[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Proposed Rules]
[Pages 43425-43446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18223]
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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. 75, No. 142 / Monday, July 26, 2010 /
Proposed Rules
[[Page 43425]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 40, 70, 170, and 171
RIN 3150-AH15
[NRC-2009-0084]
Distribution of Source Material to Exempt Persons and to General
Licensees and Revision of General License and Exemptions
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or ``the
Commission'') is proposing to amend its regulations to require that the
initial distribution of source material to exempt persons or general
licensees be explicitly authorized by a specific license, which would
include new reporting requirements. The proposed rule is intended to
provide the Commission with more complete and timely information on the
types and quantities of source material distributed for use either
under exemption or by general licensees. In addition, the NRC is
proposing to modify the existing possession and use requirements of the
general license for small quantities of source material to better align
the requirements with current health and safety standards. Finally, the
NRC is proposing to revise, clarify, or delete certain source material
exemptions from licensing to make the exemptions more risk informed.
This rule would affect manufacturers and distributors of certain
products and materials containing source material and certain persons
using source material under general license and under exemptions from
licensing.
DATES: Submit comments on the rule by November 23, 2010. Submit
comments specific to the information collections aspects of this rule
by October 25, 2010. Comments received after the above 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 this date.
ADDRESSES: Please include Docket ID NRC-2009-0084 in the subject line
of your comments. For instructions on submitting comments and accessing
documents related to this action, see Section I, ``Submitting Comments
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of
this document. You may submit comments by any one of the following
methods.
Federal Rulemaking Web site: Go to http://www.regulations.gov and
search for documents filed under Docket ID NRC-2009-0084. Address
questions about NRC dockets to Carol Gallagher, telephone 301-492-3668,
e-mail [email protected].
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 301-415-1677.
Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays (Telephone 301-
415-1677).
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 in the Paperwork Reduction Act Statement.
FOR FURTHER INFORMATION CONTACT: Gary Comfort, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
8106, e-mail: [email protected], or Catherine Mattsen, Office of
Federal and State Materials and Environmental Management Programs, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone:
301-415-6264, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Submitting Comments and Accessing Information
II. Background
A. Introduction
B. Regulatory Framework
C. Why are revisions to 10 CFR Part 40 considered necessary?
III. Discussion
A. What action is the NRC taking?
A.1 Specific Licensing of Distribution of Source Material
A.2 Distribution of Products to Persons Exempt From Regulation
A.3 Distribution of Source Material to General Licensees
A.4 Possession and Use of Source Material Under Sec. 40.22
A.5 Revision of Exemption for Thorium Lenses
A.6 Revision of Exemption for Glassware
A.7 Obsolete Exemptions
B. Whom would this action affect?
C. Specific Requests for Comment
D. What should I consider as I prepare my comments to the NRC?
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. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis
I. Submitting Comments and Accessing Information
Comments submitted in writing or in electronic form will be posted
on the NRC Web site and on the Federal rulemaking Web site http://www.regulations.gov. Because your comments will not be edited to remove
any identifying or contact information, the NRC cautions you against
including any information in your submission that you do not want to be
publicly disclosed. The NRC requests that any party soliciting or
aggregating comments received from other persons for submission to the
NRC inform those persons that the NRC will not edit their comments to
remove any identifying or contact information, and therefore, they
should not include any information in their comments that they do not
want publicly disclosed.
You can access publicly available documents related to this
document using the following methods:
NRC's Public Document Room (PDR): The public may examine and have
copied, for a fee, publicly available documents at the NRC's PDR, Room
O-1F21, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland.
NRC's Agencywide Documents Access and Management System (ADAMS):
[[Page 43426]]
Publicly available documents created or received at the NRC are
available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain
entry into 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's PDR
reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to
[email protected].
Federal Rulemaking Web Site: Public comments and supporting
materials related to this proposed rule can be found at http://www.regulations.gov by searching on Docket ID NRC-2009-0084.
II. Background
A. Introduction
Source material is regulated by the NRC under Title 10 of the Code
of Federal Regulations (10 CFR) Part 40, ``Domestic Licensing of Source
Material.'' Source material includes uranium and thorium in any
physical or chemical form. Naturally occurring uranium and thorium and
their decay chains emit alpha, beta, and gamma radiation. Uranium
exhibits toxic chemical properties that can impair kidney function when
ingested or inhaled in large quantities.\1\ Thorium dioxide is
classified as a ``known carcinogen'' by the U.S. Agency for Toxic
Substances and Disease Registry and has been linked to lung and liver
diseases.\2\ Because of the potential for uranium and thorium to
produce health effects from both chemical toxicity and radiological
effects, it is important for the NRC to understand how and in what
quantities uranium and thorium are being used under general license and
various exemptions in order to better evaluate potential impacts to
public health and safety.
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\1\ U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry. ``ToxFAQs TM'' for
Uranium,'' 1999.
\2\ U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry. ``ToxFAQs TM for
Thorium,'' 1999.
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The last major modification of 10 CFR Part 40 occurred in 1961 and
established licensing procedures, terms, and conditions for source
material that were substantially similar to those set forth, at the
time, in 10 CFR Part 30, ``Licensing of Byproduct Material.'' Since
then, the health and safety requirements in 10 CFR Part 20, ``Standards
for Protection Against Radiation,'' have been revised. In particular,
radiation dose limits for individual members of the public were
significantly reduced in the revision to 10 CFR Part 20. In addition,
training and other requirements have been moved and revised from an
earlier version of 10 CFR Part 20 into 10 CFR Part 19, ``Notices,
Instructions and Reports to Workers: Inspection and Investigations.''
Although the requirements in 10 CFR Part 30 have been revised to
address the changes to the health and safety requirements in 10 CFR
Part 20 and the training requirements in 10 CFR Part 19, these changed
standards have generally not been addressed with respect to the use of
source material in 10 CFR Part 40.
Some products currently covered by the exemptions from licensing in
10 CFR Part 40 were in use before the enactment of the original Atomic
Energy Act of 1946. Exemptions for the possession and use of many of
these products were included in the original 10 CFR Part 40 issued in
1947. As beneficial uses of radioactive material have developed and
experience with the use of such material has grown, new products
intended for use by the general public have been invented and the
regulations have been amended to accommodate the use of new products.
The regulations contained in 10 CFR Part 40 currently include no
requirements to report how much source material is being distributed in
the form of products for use under the exemptions from licensing.
Section 40.22, ``Small quantities of source material,'' provides a
general license authorizing commercial and industrial firms; research,
educational, and medical institutions; and Federal, State, and local
governmental agencies to use and transfer not more than 15 pounds (lb)
(6.8 kilograms (kg)) of source material in any form at any one time for
research, development, educational, commercial, or operational
purposes. Not more than a total of 150 lb (68 kg) of source material
may be received in any calendar year. Section 40.22 general licensees
are exempt from the provisions of 10 CFR Parts 19, 20, and 21, unless
the general licensee also possesses source material under a specific
license. The general license prohibits the administration of source
material or the radiation emanating from the source material, either
externally or internally, to human beings except as may be authorized
in a specific license issued by the Commission. There are no reporting
requirements for persons transferring source material, initially or
otherwise, for use under this general license. Thus, the NRC does not
have significant information on whom, how, or in what quantities
persons are using source material under this general license.
The current Sec. 40.22 general license (post-1961) is much less
restrictive than the previous version (1953-1961), which only permitted
receipt of up to 3 lb (1.4 kg) of source material per year by
pharmacists and physicians for medicinal purposes and by educational
institutions and hospitals for educational and medical purposes only.
In the previous version of this general license, resale of source
material was prohibited. The current general license not only
authorizes larger quantities of source material, but also allows
broader types of authorized users and uses of source material. Also,
resale is not prohibited.
In the 1990's, the NRC conducted a reevaluation of the exemptions
from licensing for byproduct and source material in the NRC's
regulations. The assessment of doses associated with most of these
exemptions can be found in NUREG-1717, ``Systematic Radiological
Assessment of Exemptions for Source and Byproduct Materials,''
published June 2001.\3\ Doses were estimated for the normal life cycle
of a particular product or material, covering distribution and
transport, intended or expected routine use, accident and misuse
scenarios, and disposal using dose estimation methods consistent with
those reflected in the current 10 CFR Part 20. The report identified
potential and likely doses to workers and members of the public under
the exemptions contained in 10 CFR Parts 30 and 40. In general, the
reevaluation concluded that no major problem exists with the use of
products containing source material under the exemptions from
licensing. Many of the products containing source material that are
used under exemption from licensing present
[[Page 43427]]
the potential for higher exposures under routine use conditions than
the products used under exemption that contain byproduct material
because of differences in allowed forms and uses; however, risks from
accidents are generally smaller. Although containment is a key to
safety for many products containing byproduct material, containment is
generally less important for products containing source material
because of the low specific activity of the source material contained
in such products.
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\3\ NUREG-1717 is a historical document developed using the
models and methodology available in the 1990s. The NUREG provides
estimates of radiological impacts from various exemptions from
licensing and is 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, Room O1-
F21, Rockville, MD.
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In 1999, the State of Colorado and the Organization of Agreement
States submitted a petition for rulemaking, PRM-40-27, which stated
their concerns regarding potential exposures to persons using source
material under the general license in Sec. 40.22. The petitioners
requested that the exemption for these general licensees from 10 CFR
Parts 19, 20, and 21 be restricted such that any licensee that has the
potential to exceed any dose limits or release limits, or generates a
radiation area as defined in 10 CFR Part 20 should be required to meet
requirements in both 10 CFR Parts 19 and 20. The petition indicated
that the State of Colorado had identified a site operated under the
general license in Sec. 40.22 at which there was significant source
material contamination. The petitioners calculated that resultant
exposures for the source material contamination were significantly
above the exposure limits allowed to members of the public in 10 CFR
Part 20. The petitioners indicated that public dose limits were
considered applicable because workers operating under the general
license were exempt from training requirements that would normally be
required for radiation workers under 10 CFR Part 19. The petitioners
also referenced other situations, which based on their research,
appeared to have resulted in Sec. 40.22 (or Agreement State
equivalent) general licensees potentially exceeding public health and
safety or disposal limits that would apply to most other licensees.
In response to the petition, the NRC sought to develop more
information on the use of the general license in Sec. 40.22. Although
the NRC had identified 6 persons distributing source material to Sec.
40.22 general licensees in the mid-1980's, the NRC was able to identify
only 1 remaining distributor in 2005. In 2006, the NRC contracted
Pacific Northwest National Laboratory (PNNL) to examine whether the
regulations concerning general licenses and certain exemptions for
source material were consistent with current health and safety
regulations. In 2007, PNNL completed their evaluation and documented
their findings in ``PNNL-16148, Rev. 1-Dose Assessment for Current and
Projected Uses of Source Material under U.S. NRC General License and
Exemption Criteria,'' (the PNNL study). A copy of the PNNL study can be
found in ADAMS by searching for Accession Number ML070750105. The study
used available information to identify and assess the primary
operations conducted under the Sec. 40.22 general license and
equivalent provisions of the Agreement States. The available data was
collected from information voluntarily submitted by specific licensees
known to have distributed source material to general licensees in the
past, through surveys to certain identified general licensees, and
through use of searches from the Internet, publications, and
professional societies. The available information was found to be
limited and may not be representative of all present day, or future,
uses of source material under the existing general license.
B. Regulatory Framework
The NRC has the authority to issue both general and specific
licenses for the use of source material and to exempt source material
from regulatory control under Section 62 of the Atomic Energy Act of
1954, as amended (``the Act'' or AEA). A general license is provided by
regulation, grants authority to a person for particular activities
involving source material as described within the general license, and
is effective without the filing of an application or the issuance of a
licensing document. Requirements for general licensees appear in the
regulations and are designed to be commensurate with the specific
circumstances covered by each general license. A specific license is
issued to a named person who has filed an application with the
Commission. Exemptions are provided in situations where there is
minimal risk to public health and safety and allow the end user, who
ordinarily requires a license, to possess or use the source material
without a license.
The NRC regulations contained in 10 CFR Part 40 set forth the basic
requirements for licensing of source material. Section 62 of the AEA
authorizes the Commission to determine that certain quantities of
source material are ``unimportant.'' Section 40.13, ``Unimportant
quantities of source material,'' sets forth several exemptions from the
licensing requirements for source material.
The regulations contained in 10 CFR Part 40 authorize a number of
different general licenses for source material; one of which is for
small quantities of source material (Sec. 40.22). Because general
licenses are effective without the filing of an application with the
NRC, there are no prior evaluations of user qualifications, nature of
use, or safety controls to be exercised. Some general licenses do
include reporting requirements for transfers of source material.
The regulations contained in 10 CFR Part 40 also authorize specific
licenses for source material. Basic requirements for submittal of an
application for a specific license are found in Sec. 40.31 and general
requirements for issuance of a specific license are found in Sec.
40.32. Terms and conditions of licenses are contained in Sec. 40.41.
With the exception of requirements found in Sec. Sec. 40.34 and 40.35,
related to the manufacture and initial transfer of products and devices
containing depleted uranium to be used under the general license in
Sec. 40.25, and the broad transfer authorizations contained in Sec.
40.51, there are no specific requirements applicable to the
distribution of products and materials containing source material.
