Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements, 275-287 [06-19]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Proposed Rules]
[Pages 275-287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-19]


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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. 71, No. 2 / Wednesday, January 4, 2006 / 
Proposed Rules

[[Page 275]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 31, 32, and 150

RIN 3150--AH41


Exemptions From Licensing, General Licenses, and Distribution of 
Byproduct Material: Licensing and Reporting Requirements

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations governing the use of byproduct material to revise 
requirements for reporting transfers to persons exempt from licensing, 
simplify the licensing of smoke detector distribution, remove obsolete 
provisions, and clarify certain regulatory provisions. These actions 
are intended to better ensure the protection of public health and 
safety in the future, make the licensing of distribution to exempt 
persons more effective and efficient, and reduce unnecessary regulatory 
burden to certain general licensees. These changes would affect 
licensees who distribute byproduct material to exempt persons, users of 
some generally licensed devices, and some exempt persons.

DATES: Submit comments by March 20, 2006. Submit comments specific to 
the information collection aspects of this rule by February 3, 2006. 
Comments received after these dates will be considered if it is 
practical to do so, but the NRC is able to assure consideration only 
for comments received on or before these dates.

ADDRESSES: You may submit comments by any of the following methods. 
Please include the number RIN 3150-AH41 in the subject line of your 
comments. Comments on rulemakings submitted in writing or in electronic 
form will be made available to the public in their entirety on the NRC 
rulemaking Web site. Personal information will not be removed from your 
comments.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: SECY@nrc.gov. If you do not receive a reply e-
mail confirming that we have received your comments, contact us 
directly at (301) 415-1966. You may also submit comments via the NRC's 
rulemaking Web site at https://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher at (301) 415-5905; e-
mail cag@nrc.gov. Comments can also be submitted via the Federal 
eRulemaking Portal at https://www.regulations.gov.
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone 
(301) 415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    You may submit comments on the information collections by the 
methods indicated under Paperwork Reduction Act Statement.
    Publicly available documents related to this rulemaking may be 
viewed electronically on the public computers located at the NRC's 
Public Document Room (PDR), Room O1 F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor 
will copy documents for a fee. Selected documents, including comments, 
may be viewed and downloaded electronically via the NRC rulemaking Web 
site at https://ruleforum.llnl.gov.
    Publicly available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at https://www.nrc.gov/reading-rm/adams.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (ADAMS), which provides text and image 
files of NRC's public documents. If you do not have access to ADAMS or 
if there are problems in accessing the documents located in ADAMS, 
contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737 or 
by e-mail to pdr@nrc.gov.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Mail Stop T8F3, Washington, DC 20555-0001, telephone (301) 
415-6264, e-mail, crm@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background
    A. Introduction
    B. Regulatory Framework
II. Proposed Actions
    A. Improved Reporting of Distribution to Persons Exempt From 
Licensing Requirements
    B. NRC Licensing of the Introduction of Exempt Concentrations
    C. Bundling of Exempt Quantities
    D. Obsolete Provisions
    E. New Product-Specific Exemption for Smoke Detectors
    F. Specific Licensees and Generally Licensed Devices--
Clarification
III. Early Agreement State Participation
IV. Summary of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Language
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact: Availability
X. Paperwork Reduction Act Statement
XI. Public Protection Notification
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfit Analysis

I. Background

A. Introduction

    The Commission has authority to issue both general and specific 
licenses for the use of byproduct material and also to exempt byproduct 
material from regulatory control under section 81 of the Atomic Energy 
Act of 1954, as amended (hereafter, ``the Act''). A general license is 
provided by regulation, grants authority to a person for certain 
activities involving byproduct material, and is effective without the 
filing of an application with the Commission or the issuance of a 
licensing document to a particular person. Requirements for general 
licensees appear in the regulations and are designed to be commensurate 
with the specific circumstances covered by each general license.
    In considering its exemptions from licensing, the Commission is 
directed by the Act to make ``a finding that the exemption of such 
classes or quantities of such material or such kinds of uses

[[Page 276]]

or users will not constitute an unreasonable risk to the common defense 
and security and to the health and safety of the public.'' As 
beneficial uses of licensed material were developed and experience 
grew, new products intended for use by the general public were invented 
and the regulations were amended to accommodate the use of new 
products. The Commission currently has 15 exemptions from licensing for 
byproduct material in its regulations, most of which were added by 
1970.
    The Commission has conducted a systematic reevaluation of the 
exemptions from licensing in parts 30 and 40 of NRC's regulations (in 
Title 10 of the Code of Federal Regulations), which govern the use of 
byproduct and source materials. A major part of the effort was an 
assessment of the potential and likely doses to workers and the public 
under these exemptions. The assessment of doses associated with most of 
these exemptions can be found in NUREG-1717,\1\ ``Systematic 
Radiological Assessment of Exemptions for Source and Byproduct 
Materials,'' June 2001. For some exemptions, the difference between 
potential (possible under the conditions of the exemption) and likely 
doses is significant because actual use of the exemption is limited or 
nonexistent, or significantly lower quantities are used in products 
than is potentially allowed under the exemption.
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    \1\ NUREG-1717 is a historical document development using the 
models and methodology available in the 1990s. The NUREG provides 
the estimate of the radiological impacts of the various exemptions 
from licensing based on what was known about distribution of 
material under the exemptions in the early 1990s. NUREG-1717 was 
used as the initial basis for evaluating the regulations for 
exemptions from licensing requirements and determining whether those 
regulations adequately ensured that the health and safety of the 
public were protected consistent with NRC policies related to 
radiation protection. The agency will not use the results presented 
in NUREG-1717 as a sole basis for any regulatory decisions or future 
rulemaking without additional analysis.
    Copies of NUREGs may be purchased from the Superintendent of 
Documents, U.S. Government Printing Office, P.O. Box 37082, 
Washington, DC 20013-7082. Copies are also available from the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161. A copy is also available for inspection and/
or copying for a fee at the NRC public Document Room, One White 
Flint North, 11555 Rockville Pike, Public File Area O1-F21, 
Rockville, MD.
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    This proposed action concerns only conclusions of the reevaluation 
of regulations governing byproduct material. Any potential revisions to 
the regulations governing source material would be addressed in the 
future. In addition to the exemptions themselves, the NRC has reviewed 
the existing regulations governing the distribution of byproduct 
material to persons for use under the exemptions.
    Generally, the systematic assessment of exemptions determined that 
no significant problems exist with the current uses of byproduct 
materials under the exemptions from licensing. Actual exposures of the 
public likely to be occurring are in line with Commission policy 
concerning acceptable doses from products and materials used under 
exemptions from licensing. However, in some cases, the regulatory 
constraints and controls in place may not be adequate to fully ensure 
that the health and safety of the public will continue to be protected 
to the extent considered appropriate for practices occurring under 
exemptions from licensing.
    Although presenting very low risks of significant individual doses 
to members of the general public, exempt products are a source of 
routine exposure to the public. A substantial portion of the population 
uses and enjoys benefits from exempt products, such as smoke detectors, 
but, at the same time, receives some radiation exposure from those 
products.
    The Commission has also decided to make the regulations more 
flexible, user-friendly, and performance-based, and to improve its 
ability to risk-inform its regulatory program. These concepts have been 
considered in developing potential revisions to the regulatory program 
in the area of distribution of byproduct material to exempt persons.
    The Commission is also proposing a revision to a certain general 
license within this same rulemaking. There are some areas where the 
regulations are not clear or explicit. This leads to inefficiencies in 
the regulatory process and can lower public confidence. Thus, a 
clarification is being proposed.
    In addition to the issues addressed by this proposed rule, the 
Commission is considering other issues that may be addressed in a 
future rulemaking to further amend parts 30, 31, and 32.

