[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32310-32343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12570]
[[Page 32309]]
Vol. 78
Wednesday,
No. 103
May 29, 2013
Part II
Nuclear Regulatory Commission
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10 CFR Parts 30, 40, 70, et al.
Distribution of Source Material to Exempt Persons and to General
Licensees and Revision of General License and Exemptions; Final Rule
Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules
and Regulations
[[Page 32310]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 40, 70, 170, and 171
[NRC-2009-0084]
RIN 3150-AH15
Distribution of Source Material to Exempt Persons and to General
Licensees and Revision of General License and Exemptions
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending its
regulations to require that the initial distribution of source material
to exempt persons or to general licensees be explicitly authorized by a
specific license, which includes new reporting requirements. The rule
is intended to provide the NRC with timely information on the types and
quantities of source material distributed for use either under
exemption or by general licensees. In addition, the rule modifies 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 rule revises,
clarifies, or deletes certain source material exemptions from licensing
to make the exemptions more risk informed. This rule affects
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: Effective Date: This final rule is effective on August 27, 2013.
ADDRESSES: Please refer to Docket ID NRC-2009-0084 when contacting the
NRC about the availability of information for this final rule. You may
access information and comment submittals related to this final
rulemaking, which the NRC possesses and is publicly available, by the
following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0084. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: [email protected]. For technical questions, contact
the individual(s) listed in the FOR FURTHER INFORMATION CONTACT section
of this final rule.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly-available documents online in the NRC
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. The ADAMS accession number
for each document referenced in this document (if that document is
available in ADAMS) is provided the first time that a document is
referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
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, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Introduction
B. Regulatory Framework
C. Why are revisions to 10 CFR Part 40 considered necessary?
II. Discussion
A. What action is the NRC taking?
B. Whom will this action affect?
C. When do these actions become effective?
D. In what situations do I now need a license?
E. With whom do I apply for a specific license?
F. What guidance is available for the rule?
III. Summary and Analysis of Public Comments on the Proposed Rule
A. Changes to the Small Quantities of Source Material General
License (Sec. 40.22)
B. Distribution of Source Material for Possession Under a
Product Exemption
C. Distribution of Source Material for Possession Under the
General License
D. Exemptions
E. Fees
F. Miscellaneous
G. Future Rulemaking Considerations
IV. Discussion of Final Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Writing
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
XIV. Congressional Review Act
I. Background
A. Introduction
Source material is regulated by the NRC under part 40 of Title 10
of the Code of Federal Regulations (10 CFR), ``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 the general license
and various exemptions in order to better evaluate potential impacts to
public health and safety.
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\1\ U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry. ``ToxFAQsTM for
Uranium,'' 1999.
\2\ U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry. ``ToxFAQs TM for
Thorium,'' 1999.
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The last major modification of 10 CFR part 40 occurred in 1961 and
established licensing procedures, terms, and conditions for source
material that were substantially similar to those set forth, at the
time, in 10 CFR part 30, ``Licensing of Byproduct Material.'' Since
then, the health and safety requirements in 10 CFR part 20, ``Standards
for Protection Against Radiation,'' have been revised. In particular,
radiation dose limits for individual members of the public were
significantly reduced in the revision to 10 CFR part 20. In addition,
training and other requirements have been moved and revised from an
earlier version of 10 CFR part 20 into 10 CFR part 19, ``Notices,
Instructions and Reports to Workers: Inspection and Investigations.''
Although the requirements in 10 CFR part 30 have been revised to
address the changes to the health and safety requirements in 10 CFR
part 20 and the training requirements in 10 CFR part 19, these changed
standards have generally not been addressed with respect to the use of
source material in 10 CFR part 40.
In the 1990s, the NRC conducted a reevaluation of the exemptions
from licensing for byproduct and source material in the NRC's
regulations. The
[[Page 32311]]
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 or byproduct material under the exemptions from licensing.
Many products containing source material used under an exemption from
licensing present the potential for higher exposures under routine use
conditions than products containing byproduct material used under an
exemption because of differences in allowed forms and uses; however,
risks from accidents are generally smaller for products containing
source material. Although containment is a key to safety for many
products containing byproduct material, containment is generally less
important for products containing source material because of the low
specific activity of the source material contained in such products.
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\3\ See http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1717/.
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In 1999, the State of Colorado and the Organization of Agreement
States (the petitioners) submitted a petition for rulemaking, PRM-40-27
(ADAMS Accession No. ML082261305), which stated their concerns
regarding potential exposures to persons using source material under
the general license in 10 CFR 40.22, ``Small quantities of source
material.'' The NRC published a notice of receipt of this petition on
July 7, 1999 (64 FR 36615), and noticed the resolution and closure of
the petition on September 10, 2009 (74 FR 46512). The petitioners
requested that the exemption for these general licensees from 10 CFR
parts 19 and 20 be restricted such that any licensee that has the
potential to exceed 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 from 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 apply to most other licensees.
In order to evaluate potential impacts of the current limits in
Sec. 40.22, the NRC tried to collect additional information on the use
of source material under the general license. However, although the NRC
had identified six persons distributing source material to Sec. 40.22
general licensees in the mid-1980's, the NRC was able to identify only
one 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 its evaluation and documented its 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) (ADAMS Accession No. ML070750105). The PNNL 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. In this study, PNNL developed and evaluated bounding
scenarios for the use of source material under the general license in
Sec. 40.22. The results suggested that reasonable scenarios exist for
uses under the general license that could result in potential doses
that can exceed 1 millisievert (mSv) per year (100 millirem (mrem) per
year) to workers or members of the public. However, the available
information was found to be limited and may not be representative of
all current, 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 (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 NRC. Exemptions are
provided in situations where there is minimal risk to public health and
safety and allow the end user 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 40.13, ``Unimportant quantities of source material,'' sets
forth several exemptions from the licensing requirements for source
material. Some products containing uranium or thorium, now covered by
the exemptions from licensing in 10 CFR part 40, were in use before the
originally enacted Atomic Energy Act of 1946. Exemptions for the
possession and use of many of these products were included in
regulations noticed on March 20, 1947 (12 FR 1855). 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. Unlike the regulations for the
distribution of byproduct material, the regulations contained in 10 CFR
part 40 do not include requirements to report how much source material
is distributed in the form of products for use under the exemptions
from licensing.
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
[[Page 32312]]
general licenses do include reporting requirements for transfers of
source material.
Section 40.22 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 by any one general licensee
in any calendar year. Section 40.22 general licensees are exempt from
the provisions of 10 CFR parts 19 and 20 and 10 CFR part 21,
``Reporting of Defects and Noncompliance,'' 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 NRC. Unlike the regulations for the distribution
of byproduct material, 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 who, how, or in what quantities persons are using source
material under this general license.
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,
``Application for specific licenses,'' and general requirements for
issuance of a specific license are found in Sec. 40.32, ``General
requirements for issuance of specific licenses.'' Terms and conditions
of licenses are contained in Sec. 40.41, ``Terms and conditions of
licenses.'' With the exception of the requirements found in Sec. Sec.
40.34, ``Special requirements for issuance of specific licenses,'' and
40.35, ``Conditions of specific licenses issued pursuant to Sec.
40.34,'' 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, ``General license for use of certain industrial
products or devices,'' and the broad transfer authorizations contained
in Sec. 40.51, ``Transfer of source or byproduct material,'' 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?
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 for 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 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 ``Schedule I: Exempted Product,'' in the original issuance
of Title 11 of the Code of Federal Regulations part 40, ``Control of
Source Material,'' in 1947.\4\ These exemptions essentially
accommodated existing practice at that time without any consideration
about 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),\5\ the NRC has periodically
evaluated potential doses from exempt products to ensure that the
exposure from any individual exempt product does 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
significantly impact public health and safety. However, because the NRC
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.
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\4\ In 1949, the regulations for atomic energy activities were
moved to Title 10.
\5\ On October 14, 2011, the Commission published a proposed
revision to this policy (76 FR 63957). It does not present
significant changes; rather, it is a general updating of the current
policy. This updated version has not yet been finalized.
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As previously stated, 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 provided 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 will 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 that some source material product exemptions
are obsolete and that certain products are no longer manufactured at
the upper limits allowed under Sec. 40.13(c). As a result, the NRC
concludes that it is preferable to remove an unused exemption 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 and whether Sec. 40.13(c)(7) should
be revised to clarify this issue.
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 and 20. The exemption was based upon the known uses of
source material 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 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
[[Page 32313]]
19 were expanded. This combination of events has led to the recognition
that some general licensees could expose workers to levels above 1 mSv
(100 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 and 20. 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 the Sec.
40.22 general license should be revised to make it consistent with
current training requirements and public health and safety standards,
as set forth in 10 CFR parts 19 and 20.
Another issue of concern is that the current Sec. 40.22 general
license allows persons to obtain 15 lb (6.8 kg) of uranium or thorium
in any form, including separated isotopes of natural uranium or thorium
that meet the definition of source material. Specifically, thorium-228
(Th-228) has a high specific activity such that 15 lb of Th-228 could
potentially result in a dose in excess of dose limits in 10 CFR part
20, and as a result, would normally require controls under other NRC
regulations. Thus, although Th-228 is not normally commercially
available in such quantities, the NRC has concluded that persons should
not be allowed to obtain quantities of Th-228 or other naturally-
occurring separated isotopes of uranium and thorium (excluding depleted
uranium) under the general license. Instead, persons desiring to
possess such isotopes (other than depleted uranium) must obtain a
specific license prior to possession.
II. Discussion
A. What action is the NRC taking?
The NRC is adding 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 final rule also makes 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 for the Distribution of Source Material
The NRC is adding two new provisions, Sec. Sec. 40.13(c)(10) and
40.22(e), which 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, without authorization by a specific license.
New reporting requirements associated with these specific licenses will
allow the NRC to track the amount and types of source material being
distributed to those persons. Other new requirements will allow the NRC
to better ensure that products for use under exemption are manufactured
and distributed within the constraints of the exemptions, and that
general licensees have a better understanding of their responsibilities
under the regulations.
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 continue to be allowed without the need to obtain a specific
license authorizing such transfers.
Because new Sec. 40.13(c)(10), in conjunction with Sec. 40.52,
requires a specific license authorizing initial transfers, 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) will no longer
be allowed to operate under the general license and, instead, needs to
obtain a specific license under this final rule.
In response to public comments concerning the possibility of an
analytical laboratory operating under a general license and the
potential unintended consequences and costs to both the laboratory and
clients, the final rule excludes transfers to or from analytical
laboratories from being required to be made under a specific license
for distribution. The NRC expects that such transfers would normally
involve small quantities and would not provide useful information on
use or amounts of source material being distributed in general. The
process for obtaining a specific license to distribute source material
is expected to be relatively straightforward.
Applications for specific licenses for distribution are made
through the provisions of Sec. 40.31 and an applicant is required to
meet the applicable provisions of Sec. 40.32. Under both Sec. Sec.
40.13(c)(10) and 40.22(e), an initial distributor is allowed to
continue distribution of products or materials containing source
material without a specific license for 1 year beyond the effective
date of this rule. Additionally, if an application for a specific
license (or license amendment, in the case of an existing NRC specific
licensee) has been submitted within 1 year of the effective date of
this rule, the applicant will be allowed to continue their
distributions until the NRC takes final action on the application.
A.2 Distribution of Products to Persons Exempt From Regulation
A specific license for the initial distribution of products for use
under an exemption listed in Sec. 40.13(c) may only be issued by the
NRC, including for those persons located in an Agreement State. This
license will be issued under a new provision Sec. 40.52, ``Certain
items containing source material; requirements for license to apply or
initially transfer.'' Conditions for Sec. 40.52 licenses are added in
a new provision in Sec. 40.53, ``Conditions of licenses issued for
initial transfer of certain items containing source material: Quality
control, labeling, and records and reports.''
In 10 CFR 150.15(a)(6), the NRC retains the authority to license
the initial transfer of materials containing source 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 source material
is also wholly reserved to the NRC by Sec. 150.15(a)(2). Thus, a
[[Page 32314]]
distributor, whether a manufacturer or an importer, that is located in
an Agreement State and involved in the initial transfer of materials or
products containing source material to exempt persons, requires
authority to distribute such material from the NRC. This NRC license is
in addition to any Agreement State license that may be required for
possession or use of the source material in the Agreement State.
Because the Agreement State continues to license possession and use
and, therefore, the health and safety of such activities, a person
initially distributing source material is exempted by the NRC from
meeting the requirements of 10 CFR parts 19 and 20.
Importers of products containing source material that meets the
requirements for possession under an exemption also need a specific
license for initial distribution under this final rule. If the importer
does not modify the product in a manner inconsistent with the
applicable exemption(s), the importer is exempt from the requirements
in 10 CFR parts 19 and 20--this is different than the existing
regulations governing the initial transfer of byproduct material, which
do not provide an exemption from 10 CFR parts 19 and 20 for importers
of finished products containing byproduct material. The exemption from
10 CFR parts 19 and 20 for importers of finished products is included,
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 by the final rule, required to obtain a
specific license for distribution. Importers of finished products are
not expected to process or modify the products under the distribution
license (except as would be expected under the normal use of the
product as allowed by the conditions of the exemption). Persons
processing or modifying the products must be authorized by a specific
license for possession and use and are not entitled to the exemption
from 10 CFR parts 19 and 20, if they are under the NRC's jurisdiction.
The new Sec. 40.52 provides conditions for approval of a license
application for initial distribution of source material to exempt
persons. Additionally, Sec. 40.53 contains a number of conditions for
initial distributors including requirements for reporting and
recordkeeping, quality control, and labeling.
For example, the new reporting and recordkeeping requirements in
Sec. 40.53(c) require an initial distributor of products for use under
an exemption in Sec. 40.13(c) to submit a report, by January 31 of
each year, regarding transfers made in the previous calendar year. The
report must identify the distributor and indicate what products, types
of source material and amounts, and the number of units distributed.
The data collected by virtue of the new requirements will provide
the NRC with a more accurate and complete representation of source
material distributed to the public for use under the exemptions in
Sec. 40.13(c). This will allow the NRC to recognize trends in
distribution that could alter earlier estimates of doses to workers and
to members of the public. This information will also provide a better
basis for considering future regulatory changes in this area and in
allocating the NRC's resources. The data collected through the final
reporting requirements will also aid in confirming that routine
exposures to the public from all sources controlled by the NRC remain
unlikely to exceed 1 mSv (100 mrem) per year.
These 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 previously been
required; however, this information is expected to be available because
of basic business recordkeeping practices. If detailed information is
not readily available for this first report, a best estimate for the
whole calendar year will be acceptable.
In addition to reporting and recordkeeping, there are a few
additional requirements being added for initial distribution of
products for use under exemption. The new requirements help to ensure
that products being distributed are within the quantity or
concentration limits for those exemptions that include such limits and
that the products are properly labeled as currently required by the
existing conditions in the exemptions. In addition, the new Sec.
40.52(b)(4) requires distributors to propose a method of labeling or
marking each unit and/or its container with information that identifies
the manufacturer or initial distributor of the product and the type of
source material in the product. In accordance with Sec. 40.53(b), the
proposed method of labeling must satisfy any exemption-specific
labeling requirements.
In NUREG-1717, certain products containing source material and used
under an exemption from licensing (e.g., welding rods and gas mantles)
were identified as having the potential for routine exposures that are
higher than is generally acceptable for use under an exemption.
However, the use of source material in many of these products has
significantly declined, being replaced by rare earth compounds, such as
lanthanum and yttrium. For example, the routine use of thorium
contained in welding rods and gas mantles is becoming less likely and
typical exposures to users is likely less than previously estimated. At
the same time, exposures can be limited by a user who is properly
informed concerning the inherent risks of exposures and methods for
reducing exposure. Thus, rather than eliminate these exemptions, the
NRC is requiring distributors of gas mantles and welding rods
containing thorium for use under the exemptions in Sec. 40.13(c)(1)(i)
and (iii), respectively, to include safe handling instructions along
with the distributed product.
The expected information to be provided in an application, as
required by Sec. 40.52, and in reports, as required in Sec. 40.53, is
described in general terms because of its applicability to a broad
range of industries and, therefore, different industries may be
required to provide different details dependent upon their individual
businesses. The exact information to be provided may be discussed with
the NRC during development of an application with the intent that the
information provided will be adequate for the NRC to ensure that
products being distributed are within the limits of the exemption and
will provide the NRC with reasonable approximations of the types and
number of products being distributed and what kinds and amounts of
source material are in those products.
New fee categories and initial fee amounts for this new specific
license type are added as revisions to Sec. Sec. 170.31 and 171.16.
There is a category for distribution and a separate category for
manufacturing or processing. Applicants and licensees under the new
licensing provision Sec. 40.52 fall 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'' in both sections (the current 2.C. ``All
other source material licenses'' is redesignated as 2.F. by this rule).
This new fee category applies to all initial distributors of products
containing source material for use under Sec. 40.13(c). The fee
associated with this category is 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. However,
[[Page 32315]]
persons located in Agreement States may be subject to separate fees set
forth by the Agreement State for the manufacture and processing of such
products. This is similar to the breakdown of fees for manufacturers
and distributors of exempt byproduct material. The initial fees
associated with the distribution aspect of licensing for source
material are lower than those related to distribution of products
containing byproduct material to exempt persons, because this rule adds
more limited requirements applicable to the distribution aspect of
licensing for source material. Initial fee amounts for the 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 is 2.E.,
``Licenses for possession and use of source material for processing or
manufacturing of products or materials containing source material for
commercial distribution'' in Sec. Sec. 170.31 and 171.16. This fee
category is not applicable to persons located in Agreement States,
although the Agreement State may impose their own fees for this
category. The fees for this new category are $5,400 for an application
and $12,400 for the annual fee and are the same as those for the
current category 2.C., ``All other source material licenses.'' As
stated in the proposed rule, these fees have been revised from those in
the proposed rule to be consistent with the current category 2.C. fees.
After the implementation of this rule, the fee amounts for these
new categories will 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 review impact 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 that
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. It should be noted that under Sec. 171.16(c), a
licensee who is required to pay an annual fee may qualify as a small
entity. If a licensee qualifies as a small entity and provides the NRC
with the proper certification along with its annual fee payment, the
maximum annual fee would be currently limited to $500 or $2,300,
depending on the size of the entity.
A.3. Conditions for the Distribution of Source Material to General
Licensees
Unlike the specific license for the distribution of source material
to an exempt person, a specific license for the initial distribution of
products or materials for use under the Sec. 40.22 general license may
be issued by the NRC or, for persons located in an Agreement State, by
the Agreement State. For licenses issued by the NRC, a specific license
for the initial distribution of source material for use under the Sec.
40.22 general license will be issued under a new provision in Sec.
40.54, ``Requirements for license to initially transfer source material
for use under the `small quantities of source material' general
license.'' Conditions for the Sec. 40.54 licenses are added in a new
section, Sec. 40.55, ``Conditions of licenses to initially transfer
source material for use under the `small quantities of source material'
general license: Quality control, labeling, safety instructions, and
records and reports.'' Section 40.54 provides conditions for approval
of a license application for the initial distribution of source
material to Sec. 40.22 general licensees. Additionally, Sec. 40.55
contains a number of conditions for initial distributors including
requirements for reporting and recordkeeping, labeling, and
notifications.
The final rule adds 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 requires that all initial
transfers be reported to the NRC annually by January 31. Additionally,
the distributor must also provide a separate report, annually by
January 31, to each Agreement State (see http://nrc-stp.ornl.gov/asdirectory.html for Agreement State contact information) to which the
distributor initially transfers source material to a general licensee.
