ML20238A049
| ML20238A049 | |
| Person / Time | |
|---|---|
| Issue date: | 07/01/1987 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC |
| Shared Package | |
| ML20237L662 | List: |
| References | |
| FRN-52FR27782, RULE-PR-30, RULE-PR-32 AB34-2-09, AB34-2-9, NUDOCS 8708280289 | |
| Download: ML20238A049 (32) | |
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NOTE TO FILE ON RULE CHANGE TO PROVIDE FOR PRE-MARKETING RADIATION SAFETY EVALUATION AND REGISTRATION OF SEALED SOURCES AND DEVICES USED UNDER S LICENSE
SUBJECT:
RESPONSES TO EDITORIAL SUGGESTIONS BY RES ON DRAFT RUEEMAKING DOCUMENTS CIRCULATED 6/9/87 FOR OFFICE CONCURRENCE RES concurred in publication of the final rule for manufacturers' registration ~
of information on certain sealed sources and devices. RES also offered three editorial suggestions for changes in the preamble to the Federal Register notice.
Those suggested changes and our responses are:
1.
At page 1, in line 6 of the
SUMMARY
, add after " manufacturer" the following: '
"and a detennination of adequacy by the NRC."
RESPONSE: This suggestion was not adopted because (a) we believe it primarily ir, repetitious of the preceding sentence where it is. stated that NRC evaluates and uses the information in the issuance of specific licenses, I
and (b) its adoption would be inconsistent with drafting instructions pro-
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vided at page 107 of NUREG/BR-0053," Regulations Handbook," which advises that the
SUMMARY
is to be a brief description of the subject and the intended effect of the regulation being adopted and is not intended to be a detailed abstract or a complete sumation of the document, t
2.
At page 4, in line 1 of the second paragraph under " Background " add "of the proposed" prior to " equipment."
RESPONSE: This suggestion was adopted. The suggested addition enables the reader to more easily relate the 10 CFR 30.33 requirement stated in the preceding paragraph to the discussion provided in the second and following paragraphs.
3.
At page 6, in line 6 of the first paragraph under " Devices," add the sentence, "In some radiography devices the source may be remotely projected out of the housing for panoramic exposures."
RESPONSE: This suggestion was not adopted. Although the statement is correct, we believe that its use would not significantly improve our simplified generic description of a device and its use could lead ts concern by the reader about devices that are not specifically mentioned, e.g., self-shielded gama irradiators where the product is transported to the constantly shielded source.
wA seven ett NMSS Project Manager f/llQ l
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8708280289 870820 PDR PR 30 52FR27782 PDR
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l Approved for Publication The Commission delegated to the EDO [10 CFR 1.40(c) and (d)] the authority to develop and promulgate rules as defined in the APA [5 U.S.C. 551(4)] subject tn the limitations in NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039,
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and 0310.
1 The enclosed final rule, entitled " Manufacturers' Registration of Radiation f
Safety Information for Certain Devices and Sealed Sources," amends 10 CFR
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Parts 30 and 32 to provide clearly for manufacturers of radiation sources and devices containing radiation sources to file with NRC radiation 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.
This final rule does not constitute a significant question of policy, nor does
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it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart C concerning l
matters of policy.
I therefore find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
(Date)
Victor Stello, Jr.
Executive Director for Operations i
[7590-01]
l NUCLEAR-REGULATORY COMMISSION 10 CFR Parts 30 and 32
. Manufacturers' Registration of Radiation Safety Information for Certain Devices and Sealed Sources AGENCY:
Nuclear Regulatory Commission.
ACTION:
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 j
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-3 2
tomers and thus expedites NRC's issuance of licenses.. The amendments, j
directed toward manufacturers, describe the information that the NRC needs for its evaluation of a source or device and state the registrant's respon-1 sibility to ensure that distributed products meet radiation safety j
specifications filed with the NRC.
EFFECTIVE DATE:
(30 days after FR publication)
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j FOR FURTHER INFORMATION CONTACT:
Steven Baggett, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commisslon, 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.