B. Regulatory Framework

    The Commission's regulations in part 30 contain the basic 
requirements for licensing of byproduct material. Part 30 includes a 
number of exemptions from licensing requirements in Sec. Sec.  30.14, 
30.15, 30.16, 30.18, 30.19, 30.20, and 30.21. These exemptions allow 
for certain products and materials containing byproduct material to be 
used without any regulatory requirements on the user. The two 
exemptions in Sec. Sec.  30.19 and 30.20, for self-luminous products 
and gas and aerosol detectors, respectively, are class exemptions, 
which cover a broad class of products. Under these provisions, new 
products can be approved for use through the licensing process if the 
applicant demonstrates that the specific product is within the class 
and meets certain radiation dose criteria. This contrasts with other 
exemptions for which the level of safety is controlled through such 
limits as specification of radionuclides and quantities. Sections 30.14 
and 30.18, exempt concentrations and exempt quantities, are broad 
materials exemptions, which allow the use of a large number of 
radionuclides. The specific radionuclide limits on these concentrations 
and quantities are contained in tables in Sec. Sec.  30.70 and 30.71, 
respectively. The remaining exemptions from licensing are product 
specific, for which many assumptions can and have been made concerning 
how the product is distributed, used, and disposed.
    Part 31 provides general licenses for the use of certain items 
containing byproduct material and the requirements associated with 
these general licenses. The general licenses are established in 
Sec. Sec.  31.3, 31.5, 31.7, 31.8, 31.10, and 31.11.
    Part 32 sets out requirements for the manufacture or initial 
transfer (distribution) of items containing byproduct material to 
persons exempt from licensing requirements and to persons using a 
general license.
    Part 150 sets out regulations for all States that have entered into 
agreements with the Commission under subsection 274b of the Act 
(Agreement States).

II. Proposed Actions

    This proposed rule would make a number of revisions to the 
regulations governing the use of byproduct material under exemptions 
from licensing and under general license and to the requirements for 
those who distribute products and materials for use under exemptions 
from licensing. The changes are intended to better ensure the 
protection of public health and safety in the future and improve the 
efficiency and effectiveness of certain licensing actions.

A. Improved Reporting of Distribution to Persons Exempt From Licensing 
Requirements

    The current reporting and recordkeeping requirements for 
distributors of products and materials to persons exempt from licensing 
in part 30 (contained in Sec. Sec.  32.12, 32.16, 32.20, 32.25(c), and 
32.29(c)) require these licensees to maintain records of these 
transfers and to submit reports to NRC once every five years. The 
reports must

[[Page 277]]

indicate the total quantity of byproduct material and/or the total 
number of exempt units listed by type transferred during the reporting 
period. The breakdown of the information by year is not required. These 
reports are also required when filing for license renewal or notifying 
the Commission of a decision to cease authorized activities.
    The resulting reports are not timely and informative enough for NRC 
to fully determine the products and amount of byproduct material 
distributed annually for exempt use. This limits the NRC's ability to 
evaluate the overall net impact of these practices on public health and 
safety. Because the date of reporting for each licensee is different 
and the information is not necessarily reported by year, it is 
difficult to estimate the amount or types of products/materials 
containing byproduct material distributed each year or to see any 
trends. Also, the information is not very current. The limitations of 
the information about the products/materials and quantities distributed 
for use under exemption greatly impacted the effort involved in 
developing the dose assessments in NUREG-1717 and contributed to the 
uncertainties in the results.
    Before 1983, reporting of transfers of exempt byproduct material 
was required on an annual basis. The regulations were amended in 1983 
to change the reporting requirement to once every 5 years to minimize 
administrative burden. However, subsequent experience with the 5-year 
reporting frequency has shown that it does not provide NRC with 
complete, accurate, or timely information on products and materials 
containing byproduct material distributed for use under exemptions from 
licensing. Reevaluation of the reporting requirements also suggests 
that annual reporting may be administratively more efficient for both 
the NRC and affected licensees than the current requirement. Experience 
shows that there have been more implementation problems under the 
current scheme than with annual reporting. For example, because of the 
long interval between reports, licensees frequently forget to file 
reports in compliance with the regulations. This lapse sometimes 
results in the need for requests for additional information to be sent 
so that an application for renewal or termination of license can be 
processed. The long interval between reports also leads to licensee 
inefficiencies in collecting the data.
    The proposed rule would require that material transfer reports 
covering transfers made during the calendar year be submitted annually 
by January 31 of the following year. These reports would also be 
required 30 days after ceasing authorized activities, rather than at 
the point of notifying the Commission of the decision to cease 
authorized activities. The reports would no longer be required when 
filing for license renewal. In the first report made after the proposed 
change, licensees would also be required to submit information on 
transfers made since the previous report. Routine annual reporting 
should be more straightforward and easier for licensees to comply with 
than consolidating and reporting five years of distribution 
information. This approach is expected to impose a minimal burden and 
be more efficient for both the NRC and licensees, particularly given 
the current state of information technology. A recent change to the 
Commission's regulations allows electronic submission as an alternative 
to standard mail submission, which reduces administrative costs.
    In addition to the lengthy period between the current reports, 
certain information is not always clear in the reports, making it more 
difficult to use the information. The proposed rule would make these 
reporting provisions more specific. The report would be required to 
include reference to the specific exemption provision under which the 
products/materials are being distributed and clearly identify the 
specific licensee submitting the report, including the license number.
    The current regulations require the licensee to identify the 
product distributed. However, this is done in a number of ways, some of 
which require the NRC to refer to other documents to obtain the 
information needed to fully interpret what is being distributed. The 
proposed rule would add model numbers, when applicable, to the required 
information. Licensees have frequently included model numbers in the 
reports, but often as the only identification of the type of product 
being transferred. The proposed rule would eliminate these 
inefficiencies without making a significant change to licensees' 
reporting burden. The address to which reports are to be sent would 
also contain the line, ``ATTN: Document Control Desk/Exempt 
Distribution,'' to make the internal distribution of the documents 
within NRC more efficient. The requirement for licensees to send an 
additional copy of the reports to the appropriate Regional office would 
be removed. Under NRC's internal procedures, the information would be 
electronically distributed to the Regional offices. These factors are 
expected to make the reporting process more efficient and to improve 
the quality of the information submitted.
    As a result of these proposed changes, the NRC would receive 
information on distribution to exempt persons that is more useful for 
evaluating both potential individual doses to the public from multiple 
sources and collective doses to the public from these products and 
materials than that provided under the existing regulations. The NRC 
would have a stronger basis for informing the public concerning such 
exposures. These changes would also provide a better basis for 
considering any future regulatory changes in this area and in 
allocating NRC resources. Finally, the period of retention for records, 
proposed to remain at one year after transfers are included in a 
report, would be up to four years shorter than under existing 
requirements.

