ML20207S695

Forwards Request for Assistance in Reviewing Encl Documents for Amend of 10CFR30 & 32 to Provide for Premarketing Radiation Safety Evaluation & Registration of Sealed Sources & Devices Used Under Specific License

ML20207S695
Person / Time
Issue date:	09/04/1986
From:	Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Goller K, Grimsley D, Nussbaumer D, Olmstead W, Partlow J NRC OFFICE OF ADMINISTRATION (ADM), NRC OFFICE OF INSPECTION & ENFORCEMENT (IE), NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
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 AB34-1-10, AB34-2-24, NUDOCS 8703200185
Download: ML20207S695 (32)

Text

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f,, UNITED STATES AB34-1 PDR

g NUCLEAR REGULATORY COMMISSION 3 WASHINGTON, D. C. 20555 l

%,...../ SEP 4 1986 MEMORANDUM FOR: James G. Partlow, Director Division of Inspection Programs, IE Donald A. Nussbaumer, Assistant Director for State Agreements Program, SP William J. Olmstead, Assistant General Counsel for Rulemaking and Fuel Cycle OGC Donnie H. Grimsley, Director Division of Rules and Pecords, ADM -

Karl R. Goller, Directo~,'

Division of Regulatory Applications, RES Joseph J. Fouchard, Director Office of Public Affairs FROM: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety, NMSS

SUBJECT:

DIVISION REVIEW REQUEST: AMENDMENT OF 10 CFR PARTS 30 AND 32 Your assistance is requested in reviewing the enclosed documents for amendment of 10 CFR Parts 30 and 32 to provide for pre-marketing radiation '

safety evaluation and registration of sealed sources and devices used under specific license. The following is a summary of this request:

1.

Title:

Registration of Sources and Devices

2. NMSS Project Manager: StevenBaggett(x79005)

3. NMSS Task Number: TFC 86-3

4. Cognizant Individuals: J. Metzger, IE L. Bolling, SP T. Dorian, 0GC M. Lesar, ADM Undesignated, RES Undesignated, PA J

8703200185 070304 PDR PR 30 52FR2540 PDR 1

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5. Requested Action:

a. RES, IE, SP, OGC, ADM: review and connent and/or concur.

b. RES, PA: designate cognizant individuals.

, c. PA: concur that a press release is not required.

d.. SP: initiate Agreement State review if SP considers the States to have an interest.

6. Requested Completion Date: DI9 $

1 7.

Background:

1 NRC regulations clearly provide for pre-marketing approval of certain sealed sources of radioactive material and devices witch incorporate those sources. Examples are: smoke detectors used under an exemption from 4 regulations,. gauges used under a general license, and certain medical

' devices used under specific license. The regulations are less clear with respect to pre-marketing evaluation of other products, e.g., industrial

! radiographic devices and in-plant gauging devices which are used urider specific license.

The proposed rule would clearly state the procedures for manufacturers and distributors of sources and devices to obtain pre-marketing evaluation and registration of products to be used under specific Ifcense.

l Consistent with present practice, the rule would require the applicant to submit for evaluation specified radiation safety information about the product.

i The proposed rule would assure that all manufacturers and distributors are informed of NRC's program for evaluation and registration of

radiation safety informat'on on sources and devices used under specific

license. The rule also would clearly state that the registrant is

! responsible for assuring that the distributed products meet the radiation i safety related specifications filed with the Connission, i

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This rulemaking was approved by the EDO and transferred from RES to NMSS on November 29, 1985. The attached draft amendments differ from earlier drafts by RES. Those earlier drafts would have established a class concept for sources and devices used under specific license whereby, for example, a specific Itcensee who was approved to possess a gauge would also be approved to receive any gauge that had been registered. The attached draft is more limited in scope and is intended to formalize the established practice for evaluation and registration of sources and devices used under specific license.

lfu& ,h Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety

Enclosure:

Memorandum to Victor Stello, Jr.

From John G. Davis w/ enc 1.

DISTRIBUTION -

FGML r/f NMSS r/f FC Central File 58aggett JHickey VMiller RWilde REcunningham All Regional Branch Chiefs I

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• MEMORANDUM FOR: Victor Stello, Jr.  !

Executive Director for Operations -

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i FROM: John G. Davis. Director I Office of Nuclear Material Safety and Safeguards -

l SugJECT: .

