[Federal Register Volume 72, Number 199 (Tuesday, October 16, 2007)]
[Rules and Regulations]
[Pages 58473-58489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19944]


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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: Final rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending 
several regulations governing the distribution of byproduct material. 
The reporting requirements for licensees distributing byproduct 
material to persons exempt from licensing are being changed, obsolete 
provisions are being deleted, certain regulatory provisions are being 
clarified, and smoke detector distribution regulations are being 
simplified. In addition, this final rule modifies the process for 
transferring a generally licensed device for use under a specific 
license. Aspects of this rule will affect distributors of exempt 
byproduct material, some general licensees, and some users of exempt 
products. These actions are intended to

[[Page 58474]]

make the licensing of distribution to exempt persons more effective and 
efficient, reduce unnecessary regulatory burden to certain general 
licensees, and better ensure the protection of public health and 
safety.

DATES: Effective Date: This final rule is effective on December 17, 
2007.

FOR FURTHER INFORMATION CONTACT: Andy Imboden, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, (301) 415-2327, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background
    A. Introduction
    B. Regulatory Framework
II. Discussion
    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 Licenses and Generally Licensed Devices--
Clarification
III. Summary of Public Comments on the Proposed Rule
    A. Meaning of the Term ``Byproduct Material''
    B. Exempt Quantity Distribution Reports
    C. Transfer of Generally Licensed Devices
    D. New Product-Specific Exemption for Smoke Detectors
    E. NRC--Agreement State Jurisdictional Issues
    F. Disposal of Exempt and Generally Licensed Devices
IV. Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Voluntary Consensus Standards
VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability
IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
XIII. Congressional Review Act

I. Background

A. Introduction

    The Commission has authority to issue both specific and general 
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'' or the 
AEA). 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 or users 
will not constitute an unreasonable risk to the common defense and 
security and to the health and safety of the public.'' To ensure that 
its exemptions meet the requirements of the Act, the Commission 
specifies limits for the radiological properties of what is distributed 
to persons exempt from licensing, and carefully oversees the 
manufacture and distribution of the approved products and materials.
    As beneficial uses of byproduct material were developed and 
experience grew, new products intended for use by the public were 
invented, and the regulations were amended to accommodate their use 
under various exemptions from licensing. These products and materials 
present very low risks of significant individual doses. However, a 
substantial portion of the public uses these products--more than 100 
million smoke detectors are in use in this country--and as a result, is 
routinely exposed to some ionizing radiation. Therefore, in the 1990s, 
the Commission conducted a systematic reevaluation of the exempt 
materials and products, most of which had been approved before 1970. A 
major part of the effort was an assessment of the potential and likely 
doses to workers and the public under the existing regulations 
governing the distribution of exempt products.
    Dose assessments associated with most exempt products can be found 
in NUREG-1717,\1\ ``Systematic Radiological Assessment of Exemptions 
for Source and Byproduct Materials,'' June 2001. 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 
occur are in line with Commission policy concerning acceptable doses 
from exempt products and materials. For some exempt products, there was 
a significant difference between potential and likely doses because the 
use of the exempt product 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 developed 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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    The Commission is also revising a certain general license within 
this final rule. General licenses are provided by regulation, grant 
authority to a person for certain activities involving byproduct 
material, and are effective without the filing of an application with 
the Commission or the issuance of licensing documents to particular 
persons. Separate and distinct from either exemptions or specific 
licenses, general licenses are designed to be commensurate with the 
specific circumstances covered by each general license. However, the 
NRC has determined that its regulations were not clear with respect to 
certain transfers of generally licensed devices. This has led to 
inefficiencies in licensing oversight and may negatively impact public 
confidence. Thus, the NRC is clarifying and simplifying its regulations 
related to this issue.
    This final rule reflects the Commission's goals to make its 
regulations more flexible, user-friendly, and performance-based, and to 
improve its ability to risk-inform its regulatory program. These 
concepts continue to be considered in developing potential revisions to 
the regulatory program in the area of distribution of byproduct 
material to exempt persons. To make optimal use of rulemaking 
resources, both for the NRC and the States who must develop conforming 
regulations, several issues have been combined into this final rule.
    A proposed rule containing these amendments was published for 
public comment in the Federal Register on January 4, 2006 (71 FR 275). 
The public comment period closed March 20, 2006. Nine comment letters 
were received. The NRC has considered these comments in this final 
rule.

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 regulations that exempt the end user from licensing 
requirements, so-called ``exemptions.'' Many of these exemptions are 
product-specific, intended only for specific purposes which are 
narrowly defined by regulation. More broadly defined are the general 
materials exemptions, which

[[Page 58475]]

allow the use of many radionuclides in many chemical and physical forms 
subject to limits on activity, and which are specified in Sec. Sec.  
30.14 and 30.18 for exempt concentrations and exempt quantities, 
respectively. The Commission's regulations also include two class 
exemptions--for self-luminous products and gas and aerosol detectors, 
in Sec. Sec.  30.19 and 30.20, respectively--which cover a broad class 
of products not limited to certain quantities or radionuclides. Under 
the class exemptions, many 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.
    Part 31 provides general licenses for the use of certain items 
containing byproduct material and the requirements associated with 
these general licenses.
    Part 32, Subpart A, sets out requirements for the manufacture or 
initial transfer (distribution) of items containing byproduct material 
to persons exempt from licensing requirements.
    Part 150 sets out regulations for all States that have entered into 
agreements with the Commission under subsection 274b of the Act.

II. Discussion

    This final rule makes 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 and improve the efficiency and effectiveness 
of certain licensing actions.

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

    The reporting and recordkeeping requirements for distributors of 
products containing byproduct material to persons exempt from licensing 
in Part 30 are being amended to improve the quality of data available 
to the NRC. The changes set forth in this rule have been made in such a 
way that there is an insignificant effect on these licensees' reporting 
and recordkeeping burdens. The reporting and recordkeeping requirements 
for these distributors are found in Sec. Sec.  32.12, 32.16, 32.20, 
32.25(c), and 32.29(c).
    Before 1983, reporting of transfers of exempt byproduct material 
was required on an annual basis. The NRC amended its regulations in 
1983 to change the reporting requirement to once every 5 years to 
minimize administrative burden. The 1983 reporting regulations required 
that an additional materials transfer report be submitted when filing 
for license renewal or notifying the NRC of a decision to cease 
licensed activities. However, subsequent experience with the 5-year 
reporting frequency has shown that it does not provide the NRC with 
complete, accurate, or timely information on products and materials 
containing byproduct material distributed for use under exemptions from 
licensing.
    A 5-year reporting cycle does not produce timely information for 
the NRC to fully determine the products and amount of byproduct 
material distributed annually for exempt use. The lack of timely 
information limits the NRC's ability to evaluate the overall net impact 
of such distribution 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 exempt products containing byproduct material distributed each 
year or to detect emerging trends. A 5-year reporting period also 
negatively affects the availability of current information. The 
limitations of the information about the products and materials and 
quantities distributed for use under exemption greatly impacted the 
effort involved in developing the dose assessments in NUREG-1717 and 
contributed to uncertainties in the results.
    Reevaluation of the reporting requirements suggests that annual 
reporting may also be administratively more efficient than a 5-year 
cycle for both the NRC and licensees. There have been more 
implementation problems with the longer cycle than with annual 
reporting. For example, because of the long interval between reports, 
licensees frequently neglect to file reports in compliance with the 
regulations. This lapse sometimes results in the need for the NRC to 
request that additional information be sent so that an application for 
renewal or termination of license can be processed. The long interval 
between reports also may lead to licensee inefficiencies in collecting 
the data. Routine annual reporting should be more straightforward and 
easier for licensees to comply with than consolidating and reporting 5 
years of distribution information.
    This final rule requires that material transfer reports covering 
transfers made during the calendar year be submitted annually by 
January 31 of the following year. In the first report made after the 
change, licensees are being required to submit information on transfers 
made since the previous report, so that there are no gaps in coverage. 
The requirements added in 1983 for licensees to file a special material 
transfer report when filing for license renewal (contained in the 
existing Sec. Sec.  32.12, 32.16, 32.20, 32.25, and 32.29) are being 
deleted. Another change is being made to the same sections so that 
material transfer reports are required 30 days after ceasing authorized 
activities, rather than at the point of notifying the Commission of the 
decision to cease authorized activities.
    In addition to the lengthy period between the 5-year reports, the 
manner in which product information and licensee information has been 
submitted in the reports has not always been clear, making the data 
more difficult to use. This final rule modifies how information is to 
be provided, improving clarity by making the reporting provisions more 
specific. Under the revised provisions, as specified in Sec. Sec.  
32.12(a)(1), 32.16(a)(1), 32.20(b)(1), 32.25(c)(1), and 32.29(c)(1), 
the report must clearly identify the specific licensee submitting the 
report, including the license number. In addition, as specified in 
Sec. Sec.  32.12(a)(2), 32.16(a)(2), 32.20(b)(2), 32.25(c)(2), and 
32.29(c)(2), the report is required to reference the specific exemption 
provision under which the products or materials are being distributed.
    The current regulations require that the licensee must identify the 
distributed product; however, different licensees have complied with 
this requirement in a number of ways, some of which necessitated that 
the NRC obtain additional information to fully interpret what was being 
distributed. Licensees have frequently included model numbers in the 
reports, but often as the only identification of the type of product 
being transferred. This final rule adds the requirement to report model 
numbers, when applicable, as part of the required information.
    Other changes are being made to reduce the licensees' reporting and 
recordkeeping burden. Under the prior framework, licensees were 
required to send a copy of the transfer reports to both the NRC 
headquarters and the appropriate Regional office. The requirement to 
send a copy of the reports to the Regional offices will be removed. 
Instead, the information will be distributed by the NRC internally to 
the appropriate personnel. To make the NRC's internal document handling 
more efficient, the address to which reports are to be sent will 
contain the line,

[[Page 58476]]

``ATTN: Document Control Desk/Exempt Distribution.'' The addressee also 
has been changed from that specified in the proposed rule to be 
consistent with the recent reorganization of the NRC's materials 
programs. Finally, the period for which licensees must retain records, 
i.e., 1 year after transfers are included in a report, will be up to 4 
years shorter than under the existing requirements. 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 changes, the NRC expects to 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 previous requirements. The NRC 
will have a stronger basis for informing the public about these 
exposures. These changes also will provide a better basis for 
considering any future regulatory changes in this area and for 
allocating NRC resources.

