ML20125D167

Notice of Issuance & Availability of Denial of Non-Destructive Testing Mgt Associates 780510 Petition to Remove App E Requirements & Delay Effective Date of Implementation of Regulation Until Proper Hearing Conducted

ML20125D167
Person / Time
Issue date:	10/02/1979
From:	Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
Shared Package
ML20125D163	List: ML20125D160 ML20125D167 ML20125D173 ML20125D181 ML20125D189 ML20125D209 ML20125D508 ML20125D522
References
RULE-PRM-71-7, TASK-OS, TASK-TP-821-3 NUDOCS 8001140138
Download: ML20125D167 (10)

Text

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[7590-01]

l NUCLEAR REGULATORY COMMISSION

[ Docket No. PRM 71-7]

NONDESTRUCTIVE TESTING MANAGEMENT ASSOCIATION; DENIAL OF PETITION FOR RULEMAKING By letter dated May 10, 1978, Mr. Walter P. Peeples, Jr. on behalf of the Non Destructive Testing Management Association, seven undesignated radiographic camera manufacturers and six undesignated source manufacturers, filed with the Nuclear Regulatory Commission a petition for rulemaking (PRM 71-7).

-s THE PETITION The petitioner requested the Commission to: (1) remove Appendix E -

Quality Assurance Criteria for Shipping Packages for Radioactive Material -

from 10 CFR Part 71, and (2) delay, "the effective date of implementation of Part 71 Appendix E until a proper hearing can be conducted and possibly total removal of the requirement".

BASIS FOR REQUEST As the tiasis for the request, the petitioner stated: "

. . . the rule was forced on the industry and not discussed nor did the Commission attempt to notify two-thirds of the manufacturers in this specific area of its attempt to create an almost insurmountable and expensive paperwork program." The petitioner further noted that the lack of uniformity in quality assurance (QA) requirements between Agreement State licensees and NRC licensees is prejudicial and effects an unfair competitive position for manufacturers in Agreement States.

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t REQUEST FOR COMMENTS ON PETITION A notice of filing of the petition, Docket No. PRM 71-7, was published in the FEDERAL REGISTER on June 14, 1978 (43 FR 25749). Interested persons were invited to submit written comments or suggestions concerning the petition by August 14, 1978. Thirty-nine comments were submitted, including one from the Air Transport Association of America attaching separate comment letters from six airline companies, and including one from Gulf Nuclear Incorporated as a protest under which the description of their quality assurance program was being filed.

Of the thirty-nine comments, thirty-two either indicated support for the petitioners request for removal of appendix E or separately asked for its 1

removal; twenty-eight thought that there was a lack of justification for Appendix E or that the requirements in Appendix E duplicated other require- i ments; twenty-seven cited large costs and expensive paperwork with these QA requirements; and fifteen believed the requirements had been forced on the industry without consultation.

• Six of the commenters w ce well-logging licensees who normally ship type A quantities of radioactive material and, thus, are not subject to the QA require-ments of 10 CFR Part 71. One of these persons suggested that, ". . .this require-ment could, on occasion, delay the transportation, handling and manufacture of such sources to final end users. . . ". The Commission is not aware of any delays that could occur unless they were due to safety-related aspects of the transportation and, as such, the QA program would be functioning as intended.

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The rest of the commenters (33) were involved in industrial radiography.

Responses to most of the comments are given in the discussion of grounds for denial below.

NRC RULEMAKING ACTION Appendix E, " Quality Assurance Criteria for Shipping Packages for Radio-active Material," was part of revised quality assurance (QA) requirements for 10 CFR Part 71 that were published in the FEDERAL REGISTER as proposed regula-tions on December 28, 1973 (38 FR 35490). At that time, comments were received from ten persons who manufacture or use shipping packages and from one State

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regulatory agency. As a result of these comments, a number of specific provi-sions in the proposed regulations were deleted. No broad objections to the Appendix E criteria were raised.

The QA requirements, including Appendix E, were published in the FEDERAL REGISTER on August 4,1977 (42 FR 39364) to be effective October 18, 1977 but allowing almost 11 months (until July 1,1978) before QA program descriptions had to be filed with NRC. This FEDERAL REGISTER Notice again invited public comments. Two draft regulatory guides were sent to users of NRC-approved pack-age designs in May 1978 which provided specific guidance on development of QA programs for packagings.

In response to several requests, including the petition, the Commission extended the date by which licensees had to file descriptions of their QA programs from July 1,1978 to January 1,1979.

