic quality centrol program? Yes 5. How muen time does it take to obtain the results from sample analys'as on both a routine basis and on an emergency basis? ~ Normally'l to 10 days depending upon the type of sample, sample preparation time, sensitivity and precision of the analysis in growth time etc. On an emergency basis, sample preparation can begin immediately upon delivery to the laboratory. Availability of results constrained as stated above. When necessary, laboratory staff can be contacted during non-routine work hours to conduct sample analysis. 6. List the number and types of laboratory instrumentation and services available. The laboratory has instrumentation to qualitatively and quantitatively analyze samples for alpha and beta radioactivity. It can also identify and quantify gamma photons greater than 30 Kev. List and types of laboratory instrumentation is available in Region I files. k

13 D. Administrative Procedures (Category II) ~ NRC Guidelines: The RCP should establish written internal procedures to assure that the staff performs its duties as required and to pro-vide a high degree of uniformity and continuity in regulatory prac-tices. These procedures should address internal processing of license applications, inspection policies and procedures, decom-missioning, and other functions required of the program. Questions: 1. What procedures are established to assure adequate and uniform regulatory practices (e.g., administrative procedures, poTicy-memos, licensing and inspection guides, escalated enforcement procedures, decommissioning procedures, etc.)? Procedures are established in all categories exemplified in this question except decommissioning procedures. 2. To what extent are the procedures documented? All procedures are documented. A Manual of Operations has been written. This manual includes general procedures for licensing and inspection of radioactive materials, and administrative policies and procedures. 3. If the RCP has separate licensing and inspection staffs, what are the procedures used to communicate between the two staffs? The written policies and procedures described above are applicable to this. In addition direct communications, one on one, meetings between the two staffs, and frequently the Program Administrator and both staffs. 4. How are personnel kept informed of current regulatory policies and practices? By written policy and procedures guides, administrative directives, and meetings. S. If the RCP collects fees, are fee collection duties assigned to non-technical staff? NA 6. How are contacts with communication media handled? MDE Media Policy addresses such contacts and requires referral to the Public Affairs Office. A copy will be provided to the Region I files. 7. What procedures exist to ensure timely release of factual i / information on matters of interest to the public, the NRC and \\ Agreement States?

~Q 14 MDE Media Policy referred to in answer No. 6 defines these r procedures. 8. If your RCP has regional offices: NA a. what procedures are in effect to assure the regions have complete copies of the procedures and files? b. how often are periodic staff meetings held with headquarters staff? c. how often are periodic visits / audits made by headquarters staff to regional offices? d. how is uniformity controlled? e, how is supervision handled? E. Management (Category II) NRC Guidelines: program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP onagement should periodically assess workload trends, resources : changes in legis-lative and regulatory responsibilities to forecast needs for increased staff, equipment, services and fundings. Program management should perform periodic reviews of selected license cases handled by each reviewer and document the results. Complex licenses (major manufacturers, large scope - Type A Broad, or potential for significant releases to environment) should receive second party review (supervisory, committee, or consultant). Supervisory review of inspections, reports and enforcement actions should also be performed. Questions: 1. How does the staff keep program management abreast of the status of regulatory actions (such as backlog, problem cases, inquiries, and revision of regulations)? By issuing monthly reports. 2. a. Is a periodic statistical tabulation of licenses, licensees, inspections and backlogs prepared by category? Yes. b. If so, specify how frequently the tabulation is prepared. Monthly. k

15 3. How does RCP management assess workload trends and resources in { order to determine future needs or the need for program changes? By reviewing the above reports and by holding meetings frequently. 4. How does the RCP management keep abreast of changes in legis-lative and regulatory responsibility? RCP staff reviews all proposed legislation introduced, and comments on it. When legislation is passed placing the responsibility, planning is begun immediately to implement it. RCP introduces proposed regulations and is responsible for follow through to adoption. 5. Discuss the procedures followed by licensing supervision or RCP management to monitor licensing quality. A 'secondcry review is conducted by a senior staff member of all new licences, license renewals and complex amendment requests. The Administrator reviews and signs all licenses and amendments. 6. Discuss the procedures used for supervisory review of inspection reports. The section head is responsible for reviewing all inspection reports. 4 7. What license review practices are followed for unusual or com-plex license applications? Complex license applications are always circulated for senior staff review, and if deemed necessary by the Administrator, meetings are held to discuss the application and resolve problems before license is issued. 8. If applicable, discuss the procedures used for supervisory review of work performed by contract agencies or regional offices. NA F. Office Equipment and Support Services (Category II) NRC Guidelines: The RCP should have adequate secretarial and clerical support. Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) programs. Similar services should be available to regional offices, if utilized. I a. In terms of the person year /100 licenses figure, what level of secretarial / clerical support is provided? 0.8 person years per 100 licenses.

D ~ 16 b. If your program has regional office, provide the figures for the support for those offices. NA 2. Describe the ADP and word processing capabilities available to the RCP. Workstation (screen & keyboard) Model # 2000 Printer (Diablo) Model # 8624862 IBM PC-AT and Printer G. Public Information (Category II) NRC Guidelines: Inspection and licensing files should be available to the public consistent with State administrative procedures. Oppor-tunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative procedure laws. Questions: 1. Are licensing and inspection files available for inspection by the public? Yes. 2. Are medical and proprietary data withheld? Yes. 3. What other parts, if any, are not available? None. 4. What written procedures and laws govern this? Please provide reference citations. There are no written procedures governing this that we are aware of. The law will have to be researched as we are not cognizant of any State law governing this. This research can be conducted upon specific request. 5. For mill States, are opportunities provided for public hearings in accordance with UMTRCA and applicable State administrative procedures and statutes? NA IV. PERSONNEL A. Qualifications of Technical Staff (Category II) NRC Guidelines: Professional staff should have a bachelor's degree { or equivalent training in the physical and/or life sciences. Addi-

~ 17 tional training and experience in radiation protection for senior g' personnel should be commensurate with the type of licenses issued and inspected by the State. Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified. Questions: 1. Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences? Yes. 2. What additional training and experience do the senior personnel. 1 need to have in radiation protection? Health Physicist II - 2 years experience in technical radiation health work. Health Physicist III - 3 years experience in technical radiation health work. Public Health Radiation Specialist - 6 years of full time experience, or its equivalent, in the field of radiological sciences. Administrator, Center for Radiological Health - 9 years experience in engineering or chemistry in fields directly related to Public Health Programs, or in radiological health; four years of which must have been in a supervisory capacity. 3. What written position descriptions describe the duties, respon-sibilities and function of each professional position? i Written position descriptions are available in Region I files. B. Staf fing Level (Category II) NRC Guidelines: Staffing level should be approximately 1-1.5 person-year per 100 licenses in effect. RCP must not have less than two professionals available with training and experience to operate RCP in a way which provides continuous coverage and continuity. For States regulating uranium mills and mill tailin d cations are that 2-2.75 professional person years' gs, current in'i-of effort, inclu-ding consultants, are needed to process a new mill license (including insitu mills) or major renewal, to meet requirements of Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological matters, hydrology, geology, and structural engineering. k