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. There are two 
exemptions for which this is not the case. One obsolete exemption, 
Sec.  30.16, ``Resins containing scandium-46 and designed for sand-
consolidation in oil wells,'' is being removed by this final rule, as 
discussed in section II.D of this document. The other exception to NRC-
only licensing of distribution of exempt byproduct material is in Sec.  
30.14, ``Exempt concentrations.''
    The exempt concentration exemption in Sec.  30.14 is a general 
materials exemption, broadly defined and not limited to a particular 
use. The exemption allows for various practices to be evaluated on a 
case-by-case basis through the licensing process. Section 30.14, 
paragraph (c), contains an exemption from licensing by the NRC for 
manufacturers, processors, or producers in Agreement States if the 
introduction of byproduct material into their product or material is 
conducted by an NRC specific licensee whose license authorizes this 
introduction.
    Previously, there were provisions in the NRC's regulations that 
allowed Agreement State licensing of the introduction of exempt 
concentrations. Agreement State licensing was added in 1963, soon after 
the regulations governing the Agreement State program were established 
the previous year (10 CFR part 150 was established in 1962). At the 
time, the only practices being regulated under these provisions related 
to quality control procedures and other radiotracer activities. 
Byproduct material was permitted to be introduced into oil, gasoline, 
plastics, and similar commercial and industrial materials. Also, at the 
time these provisions were added, it was expected that the NRC and the 
Agreement States would develop a system to obtain copies of the 
transfer reports submitted to the different regulatory bodies by 
licensees so that the NRC would have national information on 
distribution. Such a system was never implemented.
    All practices involving exempt concentrations result in increased 
radioactivity in the products. 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 explosive detection systems. These practices did not exist 
in the early 1960s, and involve consideration of issues including 
extensive national distribution. These practices involve a more complex 
dose evaluation than did the earlier practices, which were 
characterized by a single radionuclide dispersed within a product. For 
the case of irradiation of gemstones, the NRC has since required 
authorization only by an NRC license.
    It is important for the NRC to obtain information on all 
distributions of byproduct material to exempt persons in order to 
effectively and efficiently assess the overall impact of such 
distributions on the public. NRC licensing of all such distribution 
will facilitate this goal. 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 previous regulatory framework allowing 
multiple licensing jurisdictions to have the authority to issue these 
licenses had the potential to result in inconsistency in the licensing 
process.
    A regulatory framework in which there is one licensing authority is 
inherently more efficient than a framework with multiple jurisdictions 
from an administrative standpoint. A sole licensing authority 
automatically would possess data on the nationwide amount of byproduct 
material introduced into products distributed to the general public. In 
addition, because the introduction of exempt concentrations is a rarely 
used exemption, NRC-only licensing would avoid a situation in which 
every Agreement State would have to maintain resources, regulations, 
and procedures to license this practice, despite the fact that it would 
be unlikely for any individual State to have a significant number of 
these licensees.
    This final rule requires that the entity introducing byproduct 
material into products and materials for use under the exempt 
concentration provisions must have an NRC license specifically 
authorizing this practice. Specifically, the final rule changes 
Sec. Sec.  32.11 and 32.12 to compatibility category NRC. Compatibility 
categories and their meanings are explained in Section VI, ``Agreement 
State Compatibility.'' This change necessitates conforming amendments 
to related paragraphs (Sec. Sec.  30.14(c), 30.14(d), 32.11, 32.13, and 
150.20) so that only NRC may authorize the introduction of byproduct 
material into products and materials to be distributed for use under 
Sec.  30.14.
    Consistent with the practice for other exempt byproduct material 
distribution, a person introducing byproduct material into products and 
materials for use under the exempt concentration provision may have 
possession and use of the byproduct material authorized by an Agreement 
State and a distribution license from the NRC. To accommodate this 
framework, Sec.  32.11 is revised to exempt Agreement State licensees 
from Sec.  30.33(a)(2) and (3), so as not to duplicate the licensee's 
Agreement State license conditions associated with possession and use.
    Currently, the only known entities licensed under Sec.  32.11 (or 
equivalent Agreement State regulations) are a small number of 
radiotracer firms, licensed by the NRC, who introduce byproduct 
material into material like gas and oil, and steel companies who use 
sources to monitor refractory lining wear in blast furnaces. No 
Agreement State licensees of these types were identified by the NRC in 
2002, when the States were asked to comment on the rulemaking plan, or 
in 2005, when the NRC was assessing potential effects of this rule.
    Changing the licensing of introduction of exempt concentrations to 
NRC-only in this regulation will allow the NRC to obtain complete 
national data on products and materials containing byproduct material 
distributed to persons exempt from licensing and regulation. In 
addition, because the NRC licenses all other distributions of exempt 
material, NRC-only licensing of introduction of exempt concentrations 
will be consistent with the other types of exempt distribution. Since 
no Agreement State licensees have been identified who introduce

[[Page 58477]]

byproduct material into products received by persons exempt from 
licensing under Sec.  30.14, there should be no impact on distributors 
as a result of this change.
    A person who introduces byproduct material into materials or 
products distributed to persons exempt from licensing under Sec.  30.14 
must, as a result of this rule, hold a license from the NRC under Sec.  
32.11. Under Sec.  30.14, the byproduct material activity concentration 
applicable to this practice must be less than the limits established by 
Sec.  30.70, ``Schedule A--Exempt concentrations.''

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 the 
person receives, possesses, uses, transfers, owns, or acquires 
byproduct material in individual quantities, each of which does not 
exceed the applicable quantity in Sec.  30.71, Schedule B. This 
exemption is being amended to explicitly prohibit the end user from 
combining, or ``bundling'' multiple sources. Commercial distributors of 
exempt quantities are presently prohibited from incorporating the 
exempt byproduct material into any manufactured or assembled commodity, 
product, or device by regulation (under Sec.  32.18, ``Manufacture, 
distribution and transfer of exempt quantities of byproduct 
material''). However, until this final rule, there had been no 
regulation prohibiting the end-user from bundling sources.
    The NRC became aware that some persons holding byproduct material 
under the general materials exemption in Sec.  30.18 had been combining 
(bundling) multiple exempt quantities within an individual device that 
had not been evaluated or approved by the NRC. The devices were 
manufactured without any radioactive material, but were designed to be 
used with multiple exempt quantity sources of byproduct material. After 
becoming aware of this issue, the NRC originally determined in June 
1994 that, under certain limited circumstances, the 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 unlicensed devices could reach a point where 
a general or specific license would otherwise be required. As long as 
the bundled sources were considered exempt, the NRC would have no 
mechanism to ensure their safe possession, use, and disposal. As a 
result, the NRC issued Generic Letter 99-01, ``Recent Nuclear Material 
Safety and Safeguards Decision on Bundling Exempt Quantities,'' on May 
3, 1999, to clarify that bundling was not appropriate under the 
existing regulation. This position was 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 has since concluded that the regulations in Sec.  
30.18 should be amended to specifically prohibit bundling by the end 
user under the exemption. This final rule revises 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 the more restrictive of: (1) The quantity of material 
inhaled by a reference individual exposed for 1 year at the highest 
average concentration permitted in air for members of the general 
public in unrestricted areas, 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. This basis provides reasonable assurance of 
protection because, 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, 
the NRC could not assure that the exposures would not exceed the levels 
originally intended under the exemption. In addition, there would be 
the potential for other undesirable consequences, such as the disposal 
of devices containing multiple exempt sources through ordinary 
commercial waste streams or metal recycling channels resulting 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 the 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. 
The NRC has no indication that significant exposures are resulting or 
will result from the continued use of the devices evaluated in 1994, 
therefore this rule will allow continued exempt use of those devices 
distributed before 1999. This exclusion is intended to avoid imposing a 
regulatory burden on those persons (if any are still using the devices) 
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. In others, 
there are no records of any products ever having been used. Generally, 
this has occurred because new technologies have made the use of 
radioactive material unnecessary or less cost-effective.
    The Commission is deleting exemptions for products that are no 
longer being used or manufactured, or revising the regulations to 
restrict further distribution while allowing for the continued 
possession and use of previously distributed items. Obsolete exemptions 
in part 30 were for: automobile lock illuminators (formerly Sec.  
30.15(a)(2)), balances of precision (Sec.  30.15(a)(3)), automobile 
shift quadrants (formerly Sec.  30.15(a)(4)), marine compasses (Sec.  
30.15(a)(5)), thermostat dials and pointers (formerly Sec.  
30.15(a)(6)), spark gap irradiators \2\ (formerly Sec.  30.15(a)(10)), 
and resins containing scandium-46 for sand consolidation in oil wells 
(formerly Sec.  30.16).
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    \2\ This particular exemption is for a product designed to 
minimize spark delay in some electrically ignited commercial fuel-
oil burners, and is different than some products referred to as 
``spark gaps'' or ``spark gap tubes,'' which are a category of 
electron tube and exempted by Sec.  30.15(a)(8). No change is being 
made to Sec.  30.15(a)(8) at this time.
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    Of these, the exemption for resins containing scandium is the only 
one that could have resulted in significant doses, based on preliminary 
dose assessments. Because the exemption was no longer being used, the 
preliminary dose assessments were not refined or included in NUREG-
1717. These preliminary estimates indicated a potential for exposures 
higher than are appropriate for materials being used under an exemption 
from licensing. The removal of this exemption, as a result of this 
final rule, provides assurance that health and safety are adequately 
protected from possible future exempt distribution.
    With the exception of resins covered by Sec.  30.16, only the NRC 
has licensed distributors of these products. The