PROPOSED AMEN 0MENTS TO 10 CFR PARTS 30 and 32 -

MANUFACTURER $' REGISTRATION OF SAFETY INFORMAT!0W l ON RADIATION SOURCES AND DEVICES t

t 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 1

radiation safety infomation about sources and devices containing~ radio-

, active material.

! This rulemaking activity will provide clearly in the regulations for a long standing practice whereby manufacturers of sealed sources of radioactive .1

material and devices containing sealed sources file with NRC radiation i safety infomation about their products. The infomation is evaluated and, when referenced in specific license applications by the manufacturers'

! customers, is used by 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. ,

l To date this practice has been conducted under a general provision in the >

regulations (g30.32(a)) that allows an applicant for specific license to i

! incorporate by reference in an application infomation contained in previous j reports filed with the Commission.  ;

l The practice is extensively used. The NRC maintained sealed source and device  ;

j registry contains information on approximately 3,000 models of sources and l i devices from about 400 manufacturers / distributors (vendors). Both NRC and i l

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 that it l warrants 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 specific.

licensing. Pubitcation of the rule will assure that all vendors of sealed i i sources and devices are infomed of the practice and will clearly state that i manufacturers registering their ptsducts with NRC have a responsibility to ,

• NRC to assure that the d'stributed products meet the radiation safety related i j specifications filed with the registry.

! I recommend that you sign (under authority delegated in 10 CFR 1.40(c) and (d))

l the enclosed notice of proposed amendments to 10 CFR Parts 30 and 32. The  :

I appropriate Congressional comittees will be infomed of these proposed changes,

! A notice regard'ng publication of the proposed amenhents will be included in 1 j the next Weekly Report to the Commission.

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., Coordination: The Offices of Nuclear Regulatory Research. State Programs, i Inspection and Enforcement and Administration concur in the enclosed amend- i i ments to 10 CFR Parts 30 and 32. The Office of the General Counsel has no li legal objection. The Office of Public Affairs concurs that a pubile announce-l ment need not be issued. l John G. Davis. Director '

Office of Nuclear Material i Safety and Safeguards

Enclosures:

+

A. FR Notice of Proposed Rulemaking

i. B. Draft Regulatory Analysis  :

C. Draft Congressional Letter i  !

i Acoroved for Publication ,

In a final rule published March 19,1982 (47 FR 11816), the Cannission dele-1 . gated to the E00 (10 CFR 1.40(c) and (d)) the authority'to develop and promul - ,

i gate rules as defined in the APA (5 U.S.C. 551(4)) subject to the limitations in NRC Manual Chapter 0103. Organfration and Functions. Office of the Executive Director for Operations, paragraphs 0213. 038. 039, and 0310. i

The enclosed proposed rule, entitled " Manufacturers' Registration of Radiation 2

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 -

i their products for evaluation and subsequent use in NRC's consideration of appli- i cations for specific licenses authorizir.g use of the products.

l

This proposed rule does not constitute a significant question of policy, nor does i

! it amend regulations contained in 10 CFR Parts 7. 8. or 9 Subpart C. I therefore i l find that this rule is within the scope of my rulemaking authority and am proceed- l ing to issue it for public coment.

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! (Date) Victor Ste110. Jr.,

j Executive Director for Operations i i

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.N NUCLEAR REGULATORY COPWISSION .

10 CFR Parts 30 and 32 -

Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources AGENCY: Nuclear Pegulatory Connission.

i ACTION: Proposed rule.

1

SUMMARY

Manufacturers of radiation sources and devices, such as industrial

} gauging devices containing radiation sources, at present routinely file with l the Nuclear Regulatory Connission radiation safety information about them.

i l NRC evaluates and subsequently uses the information in its consideration of 1

appitcations for specific licenses to authorize acquisition and use of these

sources and devices. Filing of information by a manufacturer (called regis-tration) and subsequent reference to that information by its customers which

{ have specific Itcenses avoids multiple filings of the same information and j thus expedites NRC's consideration of app 1tcations.

NRC would like to formalize present practice. It proposes to amend its i

! regulations so that they clearly cover present practice. The proposed amend-ments, directed toward manufacturers, describe the information NRC needs for its radiation safety evaluation and registration of a device or sealed source.

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

1 Enclosure A

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ADDRESSES: Send coments to: Secretary, ij.S. Nuclear Regulatory Comission. .

Washington, DC 20555. ATTN: Docketing and Service Branch.

Hand deliver coments 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 s .

