ML20207S965

Forwards Notice of Proposed Rulemaking to Amend 10CFR30 & 32 to Provide for Mfgs Registration of Radiation Safety Info Re Sources & Devices Containing Radioactive Matl

ML20207S965
Person / Time
Issue date:	12/18/1986
From:	Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20205D544	List: ML20205D540 ML20205H439 ML20206R668 ML20206T160 ML20207A130 ML20207S558 ML20207S637 ML20207S669 ML20207S695 ML20207S845 ML20207S866 ML20207S892 ML20207S910 ML20207S926 ML20207S935 ML20207S947 ML20207S955 ML20207S965 ML20207T123 ML20207T134 ML20207T142 ML20207T145
References
FRN-52FR2540, RULE-PR-30, RULE-PR-32 AB34-1-24, AB34-2-38, NUDOCS 8703200455
Download: ML20207S965 (1)

Text

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NUCLEAR REGULATORY COMMISSION i WASHINGTON, D. C. 20555 - _

.....- .ote a se MEMORANDUM FOR: Victor Stello, Jr.

Executive Director for Operations FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards

SUBJECT:

PROPOSED AMENDMENTS TO 10 CFR PARTS 30 and MANUFACTURERS' REGISTRATION OF SAFETY INFORMATION ON RADIATION SOURCES AND DEVICES

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Enclosed for your signature is a Notice of Proposed Rulemaking which would amend 10 CFR Parts 30 and 32 to provide for manufacturers' registration of radiation

• safety information about sources and devices containing radioactive material.

This rulemaking activity will result in regulations that clearly provide for the long-standing practice whereby manufacturers of sealed sources of radioactive

, material and devices containing sealed sources file radiation safety information about their products wi.th the NRC. The information is evaluated and, when refer-enced in specific license applications by the manufacturers' customers, is used by"the NRC-and the Agreement States in determining that an applicant's proposed equipment and facilities are adequate to protect health _and minimize danger to life _or property.

This practice is currently conducted under a general provision in the regulations (S 30.32(a)) that allows an applicant for a specific license to incorporate by reference information contained in previous reports filed with the Commission.

The practice is extensisely used. The NRC maintained sealed source and device registry contains information on approximately 3,000 models of sources and devices from about 400 manufacturers / distributors (vendors). Both the NRC and the 28 Agreement State licensing groups contribute data to and use the registry.

We believe that the practice has now sufficiently matured and is used to the

extent that it warrants a specific provision in the regulations. The proposed rule would continue the practice of manufacturers, filing information and, in effect, receiving pre-marketing approval of their products for purposes of spe-cific licensing. Publication as a rule will assure that all vendors of sealed sources and devices are informed of this practice and will clearly state that manufacturers registering their products with NRC have a responsibility to ensure that the distributed products meet the radiation safety related specifications filed with the registry.

8703200455 870304 PDR PR 30 52FR2540 PDR

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Victor Stello, Jr. 2 I recommend that you sign (under authority delegated in 10 CFR 1.40'(c) and (d)) -

the enclosed Notice of Proposed Rulemaking that would amend 10 CFR Parts 30 and

32. The appropriate congressional committees will be informed of these proposed changes. A notice regarding publication of the proposed rule will be included in the next Weekly Report to the Commission.

Coordination: The Offices of Nuclear Regulatory Research, State Programs, e

Inspection and Enforcement, and Administration concur in the enclosed amend-ments to 10 reviewed CFR this Parts paper 30concurs and and 32. in The it. Office of the General Counsel has that a public announcement need not be issued.

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The Office of Public Affairs concurs l

ohn G. Davis, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. FR Notice of Proposed Rulemaking '

2. Draft Regulatory Analysis

3. Draft Congressional Letter

4. Approval for Publication

5. Weekly Report to the Commission

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OCT 301986 -

MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM:- Patricia G. Norry, Director Office of Administration

SUBJECT:

MANUFACTURERS' REGISTRATION OF' RADIATION SAFETY INFORMATION FOR CERTAIN DEVICES AND SEALED SOURCES The Office of Administration concurs on the proposed rule that would amend'10 CFR Parts 30 and 32 to provide for manufacturers' registration of radiation safety information about sources and devices containing radioactive material.

Please _ note that the proposed rule m'y a not be forwarded for signature and publication until the clearance package requesting OMB review and approval of the information collection requirements contained in this proposed rule has been sent to OMB.

If you have any questions, please have a member of your staff contact Michael

-T. Lesar, Acting Chief, Rules and Procedures Branch, on ext. 27758.

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Patricia .

M orry, D re or Office of Administrati NOTE: Per 12/10/86 telecon with ADM, they l are departing from the above instruction.

They stated that the clearance package to OMB has been signed and they will forward that package to OMB when Mr. Stello signs the proposed rule.

Accordingly, submission of the request to OMB is no longer a deterrent to forwarding the proposed rule to Mr. Stello for signature.

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u KEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM: James M. Taylor, Director Office of Inspection and Enforcement.

SUBJECT:

OFFICE CONCURRENCE REQUEST: AMENDMENT OF 10 CFR PARTS 3.0 AND 32 We concur in the proposed rule that provides for premarketing radiation safety evaluation and registration of sealed sources and devices used under specific license.

[ i n James M. Taylor, Director Office of Inspection and Enforcement cc: S. Baggett, NMSS hhkh30i9hXb I" ._ . . .

