[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Proposed Rules]
[Pages 275-287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-19]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 71, No. 2 / Wednesday, January 4, 2006 /
Proposed Rules
[[Page 275]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 31, 32, and 150
RIN 3150--AH41
Exemptions From Licensing, General Licenses, and Distribution of
Byproduct Material: Licensing and Reporting Requirements
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations governing the use of byproduct material to revise
requirements for reporting transfers to persons exempt from licensing,
simplify the licensing of smoke detector distribution, remove obsolete
provisions, and clarify certain regulatory provisions. These actions
are intended to better ensure the protection of public health and
safety in the future, make the licensing of distribution to exempt
persons more effective and efficient, and reduce unnecessary regulatory
burden to certain general licensees. These changes would affect
licensees who distribute byproduct material to exempt persons, users of
some generally licensed devices, and some exempt persons.
DATES: Submit comments by March 20, 2006. Submit comments specific to
the information collection aspects of this rule by February 3, 2006.
Comments received after these dates will be considered if it is
practical to do so, but the NRC is able to assure consideration only
for comments received on or before these dates.
ADDRESSES: You may submit comments by any of the following methods.
Please include the number RIN 3150-AH41 in the subject line of your
comments. Comments on rulemakings submitted in writing or in electronic
form will be made available to the public in their entirety on the NRC
rulemaking Web site. Personal information will not be removed from your
comments.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not receive a reply e-
mail confirming that we have received your comments, contact us
directly at (301) 415-1966. You may also submit comments via the NRC's
rulemaking Web site at http://ruleforum.llnl.gov. Address questions
about our rulemaking Web site to Carol Gallagher at (301) 415-5905; e-
mail [email protected]. Comments can also be submitted via the Federal
eRulemaking Portal at http://www.regulations.gov.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
(301) 415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
(301) 415-1101.
You may submit comments on the information collections by the
methods indicated under Paperwork Reduction Act Statement.
Publicly available documents related to this rulemaking may be
viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), Room O1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee. Selected documents, including comments,
may be viewed and downloaded electronically via the NRC rulemaking Web
site at http://ruleforum.llnl.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into the NRC's Agencywide Document
Access and Management System (ADAMS), which provides text and image
files of NRC's public documents. If you do not have access to ADAMS or
if there are problems in accessing the documents located in ADAMS,
contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737 or
by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory
Commission, Mail Stop T8F3, Washington, DC 20555-0001, telephone (301)
415-6264, e-mail, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
B. Regulatory Framework
II. Proposed Actions
A. Improved Reporting of Distribution to Persons Exempt From
Licensing Requirements
B. NRC Licensing of the Introduction of Exempt Concentrations
C. Bundling of Exempt Quantities
D. Obsolete Provisions
E. New Product-Specific Exemption for Smoke Detectors
F. Specific Licensees and Generally Licensed Devices--
Clarification
III. Early Agreement State Participation
IV. Summary of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Language
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact: Availability
X. Paperwork Reduction Act Statement
XI. Public Protection Notification
XII. Regulatory Analysis
XIII. Regulatory Flexibility Certification
XIV. Backfit Analysis
I. Background
A. Introduction
The Commission has authority to issue both general and specific
licenses for the use of byproduct material and also to exempt byproduct
material from regulatory control under section 81 of the Atomic Energy
Act of 1954, as amended (hereafter, ``the Act''). A general license is
provided by regulation, grants authority to a person for certain
activities involving byproduct material, and is effective without the
filing of an application with the Commission or the issuance of a
licensing document to a particular person. Requirements for general
licensees appear in the regulations and are designed to be commensurate
with the specific circumstances covered by each general license.
In considering its exemptions from licensing, the Commission is
directed by the Act to make ``a finding that the exemption of such
classes or quantities of such material or such kinds of uses
[[Page 276]]
or users will not constitute an unreasonable risk to the common defense
and security and to the health and safety of the public.'' As
beneficial uses of licensed material were developed and experience
grew, new products intended for use by the general public were invented
and the regulations were amended to accommodate the use of new
products. The Commission currently has 15 exemptions from licensing for
byproduct material in its regulations, most of which were added by
1970.
The Commission has conducted a systematic reevaluation of the
exemptions from licensing in parts 30 and 40 of NRC's regulations (in
Title 10 of the Code of Federal Regulations), which govern the use of
byproduct and source materials. A major part of the effort was an
assessment of the potential and likely doses to workers and the public
under these exemptions. The assessment of doses associated with most of
these exemptions can be found in NUREG-1717,\1\ ``Systematic
Radiological Assessment of Exemptions for Source and Byproduct
Materials,'' June 2001. For some exemptions, the difference between
potential (possible under the conditions of the exemption) and likely
doses is significant because actual use of the exemption is limited or
nonexistent, or significantly lower quantities are used in products
than is potentially allowed under the exemption.
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\1\ NUREG-1717 is a historical document development using the
models and methodology available in the 1990s. The NUREG provides
the estimate of the radiological impacts of the various exemptions
from licensing based on what was known about distribution of
material under the exemptions in the early 1990s. NUREG-1717 was
used as the initial basis for evaluating the regulations for
exemptions from licensing requirements and determining whether those
regulations adequately ensured that the health and safety of the
public were protected consistent with NRC policies related to
radiation protection. The agency will not use the results presented
in NUREG-1717 as a sole basis for any regulatory decisions or future
rulemaking without additional analysis.
Copies of NUREGs may be purchased from the Superintendent of
Documents, U.S. Government Printing Office, P.O. Box 37082,
Washington, DC 20013-7082. Copies are also available from the
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161. A copy is also available for inspection and/
or copying for a fee at the NRC public Document Room, One White
Flint North, 11555 Rockville Pike, Public File Area O1-F21,
Rockville, MD.
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This proposed action concerns only conclusions of the reevaluation
of regulations governing byproduct material. Any potential revisions to
the regulations governing source material would be addressed in the
future. In addition to the exemptions themselves, the NRC has reviewed
the existing regulations governing the distribution of byproduct
material to persons for use under the exemptions.
Generally, the systematic assessment of exemptions determined that
no significant problems exist with the current uses of byproduct
materials under the exemptions from licensing. Actual exposures of the
public likely to be occurring are in line with Commission policy
concerning acceptable doses from products and materials used under
exemptions from licensing. However, in some cases, the regulatory
constraints and controls in place may not be adequate to fully ensure
that the health and safety of the public will continue to be protected
to the extent considered appropriate for practices occurring under
exemptions from licensing.