[[Page 58478]]

primary bases for determining that products are obsolete are the NRC's 
records on its licensees. Industry contacts were also used to collect 
historical information concerning the use of the various products.
    For these obsolete exemptions, the specific requirements for 
manufacturers and initial distributors are being removed in their 
entirety. These include regulations for the manufacture or distribution 
of resins containing scandium-46 (formerly Sec.  32.17) and the 
prototype test procedures for automobile lock illuminators formerly 
specified in Sec.  32.40 and formerly required by Sec.  32.14(d)(2).
    The NRC's research has shown that the distribution of thermostat 
dials or pointers, spark gap irradiators, and resins containing 
scandium-46 for sand consolidation in oil wells ceased so long ago that 
it is highly unlikely that any remain in use. Therefore, the complete 
removal of these exemptions is not expected to have any negative effect 
on any persons. In the unlikely event that a person currently possesses 
any of these products for which the governing regulations have been 
removed, 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 the device was distributed: 
the user remains exempt. The distribution of balances of precision and 
marine compasses has ceased; however, some devices may still be in use. 
Therefore, these exemptions will not be completely removed. Instead, 
the regulations have been changed to limit exempt use to previously 
distributed products.
    Deleting these unnecessary and obsolete provisions will simplify 
the regulations. This action will also eliminate the need for the 
Commission to reassess the potential exposure of the public from 
possible future distributions of these products. Agreement State 
regulations will be shortened as well. Most importantly, eliminating 
obsolete exemptions adds assurance that future use of products in these 
categories will not contribute to exposures of the public.

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. From April 
1969 until this final rule, smoke detectors have been used under the 
class exemption for gas and aerosol detectors in Sec.  30.20 (and 
equivalent regulations of the Agreement States). The Commission 
established this class exemption so that detectors with similar 
purposes could be licensed for distribution without the need for 
establishing many product-specific exemptions through extensive 
rulemaking procedures. For example, the class exemption in Sec.  30.20 
has also been successfully used to cover new chemical agent detectors.
    Modern ionization chamber smoke detectors have been manufactured 
and used for many years, with consistency in the design of products. 
Earlier smoke detector designs sometimes incorporated larger amounts of 
radioactive material than what is typical today, and in some cases 
incorporated other radionuclides--such as radium-226--whereas 
americium-241 is the only radionuclide that is widely used in these 
devices today. Current designs are very consistent, in that they almost 
always entail using 1 [mu]Ci or less of americium-241, contained in a 
foil, and surrounded by an ionization chamber.
    Potential doses from the distribution, use, handling, and disposal 
of these detectors have been estimated in NUREG/CR-1156, 
``Environmental Assessment of Ionization Chamber Smoke Detectors 
Containing Am-241,'' November 1979, and more recently in NUREG-1717 
(2001). Dose assessments have been performed in numerous license 
applications under the existing class exemption structure. 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.
    Because the doses from smoke detectors are well understood, and 
modern designs are very consistent, this rule establishes a product-
specific exemption from licensing requirements for smoke detectors. 
This is intended to apply to ionization chamber smoke detectors 
containing no more than 1 [mu]Ci (37 kBq) of americium-241 in the form 
of a foil, and whose primary function is the protection of life and 
property. Based on records of currently active device designs,\3\ there 
are 106 smoke detector models that are approved for distribution under 
the class exemption. Of these, 92 percent (97 out of 106) appear to 
qualify for the new product-specific exemption because those devices 
are limited to no more than the amount 1 [mu]Ci of americium-241 in the 
form of a foil. The new product-specific exemption for ionization 
chamber smoke detectors is established as Sec.  30.15(a)(7).\4\ The 
requirements for licensees (and applicants) to distribute these 
products are contained in Sec. Sec.  32.14, 32.15, and 32.16, as 
revised by this final rule.
---------------------------------------------------------------------------

    \3\ Data taken from the sealed source and device (SS&D) registry 
September 2006.
    \4\ Section 30.15(a)(7) had been used before to provide an 
exemption for a different product. A product-specific exemption from 
licensing was provided in Sec.  30.15(a)(7) for ``glow lamps'' in 
the 1960s. Later, it was determined that glow lamps should be 
exempted along with other types of electron tubes under Sec.  
30.15(a)(8), and Sec.  30.15(a)(7) was removed. See 34 FR 6651 
(April 18, 1969). Because Sec.  30.15(a)(7) has not been used in 
such a long time, no confusion is expected from this designation for 
the product-specific exemption for smoke detectors.
---------------------------------------------------------------------------

    The primary difference between this new exemption and the existing 
class exemption in Sec.  30.20 is that an applicant for a license to 
distribute smoke detectors for use under the new 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 specific requirements 
for obtaining a license to manufacture, process, produce, or initially 
transfer gas and aerosol detectors intended for use under the existing 
class exemption in Sec.  30.20 are contained in Sec.  32.26. Conditions 
of these licenses are contained in Sec.  32.29, and include 
requirements for quality control, labeling, recordkeeping, and the 
reporting of transfers. The safety criteria (contained in Sec. Sec.  
32.27 and 32.28) for the existing class exemption 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.
    The primary emphasis of the new requirements imposed on the 
applicant 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 to distribute smoke detectors to be 
used under the new product-specific exemption are contained in 
Sec. Sec.  32.15 and 32.16. These regulations denote the quality 
assurance, labeling, recordkeeping, and reports of transfer. The 
labeling requirements for the existing class exemption are found in 
Sec.  32.29(b), and to make the product-specific labeling requirements

[[Page 58479]]

equivalent to those of the class exemption, minor amendments were made 
to Sec.  32.15.
    The NRC believes that an applicant who wishes to distribute a 
qualifying smoke detector will find the process easier and less 
expensive under the new product-specific exemption than under the class 
exemption. Compared with the existing class exemption, under the new 
exemption, license applicants are not required to perform and submit 
dose assessments to demonstrate that doses from the various stages of 
the life cycle of the product do not exceed certain values. 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 of the model in the 
SS&D registry. Detectors to be used under the new product-specific 
exemption will not be required to undergo the SS&D review, and devices 
qualifying for a product-specific exemption may be distributed without 
an SS&D certificate. As a result, distributors of qualifying smoke 
detectors will be in a different fee category for the application and 
annual fees, and likely will be charged lower fees. Relevant 
application fees both with or without SS&D review and registration are 
published in Sec.  170.31. Annual fees for licensees distributing 
devices both with or without SS&D registration are published in Sec.  
171.16. Although the fees vary, and future fees are difficult to 
project with accuracy, the fees are typically more expensive if an SS&D 
review and registration is needed. Consistent with the requirements of 
the other product-specific exemptions, the applicant for a license to 
distribute under the new exemption is required to submit basic design 
information. However, compared with the process established for the 
existing class exemption, under the new exemption a sealed source and 
device certificate need not be obtained (or maintained) to distribute 
smoke detectors that meet the requirements of the new exemption.
    The new product-specific exemption allows licensees a new option 
for distributing smoke detectors to the public that is less costly. It 
is not compulsory for all smoke detectors to be manufactured and 
distributed for use only under the new product-specific exemption. 
Furthermore, this final rule does not modify the existing regulation 
exempting users of smoke detectors from licensing (Sec.  30.20). A 
smoke detector manufacturer that produces devices that do not conform 
with the product-specific exemption (for example, if the devices 
contain 4 [mu]Ci, or another radionuclide such as nickel-63) may 
distribute them under the broader class exemption for gas and aerosol 
detectors.
    The net effect of this new product-specific exemption is that the 
regulatory burden and fees are reduced for applicants for licenses to 
distribute qualifying ionizing chamber smoke detectors. Licensees who 
currently distribute qualifying smoke detectors (1 [mu]Ci or less of 
americium-241 in the form of a foil) for use under the class exemption, 
may also realize benefits if they amend their licenses to distribute 
the devices under the new product-specific exemption. Additionally, the 
change is expected to reduce the NRC staff time needed to review these 
applications, because an evaluation of dose assessments is no longer 
necessary. Given the wide distribution these products have already 
experienced, this change is not expected to affect the overall number 
of smoke detectors distributed in the future. Thus, this change 
improves the efficiency of the regulatory process, without any impacts 
to the health and safety of the public or the environment.

F. Specific Licenses and Generally Licensed Devices--Clarification

    A device possessed and used under Sec.  31.5 is a generally 
licensed device. An entity who holds a specific license may use and 
possess such a device under the authority of the general license 
provided by regulation, or, if certain requirements are met, the entity 
may transfer the device to the authority provided by its specific 
license. This final rule amends Sec.  31.5 to explicitly state the 
actions necessary to successfully perform this type of transfer, and 
eliminates the need to obtain prior NRC approval.
    Following a revision to the general license provided by Sec.  31.5 
(65 FR 79161; December 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. 
Licensees were motivated to transfer their devices in this way 
primarily to avoid the newly established registration fees. There are 
also other, non-fee-related reasons why one would make such a transfer. 
It should be noted that this final rule does not compel eligible 
licensees to make this type of transfer.
    There has been some confusion about the licensee's responsibilities 
in enacting such a transfer. A necessary condition for this type of 
transfer is that the licensee must verify that the conditions of the 
specific license authorize the possession and use of the device. If the 
specific license does not authorize the possession of the particular 
radionuclides or activity, the licensee is unable to transfer a 
generally licensed device to its specific license. For example, the 
generally licensed device to be transferred may contain americium-241, 
but the specific license does not authorize the possession of 
transuranic radionuclides (americium is a transuranic element). If this 
is the case, the specific licensee must apply for an appropriate 
amendment to the specific license before transferring the device.
    A major issue when transferring a generally licensed device to the 
authority of a specific license has been the label of the device. 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 regulatory status (as a generally licensed 
device), provides safety instructions, and may refer to operating and 
service manuals. Retaining the label is problematic because, once the 
device is transferred to the authority of a specific license, 
instructions to the general licensee may be inappropriate. For example, 
instructions may indicate that the licensee may not conduct its own 
leak tests, which is an unnecessary restriction once the device is 
transferred to the authority of a specific license. Another problem 
with the label of the transferred device is that the labels of all 
devices held by a specific licensee must conform with Sec.  20.1904, 
``Labeling containers,'' whereas, before the transfer, these 
requirements were not applicable. It is not acceptable for a device 
being held under a specific license to be labeled in accordance with 
Sec.  32.51(a)(3); i.e., a general license label. Thus, if a device is 
transferred from generally licensed status to the authority of a 
specific license, the licensee must consider what changes should be 
made to the labeling and how those changes are to be made. The licensee 
is responsible for ensuring that the label of the transferred device 
meets the content requirements of Sec.  20.1904, that any inappropriate 
restrictions that may have been on the label are resolved, and that any 
changes to the label are done in a manner that does not damage the 
device. The licensee must also ensure that the information on the 
manufacturer, model number, and serial number is retained on the 
labeling. Persons who have previously transferred generally licensed 
devices to the authority of their specific license should review the 
status of the label of