B. NRC Licensing of the Introduction of Exempt Concentrations

    For most exemptions from licensing in part 30, distributors must 
have an NRC license even if they are in Agreement States. Reporting 
requirements for these licensees provide the NRC with national data on 
products and materials containing byproduct material distributed to 
persons exempt from licensing and regulation. There are two exemptions 
for which this is not the case. The first of these, Sec.  30.16, 
``Resins containing scandium-46 and designed for sand-consolidation in 
oil wells,'' would be removed, as noted below, because it is obsolete. 
The second is Sec.  30.14, ``Exempt concentrations,'' for which those 
who introduce byproduct material into products or materials are 
licensed under Sec.  32.11 or similar Agreement States regulations. The 
concentration limits applicable to this exemption from licensing are 
contained in Sec.  30.70, ``Schedule A--Exempt concentrations,'' and 
equivalent Agreement State regulations.
    The provisions that allow Agreement State licensing of the 
introduction of byproduct material into products and materials in 
exempt concentrations for transfer to persons exempt from licensing 
were added to NRC regulations in 1963, soon after the regulations 
governing the Agreement State program were established in 1962 (10 CFR 
part 150). At the time, the only practices being regulated under these 
provisions related to quality control procedures and other radiotracer 
activities. Exempt concentrations were permitted to be introduced into 
oil, gasoline, plastics, and similar commercial and industrial items. 
Also, at the time these provisions were added, it was expected that the 
NRC would

[[Page 278]]

develop a system with the Agreement States to obtain copies of the 
transfer reports submitted to the Agreement States by their licensees 
so that NRC would have national information on distribution. Such a 
system was never implemented.
    The exempt concentration provision in Sec.  30.14 is a general 
materials exemption that is not limited to a particular use. It allows 
for various practices to be evaluated by the NRC or an Agreement State 
on a case-by-case basis through the licensing process. A number of 
different practices have been evaluated and conducted under Sec.  
32.11, including the neutron irradiation of gemstones, silicon 
semiconductor materials, and luggage and cargo in an airport explosive 
detection system, resulting in induced radioactivity in the products. 
These practices involved consideration of issues not anticipated in the 
early 1960's, including the extensive national distribution of the 
products. For the case of irradiation of gemstones, the NRC has since 
required authorization by an NRC license.
    Section 30.14 also contains an exemption from licensing by NRC (in 
paragraph (c)) for manufacturers, processors, or producers in Agreement 
States if the introduction of byproduct material into their product or 
material is conducted by a specific licensee whose license authorizes 
this introduction. Currently, this authority may be provided under 
either an NRC license or an Agreement State license.
    Information on all distributions to exempt persons is important for 
NRC to effectively and efficiently assess the overall impact to the 
public nationally. NRC licensing of all such distribution would 
facilitate this process. Also, the concentration limits in Sec.  30.70 
do not provide the sole assurance of protection of public health and 
safety. The evaluation done in connection with the licensing process is 
also important. The current situation of multiple jurisdictions 
potentially issuing these licenses may allow for some inconsistency in 
the licensing process.
    The proposed rule would require that the entity introducing 
byproduct material into products and materials for use under the exempt 
concentration provisions have an NRC license specifically authorizing 
this introduction. Specifically, the proposed rule would make 
Sec. Sec.  32.11 and 32.12 Compatibility Category NRC (i.e., reserved 
to NRC). (For a brief explanation of compatibility categories see the 
Agreement State Compatibility section.) This change to NRC-only 
licensing would also require amendment of other provisions in the 
regulations. Thus, the proposed rule would revise the wording of the 
exemption in Sec.  30.14(c), Sec.  32.11, the prohibition in Sec. Sec.  
30.14(d) and 32.13, and the reciprocity provision in Sec.  150.20 
accordingly, so that only NRC may authorize the introduction of 
byproduct material into products and materials to be distributed for 
use under Sec.  30.14 and equivalent Agreement State regulations.
    Section 32.11 would be revised to exempt Agreement State licensees 
from Sec.  30.33(a)(2) and (3). Consistent with the practice for other 
distributors of byproduct material to exempt persons in Agreement 
States, who have possession and use of the material authorized by an 
Agreement State license and distribution authorized by an NRC license, 
the possession and use of the byproduct material to be introduced could 
remain under an Agreement State license. In that case, provisions 
similar to Sec.  30.33(a)(2) and (3) would apply under the Agreement 
State license.
    Currently, the only known entities licensed under Sec.  32.11 or 
equivalent regulations of the Agreement States are a small number of 
radiotracer firms, who introduce byproduct material into such materials 
as gas and oil, and steel companies, who use sources to monitor the 
wear of refractory lining in blast furnaces resulting in infrequent but 
expected instances of slight contamination of some steel. The Agreement 
States were requested to provide information on the number of licensees 
of this type in 2002 and 2005. No licensees were identified.
    The exemption in Sec.  30.14(c) was added specifically for persons 
in Agreement States because of the provision in Sec.  150.15(a)(6), 
which reserves for NRC the authority for licensing transfers to exempt 
persons. The proposed rule would further revise the exemption in Sec.  
30.14(c) to also apply to manufacturers, processors, or producers in 
non-Agreement States who use a radiotracer firm or other Sec.  32.11 
licensee to introduce byproduct material into their products. The 
intent of the regulations in Sec.  32.11 is to allow a licensee to 
introduce byproduct material into products and materials held by others 
who are not required to have a license, thus, there is no reason to 
limit this provision to persons in Agreement States. Therefore, Sec.  
30.14(c) would be amended to delete the reference to the Agreement 
States.

