ML23151A578

PR-030,032 - 52FR02540 - Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources

ML23151A578
Person / Time
Issue date:	01/23/1987
From:	Stello V NRC/EDO
To:
References
52FR02540, PR-030, PR-032
Download: ML23151A578 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 01/23/1987 TITLE: PR-030,032 - 52FR02540 - MANUFACTURERS' REGISTRATION OF RADIATION SAFETY INFORMATION FOR CERTAIN DEVICES AND SEALED SOURCES CASE

REFERENCE:

PR-030,032 52FR02540 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

PAGE 1 OF 2 STATUS OF RULEMAKING RECORD 1 OF 1 PROPOSED RULE: PR-030,032 RULE NAME: MANUFACTURERS' REGISTRATION OF RADIATION SAFETY IN FORMATION FOR CERTAIN DEVICES AND SEALED SOURCES PROPOSED RULE FED REG CITE: 52FR02540 PROPOSED RULE PUBLICATION DATE: 01/23/87 NUMBER OF COMMENTS: 7 ORIGINAL DATE FOR COMMENTS: I I EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 52FR27782 FINAL RULE PUBLICATION DATE: 07/24/87 NOTES ON: EDO SIGNED FINAL RULE ON 7/14/87. FINAL RULE PUBLISHED AT 52 FR 27 STATUS : 782. EFFECTIVE 8/24/87.

OF RULE:

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DOCKET NO. PR-030,032 (52FR02540)

In the Matter of MANUFACTURERS' REGISTRATION OF RADIATION SAFETY IN FORMATION FOR CERTAIN DEVICES AND SEALED SOURCES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 01/21/87 02/25/87 03/06/87 01/09/87 02/20/87 02/24/87 FEDERAL REGISTER NOTICE - PROPOSED RULE COMMENT OF NL INDUSTRIES, INC. (MARK M. MORRISON)

COMMENT OF STATE OF IOWA (JOHN A. EURE) ( 2)

( 1) 03/06/87 03/03/87 COMMENT OF MILES LABORATORIES, INC.

(JOHN H. ENGELMANN) ( 3) 03/06/87 02/16/87 COMMENT OF MARYLAND DIVISION OF RADIATION CONTROL (ROLAND G. FLETCHER) ( 4) 03/16/87 02/24/87 COMMENT OF AMERSHAM (VICTOR J. BECKER) ( 5) 03/24/87 03/23/87 COMMENT OF AIR TRANSPORT ASSOCIATION (VERN W. BALLENGER, ASST. V.P.) ( 6)

- 03/25/87 07/24/87 03/23/87 07/24/87 COMMENT OF STATE OF NEBRASKA (HAROLD R. BORCHERT) (

FEDERAL REGISTER NOTICE - FINAL RULE 7)

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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 Manufacturers' Registration of Radiation Information for Certain Devices and Sealed AGENCY: Nuclear Regulatory Commission .

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission is amending its regulations to formally endorse its 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 cus-tomers and thus expedites NRC's issuance of licenses. The 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.

EFFECTIVE DATE : (30 days after FR pub l ication)

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

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SUPPLEMENTARY INFORMATION:

Table of Contents I. Purpose of Rule.

II. Background.

A. Sealed Sources.

8. Devices.

C. Sealed Source and Device Registry.

0. Requests for Registration.

E. Certificate of Registration.

III. Public Comments IV. Environmental Impact: Categorical Exclusion.

V. Paperwork Reduction Act Statement.

VI. Regulatory Analysis.

VII. Regulatory Flexibility Act Certification.

VIII. Backfit Analysis.

List of Subjects in 10 CFR Parts 30 and 32 On January 23, 1987 (52 FR 2540), the NRC published for public comment a proposed rule that would formally endorse current administra-tive practice under which manufacturers of certain radiation sources and devices containing radiation sources file safety information about their products with the NRC. The public comments, discussed below, have been considered and the NRC is issuing the final rule without substantive change from the proposed rule.

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I. Purpose of Rule Current NRC regulations clearly provide for the issuance of specific licenses which reference so-called "pre-marketing 11 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 other products such as industrial radiographic devices and industrial gauging devices which are used under a specific license. For these prod-ucts, the NRC has developed and implemented an administrative procedure for the pre-marketing evaluation and registration of radiation safety information under general provisions of its regulations.

