ML19241B246
| ML19241B246 | |
| Person / Time | |
|---|---|
| Issue date: | 05/30/1979 |
| From: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| FRN-42FR54475, RULE-PRM-71-5 NUDOCS 7907130288 | |
| Download: ML19241B246 (6) | |
Text
.
[7590-01]
NRC PUBLIC DOCUMENT R003f NUCLEAR REGULATORY COMMISSION
[ Docket No. PRM-71-5]
CHEM-NUCLE,AR-SYSTEMS, INC.
Denial of Petition for Rule Making The Nuclear Regulatory Commission's regulation, " Packaging of Rad;a.sctive Material for Transport and Transportation of Radioactive Material Under Certain Conditions," 10 CFR Part 71, provides a general license in 10 CFR 71.12 to persons holding a general or specific Commission license, to deliver licensed material to a carrier for transport.
The licensee must have a quality assurance program whose description has been submitted to and approved by the Commission es satisfying i.he provisions of 10 CFR 71.51.
Further, if delivery is made in a package fc
- h a license, certificate of compliance (Form NRC-618) or other
, proval has been issued by the NRC or the Atomic Energy Comtr sion, the person using the package must have a copy of the specific license, certificate of compliance, or other approval authorizing use of the package and all documents referred to in the license, certificate, or other approval, as applicable (10 CFR 71.12(b)(1)(i)).
Qualit.y assurance requirements specific to the particular package design are specified in the package approval.
. r-
,7 bl/
203 THE PETITION By letter dated September 24, 1977, Chem-Nuclear Systems, Inc. filed with the Commission a petition for rule making (PRM-71-5) requesting that the Commission exempt the package owner from the requirements in 10 CFR
(
1
^907120 Q}'
~
(7590-01]
Part 71 that the package owner furnish the named user with the safety analysis report and blueprints of a particular container or package if
('1) a user of the NRC approved container or package is named a user; (2) the named user is supplied with a copy of
+.m license or certificate; and, (3) the named user is provided with specific procedures which have been developed by the owner of the container or package and filed with the NRC in accordance with the provisions of 10 CFR Part 71, Appendix E,
" Quality Assurance Criteria for Shipping Packaging for Radioactive Material."
BASES FOR REQUEST The bases for the request are set out by the patitioner as follows:
a.
Chem-Nuclear has been advised by NRC licensing staff that "all docunents referred to in the license" would include the safety analysis report and blueprints of the particular container or package.
b.
In several cases, some of the information contained in the safety analysis and blueprints is regarded by Chem-Nuclea,r as proprietary.
For competive reasons, Chem-Nuclear wishes to limit the furnishing of this information to instances where such information is necessary and where adequate safeguards can be imposed.
c.
In all cases, the license or certificate issued by the NRC clearly defines the specific conditions for use of a particular container or package.
Users of containers or packages have no sly 266 2
[7590-01]
need for the safety analysis and blueprints.
Providing the safety analysis and blueprints to the user can serve no useful purpose, but only create a large amount of additional paperwork for the owner of the container or package and adds to the risk of misuse of proprietary data.
d.
The need of the users for safety information can be met thoroughly by the specific procedures developed by the owner of the container or package and filed with the NRC in accordance with the provisions of Appendix E to 10 CFR Part 71.
REQUEST FOR CCIMENTS ON PETITION A notice of filing of petition for rule making was published in the FEDERAL REGISTER on October 6, 1977 (42 FR 54475).
The comment period expired Decemb,. 5, 1977.
No comments were received in response to the notice.
. PREVIOUS ACTION On August 4, 1977 (42 FR 39364), the Commission amended 10 CFR Part 71 to add new Appendix E and upgraded quality assurance require-ments that are the subjet.:. of the petitioner's request.
In the preamble to the final rule, the Commission discussed package manufacturers' submission of information on specific aspects of quality assurance:
The licensee who is an applicant for the package approval provides the descriptions of quality assurance programs governing the manufac-turer and use of tne package.
If t.he package is approved by the Nuclear Regulatory Commission for use in the transportation of radio-active material, a package approval is issued which in orporates b 3
[7590-01]
package description and identificat'.cn, its safety evaluation, and a description of the applicant's specific quality assurance provisions for design, fabrication, assembly, testing, use, and maintenance of the package.
Clearly, the requirement in a package approval for a description of the applicant's specific quality assurance provisions is in addition to, and not in substitution for, the package's safety evaluation which is based on the safety analysis report of the package design or application.
WITHHOLDING FROM PUBLIC DISCLOSURE Persons who submit to the Commission information believed to be privileged, confidential, or a trade secret are on notice (10 CFR 2.790) that it is the policy of the Commission to achieve an effective balance between legitimate concerns for protection of competitive positions and the right of the public to be fully apprised as to the basis for and effects of licensing actions, and that it is within the discretion of the Csmmission to withhold such information from public disclosure.
Under this policy and as a matter of licensing practice, the NRC staff issues package approvals on the basis of safety analysis reports prepared by applicants cnd refers to applications that contait blueprints.
As a
~ consequence, it is the general licensees delivering licensed radioactive material to a carrier for transport under the authority of 10 CFR 71.12(b) who must assure themselves and the NRC that the subject packages are as described in the package approvals.
(The NRC must exerc.ise its regulatory authority through its general licensees who use package approvals because the NRC has no general enforcement powers over package manufacturers or
-)
O g/
_Ou 4
[7590-01]
package owners unless they possess and use licensed radioactive material.