Street NW, Washington, DC. .

t Obtain single copies of the regulatory guides referred to in this document from Steven L. Baggett, Office of Nuclear Material Safety and Safeguards, U.S.

Nuclear Regulatory Comission, Washington, DC 20555, telephone (301) 427-9005.

FOR FURTHER INFORMATION CONTACT: Steven L. Baggett, Office of Nuclear Material

' Safety and Safeguards, U.S. Nuclear Regulatory Commission. Washington, DC

20555, telephone (301)427-9005.

SUPPLEMENTARY INFORMATION:

l

! s l Table of Contents

s,

! I. Purpose of Proposed Rule II. Background N A. Sealed Sources s B. Devices C. ' Sealed Source and Device Registn tion

., 1. Nationwide Registry N '

1 2. NARM

! 3. Devices and Sealed Sources Manufactured outside the U.S. 'x D. Requests for Registration

> F Certificate of Registration s

! III. ine Proposed Rule 's .

l IV. Environmental Impact: Categorical Exclusion ,

i V. Paperwork Reduction Act Statement

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VI. Regulatory Analysis  :

VII. Regulatory Flexibility Act Certification '

} List of subjects in 10 CFR Parts 30 and 32 s j N 1

2- 's Enclosure A s

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. q, I. ' Purpose of proposed rule i

yNRC regulations clearly provide for issuance of specific licenses

,'e. which reference so-called " pre-marketing" evaluations and registrations of radiation safety infonnation on certain sealed sources of radioactive material and on devices which incorporate those sources. Examples include smoke detec-t i

_. tors used 'under an exemption from regulations, gauges used under a general license, and certain medical devices used under specific license. The reg-sulationis are less clear about pre-marketing evaluation of other products such as. industrial radiographic devices and in-plant gauging devices which are used under specific license. With respect to these latter products, NRC has devel-oped an adninistrative procedure for pre-marketing evaluation and registration

and has implemented it under general provisions of its regulations, as dis-cussed below in the background section.

The proposed rule in 10 CFR 32.210 would add specific provisions to the

, regulations for this established adninistrative procedure. It would describe NRC's evaluation and registration criteria and would clarify the regulatory ,

j responsibility of manufacturers of products for which NRC evaluates and registers radiation safety infonnation. In particular, the proposed rule would clearly state that the registrant is required to manufacture and distribute its product I in accordance with its request for evaluation and registration and with the i tenns 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 NRC.

t Issuance of the proposed rule should assure that all manufacturers, appli-cants for specific licenses, and other interested persons are infonned of and l

comply with NRC's procedures and requirements for pre-marketing registration of radiation safety infonnation on sealed sources and devices.

r Enclosure A

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1 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 if, among other things, "the applicant's proposed f

, equipment and facilities are adequate to protect health and minimize danger to life or property."

With respect to certain equipment, particularly sealed sources of by-product materials and devices containing these, applicants for specific licenses frequently describe that equipment by referring to data already filed with NRC by the equipment manufacturer under a practice of direct comunication be-tween the Comission and the manufacturer.

This practice is ackninistratively convenient to NRC, manufacturers, and

. to applicants, because it reduces and simplifies paperwork. It is provided for. under the general provision of section 30.32 of 'Part 30, whereby "informa-

, tion contained 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 tems " sealed source" and " device" and describe the program for registration of radiation safety infomation on this equipment.

Enclosure A

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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 fimly fixed to a non-radioactive surface by electroplating or other means. The by-product material with its capsule or other confining barrier is termed a

" sealed source." The confining barrier prevents dispersion of the byproduct material under nomal and most accident conditions related to use of the source.

l There is a wide range in the amount of byproduct material used in sealed sources under specific licenses. Forexample,(1)thesealedsourcesusedin industrial gauges frequently contain several millicuries of byproduct material, (2) the sealed sources used in industrial radiography may contain tens of curies of byproduct material, and (3) a sealed source used in a teletherapy unit'for treatment of cancer may contain several thousand. curies of ' byproduct material.

Radiation safety programs for use of byproduct material as sealed sources are structured on the presumption that the byproduct material will not leak from the secled source, contaminate the environment, and expose individuals to radiation. This presumption depends upon the adequacy of the containment prop-erties of the sealed source to withstand the stresses imposed by the environment l in which the source is used.

