ML20207S926

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

ML20207S926
Person / Time
Issue date:	10/16/1986
From:	Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Beckjord E, Kerr G, Norry P, Taylor 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)
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 AB34-1-17, AB34-2-31, NUDOCS 8703200408
Download: ML20207S926 (36)

Text

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J'* 1 OCT 161986 ,

AB34-1 PDR MEMORANDUM FOR: James M. Taylor, Director .

Office of Inspection and Enforcement '

G. Wayne Kerr, Director Office of State Programs Eric S. Beckjord, Director Office of Nuclear Regulatory Research Patricia G. Norry, Director Office of Administration FROM: John G. Davis, Director Office of Nuclear Material Safety and Safeguards

SUBJECT:

OFFICE CONCURRENCE REQUEST: AMENDMENT OF 10 CFR PARTS 30 AND 32 The concurrence of your Office is requested in 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 M. Lesar, ADM Undesignated, RES

5. Requested Action: Office Concurrence

6. Requested Completion Date: OCT 31586

7.

Background:

NRC regulations clearly provide for pre-markating approval of certain sealed sources of radioactive material and devices which incorporate those sources. Examples are: smoke detectors used under an exemption l

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. OCT 161986 Multiple Addressees 2

+ from 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 under 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-license. Consistent with present practice, the rule would require the applicant to submit for evaluation specified radiation safety information about the product.

The proposed rule would assure that all manufacturers and distributors are informed of NRC's program for evaluation and registration of radiation safety information on sources and devices used under specific license. The rule also would state the registrant's responsibility to ensure that distributed products meet the radiation safety related specifications filed with the NRC.

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 licensee 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.

8. Division Level Review and Responses: ,

On 9/4/86 a draft of the enclosed documents was circulated for Division level review by IE, SP, ADM, RES, and PA. IE and SP responded with Division level concurrence. 0GC and PA responded with Office level concurrence. RES did not respond. ADM's Division of Rules and Records responded with suggestions for more closely conforming with regulation l drafting guidelines set cut in NRC Regulations Handbook (NUREG/BR-0053).

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.- OCT 161966 Multiple Addressees 3 These suggestions have been followed in preparing the enclosed documents. l ADM also noted the need to forward to OMB the new i,fomation collection '

requirement (132.210) on or before the date the proposed rule is published in the Federal Register. The request with supporting-statement for OMB approval is being prepared by NMSS.

(SIGNED) Dossid B. IAnusshant John G. Davis, Director

• j\ Office of Nuclear Material Safety and Safeguards i 1

Enclosure:

Proposed memorandum to Victor Stello, Jr.

fm. John G. Davis w/ enc 1.

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i MEMORANDUM FOR: Victor Stello, Jr.

Executive Director for Operations .

. FROM: John G. Davis, Director

" Office of Nuclear Material Safety and Safeguards i

SUBJECT:

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

MANUFACTURERS' REGISTRATION OF SAFETY INFORMATION i -

ON RADIATION SOURCES AND DEVICES Enclosed for your signature is a notice of proposed rulemaking which would amend 10 CFR Parts 30 and 32 to provide for manufacturers' registration of

' radiation safety'information about sources and devices containing radio-active material.

This rulemaking activity will result in regulations that clearly provide for the long standing practice whereby manufacturers of sealed sources of radioactive material and devices containing sealed sources file radia-l tion safety information about their products with the NRC. The infomation is evaluated and, when referenced in specific license applications by the i manufacturers' customers, is used by the NRC and the Agreement States in ,

detemining that an applicant's proposed equipment and facilities are adequate

,i to protect health and minimize danger to life or property.

This practice'is currently conducted under a general provision in the regula-tions (830.32(a)) that allows an applicant for a specific license to incorp-orate by reference infomation contained in previous reports filed with the

+

Comission.

- The practice is extensively used. The NRC maintained sealed source and device registry contains information on approximately.3,000 models of sources and

, devices from about 400 manufacturers / distributors (vendors). Both the NRC and the 28 Agreement State licensing groups contribute data to and use the registry.