C. Bundling of Exempt Quantities

    In accordance with Sec.  30.18, ``Exempt quantities,'' a person is 
exempt from the requirements for a license to the extent that person 
receives, possesses, uses, transfers, owns, or acquires byproduct 
material in individual quantities, each of which does not exceed the 
applicable quantity set forth in Sec.  30.71, Schedule B. However, a 
person who commercially distributes materials to another person for use 
under Sec.  30.18 must first obtain a distribution license from NRC in 
accordance with Sec.  32.18, ``Manufacture, distribution and transfer 
of exempt quantities of byproduct material: Requirements for license.''
    Paragraph (c) of Sec.  32.18 prohibits the distributor from 
incorporating the exempt byproduct material into any manufactured or 
assembled commodity, product, or device intended for commercial 
distribution. However, there is no stated prohibition regarding such 
application by the end-user who is not commercially distributing the 
product.
    NRC became aware that some persons holding byproduct material under 
the exemption in Sec.  30.18 had been combining (bundling) multiple 
exempt quantities within an individual device that had not been 
evaluated and approved by the NRC. The devices were manufactured 
without radioactive material, but were designed to use multiple exempt 
quantity sources of byproduct material. After first becoming aware of 
the bundling issue, NRC originally determined in June 1994, that, under 
certain limited circumstances, bundling of exempt sources did not 
present a health and safety hazard and therefore no action was taken. 
Later, the NRC became concerned that the number of exempt sources 
bundled in these devices could reach a point where a general or 
specific license would normally be required. If the bundled sources 
were considered exempt, NRC would have no mechanism to ensure their 
safe possession, use, and disposal. As a result, NRC issued a generic 
letter in 1999, ``NRC Generic Letter 99-01: Recent Nuclear Material 
Safety and Safeguards Decision on Bundling Exempt Quantities, May 3, 
1999,'' to clarify that bundling was not appropriate under the existing 
regulation. This position is supported by the language in Sec.  
32.19(d)(2), which directs the distributor to provide a label or 
accompanying brochure with any distributed exempt quantities that 
includes the statement: ``Exempt Quantities Should Not be Combined.'' 
However, the NRC believes that the regulations in Sec.  30.18 should be 
amended to specifically prohibit bundling under the exemption. The 
proposed rule would revise the exempt quantities provision in Sec.  
30.18 to explicitly prohibit combining sources to create an increased 
radiation level.
    The original basis for the quantities chosen for the exemption in 
Sec.  30.18 was

[[Page 279]]

the more restrictive of: (1) The quantity of material inhaled by a 
reference individual exposed for one year at the highest average 
concentration permitted in air for members of the general public in 
unrestricted areas at the time; or (2) for gamma emitters, the quantity 
of material that would produce a radiation level of 1 mR/hr at 10 cm 
from a point source. It was reasoned that under the conditions of the 
exemption, it is unlikely that any individual would inhale (or ingest) 
more than a very small fraction of any radioactive material being used 
or receive excessive doses of external radiation when realistic source-
to-receptor distances and exposure times are assumed. Should bundling 
be permitted, NRC cannot assure that the exposures would not exceed the 
levels originally intended under the exemption. In addition, there 
would be some potential that disposal of devices containing multiple 
exempt sources through ordinary commercial waste streams or metal 
recycling channels could result in inappropriate contamination of 
property.
    Because of the NRC's 1994 determination that, under certain limited 
circumstances, bundling of exempt sources did not present a health and 
safety hazard, the May 3, 1999, generic letter affirmed that NRC did 
not plan to take any action regarding the devices initially produced 
for use with a limited number of exempt quantity sources or their users 
unless a radiological safety hazard were to be identified. Because NRC 
has no indication that significant exposures are resulting or will 
result from the continued use of the devices evaluated in 1994, the 
proposed amendment would allow continued use of those devices. This 
exclusion is intended to avoid imposing a regulatory burden on those 
persons who otherwise might be impacted by this clarification in the 
regulation who are continuing to use devices in use before the generic 
letter was issued. Additionally, this regulation is not intended to 
impact normal storage methods of the materials held under the exemption 
in Sec.  30.18.