Before authorizing distribution and use of a sealed source containing by-product material NRC determines the adequacy of its containment and other radi-ation safety features. Its detennination is based on radiation safety infor-mation submitted by the manufacturer or distributor of the sealed source or by Er. closure A

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l the applicant for a specific license that authorizes its use. In general, NRC uses radiation safety criteria in industry standards in making this determination.

B. Devices Freque'ntly. the hyproduct 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 whereby an operator can 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 purposes as treatment of cancer or for 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." Examples of devices are teletherapy units, industrial radiographic equipment, and industrial thick-ness gauges.

Before authorizing distribution and use of byproduct material in a device, NRC determines the adequacy of the radiation safety features of the device. Its determination is based on information submitted hy the manufacturer or distrib-utor of the device or hy the applicant for a specific license that authorizes use of the device containing hyproduct material. In general, NRC uses radi-ation safety criteria in industry standards in making this determination.

Enclosure A

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, C. Sealed Source and Device Registration

1. Nationwide Registry Manufacturers and distributors of sealed sources and devices subject to regulation by NRC routinely submit radiation safety infomation about their 4

products directly to the NRC, thus avoiding. multiple and time consuming sub-

, mission of the same detailed information by each applicant for a specific -

_ license that proposes to obtain and use those products.

NRC maintains a nationwide registry of radiation safety information on sealed sources and devices containing byproduct material. Regulatory author-ities in the Agreement States (where NRC has relinquished its regulatory jur- ,

isdiction) also provide infomation to NRC for the-registry on their radiation safety evaluations and have access to all the infomation in the registry.

Thus, when a manufacturer or distributor of products within either an Agreement-i State or in NRC's regulatory jurisdiction provides detailed infomation about its sealed source or device to its regulatory agency, the results of the radia-tion safety evaluation will be available for use in granting licensing approval

( to 6sers of the sealed source or device throughout the United States, its terri-tories and possessions and in Puerto Rico.

2. NARM Radioactive material includes " byproduct material" which is radioactive 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 occurr-ing and accelerator-produced radioactive materials, is not subject to regulation t

Enclosure A

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under the Atomic Energy Act of 1954, as amended, but is ; regulated by the States. As a general rule. 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 i

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 MARM is conningled with byproduct .

material .

t

3. Devices and Sealed Sources Manufactured Outside the U.S.

A source or device manufactured outside the United States may be reg-istered with 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 NRC will be maintained, and where NRC can inspect the registrant's activities as necessary to fulfill l g the requirements of NRC's regulations.

D. Requests for Registration Requests for evaluation and registration of sealed sources and devices must contain sufficient infomation for an NRC detemination that the radia-tion safety properties of the product are adequate to protect health and minimize danger to life or property. This general guidtnce on the expected

! contes.t of a request is supplemented by detailed guidance in two NRC docu-Enclosure A i....--_. _ __

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9 ments: (1) , " Guide for the Preparation of Appkications for Radiation' Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material" (NUREG- ), and (2) " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material" (NUREG-- ). These documents, discuss the expected technical content of a request and offer a suggested fonnat. Included in each document is a checklist-that may help an applicant to assure that it submits adequate infor: nation for -

NRC's radiation safety evaluation and detennination of the conditions under which the source or device will be authorized for distribution and use. Manu-facturers and distributors of sealed sources and devices are encouraged to consider these documents when preparing requests for registration.

E. Certificate of Registration Following a detennination of the adequacy of the radiation safety i

properties'of a sealed source or device, a numbered certificate of regis-tration is issued to the manufacturer or distributor. This certificate, among other things, summarizes the submitted radiation safety infonnation 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, l

in effect, a pre-marketing approval cf the source or device, its issuance does not constitute a comitment to issue a specific license authorizing use of the l

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 l

such as training and experience qualifications of the applicant.

Enclosure A

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Copies of the registration certificate are provided to regulatory 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 continue existing practice.

- Manufacturers and distributors would file radiation safety infonnation about their sealed sources and devices and NRC would evaluate that infonnation, provide registration certificates, and use that infonnation in the issuance of specific licenses to users of the sources and devices. To date, this practice has been carried out under general provisions 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 infonned of (1) the opportunity for NRC's pre-marketing evaluation and regis-tration of sealed sources and devices intended for use under specific licenses and (2) NRC's criteria used in making its evaluations.

However, there are two additional important reasons for the proposed rule.

