ML19261A236

Responds to Re Fees for Amend to Radioisotope License,Costs of Proposed Radiographic Equipment & Design & QA Criteria for General License for Use of AM-241

ML19261A236
Person / Time
Issue date:	09/01/1978
From:	Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Tower J SENATE
References
NUDOCS 7809070200
Download: ML19261A236 (4)

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W5' The Honorable John Tower ~

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Dear Senator Tower:

I am pleased to respond to your inquiry received by the Commission August 17, 1978, regarding a letter from Mr. Walter P. Peeples, Jr.,

President of Gulf Nuclear, Inc., Houston, Texas, expressing his concern that (1) a possible restraint of trade may result from the imposition of fees for amendments to licenses issued by. the U.S. Nuclear Regulatory Commission, (2) the proposed radiography equipment design criteria and proposed quality assurance criteria for packaging and transpcrtation of industrial radiography sources would impose a financial burden in the order of millions of dollars on the industry, and (3) the deletion of the general license for americium 241 would create problems for industry.

The Nuclear Regu'latory Commission assesses fees for applications, licenses, design approvals, license amendments, and routine inspections pursuant to Title V of the Independent Offices Appropriations Act of 1952 (I0AA).

The fee which Mr. Peeples questions is $110 to amend a license which authorizes the use of' radioisotopes for industrial radiography.

Radiography licenses are issued for a period of five years and authorize the use of specific models of exposure devices and sealed sources containing a specified radioisotope and upper limit of radioactivity.

When a licensee elects to use additional equipment designs or otheraise modify his program in a manner which could effect safety, such changes must be evaluated and authorized by the Commission.

The authorization takes the form of an amendment to the license.

Earlier this year it was pointed out to Mr. Peeples that the NRC staff is examining the feasibility of issuing licenses that authorize the use of any radiography eqt ipment suitable for the user's needs that has been evaluated by the Commission and found acceptable for licensing.

If this approach is adopted, the need for amendments authorizing additional equipment would not be required.

It should be pointed out, however, that even under current licensing procedures licenses are issued for any and all models of approved equipment that is identified in the application filed by the radiographer.

2158 163 7Hf67 #p

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,ie Honorable John Tower ;

I 10AA provides in pertinent part:

It is the sense of Congress that a'ny work, service, publi-i cation, report, document, benefit, privilege, authority, I

use, franchise, license, permit, certificate, registration, or similar thing of value or utility performed, furnished, provided, granted, or issued by any Federal agency...

to or for any person...shall be self-sustaining to the full extent possible, and the head of each Federal agency is authorized by regulation...to prescribe therefor such fee, charge, or price, if any, as he shall determine...to be fair and equitable taking into consideration direct and indirect cost to the Government, value to the recipient, public policy or interest served, and other pertinent facts....

Since inception of the Commission's license fee program in 1968, it has recovered less than 10 =rcent of its regulatory budget.

Total fees collected to date approximate $74 aillion.

In FY 1977 approximately 3.7 percent of the budget was recovered through fees and FY 1978 is expected to yield less than $10 million.

The Commission will not collect hundred of millions in fees from applicants or licensees.

With respect to " restraint of trade", the Commission is cor,cerned with competition in the industry and has consciously tried not to interfere with free and open competition.

In regard to the $110 amendment fee for radiography licensing services, we do not believe it has an adverse affect upor competition and have seen no evidence that it does so.

We believe it to be a reasonable fee since it covers the cost of providing the service.

Further, the Commission has not received service, nor a copy, of any complaint filed by Mr. Peeples with the Federal Trade Commission to which he refers in his l'etter to you.

On March 27, 1978 the Commission published proposed preliminary design requi.ements for radiography exposure devices to obtain input from industrj arid those states which regulate the possession and use of byproduct, source, and special nuclear materials.

The intent was to determine how the Commission can most effectively work with industry and the states in protecting the radiography equipment user and the public.

Several comments were received from industry and they confirm that considerable work will be required before adoption of design criteria for radiography e::posure devices.

The purpose of the revised qua'ity assurance (QA) rules in 10 CFR Part 71 was to upgrade existing requirements for QA and to make them more explicit and more uniform for licensees.

These QA requirements were 2158 164

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.a cff Honorable John Tovier #

c?.sidered by the MRC since 1973, when Apoordix E criteria were first published in proposed form.

The requirements for QA programs apply to persons who are subject to 10 CFR Part 71; thus, they apply to shippers of fissile material and Type 5 quantities of other radioactive material; however, they do not apply to shipoers of Type A quantities of radioactive material.

Radiography shipments usually fall into the Type B category and, therefore, the QA requirements for shippers apply to radiography licensees (as well as to all other licensees who ship fissile material or Type B quantities of other radioactive material).

The Appendix E Criteria (18 in number) provide a sound basis for the establishment of any ca.mprehensive QA program and, as such, the criteria may be applied to many different types of activities.

In recognition of the varying ccmplexity of QA programs for different types of activities, the Conmission encourages the use of a graded approach in establishing QA programs; i.e., the applicable criteria should be applied to an extent. consistent with their importance to safety.

