ML20059B613
| ML20059B613 | |
| Person / Time | |
|---|---|
| Issue date: | 10/07/1993 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | NRC COMMISSION (OCM) |
| References | |
| FRN-58FR53159, FRN-59FR53372, RULE-PRM-21-2 AF01-1-006, AF1-1-6, NUDOCS 9310290027 | |
| Download: ML20059B613 (11) | |
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i NUCLEAR REGULATORY COMMISSION
'03 C'-7 P'C7 10 CFR PART 21
[ Docket No. PRM-21-2) l Nuclear Management and Resources Council; i
4 Receipt of Petition for Rulemaking i
AGENCY:
Nuclear Regulatory Commission.
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ACTION:
Petition for rulemaking; Notice of receipt.
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SUMMARY
The Nuclear Regulatory Commission (NRC) is publishing for public comment a notice of receipt of a petition for i
rulemaking, dated June 21, 1993, which was filed with the I
Commission by the Nuclear Management and Resources Council.
The petition was docketed by the NRC on June 22, 1993, and has been i
assigned Decket No. PRM-21-2.
The petitioner requests that the NRC amend its regulations (1) to revise the definition of the j
t term " commercial grade item"; (2) to include a flexible generic process for dedication of commercial grade items for safety-related use; and (3) to clarify that the entity performing the dedication of a commercial grade item is responsible for i
discovering, evaluating, and report.ing deficiencies as required by NRC's regulations.
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9310290027 931007 v
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DATE:
Submit comments by (75 days af ter publication -in the l
t Federal Register).
' Comments received after.this date will be i
considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
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ADDRESSES:
Submit written comments to the Secretary of the
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Conmission, U.S.
Nuclear Regulatory Commission, Washington, DC
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20555, Attention: Docketing and Service Branch.
Hand deliver comments to:
11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m.
and 4:15 p.m.
Federal workdays.
l For a copy of the petition, write the Rules Review and i
Directives Branch, Division of Freedom of Information and r
a Publications Services, Office of Administration, U.S.
Nuclear Regulatory Commission, Washington, DC 20555.
The petition and copies of comments received may be l
inspected and copied for a fee at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Michael T.
Lesar, Chief, Rules l
Review Section, Rules Review and Directives Branch, Division of Freedom of Information and publications Services, Office of l
Administratioc, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone:
301-492-7758 or Toll Free:
800-368-5642.
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SUPPLEMENTARY INFORMATION:
Petitioner The Nuclear Management and Resources Council (NUMARC) is an organization of the nuclear power industry.
NUMARC is responsible for coordinating the combined efforts of all j
utilities licensed by the NRC to construct or operate nuclear power plants, and of other nuclear industry organizations, in all i
matters involving generic regulatory policy issues and regulatory y
aspects of generic operational and technical issues affecting the l
nuclear power industry.
NUMARC's members include all utilities responsible for constructing or operating a commercial nuclear power plant in the United States, major architect / engineering firms, and all of the major nuclear steam supply system vendors.
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Background===
f Section 206 of the Energy Reorganization Act of 1974, as amended, requires that all licensees, as well as nonlicensees who
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construct facilities for licensees, supply basic components to l
l licensees, and provide services associated with basic components to licensees, report defects that could create a substantial safety hazard.
The NRC regulations that implement Section 206 are contained in 10 CFR Part 21.
This part, in conjunction with 10 CFR Part 50, Appendix B, also covers the procurement of parts i
for nuclear power plants, including basic components and I
l commercial grade items to be used in safety-related applications.
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'4 The petitioner has focused this petition on the procurement of parts described as commercial grade items because, according to the petitioner, the current procurement environment is different from the environment extant when Part 21 was adopted.
The petitioner states that because nuclear power plants have been operating for several years, many pieces of equipment now require replacement or refurbishment of their components.
According to the petitioner, current nuclear utility procurement needs primarily involve replacement parts for existing equipment rather than the purchase of major new pieces of equipment.
- However, many of the original suppliers and manufacturers no longer maintain Appendix B-qualified programs because of the diminished market, because no new plants are being ordered or are currently under construction, and because of the burden of maintaining such a quality assurance program.
Frequently, replacement parts are not available from original or other Appendix B-qualified vendors.
The combined effect of the decreased availability of parts from Appendix B-qualified vendors and the greater expense of obtaining these parts is that licensees are increasingly forced to procure commercial grade replacement parts and dedicate them for use in safety-related applications.
Discussion According to the petitioner, the provisions of Part 21 that relate to commercial grade items, the dedication of these items for use in safety-related applications, and the reporting 4
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requirements associated with these items that are imposed on e
manufacturers, suppliers, and sub-tier suppliers are unworkable,
. I ineffective, and may be counterproductive.
The petitioner states that safety may be adversely affected by delay caused by the f
inability to obtain the replacement parts needed for use as basic I
components.
i The petitioner believes that Part 21, as it relates to l
commercial grade items and their dedication, is not accomplishing its intended objectives effectively.
The petitioner believes that the current Part 21 regulations involving posting, document i
retention, and deficiency evaluation and reporting make the implementation of these regulations unnecessarily burdensome and
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create substantial liability for licensees subject to Part 21.
i The petitioner believes that the effect of these provisions has
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been to discourage vendors from maintaining Appendix.B-qualified l
programs.
j Although Part 21 provided a reasonable foundation for i
regulating procurement and imposing reporting requirements at the i
time it was promulgated, the petitioner believes that the current requirements of Part 21 often impede a utility's ability to l
obtain the highest quality part available for use in a safety-related application in a cost-and time-efficient manner.
The inability to procure appropriate parts promptly could adversely t
affect plant safety.
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The petitioner discusses several options available to l
nuclear utilities in procuring replacement parts, most of which l
have serious drawbacks directly or indirectly related to the j
1 current regulatory approach set out under Part 21.
These options l
t and drawbacks, as discussed by the petitioner, are as follows:
l 1.
Nuclear utilities could procure items from a supplier
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who maintains an Appendix B gualified program, but the cost of precuring an item from such a source is much higher than if j
cc= parable items are procured through commercial channels.
2.
Nuclear utilities could procure replacement parts that are slightly different than the original parts, but even if replacement parts are obtained from an Appendix B-qualified f
supplier, a design change is likely to be required to justify the I
use of the proposed replacement parts.
i 3.
Nuclear utilities could obtain the item frcm the surplus market or another utility, but this option may be j
impossible if the product does not fit into the basic component 4
l or commercial grade definitions.
l 4.
Nuclear utilities could procure the item as commercial j
grade, but it may be difficult to meet all of the definitional l
requirements of Part 21.
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Nuclear utilities may file an application for an exemption, but this process is impractical because of the time I
generally required to obtain a decision.
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The petitioner believes that the substitution of a more l
1 practicable definition of the term " commercial' grade item" and the addition of a flexible generic process for dedication would j
assist in resolving many of the drawbacks cited for the options available to a nuclear utility, s
The petitioner states that its suggested change to the NRC's regulations would broaden the definition of commercial grade item under 10 CFR 21.3 (a) (4) and (a-1).
The petitioner also states that Part 21 does not allow an item to qualify as commercial grade unless the item meets all three of the requirements defined in 10 CFR 21. 3 (a) (4) and (a-1).
Because many of the replacement l
parts needed are no longer available from the original manufacturers or suppliers who maintain Appendix B-qualified f
i programs, the petitioner believes that the current definition of l
the term " commercial grade item" presents a significant obstacle f
for licensees in procuring appropriate parts in the m,st cost-l and time-efficient manner.
According to the petitioner, the proposed changes would expand the definition of " commercial grade e
item" to include any item obtained on the open market.
Under the
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t petitioner's suggested amendment, it would be incumbent upon the dedication process to provide reasonable assurance that the item f
I will perform its intended function in the safety-related application and upon the dedication entity to report any I
deficiencies covered under Part 21.
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The petitioner believes that allowing commercially available i
items to qualify as commercial grade items would provide
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significant benefits without any adverse impact on safe plant l
operation.
According to the petitioner, the suggested amendment l
not only allows procurement from the original manufacturer or
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supplier even if that entity no longer maintains an Appendix B-e l
qualified program, as well as from other commercial sources, but it also reduces the potential need for design changes and permits i
a more reasonable price and delivery time.
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l In the petitioner's suggested amendment, the regulations l
l would define the dedication process as one that will provide reasonable assurance that the commercial grade item will perform its intended function.
According to the petitioner, the I
following are ways to assure that the commercial grade item will perform its intended function:
I (1) Testing and/or inspection; l
(2) Surveying the commercial grade supplier to determine l
that the appropriate quality control is in place; (3) observing the manufacturing process; and (4) Analyzing the historical record of the item for acceptable performance.
The petitioner indicates that other methods of verification for dedication may exist that are acceptable to the NRC and that should be considered in evaluating whether the reasonable assurance standard is met in this context.
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The petitioner also proposes that the dedication entity l
maintain documentation ~of.the dedication process for the purpose l
of an audit or inspection.
The petitioner believes that the I
primary benefit of establishing the dedication process suggested l
in the petition is that the user or other party performing _the dedication, who understands the safety significance of the proposed component and, therefore, is better able to identify the characteristics necessary to perform its intended function than t
the manufacturer, is responsible for the quality of the commercial grade item.
In order for the dedication entity to i
maintain documentation of the dedication process for the purpose of an audit or inspection, the utility party performing the dedication would have to evaluate the suitability of the component by analyzing the effect of the commercial. grade item on the component's performance in a safety-related application.
The petitioner believes that it is appropriate to place the i
responsibility for reporting deficiencies in commercial grade items with the entity performing the dedication process.
The f
I petitioner believes that suppliers and sub-tier suppliers do not
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t necessarily know whether a commercial grade item is destined for i
a safety-related application.
The petitioner also indicates that j
no time limitation exists on the part 21 reporting responsibility for suppliers.
The petitioner recommends that language be added
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i to S 21.21(b) to make clear that the entity performing the i
dedication of a commercial grade item is responsible for l
discovering, evaluating, and reporting deficiencies.
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The suggested Amendments i
The petitioner believes that Part 21 sh'ould be modified to accommodate the current procurement needs of the nuclear power l
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industry.
The petitioner recommends changes to 10 CTR 21.3 to 1
broaden the definition of a commercial grade item and to define j
1 and set out a standard f or the dedication process.
The petitioner believes that all parties would benefit from the inclusion of language in 10 CFR 21.21(b) clarifying the t
I responsibility associated with dedication.
According to the l
l petitioner, the recommended changes would not have any adverse I
impact on safety as the use of properly dedicated corrercially available parts neither decreases equipment performance nor i
affects safe plant operation.
The changes requested by the petitioner are set out as i
I follows:
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In 5 21.3, paragraphs (a-1) and (c-1) are revised to 5
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read as.follows:
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5 21.3 Definitions l
I (a-1) Commercial crade item means any item that has not i
been dedicated for use as a basic component.
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(c-1)
Dedication is the evaluation process undertaken to provide reasonable assurance that a commercial grade item to r
be used as a basic component will perform its intended function, i
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In S 21.21, the existing text of paragraph (b) is redesignated as paragraph (b) (1) and a paragraph (b) (2 ) is added to read as follows:
521.21 Notification of failure to comply or existence of a defect and its evaluation.
(b)
(2)
The entity that performs the dedication is responsible for identifying, evaluating, and reporting the deviations and failures to comply associated with substantial safety hazards of a corrercial grade item.
d this 1 day of Octccer 1993.
Dated at Rockville, Maryland, j or the Nuclear Regulatory Commission.
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/SamuelJ. Chi-lk,
Secretary of the Commissi n.
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