The final rule adds specific provisions to the regulations for this established administrative procedure at 10 CFR 32.210. The final rule describes NRC 1 s evaluation and registration criteria and clarifies the regulatory responsibility of manufacturers of products for which the NRC evaluates and registers radiation safety information. In particular, the final rule clearly states that the registrant is required to manu-facture 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 are expected to ensure that its product meets the specifications that the registrant furnished to the NRC.

The final rule ensures that all manufacturers, applicants for specific licenses, and other interested persons are informed of and comply with 3 Enclosure 2

1.'"'.,;,v V.LJ the NRC's procedures and requirements for pre-marketing registration of radiation safety information on sealed sources and devices.

II. Background Section 30.33 of Part 30, uRules of General Applicability to Domestic Licensing of Byproduct Material , 11 states that an app 1icat ion for a spe-cific 1i cense wi 11 be approved if, among other things, 11 the applicant I s proposed equipment and facilities are adequate to protect health and mini-mize danger to life or property."

With respect to certain of the proposed equipment, particularly sealed sources of byproduct material and devices containing sealed sources, appli-cants for specific licenses frequently describe that equipment by referring to data already filed with the NRC by the equipment manufacturer under a practice of direct communication between the NRC and the manufacturer.

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 the 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§ 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. 11 The following sections explain the key terms 11 sealed source 11 and "device 11 and describe the program for registration of radiation safety information on this equipment.

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A. Sealed Sources Byproduct material used by a specific licensee often is contained in a seal_ed*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. 11 The confining barrier prevents dispersion of the byproduct material under normal and most accident conditions related 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 byproduct material, (2) the sealed sources used in industrial radiog-raphy 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 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 ~sed.

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 5 Enclosure 2

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authorizes its use. The NRC uses its regulations and radiation safety criteria set out in industry standards in making this determination.

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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 11 device. 11 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 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 6 Enclosure 2

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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 1 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 users of the sealed source or device throughout the United States, its territories and possessions, and in Puerto Rico.

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 currently by detailed guidance in two NRC documents: (1) Regulatory Guide 10.11, 11 Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material," and (2) Regulatory Guide 10.10, 11 Guide for the Preparation of Applications for Radiation Safety Evaluation 7 Enclosure 2

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and Registration of Devices Containing Byproduct Material. 111 These docu-ments 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 1 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 After a determination of the adequacy of the radiation safety properties of a sealed source or device, the NRC or an Agreement State issues a numbered certificate of registration to the manufacturer or distributor. This certificate, among other things, summarizes 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 1 Copies of Regulatory Guides may be purchased through the U.S. Government Printing Office by calling (202) 275-2060 or by writing to the U.S.

Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082.

Copies may also be purchased from the National Technical Information Service, U.S. Department of Convnerce, 5285 Port Royal Road, Springfield, VA 22161. A copy is available for inspection and/or copying for a fee in the NRC Public Document Room, 1717 H Street, NW., Washington, DC 20555.

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requires satisfaction of other requirements listed in§ 30.33 of 10 CFR Part 30 such as the training and experience qualifications of the appli~ant.

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. Public Comments 9 The proposed rule was published for public comment on January 23, 1987.

The comment period ended March 24, 1987. A total of nine letters of comment were received. Five letters were from regulatory authorities in Agreement States supporting issuance of the final rule. One letter from a trade association and two letters from manufacturers support the rule. A third manufacturer commented that if all sources are to be included under the proposed rulemaking, a major revision should be made to clarify the condi-tions imposed upon a diverse field of manufacturers. This comment and others that suggest significant modification of the proposed rule are discussed below.

The manufacturer that submitted the comment about a needed revision if all sources were to be covered by the rule is a distributor of refer-ence standards that are used under the exemption from regulations provided in 10 CFR 30.18. The regulatory requirements for distribution of these small quantities of radioactive material are set out in 10 CFR 32.18, 32.19 and 32.20. Similarly, regulatory requirements for distribution of devices used under the general license in 10 CFR 31.5 are set out in

§§ 32.51 and 32.52. This final rule has no effect on those and similar products for which particular manufacturing requirements are set out in the regulations. This final rule pertains only to sealed sources and 9 Enclosure 2

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devices that are to be used under a specific license. To clarify this point, the text of the proposed§ 30.32(g) is changed from "An applica-tion for a license to receive and possess byproduct material in the form of a sealed source or in a device ... 11 to 11 An application for a specific license to use byproduct material in the form of a sealed source or in a device ... 11 One commenter interpreted the proposed rule to require that licensees now using sealed sources and devices determine that the products are properly registered with the NRC invnediately. The commenter asked that the due date for submitting additional information to NRC be delayed until the next license renewal or update cycle after the effective date of the final rule. This interpretation of the rule was not intended by NRC.

