[Federal Register Volume 75, Number 142 (Monday, July 26, 2010)]
[Proposed Rules]
[Pages 43425-43446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18223]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 75, No. 142 / Monday, July 26, 2010 / 
Proposed Rules  

[[Page 43425]]



NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 40, 70, 170, and 171

RIN 3150-AH15
[NRC-2009-0084]


Distribution of Source Material to Exempt Persons and to General 
Licensees and Revision of General License and Exemptions

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or ``the 
Commission'') is proposing to amend its regulations to require that the 
initial distribution of source material to exempt persons or general 
licensees be explicitly authorized by a specific license, which would 
include new reporting requirements. The proposed rule is intended to 
provide the Commission with more complete and timely information on the 
types and quantities of source material distributed for use either 
under exemption or by general licensees. In addition, the NRC is 
proposing to modify the existing possession and use requirements of the 
general license for small quantities of source material to better align 
the requirements with current health and safety standards. Finally, the 
NRC is proposing to revise, clarify, or delete certain source material 
exemptions from licensing to make the exemptions more risk informed. 
This rule would affect manufacturers and distributors of certain 
products and materials containing source material and certain persons 
using source material under general license and under exemptions from 
licensing.

DATES: Submit comments on the rule by November 23, 2010. Submit 
comments specific to the information collections aspects of this rule 
by October 25, 2010. Comments received after the above dates will be 
considered if it is practical to do so, but the NRC is able to assure 
consideration only for comments received on or before this date.

ADDRESSES: Please include Docket ID NRC-2009-0084 in the subject line 
of your comments. For instructions on submitting comments and accessing 
documents related to this action, see Section I, ``Submitting Comments 
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of 
this document. You may submit comments by any one of the following 
methods.
    Federal Rulemaking Web site: Go to http://www.regulations.gov and 
search for documents filed under Docket ID NRC-2009-0084. Address 
questions about NRC dockets to Carol Gallagher, telephone 301-492-3668, 
e-mail [email protected].
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: [email protected]. If you do not 
receive a reply e-mail confirming that we have received your comments, 
contact us directly at 301-415-1677.
    Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays (Telephone 301-
415-1677).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
301-415-1101.
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement.

FOR FURTHER INFORMATION CONTACT: Gary Comfort, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
8106, e-mail: [email protected], or Catherine Mattsen, Office of 
Federal and State Materials and Environmental Management Programs, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 
301-415-6264, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information
II. Background
    A. Introduction
    B. Regulatory Framework
    C. Why are revisions to 10 CFR Part 40 considered necessary?
III. Discussion
    A. What action is the NRC taking?
    A.1 Specific Licensing of Distribution of Source Material
    A.2 Distribution of Products to Persons Exempt From Regulation
    A.3 Distribution of Source Material to General Licensees
    A.4 Possession and Use of Source Material Under Sec.  40.22
    A.5 Revision of Exemption for Thorium Lenses
    A.6 Revision of Exemption for Glassware
    A.7 Obsolete Exemptions
    B. Whom would this action affect?
    C. Specific Requests for Comment
    D. What should I consider as I prepare my comments to the NRC?
IV. Summary of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Language
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact--Availability
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed. The NRC requests that any party soliciting or 
aggregating comments received from other persons for submission to the 
NRC inform those persons that the NRC will not edit their comments to 
remove any identifying or contact information, and therefore, they 
should not include any information in their comments that they do not 
want publicly disclosed.
    You can access publicly available documents related to this 
document using the following methods:
    NRC's Public Document Room (PDR): The public may examine and have 
copied, for a fee, publicly available documents at the NRC's PDR, Room 
O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland.
    NRC's Agencywide Documents Access and Management System (ADAMS):

[[Page 43426]]

Publicly available documents created or received at the NRC are 
available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain 
entry into ADAMS, which provides text and image files of NRC's public 
documents. If you do not have access to ADAMS or if there are problems 
in accessing the documents located in ADAMS, contact the NRC's PDR 
reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to 
[email protected].
    Federal Rulemaking Web Site: Public comments and supporting 
materials related to this proposed rule can be found at http://www.regulations.gov by searching on Docket ID NRC-2009-0084.

