ML19309H479
| ML19309H479 | |
| Person / Time | |
|---|---|
| Issue date: | 02/11/1980 |
| From: | Wenzinger E NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | Scott R, Wagman B NRC OFFICE OF ADMINISTRATION (ADM) |
| References | |
| FRN-43FR48621, RULE-PR-21 NUDOCS 8005130349 | |
| Download: ML19309H479 (7) | |
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FEB 1 1980 MEMORANDUM FOR:
R. S. Scott, Chief Document Manageclent Branch Division of Technical Information and Document Control, ADM B. L. Wagman, Acting Chief Rules and Procedures Branch Division of Rules and Records, ADM FROM:
E. C. Wenzinger, Chief Reactor Systems Standards Branch Division of Engineering Standards, OSD
SUBJECT:
IMPLEMENTATION OF COMMISSION ACTI0fl ON SECY-79-448B, "10 CFR PART 21, ANALYSIS OF COMMENT LETTERS" SECY-79-4488 dated November 2,1979 forwarded for Commissioner action a proposed reply from the Chairman to the Natural Resources Defense Council Inc. (NRDC) and informed the Commissioners of the staff's (1) plaa for distribution of (a) the Chairman's reply and (V, the coment analysis and (2) intention to notice the availability of the comment analysis in the Federal Register.
SECY memorandum dated January 8,1980, provided Comissioner action on the reply to NRDC and directed it be distributed as recomended.
Attached is a copy of the letter to NRDC, an original copy of the Federal Register Notice and an original of the comments analysis.
It is requested that the en-closed notice concerning the availability of the comment analysis be published in the Federal Register, and the letter to NRDC and the comment analysis be placed in the Public Document Room.
.9 "'S E. C. Wenzinger, Chief Reactor Systens Standards Branch Division of Engineering Standards Office of Standards Development
Enclosures:
1.
Chairman's letter to NRDC dated January 23, 1980 2.
Draft Fcderal Reaister Notice 3.
10 CFR Part 21, Coment Analysis, (43 FR 48621)
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Mr. Jonathan Lash Natural Resources Defense Council, Inc.
917 15th Street, fM.
Washington, D.C.
20005
Dear Mr. Lash:
The NRDC letter of March 2,1979, submitted 7.or Commission consideration a joint Natural.'tesources Defense Council, Inc. (NRDC) and Union of Concerned Scientists (UCS) document on the subject of 10 CFR Part 21, " Reporting of Defects and Noncompliance." That document urged the Commission (1) to repeal the amendments to Part 21 set forth in the Federal Register on October 19, 1978,(43 Fed Reg 48621),(2) to reimpose the original requirements of Part 21, (3) to direct the staff (a) to immediately begin a program to improve the understanding of Part 21 and (b) to process exemption applications based upcn the criteria proposed by NRDC/UCS.
In addition, NRDC/UCS proposed modifications to the NRC policy governing regulatory actions in relation to (1) the use of an " advance notice of proposed rulemaking" and (2) the method of processing
" staff proposals" for regulations to ensure that the public is able to comment on these proposals before such proposals are submitted to the Commission.
These latter requests concerning the policy with regard to regulatory action will be the subject of separate action by NRC.
After consideration of your comments on amendments to 10 CFR Part 21 as well as the other comments received, the Commission has determined that no further amendments to 10 CFR Part 21 are necessary at this time.
The Commission did not intend that the original Part 21 would reach to every level of manufacturer / supplier.
Indeed, we do not interpret Section 206 of the Energy Reorganization Act as requiring regulation at all levels.
We believe j
the staff has attempted a balanced implementatian of Section 206 within the Commission's direction.
NUREG-0302 addresses the issue of how far down the tiers of suppliers toward items such as bolts and nuts should Part 21 be applicable.
The guidance given in NUREG-0302 on this subject was that "all organizations, activities and products are not such that they 'could create a substantial safety hazard.'" This is believed adequate to bring within the scope of the implementing regulation (a) those items that have unique design, or specification requirements for nuclear applications and (o) all commercial grade items when they are " dedicated" to a nuclear safety application.
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The Cortaission recognizes that the implementation of 10 CFR Part 21 is compli-cated and its scope is broad.