[[Page 58480]]

the device, to ensure compliance with Sec.  20.1904 and to resolve any 
inappropriate restrictions that may have been left on the label.
    Another issue when transferring a generally licensed device to the 
authority of a specific license concerns maintenance. A specific 
licensee who plans to conduct its own maintenance activities, including 
required leak tests, must have information concerning the appropriate 
methods particular to the device. This information may have been 
provided if the device had been distributed as specifically licensed. 
However, because the device was generally licensed and, in some cases, 
the end user was not permitted to perform certain maintenance, this 
information may not have been provided when the device was obtained. A 
specific licensee who transfers a generally licensed device to the 
authority of its specific license and does not already have this 
information, could contact the manufacturer, a service provider, 
another knowledgeable licensee, or a regulatory agency to obtain 
information on the proper procedures for conducting leak testing and 
other required maintenance activities.
    Finally, this final rule simplifies reporting requirements for this 
type of transfer. Before this rulemaking, two reports were required: A 
report before the transfer (requesting permission), and a report 
concurrent with the transfer (reporting the transfer). The NRC believes 
that there is little benefit in requesting written approval from the 
NRC before the transfer; therefore, the regulations have been revised. 
To maintain the integrity of the general license tracking systems 
operated by the NRC, any transfer of a generally licensed device must 
be reported, but two reports are not needed. Therefore, Sec.  
31.5(c)(8)(iii) is amended so that the pre-transfer report (requesting 
permission) is no longer required. To keep the appropriate tracking 
systems up-to-date, it is still necessary for the licensee to file a 
transfer report per Sec.  31.5(c)(8)(ii).

III. Summary of Public Comments on the Proposed Rule

    The proposed rule on Exemptions from Licensing, General Licenses, 
and Distribution of Byproduct Material: Licensing and Reporting 
Requirements, was published on January 4, 2006 (71 FR 275). The comment 
period ended on March 20, 2006. Nine letters were received commenting 
on the proposed rule. One comment letter was submitted by a smoke 
detector manufacturer, and another by a manufacturer of sources used in 
smoke detectors. One comment was received from the Council on 
Radionuclides and Radiopharmaceuticals, Inc. (CORAR), representing 
manufacturers and distributors of exempt quantities of byproduct 
material. One comment was received from the Radiation Safety Officer 
(RSO) of a university. One comment was received from a member of the 
public who did not identify an affiliation. Officials from two 
Agreement States (Alabama and Texas) and staff from two others 
(Illinois and Georgia) also submitted comments. A discussion of the 
comments and the NRC's responses follow.

A. Meaning of the Term ``Byproduct Materia''

    Comment: One commenter noted that the Energy Policy Act of 2005 
changed the definition of ``byproduct material'' in the AEA. It was 
suggested that the NRC explain how ``byproduct material'' is defined in 
this rule.
    Response: The definition of byproduct material that applies to this 
rule is in 10 CFR 30.4, which currently reads: ``Byproduct material 
means any radioactive material (except special nuclear material) 
yielded in or made radioactive by exposure to the radiation incident to 
the process of producing or utilizing special nuclear material.'' As 
noted in the comment, the Energy Policy Act of 2005 (EPAct) expanded 
and revised the definition of byproduct material under the NRC's 
jurisdiction by incorporating certain naturally occurring and 
accelerator-produced radioactive material. The EPAct required that the 
NRC promulgate revisions to its regulations to incorporate the new 
byproduct material. The NRC published its proposed rule on July 28, 
2006 (71 FR 42952) in response to this requirement, to revise its 
regulations and revise the definition of byproduct material in certain 
of its regulations, including 10 CFR 30.4. The final rule was published 
October 1, 2007 (72 FR 55863). When the revised definition becomes 
effective November 30, 2007, the new definition will apply. 
Distributors of the newly defined byproduct material will be regulated 
by the NRC, and therefore required to follow the regulations as amended 
by this final rule. However, as these distributors are already licensed 
by the NRC for distribution of other radioactive materials, the impact 
of this final rule on these distributors will be no greater than the 
impact on other NRC exempt distribution licensees.

B. Exempt Quantity Distribution Reports

    Comment: One commenter submitted a comment on the NRC's new 
reporting requirements in Sec.  32.20(c) for distributors and 
manufacturers of materials distributed to persons exempt under Sec.  
30.18, ``Exempt quantities.'' The commenter noted that a requirement 
for a report that indicates the chemical and physical form of each 
exempt quantity could be excessively burdensome. The commenter 
suggested that the NRC should specify the names that may be used by 
licensees to describe commonly distributed materials.
    Response: The final rule was changed as a result of this comment. 
The NRC has evaluated the impact of exempt quantities on the public 
health and safety and the environment to weigh the effectiveness and 
appropriateness of its regulatory program for this exemption. The NRC 
does this for all exempt products and materials. During the last 
evaluation of exempt distribution, it was believed that knowledge of 
both the chemical and physical form of material distributed as ``exempt 
quantities'' would provide information that could increase the NRC's 
ability to estimate the impacts of this exemption on public health and 
safety and the environment. The proposed rule language, therefore, 
required that distributors of exempt quantities of radioactive material 
must report, among other things, both the chemical and physical form of 
the radioactive material. However, the NRC agrees that providing 
chemical information would be excessively burdensome for licensees, and 
that the NRC can perform the necessary evaluations based on the 
information provided on physical form.
    The Commission has changed the final rule language to address the 
commenter's concerns. The language in the final rule retains the annual 
reporting requirement for exempt quantity distribution and the 
requirement to report physical form. However, the NRC will not require 
reporting of the chemical form.
    The NRC notes that while terms such as ``solid,'' ``liquid,'' or 
``gas'' are appropriate to use for reporting the physical form of 
exempt quantities, other descriptive terms such as ``metal'' or 
``powder'' are also acceptable. The NRC does not intend to restrict 
licensees to use of particular terms; doing so may impose additional 
burden in reporting. If a licensee has made a substantial number of 
distributions, and has documentation that more quickly and easily 
provides essentially the same information and allows the NRC to 
determine the physical form of the

[[Page 58481]]

distributed material, a licensee may choose to report using its own 
terminology instead (e.g., ``solution'' instead of ``liquid'' or 
``sealed source'' instead of ``solid''). However, terms that are 
ambiguous (e.g., ``calibration standard,'' or ``radiolabeled research 
compounds'') do not specify the physical form and are not acceptable 
for reporting exempt quantity distribution.
    Reports covering any time period before the effective date of this 
final rule are only required to contain data on the total quantity of 
each radionuclide distributed. Although a report of physical form would 
be useful for historical distributions, there is no requirement to 
report the physical form before the effective date of this rule. This 
was clarified in the final rule text.