C. Why are revisions to 10 CFR Part 40 considered necessary?
Currently, 10 CFR Part 40 does not include any requirement to
report information about source material being distributed for use
under the general license in Sec. 40.22 or under any exemption from
licensing in Sec. 40.13. Because the NRC does not require the
reporting of products and materials distributed for use under the
general license or exemptions, the NRC cannot readily determine if the
source material is being maintained in accordance with the regulatory
requirements for those uses, or how or in what quantities the source
material is being used. As a result, the NRC cannot fully assess the
resultant risks to public health and safety. Despite the limited
availability of information, the NRC has assembled some data regarding
the use of source material under both exemptions and the Sec. 40.22
general license. Because of the difficulty of collecting such
information and its limited reliability, the NRC has concluded that new
reporting requirements on the distribution of source material to Sec.
40.22 general licensees and persons exempt from licensing would
significantly increase the NRC's ability to evaluate impacts and more
efficiently and effectively protect the public health and safety from
the use of source material.
Product Exemptions
NUREG-1717 identified some source material product exemptions as
being
[[Page 43428]]
obsolete or no longer manufactured at the upper limits allowed under
Sec. 40.13(c). As a result, the NRC concludes that it is preferable to
delete or reduce the concentration limits allowed in future products to
reduce the potential for exposures to the general public from these
products.
In addition, based upon numerous questions from industry in the
past, the NRC has learned that industry has generally moved from the
manufacture of optical lenses containing thorium to the manufacture of
lenses with thin coatings of thorium. This has led to the question of
the applicability of the product exemption in Sec. 40.13(c)(7) to
those lenses coated with thorium. As a result, the NRC is considering
expanding the exemption in Sec. 40.13(c)(7) to accommodate current
manufacturing practices to make the exemption more useful.
Section 40.22 General License
When the current general license in Sec. 40.22 was established in
1961, provisions were included to exempt the general licensees from 10
CFR Parts 19, 20, and 21. The exemption was based upon the known uses
of source material at the time and the health and safety requirements
at that time. Because the Sec. 40.22 general license was expanded to
include commercial applications in 1961, it is likely that some current
practices were not properly evaluated as part of that rulemaking. In
addition, since that time, limits for protecting health and safety in
10 CFR Part 20 were significantly lowered and the training requirements
in 10 CFR Part 19 were expanded. This combination of events has led to
the recognition that some general licensees could expose workers to
levels above 1 millisievert (mSv) per year (100 millirem (mrem) per
year) which would normally require radiation training under 10 CFR Part
19. In addition, because of the exemption to 10 CFR Part 20, the NRC
recognizes that some Sec. 40.22 general licensees may dispose of
source material in manners that would not be acceptable for other
licensees where 10 CFR Part 20 applies and may abandon sites with
contamination at levels exceeding 10 CFR Part 20 release limits. These
actions could result in individual members of the public being exposed
to dose levels above that permitted by 10 CFR Part 20. The PNNL study
indicated that most source material possessed under Sec. 40.22 is
likely handled in quantities, physical forms, or in uses and conditions
that would justify the continued application of the exemptions to 10
CFR Parts 19, 20, and 21. However, as indicated by PRM-40-27, and by
bounding dose calculations in the PNNL study, situations can occur
where Sec. 40.22 general licensees exceed limitations under which
certain requirements in 10 CFR Parts 19 and 20 would apply to a
specific licensee. For example, because of the current exemption to 10
CFR Part 20, a Sec. 40.22 general licensee could abandon a site
resulting in a situation where the next occupant is exposed at levels
above public dose limits in Sec. 20.1301 and the unrestricted release
limits in Sec. 20.1402. As a result, the NRC determined that
consideration should be given to making the Sec. 40.22 general license
more consistent with current training requirements and public health
and safety standards, as set forth in 10 CFR Parts 19 and 20.
In addition, the current Sec. 40.22 general license allows persons
to obtain 15 lb (6.8 kg) of uranium or thorium in any form, including
any specific isotopes. Certain isotopes of thorium and uranium have
specific activities so high that 15 lb of those isotopes could result
in doses far in excess of dose limits normally allowed under NRC's
regulations without significant controls; thus, although these
separated radioisotopes are not commercially available in such
quantities, the NRC has concluded that persons should not be allowed to
obtain large quantities of these isotopes without applying for a
specific license.
III. Discussion
A. What action is the NRC taking?
The NRC is proposing to add new requirements for those persons who
initially transfer for sale or distribution products and materials
containing source material for receipt under an exemption or the
general license in Sec. 40.22. This proposed rule would also make a
number of additional revisions to the regulations governing the use of
source material under exemptions from licensing and under the general
license in Sec. 40.22. These changes are intended to better ensure the
protection of public health and safety in an efficient and effective
manner.
A.1 Specific Licensing of Distribution of Source Material
The NRC is proposing two new provisions, Sec. Sec. 40.13(c)(10)
and 40.22(e), which would prohibit the initial transfer for sale or
distribution of products or materials containing source material to
persons exempt from licensing under Sec. 40.13(c) or to a Sec. 40.22
general licensee, respectively, by a person without authorization by a
specific license. The initial transfer for sale or distribution is
considered to be the first transfer of the product or material
containing source material to a person who will be receiving the source
material for possession under an exemption listed in Sec. 40.13(c) or
under the general license in Sec. 40.22. Subsequent transfers of
source material from exempt person to exempt person or from general
licensee to general licensee would continue to be allowed without the
requirement for a specific license.
Under the proposed Sec. 40.13(c)(10), in conjunction with the
proposed Sec. 40.52, a person currently operating under a Sec. 40.22
general license that manufactures and initially transfers or
distributes a product for possession under an exemption listed in Sec.
40.13(c) would no longer be allowed to operate under the general
license and would instead need a specific license under this proposed
rule. The NRC is not aware of any widespread production and
distribution of exempt products under the general license; however,
with the proposed expansion of the exemption in Sec. 40.13(c)(7)
(discussed further in Section A.5 of this document), persons currently
manufacturing thorium-coated lenses under the general license would be
required to obtain a specific license if the lenses are distributed for
use under the expanded exemption.
A specific license for the initial distribution of products for use
under an exemption listed in Sec. 40.13(c) would be issued only by the
NRC, including for those persons located in an Agreement State, under a
new provision Sec. 40.52, ``Certain items containing source material;
requirements for license to apply or initially transfer.'' Conditions
for the proposed Sec. 40.52 licenses are being proposed in a new
provision Sec. 40.53, ``Conditions of licenses issued under Sec.
40.52: Quality control, labeling, and records and reports.'' In 10 CFR
150.15, the Commission retains the authority to license the transfer of
possession or control by the manufacturer, processor, or producer of
any equipment, device, commodity, or other product containing source
material or byproduct material whose subsequent possession, use,
transfer, and disposal by all other persons are exempted from licensing
and regulatory requirements. The licensing of the export from and
import into the United States of byproduct and source material is also
wholly reserved to the Commission by this section. Thus, a distributor
in an Agreement State involved in the initial transfer of materials or
products containing byproduct or source material to exempt persons,
whether a manufacturer or an importer, requires authority to distribute
[[Page 43429]]
such material from the Commission in addition to any Agreement State
license.
In the past, the Commission has chosen not to require licensing of
the transfer of source material to exempt persons by manufacturers or
importers of products in Agreement States (with the exception of the
manufacture of counterweights to be used under Sec. 40.13(c)(5)). This
proposed rule, in requiring specific authorization for the initial
transfer for sale or distribution of materials or products containing
source material to exempt persons, in conjunction with 10 CFR 150.15,
would clarify that distributors in Agreement States would need specific
licenses, issued by the NRC, authorizing initial transfer of products
containing source material for sale or distribution for use under the
exemptions in Sec. 40.13(c) or equivalent Agreement State regulations.
However, the possession and use of materials or products containing
source material by Agreement State licensees would continue to be
regulated by the Agreement State.
Importers of finished products containing source material would be
exempt from 10 CFR Parts 19 and 20--this is different than the existing
regulations governing the initial transfer of byproduct material. The
exemption from 10 CFR Parts 19 and 20 for importers of finished
products is being proposed because the health and safety concerns for
this type of distributor are no different than those for a secondary
distributor of source material, who is neither currently, nor in the
proposed rule, required to obtain a specific license for distribution.
Importers of finished products would not be allowed to process the
products and would not be expected to handle the products in any way
that would create health and safety impacts beyond what is projected to
occur under the exemption.
A specific license for the initial distribution of source material
for use under the Sec. 40.22 general license would be issued under a
new provision Sec. 40.54, ``Requirements for license to initially
transfer source material for use under Sec. 40.22.'' Conditions for
the Sec. 40.54 licenses are being proposed in a new section, Sec.
40.55, ``Conditions of licenses issued under Sec. 40.54: Quality
control, labeling, safety instructions, and records and reports.''
The process for obtaining a specific license to distribute source
material is expected to be relatively straightforward. Applications for
these specific licenses for distribution would be made through the
provisions of Sec. 40.31, ``Application for specific licenses,'' and
applicants would be required to meet part or all of the provisions of
Sec. 40.32, ``General requirements for issuance of specific
licenses.'' Regulatory Guide 10.4, ``Guide for the Preparation of
Applications for Licenses to Process Source Material,'' which may be
used by non-fuel-cycle source material applicants, already addresses
the submittal of information on types and quantities of source material
planned to be distributed to exempt persons. Under both proposed
paragraphs Sec. 40.13(c)(10) and Sec. 40.22(e), an initial
distributor would be allowed to continue distribution of products or
materials containing source material for 1 year beyond the effective
date of this rule. However, if an application for a specific license
(or license amendment, in the case of an existing NRC licensee) has
been submitted, the applicant would be allowed to continue their
distributions while issuance of the license is pending. Persons legally
importing products for possession under an exemption for their own
personal use or to be given as a personal gift would not be required to
obtain a specific license for those products. Similarly, persons
importing source material for use under a general license would not be
required to obtain a specific license unless they subsequently transfer
the source material to another person for use under a general license
or exemption.
The regulations contained in 10 CFR Part 40 currently do not
require a person to obtain a specific license to distribute source
material to persons exempt from licensing or to Sec. 40.22 general
licensees (with the exception of counterweights for which this is
included as a constraint within the exemption in Sec. 40.13(c)(5)).
The regulations in Sec. 40.51 allow such transfers to occur without a
distribution license and do not require any reporting of the transfers.
This is not true for byproduct material licensees, who are required in
10 CFR Part 32 to obtain a specific license for the initial
distribution of byproduct material to persons exempt from licensing or
for use under a general license. The import of exempt materials or
products is generally licensed by 10 CFR 110.27(a)(2) and 10 CFR
110.27(a)(3) provides a general license for the import to those persons
authorized to receive products or materials under a license. However,
in the case of source material distribution to exempt persons or to
Sec. 40.22 general licensees, no other license is currently required,
nor are there any requirements to report the transfer or receipt of the
imported material.
Because of the lack of reporting requirements associated with the
possession of source material under exemption or the Sec. 40.22
general license, the NRC does not have a clear understanding of the
amounts, types, or uses of source material under exemption or under the
Sec. 40.22 general license. Most information gathered by the NRC to
date comes from a few specific licensees who have voluntarily provided
distribution data. Because this information may not fully represent
actual usage, it is difficult for the Commission to make risk-informed
decisions in updating the related source material regulations. Without
the proposed specific licenses for initial distributors, it would be
difficult or impossible to enforce reporting requirements on
unidentified distributors. Requiring initial distributors of source
material to exempt persons or to certain general licensees to obtain a
license for distribution would allow the NRC to track the amount and
types of source material being distributed to those persons through
proposed reporting requirements that would be associated with the new
specific licenses.
A.2 Distribution of Products to Persons Exempt From Regulation
A prohibition on distribution without a specific license is
proposed in a new Sec. 40.13(c)(10), which directs persons seeking to
distribute source material to exempt persons, to the proposed new Sec.
40.52. The proposed Sec. 40.52 provides conditions for approval of a
license application for initial distribution of source material to
exempt persons. Additionally, the proposed Sec. 40.53 contains a
number of conditions for initial distributors including requirements
for reporting and recordkeeping, quality control, and labeling.
The new reporting and recordkeeping requirements are proposed in
Sec. 40.53(c). An initial distributor of products for use under the
exemption in Sec. 40.13(c) would be required to submit a report, by
January 31 of each year, regarding transfers made in the previous
calendar year. The report would identify the distributor and indicate
what products, types of source material and amounts, and number of
units distributed.
The regulations contained in 10 CFR Part 40 were initially based on
the assumption that the health and safety impacts of source material
were low and that considerations of protecting the common defense and
security were more significant. When the AEA was initially written, one
of the major focuses was to ensure that the United States government
would have an adequate supply of uranium and thorium as ``source
material'' for atomic
[[Page 43430]]
weapons and the nuclear fuel cycle. Exemptions from licensing were made
for certain consumer products already in production, such as gas
mantles containing thorium, and these exemptions have not been
substantially modified since they were included in the original
issuance of 10 CFR Part 40 in 1947. These exemptions essentially
accommodated existing practice without much emphasis on health and
safety. Recent studies have indicated that the manufacture and use of
such products has decreased as alternative products, not containing
source material, have become more readily available. Consistent with a
policy statement on consumer products published on March 16, 1965 (30
FR 3462), the Commission has periodically made various evaluations of
potential doses from exempt products to ensure that exposures from any
individual exempt practice do not exceed a small fraction of the
overall recommended dose limit for the public and that the combined
effect of exposures from various exempt practices does not result in a
significant impact to public health and safety. However, because the
Commission has little data on distributions of source material to
exempt persons, these evaluations for source material have been
particularly difficult to conduct, and may not necessarily represent
real world conditions.