18 Questions: i 1. Complete a table as below, listing the person years of effort applied to the agreement or radioactive material program by individual. Include the nam 6, position, fraction of time spent and the duty (licensing, inspection, administration, etc.). Name Position FTE% Area of Effort Roland Fletcher Administrator 50 Administration William K. Bonta Chief, X-Ray Program 15 Consulted on Regulations & Emergency Mgmt Paul R. Perzynski Public Health 25 Emergency Response Radiation Specialist Richard'Brisson Public Health 10 Consulted on Inspection Radiation Specialist and Enforcement Charles Flynn Public Health 100 Licensing Radiation Specialist Thomas Ferguson Public Health 100 Licensing Radiation Specialist Carl Trump Public Health 100 Inspection & Enforcement Radiation Specialist Alan D. Jacobson Health Physicist III 100 Inspection & Enforcement Steve Stackhouse Health Physicist I 100 Inspection & Reciprocity Ray Manley Health Physicist III 100 Inspection & Enforcement 2. Compute the person year effort of person years per 100 licenses (excluding mills and burial sites). Show calculation. The total staffing effort for the materials program is 7.00 staff years. With 529 licenses currently in effect the staffing level is 1,51 staff years per 100 licenses. Calculation: 7 = X 529 100 529 X = 700 X = 1.32 3. Is the staffing level adequate to meet normal and special needs and backup? Yes.

l 19 C. Staff Supervision (Category II) l NRC Guidelines: Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel. Senior personnel should review applications and inspect licenses indepen-dently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision. Questions: 1. Identify the junior and senior personnel. Junior personnel: Alan D. Jacobson Steve Stackhouse R. Manley Senior personnel: Paul R. Perzynski R. J. Brisson C. R. Flynn T. D. Ferguson W. K. Bonta C. E. Trump 2. a. What duties are assigned to junior personnel? Junior personnel inspect radioactive materials licensees, write reports, make recommendations for enforcement action, perform investigations, and participate in emergency response operations. b. Do they review applications and perform inspections inde-pendently? They perform inspections independently but do not review applications. 3. a. What duties are assigned to senior personnel? Senior personnel - review applications, review work of junior personnel, accompany junior personnel on some inspections, and participate and act as team leaders in emergency response operations. b. Do they independently review and monitor the work of junior personnel? Yes, if they are in a supervisory role. 4. Is there adequate supervisory or senior guidance and direction for junior personnel? ( Yes.

20 5. Discuss procedures established to ensure supervisory review of the licensing, inspection and enforcement functions. We no longer conduct a routine detailed supervisory review of licenses. One senior staff member reviews the license work-ups i prepared by another senior staff member. Inspection report reviews are the responsibility of the Section Head, Inspection and Surveillance Section. Enforcement functions are initially reviewed by the Section Head followed by the Administrator Escalated enforcement actions require involvement of the Administrator and an Assistant Attorney General. 6. a. Are RCP staff members allowed to consult or work part time for State licensees? No. b. If so, how are conflicts of interest avoided? NA D. Training (Category II) NRC Guidelines: Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. (For mill States, mill training should also be included.) The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staff technical competence in areas of changing technology. Questions: 1. List all RCP personnel and the NRC training courses they have attended. Copies of DRC training records are available in Region I files. 2. How does the RCP utilize short courses and workshops to maintain staff proficiency? DRC has not utilized short courses and workshops for technical areas other than those sponsored by the NRC. Some short courses for management and clerical areas have been attended. E. Staff Continuity (Category II) NRC Guidelines: Staff turnover should be minimized by combinations of opportunities for training, promotions, and competitive salaries. Salary levels should be adequate to recruit and retain persons of appropriate k-professional qualifications. Salaries should be comparable to similar employment in the geographical area. The RCP organization

21 structure should be such that staff turnover is minimized and program j continuity maintained through opportunities for promotion. Promotion opportunities should exist from junior level to senior level or s supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility. Questions: j 1. Identify the RCP employees who have left the program since the last review and give the reasons for the turnovers. Also state whether the positions are presently vacant, filled (name re-placement), abolished or other status. R. Corcoran - retired P. Chaparala - obtained higher paying HP position ) Y. Chong - left profession j 2. List the RCP salary schedule: Position Title Grade Annual Salary Range Health Physicist I 9 $16,597 - $21,734 Health Physicitt II 12 $20,673 - $27,146 Health Physicist III 13 $22,266 - $29,241 3 Public Health Radiation Specialist 16 $27,834 - $36,506 Administrator I 19 $35,061 - $46,055 Administrator II 20 $37,866 - $49,740 3. Compare your salary schedule with similar employment alterna-tives in the same geographical area, such as industrial, medical, academic or other departments within your State. University of Mayland Health Physicists are also State employees but receive higher salaries, e.g. Position Title Grade Annual Salary Range HP I 11 $19,204 - $25,204 HP II 12 $20,673 - $27,146 HP III 14 $23,979 - $31,503 HP IV 16 $27,834 - $36,560 HP V 17 $30,061 - $39,485 k

4 8 22 4. What opportunities are there for promotion within the RCP 4 organizational structure without a staff vacancy occurring? The H.P. series is interchangeable, and, with the appropriate time in grade, promotion can be effected. Other positions require a vacancy. V. LICENSING A. Technical Quality of Licensing Actions (Category I) NRC Guidelines: The RCP should assure that essential elements of applications have been submitted to the agency, and which meet cur-rent regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, faci-lities and equipment, and operating and emergency procedures suffi-cient to establish the basis for licensing actions. Prelicensing visits should be made for complex and major licensing actions. Licenses should be clear, complete, and accurate as to isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions. The RCP should have procedures for reviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program. Questions: 1. How many specific licenses are currently in effect? 529 2. a. How many new licenses (not amendments in entirety) have been issued since the last review? 111 b. How many were major licenses? 5 3. How many specific licenses were terminated since the last review? 36 4. How many amendments were issued during the review period? 392 5. Identify unusual or complex licenses issued since the last review, including name and license number. Terumo Irradiator k

23 6. Note any variance in licensing policies and procedures granted since the last review. None. 7. Do you require license applicants to submit details on their radwaste packaging and shipping procedures? No. 8 a. When do you require licensees to submit contingency plans? When the licensee's possession of limits of radioactive materials presents a potential for accidents that could result in doses as stipulated in NRC's notice of proposed rule making published on June 3, 1981 (46FR29712). b. List the licensees who have been required to submit con-tingency plans. Neutron products, Inc. Terumo Medical Products Dickerson, Maryland Elkton, Maryland - License No. MD-31-025-01 License No. MD-15-007-02 9. How many prelicensing visits were made during this review period? 16 Prelicensing visits.

10. What criterion does the RCP use to determine the need for a prelicensing visit?

A copy of the State's policy on prelicensing visits are available in Region'I files. 11. How do you ensure up-to-date information has been submitted prior to a license renewal? We ensure up-to-date information by basing the renewal on currently submitted information without referring to previous submissions. We ask the applicant to review and revise past submittals before resubmitting them.

12. Do license files contain all necessary data required to evaluate an application prior to issuing a license?

License files do contain all necessary data required to evaluate an application. The file includes a check list used to evaluate the original application, notes of telephone call requesting further information and the applicant's follow-up letter. If needed a second sheet for a telephone call requesting still further information and its follow-up letter are also included.

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13. Has the RCP taken any unusual licensing action with respect to licensees operating under multiple jurisdiction?