B.
Devices.
C.
Sealed Source and Device Registry.
D.
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 ei,...
current administra-l 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.
Purcose of Rule Current NRC regulations clearly provide for the issuance of specific licenses which reference so-called " pre-marketing" evaluations and regis-trations of radiation safety information on certain sealed sources of radioactive material and on' devices which incorporate those sources.
Examples include smoke detectors used under'an exemption-from regulations, gauges used under a general license, and certain medical devices used under a specific license.
The regulations are less clear about pre-marketing evaluation of 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'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 informeo of and comply with 3
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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, " Rules of General Applicability to Domestic Licensing of Byproduct Material," states that an application for a spe-cific license will be approved if, among other things, "the appli; ant'_ s pnposed equipment and facilities are adequate to protect health and mini-mize danger to life or property.'"
With respect to certain of the propcsed 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.
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A single submission by a manufacturer is evaluated by the NRC and the 1
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results of the evaluation are used in NRC's review of multiple applica-tions for specific licenses, thus avoiding repetitive submissions by applicants and reviews by the NRC.
This practice is provided for under the general provision of S 30.32 of Part 30, whereby "information con-tained in previous applications, statements or reports filed with the Commission...may be incorporated by reference, provided that the reference is clear and specific."
The following sections explain the key terms " sealed source" and
" device" and describe t*1e program for registration of radiation safety information on this equipment.
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A.
Sealed Sources v.
Byproduct material used by a specific licensee often is contained in a sealed capsule, held between layers of non-radioactive metal foil, or firmly fixed to a non-radioactive surface by electroplating or other means.
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The byproduct material with its capsule or other confining barrier is termed a " sealed source." The confining barrier prevents dispersion of the byproduct material under normal and most accident conditions related 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 ccntain tens of curies of byproduct material, and (3) a sealed source used in a teletherapy unit for treatment of cancer may contain f
I several thousand curies of byproduct material.
j Radiation safety programs for the use of byproduct material as a
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sealed source are structured on the presumption that the byproduct material I
will not leak frcm the sealed source and contaminate the environment or i
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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-i l
l 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-ter of the sealed source or by the applicant for a specific license that 5
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I authorizes its use.
The NRC uses its regulations and radiation safety j
criteria set out in industry standards in making this determination.
B.
Devices 1
Frecuently, the byproduct material is contained in a sealed source j
that, in turn, is contained in a shielded source housing.
The source housing may have a shutter mechanism thtt allows an operator to greatly
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reduce the shielding in a particular direction so that a beam of radiation l
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can exit the housing.
The radiation beam is then available for such pur-I poses as che treatmer.t of cancer or for the examination of flaws in metal castings.
The source housing, together with its shutter mechanism and other
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radiation control mechanisms (if any), is commonly called a " device."
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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 l
the manufacturer or distributor of the device or by the applicant for a t
specific license that authorizes use of the dwice 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
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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 l
products'.
The NRC maintains a nationwide registry of radiation safety informa-1 tion on sealed sources and devices containing byproduct material.
Regu-latory authorities in the Agreement States (where NRC has relinquished
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9 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-I j
latory jurisdiction provides detailed information about its sealed source '
l or device to its regulatory agency, the results of.the radiation. safety cvaluation will be available for use in granting licensing approval to 1
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- users of the sealed. source or device throughout the United States, its territories and possessions, and in Puerto Rico.
s 0.
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, " Guide for the Preparation of I
Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material," and (2) Regulstory Guide 10.10,
" Guide for the Preparation of Applications for Radiation' Safety Evaluation 7
[7590-01]
and Registration of Devices Containing Byproduct Material."1 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's I
radiation safety evaluation and determination of the conditions under j
which the source or device will be authorized for distribution and use.