Although presenting very low risks of significant individual doses
to members of the general public, exempt products are a source of
routine exposure to the public. A substantial portion of the population
uses and enjoys benefits from exempt products, such as smoke detectors,
but, at the same time, receives some radiation exposure from those
products.
The Commission has also decided to make the regulations more
flexible, user-friendly, and performance-based, and to improve its
ability to risk-inform its regulatory program. These concepts have been
considered in developing potential revisions to the regulatory program
in the area of distribution of byproduct material to exempt persons.
The Commission is also proposing a revision to a certain general
license within this same rulemaking. There are some areas where the
regulations are not clear or explicit. This leads to inefficiencies in
the regulatory process and can lower public confidence. Thus, a
clarification is being proposed.
In addition to the issues addressed by this proposed rule, the
Commission is considering other issues that may be addressed in a
future rulemaking to further amend parts 30, 31, and 32.
B. Regulatory Framework
The Commission's regulations in part 30 contain the basic
requirements for licensing of byproduct material. Part 30 includes a
number of exemptions from licensing requirements in Sec. Sec. 30.14,
30.15, 30.16, 30.18, 30.19, 30.20, and 30.21. These exemptions allow
for certain products and materials containing byproduct material to be
used without any regulatory requirements on the user. The two
exemptions in Sec. Sec. 30.19 and 30.20, for self-luminous products
and gas and aerosol detectors, respectively, are class exemptions,
which cover a broad class of products. Under these provisions, new
products can be approved for use through the licensing process if the
applicant demonstrates that the specific product is within the class
and meets certain radiation dose criteria. This contrasts with other
exemptions for which the level of safety is controlled through such
limits as specification of radionuclides and quantities. Sections 30.14
and 30.18, exempt concentrations and exempt quantities, are broad
materials exemptions, which allow the use of a large number of
radionuclides. The specific radionuclide limits on these concentrations
and quantities are contained in tables in Sec. Sec. 30.70 and 30.71,
respectively. The remaining exemptions from licensing are product
specific, for which many assumptions can and have been made concerning
how the product is distributed, used, and disposed.
Part 31 provides general licenses for the use of certain items
containing byproduct material and the requirements associated with
these general licenses. The general licenses are established in
Sec. Sec. 31.3, 31.5, 31.7, 31.8, 31.10, and 31.11.
Part 32 sets out requirements for the manufacture or initial
transfer (distribution) of items containing byproduct material to
persons exempt from licensing requirements and to persons using a
general license.
Part 150 sets out regulations for all States that have entered into
agreements with the Commission under subsection 274b of the Act
(Agreement States).
II. Proposed Actions
This proposed rule would make a number of revisions to the
regulations governing the use of byproduct material under exemptions
from licensing and under general license and to the requirements for
those who distribute products and materials for use under exemptions
from licensing. The changes are intended to better ensure the
protection of public health and safety in the future and improve the
efficiency and effectiveness of certain licensing actions.
A. Improved Reporting of Distribution to Persons Exempt From Licensing
Requirements
The current reporting and recordkeeping requirements for
distributors of products and materials to persons exempt from licensing
in part 30 (contained in Sec. Sec. 32.12, 32.16, 32.20, 32.25(c), and
32.29(c)) require these licensees to maintain records of these
transfers and to submit reports to NRC once every five years. The
reports must
[[Page 277]]
indicate the total quantity of byproduct material and/or the total
number of exempt units listed by type transferred during the reporting
period. The breakdown of the information by year is not required. These
reports are also required when filing for license renewal or notifying
the Commission of a decision to cease authorized activities.
The resulting reports are not timely and informative enough for NRC
to fully determine the products and amount of byproduct material
distributed annually for exempt use. This limits the NRC's ability to
evaluate the overall net impact of these practices on public health and
safety. Because the date of reporting for each licensee is different
and the information is not necessarily reported by year, it is
difficult to estimate the amount or types of products/materials
containing byproduct material distributed each year or to see any
trends. Also, the information is not very current. The limitations of
the information about the products/materials and quantities distributed
for use under exemption greatly impacted the effort involved in
developing the dose assessments in NUREG-1717 and contributed to the
uncertainties in the results.
Before 1983, reporting of transfers of exempt byproduct material
was required on an annual basis. The regulations were amended in 1983
to change the reporting requirement to once every 5 years to minimize
administrative burden. However, subsequent experience with the 5-year
reporting frequency has shown that it does not provide NRC with
complete, accurate, or timely information on products and materials
containing byproduct material distributed for use under exemptions from
licensing. Reevaluation of the reporting requirements also suggests
that annual reporting may be administratively more efficient for both
the NRC and affected licensees than the current requirement. Experience
shows that there have been more implementation problems under the
current scheme than with annual reporting. For example, because of the
long interval between reports, licensees frequently forget to file
reports in compliance with the regulations. This lapse sometimes
results in the need for requests for additional information to be sent
so that an application for renewal or termination of license can be
processed. The long interval between reports also leads to licensee
inefficiencies in collecting the data.
The proposed rule would require that material transfer reports
covering transfers made during the calendar year be submitted annually
by January 31 of the following year. These reports would also be
required 30 days after ceasing authorized activities, rather than at
the point of notifying the Commission of the decision to cease
authorized activities. The reports would no longer be required when
filing for license renewal. In the first report made after the proposed
change, licensees would also be required to submit information on
transfers made since the previous report. Routine annual reporting
should be more straightforward and easier for licensees to comply with
than consolidating and reporting five years of distribution
information. This approach is expected to impose a minimal burden and
be more efficient for both the NRC and licensees, particularly given
the current state of information technology. A recent change to the
Commission's regulations allows electronic submission as an alternative
to standard mail submission, which reduces administrative costs.
In addition to the lengthy period between the current reports,
certain information is not always clear in the reports, making it more
difficult to use the information. The proposed rule would make these
reporting provisions more specific. The report would be required to
include reference to the specific exemption provision under which the
products/materials are being distributed and clearly identify the
specific licensee submitting the report, including the license number.
The current regulations require the licensee to identify the
product distributed. However, this is done in a number of ways, some of
which require the NRC to refer to other documents to obtain the
information needed to fully interpret what is being distributed. The
proposed rule would add model numbers, when applicable, to the required
information. Licensees have frequently included model numbers in the
reports, but often as the only identification of the type of product
being transferred. The proposed rule would eliminate these
inefficiencies without making a significant change to licensees'
reporting burden. The address to which reports are to be sent would
also contain the line, ``ATTN: Document Control Desk/Exempt
Distribution,'' to make the internal distribution of the documents
within NRC more efficient. The requirement for licensees to send an
additional copy of the reports to the appropriate Regional office would
be removed. Under NRC's internal procedures, the information would be
electronically distributed to the Regional offices. These factors are
expected to make the reporting process more efficient and to improve
the quality of the information submitted.