We believe that the practice has now sufficiently matured and is used to the extent that it warrants a specific provision in the regulations. The proposed

rule would continue the practice of manufacturers filing information and, in l effect, receiving pre-marketing approval of their products for purposes of spe-r cific licensing. Publication as a rule will assure that all vendors of sealed sources and devices are informed of this practice and will clearly state that

, manufacturers registering their products with NRC have a responsibility to ensure that the distributed products meet the radiation safety related speci-

fications filed with the registry.

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

the ent.losed notice of proposed rulemaking that would amend 10 CFR Parts 30 and j 32. The appropriate Congressional comittees will be infomed of these proposed j changes. A notice regarding publication of the proposed rule will be included i

in the next Weekly Report to the Commission.

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

Inspection and Enforcement, and Adninistration concur in the enclosed amend-ments to 10 CFR Parts 30 and 32. The Office of the General Counsel has re-viewed this paper and concurs in it. -The Office of Public Affairs concurs that a public announcenent need not be issued.

~

John G. Davis, Director  ;

Office of-Nuclear Material 7 Safety and Safeguards

Enclosures:

. A. FR Notice of Proposed Rulemaking

8. Draft Regulatory Analysis C. Draft Congressional Lettbr i

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

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

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i 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-

cations for specific licenses authorizing use of the products.

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

(Date) Victor Stello, Jr. .

I Executive Director for Operations l

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NUCLEAR REGULATORY COP 91ISSION 10 CFR Parts 30 and 32

> Manufacturers'-Registration of Radiation Safety Infonnation for .

. Certain Devices and Sealed Sources AGENCY:~ Nuclear Regulatory Connission. -

4

, ACTION: Proposed rule.

SUP9tARY: The Nuclear Regulatory Commission is proposing regulations that

. would formalize current administrative practice under which manufacturers of radiation sources and devices containing radiation sources file safety infor - -

t mation about their products with the NRC. The NRC evaluates and uses the I

infonnation in its issuance of specifid licenses- to users of the products.

Filing of information by a manufacturer (called registration) avoids multi-I ple filings of the same information by the customers and thus expedites NRC's issuance of licenses. The proposed amendnents, directed toward manufacturers, describe the information that the NRC needs for its evaluation of a source or

device and state the registrant's responsibility to ensure that distributed

, products meet radiation safety specifications filed with the NRC.

DATES: Submit comments by . Comments received after this date will be considered if it is practical to do so, but assurance of

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j consideration cannot be given except as to canments received on or before

this date.

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Enclosure A l _._

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.. . . ' s ADDRESSES: Send coments 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 regu -

lation from Steven 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 Baggett, Office of Nuclear Material

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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.

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

D. Requests for Registration.

E. Certificate of Registration.

III. 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

, Enclosure A

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I. Purpose of Proposed Rule.

Current NRC regulations clearly provide for the issuance of specific licenses which reference so-called " pre-marketing" evaluations and registrations of radia-tion safety infonnation 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 cer-tain medical devices used under a specific license.

The regulations are less clear about pre-marketing evaluation of other pro-ducts such as industrial radiographic devices and industrial gauging devices which are used under a specific license. For these products, the NRC has developed and implemented an administrative procedure for the pre-marketing evaluation and regis-tration of radiation safety infomation under general provisions of its regulations..

The proposed rule would add specific' provisions to the regulations for this established administrative procedure at 10 CFR 32.210. The proposed rule would 1

-describe NRC's evaluation and registration criteria and would clarify the regula -

tory responsibility of manufacturers of products for which the NRC evaluates and registers radiation safety infomation. In particular, the proposed rule would l 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 4

terms of NRC's registration certificate. Additionally, the registrant's quality control procedures would be expected to ensure that its product meets the speci-fications it furnished to the NRC.

The proposed rule would ensure that all manufacturers, applicants for spe-cific licenses, and other interested persons a* e infomed of and comply with the l NRC's procedures and requirements for pre-marketing registration of radiation safety infomation on sealed sources and devices.

Enclosure A

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II. Background.

Sec. tion 30.33 of Part 30, " Rules of General Applicability to' Domestic Licensing of Byproduct Material," states that an application for a specific 4 ' license will be approved if, among other things, "the applicant's proposed equipment and facilities are adequate to protect health and minimize danger a

I to life or property."

With respect to certain equipment, particularly sealed sources o'f by-product material and devices containing sealed sources, applicants for speci-fic 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.

