ML19207C114
| ML19207C114 | |
| Person / Time | |
|---|---|
| Issue date: | 08/13/1979 |
| From: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| RULE-PR-20 NUDOCS 7909060455 | |
| Download: ML19207C114 (12) | |
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Federal Register Notice SD Task No.
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DRAFT 8/13/79 NUCLEAR REGULATORY COMMISSION
[10 CFR Part 20]
Advance Notice of Rulemaking on Certification of Personnel Dosimetry Processors AGENCY:
U.S. Nuclear Regulatory Commission ACTION:
Advance notice of rulemaking to improve accuracy in personnel
, dosimetry.
SUMMARY
Tests have indicated that a significant percentage of personnel dosimetry processors may not be performing with an acceptable degree of accurracy.
Alternatives for action to correct this situation are presented.
Interested persons are invited to submit comments on these alternatives.
DATES:
Comment should be received by (30 days after FR oublication).
ADDRESSES:
Comments or suggestions for consideration in connection with these alternatives may be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission,- Washington, D.C.
20555, Attention:
Docketing and Service Branch.
Copies of comments received may be examined at the Commission's Public Document Room, 1717 H Street, N.W., Washington, D.C.
FOR FURTHER INFORMATION CONTACT:
Mr. Robert E. Alexander, Office of Standards Development, U.S. Nuclear Regulatory Commission, Washington, D.C.
20555, 301-443-5975.
SUPPLEMENTARY INFORMATION:
Recent tests indicate that a significant per-centage of the personnel dosimetry processors in the United States may not CloUbO
be performing with an acceptable degree of accurracy.* To the extent that these test results are representative of routine field conditions, the test results iadicate that the dose received by occupationally exposed personnel may often be considerably different from the dose measured by the dosimetry processor.
Under these conditions, control of individual radiation exposures may in some cases be inadequate, and compliance with regulatory dose limits may not be verified.
The test results indicate that individual doses may be over or under stated.
Although personnel dosimetry normally has not been performed for epidemiological purposes, these incorrect measurements may become a serious source of error when the dosimetry data are used in epidemiological studies intended to determine the biological effects on humans of low-level radiation.
The principal causes of the inconsistent test measurements that have been observed are not well understood.
There is some evidence that the inconsistencies are due primarily to differences between the dosimeter irradiation techniques used by the tester and those used by the processors to calibrate their dosimeters.
Such differences may not necessarily be actual inaccuracies; in some cases the processor's techniques may be more representative of the worker exposure conditions than the techniques of the tester.
Although these differences could most probably be eliminated through standardization of irradiation procedures, the result could be less accuracy.
However, actual inaccuracies may arise because of inadequate quality control in dosimeter manufacturing, or in a few cases to ineptitude on the part of the processor.
These different problems would require a
Nichols, L. L., "A Test of the Performance of Personnel Dosimeters,"
BNWL-2159, April 1977.
Pilot study currently in progress at the University of Michigan.
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mh different solutions, so that appropriate regulatory corrective action is very dependent on a better understanding of the causes of the problem.
The need for caution in the adoption of methods for correcting this problem is evident from at least two important considerations.
- First, the inconsistent test measurements discussed above refer to differences between the dose delivered to a dosimeter, under highly controlled labora-tory conditions, by the indie ~ ' tals conducting the test, and the dose sub-sequently measurvu oy the processor.
These tests do not necessarily measure the difference between the dose delivered to a dosimeter worn by a worker and the dose subsequently measured by the processor.
For example, the radiation source used by the processor to calibrate the dosimeter may emit radiation of the same or very similar quality as the radiation to which the worker is exposed, but quite different than the radiation used by the tester to irradiate the processor's test dosimeters.
Thus, standardization of calibration techniques among U.S. processors, which may be essential for achieving good performance in a test program, could in some cases produce apparent improved accuracy while actually introducing greater errors in the personnel dose measurement process.
This consideration is an integral part of the personnel dosimetry problem and must receive full consideration in corrective action planning.
Secondly, any regulatory action taken must be handled in a manner to ensure that sufficient personnel dosimetry services remain available.
Unnecessarily severe or improper corrective L-tion could reduce the number of available processors to the extent that the protection of some workers would be adversely affected.
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A known major source of error in personnel dosimetry is the potential difference between the actual dose received by the dosimeter and the actual dose received by the wearer.
Such differences can be due to shielding of the dcsimeter by the body when the worker is not facing the source of radiation and to variations in the radiation beam so as to irradiate the part of the body on which the dosimeter is worn differently than other parts of the body.
This source of error is recognized but is not being considered as a part of the problem that is reasonably subject to correction.
A Federal Interagency Policy Committee on Personnel 00simetry Accuracy has been formed to guide and coordinate correction of this dosimetry problem.
Dosimetry processors and users have indicated agreement that some corrective action is appropriate.