As a result of these proposed changes, the NRC would receive
information on distribution to exempt persons that is more useful for
evaluating both potential individual doses to the public from multiple
sources and collective doses to the public from these products and
materials than that provided under the existing regulations. The NRC
would have a stronger basis for informing the public concerning such
exposures. These changes would also provide a better basis for
considering any future regulatory changes in this area and in
allocating NRC resources. Finally, the period of retention for records,
proposed to remain at one year after transfers are included in a
report, would be up to four years shorter than under existing
requirements.
B. NRC Licensing of the Introduction of Exempt Concentrations
For most exemptions from licensing in part 30, distributors must
have an NRC license even if they are in Agreement States. Reporting
requirements for these licensees provide the NRC with national data on
products and materials containing byproduct material distributed to
persons exempt from licensing and regulation. There are two exemptions
for which this is not the case. The first of these, Sec. 30.16,
``Resins containing scandium-46 and designed for sand-consolidation in
oil wells,'' would be removed, as noted below, because it is obsolete.
The second is Sec. 30.14, ``Exempt concentrations,'' for which those
who introduce byproduct material into products or materials are
licensed under Sec. 32.11 or similar Agreement States regulations. The
concentration limits applicable to this exemption from licensing are
contained in Sec. 30.70, ``Schedule A--Exempt concentrations,'' and
equivalent Agreement State regulations.
The provisions that allow Agreement State licensing of the
introduction of byproduct material into products and materials in
exempt concentrations for transfer to persons exempt from licensing
were added to NRC regulations in 1963, soon after the regulations
governing the Agreement State program were established in 1962 (10 CFR
part 150). At the time, the only practices being regulated under these
provisions related to quality control procedures and other radiotracer
activities. Exempt concentrations were permitted to be introduced into
oil, gasoline, plastics, and similar commercial and industrial items.
Also, at the time these provisions were added, it was expected that the
NRC would
[[Page 278]]
develop a system with the Agreement States to obtain copies of the
transfer reports submitted to the Agreement States by their licensees
so that NRC would have national information on distribution. Such a
system was never implemented.
The exempt concentration provision in Sec. 30.14 is a general
materials exemption that is not limited to a particular use. It allows
for various practices to be evaluated by the NRC or an Agreement State
on a case-by-case basis through the licensing process. A number of
different practices have been evaluated and conducted under Sec.
32.11, including the neutron irradiation of gemstones, silicon
semiconductor materials, and luggage and cargo in an airport explosive
detection system, resulting in induced radioactivity in the products.
These practices involved consideration of issues not anticipated in the
early 1960's, including the extensive national distribution of the
products. For the case of irradiation of gemstones, the NRC has since
required authorization by an NRC license.
Section 30.14 also contains an exemption from licensing by NRC (in
paragraph (c)) for manufacturers, processors, or producers in Agreement
States if the introduction of byproduct material into their product or
material is conducted by a specific licensee whose license authorizes
this introduction. Currently, this authority may be provided under
either an NRC license or an Agreement State license.
Information on all distributions to exempt persons is important for
NRC to effectively and efficiently assess the overall impact to the
public nationally. NRC licensing of all such distribution would
facilitate this process. Also, the concentration limits in Sec. 30.70
do not provide the sole assurance of protection of public health and
safety. The evaluation done in connection with the licensing process is
also important. The current situation of multiple jurisdictions
potentially issuing these licenses may allow for some inconsistency in
the licensing process.
The proposed rule would require that the entity introducing
byproduct material into products and materials for use under the exempt
concentration provisions have an NRC license specifically authorizing
this introduction. Specifically, the proposed rule would make
Sec. Sec. 32.11 and 32.12 Compatibility Category NRC (i.e., reserved
to NRC). (For a brief explanation of compatibility categories see the
Agreement State Compatibility section.) This change to NRC-only
licensing would also require amendment of other provisions in the
regulations. Thus, the proposed rule would revise the wording of the
exemption in Sec. 30.14(c), Sec. 32.11, the prohibition in Sec. Sec.
30.14(d) and 32.13, and the reciprocity provision in Sec. 150.20
accordingly, so that only NRC may authorize the introduction of
byproduct material into products and materials to be distributed for
use under Sec. 30.14 and equivalent Agreement State regulations.
Section 32.11 would be revised to exempt Agreement State licensees
from Sec. 30.33(a)(2) and (3). Consistent with the practice for other
distributors of byproduct material to exempt persons in Agreement
States, who have possession and use of the material authorized by an
Agreement State license and distribution authorized by an NRC license,
the possession and use of the byproduct material to be introduced could
remain under an Agreement State license. In that case, provisions
similar to Sec. 30.33(a)(2) and (3) would apply under the Agreement
State license.
Currently, the only known entities licensed under Sec. 32.11 or
equivalent regulations of the Agreement States are a small number of
radiotracer firms, who introduce byproduct material into such materials
as gas and oil, and steel companies, who use sources to monitor the
wear of refractory lining in blast furnaces resulting in infrequent but
expected instances of slight contamination of some steel. The Agreement
States were requested to provide information on the number of licensees
of this type in 2002 and 2005. No licensees were identified.
The exemption in Sec. 30.14(c) was added specifically for persons
in Agreement States because of the provision in Sec. 150.15(a)(6),
which reserves for NRC the authority for licensing transfers to exempt
persons. The proposed rule would further revise the exemption in Sec.
30.14(c) to also apply to manufacturers, processors, or producers in
non-Agreement States who use a radiotracer firm or other Sec. 32.11
licensee to introduce byproduct material into their products. The
intent of the regulations in Sec. 32.11 is to allow a licensee to
introduce byproduct material into products and materials held by others
who are not required to have a license, thus, there is no reason to
limit this provision to persons in Agreement States. Therefore, Sec.
30.14(c) would be amended to delete the reference to the Agreement
States.
C. Bundling of Exempt Quantities
In accordance with Sec. 30.18, ``Exempt quantities,'' a person is
exempt from the requirements for a license to the extent that person
receives, possesses, uses, transfers, owns, or acquires byproduct
material in individual quantities, each of which does not exceed the
applicable quantity set forth in Sec. 30.71, Schedule B. However, a
person who commercially distributes materials to another person for use
under Sec. 30.18 must first obtain a distribution license from NRC in
accordance with Sec. 32.18, ``Manufacture, distribution and transfer
of exempt quantities of byproduct material: Requirements for license.''
