ML20138D178
| ML20138D178 | |
| Person / Time | |
|---|---|
| Issue date: | 10/18/1985 |
| From: | Murley T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Wilzack A MARYLAND, STATE OF |
| References | |
| NUDOCS 8510230207 | |
| Download: ML20138D178 (7) | |
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October 18, 1985
(
Ms. Adele Wilzack, R.N., M.S.
Secretary
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Department of Health and Mental Hygiene 201 West Preston Street Baltimore, Maryland 21201
Dear Ms. Wilzack:
This is to confirm the discussion Mr. John McGrath held on August 29, 1985 with
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Messrs. John Staubitz, William Eichbaum and David Resh following our review and evaluation of the State's radiation control program-initiated during the period June 25-28, 1985 and completed August 29-30, 1985.
The review covered the principal administrative and technical aspects of the program and included an examination of the program's legislation and regulations, organization, manage-j nent, administration, personnel, and licensing and compliance actions.
l Our review was performed in accordance with the NRC policy defined in the-
" Guidelines for NRC Review of Agreement State Radiation Control Programs."
These guidelines were published in the Federal Register on December 4, 1981 and define 30 indicators that are used for evaluating Agreement State programs.
A i
description of how the indicators are used in reporting the results of program reviews to State management is enclosed (Enclosure 1).
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During our previous review of the Maryland program, a number of deficiencies were noted.
The most significant problem area, the licensing and inspection l
backlogs, were directly related to an ir. adequate staffing level.
In response to this condition, the Department developed a plan to augment the staff and to review the existing salary structure to determine what changes are necessary to recruit and retain qualified personnel. Although action has been l
taken to assign additional staff to the radioactive materials program, the State
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should move forward promptly with its staffing plan and, most importantly, s
proceed with the review of staff salaries.
The inspection and licensing back-i logs remain and it is essential that the State be in a position to recruit l
and retain appropriately qualified staff. With regard to the licensing program, j
we suggest that the State consider providing additional staff resources in this
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This will help address the current backlog as well as provide for ex-i area.
perienced coverage of this program function in the event of future staff turn-
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With regard to the inspection backlog, we suggest that the State develop l
over.
a specific plan to address this problem area.
The plan should include a train-ing schedule for new staff, staff utilization schedules, and specific inspection backlog reduction objectives.
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4 8510230207 851018 PDR STPRO ESGPS s
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i Adele Wilzak 2
Based on our overall program review and your responses to our previous concerns, particularly with regard to the increased staff, we believe the Maryland radiation control program is adequate to protect the public health and safety.
The State has taken steps to update the radiation control regulations, however, pending the completion of this task, we are withholding a finding of compatibility with the NRC's program. contains additional comments regarding the technical aspects of our review.
These comments were discussed with Mr. Corcoran and his staff.
You may wish to have Mr. Corcoran address these comments and respond directly to us.
In accordance with NRC practice, I am providing a copy of this letter for placement in the State Public Document Room or othenvise to be made available for public review.
I appreciate the courtesy and cooperation extended by Mr. Staubitz and the other members of your staff to Mr. McGrath during the meeting.
Sincerely, su
/f,.
r Thomas E. Murley Regional Administrator
Enclosures:
As Stated cc:
R. Corcoran Distribution:
G. W. Kerr, OSP TMurley NRC Public Document Room JAllan State Public Document Room JMcGrath CNussbaumer SP01 L."
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RA JMcGrath
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85 7
0FFICIAL RECORD COPY
Application of " Guidelines for NRC Review of Agreement State Radiation Control Programs" The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Register on December 4,1981 as an NRC Policy Statement. The Guide provides 30 Indicators for evaluating Agreement State program areas. Guidance as to their relative importance to an Agreement State program is provided by categorizing the Indicators into 2 categories.
Category I indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e. those that fall under Category I indicators.
Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each coment made.
If no significant Category I coments are provided, this will indicate that the program is adequate to protect the public health and safety.
If at least one significant Category I comment is provided, the State will be notified that the program deficiency may seriously affect the State's ability to protect the public health and safety and should be addressed on a priority basis. When more than one significant Category I coment is provided, the State will be notified that the need of improvement in the particular program areas is critical.
The NRC would request an imediate response, and may perform a follow-up review of the program l
within six months.
If the State program has not improved or if additional deficiencies'have developed, the NRC may institute proceedings to suspend or revoke all or part of the Agreement. Category II coments would concern functions and activities which support the State program and therefore would not be critical to the State's ability to protect the public. The State will be asked to respond to these coments and the State's actions will be evaluated during the next regular program review.
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i ENCLOSURE 2 COMMENTS AND RECOMMENDATIONS ON TECHNICAL ASPECTS OF THE MARYLAND RADIATION CONTROL PROGRAMS FOR AGREEMENT MATERIALS I
I.
Licensing i
1.
Technical Quality of Licensing Actions is a Category I indicator.