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DISCUSSION OF GROUNDS FOR DENIAL

1. The QA requirements were published in the FEDERAL REGISTER as a pro-posed rule and as an effective rule with both inviting public comments, and the Commission did attempt to notify affected persons.

As indicated above, the proposed rule was published in the FEDERAL REGISTER in 1973, ten persons submitted comments, and the rule was revised in response to those comments. At that time, noticing a proposed rule in the FEDERAL REGISTER was considered adequate notification of affected persons, although, in this case, the Commission also issued a public announcement. More recently the NRC has adopted a policy that in addition to the FEDERAL REGISTER notice, proposed rules are to be distributed directly to affected licensees and other known interested persons.

The effective rule was published in the FEDERAL REGISTER in August 1977, and no public comments were received at that time. The effective rule was dis-cussed in a public meeting in April 1978 (43 FR 12718, March 27, 1978, " Advance Notice of Proposed Rulemaking on Design of Radiographic Exposure Devices").

Specific guidance on the content of the description of the QA program

• to be submitted to NRC to satisfy the provisions in the rule were distributed to users

of NRC approved packages, including some Agreement State licensees, in May 1978.

• Draft Regulatory Guide 7.XX, Content of the Description of a Quality Assur-ance Program for the Use, Maintenance and Repair of Shipping Packages for Certain Special Form Radioactive Material, (applicable to industrial radiog-raphy sources) May 1,1978 and Draft Regulatory Guide 7.XX, Establishment of a Quality Assurance Program for Shipping Packages for Irradiated Fuel, High Level Waste and Plutonium, May 15, 1978. Single copies are available from the Transportation Branch, Nuclear Material Safety and Safeguards, Nuclear Regula-tory Commission, Washington, D.C. 20555.

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In addition, a paper that described the QA regulations of 1977 in detail was presented in May 1978 at the Fifth International Symposium on Packaging and Transportation of Padioactive Materials.

2. The Commission has determined that application of an effective QA program is important to safety in the packaging and transportation of fissile j material and type B and large quantities of other radioactive materials.

The purpose of the revised QA requirements issued in 1977 was to upgracie existing requirements for QA in packaging and transportation to assure a con-tinued high degree of safety in view of the ever expanding operational and ship-ping activities involving radioactive materials, to improve the assurance of compliance with the regulations in those activities and to make the QA require-ments more explicit and more nearly uniform for licensees. These requirements apply to persons who are subject to 10 CFR Part 71; thus they apply to shippers of fissile material, type B and large quantities of other radioactive material, and generally do not apply to shippers of type A quantities (i.e., smaller quantities) of radioactive material. The categories of type A, type B and large quantities of radioactive material, as defined in 10 CFR Part 71, provide distinctions in the significance to health and safety for the wide range of quantities of radioactive material in transportation. Quantities of radioac-tive material in transport up to type A quantity limits present a limited poten-tial hazard but greater than type A quantities may present significant potential hazards.

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Inspection surveys show a sizable percentage of packages in transport are not in full compliance with DOT requirements. Errors in packaging, faults in packaging designs, and some items of noncompliance have contributed to the radiation exposure in a few of the incidents that have occurred in transport.

An effective QA program will identify and allow correction to be made of such conditions where they affect safety.

3. The Commission has considered costs, both to industry and to the Commission staff, of implementing these QA requirements. Also, consideration of more than 300 descriptions of QA programs already submitted to NRC to satisfy the requirements by a variety of licensees, including industrial radiographers, indicates that the paperwork is not overly expensive or inormo.'ntable.

QA programs, based on criteria similar to Appendix F, have been required for shippers of fissile material, high level waste, and pletonium packages since 1972 and, therefore, no additional costs were encountered by these licensees when the QA regulations were promulgated in 1977. Shippers of type A quantities of radioactive material are usually exempt from the requirements of 10 CFR Part 71 and, therefore, encounter no costs due to the QA requirements. Type A quantities include small quantities of radioactive material for medical uses, for calibration of instruments, and for other purposes. The QA requirements apply to fissile and type B or greater quantities of other radioactive material.

This covers a large range o.f quantities of radioactive material. In recogni-tion of the varying complexity of QA programs for different types of activities, 90021154 l

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1 the Commission encourages the use of a graded approach in establishing QA pro-l grams; i.e., the applicable criteria of Appendix E should be applied to an i extent consistent with their importance to safety. This factor was overlooked initially by some affected persons who estimated high program costs due to the QA requirements. l 1

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Although many radiography shipments involve type B quantities of radioac-tive material, they are limited quantities, much smaller than many other ship-ments, and they are always in special form (encapsulated solid material form).