Paragraph (c) of Sec. 32.18 prohibits the distributor from
incorporating the exempt byproduct material into any manufactured or
assembled commodity, product, or device intended for commercial
distribution. However, there is no stated prohibition regarding such
application by the end-user who is not commercially distributing the
product.
NRC became aware that some persons holding byproduct material under
the exemption in Sec. 30.18 had been combining (bundling) multiple
exempt quantities within an individual device that had not been
evaluated and approved by the NRC. The devices were manufactured
without radioactive material, but were designed to use multiple exempt
quantity sources of byproduct material. After first becoming aware of
the bundling issue, NRC originally determined in June 1994, that, under
certain limited circumstances, bundling of exempt sources did not
present a health and safety hazard and therefore no action was taken.
Later, the NRC became concerned that the number of exempt sources
bundled in these devices could reach a point where a general or
specific license would normally be required. If the bundled sources
were considered exempt, NRC would have no mechanism to ensure their
safe possession, use, and disposal. As a result, NRC issued a generic
letter in 1999, ``NRC Generic Letter 99-01: Recent Nuclear Material
Safety and Safeguards Decision on Bundling Exempt Quantities, May 3,
1999,'' to clarify that bundling was not appropriate under the existing
regulation. This position is supported by the language in Sec.
32.19(d)(2), which directs the distributor to provide a label or
accompanying brochure with any distributed exempt quantities that
includes the statement: ``Exempt Quantities Should Not be Combined.''
However, the NRC believes that the regulations in Sec. 30.18 should be
amended to specifically prohibit bundling under the exemption. The
proposed rule would revise the exempt quantities provision in Sec.
30.18 to explicitly prohibit combining sources to create an increased
radiation level.
The original basis for the quantities chosen for the exemption in
Sec. 30.18 was
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the more restrictive of: (1) The quantity of material inhaled by a
reference individual exposed for one year at the highest average
concentration permitted in air for members of the general public in
unrestricted areas at the time; or (2) for gamma emitters, the quantity
of material that would produce a radiation level of 1 mR/hr at 10 cm
from a point source. It was reasoned that under the conditions of the
exemption, it is unlikely that any individual would inhale (or ingest)
more than a very small fraction of any radioactive material being used
or receive excessive doses of external radiation when realistic source-
to-receptor distances and exposure times are assumed. Should bundling
be permitted, NRC cannot assure that the exposures would not exceed the
levels originally intended under the exemption. In addition, there
would be some potential that disposal of devices containing multiple
exempt sources through ordinary commercial waste streams or metal
recycling channels could result in inappropriate contamination of
property.
Because of the NRC's 1994 determination that, under certain limited
circumstances, bundling of exempt sources did not present a health and
safety hazard, the May 3, 1999, generic letter affirmed that NRC did
not plan to take any action regarding the devices initially produced
for use with a limited number of exempt quantity sources or their users
unless a radiological safety hazard were to be identified. Because NRC
has no indication that significant exposures are resulting or will
result from the continued use of the devices evaluated in 1994, the
proposed amendment would allow continued use of those devices. This
exclusion is intended to avoid imposing a regulatory burden on those
persons who otherwise might be impacted by this clarification in the
regulation who are continuing to use devices in use before the generic
letter was issued. Additionally, this regulation is not intended to
impact normal storage methods of the materials held under the exemption
in Sec. 30.18.
D. Obsolete Provisions
Some exemptions from licensing are considered obsolete in that no
products are being distributed for use under the exemption. In some
cases, no products covered by the exemption remain in use. Generally,
this has occurred because new technologies have made the use of
radioactive material unnecessary or less cost-effective.
The Commission is proposing to delete exemptions for products that
are no longer being used or manufactured, or to restrict further
distribution while allowing for the continued possession and use of
previously distributed items. These exemptions in part 30 are for:
Automobile lock illuminators (Sec. 30.15(a)(2)), balances of precision
(Sec. 30.15(a)(3)), automobile shift quadrants (Sec. 30.15(a)(4)),
marine compasses (Sec. 30.15(a)(5)), thermostat dials and pointers
(Sec. 30.15(a)(6)), spark gap irradiators (Sec. 30.15(a)(10)), and
resins containing scandium-46 (Sc-46) for sand consolidation in oil
wells (Sec. 30.16). Of these, only the exemption for resins containing
scandium could result in significant doses, which might be of concern,
if it were used.
NUREG-1717 describes the various products covered by the individual
exemptions in the second subsection of each section for a particular
exemption. Some of the conclusions in that report concerning
distribution are:
(1) On Sec. 30.15(a)(2): It is believed that automobile lock
illuminators containing H-3 (tritium) or promethium-147 have never been
manufactured for commercial use;
(2) On Sec. 30.15(a)(3): Tritium is not currently being used on
balances of precision;
(3) On Sec. 30.15(a)(4): It is believed that automobile shift
quadrants containing tritium are not being manufactured, nor have they
ever been manufactured, for commercial use;
(4) On Sec. 30.15(a)(5): Apparently, domestic manufacture and
import of marine compasses and other navigational instruments that
contain tritium has ceased;
(5) On Sec. 30.15(a)(6): Tritiated paint is not currently being
used on thermostat dials and pointers, primarily because electronic
displays are now available for illumination purposes. Neither are
gaseous tritium light sources used for thermostat dials or pointers;
(6) On Sec. 30.15(a)(10): Spark gap irradiators containing cobalt
are designed to minimize spark delay in some electrically ignited
commercial fuel-oil burners by generating free electrons in the spark
gap. The irradiators are no longer being manufactured, only about 100
irradiators were in stock in 1994, and no plans had been made to
distribute them for use. The original manufacturer is no longer in
business. The number of irradiators actually distributed is unknown,
but is not thought to be significant. [Note: there are products
referred to as ``spark gaps'' or ``spark gap tubes,'' a category of
electron tube, covered by the exemption in Sec. 30.15(a)(8), which
should not to be confused with the specific product covered by Sec.
30.15(a)(10)]; and
(7) On Sec. 30.16: Resins as the primary cementing media are no
longer used.
With the exception of resins covered by Sec. 30.16, only NRC
licenses distributors of these products. The primary bases for
determining that products are obsolete are NRC's records on its
licensees. Industry contacts were also used to collect historical
information concerning the use of the various products.