The data collected by virtue of the proposed rule would provide the
NRC with a more accurate and complete representation of material
distributed to the public for use under exemptions in Sec. 40.13(c).
This would allow the NRC to recognize trends in distribution which
could alter earlier estimates of individual or collective doses and
affect earlier findings regarding health and safety. These changes
would provide a better basis for considering any future regulatory
changes in this area and in allocating the NRC's resources. The
proposed reporting requirements would also aid in ensuring that
exposures to the public from all sources controlled by the NRC are
monitored and are unlikely to exceed 1 mSv (100 mrem) per year.
These proposed reporting and recordkeeping requirements are
expected to impose a minimal burden on those persons requiring a
specific license for initial distribution of source material,
particularly given the current state of information technology. The
first report may include information on transfers for which records
have not been required; however, this information is expected to be
available because of basic business recordkeeping practices. If exact
numbers cannot be given for this first report, a best estimate for the
whole calendar year would be acceptable.
In addition to reporting and recordkeeping, there are a few
additional requirements being proposed for initial distribution of
products for use under exemption. The new requirements would help to
ensure that products being distributed were within the quantity or
concentration limits for those exemptions that include such limits and
that the products were properly labeled as currently required by the
existing conditions in the exemptions.
In the NUREG-1717 assessment, it was identified that certain
products containing source material and used under exemptions from
licensing (e.g., welding rods and gas mantles) have the potential for
routine exposures that are higher than is generally acceptable for use
under exemption. However, the use of thorium in these products has
significantly declined, being replaced by rare earth compounds, such as
lanthanum and yttrium. As a result, routine use of thorium containing
products of these types by individuals to the exclusion of similar
products containing rare earths is less likely and typical exposures to
users is likely less than previously estimated. At the same time, the
likely exposures can be limited by the user who is properly informed
concerning the inherent risks of exposures and methods for reducing
exposure. Thus, rather than eliminate these exemptions, the Commission
is proposing to include in the proposed distributor requirements the
requirement to provide safe handling instructions. Some distributors
have done so voluntarily in the past. Welding has other inherent risks,
thus, welding rod manufacturers and importers are required by
Occupational Safety and Health Administration regulations to prepare
and distribute Material Safety Data Sheets (MSDSs) on the use of
welding rods. While these identify the presence of thorium for thorium-
containing welding rods, they typically do not include information
specifically about the radiological hazard.
New fee categories and initial fee amounts for this new specific
license type are being proposed as revisions to 10 CFR Parts 170 and
171. There would be a category for the distribution aspect and a
separate one for manufacturing or processing. The applicants and
licensees under the proposed licensing provision Sec. 40.52 would come
under a newly established fee category, 2.C. ``Licenses to distribute
items containing source material to persons exempt from the licensing
requirements of 10 CFR Part 40 of this chapter'' (the current 2.C.
``All other source material licenses'' is proposed to be redesignated
as 2.F. by this rule). This new fee category would apply to all initial
distributors of products containing source material for use under Sec.
40.13(c). The fee associated with this category would be the only fee
required by the NRC of distributors whose possession and use of source
material is licensed by an Agreement State or who only import finished
products for distribution. There would be an additional fee category
for those manufacturing or processing such products. This is similar to
the breakdown of fees for manufacturers and distributors of exempt
byproduct material. The initial fee associated with the distribution
aspect of licensing for source material would be lower than those
related to distribution of products containing byproduct material to
exempt persons, because this rule would add more limited requirements
applicable to the distribution aspect of licensing for source material.
Proposed initial fee amounts for the proposed new category 2.C. are as
follows: $7,000 for an application; $10,000 for the annual fee.
The new fee category for manufacturing and processing would be 2.E,
``Licenses for possession and use of source material for processing or
manufacturing of products or materials containing source material for
commercial distribution.'' It is proposed that the initial fees
associated with manufacturing or processing be the same amount as those
that currently apply to a manufacturer of a product containing source
material that now comes under the current fee category 2.C, ``All other
source material licenses.'' These fees are currently $10,100 for an
application and $17,400 for the annual fee, but will change to $10,200
and $21,100, respectively, on August 16, 2010, as a result of the 2010
Fee Rule published on June 16, 2010 (75 FR 34220). It is proposed that
the initial fee amounts applicable to the proposed new fee category
2.E. be the same as those for the current category 2.C. at the time
this proposed rule is finalized and the requirements are made
effective. These amounts are subject to change prior to the
finalization of this proposed rule.
After the implementation of this proposed rule, the fee amounts for
these new categories would change annually in accordance with NRC
policy and procedures. Biennially, the NRC evaluates historical
professional staff hours used to process a new license application for
materials users fee categories which often results in changes to the
flat application fees. In addition, results from the biennial
[[Page 43431]]
review impacts the annual fee for the small materials users since the
NRC bases the annual fees for each fee category within this class on
the application fees and estimated inspection costs for each fee
category. Each year the annual fee for the materials users is
calculated using a formula which distributes the NRC allocated budget
amount for the small materials users to the various fee categories
based on application fees, inspections costs, inspection frequency, and
the number of licensees in the fee category.
A.3 Distribution of Source Material to General Licensees
The prohibition on distribution without a specific license in the
proposed Sec. 40.22(e) directs persons seeking to distribute source
material to Sec. 40.22 general licensees to the proposed new Sec.
40.54. The proposed Sec. 40.54 provides conditions for approval of a
license application for initial distribution of source material to
Sec. 40.22 general licensees. Additionally, the proposed Sec. 40.55
contains a number of conditions for initial distributors including
requirements for reporting and recordkeeping, labeling, and
notifications.
The proposed rule would add Sec. 40.55(d) and (e) to establish
reporting and recordkeeping requirements for initial distributors of
source material to persons generally licensed under Sec. 40.22 or
equivalent Agreement State provisions. The rule would require that
transfers be reported to the NRC and, if applicable, to the Agreement
State where the material is transferred, annually by January 31. The
report would cover transfers of source material completed in the
previous calendar year. The reports would identify each general
licensee receiving quantities of source material greater than 50 grams
(g) (0.11 lb) within any calendar quarter by name and address, the
responsible agent who may constitute a point of contact between the NRC
or the Agreement State agency and the general licensee, and the type,
physical form, and quantity of source material transferred. In
addition, the distributor would be required to report the total
quantity of source material distributed each calendar year, including
those transfers of less than 50 g (0.11 lb) in a quarter to any person.
When the small quantity general license was originally granted, it
was intended to be used by pharmacists and physicians for medicinal
purposes and by educational institutions and hospitals for educational
and medical purposes (although the general license was later revised in
1980 to prohibit use for medicinal and medical purposes). When the
general license was expanded in 1961, both in terms of how much
material and what it could be used for, no consideration was made to
include reporting requirements at the time. As a result, the NRC has
not been able to readily identify persons using source material under
this general license nor verify its proper use.
The proposed reporting requirements, when also applied to
distributors in Agreement States by those States, would help the NRC
identify Sec. 40.22 general licensees using larger quantities of
source material. This would enable the NRC to better communicate with
or inspect these general licensees, if necessary, to ensure that public
and worker health and safety is adequately protected. The Commission
would also use collected data to assess the extent of use of this
general license in order to better evaluate alternatives for future
revisions to this general license. Because the proposed reporting
requirement is intended to apply only to anyone initially distributing
source material to Sec. 40.22 general licensees, transfers of source
material from general licensee to general licensee would still not be
reported.
Records of the initial transfer of source material for use under
Sec. 40.22 would be required to be stored for 1 year after inclusion
in a report to the Commission or to an Agreement State agency.
Maintaining records for this length of time will facilitate the
licensee's preparation of the report and allows for verification of the
accuracy of the report by the NRC or the Agreement State. This is
shorter than the recordkeeping requirements for transfers of generally
licensed devices in byproduct material regulations. For generally
licensed devices, longer recordkeeping is appropriate because of the
possible need for tracing particular devices if generic defects were
identified.
These proposed reporting and recordkeeping requirements are
expected to impose a minimal burden on those persons requiring a
specific license for initial distribution of source material,
particularly given the current state of information technology. The
first report may include information on transfers for which records
have not been required; however, this information is expected to be
available because of basic business recordkeeping practices. If exact
numbers cannot be given for this first report, a best estimate for the
whole calendar year would be acceptable.
In addition to reporting and recordkeeping, there are a few
additional requirements being proposed for distribution of material for
use under Sec. 40.22 and equivalent Agreement State provisions. The
new requirements would primarily require the licensee to ensure the
quantity or concentration of material is as labeled. The initial
distributors would be required to provide to their customers copies of
key relevant regulations and radiation safety precautions and
instructions. Requiring initial distributors to provide copies of such
regulations would make the recipient aware that the source material is
possessed under a general license and what the requirements are under
that general license.
New fee categories and fee amounts for this new specific license
type are being proposed as revisions to 10 CFR Parts 170 and 171. The
applicants and licensees under the proposed licensing provision Sec.
40.54 would come under a newly established fee category, 2.D.
``Licenses to distribute source material to persons generally licensed
under 10 CFR Part 40 of this chapter.'' Proposed initial fee amounts
are as follows: $2,000 for an application; $5,000 for the annual fee.
These applicants and licensees would also be subject to the proposed
new category, 2.E., ``Licenses for possession and use of source
material for processing or manufacturing of products or materials
containing source material for commercial distribution.'' As discussed
in section A.2 of this document, the initial fee amounts for this
category would be equal to the fee for current fee category 2.C at the
time this proposed rule is finalized and the requirements are made
effective. These fee amounts would subsequently be revised in
accordance with applicable NRC policy and procedures.
The Commission currently has no licensees under the existing
licensing provision of Sec. 40.34, which also authorizes distribution
to a category of general licensees (those licensed under Sec. 40.25
and Agreement State equivalent provisions). The proposed new fee
categories 2.D. for persons who initially distribute source material to
general licensees and 2.E. for manufacturing or processing of source
material for commercial distribution would also cover future NRC
applicants and licensees that apply for or possess a license under
Sec. 40.34.
A.4. Possession and Use of Source Material under Sec. 40.22
The NRC is proposing to revise Sec. 40.22, ``Small quantities of
source material,'' in its entirety.
[[Page 43432]]
Under the proposed Sec. 40.22(a), the general license would be
limited to thorium and uranium in their natural isotopic concentrations
and depleted uranium. This differs from the existing Sec. 40.22(a)
which allows possession of any isotopic concentration of source
material. Certain radionuclides of uranium and thorium, when
isotopically separated, have the potential to present significantly
higher doses, in particular, thorium-228, thorium-229, and uranium-232.
Thorium-230 when separated from the uranium decay series is also a
higher specific activity material. Although the NRC is not aware of
these isotopes being separated for commercial use, if the separated
isotopes were readily available, the current provisions of Sec. 40.22
would allow a person to receive quantities large enough in terms of
activity to present a security concern without obtaining a specific
license. The proposed revised general license would limit uranium and
thorium to their natural isotopic concentrations or as depleted uranium
to ensure that persons could not obtain these much higher specific
activity materials in an isotopically separated form without the
authorization and safety controls provided by a specific license.
Under the proposed Sec. 40.22(a)(1), the general licensee would be
limited to possession of less than 1.5 kg (3.3 lb) of uranium and
thorium at any one time and 7 kg (15.4 lb) per calendar year for all
uranium and thorium that is in a dispersible form or has been processed
by the general licensee. Under the current general license, assurance
of safety is based primarily on two limiting conditions: (1) The amount
of source material that may be used at any one time and (2) the amount
that may be obtained in any calendar year. It had been assumed that the
activities likely to be conducted under the general license would be
unlikely to result in significant intakes of source material. These
conditions, however, may not be totally effective in affording a proper
level of safety as raised by PRM-40-27 and substantiated by the PNNL
study. PRM-40-27 and the PNNL study indicate that situations can occur
that exceed limitations under which certain requirements in 10 CFR
Parts 19 and 20 usually would apply to specific licensees. These
situations primarily result from the use of source material used or
possessed in a dispersible form.
In PRM-40-27, the petitioners stated that they had identified a
site, where source material was likely possessed under the general
license in Sec. 40.22, that had significant amounts of surface
contamination from source material. The petitioners indicated that
resultant exposures for the source material contamination were
significantly above the dose limits (possibly as high as 1 rem (10 mSv)
per year) allowed to members of the public in 10 CFR Part 20.
The PNNL study confirmed that such exposures were possible under
the existing Sec. 40.22 general license conditions and indicated that
unprotected workers exposed to thorium and uranium powders during the
lens manufacturing process, as licensed under a Sec. 40.22 general
license, can potentially receive an annual internal radiation dose up
to 5.6 mSv (560 mrem), and an annual committed effective dose
approaching 8 mSv (800 mrem) without regard to excess contamination.
This type of manufacturing process uses source material in a powdered
form which allows for a greater chance of inhalation or ingestion of
the source material. Although the Commission expects that these doses
from manufacturing may be tremendously reduced if the process is
performed in hot cells or if workers generally use respiratory
protection (e.g., dust masks) in response to other regulatory
requirements, the NRC is concerned about the potential exposures
because a Sec. 40.22 licensee is not required to meet the health and
safety requirements for protection against radiation in 10 CFR Part 20
nor the training requirements in 10 CFR Part 19.