C. Transfer of Generally Licensed Devices

    Comment: Some commenters noted that the rule language as proposed 
in Sec.  31.5(c)(8)(iii)(C) would have required that the licensee 
obtain maintenance information from the manufacturer to transfer the 
device to its specific license, which would be impossible if the 
manufacturer is no longer in business or otherwise unwilling to provide 
maintenance information.
    Response: The final rule was changed in response to this comment. 
The intent in the proposed rule was that a specific licensee is 
responsible for maintenance activities, but the maintenance 
instructions may not have been provided to the licensee when the device 
was first purchased. Although the specific licensee must have 
sufficient expertise to conduct adequate maintenance activities, in 
some cases there are procedures developed by the manufacturer (and 
reviewed and approved by the NRC or Agreement State) that are unique to 
the device. There is no universal requirement for manufacturers to 
provide this information to general licensees, because general 
licensees are only allowed to perform maintenance activities in limited 
circumstances, and at the time of distribution it was not known that 
the device would eventually be used under the authority of a specific 
license. Therefore, it was proposed that a licensee must obtain 
maintenance information that would be applicable under the specific 
license. The language in the proposed rule could have been interpreted 
to limit licensees to obtaining this information directly from the 
device manufacturer (or initial transferor). This would be problematic 
if the manufacturer were no longer in business.
    The final rule has been changed to clarify that the needed 
information on maintenance is that originated by the manufacturer (or 
initial distributor), and that it need not be obtained directly. The 
information may be obtained from not only the device manufacturer, but 
a service provider, a regulatory agency, or another knowledgeable 
licensee. The NRC believes that service providers, in particular, 
should have the maintenance information readily available, and there 
should be an established relationship between a service provider and 
the general licensee for the devices in question. The important goal is 
that the specific licensee is aware of any device-specific maintenance 
instructions important to safety.
    Comment: Several commenters noted potential problems with the 
proposed labeling procedure in Sec.  31.5(c)(8)(iii)(B) that would 
require a licensee to remove and replace the label before the transfer 
of a generally licensed device to the authority of a specific license. 
One commenter indicated that the proposed requirement may conflict with 
the requirement in Sec.  31.5(c)(1) that prohibits a general licensee 
from removing the label, and it was suggested that a specifically 
licensed third party would be needed to complete the transaction. It 
was also noted that the NRC's labeling requirements could lead to the 
loss of additional safety warnings or leak testing instructions from 
generally licensed devices, or that the provenance of the device would 
be lost. Other commenters identified potential problems, such as damage 
to the device that could occur during the process of removing the old 
label. One commenter recommended that the NRC consider that when a 
generally licensed device is added to a specific license, the 
conditions of the specific license supersede the general license 
requirements. For instance, a specific license condition specifying 
leak tests would supersede the general license label limitations.
    Response: The final rule was changed in response to this comment. 
The proposed rule addressed the labeling procedure that would accompany 
the transfer of a generally licensed device to the authority of a 
specific license to address the case where an old label was 
unnecessarily restrictive on the end user, or where the old label would 
not comply with the requirements of Sec.  20.1904, or any circumstance 
where the old label would conflict with the device's new status and the 
licensee's new responsibilities, such as if the original label of the 
device continued to indicate that it was a generally licensed device. 
In addition, as noted by one commenter, some labels on generally 
licensed devices contain stipulations that restrict actions by the end 
user, such as indications that the licensee shall not conduct its own 
leak tests. This prohibition would be in force as long as the device is 
held under a general license; however, once the device is transferred 
to the authority of a specific license, this restriction would be 
inappropriate.
    The intent of the labeling change in the proposed rule was not to 
remove safety information, but to remove inappropriate restrictions 
that may be on some labels and to reflect the change in status from 
generally licensed to specifically licensed. As noted in one comment, 
the conditions of the specific license supercede the requirements of 
the general license once the device is transferred to the authority of 
the specific license. To address this and other potential conflicts, 
the NRC proposed that the licensee remove the existing label and 
replace it with another.
    The final rule has been changed to allow licensees several 
acceptable options--including those suggested by commenters--for the 
labeling procedure that will accompany the transfer of a generally 
licensed device to the authority of a specific license. As originally 
stated in the proposed rule, the old label may be removed entirely. 
However, the final rule provides an additional option that the old 
label may be covered or altered in whole or in part. Alternatively, the 
specific licensee may leave the old label on the device and 
conspicuously affix a new label, so long as the resulting arrangement 
makes it clear (to an inspector, for example) that the old label is 
superceded. If a licensee believes that the process of removing the old 
label would affect the integrity of a device's shielding or would 
otherwise damage the device, the licensee must use another method to 
comply with the labeling requirement, such as covering the old label.
    The final rule has also been changed to specifically identify the 
information that must be on a device that is transferred from generally 
licensed to specifically licensed status. The final rule has been 
clarified to require that the device's manufacturer, model number, and 
serial number be retained. In any case, the new label must comply with 
the requirements for all containers of specifically licensed 
radioactive material (in this case, a device) in Sec.  20.1904, and 
also include the device's manufacturer, model number, and serial 
number. The requirement that the device be labeled in accordance with 
Sec.  20.1904 is not a new requirement, as

[[Page 58482]]

that section applies to all devices held under the authority of a 
specific license; however, the requirement has been clarified in the 
final rule. The device's manufacturer, model number, and serial number 
is information that is not required by Sec.  20.1904; however, the 
final rule clarifies that this information must be retained for 
tracking purposes and so that the provenance, or origin, of the device 
is not lost.
    Concerning the comment that an existing regulation (Sec.  
31.5(c)(1)) prohibits a general licensee from removing a label, the 
regulation would no longer apply once the device is transferred to the 
authority of a specific license. It is also not necessary for a 
specifically licensed third party (such as a vendor) to change the 
label to accompany the change in status; a specific licensee who 
possesses the device is authorized to change the label.
    Comment: A commenter objected to removing the requirement in Sec.  
31.5(c)(iii) for prior approval for this category of transfer, as prior 
approval would ensure appropriate tracking and licensing of the device.
    Response: The NRC disagrees with this comment and the final rule is 
not changed. As part of transferring the device to the specific 
license, the licensee must still report the transfer under the existing 
requirement in Sec.  31.5(c)(8)(ii). The NRC believes this report is 
sufficient to allow for appropriate tracking and licensing and that 
prior approval of the transfer is unnecessary.
    Comment: Some commenters suggested additional regulatory provisions 
with regard to the transfer of a generally licensed device to the 
authority of a specific license. One commenter suggested that, along 
with the proposed simplified mechanism for transferring a generally 
licensed device to a specific license (GL to SL transfer), there should 
also be a mechanism for transferring a device from a specific licensee 
back to generally licensed status (SL to GL transfer). A separate 
suggestion was made that a requirement be added to Sec.  
31.5(c)(8)(iii)(C) requiring the general licensee to initiate a program 
to leak test the device at a frequency specified under conditions of 
the specific license. A third suggestion was made that the NRC 
``consider'' that when a generally licensed device is added to a 
specific license, the conditions of the specific license, such as the 
leak test condition, would supercede the conditions in the general 
license.
    Response: No change has been made to the final rule as a result of 
these comments. This final rule only affects the transfer of generally 
licensed devices to specifically licensed status, and does not address 
the transfer of a device from a specific license back to its original 
status as generally licensed. The general license in Sec.  31.5 only 
applies to devices received from a Sec.  32.51 specific licensee (or 
Agreement State equivalent) to ensure that the device may be used by 
persons with no radiological training, and for tracking purposes.
    With regard to the suggestion to add a provision to Sec.  31.5(c) 
to require the general licensee to leak test the device at a frequency 
specified under conditions of a specific license, once the device is 
transferred to the authority of a specific license, the regulations in 
Part 31 do not apply, because the device is no longer generally 
licensed. Therefore, any rule change to this part will be ineffective 
in governing licensee actions after the device is transferred. No rule 
change is necessary, moreover, because the commenter's concerns that 
the device continue to be leak tested in accordance with the terms of 
the specific license will be addressed on the specific license 
following the transfer. The NRC recognizes that the conditions of the 
specific license supersede the requirements of the general license once 
the device is transferred to the authority of the specific license. The 
rule language does not need to be changed to ensure that conditions of 
the specific license supersede the conditions in the general license.
    Comment: One commenter stated that the proposed revision to Sec.  
31.5(c)(8)(iii) ``is requiring additional regulation not required of 
general licensees who do not possess a specific license.'' The 
commenter indicated that an alternative approach might be ``to 
separately list GL products in a distinct license condition on specific 
licenses.'' The commenter warned that the proposed rule would ignore 
the ``safety properties of GL products and abandon their inherent 
safety features and relegate them to the same requirements imposed on 
specifically licensed products.''
    Response: No changes to the final rule are being made as a result 
of these comments. This regulation provides licensees who hold both a 
generally licensed device and a specific license the option to more 
easily transfer a generally licensed device to the authority of a 
specific license. This transfer is not mandatory for all specific 
licensees who possess a generally licensed device. No additional 
regulation is being imposed on general licensees who do not possess a 
specific license, and no additional regulation is being imposed on 
general licensees who do possess a specific license, unless the 
licensee chooses to transfer its generally licensed devices to the 
authority of its specific license.
    This final rule does not require specific licensees to list 
generally licensed devices on their specific licenses. Requiring this 
would negate a characteristic feature of the general license, which is 
valid without the issuance of a licensing document to a particular 
person. The commenter's approach--listing generally licensed devices 
held by a specific license as a license condition on a specific 
license--may lead to ambiguities with respect to the responsibilities 
of the licensee with regard to recordkeeping (such as device tracking). 
For example, generally licensed devices under Sec.  31.5 are tracked by 
the NRC, but cease to be tracked once the device is transferred to the 
authority of a specific license. A misinterpretation of the regulatory 
status of the device may result in errors in the tracking systems. 
Additionally, when the generally licensed device is disposed of or 
otherwise transferred to a specific licensee, there would be extra 
costs associated in amending the license. Therefore, the NRC does not 
believe that generally licensed devices should be required to be listed 
on specific licensing documents.
    Comment: One commenter stated that ``the transfer of the GL device 
to an end-user, in this case a specific licensee, would need to be 
reported, but not because it is being transferred as a specifically 
licensed device; it is not, it is still a GL device.''
    Response: The NRC agrees that the transfer should be reported, 
under Sec.  31.5(c)(8)(iii)(D). However, the NRC disagrees with the 
commenter's statement that the transferred device remains under a 
general license. Although a device that may be used under a general 
license may also be used under a specific license if the specific 
license authorizes the byproduct material, there should be a 
distinction as to which license is providing the authority for the 
possession and use of each device. This distinction determines which 
requirements apply to the licensee, such as reporting and maintenance.

D. New Product-Specific Exemption for Smoke Detectors

    Comment: Two commenters were concerned about the potential impact 
of a literal interpretation of the language in the proposed rule 
exempting smoke detectors. The proposed new product-specific exemption 
in Sec.  30.15(a)(7) was limited to smoke detectors containing no more 
than 1 [mu]Ci of americium-241. Both commenters noted that, due to

[[Page 58483]]

small variations caused by the manufacturing process, it is impractical 
(if not impossible) to produce smoke detectors that always contain no 
more than 1 [mu]Ci of americium-241. It was noted that this small 
variation is acceptable in current licensing practices and does not 
present any health, safety, or security risk. These commenters 
suggested that a statement should be added to the final rule allowing 
for nominal variation in the activity level of the source incorporated 
into the smoke detector.
    Response: No change to the final rule is being made as a result of 
these comments. The product-specific exemption for smoke detectors is 
intended to apply to detectors that contain sources in which the 
expected activity is 1 [mu]Ci of americium-241 or less. This expected 
quantity is also the activity that is put on the label. The NRC 
believes that variation is to be expected as a result of the 
manufacturing process, and that a degree of variation is acceptable. 
Considerations for ensuring the quality of products and the adequacy of 
measurement in various circumstances are separate from the stated 
activity, or quantity, limit for an exemption. The interpretation of 
the quantity limit of 1 [mu]Ci is only that the expected, labeled 
quantity or activity may not exceed this limit. This is consistent with 
the historical interpretation of existing quantity limits in other 
exemptions. It should be noted that this is different from the stated 
``maximum activity'' on the SS&D registration certificate. For a 
product-specific exemption, a SS&D certificate is not needed, and other 
information besides the dose assessment are available to ensure that 
the device may be safely used under an exemption from licensing.
    Comment: One commenter urged revision of the appropriate guidance 
document (NUREG-1556, Vol. 3, Rev. 1) as soon as possible to reflect 
changes to methods for approving sources and devices.
    Response: NUREG-1556, Vol. 3, Rev. 1 addresses the procedures for 
SS&Ds, and will not be updated as a result of this rule because the 
SS&D procedures are not being amended. However, NUREG-1556, Vol. 8 
provides program-specific guidance about exempt distribution products. 
Interim staff guidance to supplement NUREG-1556, Vol. 8 is to be 
provided to reflect the revisions made by this final rule. The changes 
to the guidance needed as a result of this rulemaking are relatively 
minor and will be provided in the interim staff guidance to eliminate 
inconsistencies with the revised regulations.

