[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Proposed Rules]
[Pages 49173-49175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24913]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / 
Proposed Rules  

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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.

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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-illuminated timepieces.

DATES: Submit comments by December 3, 1997. 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.

ADDRESSES: Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 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.nrc.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 [email protected].
    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 for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Mary L. Thomas, Office of Nuclear 
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington DC 
20555-0001, telephone 301-415-6230, telefax 301-415-5389, Email 
[email protected].

SUPPLEMENTARY INFORMATION:

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 watch approved for 
distribution results in manufacturers not using 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 concerning the petition.

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 unrestricted 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 
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

[[Page 49174]]

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 
license 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 licensee 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 requirements in the regulations 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 regulations. 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 issued for public comment. Further, the 
proposed rule would modify but not change the intent 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 which are likely to be 
encountered in normal use and handling. By making these modifications 
to Sec. 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 timepieces. Also, the radiation skin dose to an 
individual from timepieces containing GTLSs has been determined to be 
significantly less, per millicurie of tritium used, than the skin dose 
from timepieces containing tritium paint.

Rationale

    The licensing process is more burdensome to potential distributors 
of timepieces 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 timepieces for use under the same 
requirements of the regulations as timepieces using tritium paint (10 
CFR 30.15(a)(1)).

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.

Agreement State Compatibility

    Under the Atomic Energy Act, certain regulatory functions are 
reserved to the NRC. Among these are the distribution of products to 
persons exempt from licensing, as discussed in 10 CFR part 150. Hence, 
the proposed rule, if adopted, would 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.

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.

Paperwork Reduction Act Statement

    This proposed rule would reduce the burden to licensees for GTLS by 
allowing them to file an application under the provisions of section 
32.14 rather than under those of section 32.22, which also requires 
that the applicant obtain a registration certificate. The reduction in 
burden is estimated to be 21 hours per response. Because the 
application requirements 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 or sponsor, and a person is not required to 
respond to, an information collection unless it displays a currently 
valid 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 inspection at 
the NRC Public 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 [email protected].

Regulatory Flexibility Certification

    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 economic 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 in 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 that 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 
of Federal programs as opposed to providing special advantages to any 
individual or group.
    (e) How the regulation, as modified, would still adequately protect 
public health and safety.

Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this proposed rule, and therefore, a backfit analysis is 
not required because these amendments do not involve any provisions 
that would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects in 10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

    For the reasons set out in the preamble and under the authority of 
the

[[Page 49175]]

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 amendment to 10 CFR Part 32.

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).

    2. In Sec. 32.14, paragraph (d) is revised to read as follows:


Sec. 32.14  Certain items containing byproduct material; requirements 
for license to apply or initially 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 
conditions 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.

    Dated at Rockville, Maryland, this 15th day of September, 1997.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-24913 Filed 9-18-97; 8:45 am]
BILLING CODE 7590-01-P