4 First, it would specifically require the manufacturer or distributor (i.e., the registrant of the radiation safety infonnation) to manufacture and distribute the product in accordance with representations in its request for evaluation and with the provisions of the registration certificate. Under this require-ment, if the registrant states a particular limit for radiation levels at a I

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l l Enclosure A 1

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e specified distance from its device, and NRC accepts that limit in its evalu-ation and issuance of the registration certificate, the registrant is required to follow that limit notwithstanding any specific provision in NRC's rules-for a higher limit on devices used under specific license. Second, the registrant's t

quality control program would be. expected to ensure that each sealed source or device meets specifications fumished to NRC.

The proposed rule would require the request for review of a sealed source or device to include sufficient information about the design, manufacture, pro-totype testing, quality control program, labeling, proposed uses and leak test-ing and, additionally, in the case of a device, sufficient infomation about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety l properties of the source or device are adequate to protect health and minimize l

danger to life and property.

NRC will nomally evaluate a sealed source or a device using radiation safety criteria in accepted industry standards. Where these standards and

{

criteria do not readily apply to a particular case, NRC would fomulate rea-sonable standards and criteria, with the help of the manufacturer or distrib-utor, to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property.

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Enclosure A

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9 IV. ENVIRONMENTAL IMPACT: CATEGORICAL EXCLUSION .

The NRC has detennined that this proposed regulation is the type of

. action described in categorical exclusions 10 CFR 51.22(c)(2) and (3).

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

V. PAPERWORK REDUCTION ACT STATEMENT This proposed amendment contains revised' infomation collection require-ments 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 requirements.

VI. REGULATORY ANALYSIS The Comission has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the Comission. The draft analysis is available for inspec-tion 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 infomation contact:" heading).

The Comission requests public comment on the draft regulatory analysis.

Coments on the draft analysis may be subnitted to the NRC as indicated under the ADDRESSES heading. -,

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Enclosure A l

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VII. REGULATORY FLEXIBILITY ACT CERTIFICATION -

As required by the Regulatory Flexibility Act of'1980, 5 U.S.C. 605(b),

the Comission certifies that this rule, if adopted, will not have a sig-nificant economic impact on a substantial number of small entities. 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 distributors. Although a substantial number would be considered small entities, the proposed rule is not expected to have a significant impact on them.

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 detemines 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.

Enclosure A

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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 materials, Labeling, Nuclear Materials Penalty, Radiation Protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble, an'd 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 amendnents to 10 CFR Parts 30 and 32.

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

The authority citation for Part 30 continues 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,asamended,202, j 206, 88 Stat.1242,1244,1246 (42 U.S.C. 5841, 5842, 5846).

l Section 30.7 also issued un' der Pub.L.95-601, sec.10, 92 Stat. 2951 i

(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);

55 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 El 30.36, 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued under sec. 1610, 68 Stat.

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

Enclosure A

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

-as follows:

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1 30.32 Apolication for specific license.

(g) An application for a license to receive and possess byproduct material in the fom of a sealed source or in a device that contains the sealed source shall identify the source or device by manufacturer and model number as registered with the Comission under i 32.210 of this'part or with 4

an Agreement State; alternatively, the application shall contain the infor-mation identified in paragraph 32.210(c).

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS The authority citation for Part 32 is amended to read as follows:

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)..

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

SS 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 il 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)).

l Enclosure A ,

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2. In i 32.1, paragraph (a) is revised to add:

5 32.1 Purpose and scope.

(a)

Further, this part describes procedures and prescribes requirements for the issuance of certificates of registration (covering radiation safety infor-mation about a product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources which are to be used by persons specifically licensed under Part 30 of this chapter or equivalent regulations.

of an Agreement State.

3. Following Subpart C. " Quality Control Sampling Procedures," a new Subpart D heading and a new e 32.?10 under Subpart D are added as follows:

Subpart D - Specifically Licensed Items i 32.210 Registration of product infomation.

(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 subnit a request to-NRC for evaluation of radiation

- safety information at,out its product and for its registration.

(b)~ The request for review shall-be made in duplicate and shall be l

sent to the U.S. Nuclear Regulatory Consnission, Division of Fuel Cycle and l Material Safety, Material Licci sing Branch, Washington DC 20555.

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

! about installation, service and maintenance, operating and safety instruc-1 l

Enclosure A I ___ _ . _ _ _ . .

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4 tions, 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 and property.

