Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions, 43425-43446 [2010-18223]
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43425
Proposed Rules
Federal Register
Vol. 75, No. 142
Monday, July 26, 2010
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.
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
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
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
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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
https://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
Carol.Gallager@nrc.gov.
Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
E-mail comments to:
Rulemaking.Comments@nrc.gov. 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: Gary.Comfort@nrc.gov, 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:
Catherine.Mattsen@nrc.gov.
SUPPLEMENTARY INFORMATION:
I. Submitting Comments and Accessing
Information
II. Background
A. Introduction
B. Regulatory Framework
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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 § 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 https://
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):
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Publicly available documents created or
received at the NRC are available
electronically at the NRC’s Electronic
Reading Room at https://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
PDR.Resource@nrc.gov.
Federal Rulemaking Web Site: Public
comments and supporting materials
related to this proposed rule can be
found at https://www.regulations.gov by
searching on Docket ID NRC–2009–
0084.
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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.
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
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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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
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source material under this general
license.
The current § 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
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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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.
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 § 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 § 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
§ 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 § 40.22.
Although the NRC had identified 6
persons distributing source material to
§ 40.22 general licensees in the mid1980’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
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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 § 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
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of which is for small quantities of
source material (§ 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 § 40.31 and
general requirements for issuance of a
specific license are found in § 40.32.
Terms and conditions of licenses are
contained in § 40.41. With the exception
of requirements found in §§ 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 § 40.25, and
the broad transfer authorizations
contained in § 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 § 40.22 or under any
exemption from licensing in § 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
§ 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 § 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
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obsolete or no longer manufactured at
the upper limits allowed under
§ 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 § 40.13(c)(7) to
those lenses coated with thorium. As a
result, the NRC is considering
expanding the exemption in
§ 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
§ 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
§ 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 § 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 § 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
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calculations in the PNNL study,
situations can occur where § 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 § 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
§ 20.1301 and the unrestricted release
limits in § 20.1402. As a result, the NRC
determined that consideration should be
given to making the § 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 § 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
§ 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 § 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, §§ 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
§ 40.13(c) or to a § 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
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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 § 40.13(c) or under
the general license in § 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 § 40.13(c)(10), in
conjunction with the proposed § 40.52,
a person currently operating under a
§ 40.22 general license that
manufactures and initially transfers or
distributes a product for possession
under an exemption listed in § 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 § 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 § 40.13(c) would
be issued only by the NRC, including for
those persons located in an Agreement
State, under a new provision § 40.52,
‘‘Certain items containing source
material; requirements for license to
apply or initially transfer.’’ Conditions
for the proposed § 40.52 licenses are
being proposed in a new provision
§ 40.53, ‘‘Conditions of licenses issued
under § 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
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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
§ 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 § 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 § 40.22 general license would
be issued under a new provision
§ 40.54, ‘‘Requirements for license to
initially transfer source material for use
under § 40.22.’’ Conditions for the
§ 40.54 licenses are being proposed in a
new section, § 40.55, ‘‘Conditions of
licenses issued under § 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
§ 40.31, ‘‘Application for specific
licenses,’’ and applicants would be
required to meet part or all of the
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provisions of § 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 § 40.13(c)(10) and § 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 § 40.22 general licensees
(with the exception of counterweights
for which this is included as a
constraint within the exemption in
§ 40.13(c)(5)). The regulations in § 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 § 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
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exemption or the § 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 § 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
§ 40.13(c)(10), which directs persons
seeking to distribute source material to
exempt persons, to the proposed new
§ 40.52. The proposed § 40.52 provides
conditions for approval of a license
application for initial distribution of
source material to exempt persons.
Additionally, the proposed § 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 § 40.53(c).
An initial distributor of products for use
under the exemption in § 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
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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
§ 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
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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 thoriumcontaining 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 § 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.
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‘‘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 § 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
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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 § 40.22(e) directs persons
seeking to distribute source material to
§ 40.22 general licensees to the
proposed new § 40.54. The proposed
§ 40.54 provides conditions for approval
of a license application for initial
distribution of source material to § 40.22
general licensees. Additionally, the
proposed § 40.55 contains a number of
conditions for initial distributors
including requirements for reporting
and recordkeeping, labeling, and
notifications.