Manufacturers and distributors of sealed so'trces and devices are I
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 cf use of the sealed source or device, such as requirements for periodic leak tests and restricticas on environmental conditions of Although the certificate of registration is, in effect, a pre-l use.
i marketing approval of the source or device, its issuance does not consti-l tute a commitment to issue a specific license authorizing use of the source er 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.
l Copies may also be purchased from the National Technical Information Service, U.S. Department of Commerce, 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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I require's satisfaction of other requirements listed in S 30.33 cf 10 CFR Part 30 such as the training and experience qualifications of the applicant.
1 Copies of the registration certificate are provided to regulatory authorities in the Agreement States for their use in granting specific licensing approval to usert within their jurisdictions.
III.
Public Comments 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 j
i were received.
Five letters were from regulatory authorities in Agreement j
States supporting Issuance of the final rule.
One letter from a trade i
association and two letters from manufacturers support the rule.
A third manufacturer commented that if all sources are to b,e included under the proposed rulemaking, a major revision should be made to clarify the condi-I 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 cuantities 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 SS 32.51 and 32.52.
This firal 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
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devices that are to ce used under a specific license.
To clarify this point, the text of the proposed S 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..." to "An application for a specific license to use byproduct material in the form of a sealed source or in a device..."
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 immediately.
The commenter asked that the due date for submitting additional information to NRC be delayed until the next license renewal or update cycle af ter the effective date of the i
final rule.
This interpretation of the rule was not intended by NRC.
t The rule is merely a codification of current administre.tive practice and requires no additional action for sources and devices presently used
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i 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
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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 S 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 q!
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l manufacturers share the commenter's opinion that ali qfety evaluations 1
should be done centrally.
Other manufacturers prefer the States'
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involvement because of the increased availability of, and ease *f com-1 I
munication with, Sta'te regulatory authorities as a result of their rela-
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i tively close location.
Uper, 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 activity with the States.
One manufacturer recommended that, in addition to providing in the t
regulations for the manufacturers' registration of safety information j
about their sealed sources and devices, a system be established for manufacturers' registration of approved transportation containers for l
j 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 emendment.
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.
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those cases where sealed sources and devices contain greater than a Type A quantity of radioactive material, an administratively convenient
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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 1
a single package evaluation and approval by NRC.
However, this comment is beyond the scope of this rulemaking proceeding and the feasibility of 11 1
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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 j
described in the categorical exclusion set out in 10 CFR 51.22(c)(3)(i).
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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
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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.
1 VI.
Regulatory Analysis The Commission has prepared a regulatory analysis on this final rule. The analysis examines the costs and benefits of the alternatives I
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 "For Further Information
Contact:
" 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 substantisi number of small entities.
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-l 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 numcer would be considered small entities, the rule is rot expected to have'a significant-impact on them.
i Under present practice, the estimated average technic 31 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
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4 and as provided in the rule results in savings to manufacturers and dis-tributors and to applicant.s 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 ref' erring 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 hou s 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 tnatithe i
license applicant obtains needeo test and enginecting ' data and some assistance from the manufacturer or districator.
The increased assistance 13 1
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provided to each of its multiple customers by the manufacturer or dis-tributcr 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 d hours 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.
Vill, Beckfit Analysis The NRC has determined that the backfit analysis provisions in 10 CFR 50.109 do not apply to this rule because these al"endments apply to materials licenses issurd under Parts 30 and 32.
These amandments do not apply to licenties 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 protectioli, Reporting and recordkeeping requirements.
Part 32 - Byproduct material, Labeling, Nuclear materials, Penalty, Radiation protection, Reporting and recordkeeping requirements.
l 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 I
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. 3841, 5842, 5846).
Section 30.7 also issued under Pub. L.95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851).
Secticn 30.34(b) also issued under sec.184, 68 Stat.
954, as amended (42 U.S.C. 2234).
Section 30.61 also issued under
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sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
For purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
SS 30.3, 30.34(b) and (c), 30.41(a) and (c), and 30.53 are issued under
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sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and SS 30.6,
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l 30.36, 30.51, 30.52, 30.55, and 30.56(b) and (c) are issued ur. der sec.
j 161o, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
2.