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. MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Materials -

Safety and Safeguards

'FROM: G. k!ayne Kerr, Director Office of State Programs

SUBJECT:

AMENDPENT OF 10 CFR PART 30 and 32 RE: REGISTRATION OF SEALED SOURCES AND DEVICES 4 ,

We have reviewed the subject amendment and concur without coment. F!e -

m are sending a copy of the proposed rule to the Agreement States.

O 'd. & .

G. Wayne Kerr, Director Office of State Programs e'

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007 2 4 1986 MEMORANDUM FOR: John G. Davis, Director Office of Nuclear Material Safety and Safeguards FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research

SUBJECT:

OFFICE CONCURRENCE REQUEST: AMENDMENT OF 10 CFR

, PARTS 30 AND 32 We have reviewed the subject proposed rulemaking paper and concur in its publication.

We view the rulemaking as codification of existing licensing practice which has been demonstrated to be administratively cost-effective.

Please note that several editorial suggestions are provided in the enclosed mark-up.

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Erick S. Beckjord, rector Office of Nucleare R(gulatory Research t

Enclosure:

Mark-up v .

NOTE: RES suggested 3 minor editorial changes in the Preamble of the FRN.

These changes have been made.

$Steven Baggett, NMSS i

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SEP 151986 -

MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety

• and Safeguards FROM: William J. Olmstead, Assistant General Counsel for Rulemaking and Fuel Cycle Office of the General Counsel

SUBJECT:

REGISTRATION OF SAFETY INFORMATION ON RADIATION SOURCES AND DEVICES We concur in the proposed amendments to 10 CFR Parts 30 and 32. The

" Coordination" section on page 2 of the memorandum from Davis to Stallo should be changed to read, "The' Office of the General Counsel has reviewed this paper and concurs in it."

eN William J. Olsstead Assistant General Counsel for Rulemaking and Fuel Cycle Office of .the General Counsel NOTE: On 10/2/86, after review of editorial changes suggested by ADM, T. Dorian (OGC) confirmed that this memorandum provides Office level concurrence for OGC. The change recommended in this memorandum has been made.

YSteven Baggett, NMSS J

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%,..... September 8, 1986 MEMORANDUM FOR: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS FROM: Frank Ingram, Assistant to the Director Office of Public Affairs

SUBJECT:

PROPOSED AMENDMENT OF PARTS 30 AND 32 This replies to your September 4 memorandum. The Office of Public Affairs agrees that, since the proposed amendments formalize existing practice, a public announcement is not needed.

b% he ._ _

Frank Ingram Assistant to the Director Office of Public Affairs I

NOTE: On 10/1/86 Mr. Ingram confinned by phone that this memorandum provides Office level concurrence.

S en Baggett, NMSS T7G323@385 '

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, - l Approved for Publication

• The Commission delegated to the EDO (10 CFR 1.40(c) and (d)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limitations in NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.

The enclosed proposed rule, entitled " Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources," amends 10 CFR Parts 30 and 32 to provide clearly for manufacturers of radiation sources and devices containing radiation sources to file with NRC radiation safety information about their products for evaluation and subsequent use in NRC's consideration of appli-cations for specific licenses authorizing use of the products.

This proposed rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart C concerning matters of policy. I therefore find that this rule is within the scope of my rulemaking authority and as proceeding to issue it.

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Executive Director for Operations Enclosure 4

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.' t NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission is proposing regulations that would formalize current administrative practice under which manufacturers of radiation sources and devices containing radiation sources file safety information about their products with the NRC. The NRC evaluates and uses the information in its issuance of specific licenses to users of the products. Filing of information by a manufacturer (called registration) avoids multiple filings of the same information by the customers and thus expedites NRC's issuance of licenses. The proposed amendments, directed toward manufacturers, describe the information that the NRC needs for its evaluation of a source or device and state the registrant's respon-sibility to ensure that distributed products meet radiation safety specifications filed with the NRC.

DATES: Submit comments by . Comments received after this date will be considered if it is practical to do so, but assur-ance of consideration cannot be given except as to comments received on or before this date.

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ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.

Hand deliver comments to: Room 1121, 1717 H Street NW., Washington, DC, between 8:15 a.m. and 5:00 p.m. weekdays.

Examine comments received at: The NRC Public Document Room, 1717 H Street NW., Washington, DC.

Obtain single copies of the draft regulatory analysis on this proposed regulation from Steven Baggett, Office of Nuclear Material Safety >

and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 427-9005. .

FOR FURTHER INFORMATION CONTACT: Steven Baggett, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washingten, DC 20555, telephone (301) 427-9005.

SUPPLEMENTARY INFORMATION:

Table of Contents l I. Purpose of Proposed Rule.

t j II. Background.

l A. Sealed Sources.

8. Devices.

4 C. Sealed Source and Device Registration.

1. Nationwide Registry.

2. NARM.

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3. Devices and Sealed Sources l'

Manufactured Outside the United States.

D. Requests for Registration. .

? E. - Certificate of Registration.

1 III. The Proposed Rule.

IV. Environmental Impact: Categorical Exclusion.

l fy ' < V. Paperwork Reduction Act Statement.

EU' , . i VI. Regulatory Analysis.

VII. Regulatory Flexibility Act Certification.

VIII. Backfit Analysis.

List of Subjects in 10 CFR Parts 30 and 32 -

I. Purpose of Proposed Rule Current NRC regulations clearly provide for the issuance of specific licenses which reference so-called " pre-marketing" evaluations and regis-trations of radiation safety information on certain sealed sources of radioactive material and on devices which incorporate those sources.