E. NRC--Agreement State Jurisdictional Issues

    Comment: One commenter stated that it would be helpful to clarify 
why the regulations for exempt quantities refer to equivalent Agreement 
State regulations.
    Response: No change to the final rule is needed as a result of this 
comment. The final rule refers to Agreement State regulations because 
different agencies may have jurisdiction before, during, and after the 
distribution of exempt quantities of byproduct material. For example, 
prior to distribution, the possession of byproduct material requires a 
license, either by the NRC or an Agreement State depending on which 
regulatory body has jurisdiction. The commercial distribution of exempt 
quantities of byproduct material must be in accordance with a license 
issued by the NRC under Sec.  32.18, since the NRC has the sole 
authority for authorizing commercial transfers. After the transfer, the 
recipient of the byproduct material is exempt from regulatory 
requirements either from those of the NRC or an Agreement State, 
depending on the location of the recipient.
    Comment: One commenter raised objections to the NRC being the only 
licensing authority for exempt concentrations in Sec.  30.14 and 
objected to reclassification of Sec. Sec.  32.11 and 32.12 as 
Compatibility Category NRC. The commenter reasoned that organizations 
of State regulators, such as the Organization of Agreement States and 
the Conference of Radiation Control Program Directors could be used to 
facilitate data exchanges on exempt concentration distribution 
nationwide, and that the change to NRC-only licensing would not be 
justified on the basis of common defense and security.
    Response: The NRC disagrees with this comment and the final rule 
retains the proposed language and compatibility category. All 
distribution of byproduct material to exempt persons is presently 
solely licensed by the NRC, with the only exception being provided in 
Sec.  30.14, ``Exempt concentrations.'' (Previously, Sec.  30.16, which 
is now being removed, had also provided for Agreement State licensing.) 
This discrepancy in the Commission's regulations was identified as a 
result of the NRC's systematic evaluation of exemptions performed in 
the 1990's, and has been discussed with the Agreement States since that 
time. The distribution of radioactive materials to the public for 
uncontrolled use--which includes exempt concentrations--and the release 
of these materials into the environment involve questions of national 
policy that are best addressed by the Commission. The NRC has 
determined that this discrepancy is not warranted.
    The regulations controlling the introduction of radioactive 
material into products subsequently distributed under the exempt 
concentration exemption (Sec.  30.14) is the NRC's oldest exemption for 
byproduct material. It predates the Agreement State program. As the 
commenter notes, organizations of State regulators exist now, and could 
be used to facilitate the exchange of data on exempt concentrations. 
However, as explained below, the lack of a data exchange is not the 
only factor that the NRC considered in determining that exempt 
concentration distribution should be changed to NRC-only licensing.
    There is no administrative benefit in providing authority to States 
to license exempt concentrations of byproduct material, and in fact, 
such licensing would likely be very costly to maintain. No Agreement 
State has identified any licensees authorized to introduce byproduct 
material into materials or products that are exempt from licensing 
under this regulation. The only businesses nationwide that are involved 
in this practice are already NRC licensees. Continuing with the current 
multi-jurisdictional structure would require States to train qualified 
license reviewers, update and maintain regulations, produce guidance 
documents, and develop a data exchange process among the States and 
with the NRC, which would involve an unnecessary use of resources, 
considering that there are no licensees in State jurisdictions. NRC-
only licensing avoids these complications and costs, and a transition 
to NRC-only licensing at this time will have no regulatory impact on 
any business. It is administratively more efficient for there to be one 
licensing authority (NRC) rather than for each jurisdiction to maintain 
a licensing capability that is little used and unlike any other 
programmatic function.
    Among other reasons, the Commission has retained regulatory 
authority for exempt distribution (consumer products) to remove any 
possibility that population exposure from these products would be 
inconsistent with Commission policies. The Commission has long retained 
the position that the distribution of radioactive materials to the 
general public for uncontrolled use and the eventual disposition of 
these materials involve questions of national policy that

[[Page 58484]]

are best addressed by the NRC (March 16, 1965; 30 FR 3462). The NRC's 
retaining sole licensing authority over the distribution of exempt 
byproduct material does not have to be justified under common defense 
and security.

F. Disposal of Exempt and Generally Licensed Devices

    Comment: One commenter stated that disposal costs should be 
factored into the original cost of the exempt devices, and that a 
mechanism should be established to return exempt devices to a vendor 
for recycling or disposal. This commenter also stated that disposal 
costs should be factored into the original costs of generally licensed 
devices.
    Response: The issue of disposal costs is outside the scope of this 
rulemaking.

 IV. Amendments by Section

    10 CFR 30.14(c)--Revises the exemption for manufacturers, 
processors, and producers to require that the licensed entity must be 
an NRC licensee, and clarifies that the exemption applies in all 
jurisdictions.
    10 CFR 30.14(d)--Revises the prohibition on introducing exempt 
concentrations to apply to all persons except those authorized by an 
NRC license.
    10 CFR 30.15(a)--Removes obsolete exemptions (automobile lock 
illuminators, automobile shift indicators, thermostat dials and 
pointers, and spark gap irradiators). Limits certain exemptions 
(balances of precision and marine compasses and other navigational 
instruments) to previously distributed products. Creates a new 
exemption for smoke detectors containing no more than 1 [mu]Ci of 
americium-241 in a foil.
    10 CFR 30.16--Removes the exemption for resins containing scandium-
46 for sand consolidation in oil wells.
    10 CFR 30.18--Revises the exempt quantities provision by adding an 
explicit prohibition against combining sources to create an increased 
radiation level.
    10 CFR 31.5(c)(8)(ii)--Resolves an ambiguity with respect to 
addressing reports submitted to the NRC. Changed to reflect a 
reorganization within the NRC.
    10 CFR 31.5(c)(8)(iii)--Revises transfer provisions to explicitly 
state actions necessary for transfer of devices from generally licensed 
status to specifically licensed status. Removes the need for written 
NRC approval before transfer in that case.
    10 CFR 32.8--Removes Sec.  32.17 from the list of information 
collection requirements.
    10 CFR 32.11(a)--Exempts Agreement State licensees from the 
requirements of Sec.  30.33(a)(2) and (3).
    10 CFR 32.12--Revises the reporting period for material transfers 
to annual. Revises the content of the reports and removes the 
requirement to send copies to the Regional offices. Changed to reflect 
a reorganization within the NRC.
    10 CFR 32.13--Prohibits the introduction of exempt concentrations 
by all persons except for those authorized by an NRC license.
    10 CFR 32.14(d)--Removes reference to deleted Sec.  32.40.
    10 CFR 32.15(d)--Adds labeling requirements for smoke detectors 
distributed for use under the new product-specific exemption in Sec.  
30.15.
    10 CFR 32.16--Revises the reporting period for material transfers 
to annual. Makes minor changes to the content of the reports and 
removes the requirement to send copies to the Regional offices. Removes 
reference to deleted Sec.  32.17. Changed to reflect a reorganization 
within the NRC.
    10 CFR 32.17--Removes obsolete distributor requirements for resins 
containing scandium-46 for sand consolidation in oil wells.
    10 CFR 32.20--Revises the reporting period for material transfers 
to annual. Makes minor changes to the content of the reports and 
removes the requirement to send copies to the Regional offices. Changed 
to reflect a reorganization within the NRC.
    10 CFR 32.25(c)--Revises the reporting period for material 
transfers to annual. Makes minor changes to the content of the reports 
and removes the requirement to send copies to the Regional offices. 
Changed to reflect a reorganization within the NRC.
    10 CFR 32.29(c)--Revises the reporting period for material 
transfers to annual. Makes minor changes to the content of the reports 
and removes the requirement to send copies to the Regional offices. 
Changed to reflect a reorganization within the NRC.
    10 CFR 32.40--Removes the prototype test requirements for 
automobile lock illuminators.
    10 CFR 150.20(b)--Removes the provision for transfers to persons 
exempt under Sec.  30.14 from the reciprocity provision for Agreement 
State licensees, and the reference to Sec.  30.14(d).

 V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act of 1954, as 
amended, the Commission is issuing the final rule 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 will be subject to criminal 
enforcement.

 VI. Agreement State Compatibility

    In accordance with the ``Policy Statement on Adequacy and 
Compatibility of Agreement State Programs'' approved by the Commission 
on June 30, 1997 (62 FR 46517), NRC program elements (including 
regulations) are placed into Compatibility Categories A, B, C, D, or 
NRC, or Adequacy Category H&S. This rule does not amend any regulation 
classified as compatibility category A or adequacy category H&S. 
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 Categories 
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, 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 AEA or provisions of 10 CFR. These program elements should not be 
adopted by the Agreement States.
    Despite being amended in terms of substance, the compatibility 
category will not change for many regulations as a result of this final 
rule. Sections 32.14, 32.15, 32.16, 32.20, 32.25, 32.29, and 32.40 will 
continue to be classified as Category NRC. Amendments made by this rule 
to regulations in Parts 30 and 31, as well as Sec.  32.17, will 
continue to be classified as Category B. Sections 32.13 and 150.20 will 
continue to be classified as Category C. Section 32.8 will continue to 
be classified as Category D. Consistent with what was proposed, Sec.  
32.11 is changed from Categories C/B to Category NRC and Sec.  32.12 is 
changed from Category C to Category NRC.