The reports cover transfers of source material completed in the
previous calendar year. The reports will 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 will be required to report the total quantity of source
material distributed each calendar year, including any transfers of
less than 50 g (0.11 lb) made to any person during the calendar year.
The reporting requirements, when also applied to distributors in
Agreement States by those States, will help the NRC and the Agreement
States identify Sec. 40.22 general licensees using larger quantities
of source material. This will enable the NRC and the Agreement States
to better communicate with or inspect these general licensees, if
necessary, to ensure that public and worker health and safety is
adequately protected. The NRC will 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
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
will still not be reported.
Records of the initial transfer of source material for use under
Sec. 40.22 are required to be retained for 1 year after inclusion in a
report to the NRC 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 record
retention requirements for transfers of generally licensed devices in
byproduct material regulations. For generally licensed devices
containing byproduct material, longer record retention is appropriate
because of the possible need for tracking particular devices if generic
defects were identified.
These 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 will be
acceptable.
In addition to reporting and recordkeeping, there are a few
requirements being added for distribution of material for use under
Sec. 40.22 and equivalent Agreement State provisions. The new
requirements
[[Page 32316]]
primarily require the licensee to ensure that the quantity or
concentration of material is as labeled. The initial distributors are
required to provide to their customers copies of key relevant
regulations and radiation safety precautions and instructions to help
minimize exposures. Requiring initial distributors to provide copies of
such regulations makes 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 added as revisions to Sec. Sec. 170.31 and 171.16. The
applicants and licensees under the new licensing provision Sec. 40.54
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,'' in both sections. Initial fee amounts are as
follows: $2,000 for an application; $5,000 for the annual fee. These
applicants and licensees are also subject to the 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,'' in Sec. Sec. 170.31 and 171.16. As
discussed in section II.A.2 of this document, the initial fee amounts
for this category are equal to the fee for current fee category 2.C. at
the time this rule is made effective. These fee amounts will
subsequently be revised in accordance with applicable NRC policy and
procedures.
The NRC 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 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, 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
Section Sec. 40.22, ``Small quantities of source material,'' is
revised in its entirety. Under revised Sec. 40.22(a), the general
license is limited to thorium and uranium in their natural isotopic
concentrations and depleted uranium. This differs from the previous
Sec. 40.22(a), which allowed possession of any naturally occurring
isotopes of uranium and thorium in any isotopic concentration. In
particular, Th-228, when isotopically separated, has the potential to
present significantly higher doses because of its higher specific
activity. The current provisions of Sec. 40.22 may allow a person to
receive quantities large enough in terms of activity to present a
security concern without obtaining a specific license. The revised
general license limits uranium and thorium to their natural isotopic
concentrations or as depleted uranium to ensure that persons could not
obtain significant quantities of high-specific activity source material
in an isotopically separated form without the authorization and safety
controls provided by a specific license.
Under the revised Sec. 40.22(a)(1), the general licensee is
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. A material is considered to be in a
dispersible form if it can be readily ingested or inhaled (e.g., in a
gaseous, liquid, or powder form) in normal or accidental situations or
if it is processed in a manner such that the material containing source
material is physically or chemically changed. Under the previous
general license, assurance of safety was based primarily on two
limiting conditions: (1) The amount of source material that could be
used at any one time, and (2) the amount of source material that could
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. Both PRM-40-27 and the PNNL study suggest that situations could
occur where the general licensee exceeded 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 or
possession of source material 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. The petitioners indicated that resultant exposures for
the source material contamination were above the dose limits allowed to
members of the public in 10 CFR part 20 and were possibly as high as 1
rem (10 mSv) per year.
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 NRC expects that the 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 new limits in Sec. 40.22(a)(1) are intended to reduce the
likelihood that a person operating under the general license will
exceed dose limitations in 10 CFR part 20, and criteria in 10 CFR parts
19 and 20, that would normally require additional controls if the
person were specifically licensed. Based upon the bounding dose
calculations in the PNNL study, the NRC expects the reduction in the
possession and throughput limits will significantly decrease the
potential for a worker to be exposed at levels exceeding 1 mSv (100
mrem) per year. The reduction in possession and throughput limits also
reduces the likelihood that a person will exceed the chemical toxicity
limits for soluble uranium in Sec. 20.1201(e) that would normally
apply to an NRC specific licensee. 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) will be also be reduced. By
reducing the amount of source material that is available for inhalation
and ingestion, the NRC has concluded that the exemptions to 10 CFR
parts 19 and 20 continue to be acceptable. The exemption to 10 CFR part
21 also continues to apply, because 10 CFR part 21 addresses concerns
that are unlikely to arise under Sec. 40.22.
[[Page 32317]]
Under the final rule, 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,
are required to obtain a specific license if they cannot reduce their
possession and use of the source material to below the new limits. As a
change from the proposed rule, in Sec. 40.22(a)(1), a person requiring
a specific license because of the reduction in possession limits has up
to 1 year to apply for such license or reduce their possession of
source material to below the new limits in Sec. 40.22(a)(1). A person
who decides not to apply for a specific license has additional time (up
to the end of the calendar year following the effective date of the
final rule) to reduce their throughput so that they are not affected by
a mid-year change in a calendar year limit. A person applying for a new
possession license is allowed to operate at the previous, higher
possession limits until such license application is acted on by the
NRC. This allows persons who require a specific license for initial
distribution (if currently operating under the general license) to
continue to possess and process source material while action on their
license application is pending. It is expected that only a small number
of persons currently possessing and using source material under the
existing general license will be required to obtain a specific license
for continued use of the source material as a result of the reduction
in possession limits in Sec. 40.22(a)(1). The NRC expects that most
persons possessing source material above the limits in Sec.
40.22(a)(1) are likely manufacturing products for use under exemption
and, thus, will already be required to obtain a specific license under
the new distribution requirements in Sec. 40.52.
Under the new Sec. 40.22(a)(2), the general licensee is allowed to
possess up to a total of 7 kg (15.4 lb) total uranium and thorium at
any one time--this limit must include any inventory of source material
possessed under Sec. 40.22(a)(1). Any source material possessed in
excess of the limits in Sec. 40.22(a)(1) must be 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 by the general licensee. The
licensee is limited to the receipt of no more than 70 kg (154 lb) of
uranium and thorium per calendar year under Sec. 40.22(a)(2),
including the inventory of source material possessed under Sec.
40.22(a)(1). If the licensee does physically or chemically alter the
solid source material, that altered source material must 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 new 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.
The rule language of Sec. 40.22(a)(1) and (2) was revised in
response to comments received on the proposed rule and to better
clarify the new requirements. The intent and limits of the requirements
stated in the proposed rule were not changed by the final rule.
Under Sec. 40.22(a)(3), persons treating drinking water by
removing uranium for the primary purpose of meeting U.S. Environmental
Protection Agency regulations 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 will
adequately contain the uranium and are not expected to result in
unacceptable exposures to workers. 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
are not impacted by changes in possession limits, they are required to
meet the other requirements of the final rule. However, these persons
continue to have multiple options for operating within the NRC's
regulations, including operation under a specific license.
In response to public comments concerning the possible use of the
general license by analytical laboratories and the potential unintended
impacts of the proposed changes to their activities, a new paragraph
(a)(4) has been added to Sec. 40.22 in the final rule. This new
paragraph allows laboratories operating under the general license to
continue to receive, possess, use, and transfer up to 7 kg (15.4 lb) of
source material at one time, and to process no more than 70 kg (154 lb)
of source material per calendar year, for the purpose of determining
the concentration of the uranium and thorium contained within the
material; however, the constraint that this material be in its natural
isotopic concentrations or in the form of depleted uranium is included.
It is expected that these analytical laboratories deal with a number of
hazardous chemicals and likely have procedures that would limit the
likelihood of inadvertent exposures from the source material as well as
the hazardous chemicals normally used. In addition, under the revised
definition of ``unrefined and unprocessed ore,'' a laboratory is
allowed to analyze an unlimited amount of source material that meets
the conditions of the exemption in Sec. 40.13(b).
The revised Sec. 40.22(b) primarily provides clarification of how
existing regulations apply to Sec. 40.22 general licensees. Paragraph
(b)(1) in Sec. 40.22 restates an existing requirement prohibiting the
administration of source material to humans, unless authorized by a
specific license.
Under the revised 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 might infer that disposal of source
material by these general licensees may be exempt from regulation
because 10 CFR part 20 includes requirements for waste disposal.
However, there is no exemption from Sec. 40.51, which includes
transfer provisions for licensees (including general licensees) and
thus disposal opportunities under the general license are limited to
only those persons authorized to receive the source material. In Sec.
40.22(b)(2)(i), the NRC is specifically prohibiting abandonment of
source material, but allowing 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 is
still required to meet the applicable regulations of other agencies
regarding such disposals. The NRC concludes that such small quantities
will allow general licensees who normally only possess very small
quantities of source material at one time (e.g., uranyl acetate at
educational institutions) to more economically dispose of the source
material and will result in minimal impact to public health and safety
because its form limits the ingestion and inhalation of the source
material. The person receiving source material transferred under the
[[Page 32318]]
provisions of Sec. 40.22(b)(2)(i) is not 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 are 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 adding 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
exportation of source material.
Additionally, 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 new condition in Sec. 40.22(b)(4) obligates general licensees to
respond to the NRC's written requests for information within 30 days or
as otherwise specified in the request.
As identified in PRM-40-27, contamination may be 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, that a
licensee might abandon significant amounts of source material in place.
This abandonment could result in other persons that later inhabit the
facility unknowingly exposing their workers or others to the source
material contamination. As a result, the new Sec. 40.22(c) requires
the general licensee to minimize contamination at the site and ensure
that the site is cleaned up so as to be protective of future worker and
public health and safety. If the general licensee identifies evidence
that there may be significant contamination, the licensee is required
to notify the NRC and may consult with the NRC as to the
appropriateness of sampling and restoration activities. The goal of
this requirement is to reduce the likelihood that any remaining
contamination would have the potential to result in the 25 mrem (0.25
mSv) limits in Sec. 20.1401 being exceeded. The NRC expects a licensee
to identify a concern about significant contamination based on both
visual inspection (i.e., particulates remaining from operations) and
operational and historical data (e.g., operations often resulted in
airborne or dispersed particulates or there were history of spills,
etc.). If there is any doubt as to whether remaining contamination may
be considered significant, the licensee should consult with the NRC or
a health physics consultant.
In Sec. 40.22(d), the NRC continues to exempt persons generally
licensed under Sec. 40.22 from 10 CFR parts 19, 20, and 21, with the
exceptions concerning disposal and decommissioning in revised Sec.
40.22(b)(2) and (c). In addition, the NRC revised this exemption such
that it no longer applies to any NRC specific licensee; in the current
regulation only 10 CFR part 40 specific licensees are excluded. This
modification is expected to provide minimal impact to specific
licensees who possess source material under the general license,
because they are already subject to 10 CFR parts 19, 20, and 21 for
other licensed materials.
A.5 Revision of Exemption for Thorium Lenses
Paragraph (c)(7) in Sec. 40.13 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 homogeneously spread throughout the lens. This
position was restated in the statement of considerations (SOC) for a
1977 proposed rule, ``General License for Government Agencies'
Operational Use of Small Quantities of Source Material,'' (42 FR 43983;
September 1, 1977). In that SOC, the NRC confirmed that the exemption
in Sec. 40.13(c)(7) was not intended to be applicable to coated lenses
because the thorium was not evenly distributed in the finished lens.
The SOC for final rule (42 FR 61853; December 7, 1977), did not change
the position that the exemption applied only to thorium that is
homogeneously spread throughout the lens.
In the past, the categorization of coated lenses was not a major
concern, because such lenses could be possessed under the Sec. 40.22
general license, which currently works similarly to an exemption.
Because of the increased usage of coated lenses along with the planned
new requirements introduced for the Sec. 40.22 general license and for
initial distribution, the categorization of coated lenses has become
more important.
To clarify the regulatory status of these coated lenses and to
address coatings on mirrors, the final rule makes three changes to the
existing exemption: (1) It expands the exemption to include source
material in or on finished coated lenses and mirrors; (2) it reduces
the source material limit from 30 percent by weight to 10 percent by
weight for products distributed in the future; and (3) it expands the
exemption to include uranium. The remaining limitations on use 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 less than 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 1980, because
the industry appears to have moved to using thorium as a thin-film
coating on the surface of lenses. The NRC's evaluation found that thin-
film coated lenses contain a significantly lower total mass of thorium
than that generally found in the same size homogeneous lenses. In
addition, the NRC has learned that certain lens manufacturers also use
thorium in combination with uranium to achieve desired properties.
Although a coated lens does not contain the source material
homogeneously within the lens (as is the case with lenses that may
currently be possessed under the exemption), the PNNL study indicated
that doses from both normal and accident conditions from lenses coated
with either or both uranium and thorium were estimated to be well below
10 microsievert ([mu]Sv) per year (1 mrem per year). As a result, the
NRC is expanding the exemption to include lenses, as well as mirrors,
with thin-film coatings and to also apply the exemption to lenses and
mirrors containing uranium. The NRC's expectation is that the source
material will be fixed onto the lens or mirror and not readily removed
from the surface. The exemption prohibits, and will continue to
prohibit, shaping, grinding, polishing, and any other manufacturing
process other than assembling the finished lens into an optical system
or device.
The final rule also revises Sec. 40.13(c)(7) to limit the source
material
[[Page 32319]]
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 will 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 (c)(2)(iii) in Sec. 40.13 exempts glassware containing
up to 10 percent source material by weight. Although the estimated
doses associated with this exemption are acceptable, the benefit from
this use of source material is limited to achieving a unique color and
glow in the glassware. Such glassware has been used in products such as
dinnerware and toys. This use of source material might be considered
frivolous, which is not in keeping with the policy of the Commission
with regard to consumer products. However, this use predates the AEA,
has been ongoing for decades, and continues today. Current
manufacturing is relatively limited, and the concentration in any
recently produced items appears to be less than 2 percent source
material (uranium). The one remaining NRC-licensed manufacturer for
glassware containing source material maintains concentration in its
products to within 1 percent by weight uranium. This rule limits
products manufactured in the future to no more than 2 percent by weight
source material. This will have minimal impact on the industry, limited
to any costs associated with ensuring and documenting that products do
not exceed this limit. It will ensure that doses to members of the
public exposed to products distributed for use under this exemption in
the future would be unlikely to exceed 10 [mu]Sv (1 mrem) per year.
This is more appropriate for products with minimal societal benefit and
is consistent with the concept of as low as reasonably achievable
(ALARA).
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 deleting exemptions for products that are no longer
being used or manufactured, and is restricting further distribution
while allowing for the continued possession and use of previously
distributed items. The various products covered by the individual
exemptions are described in NUREG-1717. Two of the conclusions in that
report concerning distribution are:
For Sec. 40.13(d): It is believed that fire detection
units containing source material have not been manufactured for
commercial use; and
For Sec. 40.13(c)(2)(i): The exemption for ceramic
tableware containing source material could result in significant doses,
which might be of concern, if used as one's every day dinnerware.
Although the exemption in Sec. 40.13(d) is removed, in the event
that persons possess products covered by this provision, this action
does not change the regulatory status of any products previously
manufactured in conformance with the provisions of the regulations
applicable at that time. In the case of ceramic tableware, the final
rule limits the exemption to previously manufactured products. This
action provides assurance that health and safety are adequately
protected from possible future distribution. Preliminary estimates
indicated a potential for exposures higher than is appropriate for
radioactive material being used under an exemption. However, exposures
for the ceramic tableware were estimated using particularly
conservative assumptions for routine use as everyday dinnerware, rather
than the more typical use as a collectable.
Deleting the provision in Sec. 40.13(d) simplifies the regulations
by eliminating extraneous text. Also, the NRC 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 adds to the assurance that future use of products in these
categories will not contribute to exposures of the public and also
eliminates the need to reassess the potential exposure of the public
from possible future distributions of these products.
There are other products covered by the exemptions in Sec.
40.13(c) for which distribution is very limited and may have ceased;
however, without the new distributor requirements, it is difficult to
confirm whether any distribution continues. This risk-based approach to
exemptions is in line with the strategic plan of the NRC.
A.8 Revision of Definition of ``Unrefined and unprocessed ore,'' as
Used in Sec. 40.13(b)
Based upon comments received regarding the transfer of source
material samples to laboratories, the NRC has included a clarifying
amendment to the definition of ``Unrefined and unprocessed ore'' in
Sec. 40.4, ``Definitions,'' in the final rule to indicate that
activities related to the sample analysis of an unprocessed ore and a
few other specified activities are not considered to be processing and
that the ore would remain exempt under Sec. 40.13(b). This amendment
alleviates potential violations where a laboratory may unexpectedly
identify source material in an unprocessed ore that would normally
require licensing but the laboratory does not already have a license
for the unexpected source material; instead, the laboratory may treat
the processed sample as unprocessed ore under the exemption in Sec.
40.13(b). This change is consistent with section 65 of the AEA, which
states that ``reports shall not be required with respect to (a) any
source material prior to its removal from its place of deposit in
nature, or (b) . . . or the reporting of which will discourage
independent prospection for new deposits.'' The other examples of
activities not considered to be processing, i.e., sieving or
encapsulation of ore, are activities that were not considered when this
definition was initially established. Sieving is considered to be a
simple mechanical technique for separating particles of different sizes
in an ore where the actual physical particles themselves are not
modified (e.g., separating rocks from sand). Encapsulation would be an
activity in which the unprocessed ore is coated, for example with glass
or polyurethane, but again, the ore itself is not physically or
chemically changed.
A.9 Other Revisions
Minor clarifying changes and administrative corrections have been
made to rule language text from that found in the published proposed
rule language.
B. Whom will this action affect?
This final rule will affect manufacturers and distributors of
certain products and materials containing source material, and persons
[[Page 32320]]
using source material under the general license in Sec. 40.22. Certain
persons initially transferring source material to exempt persons or
general licensees will be required to obtain a specific license for
such distribution. Certain persons currently possessing a general
license under Sec. 40.22 may be required to obtain a specific license
for the continued possession and use of source material if they cannot
adapt their operations to the new possession limits or if they
initially transfer products containing source material. The final rule
exempts persons who possess thorium or uranium coated lenses or mirrors
from licensing requirements for those lenses and mirrors through a
revision to Sec. 40.13(c)(7).
C. When do these actions become effective?
The regulations in this final rule become effective August 27,
2013. However, persons requiring a new license for initial distribution
have up to 1 year from this date to apply for a new specific license or
discontinue such distributions. Similarly, persons in possession of
source material in excess of the limits in Sec. 40.22(a)(1) have up to
1 year from this date to apply for a specific license for possession
with the previous throughput limit applying until action is taken by
NRC on their license application. If they choose not to apply for a
license, they have through December 31, 2014, to reduce the quantity of
source material under their possession to below the new limits.
D. In what situations do I now need a license?
The new requirements in this rule require a person to obtain a
specific license in three situations: (1) If the person is an initial
distributor of source material to another person for use under an
exemption in Sec. 40.13(c); (2) if the person is an initial
distributor of source material to another person for use under the
general license in Sec. 40.22; or (3) if the person possesses and uses
source material in excess of the new limits in Sec. 40.22(a)(1) and
the source material is in a dispersible form or the material is
processed such that it modifies the material's physical or chemical
form. Normally a person requiring a specific license for initial
distribution will also be required to obtain a specific license for
possession and use of the source material.
E. With whom do I apply for a specific license?
For any activity requiring a specific license associated with the
use of source material, persons located in a State under the NRC's
jurisdiction are required to apply for the specific license in
accordance with the requirements in Sec. 40.31. Persons located in
Agreement States are required to apply for possession and use licenses
from the Agreement State in which they are located; however, persons
located in an Agreement State who are initially distributing products
containing source material for use under the exemptions in Sec.