The proposed rule would add
§ 40.55(d) and (e) to establish reporting
and recordkeeping requirements for
initial distributors of source material to
persons generally licensed under § 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
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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 § 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 § 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 § 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.
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In addition to reporting and
recordkeeping, there are a few
additional requirements being proposed
for distribution of material for use under
§ 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 § 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 § 40.34, which also
authorizes distribution to a category of
general licensees (those licensed under
§ 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 § 40.34.
A.4. Possession and Use of Source
Material under § 40.22
The NRC is proposing to revise
§ 40.22, ‘‘Small quantities of source
material,’’ in its entirety.
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Under the proposed § 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
§ 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
§ 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 § 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 § 40.22, that
had significant amounts of surface
contamination from source material.
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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 § 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 § 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 § 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
§ 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
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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 § 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 § 40.22(a)(1) is in a solid, nondispersible 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
§ 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 § 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.
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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 § 40.22(b) primarily
provides clarification of how existing
regulations apply to § 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 § 40.22(b)(2), the
NRC is clarifying disposal requirements
for source material possessed under
§ 40.22. Because § 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 § 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 § 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, nondispersible 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 § 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
§ 20.2001 (e.g., at an appropriately
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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 § 40.22 does not currently
exempt the general licensee from other
requirements in 10 CFR Part 40, the
NRC is proposing in § 40.22(b)(3) to
direct the general licensee’s attention to
other applicable sections of 10 CFR Part
40. Similarly, § 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 § 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 § 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 § 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
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with the NRC or a health physics
consultant.
In the proposed § 40.22(d), the NRC is
proposing to continue to exempt
persons generally licensed under § 40.22
from 10 CFR Parts 19, 20, and 21, with
the exceptions concerning disposal and
decommissioning in proposed
§ 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
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1980, because the industry appears to
have moved to using thorium as a thinfilm coating on the surface of lenses.
The NRC’s evaluation found that thinfilm 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 (μSv) 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
§ 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
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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 μSv (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 § 40.13(d): It is believed that fire
detection units containing source
material have not been manufactured for
commercial use; and
• For § 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 § 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
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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 § 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 § 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 § 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 § 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
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and mirrors through a proposed revision
to § 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
§ 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 § 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 § 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 § 20.1501 to ensure
that the limits in § 20.1402 are not
exceeded, in particular for those
licensees possessing source material
under the proposed § 40.22(a)(1)?
Would a requirement for such surveys
result in unnecessary expenses,
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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
§ 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 § 40.13
correct (i.e., are some products still
being manufactured at concentration
levels above the proposed concentration
limits)?
(5) In § 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 § 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 § 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 § 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
§ 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?
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(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 §§ 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 § 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 § 40.34(a)(2) be
reduced to 1 mSv (100 mrem) per year?
(4) Are there product exemptions in
§ 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 § 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.
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IV. Summary of Proposed Amendments
by Section
Section 30.6
Communications
10 CFR 30.6(b)(1)(iv)—Would add a
reference to new § 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 § 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.
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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
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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
§ 40.22 may not abandon source
material. The source material may be
transferred under § 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 nonsolid forms (e.g., is readily ingested or
inhaled) would be required to be in
accordance with § 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 § 40.22
must conduct activities so as to
minimize contamination of the facility
and the environment.
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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 § 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 §§ 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 § 40.13(c)
and equivalent provisions of Agreement
States.
Section 40.53 Conditions of Licenses
Issued Under § 40.52: Quality Control,
Labeling, and Records and Reports
10 CFR 40.53—Would establish
requirements for licenses issued under
§ 40.52, including reporting and
recordkeeping requirements for
distributions of products for use under
§ 40.13(c) and equivalent provisions of
Agreement States.
Section 40.54 Requirements for
License To Initially Transfer Source
Material for Use Under § 40.22
10 CFR 40.54—Would establish
requirements for a license authorizing
initial transfer or distribution for use
under § 40.22 and equivalent provisions
of Agreement States.
Section 40.55 Conditions of Licenses
Issued Under § 40.54: Quality Control,
Labeling, Safety Instructions, Records
and Reports
10 CFR 40.55—Would establish
requirements for licenses issued under
§ 40.54, including reporting and
recordkeeping requirements for
distributions of source material for use
under the general license in § 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 § 40.52 as a
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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
§ 40.22 and add §§ 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 https://www.nrc.gov/readingrm/doc-collections/managementdirectives/).