II. Background

A. Introduction

    Source material is regulated by the NRC under Title 10 of the Code 
of Federal Regulations (10 CFR) Part 40, ``Domestic Licensing of Source 
Material.'' Source material includes uranium and thorium in any 
physical or chemical form. Naturally occurring uranium and thorium and 
their decay chains emit alpha, beta, and gamma radiation. Uranium 
exhibits toxic chemical properties that can impair kidney function when 
ingested or inhaled in large quantities.\1\ Thorium dioxide is 
classified as a ``known carcinogen'' by the U.S. Agency for Toxic 
Substances and Disease Registry and has been linked to lung and liver 
diseases.\2\ Because of the potential for uranium and thorium to 
produce health effects from both chemical toxicity and radiological 
effects, it is important for the NRC to understand how and in what 
quantities uranium and thorium are being used under general license and 
various exemptions in order to better evaluate potential impacts to 
public health and safety.
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    \1\ U.S. Department of Health and Human Services, Agency for 
Toxic Substances and Disease Registry. ``ToxFAQs TM'' for 
Uranium,'' 1999.
    \2\ U.S. Department of Health and Human Services, Agency for 
Toxic Substances and Disease Registry. ``ToxFAQs TM for 
Thorium,'' 1999.
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    The last major modification of 10 CFR Part 40 occurred in 1961 and 
established licensing procedures, terms, and conditions for source 
material that were substantially similar to those set forth, at the 
time, in 10 CFR Part 30, ``Licensing of Byproduct Material.'' Since 
then, the health and safety requirements in 10 CFR Part 20, ``Standards 
for Protection Against Radiation,'' have been revised. In particular, 
radiation dose limits for individual members of the public were 
significantly reduced in the revision to 10 CFR Part 20. In addition, 
training and other requirements have been moved and revised from an 
earlier version of 10 CFR Part 20 into 10 CFR Part 19, ``Notices, 
Instructions and Reports to Workers: Inspection and Investigations.'' 
Although the requirements in 10 CFR Part 30 have been revised to 
address the changes to the health and safety requirements in 10 CFR 
Part 20 and the training requirements in 10 CFR Part 19, these changed 
standards have generally not been addressed with respect to the use of 
source material in 10 CFR Part 40.
    Some products currently covered by the exemptions from licensing in 
10 CFR Part 40 were in use before the enactment of the original Atomic 
Energy Act of 1946. Exemptions for the possession and use of many of 
these products were included in the original 10 CFR Part 40 issued in 
1947. As beneficial uses of radioactive material have developed and 
experience with the use of such material has grown, new products 
intended for use by the general public have been invented and the 
regulations have been amended to accommodate the use of new products. 
The regulations contained in 10 CFR Part 40 currently include no 
requirements to report how much source material is being distributed in 
the form of products for use under the exemptions from licensing.
    Section 40.22, ``Small quantities of source material,'' provides a 
general license authorizing commercial and industrial firms; research, 
educational, and medical institutions; and Federal, State, and local 
governmental agencies to use and transfer not more than 15 pounds (lb) 
(6.8 kilograms (kg)) of source material in any form at any one time for 
research, development, educational, commercial, or operational 
purposes. Not more than a total of 150 lb (68 kg) of source material 
may be received in any calendar year. Section 40.22 general licensees 
are exempt from the provisions of 10 CFR Parts 19, 20, and 21, unless 
the general licensee also possesses source material under a specific 
license. The general license prohibits the administration of source 
material or the radiation emanating from the source material, either 
externally or internally, to human beings except as may be authorized 
in a specific license issued by the Commission. There are no reporting 
requirements for persons transferring source material, initially or 
otherwise, for use under this general license. Thus, the NRC does not 
have significant information on whom, how, or in what quantities 
persons are using source material under this general license.
    The current Sec.  40.22 general license (post-1961) is much less 
restrictive than the previous version (1953-1961), which only permitted 
receipt of up to 3 lb (1.4 kg) of source material per year by 
pharmacists and physicians for medicinal purposes and by educational 
institutions and hospitals for educational and medical purposes only. 
In the previous version of this general license, resale of source 
material was prohibited. The current general license not only 
authorizes larger quantities of source material, but also allows 
broader types of authorized users and uses of source material. Also, 
resale is not prohibited.
    In the 1990's, the NRC conducted a reevaluation of the exemptions 
from licensing for byproduct and source material in the NRC's 
regulations. The assessment of doses associated with most of these 
exemptions can be found in NUREG-1717, ``Systematic Radiological 
Assessment of Exemptions for Source and Byproduct Materials,'' 
published June 2001.\3\ Doses were estimated for the normal life cycle 
of a particular product or material, covering distribution and 
transport, intended or expected routine use, accident and misuse 
scenarios, and disposal using dose estimation methods consistent with 
those reflected in the current 10 CFR Part 20. The report identified 
potential and likely doses to workers and members of the public under 
the exemptions contained in 10 CFR Parts 30 and 40. In general, the 
reevaluation concluded that no major problem exists with the use of 
products containing source material under the exemptions from 
licensing. Many of the products containing source material that are 
used under exemption from licensing present