No unusual licensing actions have been taken with respect to licensees operating under maltiple jurisdiction. 14. Prepare a table as below showing the RCP's major licensees with name, number and type. INCLUDE: Broad (Type A) Licenses LLW Disposal Licenses LLW Brokers Major Manufacturers and Distributors Uranium Mills Large Irradiators (Pool Type or Other) Other Licenses With a Potential Significant Environmental Impact Other Licensees You Consider to be " Major" Licensees Name License Number Type Univ. of Maryland 07-014-04 LLW Disposal Baltimore Campus (Incinerator) Johns Hopkins Medical 07-005-06 LLW Disposal Institutions (Incinerator) Radiation Services Org. 33-021-02 LLW Broker ~ Westinghouse-Hittman 001-02 LLW Broker Nuclear, Inc. Ellicott Machine '07-095-01 Major Manufacturer & Distributor Rad / Irid 33-05-053-01 Major Manufacturer & Distributor Neutron Products 31-025-03 Major Manufacturer (Sources) & Distributor LKB 31-071-01 Major Manufacturer & Distributor Shimadzu 27-011-01 Major Manufacturer & Distributor Industrial Gauging 31-088-01 Major Manufacturer & Control & Distributor

25 Name License Number Type t Electronucleonics 27-025-02 Major Manufacturer & Distributor Johnston Labs 05-025-01 Major Manufacturer & Distributor CGR Medical 27-028-01 Major Manufacturer & Distributor Syncor, Timonium, MD 05-058-01 Major Manufacturer & Distributor Syncor, Latham, MD 33-061-01 Major Manufacturer & Distributor Terumo Medical Products 15-007-02 Large Irradiator Neutron Products, Inc. 31-025-04 Large Irradiator Neutron Products, Inc. 31-025-05 Large Irradiator Univ. of Maryland 33-004-03 Large Irradiator College Park Radiation Oncology 05-051-01 Other (teletherapy; ) Affiliates multi-facility) B. Adequacy of Product Evaluations (Category I) NRC Guidelines: RCP evaluations of manufacturer's or distributor's data on sealed sources and devices outlined in NRC, State, or appro-priate ANSI Guides, should be sufficient to assure integrity and safety for users. The RCP should review manufacturer's information in labels and bro-chures relating to radiation health and safety, assay, and calibra-tion procedures for adequacy. Approval documents for sealed source or device designs should be clear, complete and accurate as to iso-topes, forms, quantities, uses, drawing identifications, and permis-sive or restrictive conditions. Questions: 1. How many new and revised evaluations were made of sealed sources and devices during the review period? None 2. How many SS&D evaluations have been made for which approval documents have not yet been prepared? f None.

~ 26 3. How does the RCP evaluate manufacturer's data on SS&D's to ensure integrity and safety for users? Our evaluation is based on engineering data submitted defining tests performed and results including dose profiles from sealed sources. Where it is determined that the staff does not have the competence to evaluate certain engineering data, the material is sent to the NRC with a request for technical assistance with that portion of the evaluation. 4. Do you determine whether the manufacturer's information on labels and brochures relating to health, safety, assay, and calibration procedures is adequate on all products? Yes. C. Licensing Procedures (Category II) NRC Guidelines: The RCP should have Internal licensing guides, checklists, and policy memoranda consistent with current NRC practice. License applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions. The present compliance status of licensees should be considered in licensing actions. Under the NRC Exchange-of-Information program, evaluation sheets, service licenses, and licenses authorizing dis-t tribution to general licensees and persons exempt from licensing should be submitted to NRC on a timely basis. Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide. uniformity in the licensing process. Files should be maintained in an orderly fashion to allow fast, accurate retrieval of information and documentation of discus-sions and visits. Questions: 1. Has the RCP developed its own licensing procedures or does it use NRC guides? Please provide for review. We use NRC guides. 2. What licensing guides, checklists and pclicy memoranda are made available to the staff? All NRC licensing guides are made available to the staff. Checklists provided by the NRC are provided to the staff. Policy memoranda are provided to the staff. 3. What guides and/or regulatory position statements are furnished to license and renewal applicants? NRC guides and regulatory position statements are furnished to license and renewal applicants. I i i

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27 4. Describe the system for advising classes of licensees of new licensing procedures and regulations. When new licensing procedures and regulations are developed, the licensee is either notified of their availability or the documents are mailed to the appropriate class of licensee. 5. a. How are licensing actions coordinated with the compliance staff? Licensing actions are coordinated with the compliance staff by meetings, memoranda and one on one discussions. b. Are licensing actions taken while enforcement action is pending? No. 6. For what length of time are various categories of licenses issued? All licenses are issued for 5 years. 7. a. Does the RCP use standard licensing conditions? Yes. ~ b. If so, how does the RCP assure they are comparable with those used by NRC7 They are compared with the NRC's whenever NRC changes theirs and changed accordingly. 8. Are the licensing conditions on file in the RCP office and with NRC? Yes. 9. What SS&D sheets, service, distribution and "E" licenses are available for RCP staff use? SS&D catalogs are available for RCP staff use. NRC and other Agreement State distribution and "E" licenses are filed and available to the staff. 10. Describe your practices for distributing SS&D sheets, as well as GL distribution and service licenses, to the NRC. All SS&D sheets and copies of all licenses are sent to the NRC. 11. Describe your procedures for maintaining the license files (How are files and folders arranged? Are telephone contacts and visits documented? Who is responsible for filing materials in .( folders?).

2B \\ The licensing files are arranged in alphabetical order from ( A-Z. Backup materials are filed chronologically in the front of the two hole punched report binders with ACCO fasteners and the 1 licenses and amendments are filed chronologically in a separate 1 area in the back section of the same binder.

12. Are there opportunities for license reviewers to accompany inspectors?

Yes. VI. COMPLIANCE 1 .A. Status of Inspection Program (Category I) NRC Guidelines: The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions. The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection program on a periodic basis. Information showing the number of inspections conducted, the number overdue, the length of time overdue and the priority categories should be readily available. There should be at least semiannual inspection planning for the number of inspections to be performed, assignments to senior vs. junior staff, assignments to regions, identification of special needs and periodic status reports. Questions: 1. How is statistical information maintained about the inspection program to permit periodic assessment of its status by RCP management? Manually kept on a monthly schedule on a form titled " Overdue Inspection As of..... Date". 2. Prepare a table as below, indicating the number of inspections made in the review period, by category and priority. License Scheduled Inspection Number of Category Frequency Priority Inspections Major Processors Each 3 mos. I 6 Broad Scope A, B, C Annually II, IV 6 Each 3 yrs. Each 4 yrs. Irradiators Annually II, IV 5 k-CAT IV Each 4 yrs. CAT I

j c 1 29 License Scheduled Inspection Number of f Category Frequency Priority Inspections Radiography Annually II 11 Academic Annually II, IV, V 18 Each 4 yrs. Each 5 yrs. Medical Each 3 yrs. III, IV 93 Each 4 yrs. 4 Industrial Each 3 yrs. III, IV, V 125 Each 4 yrs. Each 5 yrs. Incinerators Each 3 yrs. III Total 264 3. Prepare a table (or tables) as below which identifies the Priority 1, 2, and 3 licensees with overdue inspections. Include the license category, the due date, and the number of months the inspection is overdue. (If list is extensive, a comparable computer printout is acceptable.) None 4. Prepare a table as below indicating the number of overdue license inspections for Priorities 4 through 7. Priority IV - 4 5. How are inspection schedules planned and how are the dates and personnel assignments made? Senior staff inspection assignments are scheduled by the supervisor of the radioactive materials section. These assignments are normally based upon priority and due or maximum overdue dates. The exception to this practice is when a license is located so far away from the central office that the inspector must stay overnight. In this case, the cost effective practice is for the inspector to inspect several or maybe all of the licensees in that region. Junior staff inspection assignments are scheduled as stated above except that the assignments are limited to include the lower priority licenses. B. Inspection Frequency (Category I) NRC Guidelines: The RCP should establish an inspection priority f system. The specific frequency of inspections should be based upon I the potential hazards of licensed operations, e.g., major processors, i 'l