1 This practice is administratively convenient to the NRC, manufacturers, and to applicants because it reduces and simplifies paperwork.. A single sub-mission by a manufacturer is evaluated by the NRC and the results of the eval-untion are used in NRC's review cf multiple applicationsLfor specific licenses, ce j thus avoiding repetitive submissions by applicants and reviews by the NRC. This practice is provided for under the general provision of 130.32 of Part 30, where-

< by "information 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 terms " sealed source" and " device" and describe the program for registration of radiation safety information on this equipnent.

4 Enclosure A i

A. Sealed Sources.

Byproduct material used by a specific licensee often is contained in a sealed capsule, held between layers of non-radioactive metal foil, or firmly *'

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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.

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 radiography may contain tens of curies l of byproduct material, and (3) a sealed source used in a teletherapy unit for 4

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 op the presumption that the byproduct material will not leak from the sealed source and contaminate the environment or expose individuals j to radiation. This presumption depends upon the adequacy of the containment properties of the sealed source to withstand the stresses imposed by the envir-onment in'which the source is used.

, Before authorizing the distribution and use of a sealed source containing byproduct material, the NRC detemines the adequacy of its containment and other j radiation safety features. This determination is based on radiation safety infor-mation submitted by the manufacturer or distributor of the sealed source or by Enclosure A  :

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. 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 detemination.

B. Devices. ' '

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. 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. Tite -

radiation b'eam is then available for such purposes'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 mec'hn a' isms (if any), is commonly called a " device." Examples of devices are teletherapy units, industrial radiographic equipment, 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 infomation submitted by the neanufacturer or dis -

l i tributor 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 f

and radiation safety criteria set out in industry standards in making this deter-i I

mination. -

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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 infomation about their products-directly to the NRC. This system avoids multiple and time consuming submission ~

b .of the same detailed infomation by each applicant for a specific license that

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proposes to obtain and use those products. '

i-The NRC maintains a nationwide registry of radiation safety'infomation on sealed sources and devices containing byproduct material. Regulatory author-j' ities in the Agreement States (where NRC has relinquished its regulatory juris--

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diction) also provide information to the NRC for the registry on their radiation

safety evaluations and have access to all the infonnation contained in the regis-l

] try .- Thus, when a manufacturer or distributor of products within either an Agree-i . ment 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 users of the sealed source or device thro'ughout the United States, its terri-tories and possessions, and in Puerto Rico.

2. NARM.

Radioactive material includes " byproduct material" which is radioactive 4

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 1

! i Enclosure A I

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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 radia-tion safety evaluation.and regishttion of sealed sources or devices that will contain NARM.' There are two exceptions to this general rule. One excep-tion 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 acceler-ator 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 conningled with byproduct material.

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

A source or device manufactured outside the United States may be reg-istered with the NRC if the appropriate infomation is supplied and if NRC's administrative requirements are satisfied. Additionally, the registrant must establish an address or representative in the United States where papers may be served, where records required by the NRC will be maintained, and where the NRC can inspect the registrant's activities as necessary to fulfill the require-ments of NRC's regulations.

4 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 guidance on the expected content of a request is supplemented by detailed guidance in two NRC docu-

- 8- Enclosure A 9

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< l ments: (1) Draft Regulatory Guide FC 603-4, " Guide for the Preparation of

- Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material " and (2) Draft Regulatory Guide FC 601-4, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registra-tion of Devices Containing Byproduct Material."I These documents discuss the

, expected technical content of a request and offer a suggested fonnat. Included in each docisnent is a checklist that may help an applicant to assure" that it sub-mits adequate infonnation for NRC's radiation safety evaluation and detennination of the conditions under which the source or device will be authorized for distri-bution 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 detennination 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 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, in effect, a

I* Free single copies of Oraft Regulatory Guides FC 603-4 and FC 601-4, to the I

extent of supply, may be obtained by writing to the Publications Services Section, I Infonnation & Records Management Branch, Division of Technical Information and Document Control, U.S. Nuclear Regulatory Comissio1, Washington, DC 20555.

Copies are also available for inspection and/or copying for a fee in the NRC Public Document Room,1717 H Street, NW, Washington, DC 20555.

! 9 Enclosure A i

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pre-marketing approval of the source or device, its issuance does not constitute 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 5 30.33 of 10 CFR Part 30 such as the training andt

. experience qualifications of the applicant.