The NRC expects that the distribution of thermostat dials or
pointers, spark gap irradiators, and resins containing Sc-46 for sand
consolidation in oil wells ceased so long ago that it is highly
unlikely that any remain in use. This may or may not be the case for
balances of precision and marine compasses distributed for use under
Sec. 30.15(a)(3) and (5). As noted, automobile lock illuminators and
automobile shift quadrants were likely never commercially distributed
for use under exemption. The exemptions for automobile lock
illuminators, automobile shift quadrants, thermostat dials or pointers,
spark gap irradiators, and resins containing Sc-46 for sand
consolidation in oil wells would be removed. The exemptions for
balances of precision and marine compasses and other navigational
instruments would be retained for previously distributed products only.
This language is not being retained for the other five exemptions
considered obsolete. However, in the unlikely event that persons still
possess any of these products, this action is not intended to change
the regulatory status of any products previously distributed in
conformance with the provisions of the regulations applicable at the
time.
Specific requirements for manufacturers and initial distributors of
products that are no longer being manufactured or distributed would
also be deleted. These include Sec. 32.17 for the manufacture or
distribution of resins containing Sc-46 and the prototype test
procedures for automobile lock illuminators specified in Sec. 32.40
and required by Sec. 32.14(d)(2).
In the case of the resins containing Sc-46 for sand consolidation,
this action would provide assurance that health and safety are
adequately protected from possible future distribution. Only
preliminary dose estimates were made for this exemption. These
preliminary estimates indicated a potential for exposures higher than
is appropriate for materials being used under an exemption. However,
the preliminary dose estimates were not refined or included in NUREG-
1717, because the exemption was no longer being used.
[[Page 280]]
Deleting these unnecessary provisions would simplify the
regulations by eliminating extraneous text. Also, the Commission
periodically reevaluates the exposure of the general public from all
products and materials distributed for use under exemption, to ensure
that the total contribution of these products to the exposure of the
public will not exceed small fractions of the allowable limits.
Eliminating obsolete exemptions would add to the assurance that future
use of products in these categories would not contribute to exposures
of the public and would also eliminate the need to reassess the
potential exposure of the public from possible future distributions of
the products.
E. New Product-Specific Exemption for Smoke Detectors
One of the most widely distributed products used under an exemption
from licensing is the ionization chamber smoke detector commonly used
in residences. These smoke detectors are currently used under the class
exemption in Sec. 30.20 for gas and aerosol detectors and equivalent
regulations of the Agreement States. This class exemption was
established in April 1969. Section 30.20 also covers chemical agent
detectors and allows for new detectors with similar purposes to be
licensed for distribution without a new exemption from licensing being
established by rulemaking.
The specific requirements for obtaining a license to manufacture,
process, produce, or initially transfer gas and aerosol detectors
intended for use under Sec. 30.20 are currently contained in Sec.
32.26. Conditions of licenses are contained in Sec. 32.29 including
requirements for quality control, labeling, recordkeeping, and
reporting of transfers. NRC's licensing of a new initial distributor of
smoke detectors involves an evaluation to determine that certain safety
criteria (contained in Sec. Sec. 32.27 and 32.28) are met. The safety
criteria for gas and aerosol detectors include: (1) Radiation dose
limits for individuals from normal handling, storage, use, and disposal
of these products; and (2) radiation dose limits for individuals, in
conjunction with approximate associated probabilities of occurrence,
for accidents.
Residential ionization chamber smoke detectors and some similar
smoke detectors have been manufactured and used for many years. Current
designs are very consistent, using 0.9 to 1 [mu]Ci (33 to 37 kBq) of
americium-241 (Am-241) contained in a foil, surrounded by an ionization
chamber. Earlier designs used larger quantities of americium and, in
some cases, other radionuclides. Residential ionization chamber smoke
detectors (and similar detectors) represent a well established practice
with consistency in the design of products and with extensive licensing
experience. Potential doses from the distribution, use, handling, and
disposal of these detectors has been estimated in NUREG/CR-1156,
``Environmental Assessment of Ionization Chamber Smoke Detectors
Containing Am-241,'' November 1979, in NUREG-1717, and in various
license applications. The estimated doses under normal, routine
conditions are well under the safety criterion for routine use of 5
mrem/year (5 [mu]Sv/year) whole body, and the associated individual
organ limits.
This proposed rule would establish a specific exemption from
licensing requirements for ionization chamber smoke detectors
containing no more than 1 [mu]Ci (37 kBq) of Am-241 in the form of a
foil and designed to protect life and property from fires. This is
intended to apply to ionization smoke detectors whose primary function
is the protection of life and property. The exemption for ionization
chamber smoke detectors would be added to Sec. 30.15(a) as Sec.
30.15(a)(7). The primary difference between this proposed exemption and
the existing class exemption in Sec. 30.20 is that an applicant for a
license to distribute smoke detectors for use under this exemption
would not be required to submit dose assessments to demonstrate that
doses from the various stages of the life cycle of the product do not
exceed certain values. The applicant would still be required to submit
basic design information consistent with that required from applicants
to distribute products for use under other product-specific exemptions,
specifically for those products used under Sec. 30.15. The
requirements for applicants to distribute these products are contained
in Sec. 32.14. The primary emphasis of these requirements is to
provide assurance that the byproduct material is properly contained
within the product and will not be released under the most severe
conditions encountered in normal use and handling. Requirements for
those licensed under Sec. 32.14 are contained in Sec. Sec. 32.15 and
32.16. These latter requirements address quality assurance, labeling,
recordkeeping, and reports of transfer. The labeling requirement for
smoke detectors under the current regulation in Sec. 32.29(b) is more
specific than those in Sec. 32.15(d). In order that the more specific
labeling requirement be retained, essentially the same details would be
added to Sec. 32.15(d) as applicable specifically to ionization
chamber smoke detectors. A minor change (i.e., not referring to 10 CFR
32.27) would be made to be consistent with the new regulatory
requirements.
It is the NRC staff's licensing practice to issue licenses for the
distribution of products to be used under a class exemption only after
a Sealed Source and Device (SS & D) review and registration in the SS &
D. This is not the practice for products to be distributed for use
under a product-specific exemption. Because of this, the proposed
revision would also reduce both application and annual fees for
distributors of smoke detectors. There is a separate application fee in
Sec. 170.31, associated with device review and registration, which
would no longer apply. Also, in Sec. 171.16, there are different
annual fees based on whether a device has been evaluated for
registration in the SS & D. The primary difference is the elimination
of the fee for holding a registration certificate. For small entities,
reduced fees apply; therefore, the affect of this change on fees would
be smaller.