The proposed new limits in Sec. 40.22(a)(1) are intended to reduce
the likelihood that a person operating under a general license would be
able to exceed dose limitations in 10 CFR Parts 19 and 20, which would
require additional controls if the person were specifically licensed.
Based upon the bounding dose calculations in the PNNL study, the NRC
expects this proposed lower quantity to limit the potential for a
worker to be exposed at levels exceeding 1 mSv (100 mrem) per year. In
addition, by limiting the amount of such source material allowed to be
received in a calendar year, the NRC expects that the potential for
surface contamination buildup (similar to that identified in PRM-40-27)
would also be reduced. By reducing the amount of source material that
is available for inhalation and ingestion, the NRC has concluded the
exemptions to 10 CFR Parts 19, 20, and 21 would continue to be
acceptable.
It is expected that a small number of persons currently possessing
and using source material under the existing general license may be
required to obtain a specific license for continued use of the source
material under this proposed rulemaking. Persons currently possessing
source material in dispersible forms, or processing source material, in
quantities greater than 1.5 kg (3.3 lb) of uranium and thorium at any
one time, or receiving more than 7 kg (15.4 lb) of uranium and thorium
in 1 year, would be required to obtain a specific license if they could
not reduce their possession and use of the source material to below the
proposed new limits.
Under the proposed Sec. 40.22(a)(2), the general licensee would be
allowed to possess up to 7 kg (15.4 lb) total uranium and thorium at
any one time as long as any source material possessed in addition to
that possessed under the limits in Sec. 40.22(a)(1) is in a solid,
non-dispersible form (e.g., a metal or sintered object; contained in
protective envelope or in a foil; or plated on an inactive surface) and
not chemically or physically altered. The licensee is limited to the
receipt of no more than 70 kg (154 lb) of uranium and thorium per
calendar year. If the licensee does physically or chemically alter the
solid source material, that altered source material would be required
to fall within the 1.5 kg (3.3 lb) at one time limit and no more than 7
kg (15.4 lb) per calendar year limits of the proposed Sec.
40.22(a)(1). Because the greater impact from the possession and use of
source material results from inhalation or ingestion, allowing source
material, in a solid, non-dispersible form, to continue to be possessed
at a limit of 7 kg (15.4 lb) at any one time is not expected to
significantly impact health and safety of workers handling or near such
material because of the unlikely chance of inhalation or ingestion.
Under the proposed Sec. 40.22(a)(3), persons treating drinking
water by removing uranium for the primary purpose of meeting U.S.
Environmental Protection Agency regulations, would continue to be
allowed to possess up to 7 kg (15.4 lb) of uranium at one time and
process no more than 70 kg (154 lb) of uranium per calendar year. The
NRC has concluded that the types of activities used to remove uranium
from drinking water adequately contain the uranium to protect worker
health and safety. The NRC also is concerned that the implementation of
reduced possession limits on such persons could significantly impact
operating costs, if such facilities are required to obtain specific
licenses, and thereby impact their ability to provide safe drinking
water. Although persons operating such facilities would not be impacted
by changes in possession limits, they would be required to meet the
other requirements of the proposed rule.
[[Page 43433]]
However, these persons continue to have multiple options for operating
within the NRC's regulations, including operation under a specific
license or applying for enforcement discretion as discussed in the 2006
Regulatory Information Summary (RIS-2006-020), ``Guidance for Receiving
Enforcement Discretion When Concentrating Uranium at Community Water
Systems,'' dated September 14, 2006.
The proposed Sec. 40.22(b) primarily provides clarification of how
existing regulations apply to Sec. 40.22 general licensees. Paragraph
40.22(b)(1) restates an existing requirement prohibiting the
administration of source material to humans, unless authorized by a
specific license.
Under the proposed Sec. 40.22(b)(2), the NRC is clarifying
disposal requirements for source material possessed under Sec. 40.22.
Because Sec. 40.22 currently exempts the general licensee from the
requirements in 10 CFR Part 20, one can infer that disposal of source
material may be exempt from regulation because 10 CFR Part 20 includes
disposal requirements. However, there is no exemption from Sec. 40.51
which includes transfer provisions for licensees (including general
licensees) which, depending upon how the general licensee disposes of
the material, may be applicable and therefore limit disposal
opportunities. The NRC is proposing in Sec. 40.22(b)(2) to
specifically prohibit abandonment of source material but allow up to
0.5 kg (1.1 lb) of source material per calendar year to be permanently
disposed of without further NRC restrictions as long as the source
material is in a solid, non-dispersible form (e.g., a metal brick,
encapsulated in cement, etc.). The person receiving the source material
to be permanently disposed would still be required to meet the
applicable regulations of other agencies regarding such disposals. The
NRC concludes that such small quantities would allow small general
licensees (e.g., educational institutions) to economically dispose of
the source material and would result in minimal impact to public health
and safety because its form would limit ingestion and inhalation of the
source material. The person receiving source material transferred under
the provisions of Sec. 40.22(b)(2)(i) would not be subject to further
regulation by the NRC to the extent that the source material received
under this provision was promptly and permanently disposed of by the
recipient. Larger quantities of source material would be required to be
disposed of as radioactive material through the provisions of Sec.
20.2001 (e.g., at an appropriately licensed disposal facility, or below
the effluent release concentrations in 10 CFR Part 20, etc.) or
transferred to another person otherwise authorized to receive the
source material.
Because Sec. 40.22 does not currently exempt the general licensee
from other requirements in 10 CFR Part 40, the NRC is proposing in
Sec. 40.22(b)(3) to direct the general licensee's attention to other
applicable sections of 10 CFR Part 40. Similarly, Sec. 40.22(b)(5)
directs the general licensee's attention to regulations regarding
export of source material.
As part of its attempt to evaluate the current use of source
material under the general license, the NRC found it difficult to
obtain significant information voluntarily from general licensees. The
proposed new condition in Sec. 40.22(b)(4) would clearly obligate
general licensees to respond to the NRC's written requests within 30
days.
As identified in PRM-40-27, contamination may become problematic
for some persons using source material under the general license. The
NRC is concerned that not only might a licensee not attribute what
could be significant amounts of source material contamination to its
possession limits but also, such as in the case identified in PRM-40-
27, might abandon significant amounts of source material in place. This
abandonment could result in other persons that later inhabit the
facility from unknowingly exposing their workers or others to the
source material contamination. As a result, in proposed Sec. 40.22(c),
the NRC is proposing to require the general licensee to minimize
contamination at the site and ensure that the site is cleaned up to be
protective of future worker and public health and safety. If the
general licensee identifies evidence that there may be significant
contamination, the license would be required to notify the NRC and may
consult with the NRC as to the appropriateness of sampling and
restoration activities. The goal of this requirement is to reduce the
likelihood that any remaining contamination would have the potential to
result in the 25 mrem (0.25 mSv) limits in Sec. 20.1402 being
exceeded. The NRC would expect a licensee to identify a concern about
significant contamination based on both visual inspection (i.e.,
particulates remaining from operations) and operational and historical
data (e.g., operations often resulted in airborne or dispersed
particulates or there were history of spills, etc.). If there is any
doubt as to whether remaining contamination may be considered
significant, the licensee should consult with the NRC or a health
physics consultant.
In the proposed Sec. 40.22(d), the NRC is proposing to continue to
exempt persons generally licensed under Sec. 40.22 from 10 CFR Parts
19, 20, and 21, with the exceptions concerning disposal and
decommissioning in proposed Sec. 40.22(b)(2) and (c). In addition, the
NRC is proposing that this exemption would not extend to any NRC
specific licensee; in the current regulation only 10 CFR Part 40
licensees are excluded. This modification is expected to provide
minimal impact to those other specific licensees who possess source
material under the general license, because they would already be
subject to 10 CFR Parts 19, 20, and 21 for other licensed materials.
A.5 Revision of Exemption for Thorium Lenses
Paragraph 40.13(c)(7) exempts thorium contained in finished optical
lenses, provided that each lens does not contain more than 30 percent
by weight of thorium and meets certain use limitations, including that
the thorium not be contained in contact lenses, spectacles, or
eyepieces in binoculars or other optical instruments. Thorium is used
in or on lenses to modify optical properties of the lens. The
exemption, when originally established, was intended for uses where the
thorium was homogonously spread throughout the lens. However, more
recently, manufacturers are more likely to apply a thin coating of
thorium to the lens; this has brought up concerns of the applicability
of the existing exemption for such coated lenses. Also, NRC has
identified that source material may also be used as a coating on
mirrors.
To clarify the regulatory status of these coated lenses and to
address coatings on mirrors, the rule proposes three changes to the
existing exemption: (1) Expand the exemption to include source material
in or on finished coated lenses and mirrors; (2) reduce the source
material limit from 30 percent by weight to 10 percent by weight for
products distributed in the future; and (3) expand the exemption to
include uranium. The remaining limitations on use would continue to
apply.
Although historical information indicates that lenses containing up
to 28 percent by weight of thorium oxide were manufactured in the past,
most lenses that have been possessed under this exemption have
contained concentrations closer to 10 percent by weight of thorium. The
NRC has not been able to identify any manufacturers or distributors of
lenses containing homogeneous amounts of thorium since
[[Page 43434]]
1980, because the industry appears to have moved to using thorium as a
thin-film coating on the surface of lenses. The NRC's evaluation found
that thin-film coated lenses contain a significantly lower total mass
of thorium than that generally found in the same size homogeneous
lenses. In addition, the NRC has learned that certain lens
manufacturers also use thorium in combination with uranium to achieve
desired properties. Although a coated lens does not contain the source
material homogeneously within the lens (as is the case with lenses that
may currently be possessed under the exemption), the PNNL study
indicated that doses from both normal and accident conditions from
lenses coated with either or both uranium and thorium were estimated to
be well below 10 microsievert ([mu]Sv) per year (1 mrem per year). As a
result, the NRC is proposing to expand the exemption to include these
thin-film coatings and to also apply the exemption to lenses and
mirrors containing uranium. The NRC's expectation is that the source
material would be fixed onto the lens or mirror and not readily able to
be removed from the surface. The exemption prohibits and would continue
to prohibit shaping, grinding, polishing, and any other manufacturing
process other than assembling the finished lens into an optical system
or device.
The NRC is also proposing to revise Sec. 40.13(c)(7) to limit the
source material contained on or in the lens to no more than 10 percent
by weight of source material across the volume of the lens, although
lenses containing up to 30 percent by weight of thorium that were
produced prior to the effective date of this rule would continue to be
covered by this exemption from licensing. Based on information that the
manufacture of lenses containing homogeneous thorium is no longer
occurring and that the majority of lenses currently being manufactured,
contain concentrations less than 10 percent by weight of thorium, this
reduction in the limit is expected to have minimal impact on industry.
The actual percent by weight of source material on a thin-coated lens
is expected to be well below this limit as averaged over the entire
lens.
A.6 Revision of Exemption for Glassware
Paragraph 40.13(c)(2)(iii) exempts glassware containing up to 10
percent source material by weight. Although the estimated doses
associated with this exemption are acceptable, the benefit from this
use of source material is limited to achieving a unique color and glow
in the glassware. Such glassware has been used in products such as
dinnerware and toys. This use of source material might be considered
frivolous, which is not in keeping with the policy of the Commission
with regard to consumer products. However, this use predates the AEA,
has been ongoing for decades, and continues today. Current
manufacturing is relatively limited and the concentration in any
recently produced items appears to be less than 2 percent source
material (uranium). The one NRC-licensed manufacturer maintains
concentration in products to within 1 percent by weight uranium. This
rule proposes to limit products manufactured in the future to no more
than 2 percent by weight source material. This would have minimal
impact on the industry, limited to any costs associated with ensuring
and documenting that products do not exceed this limit. It would ensure
that doses to members of the public exposed to products distributed for
use under this exemption in the future would be unlikely to exceed 10
[mu]Sv (1 mrem) per year. This is more appropriate for products with
minimal societal benefit and is consistent with the concept of ALARA
(as low as reasonably achievable).
A.7. Obsolete Exemptions
Some exemptions from licensing are considered obsolete in that no
products are being distributed for use under the exemption. In at least
one case, 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 NRC 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. NUREG-1717 describes the various products covered by
the individual exemptions. Two of the conclusions in that report
concerning distribution are:
For Sec. 40.13(d): It is believed that fire detection
units containing source material have not been manufactured for
commercial use; and
For Sec. 40.13(c)(2)(i): The exemption for ceramic
tableware containing source material could result in significant doses,
which might be of concern, if used as one's everyday dinnerware.
The exemption in Sec. 40.13(d) would be removed; however, in the
unlikely event that persons possess products covered by this provision,
this action would not change the regulatory status of any products
previously manufactured in conformance with the provisions of the
regulations applicable at the time. In the case of ceramic tableware,
the proposed rule would limit the exemption to previously manufactured
products. This action would provide assurance that health and safety
are adequately protected from possible future distribution. Preliminary
estimates indicated a potential for exposures higher than is
appropriate for materials being used under an exemption. However, these
were estimated using particularly conservative assumptions for routine
use, rather than the more typical use as a collectable.
Deleting the provision in Sec. 40.13(d) 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
these products.
There are other products covered by the exemptions in Sec.
40.13(c) for which distribution is very limited and may have ceased,
however, without the types of distributor requirements now being
proposed, it is difficult to be certain concerning whether any
distribution continues.