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
D .......................
D .......................
B .......................
B .......................
B .......................
B .......................
...........................
B .......................
B .......................
...........................
...........................
...........................
B .......................
...........................
...........................
...........................
D
D
B
B
B
B
B
*
B
B
B
B
B
B
B
B
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
Part 40
40.5 .....................................
40.8 .....................................
40.13(c) ...............................
40.13(c)(2)(i) ........................
40.13(c)(2)(iii) ......................
40.13(c)(7) ...........................
40.13(c)(10) .........................
40.13(d) ...............................
40.22(a) ...............................
40.22(a)(1) ...........................
40.22(a)(2) ...........................
40.22(a)(3) ...........................
40.22(b) ...............................
40.22(b)(1) ...........................
40.22(b)(2) ...........................
40.22(b)(3) ...........................
VerDate Mar<15>2010
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Amend ..............
Amend ..............
Amend ..............
Amend ..............
Amend ..............
Amend ..............
New ..................
Remove ............
Amend ..............
New ..................
New ..................
New ..................
Amend ..............
New ..................
New ..................
New ..................
Jkt 220001
Communications ...............................................................
Information collection requirements: OMB approval ........
Unimportant quantities of source material ........................
Unimportant quantities of source material ........................
Unimportant quantities of source material ........................
Unimportant quantities of source material ........................
Unimportant quantities of source material ........................
Unimportant quantities of source material ........................
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material (Previously 40.22(c))
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material ..................................
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Federal Register / Vol. 75, No. 142 / Monday, July 26, 2010 / Proposed Rules
DRAFT COMPATIBILITY TABLE FOR PROPOSED RULE DISTRIBUTION OF SOURCE MATERIAL TO EXEMPT PERSONS AND TO
GENERAL LICENSEES AND REVISION OF GENERAL LICENSE AND EXEMPTIONS—Continued
Compatibility
Section
Change
Subject
Existing
40.22(b)(4) ...........................
40.22(b)(5) ...........................
40.22(c) ...............................
40.22(d) ...............................
40.22(e) ...............................
40.52 ...................................
New ..................
New ..................
New ..................
Amend ..............
New ..................
New ..................
40.53 ...................................
New ..................
40.54 ...................................
New ..................
40.55(a) ...............................
New ..................
40.55(b) ...............................
New ..................
40.55(c) ...............................
New ..................
40.55(d) ...............................
New ..................
40.55(e) ...............................
New ..................
40.82 ...................................
Amend ..............
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material ..................................
Small quantities of source material (Previously 40.22(b))
Small quantities of source material ..................................
Certain items containing source material; requirements
for license to apply or initially transfer.
Conditions of licenses issued under § 40.52: Quality control, labeling, and records and reports.
Requirements for license to initially transfer source material for use under § 40.22.
Conditions of licenses issued under § 40.54: Quality control, labeling, safety instructions, and records and reports.
Conditions of licenses issued under § 40.54: Quality control, labeling, safety instructions, and records and reports.
Conditions of licenses issued under § 40.54: Quality control, labeling, safety instructions, and records and reports.
Conditions of licenses issued under § 40.54: Quality control, labeling, safety instructions, and records and reports.
Conditions of licenses issued under § 40.54: Quality control, labeling, safety instructions, and records and reports.
Criminal penalties .............................................................
New
...........................
...........................
...........................
B .......................
...........................
...........................
D
B
C
B
B
NRC
...........................
NRC
...........................
B
...........................
B
...........................
B
...........................
B
...........................
B
...........................
C
D .......................
D
D .......................
D
D .......................
D
D .......................
D
Part 70
70.5 .....................................
Amend ..............
Communications ...............................................................
Part 170
170.31 .................................
Amend ..............
Schedules of fees for materials licenses and other regulatory services, including inspections, and import and
export licenses.
Part 171
171.16 .................................
Amend ..............
Annual fees for materials licenses and other regulatory
services.
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
* 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),
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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
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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
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//www.regulations.gov under Docket ID
NRC–2009–0084.
a voluntary consensus standard is
identified for consideration, the
submittal should explain why the
standard should be used.