D. Obsolete Provisions

    Some exemptions from licensing are considered obsolete in that no 
products are being distributed for use under the exemption. In some 
cases, no products covered by the exemption remain in use. Generally, 
this has occurred because new technologies have made the use of 
radioactive material unnecessary or less cost-effective.
    The Commission is proposing to delete exemptions for products that 
are no longer being used or manufactured, or to restrict further 
distribution while allowing for the continued possession and use of 
previously distributed items. These exemptions in part 30 are for: 
Automobile lock illuminators (Sec.  30.15(a)(2)), balances of precision 
(Sec.  30.15(a)(3)), automobile shift quadrants (Sec.  30.15(a)(4)), 
marine compasses (Sec.  30.15(a)(5)), thermostat dials and pointers 
(Sec.  30.15(a)(6)), spark gap irradiators (Sec.  30.15(a)(10)), and 
resins containing scandium-46 (Sc-46) for sand consolidation in oil 
wells (Sec.  30.16). Of these, only the exemption for resins containing 
scandium could result in significant doses, which might be of concern, 
if it were used.
    NUREG-1717 describes the various products covered by the individual 
exemptions in the second subsection of each section for a particular 
exemption. Some of the conclusions in that report concerning 
distribution are:
    (1) On Sec.  30.15(a)(2): It is believed that automobile lock 
illuminators containing H-3 (tritium) or promethium-147 have never been 
manufactured for commercial use;
    (2) On Sec.  30.15(a)(3): Tritium is not currently being used on 
balances of precision;
    (3) On Sec.  30.15(a)(4): It is believed that automobile shift 
quadrants containing tritium are not being manufactured, nor have they 
ever been manufactured, for commercial use;
    (4) On Sec.  30.15(a)(5): Apparently, domestic manufacture and 
import of marine compasses and other navigational instruments that 
contain tritium has ceased;
    (5) On Sec.  30.15(a)(6): Tritiated paint is not currently being 
used on thermostat dials and pointers, primarily because electronic 
displays are now available for illumination purposes. Neither are 
gaseous tritium light sources used for thermostat dials or pointers;
    (6) On Sec.  30.15(a)(10): Spark gap irradiators containing cobalt 
are designed to minimize spark delay in some electrically ignited 
commercial fuel-oil burners by generating free electrons in the spark 
gap. The irradiators are no longer being manufactured, only about 100 
irradiators were in stock in 1994, and no plans had been made to 
distribute them for use. The original manufacturer is no longer in 
business. The number of irradiators actually distributed is unknown, 
but is not thought to be significant. [Note: there are products 
referred to as ``spark gaps'' or ``spark gap tubes,'' a category of 
electron tube, covered by the exemption in Sec.  30.15(a)(8), which 
should not to be confused with the specific product covered by Sec.  
30.15(a)(10)]; and
    (7) On Sec.  30.16: Resins as the primary cementing media are no 
longer used.
    With the exception of resins covered by Sec.  30.16, only NRC 
licenses distributors of these products. The primary bases for 
determining that products are obsolete are NRC's records on its 
licensees. Industry contacts were also used to collect historical 
information concerning the use of the various products.
    The NRC expects that the distribution of thermostat dials or 
pointers, spark gap irradiators, and resins containing Sc-46 for sand 
consolidation in oil wells ceased so long ago that it is highly 
unlikely that any remain in use. This may or may not be the case for 
balances of precision and marine compasses distributed for use under 
Sec.  30.15(a)(3) and (5). As noted, automobile lock illuminators and 
automobile shift quadrants were likely never commercially distributed 
for use under exemption. The exemptions for automobile lock 
illuminators, automobile shift quadrants, thermostat dials or pointers, 
spark gap irradiators, and resins containing Sc-46 for sand 
consolidation in oil wells would be removed. The exemptions for 
balances of precision and marine compasses and other navigational 
instruments would be retained for previously distributed products only. 
This language is not being retained for the other five exemptions 
considered obsolete. However, in the unlikely event that persons still 
possess any of these products, this action is not intended to change 
the regulatory status of any products previously distributed in 
conformance with the provisions of the regulations applicable at the 
time.
    Specific requirements for manufacturers and initial distributors of 
products that are no longer being manufactured or distributed would 
also be deleted. These include Sec.  32.17 for the manufacture or 
distribution of resins containing Sc-46 and the prototype test 
procedures for automobile lock illuminators specified in Sec.  32.40 
and required by Sec.  32.14(d)(2).
    In the case of the resins containing Sc-46 for sand consolidation, 
this action would provide assurance that health and safety are 
adequately protected from possible future distribution. Only 
preliminary dose estimates were made for this exemption. These 
preliminary estimates indicated a potential for exposures higher than 
is appropriate for materials being used under an exemption. However, 
the preliminary dose estimates were not refined or included in NUREG-
1717, because the exemption was no longer being used.

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    Deleting these unnecessary provisions would simplify the 
regulations by eliminating extraneous text. Also, the Commission 
periodically reevaluates the exposure of the general public from all 
products and materials distributed for use under exemption, to ensure 
that the total contribution of these products to the exposure of the 
public will not exceed small fractions of the allowable limits. 
Eliminating obsolete exemptions would add to the assurance that future 
use of products in these categories would not contribute to exposures 
of the public and would also eliminate the need to reassess the 
potential exposure of the public from possible future distributions of 
the products.