~ l l 30 l broad licensees, and industrial radiographers should be inspected g approvimately annually -- smaller or less hazardous operations may be inspected loss frequently. The minimum inspection frequency should be consistent with the NRC system. Questions: 1. Enclose a copy of the RCP's inspection priority system. A copy of the State's priority system is available in Region I files. 2. Who assigns licenses to the priority categories? The Head, RAM Inspection & Surveillance Section (Mr. Carl Trump). i 3. Discuss any significant variances in the RCP's priorities from the NRC priority system. As a matter of practice we inspect fixed radiography licenses and limited medical licenses at the minimum inspection frequency consistent with the NRC. However, due to other staff work, we have been unable to rewrite the written inspection priority system so that it reflects actual State policy. However, CRH has inspected certain MD licenses more frequently depending on the nature and hazard of the license, com11ance history, and if the license has actually initiated a RAM program. 4. Is the inspection priority system designed to assure that the more hazardous and/or complex operations are inspected at an appropriate frequency? Yes. 5. Describe the RCP's policy for unannounced inspections and exceptions to the policy. All radioactive materials license inspection are unannounced except in a few cases where the licensee maintains several locations in different counties and the RSO may be at any location. 6. Describe the RCP's policy for conducting follow-up inspections. Follow-up inspections are not done routinely due to insufficient manpower. However, since the inspection backlog has decreased, CRH has been conducting follow-up inspections on a case-by-case basis. 7. a. Does the RCP inspect out-of-state firms working in the State under reciprocity or under State licensure? ( Yes. 1987-11,1988-21,1989(Jan.)-2 l - a

~ ~ " " ~ -e 31 b. How many reciprocity notices were received? i( 1987 - 202 1988 - 230 1989 - 16 c. How many were inspected? 1987 - 11 1988 - 21 1989 - 2 C. Inspector's performance and Capability (Category I) NRC Guidelines: Inspectors should be competent to evaluate health and safety' problems and to determine compliance with State regula- ~ tions. Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policie's prior to independently conducting inspections. The compliance supervisor (may be RCP manager) should conduct annual field evaluatiens of each inspector to assess performance and assure application of appropriate and consistent policies and guides. Questions: 1. a. Does the senior inspector or supervisor periodically accompany the inspectors?

Yes, b.

Are these accompaniments documented? Yes, on the inspection report prepared by the inspector. 2. Give the number of supervisory accompaniments of inspectors since the last review meeting and identify the persons accom-panied and the supervisors. 6 - Chong (2) Manley (1) All by Trump Chaparala (2) Jacobson(1) D. Responses to Incidents and Alleged Incidents (Category 1) NRC Guidelines: Inquiries should be promptly made to evaluate the need for onsite investigations. Onsite investigations should be promptly made of incidents requiring reporting to the Agency in less than 30 days (10 CFR 20.403 types). For those incidents not requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection. Onsite investigations should be promptly made of non-reportable incidents which may be of significant public interest and concern, e.g. transportation accidents. Investigations should include indepth reviews of circumstances and should be completed on a high priority basis. When appropriate,

'O 32 investigations should include reenactments and time study measure-(- ments (normally within a few days). Investigation (or inspection) results should be docu,nented and enforcement action taken when appropriate. State licensees and the NRC should be notified of pertinent information about any incident which could be relevant to other licensed operations (e.g., equipment failure, improper opera-ting procedures). Information on incidents involving failure of equipment should be provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency. The RCP should have access to medical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problems when needed. Questions: 1. How does the RCP respond to incidents and alleged incidents? Where we can asse.s that it is a true incident, we respond immediately. On >ther as promptly as possible. For alleged incidents written notification is required as per Part J. of the Regulations before any response is made. 2. Are major incidents (10 CFR 20.403 types requiring reporting in less than 30 days) investigated on a priority basis? Yes. 3. Are other incidents followed up in the next scheduled inspection? Yes. 4. Are non-reportable incidents that may be of significant public interest and concern promptly investigated? Yes. 5. How many incident investigations were conducted during the review period? 53. 6. Attach as an appendix a summary of each incident investigated. Include documentation of investigation results, enforcement action when appropriate, any reenactment and time motion studies, as well as notification of the NRC and state licensees of in-cident information that may have been relevant to other licensed operations. A summary of each incident investigated from 5/31/85 thru 1/31/87 is available in Region I files. A copy has been forwarded to AE0D and GPA. (

l 33 7. Were any incidents attributed to generic-type equipment failure? No. 1 8. What action was or would be taken by the RCP pertaining to incidents attributable to generic equipment failures in regard to notification of the NRC, other licensees and the regulatory agency which approved the device? NRC and other licensees have been notified and will continue to be notified as appropriate. 9. If a failure should occur in equipment manufactured by a RCP licensee, what action would be taken to: l a. stop the manufacture or force changes in design? Yes. b. assure retrofit of existing devices? Yes. I

10. When are other RCP licensees and the NRC notified of pertinent i

information about an incident? i Immediately by telephone followed by letter as soon as practicable. 11. a. Are. medical consultants available and used when necessary? Yes, through advice given by Radiation Control Advisory Board, Dr. Katherine Farrell (MDC-TESH), and Dr. Henry Wagner (Johns Hopkins). b. Is the State aware of the availability of medical consul-tants from NRC? Yes. 12. Explain any use of other technical consultants for special problems encountered in incident investigations. Due to October 1988 incident at Sacred Heart Hospital in Cumberland, Maryland concerning 33 therapeutic misadministrations, MDE-CRH hired the services of Peter Almond, Ph.D., Medical Physicist and Dr. Stanley Order, Oncologist from Johns Hopkins Hospital to review and evaluate these cases.

13. Were there any incidents since the last review meeting that met Abnormal Occurrence Report (AOR) criteria?

Two therapeutic misadministrations.

_ a :.~ 34 E. Enforcement Procedures (Category I) NRC Guidelines: Enforcement Procedures should be sufficient to + provide a substantial deterrent to licensee noncompliance with regulatory requirements. Provisions for the levying of monetary penalties are recommended. Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violated. Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions taken to prevent re-occurrence (normally 20-30 days). The inspector and compliance supervisor should review licensee responses. Licensee =- responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously unresolved items. Written procedures should exist for handling escalated enforcement cases of va ryi ng. degree s. Impounding of material should be in accordance with State administrative procedures. Opportunity for hearings should be provided to assure impartial administration of the radiation control program. Questions: 1. Describe the State's enforcement procedures. At closecut inspector leaves completed forms DHMH-1097A & 1097B with the licensee. However, if violations are determined to be serious in nature and a letter will be sent to the licensee, then a form 1097A is left and signed by the inspector and the licensee. Escalated enforcement is initiated when response to violations defined on the above referenced form are deemed to be i inadequate. Also, escalated enforcement can be initiated depending on the nature of the violations found and if repetitive from prior inspections or a radiation hazard was identified and is a threat to the public. 2. If the RCP can apply civil penalties, explain the procedures for keying monetary penalties to violations. The maximum civil penalty prescribed by the Radiation Control Act, H.E. Article Section 8-501(b) is $5,000. The civil penalty assessed is dependent upon the nature of the problem (s) but usually starts at the maximum and can be mitigated as determined recessary by the Assistant Attorney General. The civil penalty can be assessed at $5,000 per day the violation (s) continues or $5,000 per violation and mitigated as necessary be the Assistant Attorney General. ( i

