[Federal Register Volume 63, Number 116 (Wednesday, June 17, 1998)]
[Rules and Regulations]
[Pages 32969-32971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16014]


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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: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations that govern licensing requirements for persons who 
incorporate byproduct material into certain items or who initially 
transfer certain items containing byproduct material. This action is 
being taken in response to a petition for rulemaking submitted by mb-
microtec, Inc. (PRM-32-4), to allow the distribution of timepieces that 
contain less than 25 mCi of gaseous tritium light sources (GTLS) to be 
regulated according to the same requirements that regulate timepieces 
containing tritium paint. This final rule simplifies the licensing 
process for distribution of certain timepieces containing tritium paint 
and accommodates the use of a new technology for self-illuminated 
timepieces.

EFFECTIVE DATE: August 17, 1998.

FOR FURTHER INFORMATION CONTACT: Donald O. Nellis, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington DC 20555, Telephone (301) 415-6257 (e-mail address 
[email protected]).

SUPPLEMENTARY INFORMATION:

I. Background
II. Public Comments on the Proposed Rule
III. Response to Public Comments
IV. Agreement State Compatibility
V. Environmental Impact: Categorical Exclusion
VI. Paperwork Reduction Act Statement
VII. Regulatory Analysis
VIII. Regulatory Flexibility Certification
IX. Backfit Analysis
X. Small Business Regulatory Enforcement Fairness Act

I. Background

    A petition for rulemaking was received from mb-microtec, Inc. (RPM-
32-4), and noticed for public comment on October 29, 1993 (58 FR 
53670). This petition requested that those timepieces having GTLS be 
placed on the same regulatory basis as timepieces with luminous tritium 
paint. No public comments were received on the notice.
    NRC regulations that are relevant to this petition are the 
following:
    1. Under 10 CFR 30.15(a)(1), persons who receive, possess, use, 
transfer, own, or acquire timepieces containing byproduct material are 
exempted from NRC's licensing requirements provided that not more than 
the following quantities of byproduct material are contained in the 
timepiece or hands or dials:
    (I) 25 mCi of tritium per timepiece;
    (ii) 5 mCi of tritium per hand;
    (iii) 15 mCi of tritium per dial (bezels, when used, shall be 
considered part of the dial).
    Quantity limits for timepieces containing promethium-147 are also 
included.
    2. Broad general requirements in Sec. 32.14(d)(1) are applicable to 
the method of containment or binding of the byproduct material 
incorporated into the products specified in 10 CFR 30.15. Specific 
prototype testing requirements for tritium-painted dials, watch hands, 
and pointers are also provided in Sec. 32.14(d)(1). No prototype 
testing procedures are provided for timepieces containing GTLS.
    3. An exemption from licensing requirements in Sec. 30.19 is 
similar to that found in 10 CFR 30.15(a)(1) with respect to self-
luminous products containing tritium, krypton-85, or promethium-147; 
but unlike Sec. 30.15(a)(1), it does not limit the quantity of these 
radionuclides that may be incorporated into various parts of the 
product. However, It does require persons who manufacture, process, 
produce, or initially transfer such products to apply for a specific 
license under Sec. 32.22.
    4. An extensive list of requirements in Sec. 32.22 must be met in 
order to obtain a specific license to distribute such products, and 
Sec. 32.23 and Sec. 32.24 provide safety criteria that must be 
demonstrated prior to issuance of a license to distribute such 
products.
    The petitioner stated that current regulations were overburdensome 
and counterproductive, and that watch manufacturers do not want to 
become involved with the present licensing procedures required under 
Sec. 32.22 concerning GTLS watches.
    The NRC believes that the health and safety impact from using 
timepieces with GTLS would likely be positive because the radiation 
dose to the public from the use, storage, distribution, etc., of 
timepieces using GTLS is less than the dose to the public from 
timepieces containing tritium paint if the same amount of tritium is 
used in both types of timepieces. This is because the tritium leak rate 
from timepieces using GTLS is lower than from timepieces using tritium 
paint because of significantly lower tritium leak rates from sealed 
glass tubes than from timepieces containing the same amount of tritium 
as paint. Thus, allowing the exempt distribution of timepieces using 
GTLS under the same regulatory requirements as those used for 
timepieces containing tritium paint could result in a lower dose to an 
individual and a lower collective dose to the public. The distribution 
of timepieces containing larger quantities of gaseous tritium (up to 
200 mCi) has been approved for use under Sec. 32.22, ``Self-luminous 
products.'' These timepieces have been evaluated against the safety 
criteria specified in Secs. 32.22, 32.23, and 32.24 and have been found 
acceptable.
    The NRC believes that including GTLS in Sec. 32.14(d) to allow 
their exempt distribution for use under Sec. 30.15 would reduce 
unnecessary burdens for both the licensees and the NRC. Without the 
adoption of this alternative, licensees have to manufacture timepieces 
under the stringent criteria in Secs. 32.22, 32.23, and 32.24. The NRC 
must also review product design against these requirements. Because 
these stringent requirements are not deemed necessary for smaller 
quantities of tritium, these burdens could be avoided without affecting 
public health and safety. Based upon the foregoing, the NRC has 
concluded that the distribution under Sec. 30.15 and Sec. 32.14 should 
be allowed.
    On September 19, 1997 (62 FR 49173), the NRC published a proposed 
rule that incorporated the petition in part, by removing the existing 
specific testing procedures for tritium from the regulations and 
leaving only a modified first sentence in Sec. 32.14(d)(1):
    (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.
    This modification of Sec. 32.14(d)(1) represented a performance-
based approach by removing the existing specific testing procedures 
from the regulations and was expected to provide increased flexibility 
in the regulations and the accommodation of future developments in the 
technology of tritium illuminated timepieces, as well