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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 § 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 § 40.22 primarily
provide additional limitations on, and
clarify the requirements of, the § 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
§ 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:
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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
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43439
persons exempt from the regulations or
for use under a general license in
§ 40.22. In addition, the Commission is
also proposing to modify the existing
possession and use requirements for
§ 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
§ 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 § 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 § 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: https://www.nrc.gov/public-involve/
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Federal Register / Vol. 75, No. 142 / Monday, July 26, 2010 / Proposed Rules
doc-comment/omb/ 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 https://
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.
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
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: Gary.Comfort@nrc.gov, or
Catherine Mattsen, telephone: (301)
415–6264, e-mail:
Catherine.Mattsen@nrc.gov, 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
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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 §§ 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
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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 § 30.6, paragraph (b)(1)(iv) is
revised to read as follows:
§ 30.6
Communications.
*
*
*
*
*
(b) * * *
(1) * * *
(iv) Distribution of products
containing radioactive material to
persons exempt under §§ 32.11 through
32.30 and § 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,
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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 § 40.5, paragraph (b)(1)(iv) is
revised to read as follows:
§ 40.5
Communications.
*
*
*
*
*
(b) * * *
(1) * * *
(iv) Distribution of products
containing radioactive material to
persons exempt under §§ 32.11 through
32.30 and § 40.52 of this chapter.
*
*
*
*
*
5. In § 40.8, paragraph (b) is revised to
read as follows:
§ 40.8 Information collection
requirements: OMB approval.
*
*
*
*
*
(b) The approved information
collection requirements contained in
this part appear in §§ 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 § 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:
§ 40.13 Unimportant quantities of source
material.
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*
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(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
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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
(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
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 § 40.13(c)(5)(i) in effect
on June 30, 1969.
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containing source material to persons
exempt under this paragraph (c), or
equivalent regulations of an Agreement
State, unless authorized by a license
issued under § 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
§ 40.52 for distribution only and are
exempt from the requirements of parts
19 and 20 of this chapter, and § 40.32(b)
and (c).
*
*
*
*
*
7. Section 40.22 is revised to read as
follows:
§ 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 nondispersible. 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
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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, nondispersible 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 § 20.2001 of
this chapter.
(3) Is subject to the provisions in
§§ 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 § 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
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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 § 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
§ 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 §§ 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 § 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 § 40.32, paragraph (f) is revised
to read as follows:
§ 40.32 General requirements for issuance
of a specific license.
*
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(f) The applicant satisfies any
applicable special requirements
contained in §§ 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:
§ 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 § 40.13(c) or to initially
transfer for sale or distribution any
products containing source material for
use under § 40.13(c) or equivalent
provisions of an Agreement State will be
approved if:
(a) The applicant satisfies the general
requirements specified in § 40.32.
However, the requirements of § 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
§ 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 § 40.13(c).
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§ 40.53 Conditions of licenses issued
under § 40.52: Quality control, labeling, and
records and reports.
section for 1 year after each transfer is
included in a report to the Commission.
(a) Each person licensed under § 40.52
must ensure that the quantities or
concentrations of source material do not
exceed any applicable limit in
§ 40.13(c).
(b) Each person licensed under
§ 40.52 must ensure that each product is
labeled as provided in the specific
exemption under § 40.13(c). Those
distributing products to be used under
§ 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
§ 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 § 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 § 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 § 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 § 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 § 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
§ 40.54 Requirements for license to
initially transfer source material for use
under § 40.22.
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An application for a specific license
to initially transfer source material for
use under § 40.22, or equivalent
regulations of an Agreement State, will
be approved if:
(a) The applicant satisfies the general
requirements specified in § 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.
§ 40.55 Conditions of licenses issued
under § 40.54: Quality control, labeling,
safety instructions, and records and
reports.
(a) Each person licensed under § 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
§ 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 § 40.54
must provide the information specified
in this paragraph to each person to
whom source material is transferred for
use under § 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 §§ 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
§ 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
§ 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
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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 § 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 § 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 § 40.82, paragraph (b) is revised
to read as follows:
§ 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: §§ 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,
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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 § 70.5, paragraph (b)(1)(iv) is
revised to read as follows:
§ 70.5
Communications.
*
*
*
*
*
(b) * * *
(1) * * *
(iv) Distribution of products
containing radioactive material to
persons exempt under §§ 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
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:
§ 170.31 Schedules of fees for materials
licenses and other regulatory services,
including inspections, and import and
export licenses.