35 3. Describe th'e RCP's provisions for criminal penalties. r t No written procedures are available within the CRH for criminal penalties. Health Environmental (H.E.) Article Section 8-501(a) provides for this. 4. Describe the policies in effect for issuing field forms equiva-lent to NRC form 591 or letters for enforcement action. Forms issued at closecut (see answer to question 1, above). 5. Are there written procedures for handling escalated enforcement cases? Please provide for review. Draft Escalated Enforcement Action Procedures were submitted to NRC on February 8, 1980 for review and comment. NRC Comments were received in a letter from Wayne Kerr dated March 17, 1980 (copy attached). The draft procedures have never been fihalized by virtue of having received management approval. NRC suggestion in No. I of Mr. Kerr's letter regarding informal meetings with licensee t op management is in actual practice a part of escalated enforttment in Maryland. 6. Can the State issue Orders, including Emergency Orders? State can issue Orders, including Emergency Orders. 7. Can the RCP impound radioactive material? Yes, CRH can impound material. 8. Do RCP administrative procedures permit the opportunity for hearings in major enforcement cases? Yes, State administrative procedures permit hearings. 9. If during the review period the RCP has issued orders, applied 'l civil penalties, sought criminal penalties, impounded sources, or held a formal enforcement hearing, identify these cases and 1 enclose copies of the pertinent State enforcement correspondence 1 or orders. 1 See Appendix E. .l

10. Are enforcement letters issued within 30 days of the inspection?

CRH intent is to issue enforcement letters within 30 days.

11. Are enforcement letters written in regulatory language and reference regulations and license conditions?

Yes they are, f i

V l 36

12. Do the enforcement letters clearly differentiate between noncom-pliance items and health and safety recommendations?

( Yes. 13. If applicable, do the letters separate actions subject to the State radiation control act and State OSHA regulations? Yes. 14. a. Are enforcement lett'ers issued by inspectors or supervisors? Written by both inspectors and supervisors. b. If issued by inspectors do they undergo supervisory review prior to dispatch? Reviewed by supervisors and/or Administrator and Assistant Attorney General, in some cases. 15. Do enforcement letters require the licensee to respond within a stated time period? Note the period. Yes, written 20 calendar days. 16. a. Are licensee's responses to enforcement letters reviewed by the inspector and the supervisor? Yes. b. Are they acknowledged properly? No, the State is considering reinstituting the practice of acknowledging responses to enforcement letters. Only on a case-by-case basis. 17. Has the RCP taken escalated enforcement action against licensees who operate in multiple jurisdictions? Yes, specifically licensees who operate in Maryland under reciprocity (NRC & Agreement State) and those licensees who maintain a Maryland License also. F. Inspection procedures-(Category II) NRC Guidelines: Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the inspection of licensed programs. The NRC Agreement States Guides may be used if properly supplemented by policy memoranda, agency interpretations, etc. Written inspection policies should be issued to establish a. policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, assuring exit interviews with management, and issuing appropriate notification k

37 of violations of health and safety problems. Procedures should be established for maintaining licensees' compliance histories. Oral briefing of supervision or the senior inspector should be performed j upon return from nonroutine inspections. For States with separate k licensing and inspection staffs, procedures should be established for feedback of information to license reviewers. Questions: 1. Has the RCP developed its own inspection guides or does it use NRC guides? We have 2 inspection guides; one entitled " Guidelines for Inspection of Material - General", and " Guidelines for Inspection of Radiographic Operations". We use all those issued by the NRC. ~ 2. Are current. copies of the internal inspection forms and guides on* file in the RCP office and with NRC7 Attach any changes or guides developed since the last review. Yes. There have been no revisions since the last review. 3. Are inspectors furnished copies of inspection guides? Yes. 4. Discuss the use or non-use of inspection policy memoranda, interpretations, etc., to supplement inspectic' guides. CRP - Policies and Procedure guidelines have been issued and are being used. 5. Are there written procedures establishing policy for: a, unannounced inspections? Yes, the State follows NRC policies and procedures. 1 b. obtaining corrective action? No, but the State follows NRC policies and procedures, c. following-up and closing out previous citations of-1 violations? No, but the State follows NRC policies and procedures. 1 d. exit interviews with management? No, but the State follows NRC policies and procedures. { 1

38 e. issuing notices of violations and findings of health ) and safety problems? ( No, but the State follows NRC policies and procedures. f. categorizing the seriousness of violations? i No, but the State follows NRC policies and procedures. Please provide copies of these procedures for review. 6. What procedures have been established for maintaining licensee's compliance histories? A manually operated KARDEX System. 7. Does the senior inspector or supervisor orally debrief the inspector upon return from inspections? Yes. 8. What procedures are there for providing feedback from inspectors to licensing? We require documentation of suggested license changes on inspection reports which are to be reviewed by Licensing personnel. There is also extensive direct verbal communication between Licensing and Inspection personnel in order for immediate or appropriate action to be taken. G. Inspection Reports (Category II) NRC Guidelines: Findings of inspections should be documented in a report describing the scope of inspections, substantiating all items of noncompliance and health and safety matters, describing the scope of licensees' programs, and indicating the substance of discussions with licensee management and licensee's response. Reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive special attention at the next inspection. Reports should show the status of previous noncompliance and the independent physical measurements made by the inspector. Questions: 1. How do inspection reports document the inspection that was con-ducted and the inspection findings? Explain how the reports substantiate noncompliance and health and safety matters and describe the scope of the licensee's program. A sample inspection report form is available in Region I files. / ?

-e s 39 2. Do the reports a. relate the discussions held with licensee management and I interviews with workers? t Yes. b. include independent measurements conducted by the inspector? Yes. c. document follow-up of previous citations of violations made by the inspector? Yes. d. identify areas of the licensee's program needing special attention at the next inspection? Yes. 3. Are inspectors routinely inspecting radwaste package preparation and shipping practices and do the reports document the results?' Yes, but only if materials are packaged and ready for shipment. NPI, Inc. sends CRH written confirmation on January / July frequency as to RAD Waste Status at the plant, H. Independent Measurements (Category II) i NRC Guidelines: Independent measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensee's measurements. RCP instrumentation should be adequate for surveying license operations (e.g., survey meters, air samplers, lab counting equipment for smears, identification of isotopes, etc.). GM Survey Meter: 0-20 mr/hr Ion Chamber Survey Meter: several r/hr Neutron Survey Meter: Fast & Thermal Alpha Survey Meter: 0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 uc/ wipe Velometers Smoke tubes Lapel Air Samplers Instrument calibration services or facilities should be readily available and appropriate for instrumentation used. Licensee equip-ment and facilities should not be used unless under a service con-tract. Exceptions for other State Agencies, e.g. a State University, may be made. Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected.