[[Page 43427]]

the potential for higher exposures under routine use conditions than 
the products used under exemption that contain byproduct material 
because of differences in allowed forms and uses; however, risks from 
accidents are generally smaller. Although containment is a key to 
safety for many products containing byproduct material, containment is 
generally less important for products containing source material 
because of the low specific activity of the source material contained 
in such products.
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    \3\ NUREG-1717 is a historical document developed using the 
models and methodology available in the 1990s. The NUREG provides 
estimates of radiological impacts from various exemptions from 
licensing and is based on what was known about distribution of 
material under the exemptions in the early 1990s. NUREG-1717 was 
used as the initial basis for evaluating the regulations for 
exemptions from licensing requirements and determining whether those 
regulations adequately ensured that the health and safety of the 
public were protected consistent with NRC policies related to 
radiation protection. The agency will not use the results presented 
in NUREG-1717 as a sole basis for any regulatory decisions or future 
rulemaking without additional analysis. Copies of NUREGs may be 
purchased from the Superintendent of Documents, U. S. Government 
Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies 
are also available from the National Technical Information Service, 
5285 Port Royal Road, Springfield, VA 22161. A copy is also 
available for inspection and/or copying for a fee at the NRC Public 
Document Room, One White Flint North, 11555 Rockville Pike, Room O1-
F21, Rockville, MD.
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    In 1999, the State of Colorado and the Organization of Agreement 
States submitted a petition for rulemaking, PRM-40-27, which stated 
their concerns regarding potential exposures to persons using source 
material under the general license in Sec.  40.22. The petitioners 
requested that the exemption for these general licensees from 10 CFR 
Parts 19, 20, and 21 be restricted such that any licensee that has the 
potential to exceed any dose limits or release limits, or generates a 
radiation area as defined in 10 CFR Part 20 should be required to meet 
requirements in both 10 CFR Parts 19 and 20. The petition indicated 
that the State of Colorado had identified a site operated under the 
general license in Sec.  40.22 at which there was significant source 
material contamination. The petitioners calculated that resultant 
exposures for the source material contamination were significantly 
above the exposure limits allowed to members of the public in 10 CFR 
Part 20. The petitioners indicated that public dose limits were 
considered applicable because workers operating under the general 
license were exempt from training requirements that would normally be 
required for radiation workers under 10 CFR Part 19. The petitioners 
also referenced other situations, which based on their research, 
appeared to have resulted in Sec.  40.22 (or Agreement State 
equivalent) general licensees potentially exceeding public health and 
safety or disposal limits that would apply to most other licensees.
    In response to the petition, the NRC sought to develop more 
information on the use of the general license in Sec.  40.22. Although 
the NRC had identified 6 persons distributing source material to Sec.  
40.22 general licensees in the mid-1980's, the NRC was able to identify 
only 1 remaining distributor in 2005. In 2006, the NRC contracted 
Pacific Northwest National Laboratory (PNNL) to examine whether the 
regulations concerning general licenses and certain exemptions for 
source material were consistent with current health and safety 
regulations. In 2007, PNNL completed their evaluation and documented 
their findings in ``PNNL-16148, Rev. 1-Dose Assessment for Current and 
Projected Uses of Source Material under U.S. NRC General License and 
Exemption Criteria,'' (the PNNL study). A copy of the PNNL study can be 
found in ADAMS by searching for Accession Number ML070750105. The study 
used available information to identify and assess the primary 
operations conducted under the Sec.  40.22 general license and 
equivalent provisions of the Agreement States. The available data was 
collected from information voluntarily submitted by specific licensees 
known to have distributed source material to general licensees in the 
past, through surveys to certain identified general licensees, and 
through use of searches from the Internet, publications, and 
professional societies. The available information was found to be 
limited and may not be representative of all present day, or future, 
uses of source material under the existing general license.