Examples include smoke detectors used under an exemption from regulations, gauges used under a general license, and certain medical devices used under a specific license.

The regulations are less clear about pre-marketing evaluation of othar products such as industrial radiographic devices and industrial gauging devices which are used under a specific license. For these prod-i ucts, the NRC has developed and implemented arruaministrative procedure i for the pre-marketing evaluation and registration of radiation safety information under general provisions of its regulations.

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The proposed rule would add specific provisions to the regulations for this established administrative procedure at 10 CFR 32.210. The pro-posed rule would describe NRC's evaluation and registration criteria and would clarify the regulatory responsibility of manufacturers of products for which the NRC evaluates and registers radiation safety information.

In particular, the proposed rule would clearly state that the registrant is required to manufacture and distribute its product in accordance with its request for evaluation and registration and with the terms of NRC's registration certificate. Additionally, the registrant's quality control procedures would be expected to ensure that its product meets the speci-fications it furnished to the NRC.

The proposed rule would ensure that all manufacturers, applicants for specific licenses, and other interested persons are informed of and comply with the NRC's procedures and requirements for pre-marketing registration of' radiation safety information on sealed sources and f devices.

II. Background -

Section 30.33 of Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material," states that an application for a specific license will be approved u , a ong other things, "the applicant's proposed equipment and facilitie: va p y.uate to protect health and mini-mize danger to life or property."

With respect to certain equipment,'particularly sealed sources of byproduct material and devices containing sealed sources, applicants for specific licenses frequently describe that equipment by referring to data already filed with the NRC by the equipment manufacturer under a practice f

of direct communication between the NRC and the manufacturer.

4 Enclosure 1

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'This practice is administratively convenient to the NRC, manufac-turers, and to applicants because it reduces and simplifies paperwork.

A single submission by a manufacturer is evaluated by th'e NRC and the results of the evaluation are used in NRC's review of multiple applica-tions for specific licenses, thus avoiding repetitive submissions by applicants and reviews by the NRC. This practice is provided for under the general provision of S 30.32 of Part 30, whereby "information con-tained in previous applications, statements or reports filed with the Commission ... may be incorporated by reference, provided that the reference is clear and specific."

The following sections explain the key terms " sealed source" and

" device" and describe the program for registration of radiation safety information on this equipment.

A. Sealed Sources Byproduct material used by a specific licensee often is contained in a sealed capsule, held between layers of non radioactive metal foil, or firmly fixed to a non-radioactive surface by electroplating or other means.

The byproduct material with its capsule or other confining barrier is termed a " sealed source." The confining barrier prevents dispersion of the byproduct material under normal and most accident conditions related l

to use of the source.

There is a wide range in the amount of byproduct material used in sealed sources under a specific license. For example, (1) the sealed sources used in industrial gauges frequently contain several millicuries of bypro' duct material, (2) the sealed sources used in industrial radio-graphy may contain tens of curies of byproduct material, and (3) a sealed 5 Enclosure 1

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source used in a teletherapy unit for treatment of cancer may contain several thousand curies of byproduct material.

Radiation safety programs for the use of byproduct material as a sealed source are structured on the presumption that the byproduct material will not leak from the sealed source and contaminate the environment or expose individuals to radiation. This presumption depends upon the ade-quacy of the containment properties of the sealed source to withstand the stresses imposed by the environment in which the source is used.

Before authorizing the distribution and use of a sealed source con-taining byproduct material, the NRC determines the adequacy of its con-tainment and other radiation safety features. This determination is based on radiation safety information submitted by the manufacturer or distribu-tor of the sealed source or by the applicant for a specific license that authorizes its use. The NRC uses its regulations and radiation safety criteria set out in industry standards in making this determination.

B. Devices Frequently, the byproduct material is contained in a sealed source that, in turn, is contained in a shielded source housing. The source housing may have a shutter mechanism that allows an operator to greatly reduce the shielding in a particular direction so that a beam of radiation can exit the housing. The radiation beam is then available for such pur-poses as the treatment of cancer or for the examination of flaws in metal castings.

The source housing, together with its shutter mechanism and other radiation control mechanisms (if any), is commonly called a " device."

6 Enclosure 1

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i Examples of devices are teletherapy units, industrial radiographic equip-ment, and industrial' thickness and density gauges.

Before authorizing the distribution and use of byproduct material in-a device, the NRC determines the adequacy of the radiation safety features of the device. This determination.is based on information submitted by the manufacturer or distributor of the device or by the applicant for a specific license that authorizes use of the device containing byproduct material. The NRC uses its regulations and radiation safety criteria set out in industry standards in making this determination.

C. Sealed Source and Device Registration

1. Nationwide Registry Manufacturers and distributors of sealed sources and devices subject to NRC regulation routinely submit radiation safety information about their products directly to the NRC. This system avoids multiple and time consuming submission of the same detailed information by each applicant for a specific license that proposes to obtain and use those products.

The NRC maintains a nationwide registry of radiation safety informa-tion on sealed sources and devices containing byproduct material. Regu-latory authorities in the Agreement States (where NRC has relinquished its regulatory jurisdiction) also provide information to the NRC for the registry on their radiation safety evaluations and have access to all the information contained in the registry. Thus, when a manufacturer or dis-tributor of products within either an Agreement State or in NRC's regu-latory jurisdiction provides detailed information about its sealed source or device to its regulatory agency, the results of the radiation safety evaluation will be available for use in granting licensing approval to 7 Enclosure 1

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e users of the sealed source or device throughout the United States, its .

territories and possessions, and in Puerto Rico.