Since radiography shipments involve less significant Type B quantities of radioactive material, the QA programs required for radiography are correspondingly less ccmplex than those required for other packaging and transportation activities involving irradiated fuel, high level waste, plutonium, or normal form materials.

In fact, a two-page description of the QA program for radiographers would be adequate in most cases.

The QA regulations should not be thought of as generating entirely new requirements since most licensees already have QA programs or QA related procedures in existence.

In addition, licensees have been foliowing other QA requirements which have been in the regulations since 1967.

The Commission proposed to amend 10 CFR Part 110 to withdraw the general license for americium 241 because of concern with certain end uses of the material which could be of significance for nuclear explosive purposes.

Since publication of the proposed rule, the Commis; ion has received a number of comments objecting to the withdrawal of the general license.

bect.use of the wide use of americium 241 in legitimate civil uses.

The staff is currently reviewing these comments in cooperation with other concarned Government agencies and it may not be necessary to delete the general license in its entirety.

An attempt will be made to draft a revised general license which would permit unrestricted export of forms of americium 241 for most legitimate civil end uses.

The restriction would be against forms of americium 241 which could be used in nuclear explosive related activities and these are likely to be under control of specific licensing procedures.

The public will have the opportunity to participate in any rule making proceeding concerned with this general license.

Until ONS$$ M 2158 165

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,.s Honorable John Tower the Comission cc::pletes its study, the unrestricted general license for ar.ericiu.T. 241 will continue in effect.

If I can be of further assistance, please let me' know.

Sincerely.

(sind)

W1111:m J. Dirck.1 \\

Deputy Execu::ve Director Enclorare:

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'dustry at the time.the U.S. Nucl.'ar Regulatory Commission decided to force-its position ~ u"4r the guise of saf etv.

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' industry.andl.the Uuclear Regula t,'ry Commission met 'to ' dis; J

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dred times safer than his countm part in any industry.

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Append.ix E of Part 71 i.:as introduced at the Part i

'34 meeting seemingly as a threat to the industry on acceot-ance of the Eart.34 procedures mi l we were advised that 't i

..would be augmented the first of,Iuly, 1978.

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Howe'U...._2,er, -if " Permitted to stahd 'it will add millions o,f -

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dolfars 'to codt's in the industry and (tons of papentork. L 1.

'This-is based o'n a mishap in 1972 and another in 1974 and

~

. nothing 'since..But again the guise of ' personal safety is.

emP oved to an enviable record. ~

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[ehlatoi~y guide 8.20 has an answer atf.' ached and shows ai.

-complete disregard for costs to the~ petroleum industry.

'~

[.-~I understand this was brought on by a problem with a hos,

/

.pital' technician.kho. picked up some. leaking thyroid uptake

~ 'apsulis.

Please note these are designed for ingestion to c

.' determine. problems with' human thyroids., The Iodine-131 i,s

' one of ~ tlie most important tracers used in the_ petroleum location and producing

'industrv an3 a'ssist s our efforts in-

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The latest.croposal is Part 110 to 10..CFR and the proposal

~~Eo force a. specific license for Americium-241/ Beryllium

' neutron sources. ' Presently, tnere are many of these source

~~

in use around.the world and they are primarily used by oil:

'well logging companies.

They have~ been generally licensec,.

~

for export for many years and now the U.S. Nuclear Regula-tory Commission has~ decided to add them to specific licens creating enormous problems and delays in permitting their shi-ment.

e The b'asic points of this letter are !O The bureaucrats.

indescriminately create problems n'd as clearly pointed out in the'Part 34 meeting, genera-(o an atmosphere that 6

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bureaucracy at thePexpense of thefindustry and.-to fhe

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. Part. 3. 4..mee. t..Ing. _ ;

these costs ard pas' sed' 7

that

'I feel that'Ithis inflation by ignoring the fact

~

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d costs.

, on'to the public in' consumer goo s industry which is and,

.now' treated as a problem child bybureaucratic approach.

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.is. indicative of the bas c feel that Congress is grossly negligent in f i nced 7-3 personnel to' dictate to industry. thousands and creating a'~spirdl'o-

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-lations published'by theld make anyone f all back in ' dismay,.area dr tional disgrace.

I request'of you and others who un e

. costs that wou h

' issues'to the,

. stand and vd1 tie our-freedom to bring t ese d lwith" the.,ne-

~

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.; attention of the,, American public ~and. proceethe normal 1 w

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,_,cessary investigatio_ns.withoutt;th.e tr.u.e sense.

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I fully believe that the one' item feared most by the bure,

~ Texan cracy.is an investigation by the legislative the power'indus The petroleum industry, f industr the engineering industry and even the business o than a scrapper.

It is.on its basic home in this state.from this' state radiogr'aphy finds rythi appropriate that someone against those hidden bodies that seek to dest l

ecess be a to continue to challenge those that we consider to

' we hold.

rise system.

We fully n'

..._ basic menace to r"ir_ free enterpstand that some elem h t seet

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..: Q ffs,+2and,I feel that the American. people.and in particular

.gry, %': Texans _look to you'for,a champion in this area.'

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- :Q M,otir consideration in this matter is gratefully aopreciaEed.

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.. h..7..ery".tr'uly yours,..

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