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NUCLEAR REGULATORY COMMISSION o
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,E wAswiscrow, p. c. 20sss OCT 101986 MEM0PANDUM FOR:
Robert M. Bernero, NRR Richard W. Starostecki, IE Pichard E. Cunningham, NMS$
Denwood F. Ross, RES Clemens J. Heltemes, Jr., AE0D Joseph Scinto, OGC THRU:
John E. Zerbe, Director Regional Operations and Generic Requirements Staff FROM:
Ronald R. Bellamy Regional Operations and Generic Requirements Staff
SUBJECT:
SUMMARY
AND ISSUE IDENTIFICATION FOR CRGR MEETING NO. 98 Enclosed for your information and use is the ROGR staff summary associated with the proposed rule change that would require personnel dosimetry processors be accredited through the National Voluntary 1.aboratory Accreditation Program operated by the National Bureau of Standards. This matter is scheduled for CRGR review at Meeting No. 98 on Thursday, October 16, 1986, in room 6507 MNBB, 1-2 p.m.
k Ronald R. Bellamy Regional Operations and Generic Requirements Staff
Enclosure:
As stated cc:
J. Sniezek K. Goller, RES R. Alexander, RES D. Nellis @
g42g413e7o422 20 49FR1205 PDR
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s' Sumary and Issue Identification on CRGR Review Item, Meeting No. 98 October 16, 1986 IDENTIFICATION Proposed revision to the NRC regulations on personnel monitoring in 10 CFR Part 20 to require that personnel dosimetry processors be accredited under the National Voluntary Laboratory Accreditation Program operated by the National Bureau of Standards (Department of Comerce).
OBJECTIVE The CRGR is requested to review and recomend in favor of the proposed revision to require accreditation of personnel monitoring processors. The objective of the proposed revision is to improve the accuracy and reliability of personnel dosimetry and thereby provide a significant health benefit.
BACKGPOUND The package submitted for CPGR review was transmitted by D.F. Ross to J.H. Sniezek on September 11, 1986, and included:
Proposed rule change to 10 CFR Part 20--Federal Register Notice a.
b.
Peculatory Flexibility Analysis c.
Backfit Analysis d.
Analysis of Coments e.
Sample Congressional Letter f.
Public Announcement DISCUSSION In order to satisfy personnel monitoring requirements in 10 CFR 20.202(a) and 10 CFR 34.33(a), and the associated documentation requirements in 10 CFR 20.401(a) and 10 CFR 34.33(e), NRC licensees supply workers with dosimeters.
These dosimeters require processing after the exposure to determine what ex-posure has occurred. There are no regulations for performance standards for this dosimetry processing, even though accurate and consistent measurements are directly related to the ability of the licensees to conform to NRC regulations in 10 CFR 20.101.
The NRC sponsored two rounds of proficiency testing of processors against Health Physics Society Standards in 1977-1979, noting major changes required for some processors.
In the first round 62 percent of the individual dosimeter readings were within 30 percent of the true dose, and 73 percent were within 30 percent for the second round. The NRC issued a proposed rule change in March 1980, receiving 46 coment letters on the various options proposed.
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Review of the coments resulted in the NRC asking NBS in 1980 to establish an accreditation program under the National Voluntary Laboratory Accreditation Program (NVLAP). A third performance test was conducted, indicating 78 percent of the processed TLDs within 30 percent of the true dose. On January 10, 1984, a Notice of Proposed Rulemaking was published by NRC that would require NRC licensees to use dosimetry processors accredited by NVLAP for processing personnel dosimeters required by NRC regulations. An effective date of one year after publication of the rule is specified. The NRC received 96 comment letters, mostly favorable. The major objections were the costs to small pro-cessors and to medical and hospital licensees.
ISSUES 1.
Although generally the processors of dosimeters are doing an adequate job today, without the rule change many processors would reduce their commit-ment to providing competent analyses, and other less-than-adequate com-panies might enter the business. NVLAP certification establishes a label of competent, professional performance. Note that most power reactor licensees already use processors that are NVLAP-certified and, without the rule, many processors may decide not to continue being accredited. The Region 1 contractor to process NPC Region 1 employee dosimeters (Landauer) is HVLAP certified.
2.
Conversely, what is wrong with the status quo? If a licensee program (whether contracted out or not) is so bad that we cannot conclude they satisfy the regulations, we can simply take enforcement action--no rule change required.
3.
Should NVLAP certification take the place of NRC inspection activities?
Although it is useful for the inspector to know whether the licensee's processor is certified, is this enough? The inspector would still need to check records, see QA/QC involvement, observe onsite implementation of procedures.
Further, NRC Pegions would need timely copies of the NVLAP Quarterly Certification status.
Is a NRC-NBS Memorandum of Understanding warranted?
4 Is this area a candidate for industry self-regulation? What does ICRP, NCRP, or the Health Physics Society think?
5.
Note the rule change would be for required personnel dosimetry only--not environmental, dosimeters or additional dosimeters the licensee chooses to Yet extremity dosimeters are specifically excluded from the rule use.
change. If regulations specify allowable doses to hands and forearm, feet and ankles, wouldn't it make sense to include these dosimeters?
6.
It appears a potential benefit of NVLAP certification is missing. What about public perception? Increased confidence of the public that doses are accurate and that the NRC can adequately regulate the nuclear in-dustry? Being able to state that the dosimeters were processed by a certified laboratory should certainly make dealing with the public and press inquiries easier to handle, especially if potential overexposures, or an accident situation, are under discussion. The Backfit Analysis a'so ignores benefits of eliminating gross overestimates. This can save on inspection time, licensee evaluation time, public perception, response to outside inquiries, and management review time.
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7.
The cost of NVLAP certification is not excessive, and should be considered a " cost of doing business," similar to any other certification. Note costs are estimated at $3,000 to !8,400 annually per dosimeter type, de-pending on how many radiation categories are tested.
8.
The Rule change only affects occupational workers, and those for which doses are underestimated (if the dose would have been overestimated, the worker would not receive more exposure). Also, the rule change itself won't save dose, it only gives greater accuracy. Therefore, can you make an argument for substantial improvement in the public health and safety?
9.
CRGR may want to consider the following technical questions:
What were the number of dosimeters used in the NVLAP comparison (top a.
of page 4 of EDO memorandum to the Commission)? Is it statistically adequate?
b.
Pa'ge 12 of the proposed rule indicates the NRC plans to issue sup-plementary information to help licensees deternine appropriate testing categories. What information; how published? How is information being distributed now?
What are the one versus eight testing categories? Are eight needed?
c.
How does this affect accreditation costs?
d.
Page 3 of the Pegulatory Flexibility Analysis assumes that the small processor derives his entire income from dosimeter processing. This may not be realistic, which would make the case stronger that the cost of NVLAP certification is not of great consequence.
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