2. NARM '

Radioactive material includes " byproduct material" which is radio-active material derived from the production or use of special nuclear . .

material, see e.g., 10 CFR 30.3(d), and subject to regulation by the NRC and the Agreement States. Another class of radioactive material called "NARM," naturally occurring and accelerator produced radioactive materials, is not subject to regulation under the Atomic Energy Act of 1954, as amended, but is regulated by the States. As a general rule, the NRC does not accept applications for radiation safety evaluation and registration of sealed sources or devices that will contain NARM. There are two .

exceptions to this general rule. One exception is if the radionuclide used in the source or device is available from either a reactor (and thus defined as byproduct material) or from an accelerator (and thus defined as NARM). Cadmium-109 is an example of such a radionuclide. NRC will accept applications concerning Cd-109 assuming, for purposes of source or device evaluation and registration, that the cd-109 will be produced in a reactor.

The other exception is if the NARM is commingled with byproduct material.

3. Devices and Sealed Sources Manufactured Outside the United States 4 A source or device manufactured outside the United States may be l registered with the NRC if the appropriate information is supplied and if NRC's administrative requirements are satisfied. Additionally, the registrant must establish an address or representative in the United

, States where papers may be served, where records required by the NRC will be maintained, and where the NRC can inspect the registrant's activities as necessary to fulfill the requirements of NRC's regulations, i

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t-D. Requests for Registration Requests for evaluation and registration of sealed sources and devices must contain sufficient information for an NRC determination that the radia- '

tion safety properties of the product are adequate to protect health and minimize danger to life or property. This general guidance on the expected content of a request is supplemented by detailed guidance in two NRC docu--

ments: (1) Draft Regulatory Guide FC 603-4, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed

( Sources Containing Byproduct Material," and (2) Draft Regulatory Guide FC 601-4, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material."1 These documents discuss the expected technical content of a request and offer a suggested format. Included in each document is a checklist that may help an applicant to assure that it submits adequate information for NRC's radiation safety evaluation and determination of the conditions under which the source or device will be authorized for distribution and use. Manufacturers and distributors of sealed sources and devices are encouraged to consider these documents when preparing requests for registration.

E. Certificate of Registration Following a determination of the adequacy of the radiation safety j properties of a sealed source or device, the NRC or an Agreement State 1 Free single copies of Draft Regulatory Guides FC 603-4 and FC 601-4, to the extent of supply, may be obtained by writing to the Publications Services Section, Information & Records Management Branch, Division of Technical Information and Document Control, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Copies are also available for inspec-tion and/or copying for a fee in the NRC Public Document Room,1717 H Street, NW., Washington, DC 20555.

9 Enclosure 1 t

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issues a numbered certificate'of registration to the manufacturer or

. distributor. This certificate, among other things, s.ummarizes the sub-mitted radiation safety information and specifies the limitations and -

conditions of use of the sealed source or device, such as requirements for periodic leak tests and restrictions on environmental conditions of use. Although the certificate of registration is, in effect, a pre-marketing approval of the source or device, its issuance does not consti-tute a commitment to issue a specific license authorizing use of the source or device. Approval of an application for a specific license also

, requires satisfaction of other requirements listed in S 30.33 of 10 CFR Part 30 such as the training and experience qualifications of the applicant.

Copies of the registration certificate are provided to regulatory-i authorities in the Agreement States for their use in granting specific licensing approval to users within their jurisdictions.

III. The Proposed Rule The proposed rule in 10 CFR 32.210 would formalize this practice.

Manufacturers or initial distributors would file radiation safety information about their sealed sources and devices with the NRC and NRC would evaluate that information, provide registration certificates, and use that informa-

, tion in the issuance of specific licenses to users of the sources and devices. To date, this practice has been carried out under general pro-

• visions of NRC's regulations. The proposed specific regulatory provisions for the practice are intended to ensure that manufacturers, distributors, NRC's licensees, and the public are informed of (1) the opportunity for l NRC's pre-marketing evaluation and registration of sealed sources and 10 Enclosure 1

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e devices intended for use under specific licenses and (2) the criteria that are used by the NRC in making its evaluations.

However, there are two additional important reasons for the proposed -

rule. First, it would specifically require the manufacturer or distributor (i.e. , the registrant of the radiation safety information) to manufacture and distribute the product in accordance with representations made in the request for evaluation and with the provisions of the registration cer-tificate. Under this requirement, if the registrant states a particular limit, for radiation levels at a specified distance from its device, and NRC accepts that limit in its evaluation and issuance of the registration certificate, the registrant is required to follow that limit notwithstand-ing any specific provision in NRC's rules for a higher limit on devices used under specific license. Second, the registrant's quality control program would be expected to ensure that each sealed source or device meets the specifications that it has furnished to the NRC.

The proposed rule would require the request for review of a sealed source or device to include sufficient information about the design, manu-

.. facture, prototype testing, quality control program, labeling, proposed uses, and leak testing and, additionally, in the case of a device, suffi-cient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life or property.

The NRC normally evaluates a sealed source or a device using radia-tion safety criteria set out in industry standards. If existing industry standards and criteria do not readily apply to a particular case, the NRC 11 Enclosure 1

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formulates reasonable standards and criteria with the help of the manu-facturer or distributor. The standards and criteria used must be suffi-cient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life or property.

