ML20137R581
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- WASHINGTON, D.C. 20555 AUG 2 41983 1*s....+
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MEMORANDUM FOR: Bill Walker, Section Leader Medical Licensing Section Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS FROM: Bernard Singer, Chief Material Certification and Procedures Branch Division of Fuel Cycle and Material Safety, NMSS
SUBJECT:
REVISION OF 10 CFR PART 35 As you requested on August 23, 1983, the following are my comments on the Radiological Safety Plan and the Area Survey Procedures.
Some time ago, I concluded that it was not necessary nor desirable to obtain detailed procedures from applicants. All that is needed is a commitment by an applicant that he will have procedures which will contain certain elements which we would specify in guides. Your example of an acceptable Radiological Safety Plan for area surveys is generally in accord with the path we have taken in writing application guides for the Phase II decentralization program.
In the formulation of the particular elements for which an applicant should make a commitment for inclusion in procedures, we have tried to consider the regulatory requirements and the least burdensome commitments needed to assure compliance with the regulations.
The daily survey of an area to datermine if there is contamination present does not need to be quantitative. If the goal is to keep work areas reasonably clean, the performance of a survey with an appropriate instrument, and cleanup of any contamination fouad, is all that is needed. If licensees want to make quantitative measurements, that is their prerogative. However, we should not impose quantitative measurements which is not needed to meet regulatory require-ments such as the survey requirement in Section 35.70. Therefore, for purposes of simplification, I suggest the ~ example given, Area Survey Plan, be revised as follows:
V " Item 17: Area Survey Plan It is not necessary for you to submit the detailed written procedure for the surveys required by Section 35.70 of 10 CFR Part 35. All that is necessary for you to do is nake a written commitment that you will have and implement written procedures which contain the following:
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35 50FR30616 PDR
AUG 2 41983 (1) All areas used for elu tion, preparation, assay, or dispensing of radioactive material will be surveyed at the end of the work day.
(2) If any contamination is found, immediate steps will be taken to decontaminate the area.
(3) The survey meter used will be sufficiently sensitive to detect 0.1 mR/hr.
(4) At least once a week a survey will be per-formed where radiopharmaceuticals or radio-pharmaceutical waste is stored. If the radiation level exceeds 2 mR/hr at 18 inches from the storage ares, immediate steps will be taken to reduce the radiation level to ,
2 mR/hr at 18 inches from the storage area.
As I have discussed with you on many occasions, I strongly object to including a manual of good practice as part of an application guide. In fact, we did not support RES in its efforts to let contracts for establishing manuals of good practice on the grounds that: . -(1) it was not the role of the NRC, and (2) the particular segment of the licensee population should be more actively engaged in such endeavors. For the nuclear medical industry, we suggest that a group such as the AAPM should be preparing manuals of good pract .
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Ber rd Sin r, Ch'4f e rti icahion and Procedures ranch Division of Fuel Cycle and Material Safety, NMSS cc: R. E. Cunningham
! D. R. Chapell l V. L. Miller 1
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