Copies of the registration certificate are provided to regulatory authori-ties in the Agreement States for' their use in granting specific licensing approval-s to users within their jurisdictions, i

III. The Proposed Rule.

I The proposed rule in 10 CFR 32.210 would formalize this practice. Manufac-turers and distributors would file radiation safety infomation about-their sealed I sources and devices with the NRC and NRC would evaluate that information, provide

! registration certificates, and use that information 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, i

distributors, NRC's licensees, and the public are informed of (1) the opportunity 1{

i for NRC's pre-marketing evaluation and registration of sealed sources and devices i

j intended for use under specific licenses and (2) the criteria that are used by the j

i NRC in making its evaluations.

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

i First, it would specifically require the manufacturer or distributor (i.e., the e

! registrant of the radiation safety infomation) to manufacture and distribute the

{ product in accordance with representations made in the request for evaluation l

Enclosure A

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l and with the provisions of the registration certificate. Under this requirement.

if. the registrant states a particular limit for radiation levels at a specified distance from its device, and NRC accepts that limit in its evaluation and 4

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 quality control program would be expected to ensure that each sealed sour.ce or device neets 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, manufacture, pro-totype testing, quality control program, labeling, proposed uses, and leak test-

ing and, additionally, in the case of a device, sufficient.information about in-

! stallation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety ,

1 properties of the source or device are adequate to protect health and minimize i

. danger to life or property. .

i The NRC normally evaluates a sealed source or a device using radiation safety criteria set out in industry standards. If existing industry standards and cri-j teria do not readily apply to a pcrticular case, the NRC formulates reasonable f standards and criteria with the help of the manufactuier or distributor. The standards and criteria used must be sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and min-

imize danger to life or property.

Enclosure A i

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IV. . ENVIRONMENTAL IMPACT: CATEGORICAL EXCLUSION.

The NRC has detemined that this proposed regulation is the type of ac-tion 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 REDUCTI'ON ACT STATEMENT.

This proposed amendment contains revised' information collection require-ments that r.re 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 Commission has prepared a draft regulatory analysis on this proposed 4

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).

t The Comission requests public coment on the draft regulatory analysis, Coments on the draft analysis may be sutmitted to the NRC as indicated under the ADDRESSES heading.

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Enclosure A j

J i 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 nisnber 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 man-

) ufacturer or distributor to prepare a request for evaluation 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 I evaluation and registration.

Use of the Sealed Source and Device Registry under present practice.and as i

l provided in the proposed rule results'in savings to manufacturers and distributors i and to applicants for specific licenses in the following manner. The NRC annually processes about 1500 applications for specific licenses, or amendments thereto, i which reference safety information contained in the Registry. If, in lieu of i

referring to infonnation in the Registry, each license applicant submitted com-

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", plete 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. hours 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 addi-tional burden on any manufacturer or distributor of sealed sources and devices.

However, it is seeking coments on suggested modifications, especially from small entities, because of the widely differing conditions under which many of them operate.

Any small entily 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 coment 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 i (c) How the proposed regulations could be modified to take into account its differing needs or capabilities.

VIII. BACKFIT The NRC has detennined that the backfit analysis provisions in 10 CFR

-,r 50.109 do not apply to this proposed 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.

l 14 i

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 prote: tion, Reporting and recordkeeping requiraments.

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 amendnents to 10 CFR Parts 30 and 32.

PART 30 - RULES'0F GENERAL APPLICABILITY TO DOMESTIC ,

LICENSING OF BYPRODUCT MATERIAL

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

AUTHORIT(: 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, 206, 88 Stat. 1242, as amended, 1244,1246(42U.S.C.5841,5842,5846).

Section 30.7 also issued under Pub. L.95-601, sec.10, 92 Stat. 2951 (42. U.S.C. 5851). Section30.34(b)alsoissuedundersec.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);

il 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 16 30.6, 30.36, 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued under sec. 1610, 68 Stat.

950,asamended(42U.S.C.2201(o)).

Enclosure A

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

1 30.32 Application 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 must either - - '

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

PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITDis 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, 223'3); sec. 201, 88 Stat.1242, as amended (42U.S.C.5841).