The rule is merely a codification of current administrative practice and requires no additional action for sources and devices presently used because necessary safety information was evaluated before issuance of the specific license to the user. Consistent with administrative practice and the rule, applications submitted after the effective date of the rule must identify the source or device by manufacturer and model number as registered with the NRC or an Agreement State or the application must contain the information identified in§ 32.210(c).

A manufacturer suggested that the NRC perform all the safety evalua-tions of sealed sources and devices in lieu of sharing this activity with regulatory authorities in the Agreement States. The commenter remarked that the Agreement States often have a shortage of manpower for the per-formance of evaluations and that performance of all evaluations by a single group at NRC would enable evaluation personnel to gain the benefit of multiple experiences. The NRC is aware that some, but not all, 10 Enclosure 2

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manufacturers share the commenter's opinion that all safety evaluations should be done centrally. Other manufacturers prefer the States' involvement because of the increased availability of, and ease of com-munication with, State regulatory authorities as a result of their rela-tively close location. Upon consideration of distribution of the regula-tory burden, the States' interests in regulating their respective manu-facturers, and the established program for cooperation with the States, the NRC favors the continued sharing of this safety evaluation activ.ity

- with the States.

One manufacturer recommended that, in addition to providing in the regulations for the manufacturers' registration of safety information about their sealed sources and devices, a system be established,for manufacturers' registration of approved transportation containers for sealed sources. As proposed by the commenter, firms using radioactive sources then could use any approved .transportation container without prior approval of the NRC and license amendment. The system described by the commenter deals with the NRC's and the Department of Transporta-tion's packaging and transportation requirements for radioactive material.

The sealed sources and devices. generally contain no more than a Type A quantity of radioactive material and would be subject to the packaging and transportation requirements of the Department of Transportation. In those cases where sealed sources and devfces contain greater than a Type A quantity of radioactive material, an administratively convenient system is in place to use packages under general licenses provided in 10 CFR Part 71 and under multiple specific licenses which are related to a single package evaluation and approval by NRC. However, this convnent is beyond the scope of this rulemaking proceeding and the feasibility of 11 Enclosure 2

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the suggested system is not under consideration. This final rule is published without substantive change from the proposed rule.

IV. Environmental Impact: Categorical Exclusion The NRC has determined that this regulation is the type of action described in the categorical exclusion set out in 10 CFR 51.22(c)(3)(i).

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

V. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

These requirements were approved by the Office of Management and Budget under approval numbers 3150-0017 and 3150-0001.

VI. Regulatory Analysis The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives considered by the Commission. The analysis is available 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 11 For Further Information

Contact:

11 heading).

VII. Regulatory Flexibility Act Certification In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant economic impact on a substantial number of small entities.

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The Sealed Source and Device Registry now contains approximately 3,000 certificates of registration which have been issued to about 400 manu-facturers 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 rule is not expected to have a significant 9 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 rule does 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 rule results in savings to manufacturers and dis-tributors and to applicants for specific licenses in the following manner.

The NRC annually processes about 1,500 applications for specific licenses, or amendments to specific licenses, which reference safety information contained 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 to prepare its application 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 13 Enclosure 2

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provided to each of its multiple customers by the manufacturer or dis-tributor 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 rule does not impose an additional burden on any manufacturer or distributor of sealed sources and devices.

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

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

LIST OF SUBJECTS IN 10 CFR PARTS 30 ANO 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. 552 and 553, the NRC is adopting the following amendments to 10 CFR Parts 30 and 32.

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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).

4lt 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);

§§ 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§§ 30.6, 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(0)).

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

§ 30.32 Application for specific license.

(g) An application for a specific license to use byproduct mate-rial in the form of a sealed source or in a device that contains the sealed source must either - -

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

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS

3. The authority citation for Part 32 is revised 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); §§ 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.

220l(b)); and§§ 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.Sla, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 u.s.c. 2201(0)).