IV. ENVIRONMENTAL IMPACT: CATEGORICAL EXCLUSION The NRC has determined that this proposed regulation is the type of action described in the categorical exclusion set out in 10 CFR 51.22(c)(3)(f).

Therefore, neither an environmental impa'ct statement nor an environmental assessment has been prepared for this proposed regulation.

V. PAPERWORK REDUCTION ACT STATEMENT I

This proposed amendment contains revised information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This rule has been submitted to the Office of Management and Budget for review and approval of the paperwork require-ments.

i VI. REGULATORY ANALYSIS The Commission has prepared a draft regulatory analysis on this pro-posed regulation. The analysis examines the costs and benefits of the alternatives considered by the Commission. The draft analysis is avail-i able for inspection in the NRC Public Document Room, 1717 H Street NW.,

Washington, DC. Single copies of the analysis may be obtained from Mr. Steven Baggett (see "For further information contact:" heading).

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The Commission requests public comment on the draft regulatory analy-sis. Comments on the draft analysis may be submitted to the NRC as indi-cated under the'A00RESSES heading.

VII. REGULATORY FLEXIBILITY ACT CERTIFICATION As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),- .

the Commission certifies that this rule, if adopted, will not have a sig-nificant economic impact on a substantial number of_.smaLLentities. - The Sealed Source and Device Registry now contains approximately 3,000 certifi-cates of registration which have been issued to about 400 manufacturers and distributors. These totals include actions both by the Agreement States and by the NRC. NRC's current rate of issuance of certificates is about 100 per year to an estimated 40 manufacturers and distributors.

From year to year, there is some turnover among the manufacturers and dis-tributors. Although a substantial number would be considered small entities, the proposed rule is not expected to have a significant impact on them.

Under present practice, the estimated average technical time (in addition to time spent on laboratory work and engineering analysis) required by the manufacturer or distributor to prepare a request for eval-uation of a sealed source is 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> and for evaluation of a device is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />. The proposed rule would not change the technical time needed for the preparation of a request for an evaluation and registration.

Use of the Sealed Source and Device Registry under present practice and as provided in the proposed rule results in savings to manufacturers and distributors and to applicants for specific licenses in the following manner. The NRC annually processes about 1,500 applications for specific 13 Enclosure 1 1

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licenses, or amendments thereto, which reference safety information con-tained in the Registry.

If, in lieu of referring to information in the Registry, each license applicant submitted complete safety information for -

the source or device, .the increased technical time needed by the applicant for license is estimated to be 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> for a source and 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> for a device. These estimated times assume that the license applicant obtains needed test and engineering data and some assistance from the manufacturer or distributor. The increased assistance provided to each of multiple customers by the manufactursr or distributor is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for a source and 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for a device.

The NRC has determined that the proposed rule would not impose an additional burden on any manufacturer-or distributor of sealed sources and devices. However, it is seeking comments on suggested modifications, especially from small entities, because of the widely differing conditions under which many of them operate.

Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Commission of this in a comment that indicates the following:

(a) The manufacturer's or distributor's size in terms of annual income or revenue and number of employees; (b) How the proposed regulation would result in a significant economic burden upon it as compared to that on a large entity; and (c) How the proposed regulations could be modified to take into account its differing needs or capabilities.

14 Enclosure 1

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VIII. BACKFIT The NRC has determined that the backfit analysis provisions in 10 CFR 50.109 do not apply to this proposed rule because these amendments ~

apply to materials licensas issued under Parts 30 and 32. These amend-ments do not apply to licenses under 10 CFR Part 50.

LIST OF SUBJECTS IN 10 CFR PARTS 30 AND 32 Part 30 - Byproduct material, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.

Part 32 - Byproduct material, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble, and under' the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendments to 10 CFR Parts 30 and 32.

PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

1. The authority citation for Part 30 is revised to read as follows:

AUTHORITY: Sections 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

15 Enclosure 1

[, [7590-01]

Section 30.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 .

(42 U.S.C. 5851). Section 30.34(b) also issued under sec.184, 68 Stat.

954, as amended (42 U.S.C. 2234).' Section 30.61 also issued under sec. 187,-68 Stat. 955 (42 U.S.C. 2237).

, , For purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);

SS 30.3, 30.34(b) and (c), 30.41(a) and (c), and 30.53 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and SS 30:6, 30.36, 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued under sec. '

161o, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

~

2. Section 30.32 is amended by adding a new paragraph (g) to read

. as follows:

$ 30.32 Application for specific license, a a a a n (g) An application for a license to receive and possess byproduct material in.the form of a sealed source or in a device that contains the sealed source must either - -

(1) Identify the source or device by manufacturer and model number as registered with the Commission under S 32.210 of this chapter or with an Agreement State; or (2) Contain the information identified in 6 32.210(c).

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER v

CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS

3. The authority citation for Part 32 is revised to read as follows:

16 Enclosure 1

h , ' ,' [7590-01]

AUTHORITY: Sections 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as ,

amended (42 U.S.C. 2111,'2201, 2232, 2233); sec. 201, 88~ Stat. 1242, as amended (42 U.S.C. 5841).

Forthepurposesofsec.223,68 Stat.958,asamendNd(42U.S.C. .

2273); .S$ 32.13, 32.15(a), (c), and (d), 32.19, 32.25(a) and (b),

32.29(a) and (b), 32.54, 32.55(a), (b), and (d), 32.58, 32.59, 32.62, and 32.210 are issued under sec. 161b, 68 Stat. 948, as amended (42 U.S.C.