~ 40 Questions: 1. Discuss the RCP's policy for conducting independent measurements { as a part of each inspection (e.g., air samples, wipe samples, air flows, dose rates). Are these measurements documented in the inspection report? RCP's practice is to make independent measurements at every inspection. Results are documented. Independent measurements made as appropriate to the type (s) of materials authorized by the license. hipe sampling is read in the field initially, if possible. Samples are then delivered to Md's Radiochemistry Lab for analysis. 2. List the instrumentation that is readily available to the RCP for surveying licensed operations and conducting appropriate independent measurements. List is available in Region I files. 3. Describe the method used for calibrating survey instruments and the fraquency of calibration. We contract for calibration of all instruments used to make measurements. Monitoring and survey equipment verified with certified check sources. A. Non-Agreement Sources of Radiation Questions: 1. Are the licensing and inspection procedures for NARM the same as for agreement materials? Yes. 2. Give the number of X-ray machine (or tube) and accelerator registrants by category, e.g., dental, medical, industrial, etc. X-Ray Machine Registrants Accelerators 2 installation 21 machines Dental 2,097 installations 2,358 machines

41 3. How many machine and accelerator inspections were made in the last year (or other appropriate interval)? { Inspection During FY-84 one accelerator inspection 607 X-ray machines inspections 4. Does the RCP license X-ray or nuclear medicine technologists? No. B. Environmental Monitoring Program Questions: 1. To indicate the scope of the environmental monitoring program, describe: a. types of media sampled b. the number and location of stations sampled c. the frequency of sample collection d. the analyses run on each type of sample I a.,b.,c.,d. The scope of the environmental monitoring program is described in the State of Maryland's Radiological Environmental Monitoring Data Annual Report. This report i specifies the type media sampled, number and locations of stations sampled, frequency of sample collection, and type ) analyses run, as well as the results on each type of sample. 2. Is a copy of the latest environmental surveillance report avail-able for review? l A copy of the annual report is available in Region I files. l The report provided is for calendar year 1986. This work was performed under USNRC Contract No. 28-83-608. C. Other Areas This section of the review is for the use of either the reviewer or the RCP to address issues pertaining only to the individual State, to new areas of concern, or to generic or State-specific issues raised by NRC staff. 1. Other Generic Issues Questions: a. For radiography inspections, to what extent do you make inspections at temporary job sites?

42 At each inspection when radiographer is working at a temporary job site. If not we require a demonstration of how a field job is conducted, i L b. Are you finding Ir-192 contamination on radiographic equip-ment? No. c. What are the State's plans to adopt the low-level waste (LLW) manifest rule (if not already adopted)? This is the responsibility of the Waste Management Administration. They are currently preparing propm ed regulations. d. For States with LLW disposal sites, what are the State's plans to implement 10 CFR 617 N/A e. Will your State have access to a LLW disposal site after January, 1986. If not, what contingency plans are there for after January,1986? N/A f. Have copies of 10 CFR 61 and NRC technical positions on waste form and classification been distributed to State licensees? If there has been feedback please provide documentation. No. g. Have there been any applica. ins or approvals for incineration, compacting or disposal? 2 incinerators. University of Maryland at Baltimore and Johns Hopkins University Hospital. Neither are commercial operations. h. What use is being made of IE information notices? IE Information Notices are sent to appropriate licensees when requested by NRC, or when it is determined by the RCP that they would be beneficial to the licensee in preventing radiation safety accidents, or problems of any i kind involving radiation safety. I t

- - ~ l-e 43 1. Identify any group of materials licenses for which the RCP hi.s increased frequency of inspection due to problems with tnat general category. Please discuss the nature of those { problems. None. J. With respect to medical licensees, is the RCP making any ef fort during inspections of nuclear pharmacies' to deter-mine whether the licensee is actually conducting the re-quired molybdenum breakthrough tests, i.e., what is the RCP doing in addition to record reviews to establish compliance or noncompliance with the requirement? No special effort other than normal review of records. k. Is the RCP mounting any special effort to look at the possibility of reconcentration of radionuclides in-sanitary sewers and sewage treatment plants as part of the regular inspection program? If so, please describe. No. There are no licenses in Maryland where this would be of concern. e i

,. i 44 LIST OF APPENDICES. { Appendix A - State Organization Chart Appendix B - RCP Organization Chart Appendix C - Review of selected license files Appendix D - Review of selected inspection files 4

.. ~ ( Appendix B-1 Review of Selected License Files Summary As noted during the previous review, most application deficiencies are handled by telephone. Seventeen files were reviewed. Most deficiencies were of a very minor nature. With regard to the Terumo irradiator, the file contains a very large amount of material, some of which was submitted prior to the formal application. The " tie-down" condition needs to be reevaluated to assure that all important commitments are referenced. 1. Licensee: Mallinckrodt License No.: MD-05-105-01 Amendment No.: New Location: Baltimore License Type: Distribution of Radiopharmaceuticals 2. Licensee: Eastalco Aluminum Company License No.: MD-21-010-01 Amendment No.: 1(Termination) Location: Frederick License Type: Gas Chromatograph 3. Licensee: Tri-State Motor Transit License No.: MD-15-006-01 Amendment No.: 4 (Termination) Location: North East License Type: Calibrator, 100 mci of Cs-137 4. Licensee: American Recovery Company License No.: MD-05-075-01 Amendment No.: 2 (Termination) location: South Norwalk, CT (formerly Baltimore) License Type: Gas Chromatograph 5. Licensee: Diagnostic Imaging License No.: MD-05-077-01 Amendment No.: 11 (Termination) Location: Pikesv111e (Formerly Baltimore) License Type: Medical Group I, II, IV and other diagnostic procedures 6. Licensee: Drs. Copeland, Hyman & Shackman, PA License No.: MD-05-102-01 Amendment No.: New Location: Baltimore License Type: Possession and storage of calibration sources (took over facility from Diagnostic Imaging above) k

Appendix B-1 2 ~ 7. Licensee: Drs. Copeland, Hyman & Shackman, PA License No.: MD-05-102-01 Amendment No.: 2 Location: Baltimore License Type: Medical Groups I, II, III 8. Licensee: Johns Hopkins Hospital License No.: MD-07-005-09 Amendment No.: New Location: Baltimore License Type: Nucletron af terloader 10 curies of Ir-192 9. Licensee: Saint Joseph Hospital License No.: MD-05-005-02 Amendment No.: 3 (Renewal) Location: Towson License Type: Brachytherapy (Ru) 10. Licensee: H & H X-Ray Services, Inc. DBA H & H X-Ray Services, Inc. and Monroe X-Ray Company, Inc. License No.: MD-03-047-01 Amendment No.: New Location: Baltimore License Type: Industrial Radiography 11. Licensee: Nucletron Corporation License No.: MD-27-035-01 Amendment No.: New Location: Columbia License Type: Service and Repair afterloading devices 12. Licensee: Harford Memorial Hospital License No.: MD-L5-008-01 Amendment No.: 31 (Renewal) Location: Havre de Grace License Type: Medical Groups I-III, Xe 13. Licensee: Microbiological Associates, Inc. License No.: MD-31-023-01 Amendment No.: 18 (Renewal) Location: Bethesda License Type: Research in lower animals 14. Licensee: Washington Adventist Hospital License No.: MD-31-003-01 Amendment No.: 12 (Renewal) Location: Takoma Park License Type: Teletherapy 1 l

.o Appendix B-1 3 '( 15. Licensee: Terumo Medical Corporation License No.: MD-15-007-02 Amendment No.: New Location: Elkton License Type:- Megacurie irradiator 16. Licensee: University of Maryland License No.: MD-33-004-03 Amendment No.: 10(Renewal) Location: College Park License Type: 29,000 Ci Cobalt Gamma irradiation lab 17. Licensee: Maryland Q.C. Laboratories License No.: MD-05-075-01 Amendment No.: 11 Location: Baltimore License Type: Industrial Radiography T

q s... _ ~ Appendix B-1 4 { Comments License File 1. Exact use of I-131 was unclear. License indicated 1 " dispensing," application did not, although discuss some " manipulation" to be done in glove box. 2. Reviewer's handwritten corrections to license 1 application not tied to specific telephone conversation with applicant. 3. Requested waste pick-up activity not specifically I authorized on license. 4. A 1.0 curie Gd-151 source was not accounted for in 5 terms of disposition after termination of license. 5. Licensee had.no adequate shielding for generator. In 7 response to a question from the State, licensee indicated "would not use generators." However, Group III still authorized on license. 6. Suggested the State discuss Alabama incident with 8 Nucletron device with licensee. Close loop on investigation. 7. License does not contain conditions regarding 9 hospitalization of patients until source count and survey, but covered explicitly in procedures. (No implants done since 1984). 8. Don't know legal implications of issuing license in 10 two company names. 9. File is equivalent to about six loose leaf binders. 15 Much correspondense which occurred pre-formal application. is only generally referenced in tie-down conditions. Difficult to clearly ascertain what procedures and commit-ments the license is specifically tied to. 10. Amendment authorizing two radiogr.aphers unsupported. 17 Individuals only had 24 hours classroom and some DJT. i i / \\