Section 30.32 is amended by adding a new paragraph (g) to read as fellows:
S 30.32 Application for specific license.
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x (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 segace must either - --
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(1) Identify the source or device by manufacturer and model number as registered with the Commission under S 32.210 of this chapter or with an Agre.ement State; or (2) Contain the information identified in S 32.210(c).
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRA95FER l
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIALS 3.
The authority citation for Part 32 is revised to read is 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. E841).
For the purposes of ec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); SS 32.13, 32. 15(a), (c), and (d), 32.19, 32.25(a) and (b),
32.29(a) and (b), 12.54, 32.55(a), (b), and (d), 32.58, 32.59, 32.62, 1
and 32.210 are issued under sec.161b, 66 Stat. 948, as amended (42 U.S.C.
2201(b)); and SS 32.12, 32.16, 32.20, 32,25(c), 32.29(c), 32.51a, 32.52, 32.56, and 32.210 cre issued under sec. 1610, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
4.
In S 32.1, paragraph (a) is revised to read as follows:
S 32.1 Purposa and scope.
(a) This part prescribes requirements for thc issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to (1) persons exempted f rom the licensing requirements of Part 30 of this chapter, or (2) persons 16 1
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generally licensed under Part 31 or 35 of this, chapter.
This part also i
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 into a product or material owned by or in the possession of the licensee or another and regulations governirg holders of such licenses.
Further, this part i
describes procedures and prescribes requirements for the issuance of cer-tific6tes of registration (covering radiation safety information about a l
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.
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5.
Subpart 0 is added as follows:
Subpart 0 - Specifically Licensed Items l
S 32.210 Registration of product information.
t (a) Any manufacturer or initial distributor of a sealed source or l
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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 abcut 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, Medical, Academic, and Commercial Use Safety; Medical, Academic, and Commercial Use Safety Brar.ch; 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 testing and, for a device, the request must also include sufficient information 17
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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 standardG and criteria with the help of the manufac-turer or distributor.
The NRC shall use criteria and standards sufficient to ensure that the radiation saf<aty properties of the device or sealed source are adequate to protect health anc minimize danger to life and 1
property.
(e) After completion of the evaluation, the Commission issues a 1
I certificate of registration to th,e person reaking the, request.
The'certif-icate of registration acknowledges the availability of the submitted infor-j mation for inclusion in an application'for a specific license proposing use i
of the product.
(f) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute I
j 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, j
I Dated at Bethesda, Maryland, this day of
, 1987.
For the Nuclear Regulatory Commission, i
I Victor Stello, Jr.
i Executive Director for Operations.
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! REGULATORY ANALYSIS FOR AMENDMENTS TO 10 CFR PARTS 30 AND 32 ON Manufacturers' Registration of Radiation Safety.Information for Certain Devices and Sealed. Sources INTRODUCTION The purpose of a regulatory analysis is to ensure that NRC regulatory decisions are based on adequate information concerning the need for and con-sequences of a proposed regulatory action and to ensure that cost effective regulatory actions, consistent with providing the necessary protection of the public health and safety and common defense and security, are identified.
The procedures followed by NRC staff in preparing regulatory analyses are.
set out in NRC's published document, " Regulatory Analysis Guidelines" (NVREG-0058). Those procedures require a comprehensive analysis for a rule that is likely to result in:
An annual effect on the economy of $100,000,000 or more in direct and a.
indirect costs, or b.
A significant impact on health, safety or the environment, or A substantial increase in cost to NRC licensees, permit holders or c.
applicants, to federal, state or local governments, and geographical regions.
i The procedures in NUREG-0058 also provide for preparation of analyses for rules that will likely result in lesser impacts than identified in a, b and c.
For such rules, the evaluations are not as extensive or detailed as l
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rules wnich result in impacts a, b or c.
The rule considered in this analysis, j
" Manufacturers' Registration of Radiation Safety' Information for Certain Devices and 3ealed Sources," is in this category.