Therefore, the QA programs required for industrial radiography are correspond-ingly less complex than those required for many other packaging and transporta-tion activities; for example, those required for irradiated fuel, high level waste, plutonium, or the larger type B quantities of normal form materials. A two page description of the QA program for industrial radiographers has been shown to be acceptable to the NRC, in most cases, and the specific provisions of the program are limited in number. Many industrial organizations already have established specific procedures with respect to quality-related controjs for their packaging and transportation activities and, in these cases, the Part 71 QA program requires only a little, if any, increase in effort for recordkeeping and audit procedures. The Commission has found no evidence of large costs or expensive paperwork for the QA programs that are required for industrial radiographers.

In any case, following the ' graded approach' discussed above, the required QA programs for fissile materials or type B or large quantities of other radio-active materials are dependent on the complexity of the package and the health 90021155 7

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l and safety significance of the quantity, type and form of radioactive material '

shipped in the packaging.

4. The petitioner also noted that there was a lack of uniformity in QA requirements between Agreement State licensees and NRC licensees. The reci-procity provisions of 10 CFR Part 150, " Exemptions and Continued Regulatory

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Authority in Agreement States under Section 274," permit Agreement State licensees to conduct the same activity in non-Agreement States pursuant to a general license granted by the NRC. The QA requirements of Part 71 apply directly to NRC licensees and, under the reciprocity provisions of Pcrt 150 (6150.20), to Agreement State licensees when such licensees carry on licensed activities in non-Agreement States. The reciprocity provisions subject any Agreement State licensee who is operating in a non-Agreement State to a number of specified NRC regulations, one of which is Part 71.

Agreement State licensees are generally subject to DOT regulations for the shipment of radioactive materials. Under DOT rules, Agreement State licen, sees may use DOT specification or NRC-approved packaging, or may apply to NRC for approval of package designs for shipping fissile materials and type B and large quantities of other radioactive materials. In issuing those approvals, NRC imposes the QA program requirelaents of Part 71. Therefore, Agreement State licensees using one of the small number of DOT specification containers, and those who use designs approved before the QA requirements were adopted, may not have QA programs similar to those required by Part 71. The NRC staff has met with 00T officials to discuss quality assurance requirements, and the NRC i

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is formally requesting DOT to upgrade its quality assurance requirements for radioactive material packages to apply to shippers subject to 00T rules. This will lend a greater degree of uniformity to the QA requirements, especially as they apply to Agreement State licensees.

SUMMARY

OF GROUNDS FOR DENIAL .

The Commission has given careful consideration to the petitioner's argu-ments in PRM 71-7 and the comments received on the petition and has decided to deny the petition on the following grounds: -

1. The record shows that both the proposed rule and the effective rule were published in the FEDERAL REGISTER inviting public comments, and the Commis-sion did attempt to notify affected persons.

2. Requiring that licensees have an effective QA program for packaging and transportation will improve safety.

3. The paperwork associated with the QA requirements for packaging and transportation is not overly expensive or insurmountable.

4. Although there is some nonuniformity in the QA requirements for pack-aging and transportation imposed on NRC and Agreement State licensees, the differ-ences are not large and are being eliminated by requesting 00T to upgrade its quality assurance requirements.

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Further, the Commission does not find it necessary or advisable to hold a hearing on the QA requirements at this time. l l

Copies of the petition for rulemaking, the comments thereon, a value impact  ;

statement on the denial, and the NRC's letter of denial are available for public inspection and copying in the NRC's pJblic Document Room at 1717 H Street, N.W. ,

Washington, D.C.

Dated at Bethesda, Md. t 1i s 2nd day of Oct. , 1979.

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For the Nuclear Regulatory Commission.

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"/ Lee V. Gossick i Executive Director for Operations 1

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Mr. Walter P. Peeples, Jr. 2 The comment concerning the lack of uniformity in quality assurance requirements between Agreement State licensees and Commission licensees, noted in your peti-tion, has merit. In order to provide a greater degree of uniformity for quality assurance requirements, the Commission has requested the Department of Transpor-tation to upgrade its quality assurance requirements for radioactive material packagings.

Although your petition has been denied, the Commission is engaged in a continu-ing assessment of quality assurance with regard to the packaging and transpor-tation of radioactive material. Other actions on this subject may be reflected in later rulemaking activities.

Sincerely, .

/4ee V. M ossick Executive Director for Operations

Enclosures:

"A" Federal Register Notice "B" 43 FR 27174 90021159

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