The effect of this change would be to reduce the regulatory burden
and the fees for new applicants for licenses to distribute ionization
chamber smoke detectors. Additionally, the change would reduce the NRC
staff time needed to review these applications, because an evaluation
of dose assessments would no longer be included. Current distributors
of ionization chamber smoke detectors using no more than 1 [mu]Ci of
Am-241 (37 kBq) may also amend their licenses and SS & D registrations
to change the regulatory status of their products in order to reduce
their annual fees. Given the wide distribution this product has already
experienced, this change is not expected to affect the overall number
of ionization chamber smoke detectors distributed in the future. Thus,
a more efficient regulatory process would be used without any impacts
to the health and safety of the public or the environment.
F. Specific Licensees and Generally Licensed Devices--Clarification
Following a revision to the general license provided by Sec. 31.5
(65 FR 79161; Dec. 18, 2000) that became effective in February 2001, an
increased number of specific licensees transferred their authorization
to possess and use some devices under the Sec. 31.5 general license to
the authority provided by their specific license. These transfers were
made primarily to avoid the cost of the new registration fees for some
of these devices in addition to their specific
[[Page 281]]
license fees. There are also other, non-fee-related reasons why one
would make such a transfer. There has been some confusion as to the
applicability of some requirements with respect to the transfer of a
device from a general licensee to a specific licensee when the same
entity holds both licenses, and as to exactly what is necessary to
comply with existing requirements related to both types of license.
The general license in Sec. 31.5, under paragraph (c)(1), requires
that the original label on the device be maintained. This label, among
other things, indicates the general license regulatory status of the
device and provides safety instructions or reference to operating and
service manuals. Instructions to the general licensee may not be
appropriate for the use of the device under a specific license. For
example, instructions may indicate that the general licensee may not
conduct its own leak tests, but must have an appropriate specifically
licensed service company do so. Also, under a specific license,
different labeling requirements are applicable (Sec. 20.1904,
``Labeling containers''). It is not acceptable for a device being held
under a specific license (SL) to be labeled in accordance with Sec.
32.51(a)(3), i.e., a general license (GL) label. Thus, if a device is
to be transferred from GL status to SL status, the label needs to be
changed to comply with the appropriate labeling requirement.
A specific licensee would conduct its own maintenance activities
including required leak tests, but may need information from the
manufacturer concerning the appropriate methods for the particular
device. This information may not have been provided to the entity as a
general licensee, depending on the device and what has been determined
to be appropriate activities for a general licensee. Thus, a specific
licensee may need to contact the manufacturer to obtain the proper
procedures for conducting required leak tests and other activities.
A specific licensee may have provisions in its license that
authorize the quantities of the radionuclides used in a generally
licensed device. The licensee needs to verify that the conditions of
the specific license authorize the possession and use of the device or
apply for an appropriate amendment to the license.
Paragraph (c)(8) of Sec. 31.5 specifies acceptable specifically
licensed recipients of devices covered by this general license and
requires that a general licensee report to the NRC transfers of devices
to specific licensees. The address for reporting includes an attention
line to Document Control Desk/GLTS. GLTS refers to the General License
Tracking System, which includes information on devices in use under
Sec. Sec. 31.5 and 31.7. In order for this database to be kept up-to-
date, transfers to specific licensees must be reported and the devices
removed from the database. Paragraph (c)(8)(iii) of Sec. 31.5 requires
written approval from the NRC for transfers to any specific licensee
not identified in paragraph (c)(8)(i). Thus, a general licensee who
wishes to transfer a device to any other specific licensee, even if
that licensee is the same entity and the effect is only to transfer to
a specifically licensed status, must obtain approval for the transfer.
In this way, the NRC can verify that the specific license authorizes
this use and can ensure that the licensee is fully aware of its
responsibilities under both the general and specific license with
respect to the device. In addition, the NRC can update the GLTS.
This proposed rule would explicitly set out the required actions
for this type of transfer. It would also remove the necessity of
obtaining prior written NRC approval under these circumstances.
Paragraph 31.5(c)(8)(iii) would be revised to include details
concerning the required actions for a specific licensee to transfer a
device held under this general license to the authority provided by the
specific license. With these additional details included in the
regulation, it is not considered necessary for the specific licensee to
obtain prior written approval.
III. Early Agreement State Participation
The working group involved in the preparation of this proposed rule
included a member who was appointed by the Organization of Agreement
States (OAS), as well as the Conference of Radiation Control Program
Directors (CRCPD). This proposed rule and its draft Environmental
Assessment were also provided to the Agreement States during their
development via the use of the NRC Technical Conference Forum Web site
and notification to the States of their availability.
Two States provided comments. Both supported most of the proposed
revisions but were concerned with NRC making revisions to the general
license requirements in Sec. 31.5. The State of Wisconsin noted
particularly the revision to Sec. 31.5(c)(8) and suggested that the
NRC suspend the proposed revision of Sec. 31.5 until the Commission
has evaluated a recently submitted OAS petition for rulemaking to
determine if the petition offers a better alternative. Illinois
supported the revision of Sec. 31.5(c)(8), but disagreed with another
amendment to Sec. 31.5 included in the draft proposed rule posted for
Agreement state comment, which has not been retained in this proposed
rule. Illinois also suggested revising the labeling requirements (in
Sec. 32.19(d)(2)) so that the label would state that exempt quantities
``shall'' not be combined (rather than ``should'').
The OAS petition referred to by Wisconsin suggests that those
devices used under general license and covered by the registration
requirement in Sec. 31.5(c)(13), be required to be specifically
licensed instead. If the Commission decides to grant the OAS petition,
unregistered devices would still remain under a general license that
may be transferred to the authority of a specific license. If the
Commission decides to deny the OAS petition, both registered and
unregistered devices would remain under a general license that may be
transferred to the authority of a specific license. As a result, the
NRC has determined that the actions suggested by the OAS petition, if
taken, would not negatively impact the proposed change in this action;
the issues are sufficiently independent that the NRC does not believe
this change should await resolution of the petition.
The labeling requirement in Sec. 32.19(d) is a notification from a
licensee to a non-licensee. The label provides information to the user;
however, this direction is not enforceable. A revision to the exemption
in Sec. 30.18 itself is being proposed in order to make the intent
demonstrated by the labeling requirement more enforceable. Amending the
labeling requirement would not do so and would impose a cost on
licensees who commercially distribute exempt quantities with no real
effect.