This risk-based approach to exemptions is in line with the
strategic plan of the NRC.
B. Whom would this action affect?
This proposed rule would affect manufacturers and distributors of
certain products and materials containing source material, and persons
using source material under the general license in Sec. 40.22. Certain
persons initially transferring source material to exempt persons or
general licensees would be required to obtain a specific license for
such distribution. Certain persons currently possessing a general
license under Sec. 40.22 may be required to obtain a specific license
for the continued possession and use of source material if they cannot
adapt their operations to the newly proposed possession limits or if
they initially transfer products containing source material. The
proposed rule would exempt persons who possess thorium or uranium
coated lenses or mirrors from licensing requirements for those lenses
[[Page 43435]]
and mirrors through a proposed revision to Sec. 40.13(c)(7).
C. Specific Requests for Comment
The NRC has identified specific questions related to this proposed
rulemaking as well as some questions for consideration in potential
future rulemakings.
The NRC seeks comments, in particular, on the following specific
questions presented in the proposed rulemaking:
(1) In the proposed expansion to Sec. 40.13(c)(7), the exemption
is limited by a concentration limit. It is expected that coatings on
lenses are always very thin in practice such that it is unlikely that
coated lenses would be near the concentration limit. However, a
concentration limit may not be the most appropriate control, as it is
generally not appropriate for surface contamination or hot spots to be
averaged with other material for comparison to a concentration limit.
Should other controls (e.g., mass or activity limit) be used and if so,
what limits should be considered?
(2) On the proposed revision to the general license for small
quantities of source material in Sec. 40.22, is the limitation to
natural or depleted uranium and natural thorium the most appropriate
way to prevent persons from obtaining source material radionuclides
with high specific activities without applying for a specific license?
Does this adequately protect public health and safety from, for
example, thorium-230 extracted from ore high in uranium content? Should
an activity limit(s) be added to the weight limit? If so, what activity
limit would adequately protect health and safety without adding
significant implementation burden for ensuring the activity limit(s)
are not exceeded?
(3) In Sec. 40.22(c), the NRC proposes to require persons to
contact the NRC if they identify significant contamination but does not
specifically identify what is considered to be significant
contamination. Is this a reasonable approach or are there other
approaches the NRC should consider? Should the NRC prescribe what is
considered significant contamination, and if so, what should be defined
as significant contamination? Should the NRC instead specifically
require general licensees to complete surveys in accordance with the
provisions of Sec. 20.1501 to ensure that the limits in Sec. 20.1402
are not exceeded, in particular for those licensees possessing source
material under the proposed Sec. 40.22(a)(1)? Would a requirement for
such surveys result in unnecessary expenses, particularly for general
licensees possessing very small quantities, or should such a
requirement be limited and if so, how?
(4) In assessing proposed changes to Sec. 40.22, has the NRC
properly identified and assessed the range of activities undertaken
under the existing general license? Has the NRC overestimated or
underestimated the potential for impacts from such operations and if
so, how (e.g., is there exposure data available that the NRC did not
have available during development of the proposed rule, but should be
considering)? Similarly, are the assumptions discussed in the proposed
revisions to exemptions in Sec. 40.13 correct (i.e., are some products
still being manufactured at concentration levels above the proposed
concentration limits)?
(5) In Sec. 170.31, the NRC is proposing to add new categories
2.C., 2.D., and 2.E. and associated fees for applications for those
categories. Similarly, in Sec. 171.16, the NRC is proposing to add new
categories 2.C., 2.D., and 2.E and associated annual fees to the table
in paragraph (d). In both situations, the proposed new fees are based
upon similar existing activities, although in future years these fees
would be based upon actual NRC effort on these activities as data is
accumulated. Are these new fee categories appropriate and are the
initial fees reasonable?
(6) In Sec. 40.22(b)(2)(ii), quantities of source material greater
than 0.5 kg (1 lb) per year would be required to be disposed of as
radioactive material through the provisions of Sec. 20.2001 or
transferred to another person otherwise authorized to receive the
source material. Should the NRC consider other disposal alternatives
for these larger quantities, such as in U.S. Environmental Protection
Agency's Resource Conservation and Recovery Act (RCRA) Subtitle C
hazardous waste disposal facilities or RCRA Subtitle D municipal Solid
waste landfills?
The NRC would also welcome preliminary input on the following
issues for potential future rulemaking:
(1) Should the general license in Sec. 40.22 be expanded to cover
11(e)2 byproduct material, i.e., mill tailings and wastes, to allow for
small quantities, such as samples, to be more readily transferred for
testing, for example? Given that the entire material is 11(e)2
byproduct material, and not just the uranium or thorium contained in
the material, would higher weight limits be appropriate? If allowed,
should any other conditions be changed (e.g., waste disposal, etc.) or
added?
(2) Should explicit provisions be added to 10 CFR Part 40 and 10
CFR Part 70 to cover the inclusion of source material and special
nuclear material in items in the sealed source and device registry,
similar to 10 CFR 32.210?
(3) There has been little use of the provisions in Sec. Sec. 40.25
and 40.34 for the use of depleted uranium under a general license. How
could these provisions be revised to expand the likely use of these
provisions and make the general license more useful to the regulatory
program? Is the subjective nature of the findings in Sec. 40.34(a)(3)
and (b) concerning the usefulness of a product or device and the
benefits from the use of the depleted uranium a deterrent to
applicants/potential distributors? Also, should the exposure limits in
Sec. 40.34(a)(2) be reduced to 1 mSv (100 mrem) per year?
(4) Are there product exemptions in Sec. 40.13(c) that should be
considered obsolete and revised to allow only those products that were
previously distributed? Are there other changes to the exemptions in
Sec. 40.13(c) that should be considered?
D. What should I consider as I prepare my comments to the NRC?
Recommendations for preparing your comments:
i. Identify the rulemaking: RIN 3150-AH15; docket ID NRC-2009-0084.
ii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iii. Describe any assumptions and provide any technical information
and/or data that you used.
iv. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
v. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vi. Explain your views as clearly as possible.
vii. Make sure to submit your comments by the comment period
deadline identified.
viii. Section VI of this document contains a request for comment on
the compatibility designations for the proposed rule; Section VII
contains a request for comments on the use of plain language; Section
IX contains a request for comments on the environmental assessment;
Section X contains a request for comments on the information collection
requirements; Section XI contains a request for comments on the draft
regulatory analysis; and Section XII contains a request for comments on
the impact of the proposed rule on small businesses.
[[Page 43436]]
IV. Summary of Proposed Amendments by Section
Section 30.6 Communications
10 CFR 30.6(b)(1)(iv)--Would add a reference to new Sec. 40.52 as
a licensing category not delegated to the NRC Regions.
Section 40.5 Communications
10 CFR 40.5(b)(1)(iv)--Would add a reference to new Sec. 40.52 as
a licensing category not delegated to the NRC Regions.
Section 40.8 Information Collection Requirements: OMB Approval
10 CFR 40.8(b)--Would add sections to the list of information
collection requirements.
Section 40.13 Unimportant Quantities of Source Material
10 CFR 40.13(c)--Would clarify that persons exempt from licensing
requirements are also exempt from 10 CFR Parts 19, 20, and 21.
10 CFR 40.13(c)(2)(i)--Would restrict the exemption for use of
source material in certain ceramic tableware to that previously
manufactured.
10 CFR 40.13(c)(2)(iii)--Would revise the exemption for use of
source material in glassware to reduce the limit of 10 percent by
weight source material to 2 percent by weight source material for
glassware manufactured in the future.
10 CFR 40.13(c)(5)--Would remove paragraph (c)(5)(i), as it is
redundant with the new paragraph (c)(10), and renumber the subsequent
paragraphs within (c)(5).
10 CFR 40.13(c)(7)--Would revise the exemption for use of source
material in optical lenses to: (1) Reduce the limit of 30 percent by
weight thorium to 10 percent by weight thorium for glassware
manufactured in the future; (2) accommodate lenses with coatings; (3)
add uranium to the material that may be combined with or on the lenses;
and (4) add mirrors.
10 CFR 40.13(c)(10)--Would add paragraph (c)(10) to restrict
initial distribution under the exemption and direct one to requirements
for authorization under an NRC specific license to initially transfer
or distribute source material.
10 CFR 40.13(d)--Would remove an obsolete exemption for use of
source material in fire detection units.
Section 40.22 Small Quantities of Source Material
10 CFR 40.22(a)(1)--Would apply a limit of 1.5 kg (3.3 lb) at any
one time to certain forms of uranium and thorium that may be inhaled or
ingested during normal working conditions and would restrict receipt to
less than 7 kg (15.4 lb) per year.
10 CFR 40.22 (a)(2)--Would allow additional possession of certain
forms of uranium and thorium that are not expected to be normally
inhaled or ingested. However, the total amount of uranium and thorium
possessed under the general license would still be limited to 7 kg
(15.4 lb) at any one time and the receipt of no more than 70 kg (154
lb) of uranium and thorium per year.
10 CFR 40.22(a)(3)--Would allow persons removing uranium from
drinking water to continue to possess up to 7 kg (15.4 lb) of uranium
at any one time and to remove up to 70 kg (154 lb) of uranium from
drinking water per calendar year.
10 CFR 40.22(b)(1)--Would continue to prohibit persons from
administering source material, or the resulting radiation, either
externally or internally, to human beings except as authorized by the
NRC in a specific license.
10 CFR 40.22(b)(2)--Would clarify that any person who receives,
possesses, uses, or transfers source material under Sec. 40.22 may not
abandon source material. The source material may be transferred under
Sec. 40.51 or permanently disposed. The general licensee would be
allowed to dispose of up to a total of 0.5 kg (1.1 lb) per calendar
year of source material through transfer to any person for permanent
disposal as long as the source material is in a solid, non-dispersible
form (e.g., metal brick, encapsulated in cement, etc.). The recipient
of the source material would not be required to obtain a license from
the NRC as long as it was permanently disposed. Permanent disposal of
quantities of source material exceeding 0.5 kg (1.1 lb) of source
material per calendar year or in non-solid forms (e.g., is readily
ingested or inhaled) would be required to be in accordance with Sec.
20.2001.
10 CFR 40.22(b)(3)--Would clarify which provisions in 10 CFR Part
40 apply under the general license.
10 CFR 40.22(b)(4)--Would add a provision to explicitly require
that licensees must respond to written requests by the NRC.
10 CFR 40.22(b)(5)--Would clarify that export of source material is
subject to 10 CFR Part 110.
10 CFR 40.22(c)--Would require that any person who receives,
possesses, uses, or transfers source material in accordance with
paragraph (a) of Sec. 40.22 must conduct activities so as to minimize
contamination of the facility and the environment.
10 CFR 40.22(d)--Would revise and move the requirements currently
under paragraph (b) of this section to paragraph (d) of this section.
10 CFR 40.22(e)--Would restrict initial distribution for use under
the general license to a specific license issued under Sec. 40.54 or
equivalent provisions of an Agreement State.
Section 40.32 General Requirements for Issuance of a Specific License
10 CFR 40.32(f)--Would add Sec. Sec. 40.52 and 40.54 to the list
of sections that have special requirements that need to be satisfied
for the issuance of certain specific licenses.
Section 40.52 Certain Items Containing Source Material; Requirements
for License To Apply or Initially Transfer
10 CFR 40.52--Would establish requirements for a license
authorizing distribution for use under the exemptions from licensing in
Sec. 40.13(c) and equivalent provisions of Agreement States.
Section 40.53 Conditions of Licenses Issued Under Sec. 40.52: Quality
Control, Labeling, and Records and Reports
10 CFR 40.53--Would establish requirements for licenses issued
under Sec. 40.52, including reporting and recordkeeping requirements
for distributions of products for use under Sec. 40.13(c) and
equivalent provisions of Agreement States.
Section 40.54 Requirements for License To Initially Transfer Source
Material for Use Under Sec. 40.22
10 CFR 40.54--Would establish requirements for a license
authorizing initial transfer or distribution for use under Sec. 40.22
and equivalent provisions of Agreement States.
Section 40.55 Conditions of Licenses Issued Under Sec. 40.54: Quality
Control, Labeling, Safety Instructions, Records and Reports
10 CFR 40.55--Would establish requirements for licenses issued
under Sec. 40.54, including reporting and recordkeeping requirements
for distributions of source material for use under the general license
in Sec. 40.22 and equivalent provisions of Agreement States.
Section 40.82 Criminal Penalties
10 CFR 40.82(b)--Would add sections to the list of provisions that
are not subject to criminal sanctions.
Section 70.5 Communications
10 CFR 70.5(b)(1)(iv)--Would add a reference to the proposed Sec.
40.52 as a
[[Page 43437]]
licensing category not delegated to the NRC Regions.
Section 170.31 Schedule of Fees for Materials Licenses and Other
Regulatory Services, Including Inspections, and Import and Export
Licenses
10 CFR 170.31--Would add to the schedule of fees three new
categories for distributors of source material.
Section 171.16 Annual Fees: Materials Licensees, Holders of
Certificates of Compliance, Holders of Sealed Source and Device
Registrations, Holders of Quality Assurance Program Approvals, and
Government Agencies Licensed By NRC
10 CFR 171.16--Would add three fee categories for distributors of
source material to the annual fees.
V. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend Sec. 40.22 and add Sec. Sec. 40.53
and 40.55 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''approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
this proposed rule would be a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency among the
Agreement States and the NRC requirements. The NRC staff analyzed the
proposed rule in accordance with the procedure established within Part
III, ``Categorization Process for NRC Program Elements,''of Handbook
5.9 to Management Directive 5.9, ``Adequacy and Compatibility of
Agreement State Programs'' (a copy of which may be viewed at http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
NRC program elements (including regulations) are placed into four
compatibility categories (see the Draft Compatibility Table in this
section). In addition, the NRC program elements can also be identified
as having particular health and safety significance or as being
reserved solely to the NRC. 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 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 nationwide 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.
Health and Safety (H&S) are program elements that are not required
for compatibility but are identified as having a particular health and
safety role (i.e., adequacy) in the regulation of agreement material
within the State. Although not required for compatibility, the State
should adopt program elements in this H&S category based on those of
the NRC that embody the essential objectives of the NRC program
elements, because of particular health and safety considerations.
Compatibility Category NRC are those program elements that address
areas of regulation that cannot be relinquished to Agreement States
under the Atomic Energy Act, as amended, or provisions of Title 10 of
the Code of Federal Regulations. These program elements are not adopted
by Agreement States. The following table lists the Parts and Sections
that would be revised and their corresponding categorization under the
``Policy Statement on Adequacy and Compatibility of Agreement State
Programs.''
Draft Compatibility Table for Proposed Rule Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License
and Exemptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject ---------------------------------------------------------
Existing New
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
30.6................................ Amend...................... Communications............. D.......................... D
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
40.5................................ Amend...................... Communications............. D.......................... D
40.8................................ Amend...................... Information collection D.......................... D
requirements: OMB approval.
40.13(c)............................ Amend...................... Unimportant quantities of B.......................... B
source material.
40.13(c)(2)(i)...................... Amend...................... Unimportant quantities of B.......................... B
source material.
40.13(c)(2)(iii).................... Amend...................... Unimportant quantities of B.......................... B
source material.
40.13(c)(7)......................... Amend...................... Unimportant quantities of B.......................... B
source material.
40.13(c)(10)........................ New........................ Unimportant quantities of ........................... B
source material.
40.13(d)............................ Remove..................... Unimportant quantities of B.......................... *
source material.
40.22(a)............................ Amend...................... Small quantities of source B.......................... B
material.
40.22(a)(1)......................... New........................ Small quantities of source ........................... B
material.
40.22(a)(2)......................... New........................ Small quantities of source ........................... B
material.
40.22(a)(3)......................... New........................ Small quantities of source ........................... B
material.
40.22(b)............................ Amend...................... Small quantities of source B.......................... B
material (Previously
40.22(c)).
40.22(b)(1)......................... New........................ Small quantities of source ........................... B
material.
40.22(b)(2)......................... New........................ Small quantities of source ........................... B
material.
40.22(b)(3)......................... New........................ Small quantities of source ........................... B
material.
[[Page 43438]]
40.22(b)(4)......................... New........................ Small quantities of source ........................... D
material.
40.22(b)(5)......................... New........................ Small quantities of source ........................... B
material.
40.22(c)............................ New........................ Small quantities of source ........................... C
material.
40.22(d)............................ Amend...................... Small quantities of source B.......................... B
material (Previously
40.22(b)).
40.22(e)............................ New........................ Small quantities of source ........................... B
material.
40.52............................... New........................ Certain items containing ........................... NRC
source material;
requirements for license
to apply or initially
transfer.
40.53............................... New........................ Conditions of licenses ........................... NRC
issued under Sec. 40.52:
Quality control, labeling,
and records and reports.
40.54............................... New........................ Requirements for license to ........................... B
initially transfer source
material for use under
Sec. 40.22.
40.55(a)............................ New........................ Conditions of licenses ........................... B
issued under Sec. 40.54:
Quality control, labeling,
safety instructions, and
records and reports.
40.55(b)............................ New........................ Conditions of licenses ........................... B
issued under Sec. 40.54:
Quality control, labeling,
safety instructions, and
records and reports.
40.55(c)............................ New........................ Conditions of licenses ........................... B
issued under Sec. 40.54:
Quality control, labeling,
safety instructions, and
records and reports.
40.55(d)............................ New........................ Conditions of licenses ........................... B
issued under Sec. 40.54:
Quality control, labeling,
safety instructions, and
records and reports.
40.55(e)............................ New........................ Conditions of licenses ........................... C
issued under Sec. 40.54:
Quality control, labeling,
safety instructions, and
records and reports.
40.82............................... Amend...................... Criminal penalties......... D.......................... D
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.5................................ Amend...................... Communications............. D.......................... D
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 170
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.31.............................. Amend...................... Schedules of fees for D.......................... D
materials licenses and
other regulatory services,
including inspections, and
import and export licenses.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 171
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.16.............................. Amend...................... Annual fees for materials D.......................... D
licenses and other
regulatory services.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Denotes an existing provision that is currently designated Compatibility Category B which would be removed from the regulations as a result of these
proposed amendments. Agreement States should remove this provision from their regulations when the amendment becomes final.
The NRC invites comment on the compatibility category designations
in the proposed rule and suggests that commenters refer to Handbook 5.9
of Management Directive 5.9 for more information. The NRC notes that,
like the rule text, the compatibility category designations can change
between the proposed rule and final rule, based on comments received
and Commission decisions regarding the final rule. The NRC encourages
anyone interested in commenting on the compatibility category
designations in any manner to do so during the comment period.
VII. Plain Language
The Presidential Memorandum ``Plain Language in Government
Writing'' published June 10, 1998 (63 FR 31883), directed that the
Government's documents be in clear and accessible language. 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 in this
document.
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 establish
requirements for distributors of source material to persons exempt from
regulation and to general licensees. In addition, the proposed
amendments would modify the existing possession and use requirements
for the general license for small quantities of source material to
better align the requirements with current health and safety standards.
The Commission is also proposing to revise, clarify, or delete certain
exemptions from licensing to make the requirements for the use of
source material under the exemptions more risk informed. The NRC is not
aware of any voluntary consensus standards that address the proposed
subject matter of this proposed rule. The NRC will consider using a
voluntary consensus standard if an appropriate standard is identified.
If
[[Page 43439]]
a voluntary consensus standard is identified for consideration, the
submittal should explain why the standard should be used.
IX. 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, 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 majority of the provisions in the proposed rule come within the
scope of categorical exclusion in Sec. 51.22, and as such, an
environmental review is not necessary. The implementation of the
remaining provisions of the proposed rule would not result in any
significant negative impact to the environment. Proposed revisions to
Sec. 40.22 primarily provide additional limitations on, and clarify
the requirements of, the Sec. 40.22 general licensee, thus,
potentially reducing the impact on environmental resources from the
status quo. Similarly, certain exemptions are being revised or deleted
to limit the future use of certain products containing source material.
Although the NRC is proposing to expand the exemption from licensing in
Sec. 40.13(c)(7) to allow coated lenses, the NRC's evaluation
indicated that these products contain significantly less source
material than those currently authorized under the exemption. The
Commission has determined that the implementation of this proposed rule
would be procedural and administrative in nature.
The determination of this environmental assessment is that there
would be no significant impact to the public 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 in
this document.
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-1F21, 11555
Rockville Pike, Rockville, MD 20852, or online at http://www.regulations.gov under Docket ID NRC-2009-0084.
X. Paperwork Reduction Act Statement
This proposed rule contains new or amended information collection
requirements contained in 10 CFR Part 40 that are subject to the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). These
information requirements have been submitted to the Office of
Management and Budget for review and approval of the information
collection requirements. The proposed rule changes to 10 CFR Parts 30,
70, 170, and 171 do not contain new or amended information collection
requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR Parts 30, 40, 70,
170, and 171; Distribution of Source Material to Exempt Persons and to
General Licensees and Revision of General License and Exemptions.
The form number: NRC Form 313.
How often the collection is required: One time for licensing
applications and amendments for new initial distribution licenses or
for certain general licensees ceasing activities; annual for reports on
initial distribution of source material; occasional for responses to
direct NRC requests for information.
Who will be required or asked to report: Applicants and licensees
who manufacture or initially distribute products or materials
containing source material to persons exempt from the regulations or
for use under a general license, and some users of source material
possessed under a general license.
An estimate of the number of annual responses: 164.3 (10 CFR Part
19 = 1 response; 10 CFR Part 20 = 7 responses; 10 CFR Part 40 = 95
responses; NRC Form-313 = 12.3 responses, plus 49 recordkeepers).
The estimated number of annual respondents: 75 (10 CFR Part 19 = 1
respondent; 10 CFR Part 20 = 2.33 respondents; 10 CFR Part 40 = 75
respondents; NRC Form-313 = 11.3 respondents). Because some licensees
may report under multiple parts, the total number of respondents for
the proposed rule is 75 (40 NRC licensees plus 35 Agreement State
licensees).
An estimate of the total number of hours needed annually to
complete the requirement or request: 753.3 (10 CFR Part 19 = 45.3
hours; 10 CFR Part 20 = 255 hours; 10 CFR Part 40 = 361.4 hours, NRC
Form-313 = 91.6 hours).
Abstract: The NRC is proposing to amend its regulations in 10 CFR
Part 40 to establish new requirements for distributors of source
material to persons exempt from the regulations or for use under a
general license in Sec. 40.22. In addition, the Commission is also
proposing to modify the existing possession and use requirements for
Sec. 40.22 general licensees to align the requirements with current
health and safety standards. Finally, the Commission is proposing to
revise, clarify, or delete certain exemptions in Sec. 40.13(c) to make
the exemptions more risk informed. Conforming changes would be made to
10 CFR Parts 30, 70, 170 and 171. These changes would affect
manufacturers and distributors of products and materials containing
source material and future users of some products used under exemptions
from licensing and under the Sec. 40.22 general license.
Information collections would result from new requirements for
certain persons initially distributing source material to obtain a
specific license. These new specific licensees would be required to
provide reports regarding their initial distributions of source
material to the NRC and the Agreement States on an annual basis and
maintain records of such reports, as well as meet existing information
collection requirements in 10 CFR Parts 19 and 20. In addition,
labeling requirements and notifications to recipients would be required
for certain initial distributions of source material. Proposed
revisions to the general license provisions in Sec. 40.22 would
specifically require the general licensee to respond to NRC requests
for information in a timely manner and notify the NRC when ceasing
activities if significant contamination is identified.
The NRC is seeking public comment on the potential impact of the
information collections contained in the proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and
rule are available at the NRC worldwide Web site: http://www.nrc.gov/
public-involve/
[[Page 43440]]
doc-comment/omb/index.html for 60 days after the signature date of this
notice.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
above issues, by October 25, 2010 to the Information Services Branch
(T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, or Internet electronic mail to NEOB-10202 (3150-AH15), Office of
Management and Budget, Washington, DC 20503. Comments on the proposed
information collections may also be submitted via the Federal
Rulemaking Web site http://www.regulations.gov, docket ID NRC-2009-
0084. Comments received after this date will be considered if it is
practical to do so, but assurance of consideration cannot be given to
comments received after this date.
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.
XI. 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 in this document. The analysis is
available for inspection in the NRC Public Document Room, 11555
Rockville Pike, Rockville, MD 20852, or online at www.regulations.gov
under Docket Number ID NRC-2009-0084. Single copies of the draft
regulatory analysis are available from Gary Comfort, telephone: (301)
415-8106, e-mail: [email protected], or Catherine Mattsen,
telephone: (301) 415-6264, e-mail: [email protected], of the
Office of Federal and State Materials and Environmental Management
Programs.
XII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if
promulgated, 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.
XIII. Backfit Analysis
The NRC's backfit provisions are found in the regulations at
Sec. Sec. 50.109, 52.39, 52.63, 52.83, 52.98, 52.145, 52.171, 70.76,
72.62, and 76.76. The requirements contained in this proposed rule do
not involve any provisions that would impose backfits on nuclear power
plant licensees as defined in 10 CFR Parts 50 or 52, or on licensees
for gaseous diffusion plants, independent spent fuel storage
installations or special nuclear material as defined in 10 CFR Parts
70, 72 and 76, respectively, and as such a backfit analysis is not
required. Therefore, a backfit analysis need not be prepared for this
proposed rule to address these classes of entities. With respect to 10
CFR Part 40 licensees, the NRC has determined that there are no
provisions for backfit in 10 CFR Part 40. Therefore, a backfit analysis
need not be prepared for this proposed rule to address part 40
licensees.
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 40
Criminal penalties, Government contracts, Hazardous materials
transportation, Nuclear materials, Reporting and recordkeeping
requirements, Source material, Uranium.
10 CFR Part 70
Criminal penalties, Hazardous materials transportation, Material
control and accounting, Nuclear materials, Packaging and containers,
Radiation protection, Reporting and recordkeeping requirements,
Scientific equipment, Security measures, Special nuclear material.
10 CFR Part 170
Byproduct material, Import and export licenses, Intergovernmental
relations, Nonpayment penalties, Nuclear materials, Nuclear power
plants and reactors, Source material, Special nuclear material.
10 CFR Part 171
Annual charges, Byproduct material, Holders of certificates,
registrations, approvals, Intergovernmental relations, Nonpayment
penalties, Nuclear materials, Nuclear power plants and reactors, 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, 40, and 70 and the
following amendments to 10 CFR parts 170 and 171, as amended on June
16, 2010, at 75 FR 34220, effective August 16, 2010.
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);
Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 549 (2005).