They would, however, be subject to 10 CFR Part 21, " Reporting of Defects and. Noncompliance.") An exemption from the requirements of 10 CFR Part 71 for furnishing the safety analysis reports and blueprints as requested by the petitioner could deny general licensees information essential to the safe use of packages to deliver licensed material to carriers for transport.
In addition, for the public to be assured that general licensees comply with the terms and conditions of package approvals, the public must be apprised of the information in safety analysis reports and blueprints referred to in package approvals. Therefore, these documents cannot be exempt from public disclosure.
GROUNDS FOR DENIAL ine Commission has given careful consideration to this petition for rule making (PRM-71-5) and has decided to deny the petition on the grounds that:
(1) The requirement in a package approval for a description of the applicant's specific quality assurance provisions is in addition to, and not in substitution for, the y-6 age's safety evaluation which is based on the safety analysis report of the package design or application; and (2) The right of the public to be fully apprised as to the bases (e.g., safety
. analysis reports and blueprints) for licensing under 10 CFR 71.12(b) out-weighs the c'1cern of Chem-Nuclear Systems, Inc. for protection of a com-petitive position that may be set out in a safety analysis report or blueprint.
5
[7590-01]
A copy of the petition for rule making and the Commission's letter of deniai are available for public inspection at the Cor. mission's Public Document Room at 1717 H Street tN., Washington, D C.
Bethesda, l'aryland this day of P,ay 30th Dated at 1977.
For the Nuclear Regulatory Commission.
f W4 l(_
M
(, // Lee V. Nossick Executive Director for Operations G
51/
270 6
.c
[g>#RfCp UNIT ED STATES o,
y }* ),,
/
NUCLEAR REGULATORY COMMISSION
<c WASHINGTON, D. C. 20555
-;;.p,N s m%,
l FAY z 41978 PRM 71-5 MEMORATJ'JM FOR:
Files FROM:
Neil S. Landau, Transportation & Prod _.t Standards Branch, Office of Standards Development SUBJECl.:
SCHEDULING NiD VALUE IMPACT APPRAISAL FOR INITIATION OFSDTASKTP-805-3(PRM-71-5)
This nisarandum has been prepared in accordance with the November 13, 1975 dir2ctive from R. B. Hinogue on "Value Impact Appraisal and Scheduling for Task Initiation."
The proposed Scheduling of this task is directed at completing it in the shortest reasonable time, considering its priority and the press of othar business.
Discussions with the other NRC Offices involved in resolving the petition (NMSa, ELD, IE) indicate that no substantive disagrzements exist.
NRC policy will not be altered if the petition is denfed as the staff recocraends.
10 CFR !Firt 2, Subpart H, and SD Office policy mandate r;rompt action on petitions for rulemaking.
In accordance with the.se policies PRM-71-!5 has been discussed among the NRC staff members, who recom. mend denying me petition.
The petMion for rulemaking submitted by John L. West on behalf of Chem-Nex ' lear Systems, Inc. contains two parts, both directed at protecting the comprtitive position of a package cwner.
One part asks to amend 10 CFR 72.12(b) to require that a package owner supply a generally licensed user only with necessary information which can be safeguarced from use bv competi tus.
Currencly 171.12(b) requires the owner furnish all documents referenced on the package approval.
Second, the petition asks that the user's reed for safety related information be met by supplying the user with specific procedures developed by the owner filed in accordance with Appendix E to 10 '_FR Pc.rt 71.
Discussienrc with the licensing staff (FCMS, Transportation Branch) indicate that all information from a package owner required for package approval is necessary to ensure safe package use.
Section 71.12(b) new requires that the owner su: ply all this information to users.
ELD staff members have indica ted that the NRC already has procedures, given in 10 CFR 52.790, for protecting proprietary information.
Therefore, since the 6\\l
?\\
Enclosur,e 2 i
MAY 2 4 U 0 Memorandum for Files -
regulatioms require only necessary safety related information be supplied to package use::. and since the regulations contain adequate procedures to allcw fr.e cwnte te safeguard proprietary information, the staff recomenik denying '.he first
- rt of PRM-71-5.
The regtaet that specific procedures submitted to satisfy Appendix E of i
10 CF177.1 be pravided to users in lieu of the safety analysis and blue-prints ' fir the container, cannot be met. Appendix E dces not require the $25 mission of specific procedures; it only requires that an approved qualf.ty assurance program is established.
Since there are no specific procefures associated with this Appendix, we must deny the portion of the petition requesting their use.
Because '.ne staff believes that protecting the public health and safety requi.rr : a container user have available all safety related information, and tr,t existing regulations provide adequate ways for a container owner to r atect proprietary inform.ation, we see no grounds for granting this l
pet' _ ion.
The only alterr.ative to denial is for the petitioner to with-i dra w the petition.
He will be informed of the staff recommendation, and cf the option of withdrawal.
The ccosts of denying this petition for rulemaking include possible costs to guckage owner through tne loss of certain competitive advantages, and cosds to owners and the NRC involved with filing and processing requests for w.ithholding proprietary information. Benefits of denial include sustaining the current level of public health and safety, and general savings in time and money from naintaining the status quo.
Cost:s of granting PRM-71-5 would be NRC time and effort dealing with comreits to proposed rule changes, NRC costs to change its regulations and Tfcensing procedures, and possible costs in public health and safety.
Bene? hts from approving the petition would consist primarily of elimina-tion f possible harm to a package owner's competitive position.
Approval could also reduce his administrative costs arising from filing requests to pr tect proprietary data.
~ he.~
Neil S. Landau Transportation & Product Standards Branch Office of Standards Development l
l 4
m i
779
, \\ 'l 3
i
~
_