E. New Product-Specific Exemption for Smoke Detectors

    One of the most widely distributed products used under an exemption 
from licensing is the ionization chamber smoke detector commonly used 
in residences. These smoke detectors are currently used under the class 
exemption in Sec.  30.20 for gas and aerosol detectors and equivalent 
regulations of the Agreement States. This class exemption was 
established in April 1969. Section 30.20 also covers chemical agent 
detectors and allows for new detectors with similar purposes to be 
licensed for distribution without a new exemption from licensing being 
established by rulemaking.
    The specific requirements for obtaining a license to manufacture, 
process, produce, or initially transfer gas and aerosol detectors 
intended for use under Sec.  30.20 are currently contained in Sec.  
32.26. Conditions of licenses are contained in Sec.  32.29 including 
requirements for quality control, labeling, recordkeeping, and 
reporting of transfers. NRC's licensing of a new initial distributor of 
smoke detectors involves an evaluation to determine that certain safety 
criteria (contained in Sec. Sec.  32.27 and 32.28) are met. The safety 
criteria for gas and aerosol detectors include: (1) Radiation dose 
limits for individuals from normal handling, storage, use, and disposal 
of these products; and (2) radiation dose limits for individuals, in 
conjunction with approximate associated probabilities of occurrence, 
for accidents.
    Residential ionization chamber smoke detectors and some similar 
smoke detectors have been manufactured and used for many years. Current 
designs are very consistent, using 0.9 to 1 [mu]Ci (33 to 37 kBq) of 
americium-241 (Am-241) contained in a foil, surrounded by an ionization 
chamber. Earlier designs used larger quantities of americium and, in 
some cases, other radionuclides. Residential ionization chamber smoke 
detectors (and similar detectors) represent a well established practice 
with consistency in the design of products and with extensive licensing 
experience. Potential doses from the distribution, use, handling, and 
disposal of these detectors has been estimated in NUREG/CR-1156, 
``Environmental Assessment of Ionization Chamber Smoke Detectors 
Containing Am-241,'' November 1979, in NUREG-1717, and in various 
license applications. The estimated doses under normal, routine 
conditions are well under the safety criterion for routine use of 5 
mrem/year (5 [mu]Sv/year) whole body, and the associated individual 
organ limits.
    This proposed rule would establish a specific exemption from 
licensing requirements for ionization chamber smoke detectors 
containing no more than 1 [mu]Ci (37 kBq) of Am-241 in the form of a 
foil and designed to protect life and property from fires. This is 
intended to apply to ionization smoke detectors whose primary function 
is the protection of life and property. The exemption for ionization 
chamber smoke detectors would be added to Sec.  30.15(a) as Sec.  
30.15(a)(7). The primary difference between this proposed exemption and 
the existing class exemption in Sec.  30.20 is that an applicant for a 
license to distribute smoke detectors for use under this exemption 
would not be required to submit dose assessments to demonstrate that 
doses from the various stages of the life cycle of the product do not 
exceed certain values. The applicant would still be required to submit 
basic design information consistent with that required from applicants 
to distribute products for use under other product-specific exemptions, 
specifically for those products used under Sec.  30.15. The 
requirements for applicants to distribute these products are contained 
in Sec.  32.14. The primary emphasis of these requirements is to 
provide assurance that the byproduct material is properly contained 
within the product and will not be released under the most severe 
conditions encountered in normal use and handling. Requirements for 
those licensed under Sec.  32.14 are contained in Sec. Sec.  32.15 and 
32.16. These latter requirements address quality assurance, labeling, 
recordkeeping, and reports of transfer. The labeling requirement for 
smoke detectors under the current regulation in Sec.  32.29(b) is more 
specific than those in Sec.  32.15(d). In order that the more specific 
labeling requirement be retained, essentially the same details would be 
added to Sec.  32.15(d) as applicable specifically to ionization 
chamber smoke detectors. A minor change (i.e., not referring to 10 CFR 
32.27) would be made to be consistent with the new regulatory 
requirements.
    It is the NRC staff's licensing practice to issue licenses for the 
distribution of products to be used under a class exemption only after 
a Sealed Source and Device (SS & D) review and registration in the SS & 
D. This is not the practice for products to be distributed for use 
under a product-specific exemption. Because of this, the proposed 
revision would also reduce both application and annual fees for 
distributors of smoke detectors. There is a separate application fee in 
Sec.  170.31, associated with device review and registration, which 
would no longer apply. Also, in Sec.  171.16, there are different 
annual fees based on whether a device has been evaluated for 
registration in the SS & D. The primary difference is the elimination 
of the fee for holding a registration certificate. For small entities, 
reduced fees apply; therefore, the affect of this change on fees would 
be smaller.
    The effect of this change would be to reduce the regulatory burden 
and the fees for new applicants for licenses to distribute ionization 
chamber smoke detectors. Additionally, the change would reduce the NRC 
staff time needed to review these applications, because an evaluation 
of dose assessments would no longer be included. Current distributors 
of ionization chamber smoke detectors using no more than 1 [mu]Ci of 
Am-241 (37 kBq) may also amend their licenses and SS & D registrations 
to change the regulatory status of their products in order to reduce 
their annual fees. Given the wide distribution this product has already 
experienced, this change is not expected to affect the overall number 
of ionization chamber smoke detectors distributed in the future. Thus, 
a more efficient regulatory process would be used without any impacts 
to the health and safety of the public or the environment.

F. Specific Licensees and Generally Licensed Devices--Clarification

    Following a revision to the general license provided by Sec.  31.5 
(65 FR 79161; Dec. 18, 2000) that became effective in February 2001, an 
increased number of specific licensees transferred their authorization 
to possess and use some devices under the Sec.  31.5 general license to 
the authority provided by their specific license. These transfers were 
made primarily to avoid the cost of the new registration fees for some 
of these devices in addition to their specific

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license fees. There are also other, non-fee-related reasons why one 
would make such a transfer. There has been some confusion as to the 
applicability of some requirements with respect to the transfer of a 
device from a general licensee to a specific licensee when the same 
entity holds both licenses, and as to exactly what is necessary to 
comply with existing requirements related to both types of license.
    The general license in Sec.  31.5, under paragraph (c)(1), requires 
that the original label on the device be maintained. This label, among 
other things, indicates the general license regulatory status of the 
device and provides safety instructions or reference to operating and 
service manuals. Instructions to the general licensee may not be 
appropriate for the use of the device under a specific license. For 
example, instructions may indicate that the general licensee may not 
conduct its own leak tests, but must have an appropriate specifically 
licensed service company do so. Also, under a specific license, 
different labeling requirements are applicable (Sec.  20.1904, 
``Labeling containers''). It is not acceptable for a device being held 
under a specific license (SL) to be labeled in accordance with Sec.  
32.51(a)(3), i.e., a general license (GL) label. Thus, if a device is 
to be transferred from GL status to SL status, the label needs to be 
changed to comply with the appropriate labeling requirement.
    A specific licensee would conduct its own maintenance activities 
including required leak tests, but may need information from the 
manufacturer concerning the appropriate methods for the particular 
device. This information may not have been provided to the entity as a 
general licensee, depending on the device and what has been determined 
to be appropriate activities for a general licensee. Thus, a specific 
licensee may need to contact the manufacturer to obtain the proper 
procedures for conducting required leak tests and other activities.
    A specific licensee may have provisions in its license that 
authorize the quantities of the radionuclides used in a generally 
licensed device. The licensee needs to verify that the conditions of 
the specific license authorize the possession and use of the device or 
apply for an appropriate amendment to the license.
    Paragraph (c)(8) of Sec.  31.5 specifies acceptable specifically 
licensed recipients of devices covered by this general license and 
requires that a general licensee report to the NRC transfers of devices 
to specific licensees. The address for reporting includes an attention 
line to Document Control Desk/GLTS. GLTS refers to the General License 
Tracking System, which includes information on devices in use under 
Sec. Sec.  31.5 and 31.7. In order for this database to be kept up-to-
date, transfers to specific licensees must be reported and the devices 
removed from the database. Paragraph (c)(8)(iii) of Sec.  31.5 requires 
written approval from the NRC for transfers to any specific licensee 
not identified in paragraph (c)(8)(i). Thus, a general licensee who 
wishes to transfer a device to any other specific licensee, even if 
that licensee is the same entity and the effect is only to transfer to 
a specifically licensed status, must obtain approval for the transfer. 
In this way, the NRC can verify that the specific license authorizes 
this use and can ensure that the licensee is fully aware of its 
responsibilities under both the general and specific license with 
respect to the device. In addition, the NRC can update the GLTS.
    This proposed rule would explicitly set out the required actions 
for this type of transfer. It would also remove the necessity of 
obtaining prior written NRC approval under these circumstances. 
Paragraph 31.5(c)(8)(iii) would be revised to include details 
concerning the required actions for a specific licensee to transfer a 
device held under this general license to the authority provided by the 
specific license. With these additional details included in the 
regulation, it is not considered necessary for the specific licensee to 
obtain prior written approval.