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. 30.6, paragraph (b)(1)(iv) is revised to read as
follows:
Sec. 30.6 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material to
persons exempt under Sec. Sec. 32.11 through 32.30 and Sec. 40.52 of
this chapter.
* * * * *
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
3. The authority citation for Part 40 continues to read as follows:
Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68
Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2),
83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234,
83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093,
[[Page 43441]]
2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec.
274, Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.
97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as
amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C.
2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy
Policy Act of 2005, Pub. L. No. 109-59, 119 Stat. 594 (2005).
Section 40.7 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 40.31(g) also issued under sec. 122, 68 Stat.
939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68
Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued
under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
4. In Sec. 40.5, paragraph (b)(1)(iv) is revised to read as
follows:
Sec. 40.5 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material to
persons exempt under Sec. Sec. 32.11 through 32.30 and Sec. 40.52 of
this chapter.
* * * * *
5. In Sec. 40.8, paragraph (b) is revised to read as follows:
Sec. 40.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 40.9, 40.22, 40.23, 40.25, 40.26, 40.27,
40.31, 40.34, 40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.52,
40.53, 40.54, 40.55, 40.60, 40.61, 40.64, 40.65, 40.66, 40.67, and
appendix A to this part.
* * * * *
6. In Sec. 40.13, the introductory text to paragraph (c), and
paragraphs (c)(2)(i), (c)(2)(iii), (c)(5) and (c)(7) are revised,
paragraph (c)(10) is added, and paragraph (d) is removed.
The revisions and addition read as follows:
Sec. 40.13 Unimportant quantities of source material.
* * * * *
(c) Any person is exempt from the requirements for a license set
forth in section 62 of the Act and from the regulations in this part
and parts 19, 20, and 21 of this chapter to the extent that such person
receives, possesses, uses, or transfers:
* * * * *
(2) * * *
(i) Glazed ceramic tableware manufactured before [effective date of
final rule], provided that the glaze contains not more than 20 percent
by weight source material;
* * * * *
(iii) Glassware containing not more than 2 percent by weight source
material or, for glassware manufactured before [effective date of final
rule], 10 percent by weight source material; but not including
commercially manufactured glass brick, pane glass, ceramic tile, or
other glass or ceramic used in construction;
* * * * *
(5) Uranium contained in counterweights installed in aircraft,
rockets, projectiles, and missiles, or stored or handled in connection
with installation or removal of such counterweights: Provided, That:
(i) Each counterweight has been impressed with the following legend
clearly legible through any plating or other covering: ``Depleted
Uranium''; \2\
(ii) Each counterweight is durably and legibly labeled or marked
with the identification of the manufacturer, and the statement:
``Unauthorized Alterations Prohibited''; \2\
---------------------------------------------------------------------------
\2\ The requirements specified in paragraphs (c)(5)(i) and
(c)(5)(ii) of this section need not be met by counterweights
manufactured prior to December 31, 1969, provided that such
counterweights were manufactured under a specific license issued by
the Atomic Energy Commission and were impressed with the legend
required by Sec. 40.13(c)(5)(i) in effect on June 30, 1969.
---------------------------------------------------------------------------
(iii) The exemption contained in this paragraph shall not be deemed
to authorize the chemical, physical, or metallurgical treatment or
processing of any such counterweights other than repair or restoration
of any plating or other covering.
* * * * *
(7) Thorium or uranium contained in or on finished optical lenses
and mirrors, provided that each lens does not contain more than 10
percent by weight thorium or uranium or, for lenses manufactured before
[effective date of the final rule], 30 percent by weight of thorium;
and that the exemption contained in this paragraph does not authorize
either:
(i) The shaping, grinding or polishing of such lens or mirror or
manufacturing processes other than the assembly of such lens or mirror
into optical systems and devices without any alteration of the lens or
mirror; or
(ii) The receipt, possession, use, or transfer of uranium or
thorium contained in contact lenses, or in spectacles, or in eyepieces
in binoculars or other optical instruments.
* * * * *
(10) No person may initially transfer for sale or distribution a
product containing source material to persons exempt under this
paragraph (c), or equivalent regulations of an Agreement State, unless
authorized by a license issued under Sec. 40.52 to initially transfer
such products for sale or distribution.
(i) Persons initially distributing source material in products
covered by the exemptions in this paragraph (c) before [effective date
of the final rule] without specific authorization may continue such
distribution for 1 year beyond this date. Initial distribution may also
be continued until the Commission takes final action on a pending
application for license or license amendment to specifically authorize
distribution submitted no later than 1 year beyond this date.
(ii) Persons authorized to manufacture, process, or produce
materials or products containing source material by an Agreement State
and persons who import finished products or parts for sale or
distribution must be authorized by a license issued under Sec. 40.52
for distribution only and are exempt from the requirements of parts 19
and 20 of this chapter, and Sec. 40.32(b) and (c).
* * * * *
7. Section 40.22 is revised to read as follows:
Sec. 40.22 Small quantities of source material.
(a) A general license is hereby issued authorizing commercial and
industrial firms; research, educational, and medical institutions; and
Federal, State, and local government agencies to receive, possess, use,
and transfer uranium and thorium, in their natural isotopic
concentrations and in the form of depleted uranium, for research,
development, educational, commercial, or operational purposes in the
following forms and quantities:
(1) Not more than 1.5 kg (3.3 lb) of uranium and thorium in any
form at any one time. A person authorized to possess, use, and transfer
source material under this paragraph may not receive more than a total
of 7 kg (15.4 lb) of uranium and thorium in any one calendar year.
Source material possessed under paragraph (a)(2) of this section does
not apply toward these limits; and
(2) Not more than 7 kg (15.4 lb) of uranium and thorium at any one
time so long as the form is solid and non-dispersible. A person
authorized to possess, use, and transfer source material under this
paragraph may not receive more than a total of 70 kg (154 lb) of
uranium and thorium in any one calendar year and may not alter the
chemical or physical form of the source
[[Page 43442]]
material possessed under this paragraph. The total quantity of source
material possessed under this paragraph must include source material
possessed under paragraph (a)(1) of this section; or
(3) Not more than 7 kg (15.4 lb) of uranium, removed during the
treatment of drinking water, at any one time. A person may not remove
more than 70 kg (154 lb) of uranium from drinking water during a
calendar year under this paragraph.
(b) Any person who receives, possesses, uses, or transfers source
material in accordance with the general license in paragraph (a) of
this section:
(1) Is prohibited from administering source material, or the
radiation therefrom, either externally or internally, to human beings
except as may be authorized by the NRC in a specific license.
(2) Shall not abandon such source material. Source material may be
disposed of as follows:
(i) A cumulative total of 0.5 kg (1.1 lb) of source material in a
solid, non-dispersible form may be transferred each calendar year, by a
person authorized to receive, possess, use, and transfer source
material under this general license to persons receiving the material
for permanent disposal. The recipient of source material transferred
under the provisions of this paragraph is exempt from the requirements
to obtain a license under this part to the extent the source material
is permanently disposed. This provision does not apply to any person
who is in possession of source material under a specific license issued
under this chapter; or
(ii) In accordance with Sec. 20.2001 of this chapter.
(3) Is subject to the provisions in Sec. Sec. 40.1 through 40.10,
40.41(a) through (e), 40.46, 40.51, 40.60 through 40.63, 40.71, and
40.81.
(4) Shall respond to written requests from the NRC to provide
information relating to the general license within 30 calendar days of
the date of the request, or other time specified in the request. If the
person cannot provide the requested information within the allotted
time, the person shall, within that same time period, request a longer
period to supply the information by providing the Director of the
Office of Federal and State Materials and Environmental Management
Programs, using an appropriate method listed in Sec. 40.5(a), a
written justification for the request;
(5) Shall not export such source material except in accordance with
part 110 of this chapter.
(c) Any person who receives, possesses, uses, or transfers source
material in accordance with paragraph (a) of this section shall conduct
activities so as to minimize contamination of the facility and the
environment. When activities involving such source material are
permanently ceased at any site, if evidence of significant
contamination is identified, the general licensee shall notify the
Director of the Office of Federal and State Materials and Environmental
Management Programs by an appropriate method listed in Sec. 40.5(a)
about such contamination and may consult with the NRC as to the
appropriateness of sampling and restoration activities to ensure that
any contamination or residual source material remaining at the site
where source material was used under this general license is not likely
to result in exposures that exceed the limits in Sec. 20.1402 of this
chapter.
(d) Any person who receives, possesses, uses, or transfers source
material in accordance with the general license granted in paragraph
(a) of this section is exempt from the provisions of parts 19, 20, and
21 of this chapter to the extent that such receipt, possession, use,
and transfer are within the terms of this general license, except that
such person shall comply with the provisions of Sec. Sec. 20.1402 and
20.2001 of this chapter to the extent necessary to meet the provisions
of paragraphs (b)(2) and (c) of this section. However, this exemption
does apply to any person who also holds a specific license issued under
this chapter.
(e) No person may initially transfer or distribute source material
to persons generally licensed under paragraph (a) of this section, or
equivalent regulations of an Agreement State, unless authorized by a
specific license issued in accordance with Sec. 40.54 or equivalent
provisions of an Agreement State. Initial distribution of source
material to persons generally licensed by paragraph (a) of this section
before [EFFECTIVE DATE OF FINAL RULE] without specific authorization
may continue for 1 year beyond this date. Distribution may also be
continued until the Commission takes final action on a pending
application for license or license amendment to specifically authorize
distribution submitted no later than 1 year beyond this date.
8. In Sec. 40.32, paragraph (f) is revised to read as follows:
Sec. 40.32 General requirements for issuance of a specific license.
* * * * *
(f) The applicant satisfies any applicable special requirements
contained in Sec. Sec. 40.34, 40.52, and 40.54.
* * * * *
9. Sections 40.52, 40.53, 40.54, and 40.55 are added under the
undesignated heading ``Transfer of Source Material'' to read as
follows:
Sec. 40.52 Certain items containing source material; requirements for
license to apply or initially transfer.
An application for a specific license to apply source material to,
incorporate source material into, manufacture, process, or produce the
products specified in Sec. 40.13(c) or to initially transfer for sale
or distribution any products containing source material for use under
Sec. 40.13(c) or equivalent provisions of an Agreement State will be
approved if:
(a) The applicant satisfies the general requirements specified in
Sec. 40.32. However, the requirements of Sec. 40.32(b) and (c) do not
apply to an application for a license to transfer products
manufactured, processed, or produced in accordance with a license
issued by an Agreement State or to the import of finished products or
parts.
(b) The applicant submits sufficient information regarding the
product pertinent to the evaluation of the potential radiation
exposures, including:
(1) Chemical and physical form and maximum quantity of source
material in each product;
(2) Details of construction and design of each product, if
applicable. For coated lenses, this must include a description of
manufacturing methods that will ensure that the coatings are unlikely
to be removed under the conditions expected to be encountered during
handling and use;
(3) For products with applicable quantity or concentration limits,
quality control procedures to be followed in the fabrication of
production lots of the product and the quality control standards the
product will be required to meet;
(4) The proposed method of labeling or marking each unit, and/or
its container with the identification of the manufacturer or initial
transferor of the product and the source material in the product; and
(5) The means of providing radiation safety precautions and
instructions relating to handling, use, and storage of products to be
used under Sec. 40.13(c)(1)(i) and (c)(1)(iii).
(c) Each product will contain no more than the quantity or the
concentration of source material specified for that product in Sec.
40.13(c).
[[Page 43443]]
Sec. 40.53 Conditions of licenses issued under Sec. 40.52: Quality
control, labeling, and records and reports.
(a) Each person licensed under Sec. 40.52 must ensure that the
quantities or concentrations of source material do not exceed any
applicable limit in Sec. 40.13(c).
(b) Each person licensed under Sec. 40.52 must ensure that each
product is labeled as provided in the specific exemption under Sec.
40.13(c). Those distributing products to be used under Sec.
40.13(c)(1)(i) and (c)(1)(iii) or equivalent regulations of an
Agreement State must provide radiation safety precautions and
instructions relating to handling, use, and storage of these products
as specified in the license.
(c)(1) Each person licensed under Sec. 40.52 must file a report
with the Director, Office of Federal and State Materials and
Environmental Management Programs, by an appropriate method listed in
Sec. 40.5(a), including in the address: ATTN: Document Control Desk/
Exempt Distribution.
(2) The report must clearly identify the specific licensee
submitting the report and include the license number of the specific
licensee and indicate that the products are transferred for use under
Sec. 40.13(c), giving the specific paragraph designation, 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. 40.13(c) or equivalent
regulations of an Agreement State:
(i) A description or identification of the type of each product and
the model number(s), if applicable;
(ii) For each type of source material in each type of product and
each model number, if applicable, the total quantity of the source
material; and
(iii) The number of units of each type of product transferred
during the reporting period by model number, if applicable.
(4) The licensee must file the report, covering the preceding
calendar year, on or before January 31 of each year. Licensees who
permanently discontinue activities authorized by the license issued
under Sec. 40.52 must file a report for the current calendar year
within 30 days after ceasing distribution.
(5) If no transfers of source material have been made to persons
exempt under Sec. 40.13(c) or the equivalent regulations of an
Agreement State, during the reporting period, the report must so
indicate.
(6) The licensee must maintain all information concerning transfers
that support the reports required by this section for 1 year after each
transfer is included in a report to the Commission.