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

5532.13,32.15(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 II 32.12,

32.16,32.20,32.25(c),32.29(c),32.51a,32.52,32.56,and32.210areissued under sec. 1610,68 Stat.950,asamended(42U.S.C.2201(o)).

I t '

l Enclosure A i

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4. In 5 32.1, paragraph (a) is revised to read as follows: -

5 32.1 Purpose and scope.

(a) This part prescribes requirements for the issuance of specific li-censes to persons who manufacture, or initially transfer items containing by-product material for sale or distribution to (1) persons exempted from the licensing requirements of Part 30 of this chapter, or (2) persons generally Itcensed under Part 31 or 35 of this chapter. This part also prescribes cer-tain 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 th's 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 Itcensed under Part 30 of this chapter or equivalent regulations of an Agreement '

State.

1

5. Subpart 0 is added as follows:

Subpart 0 - 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 submit a request to NRC for evaluation of radiation safety infomation about its product and for its registration.

Enclosure A

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! (b) The request for review must be made in duplicate and t

l sent to the U.S. Nuclear Regulatory Comission, Division of Fuel Cycle and l

Material Safety Material Licensing Branch, Washington DC 20555.

(c) The request for rev1ew of a sealed source or a device must include sufficient infomation about the design, manufacture, prototype

• testing, quality control program, labeling, proposed uses and leak test-ing and, ad(itionally, 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 i

, radiation safety properties of the source or device are adequate to protect  !

health and minimize danger to liie and property.

l (d) The NRC nomally evaluates a sealed source or a device using radia-j tion safety criteria in accepted industry standards. If these standards and <

criteria do not readily apply to a particular case, the NRC fomulates reason- ,

able standardd and criteria with the help of the manufacturer or distributor.

! r l The NRC shall use criteria and standards sufficient to ensure that the radia-  !

tion safety properties of the device or sealed source are adequate to protect [

i health and minimize danger to life and property.  !

! (e) After completion of the evaluation, the Commission issues a certifi-  !

cate of registration to the person making the request. The certificate of i registration acknowledges the availability of the submitted information for 1 i  !

l inclusion in an application for a specific license proposing use of the product.  ;

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l 4

Enclosure A i

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

(1) The statements and representations, including quality control program, f

. contained in the request; and (2) The provisions of the registration certificate.

Dated at Bethesda, Maryland this day of , 1987.

For the Nuclear Regulatory Comission.

Victor Stello, Jr.,

Executive Director for Operations.

1 5

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4 pJ DRAFT REGULATORY ANALYSIS I FOR TASK-TFC 86-3 , f

N0TICE OF PROPOSED RULEMAKING - . .

! Manufacturers' Registration of .

' Radiation Safety Infomation for 7 j Certain Devices and Sealed Sources ' 1 4 -

,i INTRODUCTION , ,

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

'! j l regulatory actions, consistent with providing the necessary protection of

.the public health and safety and common defense and security, are identified. ,

The procedures followed by NRC staff in preparing regulatory analyses are l

set out in NRC's published document " Regulatory Analysis Guidelines" (NUREG- ,

0058). Those procedures require a comprehensive analysis for a rule that is i

likely to result in

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

b. A significant impact on health, safety or the environment, or I c. A substantial increase in cost to NRC licensees, permit holders

or applicants, to Federal, state or local goverments, and geo-

graphical regions.

l The procedures in NUREG-0058 also provide for preparation of analyses i

j for rules that will likely result in lesser impacts than identified in a, b l 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 I - I~ Enclosure B l

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this analysis, " Manufacturers' Registration of Radiation Safety Information for Certain:tevices and Sealed Sources," is in this category.

interested tpersons a re encouraged to coment on this analysis and

/' . . .

those commerts will be considered in determining further NRC action on the proposed rule. Comentr.. should be sent to: Secretary, U.S. Nuclear Regulatory Comission, Washington, D.C. 20555. ATTN: Docketing and Service Branch.

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i 2-i Enclosure B

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1. STATEMENT OF PROBLEM The NRC maintains a nationwide registry of radiation safety infonna-tion on sealed sources of radioactive material and devices containing sealed sources. Manufacturers or distributors of sealed sources and devices volun-tarily submit product infomation for the registry and that infonnation is

' then incorporated by reference 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 adninistered, the registry system, in effect, constitutes a system for pre-marketing clearance or approval for licensing purposes of radiation i

safety properties of sealed sources and devices that are used under specific licenses issued by NRC and the Agreement States.

l The operation and use in licensing of the registry is currently guided by 10 CFR 30.32 whereby an applicant for a specific license may incorporate by reference "information contained in previous applications, statements or reports filed with the Commission or the A'tomic Energy Commission ... ."

