ML19305E770
| ML19305E770 | |
| Person / Time | |
|---|---|
| Issue date: | 04/23/1980 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | Dallinger J EMVGENDE |
| References | |
| FRN-43FR48621, RULE-PR-21, TASK-OS, TASK-RS-519-1 NUDOCS 8005200391 | |
| Download: ML19305E770 (11) | |
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APR 2 31980 General Dynamics Electric Boat Division ATTN: Mr. J. F. Dallinger Eastern Point Road Groton, Connecticut 06340 Gentlemen:
Subject:
Comments on 10 CFR Part 21 (43 FR 48621)
This responds to your letter dated December 22, 1978, to the Secretary o.'
the Commission in which you commented on 10 CFR Part 21 and requested that:
(1) the requirements of 10 CFR Part 21 to report activities which could create a substantial safety hazard be deleted if such activities are already licensed under 10 CFR Part 34; and (2) for licenses issued under 10 CFR Part 34, the following categories of basic components be specified in the regulations:
(a) exposure devices and related source handling equipment; and (b) radiation meas-d uring devices (radiation survey meters).
In my letter tc you dated February 1, 1980, I indicated that the staff was continuing its review of certain matters as they relate to 10 CFR Part 21,
-for example, revision of the Part 21 scope to eliminate the licensed activity of radiography.
Enclosed is a staff document that abstracts and responds to your comments and requests in your letter of December 22, 1978.
The staff responses, among other things:
(1) quote NRC statements that nuclear materials licens-ees are subject to 10 CFR Part 21 for reporting defects and noncompliance involving a st.bstantial safety hazard and are also subject to 10 CFR 20.403 for reporting incidents involving licensed material; and (2) conclude that insufficient information has been accumulated to permit the writing of a detailed regulation at this time that would provide a precise correlation of all factors pertinent to tne question of what is a basic component for indus-trial radiography licensed pursuant to 10 CFR Part 30.
After consideration of your comments on 10 CFR Part 21, the staff does not propose to recommend to the Commission any further clarifying or other changes to 10 CFR Part 21.
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Mr. J. F. DE 'inger 2
APR 23580 l
Your interest and comments on 10 CFR Part 21 are appreciated.
Sincerely, AktB %~ '
Robert B. Minogue, Director Office of Standards Development
Enclosure:
Abstracts of Comments from General Dynamics and Staff Responses e
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ABSTRACTS OF COMMENTS FROM GENERAL DYNAMICS AND STAFF RESPONSES:
10 CFR PART 21 - REPORTING 0F DEFECTS AND NONCOMPLIANCE AMENDMENTS REGARDING BASIC COMPONENT
[43 FR 48621]
l March 1980 l
U.S. Nuclear Regulatory Commission Office of Standards Development
l INTRODUCTION On October 19, 1978, the Nuclear Regulatory Commission published in the Federal Register (43 FR 48621) a notice that, effective on the date of publi-cation, the Commission was amending 10 CFR Part 21 to limit the types of items that,are within the scope of its regulation, " Reporting of Defects and Noncompliance."
1 The amendments provided that items available in general commerce and having no unique requirements imposed for nuclear applications will not be within the scope of 10 CFR Part 21, as amended.
At a defined stage of procurement when a
" commercial grade item"is dedicated (designated for use as a basic component),
the item becomes subject to the requirements of 10 CFR Part 21.
In the preamble to the final rule, the Commission stated that public comments on those amendments and on other portions of 10 CFR Part 21 were invited in order to evaluate the need for any further clarifying or other changes to 10 CFR Part 21.
By letter dated December 22, 1978, General Dynamics, Electric Boat Division, l
submitted to the Secretary of the Commission comments on 10 CFR Part 21 including proposed changes to clarify the relationship between 10 CFR Part 21 requirements and industrial radiography licensed under 10 CFR Part 34.
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Abstracts of the General Dynamics comments and responses by the NRC staff are set forth below.
ABSTRACTS OF COMMENTS AND STAFF RESPONSES J. F. Da11inger, General Dynamics, Groton, Connecticut COMMENT.
"Since its implementation, we have found that the requirements of Part 21 for activities are more strict than the Parts that license the activities themselves due to the ease in which the term 'sub-stantial safety hazard' can be applied to industrial radiography."
STAFF RESPONSE.
The staff cannot agree with this comment because the requirements of 10 CFR Part 21 are both more restrictive and less restrictive than comparable requirements in other parts of 10 CFR Chapter I.