A draft. regulatory analysi.s for this rule was issued for comment.
The i
availability of the draft regulatory anlaysis was noticed in the Federal
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Register on January 23, 1987.
No comments were received on the analysis and none of th'e comments on the proposed rule suggests a need for change in the l
analysis.
Both the final rule and this regulatory analysis' are essentially the i
same as.the proposed. rule and the draft regulatory analysis which were published for comment.
1.
STATEMENT OF PROBLEM l
i The NRC maintains a nationwide registry of radiation safety information on sealed sources of radioactive material and devices containing sealed sources.
Manufacturers or distributors of sealed sources and devices voluntarily submit product information for the registry and that information is then incorporated' by reference into applications' for specific licenses by persons desiring to use the products.
I The registry contains approximately 3,000 models of sources and devices that have been registered by about 400 manufacturers or distributors.
Input to and use of the registry is shared by NRC and the Agreement States.
As administered, the registry system, in effect, constitutes a system for pre-marketing clearance or approval for licensing purposes of radiation safety properties of sealed sources and devices that are used under specific licenses issued by NRC and the Agreement States.
The operation and use in licensing of the registry is currently gui_ded by 10 CFR 30.32 whereby an applicant for a specific license may incorporate by reference "information contained in previous applications, statements or reports filed with the Commission or the Atomic Energy Commission...." The absence of t
a more specific regulatory provision' for the registry raises several questions:
(1) has adequate notice of its existence and operation been provided so that all manufacturers and distributors, particularly those entering the sealed 2
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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 i
manufacturer, have to follow some sort of quality assurance requirements for its products; and (4) what criteria does NRC use to evaluate the ' radiation safety espects of a manufacturer's product.
J 2.
OBJECTIVES i
In consideration of the above statement of the problem, the final rule has the following objectives-l A.
To provide a continuing notice to all interested persons:
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(i) that the NRC maintains a nationwide registry of radiation safety related information on sealed sources and devices, 1
l (ii) that manufacturers or distributors of sealed sources and l
I devices may file product inforniation with the registry, I
(iii) as to the general areas of safety information to be covered I
when registering a sealed source or device, (iv) as to the criteria used by NRC in evaluating a sealed source or device, and l
(v) that the registered information is available and is used in the I
issuance of specific licenses.
B.
To clearly establish that registrants of product information have a responsibility to the NRC to implement quality control programs and thus ensure that distributed products meet the product specifications that are filed with NRC, evaluated for adequacy, and relied on in the issuance of specific licenses which authorize use of the products.
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ALTERNATIVES' s
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,s y Alt &d ye 1:
Ishe a rule that clearly would provide for the voluntary registratiortyith'NRC of radiation stfety information on sources and dev1ces to be manufactured and, distributed for use under specific license.
The rule would state the information to be submitted fo7 NRC's evaluation, the standards and criterier used in NRC'St hdaluation, and the rehistrant's responsibility to assure' q
r a thatdT[tributedprodi::tsconformtotherepfsta"edinformation.
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,,, S i=y Alternative?.: tso r;ulenaking action behcontinue the voluntary registry.
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on regulatory hu'icis and branch positions to expia'in the operation.of the regis '
b try9.ahat info $ation should be registered, and hcPto. register information.
s Albihative 3:
Issue a rule that would replace the " voluntary" registry by a
" mandatory" registry.
The manufacturer or distributor would be required to register radiation safety information before receiving authority to transfer the sealed source or device for use under specific license.
Alternative 4: Discontinue the voluntary registry of information by manufac-ture/s an& distributors and require the first applicant for a specific license author M ng use of a particular source or device to submit design and construc-tion data.
When clearly and specifically referenced by subsequent applicants, i
the initially submitted information could be used in issuance of additional specific licenses.