The staff, in its review of operating infor;aatio:
and during inspections, has been nonitoring and will continue to nonitor the application cf Part 21 to deteroine if proper implementation is being achieved.
Si cerely, f
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Ac k John F. Ahearne Chairman e
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Title 10 - Energy CHAPTER I - NUCLEAR REGULAlu2Y COMMISSION Part 21 Reporting of Defects and Noncompliance w
AGENCY:
Nuclear Regulatory Commission ACTION:
Analysis of Public Comment
SUMMARY
On June 6, 1977, NRC published, as an effective rule, a new Part that requires the reporting to NRC of specific types of defects and noncompliance.
In response to a number of public comments NRC published on October 19, 1978, as an effective rule, amendments to limit the types of items that are within the scope of the above reporting rule and at the same time invited comments on the amendments and on other portions of rule.
The staff has reviewed the comments received in response to the request of October 19, 1978 and has prepared a document responding to the specific questions raised.
That document and the letters of comment are available for inspection and copying by the public in the NRC Public Document Room, 1717 H Street, NW., Washington, D.C.
SUPPLEMENTARY INFORMATION:
These amendments were distributed to over 10,000 organizations and individuals with a request for comment on these 1
amendments and other portions of 10 CFR Part 21 in order to evaluate the l
need for any further clarifying or other changes. Written comments have 1
been received from twenty organizations / individuals.
One of these com-ments endorses the amendment, one recommended that the new " Employee i
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.c m.n,.7 y Protection" provisions ir S 210 of the Energy Reorganization Act be imple-mented in conjunction with further amendments to Part 21, one recommended that the scope of Part 21 be revised to exempt certain classes of mate-rial licensees, four regaested additional relief from the current 10 CFR Part 21, two comments proposed amendments / implementation that would rescind the relief granted by the October 1978 amendment.
The remaining eleven requested clarification / guidance, asked questions, or requested confirmation of interpretation.
Seven of these eleven have interpreted, or would like to interpret, the current 10 CFR Part 21 to grant more relief.
The staff's preliminary view it that further amendments to Part 21 are not required at this time.
However, we are still reviewing a request by the General Dynamics Company to (a) remove from the scope of Part 21 the licensed activity of radiography and (b) provide a specific definition of i
the basic components used in radiography that are within the scope of l
Part 21.
We are also continuing to review a Public Citizens Litigation Group request to revise Part 21 so that it is based on the new Section 210 entitled, " Employee Protection," which Congress recently added to the Energy Reorganization Act of 1974.
FOR FURTHER INFORMATION CONTACT:
Mr. W. E. Campbell Jr.
Office of Standards Development U.S. Nuclear Regulatory Commission Washington, D.C.
20555 301-443-5913 Dated at Bethesda, MD, the day of 1980.
Lee V. Gossick Executive Director for Operations 2
10 CFR Part 21 (43 FR 48621)
C0'NENT ANALYSIS Q-1 If an item that is within the definition of a comaercial grade item, e.g., steel bar stock, is ordered from a manufacturer /-
supplier in accordance with a published product description which may be only a recognized specification; e.g., ASTM A 540, and subsequently is incorporated into a basic compor.ent of a facility licensed pursuant to Title 10 without the knowledge of the manufacturer / supplier does NRC have the authority to inspect the supplier / manufacturer? This question is based on one of the twenty letters docketed.
Yes.
As stated in the Supplementary Information (43 FR 48621)
NRC has the authority under Public Law 93-438, S 206(d) to con-duct inspections.
NRC intends to utilize that authority where reasonably necessary to aid in the identificntion by the Com-mission of defects and noncompliance reportable by licensees and suppliers of basic components.
Q-2 If an item that is used in nonnuclear applications; e.g.,
electrical connector, and will ultimately be incorporated into a basic component of a facility licensed pursuant to Title 10, is ordered from manufacturer / supplier la accordance with a published product description which may be only a recognized specification (s) that state (s) the technical requirements and none of these requirements are unique to facilities or activites licensed pursuant to Title 10, Chapter 1, Parts 30, 40, 50, 70 or 71, is it either necessary or appropriate for the purchaser to reference 10 CFR Part 21 in the procurement document? This question is based on six nf the letters.