40.13(c) are also required to apply to the NRC for a specific license,
authorizing the initial distribution of those products, in accordance
with the requirements in Sec. 40.31 (and specifically Sec. 40.52 in
this case).
F. What guidance is available for the rule?
The NRC is issuing interim guidance for the implementation of the
revised requirements of 10 CFR part 40. A notice of the public
availability of the interim guidance will be published in the Federal
Register within the next 2 weeks. The interim guidance, ``Guidance for
Implementation of the Final Rule, `Distribution of Source Material to
Exempt Persons and to General Licensees and Revision of General License
and Exemptions,' in 10 CFR parts 30, 40, 70, 170, and 171'' (ADAMS
Accession No. ML13051A824), may be obtained through the Federal
Rulemaking Web site, www.regulations.gov, by searching on Docket ID
NRC-2011-0003 or through ADAMS, when it is publically available.
The interim guidance will be reflected in the next updates of
NUREG-1556, Vol. 8, ``Consolidated Guidance About Materials Licenses:
Program-Specific Guidance About Exempt Distribution Licenses,'' and
NUREG-1556, Vol. 16, ``Consolidated Guidance About Materials Licenses:
Program-Specific Guidance About Licenses Authorizing Distribution to
General Licenses.'' These two documents will contain the final guidance
for the rule and will be published for comment after they are revised.
III. Summary and Analysis of Public Comments on the Proposed Rule
The proposed rule was published on July 26, 2010 (75 FR 43425), for
a 75-day public comment period that ended on November 23, 2010. The NRC
published an extension notice on November 18, 2010 (75 FR 70618), that
extended the public comment period until February 15, 2011, to allow
time to review proposed implementation guidance that was announced on
January 7, 2011 (76 FR 1100). The NRC received 15 comment submittals
from 10 organizations and individuals. The commenters on the proposed
rule included an individual, a radiation safety officer from a
university, an Agreement State, and representatives of industry
organizations and individual companies. Copies of the public comments
can be accessed using any of the methods provided in the ADDRESSES
section of this document. In general, all commenters opposed one or
more aspects of the rulemaking. One commenter requested significant
revision or withdrawal of the rule. Two commenters voiced concerns that
the impacts of the rule will be widespread and more significant than
the NRC envisions. One commenter did state that the process for initial
licensing appears the same as that in place for exempt byproduct
material, and that that process has worked well. The comments and
responses have been grouped into the following areas: (a) Changes to
the small quantities of source material general license (Sec. 40.22);
(b) distribution of source material for possession under a product
exemption; (c) distribution of source material for possession under the
general license; (d) exemptions; (e) fees; (f) miscellaneous; and (g)
future rulemaking considerations. To the extent possible, all of the
comments on a particular subject are grouped together. In the notice of
proposed rulemaking, the NRC also specifically requested input on a
variety of subjects. These questions are identified within the related
response group, along with any comments received on the question. A
discussion of the comments and the NRC staff's responses follow.
A. Changes to the Small Quantities of Source Material General License
(Sec. 40.22)
A.1 Definition of ``Person''
Comment: One commenter stated that the NRC issues the general
license to organizations but places the quantity limitations under 10
CFR 40.22(a)(1) & (2) on ``a person.'' The commenter stated that Sec.
20.1003 defines a person as ``[a]ny individual, corporation,
partnership, firm, association, trust, estate, public or private
institution, group . . . and any legal successor, representative,
agent, or agency of the foregoing.'' The commenter suggested that if an
organization can treat an ``individual'' as the general licensee rather
than the organization itself, it would greatly reduce the potential
problem of needing to obtain a specific license.
Response: Although the term ``person'' is used in these paragraphs
of the general license and the definition of ``person'' identified by
the commenter is
[[Page 32321]]
the same definition as that included in Sec. 40.4, the applicability
of the general license is limited to ``commercial and industrial firms;
research, educational, and medical institutions; and Federal, State,
and local government agencies,'' which is a subset of ``person.'' The
1960 SOC for the proposed rule to revise 10 CFR part 40 (25 FR 8619;
September 7, 1960), specifically identified the classes of users under
the general license and stated that ``[i]ndividual members of the
general public therefore would not be generally licensed.'' Although
the identified class of users has changed since that time, the general
license authorized specific classes of users that still do not include
individual members of the general public. However, a ``person'' under
Sec. 40.22 is not necessarily the largest entity in a class of user.
The SOC for a 1977 final rule (42 FR 61853; December 7, 1977), amending
Sec. 40.22 stated ``[m]oreover, in order to permit the greatest
flexibility in use of small quantities of source material under the
general license, the rule does not restrict application of the general
license to the largest unit in any class of person specified.'' The SOC
further states, ``this general license is applicable to any size unit,
other than individuals, which is physically separate from other units.
The purpose of the physical separation is to make it unlikely that more
than 15 lb of source material could be brought together in a single
location.'' Therefore, it is not appropriate to consider each
individual in an organization as a separate general licensee. However,
the NRC has normally considered separate facilities operated by the
same entity to be separate general licensees, even if both facilities
are in different parts of the same city.
A.2 Restriction to Only Naturally Occurring Isotopic Concentrations and
Depleted Uranium
Comment: One commenter stated that by definition, the term ``source
material'' as applied to uranium, already only includes natural uranium
and depleted uranium. The commenter stated that the definition of
``special nuclear material'' effectively removed two isotopes (U-233
and U-235) from being source material. Similarly, the commenter stated
that there are only 3 isotopes of uranium found in nature (U-234, U-
235, and U-238) and that 11 other isotopes are only manufactured as a
product of reactions occurring in nuclear reactors or accelerator
produced and should thus be considered byproduct material.
Response: After review, the NRC agrees that uranium (other than
that deemed special nuclear material) yielded from reactions in a
nuclear reactor or that is accelerator produced should be considered to
be ``byproduct material'' (under Section 11e.(1) and (3) of the AEA);
this would also be true for isotopes of thorium yielded in a nuclear
reactor or that are accelerator produced. Historically, the few persons
that have possessed these separated isotopes of uranium and thorium
have held a specific license for both byproduct and source material
that did not segregate the two types of materials and so a distinction
was not necessary. Although the definition of ``source material'' by
itself would appear to leave little question that any isotope of
uranium or thorium would be considered to be source material, Section
62 of the AEA discusses requirements for licensing source material as
beginning ``after removal from its place in nature.'' As isotopes of
uranium and thorium yielded in a reactor or from an accelerator are not
obtained from nature, the NRC believes that the intent of the AEA was
for these isotopes to be considered byproduct material. However, the
text of the final revision of Sec. 40.22(a) remains as proposed
because Th-228 is still considered to be source material and could be
possessed under the general license, if Sec. 40.22(a) were not revised
in this way. In addition, because of the past ambiguity related to this
issue, the revision would make it clear that these isotopes cannot be
possessed under the general license in Sec. 40.22.
The notice of proposed rulemaking included a specific request for
comment on whether the limitation to natural or depleted uranium and
natural thorium is the most appropriate way to prevent persons from
obtaining source material radionuclides with high specific activities
without applying for a specific license. In addition the specific
request for comment asked if this approach would adequately protect
public health and safety from, for example, thorium-230 (Th-230)
extracted from ore high in uranium content.
Comment: One commenter indicated that the proposed description
appeared adequate while a second commenter asked, relative to the
example case regarding the potential use of Th-230 extracted from
``high grade uranium ores'' for some nefarious activity, if the NRC had
any evidence that the toxicity of this isotope, a secular equilibrium
daughter of U-238, is a significant health hazard at any concentration.
The second commenter also stated that the benefit from developing
uranium ore bodies to support nuclear power generation far outweighs
the risk of terrorists utilizing a pure alpha emitter as a weapon of
mass destruction. In addition, the second commenter stated that it
should be noted that currently unlimited quantities of one percent
solutions of both natural thorium and natural uranium analytical metal
standards may be purchased by non licensed facilities.
Response: The restriction of the general license to natural and
depleted uranium and natural thorium will have no impact to the
development of ore bodies. The question concerned whether this
limitation was adequate to control both safety and security concerns
with the possible high concentration of Th-230 relative to Th-232
normally dominant in natural thorium. The specific activity of Th-230
is higher than the specific activity of Th-232 or natural thorium, by
roughly five orders of magnitude. Because of its low concentrations in
ore, the NRC is not particularly concerned about Th-230 when contained
within ores or ore wastes. However, as Th-230 could be independently
separated from natural uranium and still be considered to be in its
natural isotopic concentration, persons could potentially possess
enough Th-230 under the general license to cause significant exposures.
The NRC is currently not aware of any instances of this practice and
believes that there is minimal probability of such occurring.
The statement about one percent solutions being available to non-
licensed facilities is incorrect. These materials are likely being
obtained and possessed under the Sec. 40.22 general license and the
revisions to 10 CFR part 40 will not change this. As there has been
little communication with this category of general licensees in the
past, and a person does not have to apply for a license, many persons
are not aware of their general license status and may, instead,
incorrectly infer that the material is possessed under exemption. Under
the final rule, persons initially distributing source material for
possession and use under the Sec. 40.22 general license will be
required to provide copies of the applicable regulations to their
customers to inform the recipient about the requirements of the general
license.
A.3 New Possession Limits
Comment: One commenter recommended that based on the general
license being limited to only naturally occurring isotopes and depleted
uranium, that there was no risk basis to lower the possession limits
under the general license. The commenter argued that the primary human
health issue
[[Page 32322]]
with natural or depleted uranium is chemical toxicity and not
radiological toxicity, making uranium's primary toxicological hazard no
different than that of other heavy metals. The commenter supported its
arguments with a reference to ``Toxicological Profile for Uranium,''
(U.S. Department of Health and Human Services, Public Health Service
Agency for Toxic Substances and Disease Registry; September 1999), with
a supporting quote indicating that ``uranium is a chemical substance
that is also radioactive'' and ``no human cancer of any type has ever
been seen as a result of exposure to natural or depleted uranium.'' The
commenter also supported its argument by indicating that the chemical
toxicity limits for uranium in Sec. 20.1201(e) provided a lower limit
than the limits established based on radiologic toxicity provided in 10
CFR part 20, appendix B, Table 1 for natural uranium and fully depleted
uranium (U-238). The commenter indicated that these additional
restrictions on uranium are not necessary and are being driven more by
perceived radiological risk than real chemical risks. Similarly, the
commenter added that NRC's concerns about thorium should be alleviated
by the proposal to only allow natural isotopic concentrations of
thorium under the general license without requiring the possession
limits to be lowered, because natural thorium is predominantly Th-232,
which has a very low specific activity.
Response: The commenter is correct that the NRC's regulations
provide multiple limitations for source material in 10 CFR part 20,
including toxicity limits in Sec. 20.1201(e) and inhalation and
ingestion limits based on radiological impacts in Table B of 10 CFR
part 20. However, the current and revised Sec. 40.22 both exempt the
licensee from these requirements and instead institute the quantity
possession limit. The additional chemical risks add to the reasons for
better controlling quantities of materials in a readily inhalable or
ingestible form. If the inhalation and ingestion limits in Table B were
implemented for general licensees instead of the current quantity
limit, a licensee would be expected to incur additional costs and
possibly be required to meet numerous other requirements in 10 CFR
parts 19 and 20 that they are currently exempt from because the
inhalation and ingestion limits in Table B are based on occupational
exposures. For example, a licensee would likely need to meet the
requirements in Sec. 19.12, ``Instructions to workers,'' to be
consistent with NRC's health and safety protections to better protect
workers who may exceed exposures of 100 mrem (1 mSv) per year. Because
the regulation continues to exempt the licensee from the requirements
in 10 CFR part 19, the NRC concluded that it is best to limit potential
exposures to the extent possible below which instruction would normally
be required by Sec. 19.12. Additionally, if the limits in Table B were
applied, the licensee would need to purchase appropriate monitoring
equipment and likely need to obtain the services of a health physicist
to ensure that the limits are being met. The reduced possession limits
also help to ensure that general licensees will not exceed the chemical
toxicity limit in Sec. 20.1201(e). The PNNL report used reasonable
assumptions based on 150 lb of uranium being received in a calendar
year in their scenarios; using these same assumptions for uranium
intake, the NRC has concluded that the weekly average inhalation levels
of uranium should be below the limit in Sec. 20.1201(e) for uranium.
The reduction in the possession and throughput for dispersible source
material further reduce the chance of this limit being exceeded without
having to require more elaborate monitoring that may be required if the
limit in Sec. 20.1201(e) were used instead as a control. Finally, the
lowered limits were also chosen to limit the likelihood of large
amounts of contamination being left behind by a general licensee, which
could result in a later property owner unknowingly exposing his
employees to the radiological contamination.
Comment: Four commenters identified potential impacts on industries
from the proposed reduction in possession limits. One of these
commenters indicated that chemical suppliers routinely sell uranium and
thorium compounds in quantities of 25 to 250 g and, in the past, sales
of quantities of 500 g were not unusual, thus it would be easy for
universities or large institutions with many laboratories to quickly
exceed the new possession limits. Another of these commenters voiced
concern that their customers may be modifying exempt products under the
provision of the general license, but may no longer be able to do so
under the reduced limits in the proposed Sec. 40.22(a)(1) limits. Two
of these commenters also indicated that it would be difficult for
analytical laboratories and their customers who rely on the current
general license to stay within the new limits, thus potentially driving
up industry costs. One of these commenters indicated that the
restrictions on the end user seemed rather harsh and would be very
limiting for research and steel industry users, as well as
manufacturers of various ceramic valves and coatings for the steel
industry and manufacturers of metal halide lamps.
Response: The records that were voluntarily provided by the largest
supplier of generally licensed thorium and uranium identified by the
NRC showed that relatively few general licensees were receiving
quantities near the existing limits, and that many were receiving much
lower amounts. The revised regulations will allow a person to possess
up to 1.5 kg (3.3 lb) of uranium and thorium in any form. A monthly
transfer of 500 g (1.1 lb) would not reach the throughput limit of 7 kg
(15.4 lb). Most general licensees with a significant throughput that
exceeds the new limit are very likely manufacturers of products or
distributors that would be required to obtain a specific license
because of other provisions in the final rule. In practice, some
general licensees who use uranium and thorium in the form of ore
(considered by definition to be source material in its entirety) will
actually see allowable possession limits significantly increase under
the final rule because they only need to account for the mass of the
uranium and thorium itself rather than the ore mass. In addition, the
final rule includes a provision specifically for analytical
laboratories, which essentially maintains the limits, in order to
reduce unforeseen impacts on that particular category of user.
Comment: One commenter stated concerns that while the inventory
reduction in Sec. 40.22(a)(1) from 15 lb to 3.3 lb was a 78 percent
reduction, the reduction in the annual receipt limit from 150 lb to
15.4 lb was a 90 percent reduction. The commenter indicated that the
reason for this discrepancy was unclear and that to be consistent the
NRC should only reduce the annual usage threshold to 33 lb in the
proposed Sec. 40.22(a)(1).
Response: There is no historical record of a specific rationale for
the ratio; therefore, maintaining the ratio of quantity limit to
throughput limit was not considered to be important in establishing the
criteria for the revised rule. For readily inhalable or ingestible
materials, intake and contamination likelihoods are typically more
related to throughput than the maximum quantity of source material
present at any one time. On the other hand, external hazards are more
directly related to the quantity present. As a result, the NRC
concluded that the greater reduction in
[[Page 32323]]
the annual throughput level for dispersible source material was
merited. The new limits were developed using the bounding doses
calculated in the PNNL study by reducing possession limits by a factor
that would limit the likelihood that a person could possess source
materials in quantities that would result in doses exceeding 100 mrem
(1 mSv) per yr. Additionally, activities involving larger throughput
are generally going to involve distribution, which will be required to
be done under the authorization of a specific license under the final
rule; as a result, the NRC expects that only a few persons will be
directly impacted by the reduction in possession limits.
A.4 Clarification of Chemical or Physical Form
Comment: One commenter requested clarification of what would
constitute chemical, physical, or metallurgical treatment or
processing. The commenter provided an example that some of its
customers using thoriated tungsten alloys under Sec. 40.13(c)(4) may
very well perform some sort of physical operation on the piece (e.g.,
machining, heat treatment, welding, etc.), which would appear to
invalidate the Sec. 40.13(c)(4) exemption. However, the amount of
thorium sold to those end users typically meets the current definition
of small quantities in Sec. 40.22, thus they do not require a specific
license. The commenter recommended that, in order for users of source
material under Sec. 40.13(c)(4) and Sec. 40.22(a)(2) to better
understand the limitations on the use of source material under these
paragraphs, that the NRC provide a clear definition in Sec. 40.4 of
``altering chemical or physical form'' and ``chemical, physical, or
metallurgical treatment or processing.''
Response: Although the rule is not amending Sec. 40.13(c)(4), as
the commenter indicated, Sec. 40.13(c)(4) does not authorize the
chemical, physical or metallurgical treatment or processing of a
product possessed under the exemption, similar to the constraint
proposed in Sec. 40.22(a)(2). Under this exemption, an activity such
as machining or heat treatment, where the primary purpose of the action
is to modify the product, is not allowed; however, welding the final
product to another component would be acceptable even though there
might be slight modifications of the product while installing it as
intended. As also indicated by the commenter, these activities could be
accomplished under the general license in Sec. 40.22; however, the
resulting products, if distributed for further use under the exemption
in Sec. 40.13(c)(4) or another exemption, would require the person
modifying the product to obtain a Sec. 40.52 distribution license
because it would be considered to be the initial distribution of a new
product. If the person physically or chemically modified the material
containing source material under Sec. 40.22 but does not plan to
distribute the new product for use under an exemption, the person would
be subject to the lower possession limits found in Sec. 40.22(a)(1)
because they actively processed the source material. The NRC believes
these restrictions are necessary because chemically or physically
processing material containing source material may increase the
likelihood of some source material entering into forms that could be
more easily ingested or inhaled. If the person were allowed to modify
the exempt product without restriction, the person could create
unanalyzed health and safety issues for his workers or the public
(particularly in the form of accumulated contamination that may be more
easily ingested or inhaled). Rather than broadly restricting these
modifications, the NRC could instead implement limits on inhalation and
ingestion to prevent exposures; however, such requirements would likely
introduce additional costs in the form of air monitoring equipment and
the need for a health physicist. As a result, the NRC concluded that
limiting possession limits by use (chemical or physical alteration)
would be easier and less costly for the general licensee to identify
when the lower limits were necessary. The NRC has also concluded that
the terms ``altering chemical or physical form'' and ``chemical,
physical, or metallurgical treatment or processing'' are sufficiently
clear and do not require a specific definition in Sec. 40.4.
A.5 Disposal of Source Material Under General License
Comment: One commenter requested clarification as to whether the
disposal limit of 0.5 kg (1.1 lb) of source material proposed in Sec.
40.22(b)(2)(i) applies to just the uranium or thorium content or to the
material that contains the uranium and thorium.
Response: The limit is intended to account for only the mass of the
uranium and thorium and not the material that contains the source
material.
Comment: One commenter stated that the proposed disposal limit of
1.1 lb, only in a non-dispersible form, was very restrictive. The
commenter indicated that most users would have to resort to expensive
disposal options as a result of the rulemaking, including certain
government agencies that collect this material from schools and labs
for disposal.