The absence of a more specific regulatory provision for the registry raises ,

e several questions: (1) has adequate notice of its . existence and operation been provided so that all manufacturers and distributors, particularly those entering the sealed source and device business, have fair opportunity to register their products; (2) does the manufacturer have to assure that the distributed products meet the radiation safety related specifications filed with the registry; (3) does the manufacturer have to follow some sort of Enclosure B i

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l quality assurance requirements for its products; and (4) what criteria does

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NRC use to evaluate the radiation safety aspects of a manufacturer's product.

1

2. OBJECTIVES '

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

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

(1) that the-NRC maintains a nationwide registry of radiation safety related infomation on sealed sources and devices, (ii) that manufacturers or distributors of sealed sources and-devices may file product infomation 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 infomation is available and is used in the issuance of specific licenses.

B. To clearly establish that registrants of product information have a responsibility to the NRC to implement quality control programs and thus ensure that distribund 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.

Enclosure B

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3. ALTERNATIVES .

Alternative 1: Issue a proposed rule that clearly would provide for the

. voluntary registration with NRC of radiation safety infomation -

on sources and devices to be manufactured and distributed for use under specific license.. The rule would state the infoma-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 confom to the registered infomation.

4 Alternative 2: No rulemaking action but continue the voluntary registry;

- Rely on regulatory guides and branch positions to explain the operation of the registry, what infomation should be

. registered, and how to register infomation.-

Alternative 3: Issue a proposed rule that would replace the " voluntary" registry by a " mandatory" registry. The manufacturer or distributor would be required to register radiation safety infomation before receiving authority to transfer the sealed source or device for use under specific license.

Alternative 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 source or device to submit design and construction data.

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

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CONSEQUENCES Niternative 1: This action is consistent with accomplishing the objectives 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. Summaries and evaluations of filed infomation are placed in the central registry that is maintained by NRC and is accessible to all 29 regulatory groups. Because of sharing of registered infomation and acceptance by all the 29 regulatory groups of evaluations perfomed 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 adninistratively 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.

It would not provide clear notice of the registry system to all persons and I 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 consnunications are useful in directing the attention of new manufacturers and distributors to particular regulatory requirements and pertinent regulatory guides and branch positions. Also, this alternative would not provide a clear statement of a registrant's Enclosure B

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I responsibility to assure that distributed sources and devices satisfy the ,

i 1

radiation safety related specifications on file in the registry.

i Alternative 3: This alternative is consistent with accomplishing the objectives stated above in section 2. Also, it would be consistent with.

the NRC's regulation of products used under an exemption from regulatory requirenents (e.g., smoke detectors) or under a general license (e.g.,

luminous safety devices for use in aircraft).. However, it would not be consistent with NRC's and Agreement States' practice for regulating the use of sources and devices under specific license. That practice allows the applicant for specific license either to file infomation directly or to refer to infomation filed by the manufacturer when denonstrating that the applicant's 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 information for use in approval of an application for specific license is useful when considering.one-of-a-kind products and when considering users' modifications of standard designs to satisfy unique conditions of use.

In these cases, the applicant for license may choose to use the services of a manufacturer who has little interest in registering information directly with the NRC. That choice could be compromised by requiring " mandatory" registration by 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 this alternative of " mandatory" registration are encouraged to comment.

Enclosure B

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.e Alternative 4: This alternative would appear to unnecessarily complicate the filing of radiation safety infomation for sources and devices. Direct conmuni- '

cation between the regulatory authority and the manufacturer can be convenient and effective in clarifying submitted infomation. To require that infonnation which may be know 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 system by NRC, the States, manufacturers and users.

5. DECISION RATIONALE Under present practice, the estimated average technical time (in addition to time spent on laboratory work and engineering analysis) required by the man-ufacturer or distributor to prepare a request for evaluation and registration of a sealed source is 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. The NRC professional staff spends an average of 6 1

hours on the safety ev M tion of a sealed source. The estimated average tech-nical time required to prepare a request for. evaluation and registration of a i

device is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> and the NRC professional staff spends an average of 27.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation. The proposed rule would not change the time needed for the preparation and the review of a request for evaluation and registration nor the economic impact on specific licensees.