Sec. 40.54 Requirements for license to initially transfer source
material for use under Sec. 40.22.
An application for a specific license to initially transfer source
material for use under Sec. 40.22, or equivalent regulations of an
Agreement State, will be approved if:
(a) The applicant satisfies the general requirements specified in
Sec. 40.32; and
(b) The applicant submits adequate information on and the
Commission approves the methods to be used for quality control,
labeling, and providing safety instructions to recipients.
Sec. 40.55 Conditions of licenses issued under Sec. 40.54: Quality
control, labeling, safety instructions, and records and reports.
(a) Each person licensed under Sec. 40.54 must label the immediate
container of each quantity of source material with the type of source
material and quantity of material and the words, ``radioactive
material.''
(b) Each person licensed under Sec. 40.54 must ensure that the
quantities and concentrations of source material are as labeled and
indicated in any transfer records.
(c) Each person licensed under Sec. 40.54 must provide the
information specified in this paragraph to each person to whom source
material is transferred for use under Sec. 40.22 or equivalent
provisions in Agreement State regulations. This information must be
transferred before the source material is transferred for the first
time in each calendar year to the particular recipient. The required
information includes:
(1) A copy of Sec. Sec. 40.22 and 40.51, or relevant equivalent
regulations of the Agreement State.
(2) Appropriate radiation safety precautions and instructions
relating to handling, use, storage, and disposal of the material.
(d) Each person licensed under Sec. 40.54 must report transfers as
follows:
(1) File a report with the Director, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555. The report shall include
the following information:
(i) The name, address, and license number of the person who
transferred the source material;
(ii) For each general licensee under Sec. 40.22 or equivalent
Agreement State regulations to whom greater than 50 grams (0.11 lb) of
source material has been transferred in a single calendar quarter, the
name and address of the general licensee to whom source material is
distributed; a responsible agent, by name and/or position and phone
number, of the general licensee to whom the material was sent; and the
type, physical form, and quantity of source material transferred; and
(iii) The total quantity of each type and physical form of source
material transferred in the reporting period to all such generally
licensed recipients.
(2) File a report with the responsible Agreement State agency for
transfers of greater than 50 grams (0.11 lb) of source material
transferred to a general licensee in an Agreement State within a
calendar quarter. The report shall include the following information
specific to those transfers made to the Agreement State being reported
to:
(i) The name, address, and license number of the person who
transferred the source material; and
(ii) The name and address of the general licensee to whom source
material was distributed; a responsible agent, by name and/or position
and phone number, of the general licensee to whom the material was
sent; and the type, physical form, and quantity of source material
transferred.
(iii) The total quantity of each type and physical form of source
material transferred in the reporting period to all such generally
licensed recipients within the Agreement State.
(3) Submit each report by January 31 of each year covering all
transfers for the previous calendar year. If no transfers were made to
persons generally licensed under Sec. 40.22 or equivalent Agreement
State provisions during the current period, a report shall be submitted
to the Commission indicating so. If no transfers have been made to
general licensees in a particular Agreement State during the reporting
period, this information must be reported to the responsible Agreement
State agency upon request of the agency.
(e) Each person licensed under Sec. 40.54 must maintain all
information that supports the reports required by this section
concerning each transfer to a general licensee for a period of 1 year
after the event is included in a report to the Commission or to an
Agreement State agency.
10. In Sec. 40.82, paragraph (b) is revised to read as follows:
Sec. 40.82 Criminal penalties.
* * * * *
(b) The regulations in part 40 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12,
40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34,
[[Page 43444]]
40.43, 40.44, 40.45, 40.52, 40.54, 40.71, 40.81, and 40.82.
PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
11. The authority citation for part 70 continues to read as
follows:
Authority: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948,
953, 954, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C.
2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended,
202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42
U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended
by Pub.L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec.
1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of
2005, Pub. L. 109-58, 119 Stat. 194 (2005).
Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141,
Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
Section 70.7 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 70.21(g) also issued under sec. 122, 68 Stat.
939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub.
L. 93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44
also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C.
2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955
(42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68
Stat. 939, as amended (42 U.S.C. 2138).
12. In Sec. 70.5, paragraph (b)(1)(iv) is revised to read as
follows:
Sec. 70.5 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material to
persons exempt under Sec. Sec. 32.11 through 32.30 and 40.52 of this
chapter.
* * * * *
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
13. The authority citation for part 170 continues to read as
follows:
Authority: Sec. 9701, Pub. L. 97-258, 96 Stat. 1051 (31 U.S.C.
9701); sec. 301, Pub. L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w);
sec. 201, Pub. L. 93-438, 88 Stat. 1242, as amended (42 U.S.C.
5841); sec. 205a, Pub. L. 101-576, 104 Stat. 2842, as amended (31
U.S. C. 901, 902); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note);
sec. 623, Pub. L. 109-58, 119 Stat. 783 (42 U.S.C. 2201(w)); sec.
651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021,
2021b, 2111).
14. Section 170.31 is amended by redesignating materials license
category 2.C. as category 2.F. and revising it, and by adding new
categories 2.C., 2.D., and 2.E. to read as follows:
Sec. 170.31 Schedules of fees for materials licenses and other
regulatory services, including inspections, and import and export
licenses.
* * * * *
Schedules of Materials Fees
[See footnotes at end of table]
------------------------------------------------------------------------
Categories of materials licenses and types of fees \1\ Fee 1 2
------------------------------------------------------------------------
* * * * * * *
2. Source material.........................................
* * * * * * *
C. Licenses to distribute items containing source
material to persons exempt from the licensing
requirements of part 40 of this chapter.
Application [Program Code(s): 11240]............... $7,000
D. Licenses to distribute source material to persons
generally licensed under part 40 of this chapter.
Application [Program Code(s): 11230 and 11231]..... 2,000
E. Licenses for possession and use of source material
for processing or manufacturing of products or
materials containing source material for commercial
distribution.
Application [Program Code(s): 11710]............... 10,200
F. All other specific source material licenses.
Application [Program Code(s): 11200, 11220, 11221, 10,200
11300, 11800, 11810]..............................
* * * * * * *
------------------------------------------------------------------------
\1\ Types of fees--Separate charges, as shown in the schedule, will be
assessed for pre-application consultations and reviews; applications
for new licenses, approvals, or license terminations; possession only
licenses; issuances of new licenses and approvals; certain amendments
and renewals to existing licenses and approvals; safety evaluations of
sealed sources and devices; generally licensed device registrations;
and certain inspections. The following guidelines apply to these
charges:
(a) Application and registration fees. Applications for new materials
licenses and export and import licenses; applications to reinstate
expired, terminated, or inactive licenses except those subject to fees
assessed at full costs; applications filed by Agreement State
licensees to register under the general license provisions of 10 CFR
150.20; and applications for amendments to materials licenses that
would place the license in a higher fee category or add a new fee
category must be accompanied by the prescribed application fee for
each category.
(1) Applications for licenses covering more than one fee category of
special nuclear material or source material must be accompanied by the
prescribed application fee for the highest fee category.
(2) Applications for new licenses that cover both byproduct material and
special nuclear material in sealed sources for use in gauging devices
will pay the appropriate application fee for fee Category 1.C. only.
(b) Licensing fees. Fees for reviews of applications for new licenses,
renewals, and amendments to existing licenses, pre-application
consultations and other documents submitted to the NRC for review, and
project manager time for fee categories subject to full cost fees are
due upon notification by the Commission in accordance with Sec.
170.12(b).
(c) Amendment fees. Applications for amendments to export and import
licenses must be accompanied by the prescribed amendment fee for each
license affected. An application for an amendment to an export or
import license or approval classified in more than one fee category
must be accompanied by the prescribed amendment fee for the category
affected by the amendment, unless the amendment is applicable to two
or more fee categories, in which case the amendment fee for the
highest fee category would apply.
(d) Inspection fees. Inspections resulting from investigations conducted
by the Office of Investigations and non-routine inspections that
result from third-party allegations are not subject to fees.
Inspection fees are due upon notification by the Commission in
accordance with Sec. 170.12(c).
(e) Generally licensed device registrations under 10 CFR 31.5.
Submittals of registration information must be accompanied by the
prescribed fee.
[[Page 43445]]
\2\ Fees will not be charged for orders related to civil penalties or
other civil sanctions issued by the Commission under 10 CFR 2.202 or
for amendments resulting specifically from the requirements of these
orders. For orders unrelated to civil penalties or other civil
sanctions, fees will be charged for any resulting licensee-specific
activities not otherwise exempted from fees under this chapter. Fees
will be charged for approvals issued under a specific exemption
provision of the Commission's regulations under Title 10 of the Code
of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and
any other sections in effect now or in the future), regardless of
whether the approval is in the form of a license amendment, letter of
approval, safety evaluation report, or other form. In addition to the
fee shown, an applicant may be assessed an additional fee for sealed
source and device evaluations as shown in Categories 9.A. through 9.D.
\3\ Full cost fees will be determined based on the professional staff
time multiplied by the appropriate professional hourly rate
established in Sec. 170.20 in effect when the service is provided,
and the appropriate contractual support services expended. For
applications currently on file for which review costs have reached an
applicable fee ceiling established by the June 20, 1984 and July 2,
1990 rules, but are still pending completion of the review, the cost
incurred after any applicable ceiling was reached through January 29,
1989 will not be billed to the applicant. Any professional staff-hours
expended above those ceilings on or after January 30, 1989 will be
assessed at the applicable rates established by Sec. 170.20, as
appropriate, except for topical reports for which costs exceed
$50,000. Costs which exceed $50,000 for each topical report,
amendment, revision, or supplement to a topical report completed or
under review from January 30, 1989 through August 8, 1991 will not be
billed to the applicant. Any professional hours expended on or after
August 9, 1991 will be assessed at the applicable rate established in
Sec. 170.20.
PART 171--ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES
AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF
COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS,
AND GOVERNMENT AGENCIES LICENSED BY NRC
15. The authority citation for part 171 continues to read as
follows:
Authority: Sec. 7601, Pub. L. 99-272, 100 Stat. 146, as amended
by sec. 5601, Pub. L. 100-203, 101 Stat. 1330 as amended by sec.
3201, Pub. L. 101-239, 103 Stat. 2132, as amended by sec. 6101, Pub.
L. 101-508, 104 Stat. 1388, as amended by sec. 2903a, Pub. L. 102-
486, 106 Stat. 3125 (42 U.S.C. 2213, 2214), and as amended by Title
IV, Pub. L. 109-103, 119 Stat. 2283 (42 U.S.C. 2214); sec. 301, Pub.
L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w); sec. 201, Pub. L. 93-438,
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).
16. In Sec. 171.16, the table in paragraph (d) is amended by
redesignating materials license category 2.C. as category 2.F. and
revising it, and by adding new categories 2.C., 2.D., and 2.E. to read
as follows:
Sec. 171.16 Annual fees: Materials licensees, holders of certificates
of compliance, holders of sealed source and device registrations,
holders of quality assurance program approvals and government agencies
licensed by the NRC.
* * * * *
(d) * * *
Schedule of Materials Annual Fees and Fees for Government Agencies
Licensed by NRC
[See footnotes at end of table]
------------------------------------------------------------------------
Annual fees
Category of materials licenses 1 2 3
------------------------------------------------------------------------
* * * * * * *
2. Source Material.........................................
* * * * * * *
C. Licenses to distribute items containing source $10,000
material to persons exempt from the licensing
requirements of part 40 of this chapter [Program
Code(s): 11240].......................................
D. Licenses to distribute source material to persons 5,000
generally licensed under part 40 of this chapter
[Program Code(s): 11230 and 11231]....................
E. Licenses for possession and use of source material 21,100
for processing or manufacturing of products or
materials containing source material for commercial
distribution. [Program Code(s): 11710]................
F. All other specific source material licenses. 21,100
[Program Code(s): 11200, 11220, 11221, 11300, 11800,
11810]................................................
* * * * * * *
------------------------------------------------------------------------
\1\Annual fees will be assessed based on whether a licensee held a valid
license with the NRC authorizing possession and use of radioactive
material during the current FY. The annual fee is waived for those
materials licenses and holders of certificates, registrations, and
approvals who either filed for termination of their licenses or
approvals or filed for possession only/storage licenses before October
1, 2009, and permanently ceased licensed activities entirely before
this date. Annual fees for licensees who filed for termination of a
license, downgrade of a license, or for a possession-only license
during the FY and for new licenses issued during the FY will be
prorated in accordance with the provisions of Sec. 171.17. If a
person holds more than one license, certificate, registration, or
approval, the annual fee(s) will be assessed for each license,
certificate, registration, or approval held by that person. For
licenses that authorize more than one activity on a single license
(e.g., human use and irradiator activities), annual fees will be
assessed for each category applicable to the license. Licensees paying
annual fees under Category 1.A. (1) are not subject to the annual fees
for Categories 1.C. and 1.D. for sealed sources authorized in the
license.
\2\ Payment of the prescribed annual fee does not automatically renew
the license, certificate, registration, or approval for which the fee
is paid. Renewal applications must be filed in accordance with the
requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter.
\3\Each FY, fees for these materials licenses will be calculated and
assessed in accordance with Sec. 171.13 and will be published in the
Federal Register for notice and comment.
[[Page 43446]]
* * * * *
Dated at Rockville, Maryland, this 20th day of July 2010.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2010-18223 Filed 7-23-10; 8:45 am]
BILLING CODE 7590-01-P