Response: Unrestricted disposal of source material was never
specifically permitted under the Sec. 40.22 general license. Although
Sec. 40.22 provided an exemption to the requirements in 10 CFR part
20, a general licensee was still required to make transfers in
accordance with Sec. 40.51, which requires the transfer be to someone
authorized to receive the source material. The revised Sec. 40.22
clarifies the disposal requirements and adds an allowance for very
small quantities. As a result, schools and laboratories should be able
to do direct disposal of their very small quantities of source material
rather than requiring state government agencies to collect the source
material. There are no restrictions in the general license that prevent
the possessor from modifying the form of the source material to place
it into a solid form or other appropriate form for the chosen disposal
pathway.
In the notice of proposed rulemaking, the NRC proposed in Sec.
40.22(b)(2)(i) that quantities of source material greater than 0.5 kg
(1.1 lb) per year would be required to be disposed of as radioactive
material through the provisions of Sec. 20.2001 or transferred to
another person otherwise authorized to receive the source material. The
notice of proposed rulemaking asked if the NRC should 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 following comments were
provided in response to this question:
Comment: One commenter recommended that given the low radioactivity
of source material, the NRC should consider a wide variety of disposal
options. These options already include disposal in sanitary sewers and
could also include uranium mill tailings impoundments, processing as
alternative feed, and other types of disposal sites that can safely
contain the material. A different commenter recommended that the NRC
should establish guidelines for municipal landfills to accept naturally
occurring radioactive material (NORM), not covered by the AEA, and
certain forms of source material and byproduct material based on a
combination of mass and activity.
Response: Many of the suggested disposal alternatives have been
used to dispose of source material from specific licensees, after
receiving authorization
[[Page 32324]]
from the NRC, including disposal at Resource Conservation and Recovery
Act subtitle C facilities. The general licensee may request approval
for alternative disposals under Sec. 20.2002, ``Method for obtaining
approval of proposed disposal procedures.''
With the exception of source material and discrete sources of
radium-226, all other NORM is currently not subject to the NRC's
regulations. The NRC can only exempt persons from the requirements of
NRC's regulations, including those regulations related to specific
disposal requirements for radioactive material, if the material under
consideration is subject to the NRC's jurisdiction. Local jurisdictions
have separate authorities that may come into play that may limit the
disposal of materials containing source material (and other radioactive
materials) at municipal landfills or other locations.
A.6 Contamination Control
In the notice of proposed rulemaking, the NRC requested specific
comments on whether the NRC should require general licensees to
complete surveys in accordance with the provisions of Sec. 20.1501 to
ensure that the limits in Sec. 20.1402 are not exceeded.
Comment: One commenter indicated that the enforcement aspects of
the rulemaking needed to be further explored because the proposed
requirement in Sec. 40.22(c) had no enforcement value whatsoever. The
commenter indicated that because there is no requirement to possess or
use survey instruments, much less perform a closeout survey, most
general licensees may be long gone before any contamination is located
by authorities. The commenter recommended that if the proposed
possession limit poses a significant enough contamination hazard, the
source material should not be allowed to be possessed under a general
license and should instead be required to be possessed under a specific
license.
Response: The NRC is hesitant to require all users of source
material to formally survey their locations upon cessation of
activities because many persons likely conduct activities with source
material where there is little concern regarding contamination. The
intent of the requirements in Sec. 40.22(c) are to allow a general
licensee to consult with the regulator to determine if surveys are
necessary. Under the regulations currently in place, there are no clear
requirements for a general licensee to take any decommissioning action
because of the current exemption to the requirements in 10 CFR part 20.
Although the NRC could limit operations under the general license such
that contamination is unlikely by limiting the use of source material
to only non-dispersible forms and not allowing any processing, such
limitations would significantly reduce the benefit of the general
license while increasing the costs to licensees who would then require
a specific license. The NRC has concluded that the reduced possession
limits will satisfactorily limit most contamination concerns while the
requirements proposed in Sec. 40.22(c) will allow the regulator to
have a specific regulation to enforce in rare circumstances where
contamination is detected. As a result, the NRC concluded that no
changes to the proposed version of Sec. 40.22(c) are necessary.
A.7 Initial Distribution and Transfer Under Sec. 40.22(e)
Comment: Two commenters stated concerns about the requirement
proposed in Sec. 40.22(e) that a person, initially transferring or
distributing source material to a person receiving the source material
under the general license in Sec. 40.22, would be required to obtain a
specific license for distribution under the proposed Sec. 40.54. Their
concerns were focused on transfers of samples containing source
material to analytical laboratories. One of these commenters also
voiced concerns about the potential impact on calibrators using
depleted uranium sources. The commenter was concerned that calibrators
may encounter additional problems or expense obtaining calibration
sources because organizations that distribute calibration disks made of
depleted uranium under a general license would be required to obtain a
specific license increasing costs to calibrators. The same commenter
was also concerned that laboratories that provide standards for use
under the general license would also be required to obtain a specific
license for distribution thus increasing costs for their customers. The
second commenter requested clarification on whether a driller
identifying uranium ore deposits would require a specific license to
distribute samples for analytical characterization. Both commenters
believed this requirement could have significant impacts on the persons
exploring for and mining uranium and that it could increase costs to
their customers or deal a ``death warrant'' to exploration.
Response: The NRC acknowledges that some persons operating under
the Sec. 40.22 general license and their customers may have increased
costs as a result of needing to obtain a specific license for
distribution of their products, including calibration sources. However,
the NRC has concluded that the benefit of being able to identify who is
distributing source material, and how much material is being
distributed, outweighs those increased costs, because it will allow the
NRC to better ensure that the products do not significantly impact
public health and safety.
The NRC acknowledges that the proposed rule would have resulted in
an unclear situation concerning the transfer of analytical samples to
and/from laboratories, particularly in relation to sampling ores where
the source material content level would not be known until the sample
is analyzed. Although no laboratories provided comment on the proposed
rule, other commenters indicated that some analytical laboratories may
currently operate under a general license rather than a specific
license and thus a person providing samples to the laboratory may need
a distribution license under the proposed requirements. In addition, a
laboratory operating under a specific license that returns samples to a
general licensee would also have been required to obtain a distribution
license under the proposed requirements. The NRC agrees that this would
be overly burdensome for those parties and has revised the final rule
to maintain the current limits for laboratories doing sample analyses
by creating a separate provision for laboratories in Sec. 40.22(b).
The NRC concluded that reporting such common transfers would not
provide sufficient benefit versus the burden associated with obtaining
a specific license. As a result, Sec. 40.22(e) allows initial
transfers of source material to or from a general licensee for the
purpose of analytical sampling without a Sec. 40.54 (or equivalent)
specific license. However, this would not change the need for a
laboratory to obtain a distribution license issued under Sec. 40.54 if
the laboratory manufactured and initially transferred standards or
calibration sources containing source material for use under the Sec.
40.22 general license.
B. Distribution of Source Material for Possession Under a Product
Exemption
B.1 Requirement To Obtain a Specific License for Distribution To Exempt
Persons Only From the NRC
Comment: Four commenters questioned the requirement that they may
only obtain a specific license from the NRC for distribution of
products containing source material to persons receiving them under
exemption even if
[[Page 32325]]
they are located in an Agreement State. The commenters voiced concerns
that this would lead to unnecessary dual jurisdiction (having to obtain
a possession and use license from the Agreement State and a
distribution license from the NRC), result in the need for significant
procedure modifications, and could lead to confusion as to which
agency's requirements were applicable. Two of these commenters stated
that their Agreement State license already authorized them to
distribute their products. Further, the commenters were concerned that
the additional costs associated with obtaining and maintaining the
second license could result in products being noncompetitive,
particularly in the international marketplace. The commenters requested
that this requirement be reconsidered to allow the Agreement States to
issue such licenses.
Response: When the Agreement State program was implemented with the
publication of 10 CFR part 150 (27 FR 1351; February 14, 1962), the
authority to regulate distribution of products intended for use by the
general public was reserved to the Commission, then the Atomic Energy
Commission, in Sec. 150.15. Later, Sec. 150.15(a)(6) was expanded to
apply to all products for which the user is exempt from licensing
requirements (34 FR 7369; May 7, 1969). However, before the current
rulemaking, the NRC had not established any requirements specific to
distribution of exempt products for source material; thus, the NRC did
not require manufacturers and distributors in Agreement States to
obtain NRC licensees. Although the case of distribution of exempt
products from Agreement States will require the distributor to get two
licenses, one from the NRC and one from the State, there is no dual
jurisdiction over the same activities. In this situation, the NRC
concerns itself only with what is being distributed and actions
necessary to ensure that the product(s) is safe and within any
constraints of the exemption, while the State regulates such matters as
in-plant safety, emissions, and decommissioning. This regulatory system
has been in place and working effectively for decades in the case of
byproduct material. In the absence of NRC regulations over the
distribution of source material to exempt persons, some States may have
included some license conditions that pertain to distribution. If this
is the case, these requirements should be removed from the Agreement
State license when the distributor comes under an NRC distribution
license. Current distributors of source material to persons exempt
under Sec. 40.13(c) (and equivalent Agreement State provisions) have a
year after the effective date of this rule to apply to NRC for the
required license in order to continue distribution. This will allow
time to answer questions and resolve any confusion as to which agency's
requirements are applicable. This change should not require significant
procedural modifications, presuming that the distributor was already
ensuring that its product met any constraints in the exemptions.
Furthermore, these requirements only cover domestic distribution and
are not applicable to international distribution. Competitors that
manufacture or import similar products for distribution will be
required to meet the same requirements, thus there should be no
competitive disadvantages.
Comment: Three commenters indicated that they already held
possession and use licenses issued by an Agreement State. The
commenters stated that this rule would add excessive costs by requiring
the licensee to prepare and submit an application to the NRC for a
specific license to distribute products under exemption and also
introduce costs for modifying their procedures and existing programs to
accommodate the rule's additional requirements. One of these commenters
estimated that these costs (including new annual fees) would add more
than $37,000 per year to their current annual regulatory costs. The
costs were broken down to include $5,000 for preparation of the
application, $7,000 for the application fee, and at least $25,000 to
modify existing procedures to incorporate both NRC and Agreement State
regulatory requirements and to train employees accordingly. One
additional commenter indicated that it did not currently possess a
specific license from an Agreement State and, under the proposed rule
changes, would need to bear the new costs of procuring and maintaining
a possession license from the Agreement State and an NRC distribution
license. Associated costs would include application fees, annual fees,
and the cost of developing an Agreement State-focused compliance
program.
Response: The NRC acknowledges that some persons currently
operating under the current general license will be required to obtain
new licenses for both possession and use as well as for initial
distribution or transfer. As indicated by the comments, in the case of
a person, located in an Agreement State, who initially distributes
source material to exempt persons, the person may be required to obtain
separate licenses from two regulatory agencies (one from the Agreement
State for possession and use, and a separate license from the NRC for
distribution). When proposing the rule, the NRC considered these costs
and believes that there are significant benefits to requiring a
distribution license. The requirements will better ensure that products
being distributed meet the constraints of the exemptions and will allow
the NRC to accumulate information about the amount of, and to estimate
the impacts of, source material being distributed for use under
exemption. This information will then be used to make better informed
regulatory decisions concerning the distribution of products to be used
under exemption. Some of the costs noted by the commenters are actually
onetime costs, such as those costs for preparing and submitting the
application, and do not continue annually. However, as a commenter
identified, there are new annual fees. The annual fee for the initial
distribution of source material to exempt persons will be $10,000, but
could be as low as $500 if the distributor qualifies as a small entity
under Sec. 171.16(c). In the past, costs of the resources spent in
attempts to gather information about these products and to estimate the
extent and the conditions of their use would be recovered from fees for
other activities that the NRC regulates. Thus, this rule helps ensure
that fees are appropriately allocated.
As discussed in the previous response, the need for two licenses
cannot be avoided; however, because each agency will have separate
roles, there is not expected to be any significant or conflicting
duplicative regulation.
B.2 Obligations of the Distributor of Source Material to Persons
Receiving it Under an Exemption
Comment: Four commenters voiced questions about the obligations of
a person initially distributing products to a person for use under the
exemption if the recipient subsequently modifies the product
(presumably in compliance with the Sec. 40.22 general license). The
commenters questioned whether they would be considered as the initial
distributors of material for use under the Sec. 40.22 general license
and thus obligated to obtain a specific license under Sec. 40.54 (or
its Agreement State equivalent) along with their Sec. 40.52
distribution license. One of the commenters was also concerned that if
there is an obligation to determine how a product is used by the
recipient,
[[Page 32326]]
particularly in light of the understandable reticence customers may
have with sharing information about their operations, the initial
distributor may be forced to undertake undue burdens. One of the
commenters stated that this issue could result in increased enforcement
risk. The commenters requested that the rule or guidance be written to
clearly absolve the initial distributor of products containing source
material and received under an exemption of any responsibility of
determining the licensing status of the end user of their products. One
of the commenters also requested that the proposed rule be modified to
clearly specify the limits of a specific licensee's liability with
respect to the requirements of Sec. 40.51(c) and (d).
Response: An initial distributor of source material may only
transfer source material in accordance with the requirements in Sec.
40.51. If a distributor transfers a product that meets the conditions
of an exemption to a recipient that is authorized to receive the source
material under an exemption from licensing, then the initial
distributor has met its obligations. If the recipient subsequently uses
the product in a way that is inconsistent with the exemption (e.g.,
modifies a product in a way that the exemption does not allow) or
contrary to the requirements of other regulations (e.g., a specific
license or general license), the recipient would be solely responsible
for its misuse. In some cases, persons who receive a product for use
under an exemption may modify it under the general license in Sec.
40.22; however, if they subsequently transfer the modified product for
use under an exemption, the transfer would be considered an initial
transfer of a new product and the person who modified the product would
require a specific license for initial distribution under Sec. 40.52.
B.3 Construction and Design Information
Comment: Four commenters indicated concerns with the requirements
in the proposed Sec. 40.52(b), which would require a licensee
distributing exempt products to provide details of the construction and
design of each product as part of the license application. The
commenters indicated that submitting such information on every product
may be impracticable because they manufacture a large number of
different products of similar type (e.g., lenses of different shapes
and sizes), many of which may be manufactured infrequently or even on a
one-time basis to meet customer specifications and are subject to
change during the production process. The commenters are concerned
about the excessive burden if they had to amend their license each time
they developed a new design. The commenters requested clarification and
guidance on whether more generic information about their operations and
products, rather than model specific information, would be considered
acceptable as a means of avoiding multiple license amendments.
Response: The exemptions in Sec. 40.13(c) cover a wide range of
products. Only in limited cases are these manufactured as specific
models with model numbers. When such products are distributed, the
model information makes the recordkeeping and reporting aspects more
efficient; however, the NRC does not intend to create a situation where
licensees must amend licenses frequently because of normal variations
in products. Because of the variety of product types identified in
Sec. 40.13(c), the extent of information to be provided about the
details of construction and design may vary depending on the product.
If there are significant variations in similar product types planned to
be initially distributed, an applicant should provide some general
information on the ranges of sizes and weights, or lists of models with
more specific information. For some products, such as welding rods;
rare earth metals, compounds, and mixtures; and glassware, sufficient
information may include a description of the product and variations
planned to be distributed. For other products, such as incandescent gas
mantles, electric lamps, and tungsten parts, drawings and other details
of the products may be necessary in addition to a description, because
such additional information may be important in evaluating the safety
of the product. Operating manuals, descriptive sales literature, or
similar documents may be submitted as part of an application. If
applicable to the type of product, the applicant should describe
construction aspects of the product, including components of the
product, materials of construction, dimensions, and assembly methods,
particularly if a product may depend upon certain design considerations
to meet the conditions of the exemption or increase safety. An overall
drawing of the product identifying primary components and indicating
overall dimensions may be useful as a complement to the written
description of the product.
B.4 Labeling
Comment: Three commenters provided comments on the proposed
requirement in Sec. 40.52(b)(4) that an applicant or licensee provide
the proposed method of labeling or marking for 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.
Specifically, the commenters requested clarification if the requirement
means that the label can simply state that ``this product contains
source material'' or if the specific source material type (e.g.,
thorium or uranium) and concentration are required to be on the label.
One of the commenters was concerned that specifying the type or
concentration of source material on the label could unnecessarily alarm
users who may not understand the weight designation or are unable to
comprehend that the amount listed on the label is a trivial amount of
activity. All three commenters requested that the guidance be modified
to provide better clarification regarding the expectation for labeling.
Four commenters stated that there would be significant costs associated
with designing new packaging that meets the new labeling requirements.
One commenter indicated that it would be difficult to estimate
packaging costs in light of the fact that many of their products are
small, infrequent and/or ``one time only'' orders.
Response: Only two of the exemptions currently have labeling
requirements specified by the exemption itself: 10 CFR 40.13(c)(5) for
counterweights, and 10 CFR 40.13(c)(6) for shipping containers.
Paragraph (b) of 10 CFR 40.53, ``Conditions for licenses issued for
initial transfer of certain items containing source material: Quality
control, labeling, and records and reports,'' requires that products be
labeled to meet the constraints of the exemptions. In 10 CFR
40.52(b)(4), the NRC requires all applicants to submit information on
labeling to identify the manufacturer or distributor and the source
material. Similar requirements already exist for the distribution of
byproduct material and applicants typically provide samples or copies
of labels or packaging, although descriptions could be acceptable. The
NRC does not intend to make significant changes to industry practice
with this requirement. Many of the products covered by the exemptions
are not practical to label; and it is possible that in some cases only
the packaging would be labeled. Glassware is typically labeled either
with impressions or small stickers to identify the manufacturer. For
some products, the initial recipient would need some information about
the
[[Page 32327]]
identity and quantity or concentration of source material. In such
cases, packaging or accompanying paperwork would provide the
information. In most cases, the identification of the manufacturer or
distributor and the fact that thorium or uranium is present should
appear on point-of-sale packaging. The term, ``source material,''
should not be used in lieu of ``uranium'' or ``thorium.''
B.5 Instructions on Safe Handling and Radiation Safety Precautions
Comment: Two commenters requested clarification on what would be
considered acceptable in meeting the requirement in Sec. 40.52(b)(5),
which requires that the distributor provide information on safe
handling and radiation safety precautions. The commenters stated that
they currently provide such information in Material Safety Data Sheets
(MSDSs). The commenters were not sure if this requirement meant that
the information needed to be placed inside each container or whether
the information could be provided as part of other purchase
documentation or just referenced as being available for review. In
addition, the commenters stated that it was not clear whether this
information had to be provided before the purchase or only along with
the purchase. One of the commenters requested that the NRC consider
requiring only annual submittals to the customer instead of including
them with each shipment.
Response: The requirements in Sec. 40.52(b)(5) require the
inclusion of radiation safety precautions and instructions relating to
handling, use, and storage of products to be used under Sec.
40.13(c)(1)(i) and (iii), which apply only to thorium contained in gas
mantles and welding rods. The commenter's concerns appeared to be
associated with coated lenses, which the commenter's company
manufactured; therefore, the requirement in Sec. 40.52(b)(5) will not
apply to their products, because the products are not welding rods or
thorium mantles. In the case of welding rods and thorium mantles, safe
handling instructions can aid in significantly reducing exposures
associated with usage. Under Sec. 40.52(b)(5), the NRC would expect
individual packages to be labeled or include safety instructions
because these products may often be sold through intermediary
distributors. In the case of welding rods, the MSDS would be an
acceptable means of informing users; provided that the radiological
aspects of hazards are specifically addressed in the MSDS.
B.6 Quality Control
Comment: Four commenters stated that there would be significant
costs for developing and implementing a quality control program as
required in Sec. 40.52(b)(3). One commenter estimated the associated
costs would add more than $30,000 to their existing product quality
control program. These costs were broken down as $10,000 per year for
sample analysis, $10,000 for program development/management, and
$10,000 for data management, verification and reporting.