B. Regulatory Framework

    The NRC has the authority to issue both general and specific 
licenses for the use of source material and to exempt source material 
from regulatory control under Section 62 of the Atomic Energy Act of 
1954, as amended (``the Act'' or AEA). A general license is provided by 
regulation, grants authority to a person for particular activities 
involving source material as described within the general license, and 
is effective without the filing of an application or the issuance of a 
licensing document. Requirements for general licensees appear in the 
regulations and are designed to be commensurate with the specific 
circumstances covered by each general license. A specific license is 
issued to a named person who has filed an application with the 
Commission. Exemptions are provided in situations where there is 
minimal risk to public health and safety and allow the end user, who 
ordinarily requires a license, to possess or use the source material 
without a license.
    The NRC regulations contained in 10 CFR Part 40 set forth the basic 
requirements for licensing of source material. Section 62 of the AEA 
authorizes the Commission to determine that certain quantities of 
source material are ``unimportant.'' Section 40.13, ``Unimportant 
quantities of source material,'' sets forth several exemptions from the 
licensing requirements for source material.
    The regulations contained in 10 CFR Part 40 authorize a number of 
different general licenses for source material; one of which is for 
small quantities of source material (Sec.  40.22). Because general 
licenses are effective without the filing of an application with the 
NRC, there are no prior evaluations of user qualifications, nature of 
use, or safety controls to be exercised. Some general licenses do 
include reporting requirements for transfers of source material.
    The regulations contained in 10 CFR Part 40 also authorize specific 
licenses for source material. Basic requirements for submittal of an 
application for a specific license are found in Sec.  40.31 and general 
requirements for issuance of a specific license are found in Sec.  
40.32. Terms and conditions of licenses are contained in Sec.  40.41. 
With the exception of requirements found in Sec. Sec.  40.34 and 40.35, 
related to the manufacture and initial transfer of products and devices 
containing depleted uranium to be used under the general license in 
Sec.  40.25, and the broad transfer authorizations contained in Sec.  
40.51, there are no specific requirements applicable to the 
distribution of products and materials containing source material.

C. Why are revisions to 10 CFR Part 40 considered necessary?

    Currently, 10 CFR Part 40 does not include any requirement to 
report information about source material being distributed for use 
under the general license in Sec.  40.22 or under any exemption from 
licensing in Sec.  40.13. Because the NRC does not require the 
reporting of products and materials distributed for use under the 
general license or exemptions, the NRC cannot readily determine if the 
source material is being maintained in accordance with the regulatory 
requirements for those uses, or how or in what quantities the source 
material is being used. As a result, the NRC cannot fully assess the 
resultant risks to public health and safety. Despite the limited 
availability of information, the NRC has assembled some data regarding 
the use of source material under both exemptions and the Sec.  40.22 
general license. Because of the difficulty of collecting such 
information and its limited reliability, the NRC has concluded that new 
reporting requirements on the distribution of source material to Sec.  
40.22 general licensees and persons exempt from licensing would 
significantly increase the NRC's ability to evaluate impacts and more 
efficiently and effectively protect the public health and safety from 
the use of source material.
Product Exemptions
    NUREG-1717 identified some source material product exemptions as 
being