l ,-{ Appendix B-2 Review of Selected Compliance Files Summary Seventeen files were reviewed. A number of minor deficiencies were noted which reflect the inexperience of the inspection staff. The most significant deficiency was the failure to follow-up on an order issued to NPI during subsequent inspections of that facility. The State, however, now seems to have the NPI situation well in hand. 1. Licensee: Terumo Medical Corporation License No.: MD-15-007-02 Location: Elkton Type of License: Megacurie irradiator Inspection Date: January 5-6, 1989 Type of Inspection: Unannounced initial Inspector (s): Manley, Jacobson 2. Licensee: University of Maryland License No.: MD-33-004-03 Location: College Park Type of License: Gamma irradiator (29,000 C1) Inspection Date: April 8, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Choug 3. Licensee: Maryland Q.C. Laboratories License No.: MD-05-075-01 Location: Baltimore Type of License: Industiral Radiography Inspection Date: September 29-30, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley 4 Licensee: University of Maryland License No.: MD-33-004-01 Location: College Park Type of License: Broad Academic Inspection Date: October 19, 20, 21, 24, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley, Jacobson

~ \\ Appendix B-2 2 (- License No.: MD-33-004-01 5. Licensee: Reliance Testing Laboratories Location: Timonium Type of License: Industiral Radiography Inspection Date: January 27, 1989 Type of Inspection: Routine reinspection Inspector (s): Jacobson 6. Licensee: Neutron Products, Inc. License No.: MD-31-025-01 Location: Dickerson Type of License: Manufacturer Inspection Date: Incident occurred on May 26, 1988 Type of Inspection: Incident investigation Inspector (s): Trump, Manley, Jacobson 7. Licensee: Neutron Products, Inc. License No.: MD-31-OL5-01 Location: Dickerson Type of License: Manufacturer Inspection Date: October 27, 31, and November 1, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley, Jacobson 8. Licensee: Neutron Products, Inc. License No.: MD-31-025-01 Location: Dickerson Type of License: Manufacturer Inspection Date: July 27, 28, and August 1, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley 9. Licensee: TEI Analytical Services License No.: 37-28004-01 (NRC) Location: Washington, PA; Field Site: Williamsport, MD Type of License: Industrial Radiography Inspection Date: March 24, 1988 Type of Inspection: Reciprocity Inspector (s): Trump 10. Licensee: North American Inspection, Inc. License No.: 37-23370-01(NRC) Location: Laurys Station, PA; Field Site: Walkersv111e, MD. Type of License: Industrial Radiography Inspection Date: March 30, 1988 Type of Inspection: Reciprocity Inspector (s): Manley

1 Appendix B-2 3 i (- License No.: MD-07-014-01 11. Licensee: University of Maryland Location: Baltimore Type of License: Broad Medical / Academic Inspection Date: November 29-30 and December 1-2, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley, Jacobson 12. Licensee: Law Engineering Testing License No.: 10-00346-03 (NRC) Location: McLean, VA Type of License: Industrial Radiography Inspection Date: October 3, 1988 Type of Inspection: Reciprocity Inspector (s): Manley 13. Licensee: Syncor International License No.: MD-33-061-01 Location: Lanham Type of License: Radiopharmacy Inspection Date: October 13-14, 1988 Type of Inspection: Unannounced reinspection Inspector (s): Manley 14. Licensee: Radiology Diagnostic Center License No.: MD-33-079-01 Location: Greenbelt Type of License: Group Medical Inspection Date: August 18, 1988 Type of Inspection: Unannounced initial Inspector (s): Manley 15. Licensee: Potomac Valley Orthopedic Assoc. License No.: MD-31-156-01 Location: Olney Type of License: Bone Densitometer Inspection Date: December 21, 1988 Type of Inspection: Unannounced initial Inspector (s): Jacobson 16. Licensee: Peninsula General Hospital License No.: MD-45-001-03 Location: Salisbury Type of License: Group Medical Inspection Date: August 24, 1987 Type of Inspection: Unannounced reinspection Inspector (s): Chong (

a O Appendix B-2 4 ~ '( 17. Licensee: Johns Hopkins License No.: MD-07-005-03 Location: Baltimore Type of License: Broad Medical Inspection Date: June 16-19, 1987 Type of Inspection: Unannounced reinspection Inspector (s): Chaparala i

e i / Comments File Number \\ 1. No information on dosimeter calibrations (6 months). I 2. No check of pool area, pressure in liner channels, I source rack cables, etc. 3. No survey meter calibrations. 1 4. No review of user approvals by Committee. 4, 11 5. No indication of number of labs visited. 4, 11 6. No discussion of survey program (what RSO does vs. 4 what users do). 7. Ginna contamination incident, particularly portal 7 monitor deficiencies should have been addressed as not being corrected. Also report indicated no changes to license needed. No discussions of need to improve survey program. " Multiple areas determined to need decontaminat' ion." No information regarding new frisking procedures. 8. Citation regarding portal monitor. surveys was made. 8 Did not address total number of issues in June 23 order. What is status of above citation vis-a-vis the order? Report indicated no need for changes to license, 9. Although there were no specific requirements or 11 procedures spelled out in license, should have checked compliance with MPC's for Xe studies or I-125 from iodination hoods. Any failure to evaluate this on the part of the license would also be a violation.

10. Only information on Committee is names and date of last 11 meeting.

11. One recommendation regarding the adequacy of I-131 13 bioassay should have been resolved at time of inspection.

Possible violation regarding adequacy of surveys. 12. Repeat violation regarding radioactive waste in normal 13 trash should have been considered for escalated enforcement.

13. The inspector observed an iodine encapsulation, but did 13 not observe a generator milking and moly check.

14. One recommendation should have been a violation. Caught 15 by supervisor, but Notice of Violation form was left with licensee.

15. Exit meeting held with " office manager" rather than user. 15 16. License had previously been suspended due to lack of 15 trained user. License was apparently in effect at time of inspection, but this is unclear. On January 11, 1989 license was amended to authorize possession and storage only.

d. l 0 ( Incidents February 1, 1987 - January 31, 1989 1. 1/29/87 Transportation accident - Syncor vehicle - Balto. City - R. Manley. No spillage, fender bender 2. 1/27/87 Removal of refrigera. tor from Univ. of MD/Balto. City with CRAM label affixed, to GE facility - R. Manley. No material involved. Univ. of MD cited. 3. 2/2/87 Cylinder with CRAM label found in Silver Spring, Mont. Co. - C. Trump. No material involved. 4. 3/6/87 Citizen walked through a restricted area during industrial radiography (MDQC) at Park Charles complex in Balto. City - C. Trump. I mrem. Cited for allowing individual pass through. 5. 4/15/87 Potential Investigation Contamination of (3) Balto. City policemen at Mercy Hospital - Balto. City - R. Manley. No contamination or exposure to the individuals. 6. 4/24/87 Transportation accident - Syncor vehicle in Balto. City - R. Manley. No spillage, fender bender. 7. 4/15/87 Kay Ray level gauge broke away from its support and fell to the ground at Genstar in Frederick, MD - Y. Chong. No leakage or exposure problem. 8. 4/7/87 Service complaint froma New York Hospital concerning Therapy Services of Frederick, MD - Y. Chong. No exposures involved. 9. 5/6/87 Assistance required by the 00T in evaluating a shipment of RAM from Calvert Cliffs to New England to determine any radiation hazards at a truck weigh station in Upper Marlboro - P. Chaparala. No violations noted.

