ML19246C152
| ML19246C152 | |
| Person / Time | |
|---|---|
| Issue date: | 07/06/1979 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Paul R HOUSE OF REP. |
| Shared Package | |
| ML19246C153 | List: |
| References | |
| NUDOCS 7907230554 | |
| Download: ML19246C152 (3) | |
Text
pa areg'o UNITED STATES eE ); y. ([,j NUCLEAR 3EGULATORY COMMISSION WASmNGTON, D. C. 20555
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CHAIRMAN The Honorable Ron Paul United States House of Representatives Washington, D.C.
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Dear Congressman Paul:
Your letter of April 11, 1979 posed questions concerning (1) Appendix E,
" Quality Assurance Criteria for Shipping Packages for Radioactive Material" to 10 CFR Part 71 and (2) the Comission's policy in regard to notifying Agreement States of developments at the Commissicn.
Apoendix E to 10 CFR Fart 71 I appreciate your concern about the potential economic consequences of Appendix E to 10 CFP. Part 71.
Although we did not perform a formal detailed cost / impact analysis of Appendix E, we believe its imal.ementation has not resulted in any appreciable increase in licenser rosts.
The history of our quality assurance requirements and adoption of Appendix E provides insight into our reason for this conclusion.
Requirements for operating and inspection procedures have been a part of the transportation regulations sine 1966, as have some specific quality assurance tests and determinations.
Criteria similar tc those in Appendix E have been applied to shippers of fissile material, high level waste, and clutonium since 1972 through the NRC licensing program.
Criteria similar to those in A:penc!x E have been applied to the us' of bvproduct material in industrial radio]raphy when done in connection with civilian nuclear
?rograms.
Mendix E was par c of revised quality assurance (Q1) recuirements for 10 CFR Part 71 that were published as proposed regulations on December 98, i973 (38 FR 35490).
Coments were received at that time from ten parsons who manufacture nr use shipping packages and from one State regul ry a g; ty.
In response to the c;raes, a number of specific provisions in r.e croposed recuirements were deletec.
No broad oojections to the Apoencix E criteria were raised. The effective QA regulations, with A cendix E, were published August 4, 1977 (42 R 39364).
The implementation ca.e,
.e., the cite by which licensees had to file descriptions of
- neir QA programs witn the '.uclear Regulatory Commission (NRC), was extenced from tne original date of July 1,197E to January 1,1979 as a direct result of a :etition (PRM 71-7), filed on May 10,197E, which
-e:uested such an extension, ir"
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Honorable Ron Paul The purpose of the revision of 10 CFR Part 71 was to upgrade existing QA requirements -- in view of the increasing operational and shipping activities involving radioactive materials -- and to make them more explicit and more uniform for licensees.
It should be noted that the requirements apply to persons who are subject to 10 CFR Part 71, i.e.,
to shippers of fissile material and Type B quantities (larger and more hazardous quantities) of other radioactive material, and generally do not apply to shippers of Type A quantities (i.e., smaller quantities) of radioactive material.
Type A and Type B quantities of radioactive rnaterial defined in 10 CFR 571.4(q) are categories that originated with the International Atomic Energy Agency and distinguish between quantities cf radioactive material that, on the basis of toxicity anc potential ha:ard in transport, are of lesser and greater significance to health and safety.
Furthermore, as stated in Appendix E, the criteria in Appendix E are to be applied to an extent consistent with their importance to safety.
For example, shipping of radiographic sources (encapsulated solid form material) requires only a simple program involving small costs that can be described on two pages.
This graded approach relatt.s de costs of QA programs to the potential hazards of the shipment.
An analysis of tne costs to licensees for preparing and maintaining the initial reports describing the QA programs to meet the criteria in Appendix E and costs to NRC for reviewing those reports was completed and sent for General Accounting Office (GAO) clearance on July 27, 1977.
A copy of that letter and the GA0 response dated September 12,1977 is enclosed (Enclosure 1).
hs:i'i:ation cf Agreerent States In res:onse to your question regarding a complaint you have received
- nat tne Corraission "... does not keep Agreement States totally informed c f developments at the Cormission.
, I would emphasize that the agreements exe:uted between the Commission and Agreement States provide
- cr cc: perative arrangements for development cf rules, regulations, and p rc:ecures covering agreement materials.
For example, draf ts of proposed amendments of the Commission's regulations affecting Agreement States (i.e.,10 CFR Parts 10, 20, 30-35, 70, 71, and 150) are distributed to
- ne Ag eemen: States for coment, and those cc=ents are taken into a::oun: be' ore tne proposed regulations are submitted to the Commission
- - ap;roval.
An annual Agreement State meeting is held a.: which developing
-e;Z a:icn: and otner items of mutual interest are discussed by Agreement 5:i:e reoresentatives and Corission staff.
Honorable Ron Paul In addition to these direct contacts with Agreement States, each proposed regulation is published in the Federal Register, accompanied by a preamble explaining the basis for the proposed regulation and inviting all interested persons who so desire to submit written connents or suggestions to the Comaission.
To encourage additional public participation, the NRC's staff has adopted a procedure (see Enclosure 2) that all proposed and effective regulations of a substantive nature will be mailed to affected licensees and other known interested persons and organizations such as standards writing groups, trade associations, trade publications likely to be read by affected licensees, and public interest groups.
In the case of a regulation affecting Agreement State licensees, the Conmssion's staff provides copies to officials in all Agreement States.
I hope the above is responsive to your questions.
If I can be of fur ther assistance, please let me know.
Sincerely,
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'._;)ose'ph M. Hendrie
Enclosures:
1.
Correspondence with GA0 2.
Policy and Procedures
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