[[Page 32970]]

as other products exempt from the requirements for a license under 
Sec. 30.15.

II. Public Comments on the Proposed Rule

    The comment period on the proposed rule closed December 3, 1997. 
Three comment letters pertaining to the proposed rule were received, 
each addressing a different element of the rule. These comments are 
discussed in the following section.

III. Response to Public Comments

    The first commenter approved the changes made in Sec. 32.14(d)(1) 
but requested, as a step toward international harmonization, that the 
NRC adopt the International System of Units (SI) in prescribing the 
quantities of byproduct material incorporated into products distributed 
to persons exempt from licensing as specified in Sec. 30.15. In 
addition, the commenter requested that the quantity limit for tritium 
specified in Sec. 30.15(a)(1)(i), 25 mCi, be changed to read 27 mCi (1 
GBq) to correspond to the exempt activity of tritium specified in the 
IAEA Safety Series No. 115 standard.
    NRC practice is to use a dual system in describing units; the 
quantities are given in the SI system, followed by the quantities in 
parentheses in conventional units. This system of units is used in this 
final rule wherever radiation quantities are specified. However, no 
change in Sec. 30.15 is being made at this time so that the quantity 
limit will remain as 25 mCi. Regarding the request to change the total 
exempt activity for timepieces to 27 mCi in place of the 25 mCi now in 
use, the NRC is currently involved in an overall reevaluation of the 
exemptions from licensing in 10 CFR Parts 30 and 40, including 
Sec. 30.15(a)(1)(i), and will consider the issue during that process.
    The second commenter stated that the language of Sec. 32.14(d)(1) 
of the proposed rule appeared to require 100% containment of the 
tritium in watches using tritium paint. The commenter proposed 
alternative text that would remove this inconsistency and provide text 
equally applicable to watches that utilize either tritium paint or GTLS 
as to other exempt products under Sec. 30.15. This commenter's 
suggestion has been adopted. Section 32.14(d)(1) has been revised in 
this final rule. As revised, the rule requires that the tritium be 
properly contained. The commenter also noted that Sec. 32.14(d)(2) of 
the proposed rule did not make sense as presented and proposed 
amendatory language that contains the same concept. The language 
proposed by this commenter has been adopted in the final rule. 
Accordingly, the codified text in Sec. 32.14(d)(2) has been modified to 
refer more correctly to existing prototype testing requirements for 
automobile lock illuminators.
    The third commenter remarked that the wording of the first sentence 
of the proposed Sec. 32.14(d)(1) was similar to the opening sentence of 
the existing rule, and that the remainder of the language of 
Sec. 32.14(d)(1), which stated that the performance standard is 
satisfied if certain prototype tests (applicable only to tritium paint) 
are satisfied, has been removed. The commenter noted that the proposed 
rule also stated that guidance on specific prototype testing procedures 
would be provided in NUREG-1562, ``Standard Review Plan for 
Applications for Licenses to Distribute Byproduct Material to Persons 
Exempt from the Requirements for an NRC License.'' The commenter 
indicated support for the increased flexibility provided by the 
proposed rule and for the need for clear and unambiguous means to 
satisfy stringent performance requirements established in the previous 
Sec. 32.14(d)(1). The commenter also noted that the relevant 
modifications to the guidance document have not yet been made and 
requested that the final promulgation of the rule be coincident with 
the issuance of appropriate guidance. Also this commenter requested 
that, because many timepieces are manufactured abroad, the NRC 
acknowledge explicitly in its guidance that compliance with relevant 
international standards is sufficient to ensure compliance with the NRC 
performance standard.
    The NRC intends to have the revised guidance document completed by 
the time this rule becomes effective. Regarding the requirement that 
timepieces manufactured abroad should meet NRC requirements, those 
timepieces should fulfill the criteria specified in NUREG--1562 or its 
equivalent.