*
*
*
*
*
13. The authority citation for part 170
continues to read as follows:
SCHEDULES OF MATERIALS FEES
[See footnotes at end of table]
Categories of materials licenses and types of fees 1
*
2. Source material.
*
*
*
Fee 1 2
*
*
*
*
*
*
*
*
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] ......................................................................................................................................
D. Licenses to distribute source material to persons generally licensed under part 40 of this chapter.
Application [Program Code(s): 11230 and 11231] ...................................................................................................................
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] ......................................................................................................................................
F. All other specific source material licenses.
Application [Program Code(s): 11200, 11220, 11221, 11300, 11800, 11810] .........................................................................
*
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*
*
*
*
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2,000
10,200
10,200
*
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 § 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 § 170.12(c).
(e) Generally licensed device registrations under 10 CFR 31.5. Submittals of registration information must be accompanied by the prescribed
fee.
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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
§ 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
§ 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 § 170.20.
15. The authority citation for part 171
continues to read as follows:
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).
Authority: Sec. 7601, Pub. L. 99–272, 100
Stat. 146, as amended by sec. 5601, Pub. L.
16. In § 171.16, the table in paragraph
(d) is amended by redesignating
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
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:
§ 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 1 2 3
Category of materials licenses
*
2. Source Material.
*
*
*
*
*
*
*
*
*
*
*
C. Licenses to distribute items containing source 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 generally licensed under part 40 of this chapter [Program Code(s): 11230
and 11231] ....................................................................................................................................................................................
E. Licenses for possession and use of source material 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. [Program Code(s): 11200, 11220, 11221, 11300, 11800, 11810] ..........................
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
*
*
*
*
*
*
*
*
$10,000
5,000
21,100
21,100
*
1Annual 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
§ 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.
3Each FY, fees for these materials licenses will be calculated and assessed in accordance with § 171.13 and will be published in the FEDERAL
REGISTER for notice and comment.
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*
*
Federal Register / Vol. 75, No. 142 / Monday, July 26, 2010 / Proposed Rules
*
*
*
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
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Part 9
[Docket No. TTB–2010–0003; Notice No.
107; Re: Notice No.105]
RIN 1513–AB41
Proposed Establishment of the Pine
Mountain-Mayacmas Viticultural Area;
Comment Period Extension
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking;
extension of comment period.
AGENCY:
In response to a request from
a viticulture industry group, we are
extending the comment period for
Notice No. 105, Proposed Establishment
of the Pine Mountain-Mayacmas
Viticultural Area, a notice of proposed
rulemaking published in the Federal
Register on May 27, 2010, for an
additional 45 days.
DATES: Written comments on Notice No.
105 are now due or before September 9,
2010.
ADDRESSES: You may send comments on
this notice to one of the following
addresses:
• https://www.regulations.gov: Use the
comment form for this notice as posted
within Docket No. TTB–2010–0003 on
‘‘Regulations.gov,’’ the Federal erulemaking portal, to submit comments
via the Internet;
• Mail: Director, Regulations and
Rulings Division, Alcohol and Tobacco
Tax and Trade Bureau, P.O. Box 14412,
Washington, DC 20044–4412.
• Hand Delivery/Courier in Lieu of
Mail: Alcohol and Tobacco Tax and
Trade Bureau, 1310 G Street, NW., Suite
200–E, Washington, DC 20005.
See the ‘‘Public Participation’’ section
of this notice for specific instructions
and requirements for submitting
comments, and for information on how
to request a public hearing.
You may view copies of this notice,
the original notice of proposed
rulemaking (Notice No. 105), selected
supporting materials, and any
wwoods2 on DSK1DXX6B1PROD with PROPOSALS_PART 1
SUMMARY:
VerDate Mar<15>2010
15:19 Jul 23, 2010
Jkt 220001
comments we receive about the
proposed establishment of the Pine
Mountain-Mayacmas viticultural area
within Docket No. TTB–2010–0003 at
https://www.regulations.gov. A direct
link to this docket is posted on the TTB
Web site at https://www.ttb.gov/wine/
wine-rulemaking.shtml under Notice
No. 105. You also may view copies of
this notice, all supporting materials, and
any comments we receive about this
proposal by appointment at the TTB
Information Resource Center, 1310 G
Street, NW., Washington, DC 20220.