A working group of the Health Physics Society Stan-dards Committee has developed, and the American National Standards Institute (ANSI) has published, a draft standard for dosimetry performance (N13.ll, July 1978), and an industry committee (Personnel Dosimetry Overview Com-mittee) has been formed to assist in assuring that any proposed regulatory action is effective and appropriate to the need.
However, agreement has not been reached as to the specific action that should be taken.
Alterna-tive corrective actions under consideration are discussed below.
Recent Federal Government Action On November 30 and December 1, 1976, the Nuclear Regulatory Commis-sion and other Federal agencies conducted a public meeting at which the personnel dosimetry problem was discussed in an open forum by personnel dosimetry processors, dosimetry users, and representatives of State govern-ments and Federal agencies.
Other co-sponsors of this meeting were the National Bureau of Standards, the Energy Development and Research Adminis-tration (now the Department of Energy), and the Bureau of Radiological 4
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Health.
These discussions revealed general agreement that a personnel dosimetry problem does exist, and that the problem is sufficiently broad in scope that it should be addressed by the Federal government.
- However, many of the attendees cautioned against precipitous action and strongly recommended a pilot study (1) to evaluate the draft HPSSC/ ANSI standard and (2) to provide processors the opportunity to take any necessary correc-tive actions in their operations prior to the implementation of new Federal requiations on this problem.
These recommendations were accepted, and the Nuclear Regulatory Commission (NRC) subsequently issued a contract to the University of Michigan (UM) to conduct a two year pilot study.
The objectives of this study are:
(1) to determine whether the draft HPSSC/ ANSI standard provides an adequate and practical test of dosimetry performance.
(2) to give processors an opportunity to correct any problems that are uncovered; (3) to develop operational and administrative procedures to be used later by a permanent testing laboratory.
Conditions of the contract included a provision that any personnel dosimetry processor in the United States would be allowed to participate in the study on a strictly voluntary basis, provided only that the dosim-etry services tested be restricted to dosimeters used for purposes of providing the permanent record of occupational exposures.
Processors were told that the UM would keep test results confidential (i.e., that no
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organization other than the UM would be able to associate specific results with the name of a processor), that all results would be published (in coded form), that the UM would charge no fee for participation, that the new HPSSC/ ANSI standard would be used to evaluate their performance, that each participant would be given the opportunity to be tested twice and would also be given an opportunity to discuss with UM personnel the possible reasons for any poor performance prior to the second round of tests, that the accuracy of UM irradiation procedures, measurement and equipment would be verified by the NBS and would be open to inspection by the participants prior to the beginning of the tests. An open house was conducted for the latter purpose by the UM on April 20, 1978.
Fifty-eight processors indi-cated that they would participate in the study; it is believed that very few U.S. processors are not participating.
During the entire course of this study, the UM has submitted monthly progress reports to the NRC.
These reports are available for inspection in the Commission's Public Document Room, 1717 H Street, N.W., Washington, D.C.
At the conclusion of the first round of testing, the results were examined by the NRC staff, by the Interagency Policy Committee on Personnel Dosimetry Accuracy, and by the Personnel Dosimetry Overview Committee.
The results indicated poor performatice on the part of many processors.
Only 24% of the category tests attempted by all processors were passed, using the criteria published in the new HPSSC/ ANSI standard.
(According to the standard, the term " category" refers to the type of radiation being measured.
For example, Category 1 is gamma radiation, Category 2 is high energy X radiation, etc.).
None of the processors passed all of the tests attemoted, but every category test was passed by at least one processor.
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These results may be interpreted to indicate that the standard is not too stringent and that the problem lies with the processor and/or with differ-ences in irradiation techniques used by the UM and those used by the pro-cessors during their calibration procedures.
The participants' performance was also evaluated on a simple percentage-passed basis (as opposed to the more complicated formula of the standard).
Again, generally poor performance was indicated.
Using a 30% pass-fail criterion, only 10% of the category tests were passed.
Using a 50%
criterion, only 29% were passed.
Thus the results using the standard are similar to those using these simple criteria.
It had been anticipated at the beginning of the pilot study that most of those processors who performed poorly during the first round of testing would be able to take corrective action prior to the second round and would improve their performance.
However, the second-round results generally indicate essentially no improvement over the first round.
There was one important exception.
One processor, whose results in the first round were very poor, worked with UM personnel to identify and effect the necessary changes in the process, and then performed very well during the second round, passing all categories attempted but one.
These facts provide rather strong indications that conformance with the standard is feasible, but that many processors have not been sufficiently motivated to make the necessary changes in their operations.
After coriidering this situation, the Interagency Committee on PersonnelDosimetry Accuracy made the following recommendations:
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(1) The actual causes of the poor performance should be determined with a greater degree of certainty before finalizing plans for corrective action; (2) A notice should be published in the Federal Register for the purpose of notifying all personnel dosimetry processors, and the public, that the Federal government is taking action as necessary to correct the personnel dosimetry problem.