4. In§ 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 bypro~uct material for sale or distribution to (1) persons exempted from the licensing requirements of Part 30 of this chapter, or (2) persons 16 Enclosure 2

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generally licensed under Part 31 or 35 of this chapter. This part also prescribes certain regulations governing holders of these licenses. In addition, this part prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material ir.to 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 9 product) to manufacturers or initial transferors of sealed sources or devices containing sealed sources which are to be used by persons specifi-cally licensed under Part 30 of this chapter or equivalent regulations of an Agreement State.

5. Subpart Dis added as follows:

Subpart D - Specifically Licensed Items

§ 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 safety information about its product and for its registration.

(b) The request for review must be made in duplicate and sent to the U.S. Nuclear Regulatory Conrnission; Division of Fuel Cycle, Medical, Academic, and Commercial Use Safety; Medical, Academic, and Commercial Use Safety Branch; Washington, DC 20555.

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeli~g, proposed uses and leak testing and, for a device, the request must also include sufficient information 17 Enclosure 2

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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 health and minimize danger to life 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 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.

{e) After completion of the evaluation, the Commission issues a certificate of registration to the person making the request. The certif-icate of registration acknowledges the availability of the submitted infor-mation 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--

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(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 ~ a y o For the Nuclear Commission.

Victor Stello, Jr.

Executive Director 19 Enclosure 2

Approved for Publication The Co!'1111ission delegated to the EDO [10 CFR l.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 Operati ons, paragraphs 0213, 038, 039, and 0310.

The enclosed final rule, entitled "Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources, 11 amends 10 CFR Parts 30 and 32 to provide clearly for manufacturers of radiation sources and devices containing radiation sources to file with NRC radi ation safety informa-tion about their products for evaluation and subsequent use in NRC's considera-tion of applications for specific licenses authorizing use of the products.

Thfs final rule does not constitute a significant question of policy, nor does ft amend regulations contained fn 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 am proceeding to issue it.

JUL 14 1987 (Date) r for Operations Enclosure 1

STATE OF NEBRASKA DEPARTMENT OF HEALTH DOCK£ U US NkC KAY A. ORR GREGG F. WRIGHT, M.D. , M.Eo.

GOVERNOR DIRECTOR "87 11AR 25 P\2 :38 OFFI C:.. Jr ::::* r t1 "

OOCKE. TlNli <~ S! RVlCf.

BRA Cl-i March 23, 1987 Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATTN: Docketing and Service Branch

Dear Sir:

This is in reference to the SS&D Proposed Rule which would require manufacturers to register radiation safety information for certain sealed sources and devices.

The requirement for manufacturers to register radiation safety information for sealed sources and devices is excellent and we would urge the adoption of this proposed rule.

Should you have any questions concerning this matter, please do not hesitate to contact me.

Sincerely, bw~

A. ~o(Harold R. Borchert, Director 9' 1 Division of Radiological Health HRB/bj f 301 CENTENNIAL MALL SOUTH P. 0. BOX 95007, LINCOLN , NEBRASKA 68509-5007 AN EQUAL OPPORTUNITY/ AFFIRMATIV'A ~ ~~ d . ... -~~~. ~ .~ *~~~L-

U. t M:JetbliiR ~Gt!t.A1 Y <S9MMls&JQII DOCKETING & SERVICE SECTION. .

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Air Transport Association ata OF AMERICA')Ol K[ if:

USNRC 1709 New York Avenue, NW Washington, DC 20006-5206 "87 HAR 24 P3 :QS Phone (202) 626-4000 March 23. 1987 Secretary U.S. Nuclear Regulatory Commission Washington. D.C. 20555 Attn: Docketing and service Branc h

Subject:

Manufacturer's Registration of Safety Information for Sealed Radiation sources - NPRM Gentlemen:

The ATA members who responded to your request for comments expressed no objection to the proposed rule.

One member requested. however. that the information that should be provided should not have to be submitted until the next license renewal or update cycle after the effective date of the proposed rule. This member is a license holder and. under the proposed rule. would be required to indicate that the sealed sources/devices they purchase are properly registered with the NRC.

Your consideration of our members remarks is appreciated.

Sincerely.