(d) NRC will normally evaluate a sealed source or a device using radiation safety criteria in accepted industry standards. Where~these stan-dards and criteria do not readily apply to a particular case, NRC would fonn-

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ulate reasonable standards and criteria, with the help of the manufacturer or-distributor, to ensure that the radiation safety. properties of t.% device or sealed source are adequate to protect health and minimize danger to life and property.

(e) Upon completion of the evaluation, the Comissio1 will issue to the person making.the request a certificate of registration acknowledging the avail-ability of the submitted infonnation for incorporatice by reference into appli-cations submitted by applicants for-specific licenses ' proposing use of the product.

1 (f) The person submitting the request for evaluation and registration of i

! safety infonnation about the product is required to manufacture and distribute the product in accordance with:

(1) the statements and representations, including quality control program, t

conf ained in the request, and

! (2) the provisions of the registration certificate.

Dated at Bethesda, Maryland this day of ,1987.

i For the Nuclear Regulatory Comission.

i Victor Stello, Jr.

Executive Director for Operations Enclosure A

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DRAFT REGULATORY. ANALYSIS )

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Ji en '.p :or.. .c . . ' . ' NOTICE.0F PROPOSED RULEMAKING - :.. ,

i Manufacturers' Registration of

- Radiation Safety Information for i Certain Devices and Sealed Sources 9

TNTRODUCTION ,

The purpose of a regulatory analysis is to ensure that NRC regulatory

! decisions are based on adequate infomation concerning the need for and con-sequences of a proposed regulatory action and to ensure that cost effective regulatory actions, consistent with providing the necessary protection of the public barith and safety and common defense and sech-ity, are identified. .

The pr icedures followed by NRC staff in preparing regulatory analyses are sct out in NRC's published document, " Regulatory Analysis Guidelines" (NUREG-OC58,. 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 i

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

c. A substantial increase in cost to NRC licensees, pemit holders or applicants, to Federal, state or local goverments, and geo-l graphical 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 rules which result in impacts a, b or c. The proposed rule considered in

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this analysis, "Manufac'tdreM1tegistration of Radiation' Safety INformatio'n

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for Certain Devices'and Sialed ' Sources;" it in this catehory.

I'n'tefested ' personsaIe e6c'ouraged t'o comerit on 'this'a6alysis'and '

those coments wlli be considered in detemining further NRC action' on the proposed rule. Coments should be sent to: Secretary, U.S. Nuclear Regula' tory Comission, Washington, D.C. 20555. ATTNrbocketingand'ServiceBranch.

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1. STATEMENT OF PROBLEM S

sThe'NRC maintains a nationwide registry of radiation safety infoma-tion on sealed sources of radioactive material and devices containing sealed .

sources. . Manufacturers or distributors of sealed sources 'and devices volun-tarily submit product informatiion for the registry 'and that infomation is then incorporated by re'ference into applications 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 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 "infomation 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: (1) has adequate notice of its existence and operation

, been provided so that all manufacturers and distributors, particularly those i entering the sealed source and device business, have fair opportunity to register their products; (2) does the manufacturer have to assure that the '

i distributed products meet the radiation safety related specifications filed 1 l with the registry; (3) does the manufacturer have to follow some sort of l

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quality assurance requirements for its products;'and (4) what criteria does NRC use to evaluate the. radiation u safety aspects of a manufacturer's product.

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2. " '

OBJECTIVES .

In consideration of the above statement of'the prob'lem, the proposed rule has the following objectives:

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

(1)thattheNRCmaintainsanationwideregistryofradiation safety related infonnation on sealed sources 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 infomation 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 and is used in the '"

issuance of specific licenses.

i B.

To clearly establish that registrants of product information have a responsibility to the NRC to implement quality control programs and o

thus ensure that distributed products meet 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.

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3. ALTERNATIVES

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Alternative 1: Issue a proposed rule that clearly would provide for the voluntary registration with NRC of radiation safety inforination on sources and devices to be manufactured and distributed for use under specific license.. .The rule would state the inforina-tion to be submitted for NRC's evaluation, the standards and criteria used in NRC's evaluation, and the registrant's respon-sibility to assure that distributed products conforin to the registered information.

Alternative 2: No rulemaking action but continue the voluntary registry; Rely on regulatory guides and branch positions to explain j the operation of the registry, what infomation should be registered, and how to register inforination. '

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

, registry by a " mandatory" registry. The manufacturer or i

, distributor would be required to register radiation safety

! infomation before receiving authority to transfer the i

sealed source or device for use under specific license.