No since the item would meet the definition of a commercial grade item (S 21.3(a-1)).
Q-3 Can the regulations be amended to make it a violation of 10 CFR Part 21 if a purchaser includes 10 CFR Part 21 as a part of the procurement document ($ 21.31) when 10 CFR Part 21 is not appli-l cable? This question is based on two of the letters.
No.
This prohibition is considered beyond the scope of the i
regulation.
Q-4 If an item whose failure could create a substantial safety hazard is being procured to a published product description with i
the addition of only 1) the requirements of 10 CFR 50, Appen-dix B, or 2) the requirements of NCA-3800 of Section III of the ASME Boiler & Pressure Vessel Code or 3) the requirements of ANSI /ASME N45.2 can the item be classed as a commercial grade item ($ 21.3(a-1))?
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This question is based on four of the letters.
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No.
If the above requirements are properly applied such an item does not meet the definition of a commercial grade item since the requirements are considered to be unique specification requirements.
Q-5 If an item whose failure could create a substantial safety hazard is being procured to a published product description, e.g., reinforcing bars to ASTM A 615, and the item is manu-factured and uniquely shaped for a use within the scope of 10 CFR Part 21, by the material manufacturer per procurement document specification rcquirements is it necessary to make 10 CFR Part 21 applicable to the single procurement document covering manufacture and shaping? This question is based on three of the letters.
Yes.
The unique shaping for a nuclear application brings the combined procurement within the scope of 10 CFR Part 21.
Q-6 The final sentence of S 21.3(a) as published in 42 FR 28894 states
"... " basic component" includes design, inspection, testing, or consulting services important to safety that are associated with the component hardware, whether these services are performed by the component supplier or others."
and the Supplementary Information (42 FR 28893) states that "Only when such a design or consultation can result in the creation of a substantial safety hazard is it appropriate to specify the applicability of Part 21 in the procurement document."
Do the amendments to 10 CFR Part 21 published on October 19, 1978 have any effect upon the applicability to services, e.g.,
nondestructive testing? This question is based on one of the letters.
No.
The amendments neither delete any services from nor add any services to the scope of 10 CFR Part 21.
Q-7 If an item is actually a " basic component" ($ 21.3(a)) but the purchaser does not make 10 CFR Part 21 applicable in the procure-ment document and the manufactuer/ supplier is not aware it is a basic component how is the item manufacturer / supplier to know that 10 CFR Part 21 is applicable? This question is based on one of the letters.
In the above case the manufacturer / supplier has no way of knowing that 10 CFR Part 21 is applicable and therefore has no requirement s
to report defects.
The manufacturer / supplier may, under the cir-cumstances described in to reply to question 1, be subject to inspections by NRC even though 10 CFR Part 21 is not included in the procurement document.
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Q-8 Is " dedication" (9 21.3(c-1)) applicable to a " basic compocant"
($ 21.3(a)) or is it applicable to " commercial grade item" (S 21.2(a-1))? This question is based on four of the letters.
Dedication is applicable to commercial grade item and may occur, for example, a) when the commercial grade item is assembled with other items and becomes a " basic component," or b) when additional nondestructive testing, which is unique to a nuclear application, is satisfactorily accomplished on the commercial grade item.
Q-9 For a commercial grade item that becomes a basic component is there any responsibility for compliance with 10 CFR Part 21 on the part of the material manufacturer / supplier? This question is based on two of the letters.
Responsibility for compliance with Part 21 begins with the organiza-tion dedicating the item and does not extend to prior stages in the procurement process.
A material manufacturer / supplier may report to the Commission a known or suspected defect or failure to comply that relates to a commercial grade item that has been delivered by him.
The manufacturer / supplier may under the circumstances described in the reply to question 1, be subject to inspections by NRC.
Q-10 The amendment in S 21.3(a-1) states that three conditions nust be satisfied to allow an item to meet the definition of a "com-mercial grade item." Can 6 21.3(a-1) be revised so it would j
read as follows:
" commercial grade item" means that (1)...