Vern w. Ballenger Assistant Vice President Engineering and Maintenance DWL: jp MAR 2 7 1987 AcknOWle~d by card . **** , ***** .,. ;,, .,. ,i.,~

U.S. NUCLE-M REGULATORY COMMISSIOB DOCKETING & SERVICE SECTION O FFIG ('~ ..-.,: c:::P.fiARY Postmark ,.

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Secretary BRANCH U.S. Nuclear Regulatory Conunission Washington, DC 20555 ATTN: Docketing and Service Branch

Dear Sir:

Pursuant to your invitation to comment on your proposal to amend 10 CFR Parts 30 and 32 as described in the Federal Register, pages 2540-2545, dated 23 January 1987, we offer the following:

The proposed amendments would formalize the current practice of the NRC under which manufacturers of radiation sources and devices containing radiation sources file information about their products with the NRC or with appropriate authorities in the Agreement States so that their products will be evaluated and registered. We believe that this NRC practice has been a useful one, both to avoid multiple evaluations for the purpose of licensing prospective users of the equipment and to provide knowledgeable review of the equipment design, and we are therefore in favor of the proposed amendment.

However, the amendments as they stand will freeze the current role of the Agreement States in this review. We have found that Agreement States are generally not capable of providing knowledgeable analyses of the safety aspects of such equipment, and often cannot devote more than a single engineer's time to this activity, in spite of the fact that you estimate that 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />' time is needed for evaluation of a device. Such evaluation should be done centrally so that evaluation personnel will gain the benefit of multiple experience.

We therefore recommend that in proposed 30. 32 ( g) (1), the words "or with an Agreement State" be deleted, and in proposed 32. 210(a), the words "shall submit" be substituted for the words "may submit."

Sincerely, Victor J. Becker Operations Manager ETC:cmr mersham i\eknow ed by ca r-1 **** r ... ..,..-~.......;~b....

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• BALTIMORE, MARYLAND 21201

• AREA CODE 301 * ~ 333-3130 TTY FOR DEAF: Saito. Area 383* 7555 D.C. Metro 565-0451 Adele Wilzack, R.N., M.S., Secretary William M. Eichbaum, Assistant Secretary February 18 , 1987 Donald A. Nussbaumer Assistant Director for State Agreements Program Office of the State Programs U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Nussbaumer:

The Maryland Division of Radiation Control (DRC) concurs with the provisions of 10 CFR Parts 30 and 32, Man ufacturers Registration of Radiation Safety Information for Certain Devices and Sealed Sources, and encourages its adoption . The DRC will consider recommending the adoption of a similar regulation at State level.

Should you have questions or comments please contact me or Mr. Charles R.

Flynn at (301) 333-3130.

Sincerely,

&~!t~~

Roland G. Fletcher Director of Radiation Control RGF/amc cc : Mr. David L. Resh, Jr.

MAR 9 1987

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CKETING L SE ~V\CL ll~,lNCH John H. Engelmann Miles L.IDoratories, Inc.

Assistant Counsel P. 0. Box 40 March 3, 1987 Elkhart, IN 46515 (219) 262-7482 Secretary of the Commission U. S . Nuclear Regulatory Commission Washington , D.C . 20555 Attention: Docketing and Service Branch

Subject:

Comment on Petition for Proposed Rulemaking Published in Federal Register, page 2540, January 23, 1987 - Docket No.: FR 87-1575

Dear Sir:

Miles Laboratories, Inc. conducts research, manufactures and distributes products in the health care sector, including isotope labeled products and, accordingly, appreciate this opportunity to comment on the proposed rulemaking petition.

We are a distributor of reference standards licensed under the requirement of 10 CPR 32 . 18 thru 32.20 for distribution to those exempted under 10 CPR 30.18 . These items are manufactured in individual quantities each of which does not exceed the applicable quantity set forth in Appendix B of 10 CPR 30 . 71. These items are not mentioned distinctly in the proposed rulemaking. The present references under 10 CPR 32.18 thru 32.20 do not require further prototype testing, nor does the proposed rulemaking indicate that 10 CPR 32 . 18 thru 32 . 20 be revised to include further testing and quality checks.

Our comments on the proposed rule cover two areas. First, further clarification is needed regarding the term "sealed source or device ." There is a wide range of sealed sources, starting with low-level activity sources used for many purposes and manufactured to meet diverse requirements in parts 10 CFR 31-35, to sources of high activity manufactured under 10 CFR 32.51. Clarification is needed to specifically identify what type of sealed sources the proposed 10 CFR 32 . 210 will apply.