Please call 202–453–2270 to make an
appointment.
FOR FURTHER INFORMATION CONTACT: N.A.
Sutton, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
Trade Bureau, 925 Lakeville St., No.
158, Petaluma, CA 94952; phone 415–
271–1254.
SUPPLEMENTARY INFORMATION: TTB
received a petition from Sara Schorske
of Compliance Service of American,
prepared and filed on her own behalf
and that of local wine industry members
to establish the 4,600-acre Pine
Mountain-Mayacmas viticultural area in
northern California. About two-thirds of
the proposed viticultural area lies in the
extreme southern portion of Mendocino
County, with the remaining one-third
located in the extreme northern portion
of Sonoma County.
The proposed Pine MountainMayacmas viticultural area is totally
within the multicounty North Coast
viticultural area (27 CFR 9.30) and it
overlaps the northernmost portions of
the established Alexander Valley
viticultural area (27 CFR 9.53) and the
Northern Sonoma viticultural area
(27 CFR 9.70).
In Notice No. 105 published in the
Federal Register (75 FR 29682) on
Thursday, May 27, 2010, we described
the petitioners’ rationale for the
proposed establishment of the Pine
Mountain-Mayacmas viticultural area
and requested comments on the
proposal on or before July 26, 2010.
On July 16, 2010, we received a letter
request from attorney Richard
Mendelson on behalf of the Napa Valley
Vintners (NVV), a wine industry trade
association. The request explained that
due to the periodic scheduling of the
NVV’s committee and board of directors
meetings, the group would be unable to
meet the original July 26, 2010,
comment deadline for Notice No. 105.
The letter therefore requested a 45-day
extension to the comment period for
Notice No. 105 to allow the NVV to
complete and thoroughly vet its
comments on the proposed viticultural
area.
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In response to this request we extend
the comment period for Notice No. 105
an additional 45 days. Therefore, the
comments on Notice No. 105 are now
due on or before September 9, 2010.
Drafting Information
Michael Hoover of the Regulations
and Rulings Division drafted this notice.
Signed: July 20, 2010.
John J. Manfreda,
Administrator.
[FR Doc. 2010–18177 Filed 7–23–10; 8:45 am]
BILLING CODE 4810–31–P
DEPARTMENT OF JUSTICE
28 CFR Part 35
[CRT Docket No. 111]
RIN 1190–AA62
Nondiscrimination on the Basis of
Disability in State and Local
Government Services; Accessibility of
Next Generation 9-1-1
Department of Justice, Civil
Rights Division.
ACTION: Advance notice of proposed
rulemaking.
AGENCY:
The Department of Justice
(Department) is considering revising the
regulation implementing title II of the
Americans with Disabilities Act (ADA)
to address in what manner public
entities that operate 9-1-1 call-taking
centers (also known as Public Safety
Answering Points (PSAPs)) should be
required to make changes in
telecommunication technology to reflect
developments that have occurred since
the publication of the Department’s
1991 regulation. Under its existing title
II regulation, the Department requires
that PSAPs provide direct, equal access
to telephone emergency centers for
individuals with disabilities who use
analog text telephones (TTYs).1 Many
individuals with disabilities now use
the Internet and wireless text devices as
their primary modes of
telecommunications. At the same time,
PSAPs are considering and planning to
shift from analog telecommunications
technology to new Internet-Protocol
(IP)-enabled Next Generation 9-1-1
services (NG 9-1-1) that will provide
voice and data (such as text, pictures,
and video) capabilities. This ANPRM
seeks information on possible revisions
to the Department’s regulation to ensure
SUMMARY:
1 TTYs are also known as ‘‘telecommunications
devices for the deaf’’ (TDDs).
E:\FR\FM\26JYP1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Proposed Rules]
[Pages 43425-43446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18223]
========================================================================
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.
========================================================================
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.
-----------------------------------------------------------------------
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 https://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 Carol.Gallager@nrc.gov.
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: Rulemaking.Comments@nrc.gov. 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: Gary.Comfort@nrc.gov, 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: Catherine.Mattsen@nrc.gov.
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 https://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 https://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
PDR.Resource@nrc.gov.
Federal Rulemaking Web Site: Public comments and supporting
materials related to this proposed rule can be found at https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
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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
