[Federal Register: October 16, 2007 (Volume 72, Number 199)]
[Rules and Regulations]
[Page 58473-58489]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc07-2]
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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 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, asi@nrc.gov.
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, asi@nrc.gov.
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