ML20217K310
| ML20217K310 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| Shared Package | |
| ML20217K306 | List: |
| References | |
| FRN-62FR49173 CCS, PR-970915-01, PR-970915-1, NUDOCS 9710240255 | |
| Download: ML20217K310 (11) | |
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NUCLEAR REGULATORY COMMISSION 10 CFR Part 32 RIN: 3150-AF76 License Applications for certain items Containing Byproduct Material -
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is resolving a petition for rulemaking submitted by mb-microtec, Inc. (PRM 32-4) by proposing to amend its regulations to permit the distribution of timepieces containing gaseous tritium light sources (GTLS) to be regulated in accordance with the same requirements as timepieces containing tritium paint.
The proposed rule would remove from the regulations the specific requirements for prototype testing of these products containing tritium, and provide guidance for prototype testing in a separate document. If adopted, this proposed amendment would simplify the licensing process for distribution of certain timepieces containing tritium and would facilitate the use of a new technology in self illumirated timepieces.
' DATES: Submit comments by [ Insert the date 75 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
97102402b5 971015 PDR ORG NRCC
h I kDDRESSES: Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 0001, ATTN: Rulemakings and Adjudications Staff.
Deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm, Federal workdays.
Examine comments received, the regulatory analysis, and other documents related to this rulemaking at the NRC Public Document Room,2120 L Street NW., (Lower Level),
Washington, DC.
You may also provide comments via the NRC's interactive rulemaking website through the NRC home page (http://www.nre gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher,301-415 5905; Email CAG@nrc. gov.
Single copies of this proposed rulemaking may be obtained by written request or telefax from Mary L. Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission. These same documents may also be viewed and downloaded via the interactive rulemaking website established by NRC fo.r this rulemaking.
FOR FURTHER INFORMATION CONTACT: Mary L. Thomas, Office of Nuclear Regt iatory Research, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001,
- telephone 301-4'.5-6230, telefax 301-415 5389, Email MLT1@NRC. GOV.
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bUPPl.EMENTARY INFORMATION:
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Background
The Petition for Rulemaking In a letter dated July 30,1993, mb-microtec, Inc. petitioned the NRC to amend its regulations 'to include timepieces containing gaseous tritium light sources (GTLS) on the same regulatory basis as those with tritium paint in regard to their distribution exempt from the requirements of 10 CFR 32.14(d).? -
in the petition, the petitioner stated the following:
With new technology greater illumination could be achieved with less radioactivity than needed for a painted watch but that the additional requirements to get a GTLS watet. approved for distribution results in manufacturers not uaing this technology.
On August 9,1993, the NRC docketed the letter as a petition for rulemaking (Docket No. PRM 32-4). A notice of receipt of petition for rulemaking was published for public comment in the Federal Register on October 29,1993 (58 FR 52670). No public comments were received on the notice conceming the petition.
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Current NRC Regulations for Certain items Containing Byproduct Material
! Section 30.15(a)(1) states.that if a timepiece containing byproduct material is to be distributed to persons exempt from the NRC's licensing requirements, it may not contain more than 5 millicuries per hand, not more than 15 millicuries in the dial, and not more than 25 millicuries of tritium in total. Section 32,14(d)(1) contains overall performance requirements for the binding of tritium to watch hands, pointers, and dials, as well as specific prototype testing requirements for tritium-painted watch hands, pointers, and dials. Although 10 CFR 30.15(a)(1) does not specify a form for tritium in timepieces, the prototype testing requirements in 10 CFR 32.14(d)(1) - the section of the NRC's regulations under which a specific license to distribute watches exempt under 10 CFR 30.15(a)(1) is granted - are only applicable to timepieces employing tritium paint.
Watches containing greater than 25 millicuries of tritium in GTLSs may be distributed to persons exempt from licensing requirements in accordance with 10 CFR 30.19, "Self-luminous products containing tritium, krypton-85, or promethium 147," which, unlike 10 CFR 30.15(a)(1), specifies neither a limit on the amount of tritium that may be incorporated into self luminous products nor the end use of the product. However, to distribute a self luminous watch containing tritium to persons exempt from licensing requirements in 10 CFR 30.19, a specific license must be obtained in accordance with 10 CFR 32.22. To manufacture, process, produce, or initially transfer self-luminous products containing unrestncted amounts of tritium under 10 CFR 32.22(a)(2), the applicant must submit detailed information and analyses concerning the particular product in order to obtain approval for distribution. The information required by 10 CFR 32.22 must be sufficient to demonstrate that the product meets a number of specific safety criteria, including dose criteria for use and disposal. The 4
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application must include proposed prototype testing procedures, which must be approved by the NRC Further, the evaluations conducted by both the licensee and the staff, as well as the prototype testing proposed, apply to the entire product rather than its components Conversely, approval for distribution of timepieces containing less than 25 millicuries of tritium to persons exempt from licensing requirements in 10 CFR 30.15(a)(1)(i) requires a specific licence under 10 CFR 32.14, but only requires satisfaction of the prototype testing requirements contained in 10 CFR 32.14(d). Consequently, it is less burdensome upon a licens?e to distribute watches employing tritium illumination under 10 CFR 32.14 than under 10 CFR 32.22.
