ML20209B031
| ML20209B031 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/1986 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20209A892 | List:
|
| References | |
| FRN-49FR1205, RULE-PR-20 AA39-2-003, AA39-2-3, NUDOCS 8704280346 | |
| Download: ML20209B031 (7) | |
Text
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MV 2 41986 MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: Eric S. Beckford, Director Office of Nuclear Regulatory Research
SUBJECT:
FINAL AMENDMENT OF 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL DOSIMETRY PROCESSORS Attached for your signature is a Commission paper with enclosures which recommends amending 10 CFR Part 20 to require NRC licensees to use the services of accredited personnel dosimetry processors.
NRC regulations require licensees to provide personnel monitoring under 10 CFR 20.202(a)and-10CFR34.33(a). Although some of the monitoring provided consists of dosimeters which require processing to obtain dose readings, the regulations do not require performance standards for personnel dosimetry processors. In spite of the identification of problems with such dosimetry processing as early as 1955, it was not until 1976 that a suitable performance standard became available.
Between 1977-1979, the NRC sponsored two rounds of personnel dosimetry testing against the 1976 draft standard and another test against the revised standard in 1982. The results of these tests indic'ited a significant percentage of processors were performing with a degree of accuracy unacceptable to the NRC.
Many of those tested exceeded the tolerance limit of the standard by factors of 2 or more; a few exceeded the tolerance limit by factors as high as 2000. At the same time, the percentage of the test categories passed increased from 48% in pilot test I to 75% in pilot test 3. indicating that processors were capable of consi.derable improvement in their procedures.
In view of these results the NRC concluded that rulemaking was needed to j re. quire periodic evaluat' ion of personnel dosimetry processors. An Advance j Notice of Proposed Rulemaking was published on March 28, 1980, (45 FR 20493),
- and a Notice of Proposed Rulemaking on January 10, 1983, (49 FR 1205). The
! ANPRM listed 4 alternatives to the selection of a Proficiency Testing i Laboratory and-the NPRM proposed requiring NRC licensees to use'the services of processors who had been accredited under the National Voluntary Laboratory Accreditation Program of the National Bureau of Standards.
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W 2 41986 Public comments on the ANPRM were in favor of a Federal Government controlled proficiency testing laboratory. The majority of public comments on the NPRM were favorable, with most of the unfavorable comments directed against the costs to small processors and medical and hospital licensees. As a result of public comments, the requirement for licensees to maintain copies of their processor's accreditation certificate has been deleted from the final rule.
Although the final rule is expected to have a significant impact on about 10 small processors, the benefits to workers, licensees, and the general public render it necessary. To date over 54 processors have voluntarily applied for accreditation under NVLAP and 45 of these have already been accredited.
Failure to promulgate this rule could result in these processors dropping out of NVLAP in order to compete economically with less qualified processors.
The NVLAP is self supported from fees paid by the processors and will require less than 0.1 person-years / year of NRC staff time to oversee the program.
The Offices of Nuclear Reactor Regulation, Nuclear Materials Safety and Safeguards, Inspection and Enforcement, State Programs, Office of the General Council and Administration concur in these amendments to 10 CFR Part 20.* The ACRS and the CRGR have also reviewed the rule package and concur in the proposed action.
I4/
Eric S. Beckford, Director Office of Nuclear Regulatory Research
Enclosure:
Commission Paper with Enclosures Distribution:
- See memos attached from:
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For: The Commissioners From: . Victor Stello, Jr.
Executive Director for Operations
Subject:
AMENDMENTS TO 10 CFR PART 20 TO REQUIRE THE USE OF ACCREDITED PERSONNEL DOSIMETRY PROCESSORS
Purpose:
To obtain Consnission approval of a notice of final rulemaking.
Issue: Whether to require NRC licensees to use an accredited processor to process personnel dosimeters that are utilized by them to comply with certain NRC requirements.