Ybe following comments and recommendations are, however, considered minor in nature.
f Comment l
State licenses were for the most part adequately supported by information in the applicant's supporting documentation.
A few minor deficiencies were noted however. These included insufficient details on radiographer refresher training, provisions for backup survey meters, security over storage areas, facility descriptions, i
and the authorizing of medical Group III when only unit doses were requested.
Recommendation
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We believe that a more careful review of applications should be a t
Division goal. The current licensing workload is being handled by i
one person. We believe that this is an unsatisfactory situation, which may be contributing to the minor oversights discussed in the above comment.
The Division should provide backup in the Licensing program.
2.
Adequacy of Product Evaluations is a Category I indicator.
The following comment and recommendation is considered minor in nature.
i Comment During the review period, the State evaluated and issued a catalog l
sheet for a cobalt 60 teletherapy unit. The evaluation for the most l
part covered the necessary points, however, our review of the i
supporting documentation raised two questions which could not be I
resolved.
(1) The unit's drive wheel is capable of being retracted by hand in an emergency. Although the instructions indicated that i
the wheel should be turned clockwise, certain drawings provided would indicate that it should be turned counterclockwise.
(2) The manufac-turer indicated that the unit comes.with an optional beam stop, and that the beam stop was " retractable." There was no information indicating why the_ beam stop was retractable or under what conditions it could be retracted.
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2 Recommendation We believe that the manufacturer should be requested to clarify the information concerning the rotational direction of the drive wheel and provide additional information on the beam stop so it can be determined that it could not be retracted in such a manner as to affect safety.
II.
Compliance 1.
Inspection Procedures is a Category II indicator.
The following comment and recommendation is of concern because of the non-uniformity of Maryland's interpretation of a key regulatory requirement with NRC and other Agreement States.
Comment The review of two compliance actions involving in-house radiographers raised a number of concerns.
The first involved the State's inter-pretation of Section D.105 of the Maryland regulations.
Independent measurements taken adjacent to the licensees' facilities _ indicated radiation levels of 0.5 - 13.5 mr/hr.
One licensee was cited against D.105, exceeding 0.5 rem per year in an unrestricted area.
Later enforcement action required both licensees to meet 170 mrem per year at the boundary of the restricted area.
The use of the 170 mrem per year limit was based on the State's interpretation of D.105 and NCRP Report 39, paragraph 247. We believe that this is a mis-interpretation of NRCP guidelines.
The 170 mrem per year is an i
average figure for large p'opulations, and was not meant to apply to an individual at the boundary of a restricted area, where the 0.5 rem per year limit of D.105 applies.
The State, in determining compliance, did not allow for use factors in the calculation showing noncompliance with D.105 although the inspection reports indicated that the licensees had records concerning use.
One inspection report indicated that the State's surveys were performed with an uncollimated source, although the licensee indicated that a collimator was always used.
The " policy" concerning the applicability of the 170 mrem per year limit and the disallowance of use factors was never formally i
established as Department policy and was selectively applied to certain licensees.
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3 Recommendation We recommend that the State no longer apply the 170 mrem per year value as a limit applicable to the boundary of a restricted area.
The wording of D.105 (and 10 CFR 20.105, on which it is based) makes it clear that the application of use factors for determining compliance with that section is always allowable.
If the licensee has adequate records regarding the use of sources these must be taken into account in determining compliance.
If such records are not available, or the State has some reason to question their accuracy, the enforcement action can reflect this.
We recommend that in performing independent measurements, the exposure setup should reflect, as closely as possible, the licensee's operating procedure.
If the licensee's procedures call for routine use of a collimator, and there is no' indication that 1
this procedure was violated, it is inappropriate to base compliance actions on measurements without a collimator in use.
We recommend that the State's regulations be consistently applied to all licensees.
The singling out 6f a particular category of licensee and applying a special interpretation of the regulations, calls into question the State's fair and impartial administration of program requirements.
In addition, we recommend that all " interpretations" of the regulations receive Department review and be formalized as Depart-ment policy. The NRC should also be given an opportunity to review and comment on the State's position prior to implementation.
2.
Enforcement Procedures is a Category I indicator.
The following comment and recommendation is considered minor in nature.
Comment During our previous review, we noted that the program had recently been given civil penalty authority and we recommended that the Division prepare written procedures to implement this authority.
We i
note that the State has not yet prepared these procedures.
Recommendation The Division has had a draft procedure for escalated enforcement actions since. January 1980. We believe that this draft should be updated and finalized and that it include the procedure for handling the issuance of civil penalties.
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4 3.
Inspection Reports is a Category II indicator.
Comment The inspection report referenced in comment II.1 above included detailed information on the State's facility survey.
Handwritten drawings and survey results were not always clear enough to determine where readings were actually made.
Recommendation Inspection documentation, particularly when supporting enforcement actions, should be clear and concise such that a third party reviewing the report would come to the same conclusion as the inspector regarding the compliance determination.
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