2201(b)); and-SS--32.-12;-32.16, 32.20, 32.25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).

4. In S 32.1, paragraph (a) is revised'to read as follows:

$ 32.1 Purpose and scope. '

(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture, or initially transfer items containing byproduct material for sale or distribution to (1) persons exempted from the licensing requirements of Part 30 of this chapter, or (2) persons gen-erally licensed under Part 31 or 35 of this chaptei. This pa'rt also pre-scribes certain regulations governing holders of such licenses. In addition, this part. prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material into a product or material owned by or in the possession of the licensee or another and regulations governing holders of such licenses. Further, this part describes procedures and prescribes requirements for the issuance of cer-tificates of registration (covering radiation safety information about a product) to manufacturers or initial transferors of sealed sources or 17 Enclosure 1

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).',*' '

[7590-01]

devices containing sealed sources which are to be used by persons specifi ,

cally licensed under Part 30 of this chapter or equivalent regulations of '

s an Agreement State. '

A i 2

• A

5. Subpart D is added as follows:

Subpart 0 - Specifically Licensed Items S 32.210 Registration of product.information. '

(a) Any manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under .

a specific license may submit a request to NRC for evaluation of radiation 5

safety information about its product and for its registration.

(b) The request for review must be made in duplicate and sent to i

the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle and Material Safety, Material Licensing Branch, Washingto,n, DC 20555.

(c) The request for review of a seale,d source or a device must include sufficient information about the design,. manufacture, prototype testing, quality control program, labeling, proposed uses and leak test-c ing and, additionally, in the case of a device, sufficient information

about installation, service and maintenance, operating and safety instruc-tions, and its potential hazards, to provide reasonable assurance that the

. radiation safety properties of the source or device are adequate to protect 4

health and minimize danger to Iffe and property.

(d) The NRC normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards.

If these stan-dards and criteria do not readily apply to a particular case, the NRC

, formulates reasonable standards and criteria with the help of the manufac-turer or distributor. The NRC shall use criteria and standards sufficient 18 Enclosure 1 r

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[7590-01]

to ensure,that the radiation safety properties of the device or sealed '

source are adequate to protect health and minimize danger to life and e . .>

property.

(e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certif-I icate of registration acknowledges the availability of the submitted infor-nation for inclusion in an application for a specific license proposing use of the product.

(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with--

(1) The statements and representations, including quality control program, contained in the request; and '

(2) The provisions of the registration certificate. -

Dated at Bethesda, Maryland, this day o It//h 198f.

FortheNuclearMgulatory!ommission.

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! Vfc(orStello,' r. / l l Executive Dire for Operations.

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19 Enclosure 1

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- H

(

DRAFT REGULATORY ANALYSIS FOR TASK-TFC 86-3 NOTICE OF PROPOSE 0 RULEMAKING -

Manufacturers' Registration of

' Radiation Safety Information for ,

Certain Devices and Sealed Sources INTRODUCTION The purpose of a regulatory analysis is to ensure that NRC regulatory decisions are based on adequate information concerning the nedd for and con-l sequences of a proposed regulatory action and to ensure that cost effective regulatory actions, consistent with providing the necessary protection of the public health and safety and common defense and security, are identified.

The procedures followed by NRC staff in preparing regulatory analyses are set out in NRC's published document, " Regulatory Analysis Guidelines" .

(NUREG-0058). Those procedures require a comprehensive analysis for a rule that is likely to result in:

a. An annual effect on the economy of $100,000,000 or more in direct and

, indirect costs, or

b. A significant impact on health, safety or the environment, or

c. A substantial increase in cost to NRC licensees, permit holders or applicants, to Federal, State or local governments, and geographical regions.

The procedures in NUREG-0058 also provide for preparation of analyses for rules that will likely result in lesser impacts than identified in a, b and c. For such rules, the evaluations are not as extensive or detailed as 1 Enclosure 2 i- m - - - _ -

g- -"

"' memsW:

. rules which result in impacts a, b or c. .The proposed rule considered in ,

this analysis, " Manufacturers' Registration of Radiation Safety Information

.for Certain Devices and Sealed Sources," is in this category. .

Interested persons are encouraged to comment on this analysis and those comments will be considered in determining further NRC action on the proposed rule. Comments should be sent to:

Secretary,' U.S. Nuclear Regulatory l Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.

1. STATEMENT.0F PROBLEM The NRC maintains a nationwide registry of radiation safety information on sealed sources of radioactive material and devices containing sealed sources.

Manufacturers or distributors of sealed sources and devices voluntarily submit product information for the registry and that information is then incorporated by reference'into applic'tionsa for specific licenses by persons desiring to use .

the products.

The registry contains approximately 3,000 models of sources and devices that have been registered by about 400 manufacturers or distributors. Input i

to and use of the registry is shared by NRC and the Agreement States.

As administered, the registry system, in effect, constitutes a system for pre-marketing clearance or approval for licensing purposes of radiation safety properties of sealed sources and devices that are used under specific licenses issued by NRC and the Agreement States.