Background:
NRC licensees are required to provide personnel monitoring equip-
, menttocertainindividualsasspecifiedin10CFR20.202(a)and 10 CFR 34.33(a), and to maintain these individuals' radiation exposure records as specified in 10 CFR 20.401(a) and 10 CFR 34.33(e). Among the types of monitoring equipment in use are dosimeters such as film badges, track-etch-type dosimeters, and thermoluminescent dosimeters (TLDs), all of which require processing in order to determine the radiation dose by observing a particular radiation-induced effect in the dosimeter. Although the ' processing of these dosimeters must be done accurately and consistently to provide acceptable dose values, NRC regulations .,
have not required performance standards for dosimetry processing despite the fact that the accuracy of the doses reported from these dosijneters is directly related to the ability of licensees to conform to the NRC regulatory requirements.
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Problems with dosimetry processing were recognized as early as 1955 when the Atomic Energy Commission contracted.with the National Bureau of Standards (NBS) to conduct an intercomparison of film badge interpretations. Despite the early recognition and identification of problems from this and subsequent studies, it
Contact:
i Donald O. Nellis, RES 427-4588
l The Commissioners 2 I
was not until 1976 that the Health Physics Society Standards Committee (HPSSC) recommended a suitable performance standard for personnel dosimetry processing. Between 1977 and 1979, the NRC i sponsored two rounds of proficiency testing of processors against this standard at the University of Michigan. The results of 1
these tests indicated that a significant percentage of the pro-cessors were not performing at a level of accuracy acceptable to the NRC. Most of those who failed to pass one or more of the i test categories exceeded the tolerance limit (or criterion) by
, factors of 2 or more, indicating that only minor adjustments in procedures were probably needed. For some processors, however, t
this factor was as high as 2,000, indicating that major changes in procedures or facilities or both were required.
As a result of these tests, the NRC concluded that rulemaking was needed to require periodic evaluation of personnel dosimetry pro-cessors and, on March 28, 1980, issued an Advance Notice of Pro-
, posed Rulemaking (ANPRM) (45 FR 20493). The ANPRM presented four alternatives for the operation of a proficiency testing laboratory. During the coment period, 46 coment letters were received. The majority stated a preference for a laboratory '
controlled by the Federal Government, and a fifth alternative for the operation of a proficiency testing laboratory was identified.
This alternative would utilize the National Voluntary Laboratory Accreditation Program (NVLAP) operated by the National Bureau of Standards (NBS). Several of the coment letters also requested a i third round of performance testing against the HPSSC standard, which had been significantly revised following the first two rounds of testing. l As'a result, the NRC asked NBS in 1980 to establish an accredita-tion program under NVLAP for personnel dosimetry processors and, in 1981, authorized a third round of perfomance testing against L the revised HPSSC standard by the University of Michigan. The l third round of perfomance testing was completed in 1982, and
! analysis of the results indicated that, although 25% of the radiation category tests attempted were not passed, 78% of the
! individual dosimeter readings were within 130% of the true dose delivered to the dosimeters. This compared to 625 for the first ,
round of testing and 73% for the second, indicating that person- '
, nel dosimetry processors were capable of considerable improve-ment. In light of these results, the NRC published on January 10, 1984, a Notice of Proposed Rulemaking (NPRM)
(49 FR 1205) that would require NRC licensees to utilize the services of processors accredited under the NVLAP of the National Bureau of Standards for processing personnel dosimeters that are i utilized to comply with NRC regulations. Also included in this NPRM was a notice concerning the availability of dosimetry accreditation through NVLAP starting in January 1984.