[[Page 43428]]

obsolete or no longer manufactured at the upper limits allowed under 
Sec.  40.13(c). As a result, the NRC concludes that it is preferable to 
delete or reduce the concentration limits allowed in future products to 
reduce the potential for exposures to the general public from these 
products.
    In addition, based upon numerous questions from industry in the 
past, the NRC has learned that industry has generally moved from the 
manufacture of optical lenses containing thorium to the manufacture of 
lenses with thin coatings of thorium. This has led to the question of 
the applicability of the product exemption in Sec.  40.13(c)(7) to 
those lenses coated with thorium. As a result, the NRC is considering 
expanding the exemption in Sec.  40.13(c)(7) to accommodate current 
manufacturing practices to make the exemption more useful.
Section 40.22 General License
    When the current general license in Sec.  40.22 was established in 
1961, provisions were included to exempt the general licensees from 10 
CFR Parts 19, 20, and 21. The exemption was based upon the known uses 
of source material at the time and the health and safety requirements 
at that time. Because the Sec.  40.22 general license was expanded to 
include commercial applications in 1961, it is likely that some current 
practices were not properly evaluated as part of that rulemaking. In 
addition, since that time, limits for protecting health and safety in 
10 CFR Part 20 were significantly lowered and the training requirements 
in 10 CFR Part 19 were expanded. This combination of events has led to 
the recognition that some general licensees could expose workers to 
levels above 1 millisievert (mSv) per year (100 millirem (mrem) per 
year) which would normally require radiation training under 10 CFR Part 
19. In addition, because of the exemption to 10 CFR Part 20, the NRC 
recognizes that some Sec.  40.22 general licensees may dispose of 
source material in manners that would not be acceptable for other 
licensees where 10 CFR Part 20 applies and may abandon sites with 
contamination at levels exceeding 10 CFR Part 20 release limits. These 
actions could result in individual members of the public being exposed 
to dose levels above that permitted by 10 CFR Part 20. The PNNL study 
indicated that most source material possessed under Sec.  40.22 is 
likely handled in quantities, physical forms, or in uses and conditions 
that would justify the continued application of the exemptions to 10 
CFR Parts 19, 20, and 21. However, as indicated by PRM-40-27, and by 
bounding dose calculations in the PNNL study, situations can occur 
where Sec.  40.22 general licensees exceed limitations under which 
certain requirements in 10 CFR Parts 19 and 20 would apply to a 
specific licensee. For example, because of the current exemption to 10 
CFR Part 20, a Sec.  40.22 general licensee could abandon a site 
resulting in a situation where the next occupant is exposed at levels 
above public dose limits in Sec.  20.1301 and the unrestricted release 
limits in Sec.  20.1402. As a result, the NRC determined that 
consideration should be given to making the Sec.  40.22 general license 
more consistent with current training requirements and public health 
and safety standards, as set forth in 10 CFR Parts 19 and 20.
    In addition, the current Sec.  40.22 general license allows persons 
to obtain 15 lb (6.8 kg) of uranium or thorium in any form, including 
any specific isotopes. Certain isotopes of thorium and uranium have 
specific activities so high that 15 lb of those isotopes could result 
in doses far in excess of dose limits normally allowed under NRC's 
regulations without significant controls; thus, although these 
separated radioisotopes are not commercially available in such 
quantities, the NRC has concluded that persons should not be allowed to 
obtain large quantities of these isotopes without applying for a 
specific license.