The NRC annually processes about 1500 applications for specific licenses, or amendments thereto, which reference safety information contained in the Reg-istry. If, in lieu of referring to infomation in the Registry, each license applicant submitted complete safety infomation for the sealed source or device, the applicant would have an increased technical effort in preparing the appli-l Enclosure B '

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

If the Registry is not used, the increased technical time to prepare an

, application for specific license is estimated to be 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> for a source and 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br /> for a device. These estimated times assume that the license' applicant -

obtains the needed test and engineering data and some assistance from the manu-facturer or distributor and, with additions or modifications as appropriate .

forwards that data as part of the license application. The increased assistance provided to each of multiple customers by the manufacturer or distributor is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for a source and 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for a device.

l If the. Registry was not used, the technical time that would be spent by-manufacturers and distributors in assisting their customers in preparation of applications for specific licenses is estimated to be an order of magnitude

, greater than the total time now spent on such assistance and on preparing re-quests for evaluation and registration.

The NRC saves professional staff time through use of the Registry. If 1500 applicants for specific licenses annually submitted detailed safety infonnation in lieu of referring to information in the Registry, the NRC professional staff time spent on source and device reviews would be multiplied by a factor of 15.

About 22 man-years annually would be required for NRC's reviews instead of the present 1.5 man-year.

_9 Enclosure B i

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.t. L 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 pennits continued operation of the efficient and effective registry system that has been developed and implenented by NRC and 28 Agreement States, and (2) the proposed rule would answer the several questions about the registry system, i.e., have all interested parties been infonned about.the system, what criteria 'are used by MRC in its evaluations, and what responsibility' does the manufacturer have to assure that distributed products satisfy the specifications that have been registered?

In addition, the proposed action provides opportunity for public coment on the Commission's program for evaluation and registration of radiation safety information on devices and sources used under specific license. This oppor-tunity, which may result in an improved programs would not be provided by -

Alternative 2 (status quo).

, 6. IMPLEMENTATION i

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

Following evaluation of the comments and assuming that the proposed action 4 is still warranted, a final' rule would be published, to be effective 30 days after publication in the Federal Register.

10 - Enclosure B i

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The proposed rule is not expected to change the operation and use -

of the existing sealed source and device registry system. The proposed rule should assist in early recognition by new manufacturers and distrib-utors of the opportunity to register their products. Implementation of the rule may result in NRC's increased attention to review of manufacturers' quality control programs. This action would occur during routine inspections of manufacturers' in-plant radiation safety' programs and possibly also would occur if users encounter safety problems that are attributable to poor quality.

This attention to quality control is intended to make sure that distributed I products satisfy the radiation safety related specifications that are on file in the sealed source and device registry.

t Enclosure B l

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I DRAFT CONGRESSIONAL LETTER i l

l Enclosed for the information of the subcomittee are copies of a Notice of Proposed Rulemaking to be published in the Federal Register. I l

The proposed amendnents to 10.CFR Parts 30 and 32. will provide clearly in

"- the regulations for the long standing practice whereby manufacturers of sealed sources of radioactive material and devices._containing sealed sources file radiation safety infomation about their products with the Nuclear Regulatory Consission. The infomation is evaluated and when referenced in specific li-cense applications by the manufacturers' customers, is used by the NRC and the

, Agreement States in detemining that an applicant's proposed equipment and I facilities are adequate to protect health and minimize danger to life or prop-erty.

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

The practice is extensively used. The NRC maintained sealed source and device registry contains infomation on approximately 3,000 models of sources and +

devices from about 400 manufacturers and distributors (vendors). Both the NRC and the 28 Agreement State licensing groups contribute data to and use the registry.

We believe that the practice has now sufficiently matured and is used to the extent that it warrants specific provision in the regulations. Publication of

the rule will assure that all vendors of sealed sources and devices are informed .

of this practice and will clearly state that manufacturers registering their products with the NRC have a responsibility to ensure that the distributed pro-ducts meet the radiation safety related specifications filed with the registry.

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

i Enclosure C I

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