Response: The new requirement in Sec. 40.52(b)(3) only applies to
those products where there is an applicable quantity or concentration
limit associated with the product exemption. The information necessary
to satisfy this requirement would only need to describe how the
manufacturer will ensure that the product does not exceed the limits
associated with the exemption and is likely already accomplished under
existing quality control programs. The assurance may be shown through
calculation, description of existing quality assurance programs, or, if
necessary, through batch sampling. The NRC expects that most
manufacturers would already have some quality assurance program in
place to ensure that the customer is receiving what is advertised and,
therefore, it is not anticipated that there would be significant costs
associated with providing assurances that the limits are met. For
example, the NRC expects that most optics require a relatively high
precision on the amount of source material that is contained in a
coating in order to achieve the desired optical effect and that
procedures are used to ascertain that the amount is correct. A
description of these procedures or how this precision is achieved would
be sufficient to satisfy the requirement for describing the quality
control program. As a result, the NRC expects that, in most cases, the
added costs from this requirement would be minimal. The NRC's analysis
of the costs associated with this rule is contained in the regulatory
analysis (ADAMS Accession No. ML13079A302) associated with the rule.
B.7 Annual Reports
Comment: Three commenters indicated that the requirement to provide
an annual report to the NRC, as proposed in Sec. 40.53(c), would
result in significant burden to their operations. The commenters stated
that, contrary to the NRC's conclusion in the notice of proposed
rulemaking, the information requested was not part of their existing
business recordkeeping practices and therefore the information would
not be a minimal burden to provide. One commenter indicated that they
sold optics with thorium coatings and without thorium coatings and that
this requirements would result in the commenter needing to institute
separate tracking and reporting systems for both types of optics. The
commenters indicated that they would have to develop, implement, and
staff a data acquisition management system for which they would have no
need other than this rulemaking at a cost of significant resources.
Response: The NRC recognizes that a distributor's current data
handling system may not be designed to provide the required
information; however, with the capabilities of current information
technology, the NRC expects information could be readily assembled and
provided in a form and content that is acceptable to the NRC without
imposing significant burden on the licensee. In the past, the NRC has
occasionally requested distributors of source material to general
licensees to voluntarily assemble and provide not only product and
quantity information, but also to provide information about recipients
of the source material. These distributors were able to fulfill
requests without significant notice and did not voice concerns about
the burden associated with the requests. Under the regulations in Sec.
40.53(c), distributors of products for use under an exemption are not
required to submit as much information, as there is no obligation to
submit information about customers. The NRC does not expect the
distributor to have to develop, implement, and staff a data acquisition
management system to fulfill this requirement and leaves it up to the
distributor how best to fulfill the requirement. Byproduct material
distributors have been required to submit such reports for decades.
Also, source material distributors have one year to apply for a
license, and are not required to submit such a report until the year
after their specific license is issued, which should allow the
distributors sufficient time to develop cost-effective systems to meet
the requirement. The information to be provided in these reports is
important for the NRC to understand how much source material is
distributed for use under exemption and to ensure that the products
distributed for use under exemption are and continue to be safe. The
NRC has concluded that these benefits outweigh the costs associated
with providing this information.
Comment: Four commenters requested clarification about the level of
[[Page 32328]]
precision that was expected under the proposed requirements in Sec.
40.53(a) and (c)(3)(ii). The commenters indicated uncertainty as to
whether each item had to be assessed individually or if they could
provide alternative verifications and indicate that the amount of
source material was below the percentage or quantity limit. The
commenters were concerned that being required to determine the actual
source material content on a per product or batch basis would increase
the contamination potential of operations and increase the product
costs, delivery times, and personnel exposures. The commenters
requested that guidance clarifying these requirements be provided and
recommended that the NRC allow the reporting of nominal concentrations
(i.e., less than 10 percent) or quantities rather than product specific
numbers or per individual product in the annual report. One commenter
also requested clarification on whether the reporting units should be
weight percent (i.e., ppm) or activity (i.e., Ci or Bq).
Response: Simply providing information that the source material was
below a concentration or quantity limit would not generally be
acceptable. The better the characterization that can be provided by the
distributor, the better the NRC will be able to refine its estimates of
impacts to the public from exempt products in the future. However, the
intent is not to require additional sampling or any significant
analysis that is not already performed. The form of the information
that is appropriate will vary for the type of product. Nominal values
for specific products and total quantity of source material distributed
in those products may be adequate. If products can be categorized by
type, one approach may be to give the range of source material content
for each type and provide the total quantity for each type distributed.
While information on weight percent may be provided, total weight would
also be needed to meet the requirement of reporting the total quantity
of source material in each type of product. While it would be more
convenient for the NRC to receive information in consistent units from
all distributors, the final rule does not specify the units so as to
allow distributors to report in whatever units they are currently
keeping records.
Comment: Four commenters stated concerns about the requirements in
the proposed Sec. 40.53(c) that require the distributor to provide the
NRC with annual reports detailing who their customers were and
frequency, type, and amount of sales to those customers. The commenters
indicated that this was proprietary information, which would have to be
submitted as such and would be burdensome.
Response: The proposed Sec. 40.53(c) does not contain any language
that would require the submittal of customer information or any
information specifically related to individual customers. This was not
changed in the final rule. The commenters also addressed a similar
concern with respect to the annual reporting requirement proposed in
Sec. 40.55(d), which applies to initial distributors of source
material for use under the general license in Sec. 40.22. The Sec.
40.55(d) reports must include information about certain customers and
frequency, type, and amount of sales to those customers. A response to
that concern is provided in section III.C.4, of this document.
Comment: One commenter indicated that the reporting requirement in
Sec. 40.53(c) appeared to be parallel to the general licensing
reporting system currently in place for devices containing byproduct
material. The commenter requested clarification on what kind of
regulatory oversight is intended for these reports. For example, would
the NRC and the Agreement States need to establish databases and
tracking systems and would there be inspections in the field?
Response: Although the NRC may develop databases internally to
evaluate reports, the NRC does not plan to institute a database capable
of tracking materials similar to that currently used for tracking
generally licensed devices containing byproduct material. The reporting
requirement in Sec. 40.53(c) parallels the various 10 CFR part 32
reporting requirements concerning distribution of products for use
under the exemptions from licensing in 10 CFR part 30. The NRC plans to
periodically aggregate the collected information related to
distribution of products to exempt persons and assess the information
to ensure that the exemptions are being properly used and that the
overall impact of all such products is not inappropriate. The data
would also be analyzed to determine if additional changes to the
regulations are required to improve or verify the safety of the
exemption. Although field inspections solely to verify records of
transfers are not envisioned as a normal practice, review of a
licensee's recordkeeping practices may be included as part of any
routine inspection of the specific licensee.
B.8 Cost/Benefit Considerations
Comment: Four commenters provided comments regarding their concerns
about costs associated with implementing the proposed new requirements.
One commenter argued that the summations of the additional costs will
impact the competitive nature of their products in the national and
international marketplace. Two commenters stated that they were not
convinced that the risks associated with the use of source material
under the current regulations, as described in NUREG-1717, justified
the significant costs that would be associated with implementing the
proposed rule requirements. One of these commenters added that their
products, which entailed the use of thorium in finished optics, were
estimated to be well within the range of normal background radiation
exposures incurred by the U.S. population. Another commenter summarized
that it was not clear how the benefits of the proposed rule, in light
of the trivial risk of using their products, outweigh the significant
increase in cost. This same commenter was also concerned that due to
the contractual nature of their business, they may not be able to
recover costs until their current contracts expire thus placing them in
financial jeopardy.
Response: The costs of these requirements are projected by the NRC
to be less than the costs indicated by the commenters, who mostly
represent the optics industry. The NRC's analysis of the costs
associated with this rule is contained in the regulatory analysis
(ADAMS Accession No. ML13079A302) associated with the rule.
In addition, although products used under exemptions from licensing
generally present low risks, comparison with normal background
radiation exposures is not appropriate for judging the acceptability of
these products. It has been difficult for the NRC to adequately ensure
that the products distributed are as they should be, and that the
overall impact to the public from all of the products distributed for
use under exemption is acceptable. Requiring distributors to be
specifically licensed and to provide transfer reports will greatly
improve the NRC's ability to do these things and will improve the
efficiency and effectiveness of the NRC in carrying out these
responsibilities. The NRC has, to the extent possible with only
incomplete information available, designed this rule to minimize the
impacts on industry while establishing a basic regulatory framework for
control of distribution of source material to exempt persons. Finally,
although the distributor may undertake some additional costs, they will
have one year to submit a license application and additional time until
that license may be approved, during which the distributor can
potentially
[[Page 32329]]
alter or implement new contracts with customers. This time is in
addition to the advance notice already provided by the proposed rule
about these new requirements. Additionally, competitors will equally
face similar issues.
C. Distribution of Source Material for Possession Under the General
License
C.1 Notifications to Customers
Comment: Four commenters stated that there would be significant
costs associated with developing a program to track and distribute
applicable regulations and safety instructions to customers (estimated
to be $10,000 annually by one commenter). A separate commenter noted
that general licensees have in the past had very few responsibilities
other than those related to disposal. The commenter recommended that,
because the rulemaking adds significant new requirements to persons
possessing source material under the Sec. 40.22 general license, the
NRC should place additional responsibilities on the distributor to
require the distributor to not only provide the customer with a copy of
the applicable regulations, but to also obtain documentation from the
general licensee acknowledging their understanding of their
responsibilities under the general license.
Response: The NRC is concerned that some persons receiving source
material for possession or use under the general license may not be
aware of the specific regulatory requirements applicable to their
possession and use of that material. For example, one commenter
provided an observation that currently unlimited quantities of one
percent solutions of both natural thorium and natural uranium
analytical metal standards may be purchased by non-licensed facilities.
This conclusion may have been reached because some persons have
incorrectly assumed that these materials were being possessed under
exemption instead of the Sec. 40.22 general license as a result of the
lack of specific requirements in the former Sec. 40.22 general license
and the fact that no information was provided by the distributor to
indicate otherwise. The costs to initial distributors of source
material for use under the Sec. 40.22 general license to make and
provide copies of applicable safety information and the regulations to
recipients of the source material is justified to ensure that the
recipient is aware of the existing regulations that are applicable to
its possession and use of the source material. This requirement should
help ensure the safe use of the material by the recipient. The NRC is
currently aware of only one primary distributor of source material to
general licensees and did not receive any comments from this
distributor. As indicated by one commenter, general licensees in the
past have had very few responsibilities and these notifications would
help alert them of the final rule changes in Sec. 40.22. Although one
commenter requested that the rule require the distributor to obtain an
acknowledgement of receipt of the notifications, at this time, the NRC
believes this will place unnecessary burden on the distributor and the
general licensee without providing significant additional benefit.
After the NRC has these requirements in place for a few years, the NRC
will be better able to determine if the additional burden of such a
requirement is warranted.
Comment: One commenter requested that the regulations be modified
to require that any person who transfers source material to a general
licensee, where the person receiving the material also possesses a
specific license of any kind issued by an Agreement State or the NRC,
be required to report to and receive acknowledgement from the radiation
safety officer or other official named on the recipient's license of
such transfer.
Response: The commenter is part of an organization that may hold a
single specific license but may have numerous, distinct operations that
use source material under separate general licenses. Such a requirement
would likely be useful in helping an organization to ensure that it
does not surpass the possession limits of the general license or face
other violations because the exemptions to 10 CFR parts 19 and 20 do
not apply to the source material held by a specific licensee. The NRC
believes this will place unnecessary burden on the distributor. An
organization can implement internal procedures to achieve the same
results, such as by allowing purchases of source material to be made
only through the radiation safety officer, without the need for NRC to
implement new regulations.
C.2 Quality Control
Comment: Four commenters stated that there would be significant
costs for developing and implementing a quality control program as
required in Sec. 40.55. One commenter estimated the associated costs
would add more than $30,000 to their existing product quality control
program. These costs were broken down as $10,000 per year for sample
analysis, $10,000 for program development/management, and $10,000 for
data management, verification and reporting.
Response: Paragraph (a) in Sec. 40.55 requires that each person
licensed under Sec. 40.54 label the immediate container of each
quantity of source material with the type of source material and
quantity of material. Paragraph (b) in Sec. 40.55 requires that the
licensee ensure that the quantities and concentrations of source
material are as labeled and as indicated in any transfer records. The
information required to meet Sec. 40.54(b), with respect to quality
control, should be sufficient if it includes a description of an
existing quality control or quality assurance program or how the amount
of source material in a material or product will be controlled (e.g.,
through batch sampling). The NRC expects that most manufacturers would
already have some quality assurance program in place to ensure that the
customer is receiving what was ordered and that costs to meet this new
requirement would therefore be minimal.
C.3 Labeling Requirements
Comment: Four commenters stated that there would be significant
costs associated with designing new packaging that meets the new
labeling requirements. One commenter indicated that it would be
difficult to estimate packaging costs in light of the fact that many of
their products are small, infrequent and/or ``one time only'' orders.
Response: The NRC expects that most products are already delivered
in some type of individual packaging or bulk packaging for similar
products. It is expected that the manufacturer, in most cases has an
idea of the specific amount of material included in the product. For
most uses, the recipient would be ordering a specific amount and/or
concentration and would expect that the package/container or invoice
would tell them what they received. Although there may be some costs
associated with modifying the labeling, the NRC believes that the
benefit of the customer knowing this information outweighs the costs of
modifying the label because the customer will have better knowledge of
how to safely deal with the material. Also, existing distributors are
being given one year to apply for a license to allow for an easy
transition. At that point, the existing distributors would provide
plans for meeting the requirements of the license for which they are
applying and would not have to implement them until the license is
issued.
The NRC acknowledges that some products may fall under a general
license only because the source material is contained within an ore
that was processed and so exact amounts of
[[Page 32330]]
uranium or thorium contained within the ore may not be known. Instead,
average or maximum concentrations, as approved by the NRC in a specific
license, could be used to reduce the costs that would be required by
sampling each batch. In many cases, incoming ores may already have such
concentrations listed. This labeling is important such that the
recipient of the material under a general license can ensure that they
are staying within the possession limits.
C.4 Annual Reports
Comment: Under Sec. 40.55(d), the NRC proposed that each initial
distributor must provide an annual report to the NRC, which is to
include certain information as specified in the proposed regulation.
Two commenters indicated that this requirement would result in
significant burdens to their operations. The commenters stated that,
contrary to the NRC's conclusion in the notice of proposed rulemaking,
the information requested is not part of their existing business
recordkeeping practices and therefore the information would not be a
minimal burden to provide. The commenters indicated that they would
have to develop, implement, and staff a data acquisition management
system for which they would have no other need than this rulemaking at
a cost of significant resources.
Response: The NRC recognizes that a distributor's current data
handling may not be designed to instantly provide the required
information; but, with the capabilities of current information
technology, the NRC expects information could be readily assembled and
provided in a form and content that is acceptable to the NRC without
incurring significant burden on the licensee. In the past, the NRC has
occasionally requested distributors of source material to general
licensees to voluntarily assemble and provide not only product and
quantity information, but also to provide information about recipients
of the source material. These distributors were able to fulfill the
requests without significant notice and did not voice concerns about
the burden associated with the requests. The only currently identified
distributor of source material to general licensees has voluntarily
provided similar information in the past and so requiring an annual
submission does not seem overly burdensome. The NRC does not expect the
distributor to have to develop, implement, and staff a data acquisition
management system to fulfill this requirement and leaves it up to the
distributor how best to fulfill the requirement. Byproduct material
distributors have been required to submit such reports, at least
annually, for decades. Also, source material distributors will have one
year to apply for a license, and would not be required to submit such a
report until the year after their specific license is issued. This
should allow sufficient time to develop a cost-effective system to meet
the reporting requirement. The NRC has concluded that the information
to be provided in these reports is important for the NRC to understand
and ensure that products and materials distributed for use under the
general license are, and continue to be, safe. In addition, such
reports will help identify who currently is operating under a general
license.
Comment: Four commenters stated concerns about requirements in the
proposed Sec. 40.55(d) requiring the distributor to provide the NRC
with annual reports detailing who their customers were and frequency,
type, and amount of sales to those customers. The commenters indicated
that this was proprietary information, which would have to be submitted
to the NRC as such and the process would be burdensome. Two of these
commenters indicated it was unclear how this information would be
protected. One of these commenters indicated that because their
transactions are subject to security restrictions they may be
prohibited from submitting the information in such a report. Three of
these commenters stated that having to file to protect this information
pursuant to Sec. 2.390 for each report would be burdensome and
recommended that NRC eliminate the requirements for providing customer
specific data from the annual reporting requirement. One of these
commenters recommended that the annual report only include generic
information transferred on a state basis, while the other two
commenters recommended that they be allowed to maintain such records at
their site for NRC review during inspections.
Response: The NRC has procedures in place for protecting
proprietary information. Generally, the Agreement States have
procedures in place that are designed to protect proprietary
information to the extent permissible under state law. Similar
requirements have applied to the distribution of byproduct material for
decades, in most cases on a quarterly basis. The information is
pertinent to allow both the NRC and the Agreement States to understand
who is receiving source material under their jurisdiction to better
ensure that the source material is being properly handled. The NRC
recognizes that customer information may be considered proprietary
under Sec. 2.390 and would treat it as such in accordance with the
NRC's regulations and procedures. Distributors would need to mark the
information as proprietary to ensure that it is treated accordingly.
For annual reports related to the distribution of byproduct material,
after the first annual report and associated affidavit is submitted
under Sec. 2.390(b), the NRC typically waives the affidavit
requirements under Sec. 2.390(b)(ii), for subsequent annual reports if
the reports are appropriately marked as proprietary and reference a
previously submitted affidavit. The NRC anticipates that the annual
reports provided for under Sec. 40.55(d) will be handled in a similar
manner. Thus, the requirements for requesting withholding of
proprietary information under Sec. 2.390 for annual reports required
by Sec. 40.55(d) are not as burdensome as they may appear. Although
the information could be held at the distributor's facility, such a
plan would not allow individual Agreement States to be notified of who
is receiving source material under their regulatory jurisdiction. Upon
the request of a distributor who believes they are prohibited from
providing information to the NRC in an annual report because of
security restrictions imposed by other agencies, the NRC will evaluate
the security restrictions on a case-by-case basis.
Comment: Three commenters identified that the proposed Sec.
40.55(d) only requires the name and address of general licensees who
received greater than 50 g (0.11 lb) of source material but that the
reporting requirement under Sec. 40.53 have no such threshold. Two of
these commenters questioned why there is a difference and requested
clarification of why the threshold is only 50 g. These commenters
recommended that the threshold be raised to be consistent with the
possession limit in Sec. 40.22(a).
Response: As indicated earlier, the reporting requirement in Sec.
40.53(c) does not require the reporting of customer information and so
a comparison between the reporting requirements under Sec. 40.53(c)
and Sec. 40.55(d) is not appropriate. In Sec. 40.55(d), the NRC is
requesting the reporting of customer names who receive source material
under the general license to better ensure that persons operating under
the Sec. 40.22 general license can be identified by the regulator.
This will allow the regulator to better ensure the general licensee
meets the requirements of Sec. 40.22. The threshold of 50 g was
determined by looking at distribution reports that were voluntarily
submitted to the NRC in the past and intended to
[[Page 32331]]
reduce burden on distributors who distribute significantly smaller
quantities of source material that are less likely to result in
significant health and safety or contamination issues. Using the
possession limit for the cutoff for reporting identities of general
licensees would result in no general licensees being identified.