IV. Summary of Proposed Amendments by Section
10 CFR 30.14(c)--Would revise the exemption for manufacturers,
processors, and producers to require that the licensed entity must be
an NRC licensee, and clarify that the exemption applies in all
jurisdictions.
10 CFR 30.14(d)--Would revise the prohibition on introducing exempt
concentrations to apply to all persons except those authorized by an
NRC license.
10 CFR 30.15(a)--Would (1) remove exemptions for automobile lock
illuminators, automobile shift quadrants, thermostat dials and
pointers, and spark gap irradiators; (2) limit the exemptions for
balances of precision and marine compasses and other navigational
instruments to products previously distributed; and (3)
[[Page 282]]
add an exemption for ionization chamber smoke detectors containing no
more than 1 [mu]Ci of Am-241 in a foil.
10 CFR 30.16--The exemption for resins containing Sc-46 for sand
consolidation in oil wells would be removed.
10 CFR 30.18--Would revise the exempt quantities provision by
adding an explicit prohibition in a new paragraph (e) against combining
sources to create an increased radiation level.
10 CFR 31.5(c)(8)(ii)--Would resolve a minor ambiguity with respect
to addressing reports.
10 CFR 31.5(c)(8)(iii)--Would revise transfer provisions to
explicitly state actions necessary for transfer of devices from general
license to specific license status and remove the need for written NRC
approval in that case.
10 CFR 32.11(a)--Would be revised to exempt Agreement State
licensees from Sec. 30.33(a)(2) and (3).
10 CFR 32.12--Would revise the period of reporting for material
transfers to annual and make minor changes to the content of reports.
10 CFR 32.13--Would revise the prohibition on introducing exempt
concentrations to apply to all persons except those authorized by an
NRC license.
10 CFR 32.14(d)--Would remove the reference to Sec. 32.40.
10 CFR 32.15(d)--Would add specific labeling requirements for smoke
detectors distributed for use under Sec. 30.15 consistent with that
currently applicable under the gas and aerosol detector provisions in
Sec. 32.29.
10 CFR 32.16--Would revise the period of reporting for material
transfers to annual, make minor changes to the content of reports, and
remove reference to Sec. 32.17.
10 CFR 32.17--Requirements for distribution of resins containing
Sc-46 for sand consolidation in oil wells would be removed.
10 CFR 32.20--Would revise the period of reporting for material
transfers to annual and make minor changes to the content of reports.
10 CFR 32.25(c)--Would revise the period of reporting for material
transfers to annual and make minor changes to the content of reports.
10 CFR 32.29(c)--Would revise the period of reporting for material
transfers to annual and make minor changes to the content of reports.
10 CFR 32.40--Prototype test requirements for automobile lock
illuminators would be removed.
10 CFR 150.20(b)--Would remove provision for transfers to persons
exempt under Sec. 30.14 from the reciprocity provision for Agreement
State licensees.
V. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 10 CFR parts 30, 31, 32, and 150 under
one or more of Sections 161b, 161i, or 161o of the AEA. Willful
violations of the rule would be subject to criminal enforcement.
VI. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' which became effective on September 3, 1997
(62 FR 46517), NRC program elements (including regulations) are placed
into compatibility categories A, B, C, D, NRC or adequacy category H&S.
Compatibility Category A are those program elements that are basic
radiation protection standards and scientific terms and definitions
that are necessary to understand radiation protection concepts. An
Agreement State should adopt category A program elements in an
essentially identical manner in order to provide uniformity in the
regulation of agreement material on a nationwide basis. Compatibility
Category B are those program elements that apply to activities that
have direct and significant effects in multiple jurisdictions. An
Agreement State should adopt Category B program elements in an
essentially identical manner. Compatibility Category C are those
program elements that do not meet the criteria of Category A or B, but
the essential objectives of which an Agreement State should adopt to
avoid conflict, duplication, gaps, or other conditions that would
jeopardize an orderly pattern in the regulation of agreement material
on a national basis. An Agreement State should adopt the essential
objectives of the Category C program elements. Compatibility Category D
are those program elements that do not meet any of the criteria of
Category A, B, or C, above, and, thus, do not need to be adopted by
Agreement States for purposes of compatibility. Compatibility Category
NRC are those program elements that address areas of regulation that
cannot be relinquished to the Agreement States under the Atomic Energy
Act of 1954, as amended, or provisions of Title 10 of the Code of
Federal Regulations. These program elements should not be adopted by
the Agreement States. Health and Safety (H&S) are program elements that
are required because of a particular health and safety role in the
regulation of agreement material within the State and should be adopted
in a manner that embodies the essential objectives of the NRC program.
The proposed rule would be a matter of compatibility between the
NRC and the Agreement States, thereby providing consistency among
Agreement State and NRC requirements. The revisions to parts 30 and 31
would be classified as Compatibility Category B and the revisions to
Sec. Sec. 32.13 and 150.20 would be classified as Category C. Sections
32.11 and 32.12 would be changed from Compatibility Categories C/B and
C respectively to Category NRC. Section 32.17 is Compatibility Category
B. Sections 32.15, 32.16, 32.20, 32.25, and 32.29 are classified as
Compatibility Category NRC. The existing compatibility designation for
these regulations are not affected.
Specific information about the compatibility or health and safety
components assigned to this rule may be found at the Office of State
and Tribal Programs Web site, http://www.hsrd.ornl.gov/nrc/home.html.
VII. Plain Language
The Presidential Memorandum dated June 1, 1998, entitled, ``Plain
Language in Government Writing'' directed that the Government's writing
be in plain language. This memorandum was published on June 10, 1998
(63 FR 31883). The NRC requests comments on this proposed rule
specifically with respect to the clarity and effectiveness of the
language used. Comments should be sent to the address listed under the
ADDRESSES heading above.
VIII. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113) requires that Federal agencies use technical standards that
are developed or adopted by voluntary consensus standards bodies unless
the use of such a standard is inconsistent with applicable law or
otherwise impractical. In this proposed rule, the NRC would amend its
regulations governing the use of byproduct material to revise reporting
of transfers to persons exempt from licensing, simplify the licensing
of smoke detector distribution, remove obsolete provisions, and make
some clarifications to the regulations. None of these actions
constitute the establishment of a standard that establishes generally
applicable requirements.
IX. Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the
[[Page 283]]
Commission's regulations in subpart A of 10 CFR part 51, not to prepare
an environmental impact statement for this proposed rule because the
Commission has concluded on the basis of an environmental assessment
that this proposed rule, if adopted, would not be a major Federal
action significantly affecting the quality of the human environment.