MAR 9 1987 owledged by ca rd. . * * ............. * ........ ...,_

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Secretary of the Commission March 3, 1987 Page 2 Secondly, we propose that if all sources are to be included under the proposed rulemaking, that further revision be made. Since there is a wide range of activity levels, a multi-tiered approach should be considered in the proposed testing criteria. For example, items manufactured in activity levels below the maximum allowable for exempt quantity distribution, 10 CFR 32.18 thru 32.20, should be truly exempt. Another range of activity levels would meet minimum testing requirements, with high activity sources and gauges meeting the strictest test parameters.

In summary, Miles believes the proposed rulemaking does not adequately cover the subject matter, and needs a major revision to clarify the conditions imposed upon a diverse field of manufacturers.

Very truly yours, MILES LABORATORIES, INC.

John H. Engelmann JHE/kab cc: K. D. Yoder

IIIIE .

STATC: OF I-TERRYE. BRANSTAD, GOVERNOR DEPARTME~f. Qndrl..l.B L1f212°t.i! LTH MA ~~*t_ ELLIS, COMMISSIONER February 24, 1987 Donald A. Nussbaumer Assistant Director State Agreements Program U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Mr. Nussbaumer:

Reference is made to your letter dated Feb ruary 3, 1987, in which you outline proposed rules adding specific provisions to 10 CFR 32.210 requiring manufacturers to register e radiation safety information for certain sealed sources and devices. We concur with the proposal and offer the following additional comments relating to NARM:

Recognizing that NRC cannot accept applications for radiation safety evaluation and registration of sealed sources or devices that contain NARM, we believe identical standards must be adopted by states that do evaluations of NARM. The Conference of Radiation Control Program Di rectors, Inc. {CRCPD) through its "Licensing State" concept is making progress as it relates to a uniform policy on regulation of sealed sources and devices {SS&D) containing NARM. We suggest that NRC coordinate closely with CRCPD so that requirements from manufacturers of SS&D containing by-product material are no different from those required from manufacturers of SS&D containing NARM.

If you have any questions, please do not hesitate to contact me .

.;;;Yi. £_

John A. Eure, Chief Bureau of Environmental Health 515/281-4928 JAE/bf cc: Charles M. Hardin, CRCPD MAR 9 198T nowled ed by C"' rd .********* ~* ** n ...

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• a7 FEB 25 p 2 :o 4 0n, DC February 20, 1987 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch

Dear Sirs:

This letter transmits comments on the proposed changes to 10 CFR Part 30 and 32 listed in the Federal Register, Vol. 52, No. 15, dated January 23, 1987.

I recommend that approved transportation containers for sealed sources, whether Type A or B, be registered with the Commission by the manufacturer rather than the user in his license. This inclusion in the proposed regu-lation will ultimately allow firms using radioactive sources to use any approved transportation container without prior approval of the Commission and license amendment.

I feel that simplified registration of sealed sources, as well as transport containers, would benefit industrial users and the agency by decreasing the administrative costs of multiple registration.

Respectfully,

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Mark M. Morrison Radiation Protection Officer NL Baroid MWD cc: w. Paske J. Sutherland W. Hendricks P. Rodney M. Street Technology Systems NL Information Services Group/NL Industries, Inc .

P.O. Box 60070, Houston, Texas 77205 Tel. (713) 987-5800

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BOCKETED USNRC NUCLEAR REG ~-ATORY COMMISSION

'87 JAN 21 Pl2 :19 10 CFR Parts 30 and 32 Manufacturers' Regist~ation of Radiation Safety Information for Certa i- Devices and Sealed Sources AGENCY: Nuclear Regulatory Comm;ssion.

ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory c,mmi ssion is proposing regulations that would formalize current admin istra:i ve practice under which manufacturers of radiation sources and devices containing radiation sources file safety information about their products wi th the NRC. The NRC evaluates and uses the information in its issuar:e of specific licenses to users of the products. Filing of information by a manufacturer (called registration) avoids multiple filings of the sam~ information by the customers and thus expedites NRC 1 s issuance of lice nse s. The proposed amendments, directed toward manufacturers, describe the information that the NRC needs for its evaluation of a source or dev i ce and state the registrant's respon-sibility to ensure that distributed products meet radiation safety specifications file d with the NRC.