Durir.g the development of the Energy Reorganization Act of 1974, the Congress identified a need for an effective means to " anticipate problems before the event." Section 206, " Noncompliance," of that Act was developed to fill the need.
On June 6, 1977 (42 Fit 28891), the Commission published in the Federal Register 10 CFR Part 21, " Reporting of Defects and Noncompliance," to establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act, as amended.
l The Commission requires that a number of reports and notifications be submitted by licensees.
These include licensee's report of incidents required under 10 CFR 20.403, and other kinds of reports and notifications under other Commis-l sion regulations.
The regulations in 10 CFR Part 21 add another required noti-fication.
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The requirements of 10 CFR Part 21 are more restrictive than the requirements of other parts of 10 CFR Chapter I because they impose the responsibility for reporting defects and noncompliance on the director or responsible officer subject to the regulations in 10 CFR Part 21 rather than on the licensee subject to licensing requirements in 10 CFR Chapter I.
In the area of noncompliance, the requirements of 10 CFR Part 21 are less restrictive because notification is limited to a failure to comply relating to a substantial safety hazard.
Under 10 CFR 20.403, notification covers any incident meeting certain criteria.
The incident does not necessarily involve noncompliance but rather may involve flood, fire, earthquake, or other forces external to licensed activities.
COMMENT.
"For industrial radiography, this means that the smallest infraction of industrial radiography procedures could tm interpreted, if suf-ficiently extrapolated, as a potential subst4ntial safety hazard."
STAFF RESPONSE.
The staff does not agree with this comme..t because the commenter overlooked many essential elements of what must be reported under the requirements of 10 CFR Part 21.
On January 11, 1980, the Commission published in the Federal Register (45 FR 2313) a notice that, effective on March 3, 1980, the Comrrission was amending 10 CFR Part 34 by adding a new 10 CFR 34 new S34.32(1) to require that radiographers receive instruction in the applicable sections of 10 CFR Part 21.
In the pre-amble to that rule change, the Commission stated, "Altnough the requirements of Part 21 are still binding on radiographers, the reference to Part 21 in Part 34 will insure that the requirement will not be overlooked by radiography licensees."
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Specifically, the licensee's operating and emergency procedures must include the procedure (s) for identifying and reporting defects and noncompliance, as required by 10 CFR Part 21.
In these procedures, the pertinent requirements of 10 CFR Part 21 can be applied in a graded approach, i.e., applied to an extent consistent with their importance to a failure to comply relating to a substantial safety hazard.
For notification under 10 CFR Part 21, the failure to comply must relate to a loss of safety function to the extent that there is a major reduction in the degree of protection provided to the pub'ic health and safety.
Criteria that are appropriate for determination of creation of a substantial safety hazard include:
Moderate exposure to, or release of, licensed material.
Major degradation of essential safety-related equipment.
Major deficiencies involving design, construction, inspection, test, or use of licensed material.
By applying these factors in a graded approach, the licensee could identify three categories of failures to comply:
(1) those that cannot relate to a substantial safety hazard; (2) those that may or may not relate to a substan-tial safety hazard; and (3) those that relate to a substantial safety hazard.
Pre evaluation of industrial radiography procedures should result eventually in prudent, responsible notification of only failures to comply relating to a substantial safety hczard.
COMMENT.
"Because Part 20.403(a) already requires the reporting of an activity 'which may have caused or threatens to cause' the receipt of an exposure in excess of the applicable limits, reporting under Part 21 activities which may cause a substantial safety hazard duplicates and confuses the system for reporting noncompliance."
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STAFF RESPONSE.
The staff does not agree with this comment because the staff telieves that the director, responsible officer,'or designated person can exercise proper care to avoid confusing the system for reporting noncompliance.
The staff has discussed previously the substantive differences in the requirements of 10 CFR 20.403 and 10 CFR Part 21.
The staff does, however, recognize that under certain circumstances an incident under 10 CFR 20.403 could also be a failure to comply involving a substantial safety hazard under 10 CFR Part 21.
Even in that case, the written reports would contain essentially no duplicative information.
A close inspection of the information requirements for written reports indicates that 10 CFR 20.405(a) concerns th.e cause and effect of exposure of individuals to radiation and levels of radiation and concentrations of radioactive material, and corrective steps taken or planned to assure against a recurrence, whereas 10 CFR 21.21(b)(3) concerns the name and address of the individual or indviduals informing the Commission, identification of the activity, the nature of the failure to comply, the safety hazard created (which might laclude moderate exposure to, or release of, licensed material), and the corrective action which has been, is being, or will be taken.