Proposed Amendments The NRC has carefully reviewed the arguments presented by the petitioner and is proposing to resolve the petition by initiating this rulemaking that incorporates the petition in -
part. Rather than revise the specific testing requiremeats in the regulatione as proposed by the petitioner to accommodate both tritium paint and GTLSs, the NRC is proposing a more performance based approach by removing the existing specific testing procedures from the regulrdons.' Guidance on specific prototype testing procedures will be provided in draft NUREG 1562, " Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License," which will be issJed for public comment. Further, the proposed rule would modify but not change the Lintent of the existing general performance standard.- This modification will state that the method of containment or binding of the byproduct be such that the radioactive material will be bound and will not become detached from the product under the most severe conditions 5
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which are likely to be encountered in normal use and handling. By making these -
hiodifications to 9 32.14(d), increased flexibility in the regulations will be provided and future developments in technology and design of tritium illuminated timepieces will be accommodated. These modifications will not decrease the level of radiation protection
, provided to users of tritium illuminated timeplaces. Also, the radiation skin dose to an individual from timeplaces containing GTLSs has been determined to be significantly less, per millicurie of tritium used, than the skin dose from timepieces containing tritium paint. I Rationale -
The licensing process is more burdensome to potential distributors of timepleces under 10 CFR 30.19 than under 10 CFR 30.15(a)(1). Changing the prototype testing
_. requirements in 10 CFR 32.14(d)(1) would simplify the licensing process for distributors of timepieces containing small quantities of tritium in the GTLS form by allowing them to apply to distribute these timepleces for use under the same requirements of the regulations as timepieces using tritium paint (10 CFR 30.15(a)(1)).
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l Effects of the Proposed Amendments The effect of this proposed amendment would allow distribution of self-illuminated timepieces that utilize a new technology (GTLS) under the same requirements that currently allow distribution of timepieces using tritium paint.
A Agreement State Compatibility Under the Atomic Energy Act, certain regulatory functions are reserved to the NRC.
Among these are the distnbution of products to persons exempt from licensing, as discussed in 10 CFR Part 150. Hence, the proposed rule, if adopted, wou'd be an NRC Category of compatibility with regard to the manufacture and initial distribution of watches and other products for use. NRC Category rules address those regulatory areas which are reserved to NRC pursuant to the Atomic Energy Act and 10 CFR Part 150.
i Environmental Impact: Categorical Exclusion The NRC has determined that the proposed rule is the type of action described as a categorical exclusion in 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed rule.
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Paperwork Reduction Act Statement This proposed rule would reduce the burden to licensees for GTLS by allowing them to file an applicatiM under the provisions of ses ion 32.14 rather than under those of section 32.22, which also n3 quires that the applicant obtain a registration certificate. The reouction in ,
burden is estimated to be 21 hours2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br /> per esponse. Because the application requirements v
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contained in sections 32.14 and 32.22 are not being substantively changed, no Office of -
Management and Budget (OMB) clearance is required.10 CFR Part 32 requirements are approved by the OMB approval number 3150-0001.
Public Protection Notification The NRC may not conduct nr sponsor, and a person is not required to respond to, an information collection unlesc 4 displays a currertly vald OMB control number.
Regulatory Analysis The NRC has prepared a draft regulatory analysis for the proposed amendment. The analysis examines the benefits and impacts considered by the NRC. The draft regulatory analysis is available for inFpection at the NRC Publir. Document Room,2120 L Street NW.
(Lower Level), Washington, DC. Single copies may be obtained from Mary L Thomas, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC ,
20555-0001, telephone 301-415-6230 or e-mail at MLT10NRC. GOV.
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- Regulatory Flexibility Cortification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission certifies that this rule will not have a significant economic impact upon a substantial number of small entities. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionate adverse econcmic impact should notify the Commission of this in a comment that indicates the following
(a) The licensee's size and how the regulation would result ;a a significant economic burden upon the licensee as compared to the economic burden on a larger licensee.
(b) How the regulations could be modified to take into account the licensee's differing needs or capabilities.
(c) The benefits thet would accrue, or the detriments that would be avoided, if the regulations were modified as suggested by the licensee.
(d) How the regulation, as modified, would more closely equalize the impact of regulations or create more equal access to the benefits c,1 Federal programs as opposed to providing special advantages to any individual or group.
's) How the regulation, as modified, would still adequately protect public health and safety.
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.-...-.y Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not appiy to this proposed rule, and therefore, a L1ckfit analysis is not required because these amendments do not involve any provisions that vould impose backfits as defined in 10 CFR 50.109(a)(1).
8.ist of Subjects in 10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materie5 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 amendeo, and 5 U.S.C.
553, the NRC is proposing to adopt the following amendment to 10 CFR Part 02.
PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
- 1. The authority citation for Part 32 continues to read as follows:
AUTHORITY: Secs. 81,161,183,186,68 Stat. 935,948,953,954, as amended, (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended, (42 U.S.C. 5841).
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2, in 9 32.14, paragraph (d) is revised to read as follows:
'A 32.14 Certain items containina bvoroduct material: reauirements for license to apoly or
_ [nitially transfer.
(d) The Commission determines that:
(1) The method of containment or binding of the byproduct material in the product is such that the radioactive material will be bound and will not become detached from the product under the most severe condnions which are likely to be encountered in normal use-
. and handling.
(2) Prototype tests for automobile lock illuminators are prescribed by 10 CFR 32.40, Schedule A.
A Dcted at Rockville, Maryland, this /D aay of September,1997.
For the Nuclear Regulatory Commission.
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John C/ Hoyle, /
Secpary of the Commission.
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