Comment: Three commenters requested clarification as to whether the
reports required to be filed with a responsible Agreement State under
Sec. 40.55(d)(2) only need to be submitted to the Agreement State in
which the distributor was located or to, effectively, all the Agreement
States and the NRC.
Response: Paragraph Sec. 40.55(d)(1) requires that the distributor
provide a complete report of all distributions to the NRC, including
for those transfers made to general licensees in Agreement States.
Paragraph (d)(2) in Sec. 40.55 requires that the distributor issue a
separate report to each Agreement State into which the material was
distributed to provide those Agreement States with a better
understanding of who is receiving source material and how much under
the equivalent Agreement State regulation. The reports to the Agreement
States are only required to identify those persons within that
individual Agreement State that received more than 50 g of source
material; however, even if each person received less than 50 g within
an individual Agreement State, the distributor would still be expected
to provide a report of how much source material in total was
distributed into the individual Agreement State. If no source material
was distributed into an Agreement State in the previous calendar year,
the distributor does not need to provide a report to the Agreement
State, unless the particular State requests it. In that case, the
distributor must provide a report to that Agreement State that
indicates that no source material was distributed in the previous
calendar year. As a result of comments and to better clarify that
reports should be sent to each Agreement State into which source
material is transferred, Sec. 40.55(d)(2) was revised.
Comment: The Agreement State commenter indicated that the reporting
requirement in Sec. 40.55(d) appeared to be parallel to the general
licensing reporting system currently in place for byproduct material
devices. The commenter requested clarification on what kind of
regulatory oversight the NRC intends for these reports--for example,
will the NRC and the Agreement States need to establish databases and
tracking systems and will there be inspections in the field?
Response: Although the NRC may develop databases internally to
evaluate reports, the NRC does not plan to institute a database capable
of tracking materials similar to that currently used for tracking
generally licensed byproduct devices. The NRC plans to periodically
aggregate the collected information related to distribution of source
material to general licensees. The data would be used to identify
general licensees and to determine if additional changes in the
regulations are required to improve safety. Identifying general
licensees will allow the NRC to contact them to provide or to request
information, or to inspect them if it deems it appropriate. Although
field inspections solely to verify records of transfers are not
envisioned as a normal practice, review of a licensee's recordkeeping
practices may be included as part of any routine inspection of the
specific licensee.
D. Exemptions
The notice for proposed rulemaking included a request for comments
on whether or not it is appropriate to limit source material on coated
lenses through use of a concentration limit.
Comment: One commenter suggested that an activity per unit area
(square centimeter) would seem more appropriate. The commenter did not
suggest a limit.
Response: The NRC is concerned that a concentration limit may not
be the best method to limit uranium and thorium content in the coating
of a lens because the activity is concentrated on the outer boundary.
Although an activity per unit of surface area is likely a better
control, the NRC is hesitant to impose such a limit at this time,
without receiving more complete information on the range of products,
sizes, quantities of source material, coating thicknesses, etc. Based
on the evaluation and findings in the PNNL study, the total source
material content is normally significantly less for a coated lens than
a lens with a homogeneous content. As a result, the NRC has concluded
that the proposed limit is acceptable. One of the key assumptions for
these lenses, however, is that the coating is not easily removable. As
the key concern with safety for these lenses is how easily removable
the coatings might be, Sec. 40.52(b)(2) will require the manufacturer
to submit a description of its manufacturing process, as part of a
license application, that would ensure that the coating is not easily
removable. After the NRC receives more information regarding the
distribution of these lenses as a result of the new reporting
requirements, the NRC may reconsider the issue.
E. Fees
The notice of the proposed rulemaking included a request for
comments on whether the proposed categories and fees in Sec. 170.31
and Sec. 171.16 were appropriate and reasonable.
Comment: One commenter indicated that any additional fees would be
burdensome. This commenter was concerned that under the proposed rule,
a facility providing sample characterization for source and [10 CFR
part 30] byproduct material for licensees and non-licensees could
potentially be charged greater than $30,000 annually and more than
$15,000 in applications fees. These costs did not include the cost of
preparing an application or implementing the new regulatory programs.
The commenter stated that these fees eclipse the cost for both
conventional and in situ recovery facilities that produce millions of
pounds of source material annually.
Response: The commenter is correct that a person distributing
source material and byproduct material for use under exemptions and
general licenses could be subject to fees under a number of different
fee categories. However, the fee categories for byproduct material
distribution are not new and should not be addressed as new costs. The
commenter is correct that a person manufacturing and distributing
byproduct material and source material for use under exemptions and
general licenses (thereby being affected by up to six separate fee
categories) could have a total annual fee that exceeds the annual fees
for conventional or in situ recovery facilities. This is because the
NRC handles each of these (possession, distribution, source material,
byproduct material, etc.) as a separate activity. In the past, costs of
the resources spent in attempts to gather and evaluate information
about the use of source material under exemption and the Sec. 40.22
general license and to estimate the extent and the conditions of their
use would be recovered from fees for other NRC-regulated activities
unrelated to source material activities. Thus, this rule helps ensure
that fees are appropriately allocated. These fees are expected to
change periodically based upon the actual amount of effort the NRC
spends in actively regulating licensees in these categories. In
addition, small businesses are granted some relief from these fees and
are allowed to pay significantly lower fees.
[[Page 32332]]
F. Miscellaneous
F.1 Scope of ``Other Glass or Ceramic'' in Sec. 40.13(c)(2)(iii)
Comment: One commenter requested that the NRC clarify the scope of
the term ``other glass or ceramic'' as it appears in Sec.
40.13(c)(2)(iii). The commenter stated that the scope should extend to
industrial use ceramics that are not used in residential or commercial
building construction. The commenter stated that the phrase ``used in
construction'' means used in the construction of residential or
commercial buildings and not ``used in construction'' of industrial
crucibles, jet engines, chemical manufacturing facilities, or military
radar. The commenter discussed the fact that since other forms of
ceramics are allowed under other exemptions in Sec. 40.13(c)(2)(i) and
(ii), that the exemption in Sec. 40.13(c)(2)(iii) should be considered
to include any other ceramics except those in Sec. 40.13(c)(2)(i) and
(ii) and those ceramics used in residential and commercial building
construction.
Response: The fact that there are other exemptions that cover
specific types of ceramics is in fact evidence that the exemption for
glassware in Sec. 40.13(c)(2)(iii) is not meant to cover all ceramics.
The exclusionary language at the end of that exemption had previously
been associated with the exemptions in Sec. 40.13(c)(2)(i) and (ii) in
addition to Sec. 40.13(c)(2)(iii). However, these exemptions are
specific enough as to no longer need such clarification. Also, the
glaze on some ceramics, such as ceramic tiles, may itself be considered
glass. Thus, maintaining the exclusionary language concerning ceramic
tile and other tile used in construction is appropriate. The NRC agrees
that the phrase ``used in construction'' means used in the construction
of residential or commercial buildings and not ``used in construction''
of industrial crucibles, jet engines, chemical manufacturing
facilities, or military radar. Nevertheless, the exemption in Sec.
40.13(c)(2)(iii) does not cover ceramic material.
F.2 Applicability of Specific Product Exemption vs. Broader 0.05
Percent Exemption
Comment: One commenter indicated that it manufactures a wide
variety of ``windows'' that are nominally 18 inches by 12 inches, in
addition to small lenses that are less than 1 inch in diameter. Some of
these products contain less than 0.05 percent by weight of uranium and
thorium. The commenter requested clarification on whether the product
exemption in Sec. 40.13(c)(7) or the broader exemption in Sec.
40.13(a) takes precedence. If the former, the manufacturer would be
required to distribute the product under the proposed distribution
license in Sec. 40.52. The commenter recommended that this potential
point of confusion be addressed in guidance.
Response: Although there is not a stated definition for what
constitutes a lens in the NRC's regulations, the Merriam-Webster
Dictionary \6\ defines a lens as ``a piece of transparent material (as
glass) that has two opposite regular surfaces either both curved or one
curved and the other plane and that is used either singly or combined
in an optical instrument for forming an image by focusing rays of
light.'' Similarly a mirror is intended to reflect waves of light or
other radiation. Because a ``window'' is usually intended to only allow
transmittal of light (not reflect or focus it), the NRC does not
consider a window to be a lens and thus the exemption in Sec.
40.13(c)(7) would not normally apply to a window. When determining the
appropriate exemption, it would be inappropriate to use the exemption
limit in Sec. 40.13(a) for a product in which the source material is
intentionally applied or included. As a result, for coated lenses, the
only applicable exemption would be in Sec. 40.13(c)(7) and thus the
initial distribution of all coated lenses would require a license under
Sec. 40.52.
---------------------------------------------------------------------------
\6\ See Web site http://www.merriam-webster.com/dictionary/lens.
---------------------------------------------------------------------------
F.3 Threshold for Licensable Source Material
Comment: One commenter requested guidance about when uranium or
thorium is actually considered source material. In particular, the
commenter asked if source material is defined as being controlled by a
licensee, or if it includes any material that may contain greater than
0.05 percent by weight of uranium or thorium, including outcrops, mine
workings, and cores required to ascertain if material is minable. The
commenter also wondered how one handles ores that are being
analytically sampled when one doesn't know the concentration of uranium
and thorium until the analysis is completed. The commenter was also
concerned that some inspectors have indicated that as soon as you add
acids to the ore, for analytical sample preservation as required by
approved analytical methodologies for uranium testing, that the
material should be classified as source material, even if you don't
know whether the concentration in the sample exceeds the 0.05 percent
limit.
Response: The NRC acknowledges that because of the ubiquitous
nature of uranium and thorium, knowing if a material is an ore or is
source material is problematic. As long as the source material remains
in its place in nature, the source material is not subject to
regulation under the AEA. Furthermore, until the ore is actually
processed, because of the exemption in Sec. 40.13(b), a person is not
required to obtain a license from the NRC for possession or use of the
material nor meet the requirements of 10 CFR part 40. However, once
processing occurs, the processor would need a license (either general
or specific) to possess and process the source material if the
material's content exceeds 0.05 percent by weight of the material. If
the processed material is then transferred to someone else for use
under a product exemption in Sec. 40.13(c) or the general license in
Sec. 40.22, that person would need a distributor license.
Based on comments, the NRC has concluded that transfers of source
material to analytical laboratories (and potentially back to the
client) for determining concentrations would be extremely burdensome to
track and need not be covered by licensing requirements for initial
distribution. As a result, the NRC has modified the proposed Sec.
40.22(e) to include a provision specifically to address analytical
laboratories and, as such, a specific license for the initial
distribution of source material is not required in order to transfer
source material to an analytical laboratory operating under a Sec.
40.22 general license for the purpose of determining the source
material concentration of the material. Similarly, the laboratory would
not be required to obtain a distribution license to return the sample
to the person that originally provided the sample for analysis. The NRC
expects that most laboratories routinely analyzing radioactive
materials are operating under a specific license. However, to the
extent that the general license of Sec. 40.22 is used for this
purpose, it is not necessary to capture such transfers under a
distribution license. Furthermore, the NRC modified Sec. 40.22(a) to
allow laboratories receiving uranium and thorium for the purpose of
determining its concentration to essentially maintain the same quantity
limits as have been allowed by Sec. 40.22 in the past.
The NRC also acknowledges that there may be issues when handling
unprocessed ores when the source material content is not known. To
[[Page 32333]]
alleviate potential violations where a laboratory may unexpectedly
identify source material in an ore that would normally require
licensing, a clarifying amendment was made to the definition of
``unrefined and unprocessed ore'' in Sec. 40.4 to indicate that
activities related to the sample analysis of an unprocessed ore are not
considered as processing and an analytical laboratory may treat the
sample as unprocessed ore under the exemption in Sec. 40.13(b). This
change is consistent with Section 65 of the AEA, which states that
``reports shall not be required with respect to (a) any source material
prior to its removal from its place of deposit in nature, or (b) . . .
or the reporting of which will discourage independent prospecting for
new deposits.''
Comment: One commenter stated that the NRC should clarify that
compliance assessments for uranium and/or thorium in a material can be
reported to three significant figures, if justified by analytical
accuracy and precision. The commenter explained that the regulatory
language of Sec. 40.13(a) of ``one twentieth of one percent''
describes a fraction of a fraction and provides a numeral example in
parenthesis of 0.05 percent. The commenter further stated that
following accepted rounding convention, an analytical value of 0.049
percent rounds to 0.05 percent and thus is considered licensable source
material if analysis to only two significant figures is allowed by
Sec. 40.13(a). The commenter requested that given that improvement in
analytical sensitivity over the years, it is appropriate to clarify
that the number of significant figures to which source material content
is reported should be limited only by the validated accuracy and
precision of the analytical method used.
Response: Although the numeric value in Sec. 40.13(a) is only
stated out to one significant figure, the NRC does not require rounding
if a more precise analysis is made. Thus if the analysis indicated that
the material was 0.049 percent by weight, the NRC would not consider
the material containing the uranium or thorium to require a license.
F.4 Revision of the Exemption in Sec. 40.13(b) for Unrefined Ores
Comment: One commenter stated the exemption for unrefined and
unprocessed ore found in Sec. 40.13(b) is a critical part of 10 CFR
part 40 and rightfully remains unchanged because it--(1) Exempts mining
of source material from the regulation; (2) rightfully exempts natural
materials from the regulations; and (3) starts the regulatory regime
only upon processing of naturally occurring materials thus limiting the
regulation to anthropogenic materials.
Response: The NRC has no plans to revise Sec. 40.13(b) in any way
that would reduce the benefits identified by the commenter at this
time. However, based upon comments received, the NRC has included a
clarifying amendment to the definition of ``unrefined and unprocessed
ore'' in Sec. 40.4 in the final rule to indicate that activities
related to the sample analysis of an unprocessed ore and a few other
specified activities as discussed in more detail in section II.A.8 of
this document, are not considered to be processing and that the
material would continue to be considered an unprocessed or unrefined
ore and thus remain exempt under Sec. 40.13(b).
G. Future Rulemaking Considerations
The notice of the proposed rulemaking included a request for
comments on certain issues that could be considered for future
rulemakings. The following comments were provided in response to the
NRC's questions. The NRC would like to thank respondents for taking the
time to provide these comments, and will consider them when evaluating
the need and scope of future rulemaking in this area. The NRC is not
providing a response to these comments at this time.
G.1 Addition of 11e.(2) Byproduct Material to the Sec. 40.22 General
License
The notice of proposed rulemaking included a request for comment on
whether the general license in Sec. 40.22 should be expanded to cover
11e.(2) byproduct material (mill tailings or waste).
Comment: Three commenters responded positively to expanding the
Sec. 40.22 general license to include provisions for 11e.(2) byproduct
material. One of the commenters indicated that current regulations are
hampering the ability of analytical laboratories to perform necessary
testing on waste material generated by an in situ recovery facility
because the laboratory requires a specific license. Another of these
commenters indicated that such a change would be a boon for
laboratories serving the uranium recovery industry. The commenter
argued that uranium mill tailings (which are a major component of
11e.(2) byproduct material) are lower in activity than unrefined and
unprocessed ores, which are considered to be exempt under Sec.
40.13(b). The commenter provided suggested limits for inclusion in any
proposed general license expansion to be 150 lb of 11e.(2) byproduct
material at one time and receipt of no more than 1,000 lb per year. The
third commenter indicated that higher limits were appropriate if the
dose limits were not likely to be exceeded but also identified the need
that additional provisions for disposition may be needed.
G.2 Sealed Source and Device Registry
The notice of proposed rulemaking included a request for comment on
whether explicit provisions should be added to 10 CFR parts 40 and 70
to cover the inclusion of source material and special nuclear material
in items in the sealed source and device registry, similar to Sec.
32.210.
Comment: One commenter supported making this revision for devices
and specific products.
G.3 Usefulness of Provisions in Sec. Sec. 40.25 and 40.34
The notice of proposed rulemaking included a request for comment on
whether the provisions in Sec. Sec. 40.25 and 40.34 should be revised
to make the general license more useful to the regulatory program,
whether the usefulness clause is too subjective and acting as
deterrent, and if the exposure limits in Sec. 40.34(a)(2) should be
reduced to 1 mSv (100 mrem) per year.
Comment: One commenter indicated that most persons have chosen to
possess materials under their specific license instead of under these
provisions. The commenter indicated that there are some accelerator/
cyclotron facilities that still use material under this general
license. The commenter continued that the usefulness of the product
should always be a primary consideration in the evaluation process and
should be maintained in the rule language. Finally, the commenter
indicated that exposure limits should be consistent with those for
other generally licensed products.
IV. Discussion of Final Amendments by Section
Section 30.6 Communications
10 CFR 30.6(b)(1)(iv)--Adds a reference to new Sec. 40.52 as a
licensing category not delegated to the NRC Regions.
Section 40.4 Definitions
10 CFR 40.4--Revises the definition of ``Unrefined and unprocessed
ore'' to clarify that certain activities are not considered processing
in this regard.
Section 40.5 Communications
10 CFR 40.5(b)(1)(iv)--Adds a reference to new Sec. 40.52 as a
licensing
[[Page 32334]]
category not delegated to the NRC Regions.
Section 40.8 Information Collection Requirements: OMB Approval
10 CFR 40.8(b)--Adds sections to the list of information collection
requirements.
Section 40.13 Unimportant Quantities of Source Material
10 CFR 40.13(c)--Clarifies that persons exempt from licensing
requirements are also exempt from 10 CFR parts 19, 20, and 21.
10 CFR 40.13(c)(2)(i)--Restricts the exemption for use of source
material in certain ceramic tableware to that previously manufactured.
10 CFR 40.13(c)(2)(iii)--Revises 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)--Removes paragraph (c)(5)(i), as it is redundant
with the new paragraph (c)(10), and renumbers the subsequent paragraphs
within (c)(5).
10 CFR 40.13(c)(7)--Revises 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 optical lenses
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)--Adds paragraph (c)(10) to prohibit initial
distribution for use under the exemptions in Sec. 40.13(c) without a
specific license issued under Sec. 40.52.
10 CFR 40.13(d)--Removes 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)--Applies a limit of 1.5 kg (3.3 lb) at any one
time to certain forms of uranium and thorium that may be inhaled or
ingested during normal working conditions and restricts receipt of
these forms to less than 7 kg (15.4 lb) per year. Also, allows a
person, currently possessing quantities greater than these limits, one
year from the effective date of the rule to reduce possession limits or
apply for a specific license for possession and use; however, a person
not applying for a specific license has until the end of the calendar
year following the effective date of the rule to reduce throughput to
the new limits.
10 CFR 40.22 (a)(2)--Allows additional possession of forms of
uranium and thorium that are not expected to be normally inhaled or
ingested.
10 CFR 40.22(a)(3)--Allows 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(a)(4)--Allows laboratories handling samples for the
purpose of determining uranium or thorium content to continue to
possess up to 7 kg (15.4 lb) of source material at any one time and up
to 70 kg (154 lb) of source material per calendar year.
10 CFR 40.22(b)(1)--Continues 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)--Clarifies that any person who receives,
possesses, uses, or transfers source material under Sec. 40.22 may not
abandon source material and that the source material must be
transferred under Sec. 40.51 or permanently disposed of in accordance
with Sec. 20.2001. An exception is that a general licensee is 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
and that the recipient is not required to obtain a license from the NRC
as long as it was permanently disposed in accordance with local laws.
10 CFR 40.22(b)(3)--Clarifies which provisions in 10 CFR part 40
apply under the general license.
10 CFR 40.22(b)(4)--Adds a provision to explicitly require that
licensees must respond to written requests by the NRC.