[[Page 58485]]

 VII. 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. This action does not constitute the 
establishment of a standard that establishes generally applicable 
requirements.

 VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, that this rule is not a major Federal 
action significantly affecting the quality of the human environment and 
therefore an environmental impact statement is not required. The 
Commission has prepared an environmental assessment for this final rule 
and has made a finding of no significant impact as a result of this 
final rule.
    Many of the individual amendments in this rule belong to a category 
of actions which the Commission, by Sec. Sec.  51.22(c)(1) and 
51.22(c)(3)(ii) and (iii), has declared to be a categorical exclusion. 
The amendments to Sec. Sec.  30.14, 32.11, and 32.13 related to NRC 
licensing of the introduction of exempt concentrations do not change 
any provision that regulates the physical nature of the products. The 
amendments to Sec. Sec.  30.15, 30.16, 32.17, and 32.40 related to 
deleting obsolete provisions do not constitute a significant change to 
current practices. Similarly, the amendment to Sec.  30.18 which 
prohibits combining exempt quantities does not change current 
practices. The new product specific exemption for smoke detectors in 
Sec.  30.15(a)(7) does not change any provision that regulates the 
physical nature of the products and is not likely to affect any 
environmental resources.
    The detailed environmental assessment supporting this final rule is 
available for public inspection at the NRC Public Document Room, O-
1F23, 11555 Rockville Pike, Rockville, MD. Single copies of the 
Environmental Assessment may be obtained from Andy Imboden, Office of 
Federal and State Materials and Environmental Management Programs, U.S. 
Nuclear Regulatory Commission, (301) 415-2327, [email protected].

 IX. Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.). This final rule makes minor revisions to the burden on existing 
and future licensees for reporting and recordkeeping under Sec. Sec.  
31.5, 32.12, 32.16, 32.20, 32.25(c), and 32.29(c). New licensees under 
Sec.  32.14 will find their burden reduced as compared to the existing 
licensing under Sec.  32.26. The public burden for this information 
collection is estimated to average 1 hour per request. Because the 
burden for this information collection is insignificant, Office of 
Management and Budget (OMB) clearance is not required. Existing 
requirements were approved by OMB under numbers 3150-0001, 3150-0014, 
3150-0016, and 3150-0120.

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.

 X. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The analysis is available 
for inspection in the NRC Public Document Room, 11555 Rockville Pike, 
Rockville, MD. Single copies of the regulatory analysis are available 
from Andy Imboden, Office of Federal and State Materials and 
Environmental Management Programs, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, (301) 415-2327, [email protected].

 XI. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (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 majority of companies that are affected by this rule do not fall 
within the scope of the definition of ``small entities'' set forth in 
the Regulatory Flexibility Act or the size standards established by the 
NRC in 10 CFR 2.810.

 XII. Backfit Analysis

    The NRC has determined that the backfit rule (Sec. Sec.  50.109, 
70.76, 72.62, or 76.76) does not apply to this final rule because these 
amendments do not involve any provisions that would impose backfits as 
defined in 10 CFR Chapter 1. Therefore, a backfit analysis is not 
required.

 XIII. Congressional Review Act

    In accordance with the Congressional Review 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.

Lists of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.

10 CFR Part 32

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

10 CFR Part 150

    Criminal penalties, Hazardous materials transportation, 
Intergovernmental relations, Nuclear materials, Reporting and 
recordkeeping requirements, Security measures, Source material, Special 
nuclear material.


0
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. 552 and 553; the NRC is adopting the 
following amendments to 10 CFR Parts 30, 31, 32, and 150.

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

0
1 . The authority citation for part 30 continues to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 
2021, 2021b, 2111).

[[Page 58486]]

    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).


0
2 . In Sec.  30.14, paragraphs (c) and (d) are revised to read as 
follows:


Sec.  30.14  Exempt concentrations.

* * * * *
    (c) A manufacturer, processor, or producer of a product or material 
is exempt from the requirements for a license set forth in section 81 
of the Act and from the regulations in this part and parts 31 through 
36 and 39 of this chapter to the extent that this person transfers 
byproduct material contained in a product or material in concentrations 
not in excess of those specified in Sec.  30.70 and introduced into the 
product or material by a licensee holding a specific license issued by 
the Commission expressly authorizing such introduction. This exemption 
does not apply to the transfer of byproduct material contained in any 
food, beverage, cosmetic, drug, or other commodity or product designed 
for ingestion or inhalation by, or application to, a human being.
    (d) No person may introduce byproduct material into a product or 
material knowing or having reason to believe that it will be 
transferred to persons exempt under this section or equivalent 
regulations of an Agreement State, except in accordance with a license 
issued under Sec.  32.11 of this chapter.

0
3. In Sec.  30.15, paragraphs (a)(2), (a)(4), (a)(6), and (a)(10) are 
removed and reserved, paragraphs (a)(3) and (a)(5) are revised, and 
paragraph (a)(7) is added to read as follows:


Sec.  30.15  Certain items containing byproduct material.

    (a) * * *
    (2) [Reserved]
    (3) Balances of precision containing not more than 1 millicurie of 
tritium per balance or not more than 0.5 millicurie of tritium per 
balance part manufactured before December 17, 2007.
    (4) [Reserved]
    (5) Marine compasses containing not more than 750 millicuries of 
tritium gas and other marine navigational instruments containing not 
more than 250 millicuries of tritium gas manufactured before December 
17, 2007.
    (6) [Reserved]
    (7) Ionization chamber smoke detectors containing not more than 1 
microcurie ([mu]Ci) of americium-241 per detector in the form of a foil 
and designed to protect life and property from fires.
* * * * *
    (10) [Reserved]
* * * * *


Sec.  30.16  [Removed]

0
4. Section 30.16 is removed.

0
5. In Sec.  30.18, paragraph (a) is revised and paragraph (e) is added 
to read as follows:


Sec.  30.18  Exempt quantities.

    (a) Except as provided in paragraphs (c) through (e) of this 
section, any person is exempt from the requirements for a license set 
forth in section 81 of the Act and from the regulations in parts 30 
through 34, 36, and 39 of this chapter to the extent that such 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.
* * * * *
    (e) No person may, for purposes of producing an increased radiation 
level, combine quantities of byproduct material covered by this 
exemption so that the aggregate quantity exceeds the limits set forth 
in Sec.  30.71, Schedule B, except for byproduct material combined 
within a device placed in use before May 3, 1999, or as otherwise 
permitted by the regulations in this part.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

0
6 . The authority citation for part 31 continues to read as follows:

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 
Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 
Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).

0
7. In Sec.  31.5, paragraph (c)(8)(ii) introductory text and paragraph 
(c)(8)(iii) are revised to read as follows:


Sec.  31.5  Certain detecting, measuring, gauging, or controlling 
devices and certain devices for producing light or an ionized 
atmosphere.\5\
---------------------------------------------------------------------------

    \5\ Persons possessing byproduct material in devices under a 
general license in Sec.  31.5 before January 15, 1975, may continue 
to possess, use, or transfer that material in accordance with the 
labeling requirements of Sec.  31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------

* * * * *
    (c) * * *
    (8) * * *
    (ii) Shall, within 30 days after the transfer of a device to a 
specific licensee or export, furnish a report to the Director of the 
Office of Federal and State Materials and Environmental Management 
Programs by an appropriate method listed in Sec.  30.6(a) of this 
chapter, including in the address: ATTN: Document Control Desk/GLTS. 
The report must contain--
* * * * *
    (iii) Shall obtain written NRC approval before transferring the 
device to any other specific licensee not specifically identified in 
paragraph (c)(8)(I) of this section; however, a holder of a specific 
license may transfer a device for possession and use under its own 
specific license without prior approval, if, the holder:
    (A) Verifies that the specific license authorizes the possession 
and use, or applies for and obtains an amendment to the license 
authorizing the possession and use;
    (B) Removes, alters, covers, or clearly and unambiguously augments 
the existing label (otherwise required by paragraph (c)(1) of this 
section) so that the device is labeled in compliance with Sec.  20.1904 
of this chapter; however the manufacturer, model number, and serial 
number must be retained;
    (C) Obtains the manufacturer's or initial transferor's information 
concerning maintenance that would be applicable under the specific 
license (such as leak testing procedures); and
    (D) Reports the transfer under paragraph (c)(8)(ii) of this 
section.
* * * * *

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

0
8. The authority citation for part 32 continues to read as follows:

    Authority: Secs. 81, 161, 182, 183, 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); sec. 1704, 112 Stat. 2750 (44 
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 
(42 U.S.C. 2014, 2021, 2021b, 2111).

0
9. In Sec.  32.8, paragraph (b) is revised to read as follows:


Sec.  32.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.  32.11, 32.12, 32.14, 32.15, 32.16, 
32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 
32.29, 32.51, 32.51a, 32.52, 32.53,

[[Page 58487]]

32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 
and 32.210.
* * * * *

0
10. In Sec.  32.11, paragraph (a) is revised to read as follows:


Sec.  32.11  Introduction of byproduct material in exempt 
concentrations into products or materials, and transfer of ownership or 
possession: Requirements for license.

* * * * *
    (a) Satisfies the general requirements specified in Sec.  30.33 of 
this chapter; provided, however, that the requirements of Sec.  
30.33(a)(2) and (3) do not apply to an application for a license to 
introduce byproduct material into a product or material owned by or in 
the possession of the licensee or another and the transfer of ownership 
or possession of the product or material containing the byproduct 
material, if the possession and use of the byproduct material to be 
introduced is authorized by a license issued by an Agreement State;
* * * * *

0
11. Section 32.12 is revised to read as follows:


Sec.  32.12  Same: Records and material transfer reports.