, (2)... and (3) is or could be ordered from the manufacturer / supplier on the basis of specifications set forth in the manufacturer's published product description (for example a catalog)."
(Words underscored are new).
This question is based on one letter.
4 No.
The proposed words would not meet the intent of the amend-ment to 10 CFR Part 21 that were published on October 19, 1978.
An intent of the amendments was to remove from the scope of 10 CFR Part 21 those items that do not have unique nuclear design ne specifications requirements, and are used in nonnuclear applications and have matured to the extent that the manufac-turers lists them in his published product description.
0-11 How can an organization routinely be notified of and receive copies of revisions of 10 CFR Part 21 as well as other regula-tions issued by NRC? This question is based on one letter, 3
All regulations and amendments to regulations are announced in the Federal Register at or prior to the time they become effec-tive.
Some regulations are also announced in the Federal Register when they are proposed.
The Federal Register is widely distributed and notice in it fulfills the requirements of the Administrative Prr.cedure Act.
NRC publishes a weekly compilation of press releases.
Most rulemaking actions are the subject of a press re' ease by NRC.
An organization may be placed on the distribution list of that campilation by writing to:
Office of Public Affairs U.S. Nuclear Regulatory Commission Washington, D.C.
20555 Q-12 The supply of some items that may ultimately be used for con-struction1 of vessels, piping systems, etc, unJer Section III of the ASME Boiler and Pressure Vessel Code is bting accomplished by a "two stage" procurement as outlined below.
A " Material Supplier"1 purchases commercial grade items (as defined by 10 CFR 21.3 (a-1)) from a " Material Manufacturer"1 without the imposition of the requirements of NCA-3800.
After receipt of the item by the " Material Supplier" and the ultimate use of the item is identified as a Section III vessel, piping system, etc, the Material Supplier requests by a procurement document that the Material Manufacturer verify that certain additional require-
- ments, e.g., NCA-3800, were met during the production of the item by the Material Manufacturer.
The Material Manufacturer supplies, where appropriate, the certification that the require-ments of NCA-3800 were met.
Does this "two stage" procurement of a " basic component" require the imposition of 10 CFR Part 21?
This question is based directly on one letter.
As stated in the reply to question 2, 10 CFR Part 21 should not be invoked in procurement documents of " commercial grade items".
Since the second stage does involve " unique specification" require-ments; i.e., imposition of Section III requirements, 10 CFR Part 21 should be it the second procurement document.
The use of this "two stage" procurement method raises a question as to the appropriateness of the certifications procured during the second stage. Many individuals, during discussions with the Staff, have stated that the procedural controls applied to "commer-cial grade items" are less than those imposed by some of the 1The terms " construction", " Material Supplier" and " Material Manufacturer" as used here are as used in the ASME Boiler and Pressure Vessel Code,Section III, 1977 Edition.
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nuclear unique requirements, e.g., NCA-3800, 10 CFR Part 50 Appendix B or N45.2.
Jf the appropriate controls were, in fact, not applied to the items the certifications would be improper and may lead to a >
il penalty as provided in 10 CFR Part 21.61.
Q-13 Ca 10 CFR Part 21 5e revisec' to (a) remove from its scope the licensed activity of radiogrvphy (10 CFR Part 34) and (b) provide specific d nition of the bcsic components used in radiography that ar.
- hin the scope of 10 CFR Part 21? This question is based on one letter.
The Staff has this comment under evaluation.
Q-14 Can 10 CFR Part 21 be amended to include reference to the pro-visions of Section 210 of the Energy Reorganization Act which (a) prohibition of discrimination against individuals who provide information to NRC and (b) provide a remedy for the individual in the event that discrimination is believed to have occurred.
This question is based on one letter.
The Staff has this comment under evaluation.
Staff recommendations on how to implement Sectior. 210 are being prepared and will be forwarded for Commission action.
Q-15 Can the amendments that were published effective in October 1978 be repealed, the original Part 21 be reimposed, processing of exemptions commence and the Staff commence a program to improve the understanding of Part 21? Parts of this question are in three letters.
No new information was presented in the comments to warrent a return to the previous 10 CFR Part 21 which could include case-by-case exemptions in the area of commercial grade items.
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