IV. 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. 
Therefore, this final rule will be an ``NRC'' Category of compatibility 
with regard to the manufacture and initial distribution of watches and 
other products for use under an exemption for licensing. NRC Category 
rules address those regulatory areas which are reserved to the NRC 
pursuant to the Atomic Energy Act and 10 CFR Part 150.

V. Environmental Impact: Categorical Exclusion

    The NRC has determined that this final 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 final rule.

VI. Paperwork Reduction Act Statement

    This final rule reduces the burden to applicants for licenses to 
distribute timepieces by allowing them to file an application under the 
provisions of Sec. 32.14 rather than under the provisions of Sec. 32.22 
that, in practice, 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 
Sec. 32.14 and Sec. 32.22 are not being substantively changed, no 
Office of Management and Budget (OMB) clearance is required. 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.

VII. Regulatory Analysis

    The NRC has prepared a regulatory analysis on this final rule. The 
analysis examines the costs and benefits of the revisions provided by 
the rule and indicates an annual total cost saving to the industry to 
be approximately $15,000. This regulatory analysis is available for 
inspection at the NRC Public Document Room, 2120 L Street, NW (Lower 
Level), Washington, DC.

VIII. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), 
the Commission certifies that this rule does not have a significant 
economic impact on a substantial number of small entities. The NRC has 
prepared a regulatory analysis that includes consideration of the 
impact of this final rule on small entities. A copy of this regulatory 
analysis is available for inspection or copying at the NRC Public 
Document Room, 2120 L Street, NW (Lower Level), Washington, DC. The 
analysis states that this regulation would currently affect 10 
licensees and would result in a cost savings for the industry of 
approximately $15,000 per year.

[[Page 32971]]

IX . Backfit Analysis

    The NRC has determined that the backfit rule does not apply to this 
final rule and, therefore, a Backfit analysis is not required for this 
final rule because these amendments do not involve any provisions that 
would impose backfits as defined in 10 CFR Chapter I.

X. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

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 Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is adopting the 
following amendments 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, (43 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 byproduct material is properly contained in the product 
under the most severe conditions that are likely to be encountered in 
normal use and handling.
    (2) For automobile lock illuminators, the product has been 
subjected to and meets the requirements of the prototype tests 
prescribed by Sec. 32.40, Schedule A.

    Dated at Rockville, Maryland, this 9th day of June, 1998.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 98-16014 Filed 6-16-98; 8:45 am]
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