DATES: Submit comments by IIAR 2 4 1987 Comments received after this date will be considered if it is practical to do so, but assur-ance of consideration cannot be giJen 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, Washington, DC 20555, telephone (301) 427-9005.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Purpose of Proposed Rule.

II. Background.

A. Sealed Sources.

B. Devices.

C. Sealed Source and Device Registration.

1. Nationwide Registry.

2. NARM.

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3. Devices and Sealed Sources Manufactured Outside the United States.

D. Requests for Registration.

E. Certificate of Registration.

II I. The Proposed Rule.

IV. Environmental Impact: Categorical Exclusion.

V. Paperwork Reduction Act Statement.

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 11 pre-marketing 11 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 other products such as industrial radiographic devices and industrial gauging devices which are used under a specific license. For these prod-ucts, the NRC has developed and implemented an administrative procedure 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 1 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 1 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 1 s procedures and requirements for pre-marketing registration of radiation safety information on sealed sources and devices.

II. Background Section 30.33 of Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material, 11 states that an application for a specific license will be approved if, among other things, "the applicant's proposed equipment and facilities are adequate to protect health and mini-mize danger to life or property. 11 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 of direct communication between the NRC and the manufacturer.

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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 the 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§ 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 11 sealed source 11 and 11 device 11 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 contpined 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. 11 The confining barrier prevents dispersion of the byproduct material under normal and most accident conditions related 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 byproduct material, (2) the sealed sources used in industrial radio-graphy may contain tens of curies of byp~oduct material, and (3) a sealed 5

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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 11 device. 11 6

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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

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users of the sealed source or device throughout the United States, its territories and possessions, and in Puerto Rico.

2. NARM Radioactive material includes 11 byproduct material 11 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, 11 naturally occurring and accelerator-produced radioactive materia 1s, 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 Sea1ed Sources Manufactured Outside the United States A source or device manufactured outside the United States may be registered with the NRC if the appropriate information is supp1ied and if NRC 1 s administrative requirements are satisfied. Additionally, the registrant must establish an address or representative in the United States where papers may be served, wh~re records required by the NRC will be maintained, and where the NRC can inspect the registrant 1 s activities as necessary to fulfil1 the requirements of NRC 1 s regulations.

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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,ll and (2) Draft Regulatory Guide 11 FC 601-4, Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material. 111 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 1 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 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.

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issues a numbered certificate of registration to the manufacturer or distributor. This certificate, among other things, summarizes 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§ 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 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 NRC 1 s pre-marketing evaluation and registration of sealed sources and 10

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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 partic~lar 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 1 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

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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)(i).

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 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.

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-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 11 For further information contact: 11 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 ADDRESSES 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 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 1 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

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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 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.

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.

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VIII. BACKFIT The NRG '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 licenses 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).

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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);

§§ 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. 220l(b)); and§§ 30.6, 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(0)).

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

§ 30.32 Application for specific license.

{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§ 32.210 of this chapter or with an Agreement State; or (2) Contain the information identified in§ 32.210(c).

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS

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

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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); §§ 32.13, 32.lS(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§§ 32.12, 32.16, 32.20, 32.25(c), 32.29(c), 32.Sla, 32.52, 32.56, and 32.210 are issued under sec. 1610, 68 Stat. 950, as amended (42 u.s.c. 2201(0)).

4. In§ 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 chapter. This part 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

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devices containing sealed sources which are to be used by persons specifi-cally licensed under Part 30 of this chapter or equivalent regulations of an Agreement State.

5. Subpart Dis added as follows:

Subpart D - Specifically Licensed Items

§ 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 safety information about its product and for its registration.

(b) The request for review must be made in duplicate and sent to the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle and Material Safety, Material Licensing Branch, Washington, DC 20555.

(c) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak test-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 health and minimize danger to life 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

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• • I to ensure that the radiation safety properties of the device or sealed source are adequate to protect hea1th and minimize danger to life and property.

(e) After completion of the evaluation, the Commission issues a certificate of~registration to the person making the request. The certif-icate of registration acknowledges the availability of the submitted infor-mation 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.

1 Dated at Bethesda, Maryl and, this .!l!!__ day o /-lJ.....C:.:::.:::..=...:::c...,~* 198l(.

For the Nuclear vfctor Stello, Executive Dire for Operations.

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