In summary, the staff believes that if each individual, corporation, partnership, or other entity subject to the requirements of 10 CFR Part 21 were to apply those requirements in a graded approach, i.e., to an extent consistent with their importance to a substantial safety hazards, they would eliminate or greatly reduce any duplication or confusion in the system for reporting defects and noncompliarie.
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COMMENT.
"It is requested that the following sentence be added to Part 21.2, Scope, to read:
The regulations in this part do not apply to the activities licansed under Part 34 but do apply to the basic components used by Part 34 licensees."
STAFF RESPONSE.
The staff cannot agree with this request.
The. requested amendment of 10 CFR 21.2 would grant relief to certain directors or responsible officers from some 10 CFR Part 21 reporting requirements.
Both section 206 of the Energy Reorganization Act of 1974, as amended, and 10 CFR Part 21 impose the responsibility for reporting defects and noncompliance on the director er responsible officer of a firm owning or operating an activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended.
No information has been brought to the attention of the staff to indicate that granting relief to such director or responsible officer is authorized by law or is otherwise in the public interest.
The requested amendment of 10 CFR 21.2 also could result in failures to report noncompliance relating to deficiencies involving uses of licensed material.
The subject of information obtained by the NRC in reports from licensees was surveyed by the General Accounting Office in " Reporting Unscheduled Events at Commercial Nuclear Facilities:
Opportunities to Improve Nuclear Regulatory Commission Oversight," EMD-79-16, January 26, 1979.
On page 20 of that report, the GA0 stated:
"We recommend that the Chairman, NRC, extend its event and incident reporting requirements to require 6
--nuclear materials licensees using equipment containing hazardous radioactive materials to report equipment design deficiencies and malfunctions,..."
In the NRC Response to GAO Report, EMD-79-6, the NRC response was:
" Existing regulations require nuclear materials licensees to report equipment design deficiencies and malfunctions.
Materials licensees are subject to 10 CFR Part 21 which requires reporting of defects and noncom-pliance where a substantial safety hazard is involved.
They are also subject to 10 CFR 20.403 which requires a report of any incident involving licensed material which has caused or threatens to cause (1) overexposures to radiation in excess of tne annual allowable limits, (2) potentially significant releases or radioactivity, (3) a loss of one day or more of operation, (4) property damage in excess of $2000....
"The receipt of information in accordance with NRC requirements is dependent upon licensee awareness and understanding of the rules, an area which the NRC may need to emphasize.
The NRC staff will examine ways to enhance licensee awareness and understanding of existing reporting requirements."
The staff believes that maintaining the status quo with respect to the activities licensed under 10 CFR Part 34 being subject to the requirements of 10 CFR Part 21 is consistent with the NRC response above that materials licensees are subject to 10 CFR Part 21.
COMMENT.
"To emphasize the effect of these regulations on those components that are crucial to the creation of a substantial safety hazard, it is requested that the following... sentence be added to Part 21.3(a)(3):
For licenses issued in accordance with Part 34 of these regulations, basic component means:
(a) exposure devices and related source handling equipment, and (b) radiation measuring devices."
STAFF RESPONSE.
The staff cannot agree with this request because insufficient information has been accumulated to permit the writing of a detailed regulation at this time that would provide a precise correlation of all factors pertinent to the question of what is a basic component for industrial radiography licensed pursuant to 10 CFR Part 30.
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l The requested addition to 10 CFR 21.3(a)(3) would specify only certain component l
hardware and would raise questions whether the intent was to eliminate from the t
requirements of 10 CFR Part 21 all other component hardware, structures, systems, or parts thereof and the design, inspection, testing, or consulting services l
important to safety that are assocated with component hardware.
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The following is an example of the uncertainties involved.
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paragraph (b) specifies the requirement of audible and visible alarms on entrances to permanent radiographic installations.
However, if the instal-lation has a source retraction device meeting the requirement of 10 CFR 20.203(c)(2)(i), then 10 CFR 34.29 does not apply.
This is a case where com-ponent hardware and a separate system are equivalent for protection purposes.
Also, 10 CFR 34.41 requires direct surveillance to prevent unauthorized personnel from entering high radiation areas with control devices, alarm systems, or locking the high radiation area as acceptable alternatives.
Locks are a mechanical means not dependent on the constant attention of the radio-grapher.
This is a case where a procedure and component hardware are equivalent for security purposes.
Accordingly, the staff believes that component hardware being an acceptable alternative for a system or a procedure precludes establishing a precise definition of " basic component" for activities licensed pursuant to 10 CFR Parts 30 and 34.
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