10 CFR 40.22(b)(5)--Clarifies that export of source material is
subject to 10 CFR part 110.
10 CFR 40.22(c)--Requires that any person who receives, possesses,
uses, or transfers source material in accordance with paragraph (a) of
Sec. 40.22 must conduct activities so as to minimize contamination of
the facility and the environment.
10 CFR 40.22(d)--Revises and moves the requirements currently under
paragraph (b) of this section to paragraph (d) of this section.
10 CFR 40.22(e)--Restricts initial distribution for use under the
general license to a specific license issued under Sec. 40.54 or
equivalent provisions of an Agreement State.
Section 40.32 General Requirements for Issuance of a Specific License
10 CFR 40.32(f)--Adds Sec. Sec. 40.52 and 40.54 to the list of
sections that have special requirements that need to be satisfied for
the issuance of certain specific licenses.
Section 40.52 Certain Items Containing Source Material; Requirements
for License To Apply or Initially Transfer
10 CFR 40.52--Establishes requirements for a license authorizing
distribution for use under the exemptions from licensing in Sec.
40.13(c) and equivalent provisions of Agreement States.
Section 40.53 Conditions of Licenses Issued for Initial Transfer of
Certain Items Containing Source Material: Quality Control, Labeling,
and Records and Reports
10 CFR 40.53--Establishes requirements for licenses issued under
Sec. 40.52, including reporting and recordkeeping requirements for
distributions of products for use under Sec. 40.13(c) and equivalent
provisions of Agreement States.
Section 40.54 Requirements for License To Initially Transfer Source
Material for Use Under the `Small Quantities of Source Material'
General License
10 CFR 40.54--Establishes requirements for a license authorizing
initial transfer or distribution for use under Sec. 40.22(a) and
equivalent provisions of Agreement States.
Section 40.55 Conditions of Licenses To Initially Transfer Source
Material for Use Under the `Small Quantities of Source Material'
General License: Quality Control, Labeling, Safety Instructions,
Records and Reports.
10 CFR 40.55--Establishes requirements for licenses issued under
Sec. 40.54, including reporting and recordkeeping requirements for the
distribution of source material for use under the general license in
Sec. 40.22 and equivalent provisions of Agreement States.
Section 40.82 Criminal Penalties
10 CFR 40.82(b)--Adds sections to the list of provisions that are
not subject to criminal sanctions.
Section 70.5 Communications
10 CFR 70.5(b)(1)(iv)--Adds a reference to the new Sec. 40.52 as a
licensing category not delegated to the NRC Regions.
[[Page 32335]]
Section 170.31 Schedule of Fees for Materials Licenses and Other
Regulatory Services, Including Inspections, and Import and Export
Licenses
10 CFR 170.31--Adds three new categories for distributors of source
material to the schedule of fees.
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--Adds three fee categories for distributors of source
material to the annual fees.
V. Criminal Penalties
For the purpose of Section 223 of the AEA, the Commission is
amending Sec. 40.22 and adding Sec. Sec. 40.53 and 40.55 under one or
more of Sections 161b, 161i, or 161o of the AEA. Willful violations of
the rule will 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 final rule is 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 final 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'' (see http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
NRC program elements (including regulations) are placed into four
compatibility categories (see the 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, 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 AEA, as amended, or provisions of 10 CFR. These program
elements are not adopted by Agreement States. The following table lists
the parts and sections that have been created or revised and their
corresponding categorization under the ``Policy Statement on Adequacy
and Compatibility of Agreement State Programs.'' A bracket around a
category means that the section may have been adopted elsewhere, and it
is not necessary to adopt it again.
The Agreement States have 3 years from the effective date of the
final rule to adopt compatible regulations.
Compatibility Table for Final Rule
[Distribution of source material to exempt persons and to general licensees and revision of general license and
exemptions]
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -------------------------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Part 30
----------------------------------------------------------------------------------------------------------------
30.6............................ Amend.............. Communications..... D................ D
----------------------------------------------------------------------------------------------------------------
Part 40
----------------------------------------------------------------------------------------------------------------
40.4............................ Amend.............. Definitions........ B................ B
Unrefined and
unprocessed ore.
40.5............................ Amend.............. Communications..... D................ D
40.8............................ Amend.............. Information D................ D
collection
requirements: OMB
approval.
40.13(c)........................ Amend.............. Unimportant B................ B
quantities of
source material.
40.13(c)(2)(i).................. Amend.............. Unimportant B................ B
quantities of
source material.
40.13(c)(2)(iii)................ Amend.............. Unimportant B................ B
quantities of
source material.
40.13(c)(5)(i).................. Remove............. Unimportant B................ B
quantities of
source material.
40.13(c)(5)(ii)................. Redesignate........ Unimportant B................ B
quantities of
source material
(becomes
40.13(c)(5)(i)).
40.13(c)(5)(iii)................ Redesignate........ Unimportant B................ B
quantities of
source material
(becomes
40.13(c)(5)(ii)).
40.13(c)(5)(iv)................. Redesignate........ Unimportant B................ B
quantities of
source material
(becomes
40.13(c)(5)(iii)).
40.13(c)(5)(v).................. Redesignate........ Unimportant NRC.............. NRC
quantities of
source material
(becomes
40.13(c)(5)(iv)).
[[Page 32336]]
40.13(c)(7)..................... Amend.............. Unimportant B................ B
quantities of
source material.
40.13(c)(10).................... New................ Unimportant ................. B
quantities of
source material.
40.13(d)........................ Remove............. Unimportant B................ *
quantities of
source material.
40.22(a)........................ Amend.............. Small quantities of B................ B
source material.
40.22(a)(1)..................... New................ Small quantities of ................. B
source material.
40.22(a)(2)..................... New................ Small quantities of ................. B
source material.
40.22(a)(3)..................... New................ Small quantities of ................. B
source material.
40.22(a)(4)..................... New................ Small quantities of ................. B
source material.
40.22(b)........................ Amend.............. Small quantities of B................ B
source material.
40.22(b)(1)..................... New................ Small quantities of ................. B
source material.
40.22(b)(2)..................... New................ Small quantities of ................. B
source material.
40.22(b)(3)..................... New................ Small quantities of ................. B
source material.
40.22(b)(4)..................... New................ Small quantities of ................. D
source material.
40.22(b)(5)..................... New................ Small quantities of ................. B
source material.
40.22(c)........................ New................ Small quantities of ................. C
source material.
40.22(d)........................ Amend.............. Small quantities of B................ B
source material
(Previously
40.22(b)).
40.22(e)........................ New................ Small quantities of ................. B
source material.
40.32(f)........................ Amend.............. General D................ D
requirements for
issuance of a
specific license.
40.52........................... New................ Certain items ................. NRC
containing source
material;
requirements for
license to apply
or initially
transfer.
40.53........................... New................ Conditions of ................. NRC
licenses issued
for initial
transfer of
certain items
containing source
material: Quality
control, labeling,
and records and
reports.
40.54........................... New................ Requirements for ................. B
license to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license.
40.55(a)........................ New................ Conditions of ................. B
licenses to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license: Quality
control, labeling,
safety
instructions, and
records and
reports.
40.55(b)........................ New................ Conditions of ................. B
licenses to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license: Quality
control, labeling,
safety
instructions, and
records and
reports.
40.55(c)........................ New................ Conditions of ................. B
licenses to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license: Quality
control, labeling,
safety
instructions, and
records and
reports.
40.55(d)........................ New................ Conditions of ................. B
licenses to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license: Quality
control, labeling,
safety
instructions, and
records and
reports.
40.55(e)........................ New................ Conditions of ................. C
licenses to
initially transfer
source material
for use under the
`small quantities
of source
material' general
license: Quality
control, labeling,
safety
instructions, and
records and
reports.
40.82........................... Amend.............. Criminal penalties. D................ D
----------------------------------------------------------------------------------------------------------------
Part 70
----------------------------------------------------------------------------------------------------------------
70.5............................ Amend.............. Communications..... D................ D
----------------------------------------------------------------------------------------------------------------
Part 170
----------------------------------------------------------------------------------------------------------------
170.31.......................... Amend.............. Schedules of fees D................ D
for materials
licenses and other
regulatory
services,
including
inspections, and
import and export
licenses.
----------------------------------------------------------------------------------------------------------------
Part 171
----------------------------------------------------------------------------------------------------------------
171.16.......................... Amend.............. Annual fees for D................ D
materials licenses
and other
regulatory
services.
----------------------------------------------------------------------------------------------------------------
* Denotes an existing provision that is currently designated Compatibility Category B, which will be removed
from the regulations as a result of these amendments. Agreement States should remove this provision from their
regulations.
[[Page 32337]]
VII. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, well-organized manner
that also follows other best practices appropriate to the subject or
field and the intended audience. The NRC has attempted to use plain
language in promulgating this rule consistent with the Federal Plain
Writing Act guidelines.
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 final rule, the NRC is establishing
requirements for distributors of source material to persons exempt from
regulation and to general licensees. In addition, the final amendments
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 revising, clarifying, or deleting certain exemptions from
licensing to make the requirements for the use of source material under
the exemptions more risk informed. This action does not constitute the
establishment of a standard that establishes generally applicable
requirements.
IX. Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, not to prepare an environmental impact
statement for this final rule because the Commission has concluded on
the basis of an environmental assessment that this final rule, if
adopted, would not be a major Federal action significantly affecting
the quality of the human environment.
The determination of this environmental assessment is that there
will be no significant impact to the public from this action.
The majority of the provisions in the final rule come within the
scope of categorical exclusion in Sec. 51.22, and as such, an
environmental review is not necessary. The NRC has also determined that
implementation of the remaining provisions of the final rule would not
result in any significant impact to the environment. Revisions to Sec.
40.22 primarily provide additional limitations on, and clarify the
requirements of, the Sec. 40.22 general licensee, thus, potentially
reducing the impact on environmental resources from the status quo.
Similarly, certain exemptions are being revised or deleted to limit the
future use of certain products containing source material. Although the
NRC is expanding the exemption from licensing in Sec. 40.13(c)(7) to
allow coated lenses and mirrors, 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 final rule would be procedural and
administrative in nature.
This conclusion was published in the environmental assessment that
was posted to the NRC rulemaking Web site, http://www.regulations.gov
for 75 days after publication of the proposed rule. No comments were
received on the content of the environmental assessment.
X. Paperwork Reduction Act Statement
This final rule contains new or amended information collection
requirements contained in 10 CFR parts 19, 20, 40, and NRC Form 313,
that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). These requirements were approved by the Office of Management
and Budget, approval numbers 3150-0044, -0014, -0215, -0020, and -0120.
The final rule changes to 10 CFR parts 30, 70, 170, and 171 do not
contain new or amended information collection requirements.
The burden to the public for these information collections is
estimated to average 4.2 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
information collection. Send comments on any aspect of these
information collections, including suggestions for reducing the burden,
to the Information Services Branch (T-5 F53), U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, or by Internet electronic mail
to [email protected]; and to the Desk Officer, Office of
Information and Regulatory Affairs, NEOB-10202, (3150-0215), Office of
Management and Budget, Washington, DC 20503. You may also email
comments to [email protected] or comment by telephone at
202-395-4718.
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 regulatory analysis on this
regulation (ADAMS Accession No. ML13079A302). The analysis examines the
costs and benefits of the alternatives considered by the Commission.
The analysis is available for inspection on http://www.regulations.gov
by searching on Docket ID NRC-2009-0084 and in the NRC's PDR, 11555
Rockville Pike, Rockville, MD 20852.
XII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. A significant number of the licensees affected by
this action may 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 revisions to the regulatory program
will result in a significant economic impact on the affected entities.
XIII. Backfit Analysis
The NRC's backfit provisions are found in the regulations at
Sec. Sec. 50.109, 52.39, 52.63, 52.83, 52.98, 52.145, 52.171, 70.76,
72.62, and 76.76. The requirements contained in this final rule do not
involve any provisions that 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 final rule
to address these classes of entities. With respect to 10 CFR part 40
licensees, there are no provisions for backfit in 10 CFR part 40.
Therefore, a backfit analysis has not been prepared for this final rule
to address 10 CFR part 40 licensees.
XIV. Congressional Review Act
In accordance with the Congressional Review Act of 1996, the NRC
has determined that this action is not a
[[Page 32338]]
major rule and has verified this determination with the Office of
Information and Regulatory Affairs of OMB.
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, Non-payment penalties, Nuclear materials, Nuclear power
plants and reactors, Source material, Special nuclear material.
10 CFR Part 171
Annual charges, Byproduct material, Holders of certificates,
registrations, approvals, Intergovernmental relations, Nonpayment
penalties, Nuclear materials, Nuclear power plants and reactors, Source
material, Special nuclear material.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting
the following amendments to 10 CFR parts 30, 40, 70, 170, and 171.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
0
1. The authority citation for part 30 continues to read as follows:
Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183,
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236,
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-
58, 119 Stat. 549 (2005).
Section 30.7 also issued under Energy Reorganization Act sec.
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec.
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
2. In Sec. 30.6, paragraph (b)(1)(iv) is revised to read as follows:
Sec. 30.6 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material under
Sec. Sec. 32.11 through 32.30 and 40.52 of this chapter to persons
exempt from licensing requirements.
* * * * *
PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL
0
3. The authority citation for part 40 continues to read as follows:
Authority: Atomic Energy Act secs. 11(e)(2), 62, 63, 64, 65,
81, 161, 181, 182, 183, 186, 193, 223, 234, 274, 275 (42 U.S.C.
2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2231,
2232, 2233, 2236, 2243, 2273, 2282, 2021, 2022); Energy
Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005, Pub. L. 109-59, 119 Stat. 594
(2005).
Section 40.7 also issued under Energy Reorganization Act sec.
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec.
2902 (42 U.S.C. 5851). Section 40.31(g) also issued under Atomic
Energy Act sec. 122 (42 U.S.C. 2152). Section 40.46 also issued
under Atomic Energy Act sec. 184 (42 U.S.C. 2234). Section 40.71
also issued under Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
4. In Sec. 40.4, the definition of Unrefined and unprocessed ore is
revised to read as follows:
Sec. 40.4 Definitions.
* * * * *
Unrefined and unprocessed ore means ore in its natural form prior
to any processing, such as grinding, roasting or beneficiating, or
refining. Processing does not include sieving or encapsulation of ore
or preparation of samples for laboratory analysis.
* * * * *
0
5. In Sec. 40.5, paragraph (b)(1)(iv) is revised to read as follows:
Sec. 40.5 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material under
Sec. Sec. 32.11 through 32.30 and 40.52 of this chapter to persons
exempt from licensing requirements.
* * * * *
0
6. In Sec. 40.8, paragraph (b) is revised to read as follows:
Sec. 40.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 40.9, 40.22, 40.23, 40.25, 40.26, 40.27,
40.31, 40.34, 40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.52,
40.53, 40.54, 40.55, 40.60, 40.61, 40.64, 40.65, 40.66, 40.67, and
appendix A to this part.
* * * * *
0
7. In Sec. 40.13:
0
a. Paragraphs (c) introductory text, (c)(2)(i), and (c)(2)(iii) are
revised;
0
b. Paragraph (c)(5)(i) is removed;
0
c. Paragraphs (c)(5)(ii) through (v) are redesignated as paragraphs
(c)(5)(i) through (iv);
0
d. Paragraph (c)(7) is revised;
0
e. Paragraph (c)(10) is added;
0
f. Paragraph (d) is removed; and
0
g. Footnote 2 is revised.
The revisions and addition read as follows:
Sec. 40.13 Unimportant quantities of source material.
* * * * *
(c) Any person is exempt from the requirements for a license set
forth in section 62 of the Act and from the regulations in this part
and parts 19, 20, and 21 of this chapter to the extent that such person
receives, possesses, uses, or transfers:
* * * * *
(2) * * *
(i) Glazed ceramic tableware manufactured before August 27, 2013,
provided that the glaze contains not more than 20 percent by weight
source material;
* * * * *
(iii) Glassware containing not more than 2 percent by weight source
material or, for glassware manufactured before August 27, 2013, 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;
* * * * *
(7) Thorium or uranium contained in or on finished optical lenses
and mirrors, provided that each lens or mirror does not contain more
than 10 percent by weight thorium or uranium or, for lenses
manufactured before August 27, 2013, 30 percent by weight
[[Page 32339]]
of thorium; and that the exemption contained in this paragraph does not
authorize either:
(i) The shaping, grinding or polishing of such lens or mirror or
manufacturing processes other than the assembly of such lens or mirror
into optical systems and devices without any alteration of the lens or
mirror; or
(ii) The receipt, possession, use, or transfer of uranium or
thorium contained in contact lenses, or in spectacles, or in eyepieces
in binoculars or other optical instruments.
* * * * *
(10) No person may initially transfer for sale or distribution a
product containing source material to persons exempt under this
paragraph (c), or equivalent regulations of an Agreement State, unless
authorized by a license issued under Sec. 40.52 to initially transfer
such products for sale or distribution.
(i) Persons initially distributing source material in products
covered by the exemptions in this paragraph (c) before August 27, 2013,
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 these
materials or products containing source material by an Agreement State,
and persons who import finished products or parts, for sale or
distribution must be authorized by a license issued under Sec. 40.52
for distribution only and are exempt from the requirements of parts 19
and 20 of this chapter, and Sec. 40.32(b) and (c).
* * * * *
\2\ The requirements specified in paragraphs (c)(5)(i) and (ii)
of this section need not be met by counterweights manufactured prior
to Dec. 31, 1969, provided that such counterweights were
manufactured under a specific license issued by the Atomic Energy
Commission and were impressed with the legend required by Sec.
40.13(c)(5)(ii) in effect on June 30, 1969.
0
8. Section 40.22 is revised to read as follows:
Sec. 40.22 Small quantities of source material.
(a) A general license is hereby issued authorizing commercial and
industrial firms; research, educational, and medical institutions; and
Federal, State, and local government agencies to receive, possess, use,
and transfer uranium and thorium, in their natural isotopic
concentrations and in the form of depleted uranium, for research,
development, educational, commercial, or operational purposes in the
following forms and quantities:
(1) No more than 1.5 kg (3.3 lb) of uranium and thorium in
dispersible forms (e.g., gaseous, liquid, powder, etc.) at any one
time. Any material processed by the general licensee that alters the
chemical or physical form of the material containing source material
must be accounted for as a dispersible form. 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. Persons possessing source material in excess of
these limits as of August 27, 2013, may continue to possess up to 7 kg
(15.4 lb) of uranium and thorium at any one time for one year beyond
this date, or until the Commission takes final action on a pending
application submitted on or before August 27, 2014, for a specific
license for such material; and receive up to 70 kg (154 lb) of uranium
or thorium in any one calendar year until December 31, 2014, or until
the Commission takes final action on a pending application submitted on
or before August 27, 2014, for a specific license for such material;
and
(2) No more than a total of 7 kg (15.4 lb) of uranium and thorium
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 70 kg (154 lb) of uranium and thorium in any one calendar year. A
person may not alter the chemical or physical form of the source
material possessed under this paragraph unless it is accounted for
under the limits of paragraph (a)(1) of this section; or
(3) No 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; or
(4) No more than 7 kg (15.4 lb) of uranium and thorium at
laboratories for the purpose of determining the concentration of
uranium and thorium contained within the material being analyzed 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 70
kg (154 lb) of source material in any one calendar year.
(b) Any person who receives, possesses, uses, or transfers source
material in accordance with the general license in paragraph (a) of
this section:
(1) Is prohibited from administering source material, or the
radiation therefrom, either externally or internally, to human beings
except as may be authorized by the NRC in a specific license.
