ML19289G158

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Responds to Re Ds Gooden Ltr Questioning Fee for Insp of Radioisotope Program.Discusses NRC Authority to Perform Insps & Charge Fees.Forwards 10CFR30,35 & 170 & Fr Notice.W/O Encls
ML19289G158
Person / Time
Issue date: 05/25/1979
From: Gossick L
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Jackie Jones
HOUSE OF REP.
References
RULE-PR-30 NUDOCS 7906280255
Download: ML19289G158 (3)


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>RRECy)o UNITED STATES g

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,( 3 g NUCLEAR REGULATORY COMMISSION j :p WASHINGTON, D. C. 20555 o$

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The Honorable James R. Jones United States House of Representatives Washington, D.C.

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Dear Congressman Jones:

I am pleased to respond to your inquiry of April 27, 1979, concerning a letter from Dr. David S. Gooden, Saint Francis Hospital, Tulsa, Oklahoma, regarding the assessment of a fee for the inspection of the Hospital's radioisotopes program. Dr. Gooden questioned the Commission's authority to charge fees for inspection of NRC licensed facilities.

Section 81 of the Atomic Energy Act of 1954, as amended, gives the Commission the responsibility of regulating the receipt, possession, and i'

tse of byproduct material. Further, the Act authorizes the Commission to establish by rule, regulation, or order, such standards, instructions and procedures necessary or desirable to protect the health and safety of the public. Accordingly, the Commission has adopted regulations (10 CFR Parts 30 anf 35, copies enclosed) which govern the licensing and use of byproduct material for medical purposes.

In order for Saint Francis Hospital to possess and use radiopharmaceuticals for medical purposes, it must hold a specific license from the Commission. Such a license subjects the licensee to the conditions specified in Section 183 of the Act. Section 183 provides j

in part that "Each license shall be in such form and contain such terms and s'

f corditions as the Ccmmission may, by rule or regulation, prescribe to f

effectuate the provisiens of this Act....".

Inspections are a requiremen' of holding a license from the Comission.

j Section 161(o) of the Act, 42 U.S.C. 52201(o), provides that the Commission l

may " require by rule or regulation, or order,... such inspections... as may be necessary to effectuate the purposes of this Act." To implement this statutory provision, the Commission has promulgated regulations requiring licensees to permit inspections of records, premises and licensed activities.

The purpose of such inspections is to assure that licensees conduct licensed activities in a' manner that adequately protects the environment, health, s

safety, and security of the public, including that of the licensee's employees.

As mentioned in our March 15, 1979 letter to you, the scheduling and frec'aency for inspection of a particular licensee is based upon the scope and complexity of the program. For hospitals and other medical institutions, the frequency of inspection is once every three years.

In addition to fulfilling a replatory requirement, inspections frequently reveal situations, which, unless corrected, could have an adverse impact upon the licensee's operations.

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The Honorable Jame: R. Jone. The Comission's fee program is based on the Independent Offices Appropriation Act of 1952, 31 U.S.C. !i483(a), under which the Comission is authorized and encouraged to recover costs attributable to specific services provided to identifiable recipients. The Comission guidelines for fees also take into account several court decisions concerned with fees under the Independent Offices Appropriation Act (IOAA).

On March 4, 1974, the United States Supreme Court decided t.to cases challenging certain fees charged by the Federal Communications Comission and the Federal Power Comission under the IOAA. National Cable Television 1

Association Inc. v. United States, 415 U.S. 336 ("NCTA_") and FPC v. New l

England Power Coroa_n,v,("NEP"), 415 U.S. 345. The Court ruled that the 10AA

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dllowed an agency to charge fees only for special benefits rendered to C

identifiable persons measured by the "value to the recipient" of the agency li service.

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On December 16, 1976, the District of Columbia Circuit Court held that an agency is authorivsd under the 10AA to charge a fee for providing services mandated by regulations. National Cable Television Association v. FCC, 554 j

F.2D 1094,1101 (1976). The Circuit Court further held that federal agencies may recover the full cost of providing a service to an identifiable recipient, even though that service may also benefit -- even predominatcly -- the public.

Electronic Industries Association v. FCC, 554 F.201109,1114 (1976). The Comission believes that the District of Columbia Circuit Court correctly interpreted the 10AA and that any other result would be inconsistent with the Congressional mandate expressed in the 10AA that " federal agencies ce self-sustaining to the full extent possible".

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Under the 10AA the Comission is authorized to recover the full cost of any expenses incurred in assisting an applicant & licensee to comply with i

statutory or regulatory requirements. Because ingections are consitered as ossisting an applicant or licensee in complying with statutory and regulatory requirements, inspection fees are assessed. Though hospitals and laboratories may not directly ask for unrelicited inspections ir the same manner as filing for s license, an applicant or licensee, in ef fect, obligates him: elf to the requirements of the Act and Commission regt lations at the time he makes application for a license. As you requested, ne are enclosing a copy of the Federal Register notice which gives additio1al information pertaining to the establishment of NRC's schedule of feas.

In response to your question concerning whether the NRC is appropristed funds to cover inspection activities, the NRC appropriations do cover the total regulatory program, including inspection activities. All fer=s 2080 309

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The Honorable James R. Jones collected are deposited in the Treasury as miscellaneous receipts in accordance with the provisions of the 10AA.

If we can be of further assistance, please let us know.

Sincerely, Q:;n:0Laa%f33@EL Leo V. Ge M bxcur: 2.:.ct:z Icz Cwzsuous

Enclosures:

1.10 CFR 30 and 35

2. Federal Register Notice
3. 10 CFR 170 2080 310 l

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