The operation and use in licensing of the registry is currently guided by 10 CFR 30.32 whereby an applicant for a specific license may incorporate by reference "information contained in previous applications, statements or reports filed with the Commission or the Atomic Energy Commission ...." The absence of a more specific regulatory provision for the registry raises several questions:

2 Enclosure 2

, > s

~ s (1) has adequate notice of its existence and operation been provided so that all manufacturers and distributors, particularly those entering the sealed source and device business, have fair opportunity to register their products; (2) does the manufacturer have to assure that the distributed products meet the radiation safety related specifications filed with the registry; (3) does the manufacturer have to follow some sort of quality assurance requirements for its products; and (4) what criteria does NRC use to evaluate the radiation safety aspects.of a manufacturer's product.

2. OBJECTIVES In consideration of the above statement of the problem, the proposed rule has the following objectives:

A. To provide a continuing notice to all interested persons:

(i) that the NRC maintains a nationwide registry of radiation safety related information on sealed sourc'es and devices, ,

(ii) that manufacturers or distributors of sealed sources and devices may file product information with the registry, (iii) as to the general areas of safety information to be covered when registering a sealed source or device, (iv) as to the criteria used by NRC in evaluating a sealed source or device, and (v) that the registered information is available ard is used in the issuance of specific licenses.

B. To clearly establish that registrants of product information have a responsibility to the NRC to implement quality control programs and thus ensure that distributed products treet the product specifications that are filed with NRC, evaluated for adequacy, and relied on in the issuance of specific licenses which authorize use of the products.

3 Enclosure 2

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3. ALTERNATIVES Alternative 1: Issue a proposed rule that clearly would provide for_ the voluntary registration with NRC of radiation safety information on sources and devices to be manufactured and distributed for use under specific license. The t

rule would state the information to be submitted for NRC's evaluation, the stan-

, dards and criteria used in NRC's evaluation, and the registrant's responsibility to assure that distributed products conform to the registered information.

Alternative 2: No rulemaking action but continue the voluntary registry. Rely on regulatory guides and branch positions to explain the _ operation of the regis-try, what information should be registered, and how to register information.

Alternative 3: Issue a proposed rule that would replace the " voluntary" regis--

l try by a " mandatory" registry. The manufacturer or distributor would be required to register radiation safety information before receiving authority to transfer l the sealed source or device for use under specific license.

Alternative 4

Discontinue the voluntary registry of information by manufac-turers and distributors and require the first applicant for a specific license i authorizing use of a particular source or device to submit design and construc-tion data. When clearly and specifically referenced by subsequent applicants, the initially submitted information could be used in issuance of additional

specific licenses.

t 4. CONSEQUENCES

, Alternative 1: This action is consistent with accomplishing the objectives stated above in Section 2. This action also is consistent with the continued

operation of the established and matured registration program that is adminis-tered b3 NRC and the 28 Agreement States. Licensing authorities in these jurisdictions accept and evaluate radiation safety information that is filed by

their respective manufacturers and distributors of sources and devices. Summa-ries and evaluations of filed information are placed in the central registry that is maintained by NRC and is accessible to all 29 regulatory groups.

4 Enclosure 2

._ _ _ . _ _ _ _ _ _ . . _ _ _ - - . _ = .. = x.: __n.u u _ _ n

-s Because of sharing of registered information and acceptance by all the 29 regulatory groups of evaluations performed by any one of the 29 groups, a manu-facturer or distributor needs to submit detailed safety information to only a -

single regulatory group in order for that information to be available for use in issuing specific licenses throughout the U.S.

Alternative 2: This alternative would maintain the status quo. It allows con-tinued operation of the administratively efficient registry system for radia-tion safety information on sources and devices. However, it would not adequately answer the several questions presented above in Section 1. It would not provide clear notice of the registry system to all persons and would not increase the probability of early communication between NRC and persons entering the business of manufacturing or distributing sources and devices for use under specific licenses. These early communications are useful in directing the attention of new manufacturers and distributors to particular regulatory requirements and pertinent regulatory guides and branch positions. Also, this alternative would not provide a clear statement of a registrant's responsibility to assure that distributed sources and devices satisfy the radiation safety related specifica-tions on file in the registry.

Alternative 3: This alternative is consistent with accomplishing the objec-tives stated above in Section 2. Also, it would be consistent with the NRC's regulation of products used under an exemption from regulatory requirements (e.g., smoke detectors) or under a general license (e.g., luminous safety devices for use in aircraft). However, it would not be consistent with NRC's and Agreement States' practice for regulating the use of sources and devices under specific license. That practice allows the applicant for specific license either to file information directly or to refer to information filed by the manufacturer when demonstrating that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or prop-erty. This flexibility with respect to which party directly submits informa-tion for use in approval of an application for specific license is useful when considering one-of-a-kind products and when considering users' modifications of standard designs to satisfy unique conditions of use. In these cases, the applicant for license may choose to use the services of a manufacturer who has little interest in registering information directly with the NRC. That choice 5 Enclosure 2

~

. - a could be compromised by requiring " mandatory" registration by the manufacturer.

4 Further, and perhaps more important, we are not aware of compelling health and safety reasons to change the established " voluntary" registry to a " mandatory" registry.*

' Alternative 4: This alternative would appear to unnecessarily complicate the filing of radiation safety information for sources and devices. Direct commu-nication between the regulatory authority and the manufacturer can be conve-nient and effective in clarifying submitted information. To require that information which may be known only to the manufacturer must always be funneled to NRC through the first ifcense applicant would add to the paperwork burden of NRC, users and manufacturers. The staff does not consider this to be a viable alternative in view of the extensive and effective use of the voluntary regis-try system by NRC, the States, manufacturers and users.