Altemative 4: Discontinue the voluntary registry of infomation by manu-facturers and distributors and require the first applicant for a specific license authorizing use of a particular l source or device to submit design and construction data.

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. When clearly and specifically referenced by subsequent applicants, the initially submitted infor1 nation could be used in issuance of additional specific licenses.

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4. CONSEQUENCES .

Alternative 1: This action is consistent with accomplishing the objectives f stated above in section 2. This action also is consistent with the con-tinued operation of the established and matured registration program that is administered by 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. Sunmaries and evaluations of filed information are placed in the central registry that is maintained by NRC and is accessible to t

all 29 regulatory groups. 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 manufacturer or distributor needs to sub-mit 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 continued operation of the administratively efficient registry system for radiation safety information on sources and devices. However,'it would not adequately answer the several questions presented above in section 1.

i 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 requirenents and pertinent regulatory guides and branch positions Also, I

l this alternative would not provide a clear statement of a registrant's 1

Enclosure B

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...I responsibility to assure that distributed sources and devices satisfy the.- >-0 -l radiation safety related specifications on file in the registry. .

Alternative 3: This alternative is consistent with accomplishing the b objectives 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 I applicant for specific license either to file infomation directly or to refer to infomation filed by the man'ufacturer when demonstrating that the applicant's 4

• proposed equipment and facilities are adequate to protect health 'and minimize danger to life or property. This flexibility with respect to which party directly submits infomstion 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 infomation directly with the NRC. That choice could be compromised by requiring " mandatory" registration ty the manufacturer. 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.*

• NOTE: Persons with infomation that is important to consideration of thik.4 alternative of " mandatory" registration are encouraged to comment.

' Enclosure B

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Alternative 4:lThis alternative N'uld appear to unnecessarily complicate the filing of radiation safety information for sources and devices. Direct comuni-cation between the regulatory authority and the manufacturer can be convenient and effective in clarifying submitted infomation. To require that information which may be known only to the manufacturer must always be funneled to NRC through the first license 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 registry i system by NRC, the States, manufacturers and users.

j 5. DECISION RATIONALE The proposed action of issuance of a proposed rule to provide clearly for the voluntary registration with NRC of radiation safety infomation on sources and devices is recommended because:. (1) the proposed rule pemits continued operation of the efficient and effective registry system that has been developed and implemented by NRC and 28 Agreement States, and (2) the proposed rule would answer the several questions about the registry

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system, i.e., have all {nterested parties been infomed 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 regiftered?

In addition, the proposed action provides opportunity for public comment on the Comission's progr5m for evaluation and registration of r$diation safety information on devices and sources used under spect fic license. This oppor- .

. tunity, which may result in an improved program, would not be provided by Alternative *5 (status quo).

Enclosure B

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6. IMPLEMENTATION ,

The notice of proposed rulemaking would be published in the Federal -

Register and the public would be provided a period of 60 days to consent.

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 Register.

The proposed rule is not expected to change the operation and use of th'e existing sealed source and device registry system. The proposed l rule should assist in early recognition by new manufacturers and distrib-

) utors of the opportunity to register their products. Implementation of f

the rule may result in NRC's increased attention to review of manufacturers'

! quality control programs. This action would occur during routine inspections ,

i of manufacturers' in-plant radiation safety programs and possibly also would  ;

occur if users encounter safety problems that are attributabo 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.

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

, The proposed amenhents to 10 CFR Parts 30 and 32 will provide clearly in  ;

the regulations for a long standing practice whereby manufacturers of sealed sources of radioactive material and devices containing sealed sources file with the Nuclear Regulatory Comission radiation safety information about their ,1roducts. The information is evaluated and when referenced in specific' .

license applications by the manufacturers' customers, is used by NRC and the l Agreement States in determining that an applicant's proposed equipment and

, facilities are adequate to. protect health and minimize danger to life or property.

i To date this practice has been conducted under a general provision in the regulations that allows an applicant for specific license to incorporate by t

reference in an application information contained in previous reports filed t with the Comission.

The practice is extensively used. The NRC maintained sealed source and device i

registry contains infomation on approximately 3,000 models of sources and devices from about 400 manufacturers and distributors (vendors). Both NRC l and the 28 Agreement State licensing groups contribute data to and use the registry.

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

In view of the minor nature of the proposed amenhents which merely fomalize present practice, the Comission considers that issuance of a public announce-

, ment is not warranted.

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I l

Enclosure C i

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