10. 4/27/87 Investigation of (7) workers at Westvaco in Lake, MD concerning radiation exposures due to industrial radiography operations - C. Trump.

Reciprocity licensee. Reanactment of circumstances showed no exposure.

11. 6/25/87 Radiation containers (boxes) found in basement of former physician's office P. Y. Liang, Balto. City - R. Baisson.

RSO retrieved source.

12. 7/29/87 Stolen lixiscope of Dr. Larry Hotchkiss of Rockville -

Y. Chong. Never recovered. Cited for unauthorized location.

13. 8/11/87 Response to RAM package potentially contaminated during shipment in Chevy Chase - R. Manley.

No contamination found.

14. 8/20/87 Emergency response to a container found with a CRM label affixed in PG Co. - Y. Chong.

No aterial in container.

15. 8/17/87 Investigation of a facility possessing and using a moisture / density gauge without a license - R. Manley.

Civil penalty issued. f

l*.- A 2 -( 16. 9/4/87 Investigation of the potential unsafe conditions and unauthorized storage of RAM at the Chesapeake Biological Lab at Solomons Island - Y. Chong. Waste drums in an authorized location. No exposures. No violations.

17. 9/3/87 Emergency response to a residence in Hampstead where RAM were found - R. Brisson. Old civil defense check sources.

State impounded.

18. 7/15/87 Investigation of a "revigator" containing Ra-226 at antique shop in Northeast, MD - R. Manley.

Inpounded and sent to Oak Ridge. 19. 9/17/87 Investigation at a residence in Chevy Chase where a-jar of uranium nitrate was found in a basement - R. Manley, RSO packaged and took source.

20. 9/20/87 Investigation at a physician's office in Chevy Chase where-I-131 liquid was spilled - R. Manley.

Contamination found. Civil Penalty issued. 21. 10/8/87 Transportation accident - moisture / density gauge dropped out of vehicle onto road bed near Savage - Y. Chong. No damage to gauge. 22. 11/19/87 Emergency response - moisture / density gauge was involved in fire in Hancock - Y. Chong. No damage to source. 23. 10/27/87 Investigation of out-of-state licensee demonstrating lead paint analyzer in MD without authorization - R. Manley. Licensee ushered out of state. 24. 12/15 & 27/87 Investigation of CRAM labeled molygenerators at PG Airport in Fredrick, MD - P. Chaparala, 25. 10/16/87 Investigation at Towson St. Univ. concerning the finding i of RAM (check sources) unsecured by security staff - P. Chaparala. Check sources left in unlocked lab. 26, 11/9/87 Emergency response parked tractor trailer was exhibiting " radioactive placards" in a residential neighborhood in Suitland - R. Manley. No violations.

27. 3/15-16/88 Special survey of Christopher Photo Lab in Cumberland determined that contamination from a 3M air nozzle contaminated the lab - C. Trump /Y. Chong.

3M case.

28. 8/13/88 Telecon notification to CRH from Nucletron concerning an Iridium-192 source used in a remote afterloader - T.

Ferguson. Licensee investigated. No source problem.

29. 2/5/88 Radiation survey of women's jewelry at CRH. Cloissone jewelry.

30. 1/27/88 Investigation of an out-of-state licensee conducting service / maintenance in MD without authorization in Balto. - R. Manley. J. L. Shepard cited for violation. j 31. 3/29/88 Investigation of RAM at Linganore H.S. Fredrick Co. - 1 R. Manley. No violations noted. t 32, 6/3/88 Emergency response telecon with a citizen concerning Martin Marietta where a fire and allegedly an atmospheric release of radioactivity occurred in Relay, MD - R. i Brisson. No radioactivity involved. l

4. 3 (- 33. 5/16/88 Investigation of a P-32 spill of Univ of MD - College Park - R. Manley. Licensee cleaned up. No violations.

34. 5/2/88 Investigation of radiation exposure to an NMT at Physicians Mem. Hospital in LaPlata - R. Manley, Badge exposure only. Administrative dose assigned.

35. 5/26/88 Investigation of " Radioactive" placarded trucks at Rollins Truck Leasing Terminal in Balto. Co. - R. Manley. Nothing abnormal.

No violation. 36. 5/27/88 Investigation of a BACTEC vial containing C-14 (labeled CRM) found at the Pulaski Hwy Incinerator in Calto. City - R. Chaparala. General licensed material. No violation.

37. 5/27/88 &

Investigation at NPI in Dickerson concerning employees 6/1/88 carrying cobalt-60 contamination outside the plant - C. Trump /R. Manley. Ginna incident. 38. 7/2/88 Investigation of RAM found in vacant house in Silver Spring - T. Ferguson. Check sources impounded by State.

39. 7/5/88 Emergency response - M/D gauge was pulled from a lake in Rockville - R. Manley/C. Trump. No exposure.

State impounded. Sent back to Licensee. 40. 6/20/88 Investigation of a residence in Silver Spring where RAM were found in a basement - R. Manley/Y. Chong. Radium sources and uranium ore. Went to licensee or RSO for disposal. 41. 9/21/88 Investigation of potential RAM storage and contamination using C-14 at a private residence in Towson - C. Trump /A. Jacobson. Bactec vials. No violation of regulations. ( 42. 9/24/88 Emergency response - to PG Co. police at Seat Pleasant concerning a stolen M/D Troxler gauge which was recovered - C. Trump. 43. 8/15/88 Investigation of the unauthorized collection and disposal of C-14 (BACTEC) hospital waste in a dumpster in Parksville, M.D - R. Manley/C. Trump /A. Jacobson. 44. 9/8/88 Radiation Survey of a pump motor received from Carolina Power & Light NPP at Westinghouse in Balto. City - R. Manley. No contamination found. 45. 9/2/88 Investigation of a therapy misadministration at Sacred Heart Hospital in Cumberland - R. Manley. 46. 10/27/88 Investigation of a therapy misadministration of 33 patients at Sacred Heart Hospital in Cumberland - C. Trupm/R. Manley/A. Jacobson. 47. 11/4/88 Investigation concerning the allegations of unauthorized selling, transfer and receipt of RAM in MD - R. Manley. Everything in accordance with license. 48. 12/1/88 Investigation of RAM (mock iodine-129) found in Silver Spring - C. Trump. State impounded. 49. 1/3/89 Investigation with the NRC Hdqtts. concerning two (2) GL sealed sources found in a desk purchased at a auction in Balto. City - C. Trump. Still under investigation. L. Bolling, NRC retrieved. 4 (

3 4 ~(, S0. 1/20/89 Investigation concerning an employee's concern about Kr-85 cathode electron tubes of GE facility - C. Trump. Exempt sources. 51. 1/26/89 Investigation concerning unauthorized transfer of GL devices from Virginia to a MD facility in Helron, Wicomico Co. - C. Trump. NRC notified. Maryland GL cited. 52. 1/27/89 Investigation at residence in Gaithersburg concerning Co-60 contamination - C. Trump /R. Manley. Former NPI employee. 53. 1/13/89 -Investigation of U.S. Ecology personnel of packaging of Ra-226 at JHMI in Balto. City for preparation of shipment to California - R. Manley. ( t -r _}}