The following is a summary of the Environmental Assessment: Many of the
individual actions being proposed are the type of actions described in
the categorical exclusions of Sec. 51.22(c)(1) and (3). In addition,
the proposed rule would remove provisions applicable to practices that
no longer exist, establish a separate exemption from licensing for
ionization smoke detectors containing no more than 1 [mu]Ci of
americium-241, explicitly prohibit combining exempt quantity sources,
and require NRC licensing of the introduction of exempt concentrations
into products and materials. The removal of unused provisions would not
result in a change to any practices except to ensure that these
activities do not resume in the future without reconsideration by the
Commission. The new exemption for smoke detectors is not expected to
have any impact on the design or number of smoke detectors distributed
to the public. The prohibition on combining exempt quantities
reinforces the intent of existing regulations. The safety standards
related to the exempt concentration provisions would not change. The
Commission has concluded that none of these actions would have any
significant impacts to the environment or otherwise include any
condition requiring consultation under section 102(2)(C) of NEPA.
The determination of the Environmental Assessment for this proposed
rule is that there will be no significant impact to the public or the
environment from this action. However, the general public should note
that the NRC welcomes public participation. Comments on any aspect of
the Environmental Assessment may be submitted to the NRC as indicated
under the ADDRESSES heading.
The NRC has sent a copy of the Environmental Assessment and this
proposed rule to every State Liaison Officer and requested their
comments on the Environmental Assessment. The Environmental Assessment
may be examined at the NRC Public Document Room, O-1F23, 11555
Rockville Pike, Rockville, MD. Single copies of the Environmental
Assessment are available from Andy Imboden of the Office of Nuclear
Material Safety and Safeguards, telephone (301) 415-6128, e-mail,
[email protected].
X. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). The proposed rule makes minor revisions to the burdens on
licensees for reporting and recordkeeping under Sec. Sec. 31.5, 32.12,
32.16, 32.20, 32.25(c), and 32.29(c). It reduces the burden for new
applicants to distribute ionization chamber smoke detectors by allowing
them to obtain licenses under Sec. 32.14 rather than Sec. 32.26. The
public burden for this information collection is estimated to average 1
hour. Because the burden for these revisions to the information
collections is insignificant, Office of Management and Budget (OMB)
clearance is not required. Existing requirements were approved by the
Office of Management and Budget, approval numbers 3150-0001, 3150-0014,
3150-0016, and 3150-0120.
Send comments on any aspect of this collection of information,
including suggestions for reducing the burden, to the Information and
Records Management Branch (T-5 F53), U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by e-mail to [email protected].
XI. Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.
XII. Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft analysis may be submitted to the NRC as
indicated under the ADDRESSES heading. The analysis is available for
inspection in the NRC Public Document Room, 11555 Rockville Pike,
Rockville, MD. The regulatory analysis can also be viewed and
downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov. Single copies of the regulatory analysis are
available from Catherine R. Mattsen, telephone (301) 415-6264, e-mail,
[email protected] of the Office of Nuclear Material Safety and Safeguards.
XIII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this proposed rule, if adopted,
would not have a significant economic impact on a substantial number of
small entities. A significant number of the licensees affected by this
action would meet the definition of ``small entities'' set forth in the
Regulatory Flexibility Act or the Small Business Size Standards set out
in regulations issued by the Small Business Administration at 13 CFR
Part 121. However, none of the proposed revisions to the regulatory
program would result in a significant economic impact on the affected
entities.
XIV. Backfit Analysis
NRC has determined that the backfit rule does not apply to this
proposed rule; therefore, a backfit analysis is not required for this
proposed rule because it does not involve any provisions that would
impose backfits as defined in Chapter I.
List 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.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to
adopt the following amendments to 10 CFR Parts 30, 31, 32, and 150.
[[Page 284]]
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
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).
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).
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.
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 (insert effective date of rule).
(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 (insert
effective date of rule).
(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]
4. Section 30.16 is removed.
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
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).
7. In Sec. 31.5, paragraphs (c)(8)(ii) and (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.
* * * * *
(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
Nuclear Material Safety and Safeguards 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--
(A) The identification of the device by manufacturer's (or initial
transferor's) name, model number, and serial number;
(B) The name, address, and license number of the person receiving
the device (license number not applicable if exported); and
(C) The date of the transfer.
(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 and obtains an amendment to the license authorizing
the possession and use;
(B) Removes the label otherwise required by paragraph (c)(1) of
this section and replaces it with an appropriate label to comply with
Sec. 20.1904 of this chapter;
(C) Obtains information from the manufacturer (or initial
transferor) concerning maintenance such as leak testing that would be
applicable under the specific license; 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
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).
9. In Sec. 32.11, paragraph (a) is revised to read as follows:
[[Page 285]]
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;
* * * * *
10. 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 Nuclear Material Safety and Safeguards 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 (Insert the effective date of this rule), 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 a
period of one year after the transfer is included in a report to the
Commission.
11. 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.
12. 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.
13. 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.
14. 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 Nuclear Material Safety and Safeguards 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 device and each model
number, if applicable, the total quantity of the radionuclide;
(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
[[Page 286]]
year, on or before January 31 of each year. In its first report after
(Insert the effective date of this rule), 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 a
period of one year after the transfer is included in a report to the
Commission.
Sec. 32.17 [Removed]
15. Section 32.17 is removed.
16. 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 chemical and physical form of
byproduct material transferred.
(b) The licensee shall file a summary report with the Director of
Nuclear Material Safety and Safeguards 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 chemical and physical form, the
report shall indicate the total quantity of each radionuclide and the
chemical and 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 (Insert the effective date of this rule), 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. 32.18 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 a
period of one year after the transfer is included in a summary report
to the Commission.
17. 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 Nuclear Material Safety and Safeguards 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 (Insert the effective date of this rule), 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 a
period of one year after the transfer is included in a report to the
Commission.
18. 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 Nuclear Material Safety and Safeguards 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 (Insert the effective date of this rule), 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 a
period of one year after the transfer is included in a report to the
Commission.
Sec. 32.40 [Removed]
19. Section 32.40 is removed.
PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274
20. The authority citation for part 150 continues to read as
follows:
[[Page 287]]
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).
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).
21. In Sec. 150.20, paragraph (b)(3) is revised to read as
follows:
Sec. 150.20 Recognition of Agreement State licensing.
* * * * *
(b) * * *
(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 28th day of December, 2005.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 06-19 Filed 1-3-06; 8:45 am]
BILLING CODE 7590-01-P