Subsequently, the NRC staff authorized the UM to conduct a series of site visits with eight of the largest processors to try to determine the causes of poor performance.
At the conclusion of these site visits t1e UM personnel prepared a report which indicates five major causes:
(1)
Inadequate calibration sources, (2) Variability in the thermoluminescent dosimeter chips, (3) Clerical errors, (4) Lack of effort on the part of the processors, and (5) Dosimeter design.
This report, dated May, 1979, is available in the Commission's Public Document Rocm in the file on personnel dosimetry performance testing.
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Future Action The pilot study is scheduled for completion by the VM on September 30, 1979, including issuance of the final report.
Since future action will be based in part on this report, final plans can not be made with certainty at this time.
However, it is possible to identify the following actions that the NRC has under consideration.
Processor Certification According to this plan, the NRC would issue new regulations stating that personnel dosimetry results would be acceptable only if acquired by a processor who is certified by a testing (i.e., certifying) laboratory approved by, or specified by, the NRC.
These processors would have to obtain and maintain their certification by passing, at a specified frequency, performance tests performed by the certifying laboratory. The certifying laucratory(s) would use performance criteria published by the American National Standards Institute (ANSI) and established in the new regulations.
These regulations would adopt ANSI standard N13.11, would specify how frequently processors would have to demonstrate, through testing, their ability to comply with this standard, would establish the procedure to be used by the NRC to let its licensees know which processors have been certified as well as those who have lost their certification, would (except for one possibility noted below) name the testing and certification laboratory (s) required to be used, would stipulate that the laboratory (s) would be monitored for technical competence by the National Bureau of Standards, and would specify the procedure to be used for reinstating a processor who has lost his or her certification and has appealed.
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Subseqently, other affected Federal and State agencies would consider adopting similar regulations.
Although it is estimated that only about 15%
of U.S. personnel occupationally exposed to ionizing radiation are engaged in NRC-licensed activities, it should be recognized that the new 10 CFR Part 20 anendments would immediately affect a much larger percentage.
This fact is evident from the considerations that commercial processors serve many customers other than NRC licensees, and that any improvements in their operations would be likely to benefit all of their customers rather than just the NRC licensees.
However, there could be considerable delay in obtaining coverage for workers in activities not licensed by NRC where personnel monitoring is conducted "in house."
Several alternatives are possible as to the operation of the testing and certification laboratory (s):
(1) Unsoecified Laboratory (s).
According to this alternative, the NRC would amend its regulations as described above but without naming the laboratory (s).
Thus the processors and users would be left to their own devices, with neither inter-ference nor support from governmental agencies, to establish one or more laboratories.
The NRC would have no control over the labortory(s), except through regulations applying to its licensees.
However, if it is stipulated that the licensee must obtain personnel dosimetry results under conditions described above (except for naming the testing and certification labora-tory (s)), the licensee is not likely to deliberately violate 10 CFR Part 20 by contracting with a processor who does not voluntarily comply with all of these conditions, including 10
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monitoring by the NBS.
Several important disadvantages with this alternative have been identified.
First, if no laboratory is specified, by conducting his or her own testing a processor would be permitted, in effect, to certify himself or herself.
- Second, there would be no assurance that laboratory service would always be available.
Third, it does not appear likely that there would be enough business volume to support more than one laboratory.
Fourth, the NRC would have no direct control should the NBS find that a laboratory is incompetent.
Fifth, there would be no certification by the Federal Government, and perhaps less credi-bility.
(2) NRC-Ocerated Laboratory.
In theory this alternative would solve the problems mentioned above.
By charging an appropriate testing fee, expenditure of public funds could be avoided.
- However, additions to the Federal work force would be required, and the NRC would be embarking on a type of service for which it is not accustomed or well prepared.
(3) NRC-Contracted Laboratory.
This alternative would avoid the disadvantages listed above in (1) and (2).
However, a problem of a different nature would arise.
The NRC would, in its new regulation, be creating a monopolistic business opportunity, x
and would then, through its contracting process, be selecting the organization that is to benefit from that opportunity.
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(4) Federal Government (non-NRC) Ooerated Laboratory.
This approach D
could be organized in a manner to avoid all of the problems listed above except the necessary additions to the Federal work force.
Several Federal agencies are experienced in laboratory testing work and could establish this program using existing expertise or by employing qualified personnel.
No disadvantages with this approach have been identified.
However, it would be necessary to obtain agreement from the agency tnat would conduct the testing and certification program.
It is possible that this approach would enjoy more public credibility than the other alternatives.
Invitation to Comment Information pertaining to the personnel dosimetry problem discussed in this notice is invited, including comments on the alternative solutions described, or suggestions of other alternatives.
Comments should be received by
, 1979.
Dated at Washington, D.C.,
this day of 1979.
For The Nuclear Regulatory Commission.
n Lee v. Gossick Executive Director of Operations 12 c.t G u' ?
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