III. Early Agreement State Participation

    The working group involved in the preparation of this proposed rule 
included a member who was appointed by the Organization of Agreement 
States (OAS), as well as the Conference of Radiation Control Program 
Directors (CRCPD). This proposed rule and its draft Environmental 
Assessment were also provided to the Agreement States during their 
development via the use of the NRC Technical Conference Forum Web site 
and notification to the States of their availability.
    Two States provided comments. Both supported most of the proposed 
revisions but were concerned with NRC making revisions to the general 
license requirements in Sec.  31.5. The State of Wisconsin noted 
particularly the revision to Sec.  31.5(c)(8) and suggested that the 
NRC suspend the proposed revision of Sec.  31.5 until the Commission 
has evaluated a recently submitted OAS petition for rulemaking to 
determine if the petition offers a better alternative. Illinois 
supported the revision of Sec.  31.5(c)(8), but disagreed with another 
amendment to Sec.  31.5 included in the draft proposed rule posted for 
Agreement state comment, which has not been retained in this proposed 
rule. Illinois also suggested revising the labeling requirements (in 
Sec.  32.19(d)(2)) so that the label would state that exempt quantities 
``shall'' not be combined (rather than ``should'').
    The OAS petition referred to by Wisconsin suggests that those 
devices used under general license and covered by the registration 
requirement in Sec.  31.5(c)(13), be required to be specifically 
licensed instead. If the Commission decides to grant the OAS petition, 
unregistered devices would still remain under a general license that 
may be transferred to the authority of a specific license. If the 
Commission decides to deny the OAS petition, both registered and 
unregistered devices would remain under a general license that may be 
transferred to the authority of a specific license. As a result, the 
NRC has determined that the actions suggested by the OAS petition, if 
taken, would not negatively impact the proposed change in this action; 
the issues are sufficiently independent that the NRC does not believe 
this change should await resolution of the petition.
    The labeling requirement in Sec.  32.19(d) is a notification from a 
licensee to a non-licensee. The label provides information to the user; 
however, this direction is not enforceable. A revision to the exemption 
in Sec.  30.18 itself is being proposed in order to make the intent 
demonstrated by the labeling requirement more enforceable. Amending the 
labeling requirement would not do so and would impose a cost on 
licensees who commercially distribute exempt quantities with no real 
effect.

IV. Summary of Proposed Amendments by Section

    10 CFR 30.14(c)--Would revise the exemption for manufacturers, 
processors, and producers to require that the licensed entity must be 
an NRC licensee, and clarify that the exemption applies in all 
jurisdictions.
    10 CFR 30.14(d)--Would revise the prohibition on introducing exempt 
concentrations to apply to all persons except those authorized by an 
NRC license.
    10 CFR 30.15(a)--Would (1) remove exemptions for automobile lock 
illuminators, automobile shift quadrants, thermostat dials and 
pointers, and spark gap irradiators; (2) limit the exemptions for 
balances of precision and marine compasses and other navigational 
instruments to products previously distributed; and (3)

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add an exemption for ionization chamber smoke detectors containing no 
more than 1 [mu]Ci of Am-241 in a foil.
    10 CFR 30.16--The exemption for resins containing Sc-46 for sand 
consolidation in oil wells would be removed.
    10 CFR 30.18--Would revise the exempt quantities provision by 
adding an explicit prohibition in a new paragraph (e) against combining 
sources to create an increased radiation level.
    10 CFR 31.5(c)(8)(ii)--Would resolve a minor ambiguity with respect 
to addressing reports.
    10 CFR 31.5(c)(8)(iii)--Would revise transfer provisions to 
explicitly state actions necessary for transfer of devices from general 
license to specific license status and remove the need for written NRC 
approval in that case.
    10 CFR 32.11(a)--Would be revised to exempt Agreement State 
licensees from Sec.  30.33(a)(2) and (3).
    10 CFR 32.12--Would revise the period of reporting for material 
transfers to annual and make minor changes to the content of reports.
    10 CFR 32.13--Would revise the prohibition on introducing exempt 
concentrations to apply to all persons except those authorized by an 
NRC license.
    10 CFR 32.14(d)--Would remove the reference to Sec.  32.40.
    10 CFR 32.15(d)--Would add specific labeling requirements for smoke 
detectors distributed for use under Sec.  30.15 consistent with that 
currently applicable under the gas and aerosol detector provisions in 
Sec.  32.29.
    10 CFR 32.16--Would revise the period of reporting for material 
transfers to annual, make minor changes to the content of reports, and 
remove reference to Sec.  32.17.
    10 CFR 32.17--Requirements for distribution of resins containing 
Sc-46 for sand consolidation in oil wells would be removed.
    10 CFR 32.20--Would revise the period of reporting for material 
transfers to annual and make minor changes to the content of reports.
    10 CFR 32.25(c)--Would revise the period of reporting for material 
transfers to annual and make minor changes to the content of reports.
    10 CFR 32.29(c)--Would revise the period of reporting for material 
transfers to annual and make minor changes to the content of reports.
    10 CFR 32.40--Prototype test requirements for automobile lock 
illuminators would be removed.
    10 CFR 150.20(b)--Would remove provision for transfers to persons 
exempt under Sec.  30.14 from the reciprocity provision for Agreement 
State licensees.

V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is proposing to amend 10 CFR parts 30, 31, 32, and 150 under 
one or more of Sections 161b, 161i, or 161o of the AEA. Willful 
violations of the rule would be subject to criminal enforcement.