5. DECISION RATIONALE f

Under present practice, the estimated average technical timo (in addition to time spent on, laboratory work and engineering analysis) required by the manu-1 facturer or distributor to prepare a request for evaluation and registration of a sealed source is 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. The NRC professional staff spends an average of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation of a sealed source. The estimated average technical time required to prepare a request for evaluation and registration of a device is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> and the NRC professional staff spends an average of 27.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation. The proposed rule would not change the time needed for the preparation and the review of a request for evaluation and regis-tration nor the economic impact on specific licensees.

The NRC annually processes about 1,500 applications for specific licenses, or amendments thereto, which reference safety information contained in the Regis-try. If, in lieu of referring to information in the Registry, each license applicant submitted complete safety information for the sealed source or de-vice, the applicant would have an increased technical effort in preparing the

• NOTE: Persons with information that is important to consideration of this alternative of " mandatory" registration are encouraged to comment.

6 dnclosure 2 n.__-_-.,-.-.. - . - - -

. - - .___ - = = = _ _ = -

.. a. .

. a .

application, the manufacturers and distributors would spend more time in ,

assisting customers in the preparation of applications for specific licenses, and the NRC professional staff would spend more time reviewing the applications.

If the' Registry is not used, the increased technical time to prepare an application for specific license is estimated to be 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> for a source and 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> for a device. These estimated times assume that the license applicant obtains the needed test and engineering data and some assistance from the manu-facturer or distributor and, with additions or modifications as appropriate, forwards that data as part of the license application. The increased assistance provided to each of multiple customers by the manufacturer or distributor is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for a source and 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for a device.

If the Registry was not used, the technical time that would be spent by '

manufacturers and distributors in assisting their customers in preparation of applications for specific licenses is estimated to be an order of magnitude greater than the total time now spent on such assistance and on preparing requests for evaluation and registration.

The NRC saves professional staff time through use of the Registry. If 1,500 aoplicants for specific licenses annually submitted detailed safety infor-mation in lieu of referring to information in the Registry, the NRC professional staff time spent on source and device reviews would be multiplied by a factor of 15. About 22 man years annually would be required for NRC's reviews instead of the present 1.5 man year.

The proposed action of issuance of a proposed rule to provide clearly for the voluntary registration with NRC of radiation safety information on sources and devices is recommended because: (1) the proposed rule permits continued operation of the efficient and effectise registry system that has been devel-oped and implemented by NRC and 28 Agreement States, and (2) the proposed rule would answer the several questions about the registry system, i.e. , have all interested parties been informed about the system, what criteria are used by NRC in its evaluations, and what responsibility does the manufacturer have to assure that distributed products satisfy the specifications that have been registered?

7 Enclosure 2

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In addition, the proposed action provides opportunity for public comment '

on the Commission's program for evaluation and registration of radiation safety information on devices and sources used under specific license. This opportu- ,

nity, which may result in an improved program, would not be provided by Alter-native 2 (status quo).

6. IMPLEMENTATION The notice of proposed rulemaking would be published in the Federal Reafster and the public would be provided a period of 60 days to comment.

Following evaluation of the comments and assuming that the proposed action is still warranted, a final rule would be published, to be effective 30 days after publication in the Federal Reafster.

The proposed rule is not expected to change the operation and use of the existing sealed source and device registry system. The proposed rule should assist in early recognition by new manufacturers and distributors of the oppor-tunity to register their products. Implementation of the rule may result in NRC's increased attention to review of manufacturers' quality control programs.

This action would occur during routine inspections of manufacturers' in plant radiation safety programs and possibly also would occur if users encounter safety problems that are attributable to poor quality. This attention to quality control is intended to make sure that distributed products satisfy the radiation safety related specifications that are on file in the sealed source and device registry.

i i

8 Enclosure 2 c.-. . . . . - . . - - - - - . . . . - . - . . - . . - - . . - - . . - . . . _ - . . .

r _ ,

ii: -

DRAFT CONGRESSIONAL LETTER Enclosed for the information of the subcommittee are copies of a Notice of Proposed Rulemaking to be published in the Federal Register.

The proposed amendments to 10 CFR Parts 30 and 32 will provide clearly in the regulations for the long-standing practice whereby manufacturers of sealed sources of radioactive material and devices containing sealed sources file radiation safety information about their products with the Nuclear Regulatory Commission. The information is evaluated and when referenced in specific license appifcations by the manufacturers' customers, is used by the NRC and the Agreement States in determining that an applicant's proposed equipment.and facilities are adequate to protect health and minimize danger to life or d property.

This practice is currently conducted under a general provision in the regulations 2 that allows an applicant for specific license to incorporate by reference in an application information contained in previous reports filed with the Commission.

The practice is extensively used. The NRC maintained sealed source and device registry contains information on approximately 3,000 models of sources and devices from about 400 manufacturers and distributors (vendors). Both the NRC and the 28 Agreement State licensing groups contribute data to and use the registry.

We believe that the practice has now sufficiently matured and is used to the extent that it warrants specific provision in the regulations. Publication of the rule will assure that all vendors of sealed sources and devices are informed of this practice and will clearly state that manufacturers registering their products with the NRC have a responsibility to ensure that the distributed prod-ucts meet the radiation safety related specifications filed with the registry.

In view of the minor nature of the proposed amendments which merely formalize present practice, the Commission considers that issuance of a public announce-ment is not warranted.

1 Enclosure 3 7 -.-- . ..

-