    (a) Each person licensed under Sec.  32.11 shall maintain records 
of transfer of byproduct material and file a report with the Director 
of the Office of Federal and State Materials and Environmental 
Management Programs by an appropriate method listed in Sec.  30.6(a) of 
this chapter, including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the byproduct material is 
transferred for use under Sec.  30.14 of this chapter or equivalent 
regulations of an Agreement State.
    (b) The report must identify the:
    (1) Type and quantity of each product or material into which 
byproduct material has been introduced during the reporting period;
    (2) Name and address of the person who owned or possessed the 
product or material, into which byproduct material has been introduced, 
at the time of introduction;
    (3) The type and quantity of radionuclide introduced into each 
product or material; and
    (4) The initial concentrations of the radionuclide in the product 
or material at time of transfer of the byproduct material by the 
licensee.
    (c)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first 
report after December 17, 2007, the licensee shall separately include 
data for transfers in prior years not previously reported to the 
Commission or to an Agreement State.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.11 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (d) If no transfers of byproduct material have been made under 
Sec.  32.11 during the reporting period, the report must so indicate.
    (e) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

0
12. Section 32.13 is revised to read as follows:


Sec.  32.13  Same: Prohibition of introduction.

    No person may introduce byproduct material into a product or 
material knowing or having reason to believe that it will be 
transferred to persons exempt under Sec.  30.14 of this chapter or 
equivalent regulations of an Agreement State, except in accordance with 
a license issued under Sec.  32.11.

0
13. 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 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.

0
14. In Sec.  32.15, paragraph (d) is revised to read as follows:


Sec.  32.15  Same: Quality assurance, prohibition of transfer, and 
labeling.

* * * * *
    (d)(1) Label or mark each unit, except timepieces or hands or dials 
containing tritium or promethium-147, and its container so that the 
manufacturer or initial transferor of the product and the byproduct 
material in the product can be identified.
    (2) For ionization chamber smoke detectors, label or mark each 
detector and its point-of-sale package so that:
    (i) Each detector has a durable, legible, readily visible label or 
marking on the external surface of the detector containing:
    (A) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
    (B) The name of the radionuclide (``americium-241'' or ``Am-241'') 
and the quantity of activity; and
    (C) An identification of the person licensed under Sec.  32.14 to 
transfer the detector for use under Sec.  30.15(a)(7) of this chapter 
or equivalent regulations of an Agreement State.
    (ii) The labeling or marking specified in paragraph (d)(2)(I) of 
this section is located where it will be readily visible when the 
detector is removed from its mounting.
    (iii) The external surface of the point-of-sale package has a 
legible, readily visible label or marking containing:
    (A) The name of the radionuclide and quantity of activity;
    (B) An identification of the person licensed under Sec.  32.14 to 
transfer the detector for use under Sec.  30.15(a)(7) or equivalent 
regulations of an Agreement State; and
    (C) The following or a substantially similar statement: ``THIS 
DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT FROM 
ANY REGULATORY REQUIREMENTS.''
    (iv) Each detector and point-of-sale package is provided with such 
other information as may be required by the Commission.

0
15. Section 32.16 is revised to read as follows:


Sec.  32.16  Certain items containing byproduct material: Records and 
reports of transfer.

    (a) Each person licensed under Sec.  32.14 shall maintain records 
of all transfers of byproduct material and file a report with the 
Director of the Office of Federal and State Material and Environmental 
Management Programs by an appropriate method listed in Sec.  30.6(a) of 
this chapter, including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.  30.15 of this chapter, giving the specific paragraph 
designation, or equivalent regulations of an Agreement State.
    (b) The report must include the following information on products 
transferred to other persons for use under Sec.  30.15 or equivalent 
regulations of an Agreement State:
    (1) A description or identification of the type of each product and 
the model number(s), if applicable;
    (2) For each radionuclide in each type of product and each model 
number, if

[[Page 58488]]

applicable, the total quantity of the radionuclide; and
    (3) The number of units of each type of product transferred during 
the reporting period by model number, if applicable.
    (c)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first 
report after December 17, 2007, the licensee shall separately include 
data for transfers in prior years not previously reported to the 
Commission.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.14 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (d) If no transfers of byproduct material have been made under 
Sec.  32.14 during the reporting period, the report must so indicate.
    (e) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.


Sec.  32.17  [Removed]

0
16. Section 32.17 is removed.
0
17. Section 32.20 is revised to read as follows:


Sec.  32.20  Same: Records and material transfer reports.

    (a) Each person licensed under Sec.  32.18 shall maintain records 
of transfer of material identifying, by name and address, each person 
to whom byproduct material is transferred for use under Sec.  30.18 of 
this chapter or the equivalent regulations of an Agreement State and 
stating the kinds, quantities, and physical form of byproduct material 
transferred.
    (b) The licensee shall file a summary report with the Director of 
the Office of Federal and State Materials and Environmental Management 
Programs by an appropriate method listed in Sec.  30.6(a) of this 
chapter, including in the address: ATTN: Document Control Desk/Exempt 
Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the materials are transferred for 
use under Sec.  30.18 or equivalent regulations of an Agreement State.
    (c) For each radionuclide in each physical form, the report shall 
indicate the total quantity of each radionuclide and the physical form, 
transferred under the specific license.
    (d)(1) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first 
report after December 17, 2007, the licensee shall separately include 
the total quantity of each radionuclide transferred for transfers in 
prior years not previously reported to the Commission.
    (2) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.18 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (e) If no transfers of byproduct material have been made under 
Sec.  32.18 during the reporting period, the report must so indicate.
    (f) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a summary report to the 
Commission.

0
18. In Sec.  32.25, paragraph (c) is revised to read as follows:


Sec.  32.25  Conditions of licenses issued under Sec.  32.22: Quality 
control, labeling, and reports of transfer.

* * * * *
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Federal and State Materials and Environmental 
Management Programs by an appropriate method listed in Sec.  30.6(a) of 
this chapter, including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.  30.19 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.  30.19 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s);
    (ii) For each radionuclide in each type of product and each model 
number, the total quantity of the radionuclide;
    (iii) The number of units of each type of product transferred 
during the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first 
report after December 17, 2007, the licensee shall separately include 
data for transfers in prior years not previously reported to the 
Commission.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.22 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under 
Sec.  32.22 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

0
19. In Sec.  32.29, paragraph (c) is revised to read as follows:


Sec.  32.29  Conditions of licenses issued under Sec.  32.26: Quality 
control, labeling, and reports of transfer.

* * * * *
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Federal and State Materials and Environmental 
Management Programs by an appropriate method listed in Sec.  30.6(a) of 
this chapter, including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the products are transferred for 
use under Sec.  30.20 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.  30.20 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s);
    (ii) For each radionuclide in each type of product and each model 
number, the total quantity of the radionuclide;
    (iii) The number of units of each type of product transferred 
during the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year. In its first 
report after December 17, 2007, the licensee shall separately include 
data for transfers in prior years not previously reported to the 
Commission.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.26 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under 
Sec.  32.26 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for one 
year after the transfer is included in a report to the Commission.

[[Page 58489]]

Sec.  32.40  [Removed]

0
20. Section 32.40 is removed.

PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN 
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274

0
21. The authority citation for part 150 continues to read as follows:

    Authority: Sec. 161, 68 Stat. 948, as amended, sec. 274, 73 
Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as 
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 
note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 
2014, 2021, 2021b, 2111).
    Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued 
under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84, 
92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 2113, 2114). Section 
150.14 also issued under sec. 53, 68 Stat. 930, as amended (42 
U.S.C. 2073). Section 150.15 also issued under secs. 135, 141, Pub. 
L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 
150.17a also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). 
Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C. 
2282).


0
22. In Sec.  150.20, paragraph (b) introductory text, and paragraph 
(b)(3) are revised to read as follows:


Sec.  150.20  Recognition of Agreement State licenses.

* * * * *
    (b) Notwithstanding any provision to the contrary in any specific 
license issued by an Agreement State to a person engaging in activities 
in a non-Agreement State, in an area of exclusive Federal jurisdiction 
within an Agreement State, or in offshore waters under the general 
licenses provided in this section, the general licenses provided in 
this section are subject to all the provisions of the Act, now or 
hereafter in effect, and to all applicable rules, regulations, and 
orders of the Commission including the provisions of Sec. Sec.  30.7(a) 
through (f), 30.9, 30.10, 30.34, 30.41, and 30.51 through 30.63 of this 
chapter; Sec. Sec.  40.7(a) through (f), 40.9, 40.10, 40.41, 40.51, 
40.61 through 40.63, 40.71, and 40.81 of this chapter; Sec. Sec.  
70.7(a) through (f), 70.9, 70.10, 70.32, 70.42, 70.52, 70.55, 70.56, 
70.60 through 70.62 of this chapter; Sec. Sec.  74.11, 74.15, and 74.19 
of this chapter; and to the provisions of 10 CFR parts 19, 20 and 71 
and subparts C through H of part 34, Sec. Sec.  39.15 and 39.31 through 
39.77 of this chapter. In addition, any person engaging in activities 
in non-Agreement States, in areas of exclusive Federal jurisdiction 
within Agreement States, or in offshore waters under the general 
licenses provided in this section:
* * * * *
    (3) Shall not, in any non-Agreement State, in an area of exclusive 
Federal jurisdiction within an Agreement State, or in offshore waters, 
transfer or dispose of radioactive material possessed or used under the 
general licenses provided in this section, except by transfer to a 
person who is specifically licensed by the Commission to receive this 
material.
* * * * *

    Dated at Rockville, Maryland, this 3rd day of October 2007.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
 [FR Doc. E7-19944 Filed 10-15-07; 8:45 am]
BILLING CODE 7590-01-P