[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
________________________________________________________________________
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
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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
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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]
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