VI. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' which became effective on September 3, 1997 
(62 FR 46517), NRC program elements (including regulations) are placed 
into compatibility categories A, B, C, D, NRC or adequacy category H&S. 
Compatibility Category A are those program elements that are basic 
radiation protection standards and scientific terms and definitions 
that are necessary to understand radiation protection concepts. An 
Agreement State should adopt category A program elements in an 
essentially identical manner in order to provide uniformity in the 
regulation of agreement material on a nationwide basis. Compatibility 
Category B are those program elements that apply to activities that 
have direct and significant effects in multiple jurisdictions. An 
Agreement State should adopt Category B program elements in an 
essentially identical manner. Compatibility Category C are those 
program elements that do not meet the criteria of Category A or B, but 
the essential objectives of which an Agreement State should adopt to 
avoid conflict, duplication, gaps, or other conditions that would 
jeopardize an orderly pattern in the regulation of agreement material 
on a national basis. An Agreement State should adopt the essential 
objectives of the Category C program elements. Compatibility Category D 
are those program elements that do not meet any of the criteria of 
Category A, B, or C, above, and, thus, do not need to be adopted by 
Agreement States for purposes of compatibility. Compatibility Category 
NRC are those program elements that address areas of regulation that 
cannot be relinquished to the Agreement States under the Atomic Energy 
Act of 1954, as amended, or provisions of Title 10 of the Code of 
Federal Regulations. These program elements should not be adopted by 
the Agreement States. Health and Safety (H&S) are program elements that 
are required because of a particular health and safety role in the 
regulation of agreement material within the State and should be adopted 
in a manner that embodies the essential objectives of the NRC program.
    The proposed rule would be a matter of compatibility between the 
NRC and the Agreement States, thereby providing consistency among 
Agreement State and NRC requirements. The revisions to parts 30 and 31 
would be classified as Compatibility Category B and the revisions to 
Sec. Sec.  32.13 and 150.20 would be classified as Category C. Sections 
32.11 and 32.12 would be changed from Compatibility Categories C/B and 
C respectively to Category NRC. Section 32.17 is Compatibility Category 
B. Sections 32.15, 32.16, 32.20, 32.25, and 32.29 are classified as 
Compatibility Category NRC. The existing compatibility designation for 
these regulations are not affected.
    Specific information about the compatibility or health and safety 
components assigned to this rule may be found at the Office of State 
and Tribal Programs Web site, https://www.hsrd.ornl.gov/nrc/home.html.

VII. Plain Language

    The Presidential Memorandum dated June 1, 1998, entitled, ``Plain 
Language in Government Writing'' directed that the Government's writing 
be in plain language. This memorandum was published on June 10, 1998 
(63 FR 31883). The NRC requests comments on this proposed rule 
specifically with respect to the clarity and effectiveness of the 
language used. Comments should be sent to the address listed under the 
ADDRESSES heading above.

VIII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113) requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
the use of such a standard is inconsistent with applicable law or 
otherwise impractical. In this proposed rule, the NRC would amend its 
regulations governing the use of byproduct material to revise reporting 
of transfers to persons exempt from licensing, simplify the licensing 
of smoke detector distribution, remove obsolete provisions, and make 
some clarifications to the regulations. None of these actions 
constitute the establishment of a standard that establishes generally 
applicable requirements.

IX. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the

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Commission's regulations in subpart A of 10 CFR part 51, not to prepare 
an environmental impact statement for this proposed rule because the 
Commission has concluded on the basis of an environmental assessment 
that this proposed rule, if adopted, would not be a major Federal 
action significantly affecting the quality of the human environment. 
The following is a summary of the Environmental Assessment: Many of the 
individual actions being proposed are the type of actions described in 
the categorical exclusions of Sec.  51.22(c)(1) and (3). In addition, 
the proposed rule would remove provisions applicable to practices that 
no longer exist, establish a separate exemption from licensing for 
ionization smoke detectors containing no more than 1 [mu]Ci of 
americium-241, explicitly prohibit combining exempt quantity sources, 
and require NRC licensing of the introduction of exempt concentrations 
into products and materials. The removal of unused provisions would not 
result in a change to any practices except to ensure that these 
activities do not resume in the future without reconsideration by the 
Commission. The new exemption for smoke detectors is not expected to 
have any impact on the design or number of smoke detectors distributed 
to the public. The prohibition on combining exempt quantities 
reinforces the intent of existing regulations. The safety standards 
related to the exempt concentration provisions would not change. The 
Commission has concluded that none of these actions would have any 
significant impacts to the environment or otherwise include any 
condition requiring consultation under section 102(2)(C) of NEPA.
    The determination of the Environmental Assessment for this proposed 
rule is that there will be no significant impact to the public or the 
environment from this action. However, the general public should note 
that the NRC welcomes public participation. Comments on any aspect of 
the Environmental Assessment may be submitted to the NRC as indicated 
under the ADDRESSES heading.
    The NRC has sent a copy of the Environmental Assessment and this 
proposed rule to every State Liaison Officer and requested their 
comments on the Environmental Assessment. The Environmental Assessment 
may be examined at the NRC Public Document Room, O-1F23, 11555 
Rockville Pike, Rockville, MD. Single copies of the Environmental 
Assessment are available from Andy Imboden of the Office of Nuclear 
Material Safety and Safeguards, telephone (301) 415-6128, e-mail, 
asi@nrc.gov.

X. Paperwork Reduction Act Statement

    This proposed rule amends information collection requirements that 
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). The proposed rule makes minor revisions to the burdens on 
licensees for reporting and recordkeeping under Sec. Sec.  31.5, 32.12, 
32.16, 32.20, 32.25(c), and 32.29(c). It reduces the burden for new 
applicants to distribute ionization chamber smoke detectors by allowing 
them to obtain licenses under Sec.  32.14 rather than Sec.  32.26. The 
public burden for this information collection is estimated to average 1 
hour. Because the burden for these revisions to the information 
collections is insignificant, Office of Management and Budget (OMB) 
clearance is not required. Existing requirements were approved by the 
Office of Management and Budget, approval numbers 3150-0001, 3150-0014, 
3150-0016, and 3150-0120.
    Send comments on any aspect of this collection of information, 
including suggestions for reducing the burden, to the Information and 
Records Management Branch (T-5 F53), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by e-mail to bjs1@nrc.gov.

XI. Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

XII. Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory