Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements, 58473-58489 [E7-19944]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 72, Number 199 (Tuesday, October 16, 2007)]
[Rules and Regulations]
[Pages 58473-58489]
From the Federal Register Online via the Government Printing 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, 
asi@nrc.gov.

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 spec