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The Comissioners 3 J
The NRC received 96 public comment letters in response to the NPRM, most of which were favorable. The major objections to the rule were the costs to small processors and medical and hospital i licensees. An analysis of comments has been prepared and may be found in Enclosure C to this paper. l The NVLAP accreditation program was initiated in January 1984
- NVLAP analyzed the results of the first 1-1/2 years of operation j of that program and found that 90% of the individual dosimeter readings were within 130% of the true dose delivered to the dosi-i ' meters. Since the number of dosimeters used in the NVLAP analysis was approximately the same as the number used in each of the three rounds of testing, one can have confidence that the
, improvement shown in individual dosimeter readings of the NVLAP analysis over the individual dosimeter readings of the pilot
- tests reflects the value of the accreditation program. Also, the
- pass-fail criterion used in the NVLAP accreditation ensures that the recorded dose will be within + 50% of the actual dose at the
- 95% confidence level. The NVLAP aiialysis can often detect the i source of processor errors, and this information is promptly relayed to the processor. The analysis indicates all processors should be able to meet a standard deviation of less than 20% for 1 the 15 dosimeters required for each radiation category.
f The long time interval since the early recognition of this prob-i lem to the present (about 30 years) without an effective remedy l is disquieting and potentially embarrassing and does not reflect
! the importance and urgency of improving the accuracy and relia-bility of worker radiation dose records. The integrity of worker I dose records is essential because:
(1) The NRC needs accurate dose information on workers in order .
j to regulate properly.
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! (2) NRC 1,1censees need accurate dose information on workers in
- order' to control risks and to comply with regulations.
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j (3) Workers need accurate dose information:
1 (a) To assure them that their working conditions are safe.
! (b) To assure them that their doses are not being overesti-4 mated and that their availability for work is thereby i being limited unnecessarily.
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- (4) Accurate dose information will be important in the future
- use of these data for epidemiology studies to improve know-ledge concerning the effects of low-level radiation.
I In early 1984, the American Nuclear Insurers issued a bulletin to I
- their nuclear utility policy holders recommending that they or
- their commercial dosimetry processors participate in the NVLAP 1
k ,
The Commissioners 4 program. Fifty-four of the 90 known processors have now voluntarily applied for accreditation under NVLAP, and 45 of these are currently accredited. If this rule is not approved in the near future, these processors may drop out of the program in order to better compete with the processors that have not yet applied for accreditation. The proposed final rule has been developed in concert with other Federal and State agencies that are waiting for NRC to promulgate the rule prior to imposing similar requirements on persons or organizations under their jurisdiction. The program is self-supporting from fees paid by
'the processors, and it will have little effect on staff resources (less than 0.1 FTE per year).
R: commendation: That the Commission:
- 1. Approve publication in the Federal Register of the final amendments to Part 20 (Enclosure A) that would become effective 1 year after publication in the Federal Register.
- 2. Approve the staff's conclusions set forth in the Final Regu-latory Flexibility Analysis (Enclosure D) that the benefits to the public health and safety that would result from the proposed accreditation programs outweigh the program's pos-sible economic ir: pact upon some small entities. The Chief Counsel for Advocacy of the Small Business Administration l will be informed of this rulemaking and the reason for it, as required by Section 605(b) of the Regulatory Flexibility Act.
- 3. Approve the staff's conclusions set forth in the Backfit Analysis (Enclosure E) which provides the analysis called for by the Backfit Rule of Part 50 of NRC's regulations.
- 4. Note that:
- a. 'With respect to the Agreement States, this item will be
. made a matter of compatibility because it concerns basic radiation standards,
- b. The appropriate Congressional comittees will be informed.
- c. A public announcement such as Enclosure G will be issued when the Federal Register notice is filed with the Office of the Federal Register.
- d. Copies of the final rule will be sent to all NRC licensees, to all known personnel dosimetry processors, and to other interested persons and organizations by the Office of Administration.
e The Commissioners 5
- e. This f:aal rule does not contain a new or amended infornetion collection requirement subject to the Paperwnk Reduction Act of 1980 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Managenent and Budget approval number 3150-0014.
- f. This final rule is the type of action described in categorical exclurion 10 CFR 51.22(c)(3). Therefore, neither an erwironmental impact statement nor an environmentai assessment has been prepared for the final rule.
Victor 5tello, Jr.
Executive Director for Operations
Enclosures:
A. Federal Register Notice B. Regulatory Analysis C. Analysis of Comments D. Regulatory Flexibility Analysis E. Backfit Analysis F. Draft Congressional Letter G. Public Announcement
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