(2) Shall not abandon such source material. Source material may be
disposed of as follows:
(i) A cumulative total of 0.5 kg (1.1 lb) of source material in a
solid, non-dispersible form may be transferred each calendar year, by a
person authorized to receive, possess, use, and transfer source
material under this general license to persons receiving the material
for permanent disposal. The recipient of source material transferred
under the provisions of this paragraph is exempt from the requirements
to obtain a license under this part to the extent the source material
is permanently disposed. This provision does not apply to any person
who is in possession of source material under a specific license issued
under this chapter; or
(ii) In accordance with Sec. 20.2001 of this chapter.
(3) Is subject to the provisions in Sec. Sec. 40.1 through 40.10,
40.41(a) through (e), 40.46, 40.51, 40.56, 40.60 through 40.63, 40.71,
and 40.81.
(4) Shall respond to written requests from the NRC to provide
information relating to the general license within 30 calendar days of
the date of the request, or other time specified in the request. If the
person cannot provide the requested information within the allotted
time, the person shall, within that same time period, request a longer
period to supply the information by providing the Director of the
Office of Federal and State Materials and Environmental Management
Programs, using an appropriate method listed in Sec. 40.5(a), a
written justification for the request;
(5) Shall not export such source material except in accordance with
part 110 of this chapter.
(c) Any person who receives, possesses, uses, or transfers source
material in accordance with paragraph (a) of this section shall conduct
activities so as to minimize contamination of the facility and the
environment. When activities involving such source material are
permanently ceased at any site, if evidence of significant
contamination is identified, the general licensee shall notify the
Director of the Office of Federal and State Materials and Environmental
Management Programs by an appropriate method listed in Sec. 40.5(a)
about such contamination and may consult with the NRC as to the
appropriateness of sampling and
[[Page 32340]]
restoration activities to ensure that any contamination or residual
source material remaining at the site where source material was used
under this general license is not likely to result in exposures that
exceed the limits in Sec. 20.1402 of this chapter.
(d) Any person who receives, possesses, uses, or transfers source
material in accordance with the general license granted in paragraph
(a) of this section is exempt from the provisions of parts 19, 20, and
21 of this chapter to the extent that such receipt, possession, use,
and transfer are within the terms of this general license, except that
such person shall comply with the provisions of Sec. Sec. 20.1402 and
20.2001 of this chapter to the extent necessary to meet the provisions
of paragraphs (b)(2) and (c) of this section. However, this exemption
does not 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)(1) or (2) of this
section, or equivalent regulations of an Agreement State, unless
authorized by a specific license issued in accordance with Sec. 40.54
or equivalent provisions of an Agreement State. This prohibition does
not apply to analytical laboratories returning processed samples to the
client who initially provided the sample. Initial distribution of
source material to persons generally licensed by paragraph (a) of this
section before August 27, 2013, 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 on or before August 27, 2014.
0
9. In Sec. 40.32, paragraph (f) is revised to read as follows:
Sec. 40.32 General requirements for issuance of a specific license.
* * * * *
(f) The applicant satisfies any applicable special requirements
contained in Sec. Sec. 40.34, 40.52, and 40.54.
* * * * *
0
10. Sections 40.52, 40.53, 40.54, and 40.55 are added under the
undesignated heading Transfer of Source Material to read as follows:
Sec. 40.52 Certain items containing source material; requirements for
license to apply or initially transfer.
An application for a specific license to apply source material to,
incorporate source material into, manufacture, process, or produce the
products specified in Sec. 40.13(c) or to initially transfer for sale
or distribution any products containing source material for use under
Sec. 40.13(c) or equivalent provisions of an Agreement State will be
approved if:
(a) The applicant satisfies the general requirements specified in
Sec. 40.32. However, the requirements of Sec. 40.32(b) and (c) do not
apply to an application for a license to transfer products
manufactured, processed, or produced in accordance with a license
issued by an Agreement State or to the import of finished products or
parts.
(b) The applicant submits sufficient information regarding the
product pertinent to the evaluation of the potential radiation
exposures, including:
(1) Chemical and physical form and maximum quantity of source
material in each product;
(2) Details of construction and design of each product, if
applicable. For coated lenses, this must include a description of
manufacturing methods that will ensure that the coatings are unlikely
to be removed under the conditions expected to be encountered during
handling and use;
(3) For products with applicable quantity or concentration limits,
quality control procedures to be followed in the fabrication of
production lots of the product and the quality control standards the
product will be required to meet;
(4) The proposed method of labeling or marking each unit, and/or
its container with the identification of the manufacturer or initial
transferor of the product and the source material in the product; and
(5) The means of providing radiation safety precautions and
instructions relating to handling, use, and storage of products to be
used under Sec. 40.13(c)(1)(i) and (c)(1)(iii).
(c) Each product will contain no more than the quantity or the
concentration of source material specified for that product in Sec.
40.13(c).
Sec. 40.53 Conditions for licenses issued for initial transfer of
certain items containing source material: Quality control, labeling,
and records and reports.
(a) Each person licensed under Sec. 40.52 shall ensure that the
quantities or concentrations of source material do not exceed any
applicable limit in Sec. 40.13(c).
(b) Each person licensed under Sec. 40.52 shall ensure that each
product is labeled as provided in the specific exemption under Sec.
40.13(c) and as required by their license. Those distributing products
to be used under Sec. 40.13(c)(1)(i) and (iii) or equivalent
regulations of an Agreement State shall provide radiation safety
precautions and instructions relating to handling, use, and storage of
these products as specified in the license.
(c)(1) Each person licensed under Sec. 40.52 shall file a report
with the Director, Office of Federal and State Materials and
Environmental Management Programs by an appropriate method listed in
Sec. 40.5(a), including in the address: ATTN: Document Control Desk/
Exempt Distribution.
(2) The report must clearly identify the specific licensee
submitting the report and include the license number of the specific
licensee and indicate that the products are transferred for use under
Sec. 40.13(c), giving the specific paragraph designation, or
equivalent regulations of an Agreement State.
(3) The report must include the following information on products
transferred to other persons for use under Sec. 40.13(c) or equivalent
regulations of an Agreement State:
(i) A description or identification of the type of each product and
the model number(s), if applicable;
(ii) For each type of source material in each type of product and
each model number, if applicable, the total quantity of the source
material; and
(iii) The number of units of each type of product transferred
during the reporting period by model number, if applicable.
(4) The licensee shall file the report, covering the preceding
calendar year, on or before January 31 of each year. Licensees who
permanently discontinue activities authorized by the license issued
under Sec. 40.52 shall file a report for the current calendar year
within 30 days after ceasing distribution.
(5) If no transfers of source material have been made to persons
exempt under Sec. 40.13(c) or the equivalent regulations of an
Agreement State, during the reporting period, the report must so
indicate.
(6) The licensee shall maintain all information concerning
transfers that support the reports required by this section for 1 year
after each transfer is included in a report to the Commission.
Sec. 40.54 Requirements for license to initially transfer source
material for use under the `small quantities of source material'
general license.
An application for a specific license to initially transfer source
material for use under Sec. 40.22, or equivalent regulations of an
Agreement State, will be approved if:
(a) The applicant satisfies the general requirements specified in
Sec. 40.32; and
[[Page 32341]]
(b) The applicant submits adequate information on, and the
Commission approves the methods to be used for quality control,
labeling, and providing safety instructions to recipients.
Sec. 40.55 Conditions of licenses to initially transfer source
material for use under the `small quantities of source material'
general license: Quality control, labeling, safety instructions, and
records and reports.
(a) Each person licensed under Sec. 40.54 shall label the
immediate container of each quantity of source material with the type
of source material and quantity of material and the words,
``radioactive material.''
(b) Each person licensed under Sec. 40.54 shall ensure that the
quantities and concentrations of source material are as labeled and
indicated in any transfer records.
(c) Each person licensed under Sec. 40.54 shall provide the
information specified in this paragraph to each person to whom source
material is transferred for use under Sec. 40.22 or equivalent
provisions in Agreement State regulations. This information must be
transferred before the source material is transferred for the first
time in each calendar year to the particular recipient. The required
information includes:
(1) A copy of Sec. Sec. 40.22 and 40.51, or relevant equivalent
regulations of the Agreement State.
(2) Appropriate radiation safety precautions and instructions
relating to handling, use, storage, and disposal of the material.
(d) Each person licensed under Sec. 40.54 shall report transfers
as follows:
(1) File a report with the Director, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555. The report shall include
the following information:
(i) The name, address, and license number of the person who
transferred the source material;
(ii) For each general licensee under Sec. 40.22 or equivalent
Agreement State provisions to whom greater than 50 grams (0.11 lb) of
source material has been transferred in a single calendar quarter, the
name and address of the general licensee to whom source material is
distributed; a responsible agent, by name and/or position and phone
number, of the general licensee to whom the material was sent; and the
type, physical form, and quantity of source material transferred; and
(iii) The total quantity of each type and physical form of source
material transferred in the reporting period to all such generally
licensed recipients.
(2) File a report with each responsible Agreement State agency that
identifies all persons, operating under provisions equivalent to Sec.
40.22, to whom greater than 50 grams (0.11 lb) of source material has
been transferred within a single calendar quarter. The report shall
include the following information specific to those transfers made to
the Agreement State being reported to:
(i) The name, address, and license number of the person who
transferred the source material; and
(ii) The name and address of the general licensee to whom source
material was distributed; a responsible agent, by name and/or position
and phone number, of the general licensee to whom the material was
sent; and the type, physical form, and quantity of source material
transferred.
(iii) The total quantity of each type and physical form of source
material transferred in the reporting period to all such generally
licensed recipients within the Agreement State.
(3) Submit each report by January 31 of each year covering all
transfers for the previous calendar year. If no transfers were made to
persons generally licensed under Sec. 40.22 or equivalent Agreement
State provisions during the current period, a report shall be submitted
to the Commission indicating so. If no transfers have been made to
general licensees in a particular Agreement State during the reporting
period, this information shall be reported to the responsible Agreement
State agency upon request of the agency.
(e) Each person licensed under Sec. 40.54 shall 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.
0
11. In Sec. 40.82, paragraph (b) is revised to read as follows:
Sec. 40.82 Criminal penalties.
* * * * *
(b) The regulations in part 40 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12,
40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34, 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
0
12. The authority citation for part 70 continues to read as follows:
Authority: Atomic Energy Act secs. 51, 53, 161, 182, 183, 193,
223, 234 (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2243, 2273, 2282,
2297f); secs. 201, 202, 204, 206, 211 (42 U.S.C. 5841, 5842, 5845,
5846, 5851); Government Paperwork Elimination Act sec. 1704 (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 70.21(g) also issued under Atomic Energy Act sec. 122
(42 U.S.C. 2152). Section 70.31 also issued under Atomic Energy Act
sec. 57(d) (42 U.S.C. 2077(d)). Sections 70.36 and 70.44 also issued
under Atomic Energy Act sec. 184 (42 U.S.C. 2234). Section 70.81
also issued under Atomic Energy Act secs. 186, 187 (42 U.S.C. 2236,
2237). Section 70.82 also issued under Atomic Energy Act sec. 108
(42 U.S.C. 2138).
0
13. In Sec. 70.5, paragraph (b)(1)(iv) is revised to read as follows:
Sec. 70.5 Communications.
* * * * *
(b) * * *
(1) * * *
(iv) Distribution of products containing radioactive material under
Sec. Sec. 32.11 through 32.30 and 40.52 of this chapter to persons
exempt from licensing requirements.
* * * * *
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
0
14. The authority citation for part 170 continues to read as follows:
Authority: Independent Offices Appropriations Act sec. 501 (31
U.S.C. 9701); Atomic Energy Act sec. 161(w) (42 U.S.C. 2201(w));
Energy Reorganization Act sec. 201 (42 U.S.C. 5841); Chief Financial
Officers Act sec. 205 (31 U.S.C. 901, 902); Government Paperwork
Elimination Act sec. 1704, (44 U.S.C. 3504 note); Energy Policy Act
secs. 623, Energy Policy Act of 2005 sec. 651(e) Pub. L. 109-58, 119
Stat. 783 (42 U.S.C. 2201(w), 2014, 2021, 2021b, 2111).
0
15. In Sec. 170.31, the table. ``Schedule of Materials Fees'' is
amended by redesignating materials license category 2.C. as category
2.F. and adding new categories 2.C., 2.D., and 2.E. to read as follows:
Sec. 170.31 Schedule of fees for materials licenses and other
regulatory services, including inspections, and import and export
licenses.
* * * * *
[[Page 32342]]
Schedule of Materials Fees
[See footnotes at end of table]
------------------------------------------------------------------------
Categories of materials licenses and type of fees \1\ Fee 2 3
------------------------------------------------------------------------
* * * * * * *
2. Source material:
* * * * * * *
C. Licenses to distribute items containing source
material to persons exempt from the licensing
requirements of part 40 of this chapter............
Application [Program Code(s): 11240]............ $7,000
D. Licenses to distribute source material to persons
generally licensed under part 40 of this chapter...
Application [Program Code(s): 11230 and 11231].. 2,000
E. Licenses for possession and use of source
material for processing or manufacturing of
products or materials containing source material
for commercial distribution........................
Application [Program Code(s): 11710]............ 5,400
F. All other source material licenses...............
Application [Program Code(s): 11200, 11220, 5,400
11221, 11300, 11800, 11810]....................
* * * * * * *
------------------------------------------------------------------------
\1\ Types of fees--Separate charges, as shown in the schedule, will be
assessed for preapplication 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, preapplication
consultations and other documents submitted to the NRC for review, and
project manager time for fee categories subject to full cost fees are
due upon notification by the Commission in accordance with Sec.
170.12(b).
(c) Amendment fees. Applications for amendments to export and import
licenses must be accompanied by the prescribed amendment fee for each
license affected. An application for an amendment to an export or
import license or approval classified in more than one fee category
must be accompanied by the prescribed amendment fee for the category
affected by the amendment, unless the amendment is applicable to two
or more fee categories, in which case the amendment fee for the
highest fee category would apply.
(d) Inspection fees. Inspections resulting from investigations conducted
by the Office of Investigations and nonroutine inspections that result
from third-party allegations are not subject to fees. Inspection fees
are due upon notification by the Commission in accordance with Sec.
170.12(c).
(e) Generally licensed device registrations under 10 CFR 31.5.
Submittals of registration information must be accompanied by the
prescribed fee.
\2\ Fees will not be charged for orders related to civil penalties or
other civil sanctions issued by the Commission under 10 CFR 2.202 or
for amendments resulting specifically from the requirements of these
orders. For orders unrelated to civil penalties or other civil
sanctions, fees will be charged for any resulting licensee-specific
activities not otherwise exempted from fees under this chapter. Fees
will be charged for approvals issued under a specific exemption
provision of the Commission's regulations under Title 10 of the Code
of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and
any other sections in effect now or in the future), regardless of
whether the approval is in the form of a license amendment, letter of
approval, safety evaluation report, or other form. In addition to the
fee shown, an applicant may be assessed an additional fee for sealed
source and device evaluations as shown in Categories 9.A. through 9.D.
\3\ Full cost fees will be determined based on the professional staff
time multiplied by the appropriate professional hourly rate
established in Sec. 170.20 in effect when the service is provided,
and the appropriate contractual support services expended. For
applications currently on file for which review costs have reached an
applicable fee ceiling established by the June 20, 1984, and July 2,
1990, rules, but are still pending completion of the review, the cost
incurred after any applicable ceiling was reached through January 29,
1989, will not be billed to the applicant. Any professional staff-
hours expended above those ceilings on or after January 30, 1989, will
be assessed at the applicable rates established by Sec. 170.20, as
appropriate, except for topical reports for which costs exceed
$50,000. Costs that exceed $50,000 for each topical report, amendment,
revision, or supplement to a topical report completed or under review
from January 30, 1989, through August 8, 1991, will not be billed to
the applicant. Any professional hours expended on or after August 9,
1991, will be assessed at the applicable rate established in Sec.
170.20.
PART 171--ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES
AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF
COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS,
AND GOVERNMENT AGENCIES LICENSED BY NRC
0
16. The authority citation for part 171 continues to read as follows:
Authority: Consolidated Omnibus Budget Reconciliation Act sec.
7601 Pub. L. 99-272, as amended by sec. 5601, Pub. L. 100-203 as
amended by sec. 3201, Pub. L. 101-239, as amended by sec. 6101, Pub.
L. 101-508, as amended by sec. 2903a, Pub. L. 102-486 (42 U.S.C.
2213, 2214), and as amended by Title IV, Pub. L. 109-103 (42 U.S.C.
2214); Atomic Energy Act sec. 161(w), 223, 234 (42 U.S.C. 2201(w),
2273, 2282); Energy Reorganization Act sec. 201 (42 U.S.C. 5841);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005 sec. 651(e), Pub. L. 109-58 (42
U.S.C. 2014, 2021, 2021b, 2111).
0
17. In Sec. 171.16, the table in paragraph (d) is amended by
redesignating materials license category 2.C. as category 2.F. and
adding new categories 2.C., 2.D., and 2.E. to read as follows:
Sec. 171.16 Annual fees: Materials licensees, holders of certificates
of compliance, holders of sealed source and device registrations,
holders of quality assurance program approvals, and government agencies
licensed by the NRC.
* * * * *
(d) * * *
[[Page 32343]]
Schedule of Materials Annual Fees and Fees for Government Agencies
Licensed by NRC
[See footnotes at end of table]
------------------------------------------------------------------------
Annual fees 1
Category of materials licenses 2 3
------------------------------------------------------------------------
* * * * * * *
2. Source Material:
* * * * * * *
C. Licenses to distribute items containing source $10,000
material to persons exempt from the licensing
requirements of part 40 of this chapter [Program
Code(s): 11240]....................................
D. Licenses to distribute source material to persons 5,000
generally licensed under part 40 of this chapter
[Program Code(s): 11230 and 11231].................
E. Licenses for possession and use of source 12,400
material for processing or manufacturing of
products or materials containing source material
for commercial distribution. [Program Code(s):
11710].............................................
F. All other source material licenses. [Program 12,400
Code(s): 11200, 11220, 11221, 11300, 11800, 11810].
* * * * * * *
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\1\Annual fees will be assessed based on whether a licensee held a valid
license with the NRC authorizing possession and use of radioactive
material during the current FY. The annual fee is waived for those
materials licenses and holders of certificates, registrations, and
approvals who either filed for termination of their licenses or
approvals or filed for possession only/storage licenses before October
1, 2011, and permanently ceased licensed activities entirely before
this date. Annual fees for licensees who filed for termination of a
license, downgrade of a license, or for a possession-only license
during the FY and for new licenses issued during the FY will be
prorated in accordance with the provisions of Sec. 171.17. If a
person holds more than one license, certificate, registration, or
approval, the annual fee(s) will be assessed for each license,
certificate, registration, or approval held by that person. For
licenses that authorize more than one activity on a single license
(e.g., human use and irradiator activities), annual fees will be
assessed for each category applicable to the license. Licensees paying
annual fees under Category 1.A.(1) are not subject to the annual fees
for Categories 1.C. and 1.D. for sealed sources authorized in the
license.
\2\ Payment of the prescribed annual fee does not automatically renew
the license, certificate, registration, or approval for which the fee
is paid. Renewal applications must be filed in accordance with the
requirements of 10 CFR parts 30, 40, 70, 71, 72, or 76 of this
chapter.
\3\ Each FY, fees for these materials licenses will be calculated and
assessed in accordance with Sec. 171.13 and will be published in the
Federal Register for notice and comment.
* * * * *
Dated at Rockville, Maryland, this 21st day of May, 2013.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2013-12570 Filed 5-28-13; 8:45 am]
BILLING CODE 7590-01-P