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[045EQUENCES s
s r n Ah,prattve1:
This action is consistent with accomplishing the objectives l
statedDove in Section 2. 'This action also is consistent dith the continued k
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operation of the established and matured' registrati,on program that is adminis-tered by NRC and Jhe 29 Agreement States., Licensing authorities in these jurisdictions accept cod evaluite radiatio [hafety information that is. filed by their respective marif acturars and distributors of sources and devices.
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SLm-mariesind Oaluations o'f file $ inform $1on are placed in the central registry-l u
that to ta,idt.ained by NRC and i:Paccess e to all 30 regulatory groups.
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Because of sharing of registered information and acceptsnce by all the 30 regulatory groups of evaluations performed by any one of the 30 groups, a manu-I facturer or distributor needs to submit detailed safety information to only a single regulatory group in order for that information to be available for use i
j in issuing specific licenses throughout the U.S.
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Alternative 2:
This alternative would maintain the status ouo.
It allows con-tinued operation of the administratively efficient registry system for radia-tion safety information on sources and devices.
However, it would not adequately answer the several questions presented above in Section 1.
It would not provide clear notice of the registry system to all persons and would not increase the probability of early communication between NRC and persons entering the business of manufacturing or distributing sources and devices for use under specific licenses.
These early communications are useful in directing the attention of new manufacturers and distributors to particular regulatory requirements and pertinent regulatory gui. des and branch positions.
Also, this alternative would not provide a clear statement of a registrant's responsibility to assure that distributed sources and devices satisfy the radiat'nn cafety related specifica-tions on file in the registry.
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Alternative 3:
This alternative is consistent with accomplishing the cbjec-tives stated above in Section 2.
Also, it would be consistent with the NRC's regulation of products used under an exemption from regulatory requirements l
(e.g., smoke detectors) or under a general license (e.g., luminous safety j
devices for use in aircraft).
However, it would not be consistent with NRC's l
and Agreement States' practice for regulating the use of sources and devices under specific license.
That practice allows the applicant for specific license either to file information directly or to refer to information filed by the j
manufacturer when demonstrating that the applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or prop-erty. This flexibility with respect to which party directly submits informa-3 tion for use in approval of an application for specific license is useful when I
considering one-of-a-kind products and when considering users' modifications of standard designs to satisfy unique concitions of use.
In these cases, the applicant for license may choose to use the services of a manufacturer who has little interest in registering information directly with the NRC.
That choice 5
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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.
Alternative 4:
This alternative would appear to unnecessarily complicate the filing of radiation safety information for sources and devices.
Direct commu-nication between the regulatory authority and the manufacturer can be conve-nient and effective in clarifying submitted information.
To require that information which may be known only to the manufacturer must always be funneled to NRC through the first 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 viaw of the extensive and effective use of the voluntary regis-try system by NRC, the States, manufacturers and users.
5.
DECISION RATIONALE i
Under present practice, the estimated average technical time (in addition to time spent on laboratory work and engineering analysis) required by the manu-facturer or distributor to, prepare a request for evaluation and registration of a sealed source is 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />.
The NRC professional staff spends an average of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation of a sealed source.
The estimated average technical time required to prepare a request for evaluation and registration of a device is 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> and the NRC professional staff spends an average of 27.6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> on the safety evaluation.
The rule would net change the time needed for the preparation and the review of a request for evaluation and registration nor the economic impact on specific licensees, i
The NRC annually processes about 1,500 applications for.specifi; 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 sealed source or device, the applicant would have an increased technical effort in preparing the application, the manufacturers and distributors would spend more time in assisting customers in the preparation of applications for spec:fic licenses, and the NRC professional staff would spend more time reviewing the applications.
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If the Registry is not used, the increased technical time to prepara an i
I 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
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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
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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 orovided to each of multiple customers by the manufacturer or distributor is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for a source and 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for a device.
If the Registry was not used, the technical time that would be spent by manufacturers and distributors in assisting their customers in preparation of applications for specific licenses is estimated to be an order of magnitude greater than the total time now spent on such assistance and on preparing i
l requests for evaluation and registration.
The NRC saves professional staff time through use of the Registry.
If 1,500 applicants for specific licenses annually submitted detailed safety infor-mation in lieu of referring to information in the Registry, the NRC professional staff time spent on source and device reviews would be multiplied by a factor of 15. About 22 person years annually would be required for NRC's reviews instead of the present 1.5 person years 4
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r The issuance of a final rule to provide clearly for the voluntary registration with NRC of radiation safety information on sources and devices is recommended because:
(1) the rule permits continued operation of the efficient I
and effective registry system that has been developed and implemented by NRC and 29 Agreement States, and (2) the rule would answer the several questions about the registry system, i.e., have all interested parties been informed about the registry system, what criteria are used by NRC in its evaluations, and what responsibility does the manufacturer have to ensure that distributed products satisfy the specifications that have been registered?
6.
IMPLEMENTATION The notice of final rulemaking would be published in the Federal Register and would be effective 30 days after publication.
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4 The rule is not exoected to change the operation and use of the existing sealed source ar.d device registry system.
The rule should assist in early
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recognition by new manufacturers and distributors of the opportunity to register j
i their products.
Implementation of the rule may result in NRC's increased
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attention to review of manufacturers' ouality control programs.
This action would occur during routine inspections of manufacturers' in-plant radiation l
l safety programs and possibly also would cccur if users encounter safety problems that are attributable to poor quality. This attention to quality control is intended to make sure that distributed products satisfy the radiation safety related specifications that are on file in the sealed source and device l
regi st ry.
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DRAFT CONGRESSIONAL LETTER
Dear Mr. Chairman:
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1 Enclosed for the information of the Subcommittee are copies 'of a final rule to I
be published in the Federal Register.
The Nuclear Regulatory Commission is amending its regulations to provide clearly' for the long-standing practice whereby manufacturers of sealed sources of radio-active material and devices containing sealed sources file radiation safety information about their products with the NJclear Regulatory Commission (NRC).
The information is evaluated and, when referenced in specific license applica-tions by the manufacturers' customers, is used by the NRC and the Agreement States in determining that an applicant's proposed equipment and facilities are adequate to protect health and minimize danger to life or property.
This practice is currently conducted under a general provision in the regulations that allows an applicant for specific license to incorporate, by reference in an application, information contained in previous reports filed with the Commi:sfon.
l The practice is extensively used. The NRC maintained sealed source and device registry contains information on approximately 3,000 models of sources and devices from about 400 manufacturers and distributors (vendors).
Both the NRC i
and.the 29 Agreement State licensing groups contribute data to and use the registry.
Publication of the amendment will a.ssure that all vendors of sealed sources and devices are informed of this practice and will clearly state that manufacturers i
registering their products with the NRC have a responsibility to ensure that the distributed products meet the radiation safety related specifications filed with the registry.
This rulemaking proceeding was supported by manufacturers, Agreement State licensing groups and the Air Transport Association of America.
No other persons i
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The final amendmen is substantially the same as the proposed amendment.
i In view of the minor nature of the amendment which merely formalizes present i
practice, the Commission considers that issuance of a public announcement is f
not warranted.
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Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards i
Enclosure:
As stated cc: Minority Members l
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l DRAFT DAILY STAFF NOTES ITEM I
1 On
, 1987, the Executive Director for Operations approved a final rule that amends 10 CFR Parts 30 and 32 to formalize the current adminis-trative practice under which manufacturers of radiation sources' and devices containing radiation sources file safety information about their products with l
the NRC. The staff evaluates and uses the information in its issuance of spe-cific licenses to users of the products. The amendments, directed toward manu-facturers, describe the information that the staff needs for its evaluation of a source or a device and state the manufacturer's responsibility to ensure that l
distributed products meet radiation safety specifications filed with the NRC.
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This constitutes notice to the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has signed this final rule and proposes to forward it on
..__ __ to the Office of the Federal Register for publication, unless otherwise directed by the Commission.
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