III. Discussion

A. What action is the NRC taking?

    The NRC is proposing to add new requirements for those persons who 
initially transfer for sale or distribution products and materials 
containing source material for receipt under an exemption or the 
general license in Sec.  40.22. This proposed rule would also make a 
number of additional revisions to the regulations governing the use of 
source material under exemptions from licensing and under the general 
license in Sec.  40.22. These changes are intended to better ensure the 
protection of public health and safety in an efficient and effective 
manner.
A.1 Specific Licensing of Distribution of Source Material
    The NRC is proposing two new provisions, Sec. Sec.  40.13(c)(10) 
and 40.22(e), which would prohibit the initial transfer for sale or 
distribution of products or materials containing source material to 
persons exempt from licensing under Sec.  40.13(c) or to a Sec.  40.22 
general licensee, respectively, by a person without authorization by a 
specific license. The initial transfer for sale or distribution is 
considered to be the first transfer of the product or material 
containing source material to a person who will be receiving the source 
material for possession under an exemption listed in Sec.  40.13(c) or 
under the general license in Sec.  40.22. Subsequent transfers of 
source material from exempt person to exempt person or from general 
licensee to general licensee would continue to be allowed without the 
requirement for a specific license.
    Under the proposed Sec.  40.13(c)(10), in conjunction with the 
proposed Sec.  40.52, a person currently operating under a Sec.  40.22 
general license that manufactures and initially transfers or 
distributes a product for possession under an exemption listed in Sec.  
40.13(c) would no longer be allowed to operate under the general 
license and would instead need a specific license under this proposed 
rule. The NRC is not aware of any widespread production and 
distribution of exempt products under the general license; however, 
with the proposed expansion of the exemption in Sec.  40.13(c)(7) 
(discussed further in Section A.5 of this document), persons currently 
manufacturing thorium-coated lenses under the general license would be 
required to obtain a specific license if the lenses are distributed for 
use under the expanded exemption.
    A specific license for the initial distribution of products for use 
under an exemption listed in Sec.  40.13(c) would be issued only by the 
NRC, including for those persons located in an Agreement State, under a 
new provision Sec.  40.52, ``Certain items containing source material; 
requirements for license to apply or initially transfer.'' Conditions 
for the proposed Sec.  40.52 licenses are being proposed in a new 
provision Sec.  40.53, ``Conditions of licenses issued under Sec.  
40.52: Quality control, labeling, and records and reports.'' In 10 CFR 
150.15, the Commission retains the authority to license the transfer of 
possession or control by the manufacturer, processor, or producer of 
any equipment, device, commodity, or other product containing source 
material or byproduct material whose subsequent possession, use, 
transfer, and disposal by all other persons are exempted from licensing 
and regulatory requirements. The licensing of the export from and 
import into the United States of byproduct and source material is also 
wholly reserved to the Commission by this section. Thus, a distributor 
in an Agreement State involved in the initial transfer of materials or 
products containing byproduct or source material to exempt persons, 
whether a manufacturer or an importer, requires authority to distribute

[[Page 43429]]

such material from the Commission in addition to any Agreement State 
license.
    In the past, the Commission has chosen not to require licensing of 
the transfer of source material to exempt persons by manufacturers or 
importers of products in Agreement States (with the exception of the 
manufacture of counterweights to be used under Sec.  40.13(c)(5)). This 
proposed rule, in requiring specific authorization for the initial 
transfer for sale or distribution of materials or products containing 
source material to exempt persons, in conjunction with 10 CFR 150.15, 
would clarify that distributors in Agreement States would need specific 
licenses, issued by the NRC, authorizing initial transfer of products 
containing source material for sale or distribution for use under the 
exemptions in Sec.  40.13(c) or equivalent Agreement State regulations. 
However, the possession and use of materials or products containing 
source material by Agreement State licensees would continue to be 
regulated by the Agreement State.
    Importers of finished products containing source material would be 
exempt from 10 CFR Parts 19 and 20--this is different than the existing 
regulations governing the initial transfer of byproduct material. The 
exemption from 10 CFR Parts 19 and 20 for importers of finished 
products is being proposed because the health and safety concerns for 
this type of distributor are no different than those for a secondary 
distributor of source material, who is neither currently, nor in the 
proposed rule, required to obtain a specific license for distribution. 
Importers of finished products would not be allowed to process the 
products and would not be expected to handle the products in any way 
that would create health and safety impacts beyond what is projected to 
occur under the exemption.
    A specific license for the initial distribution of source material 
for use under the Sec.  40.22 general license would be issued under a 
new provision Sec.  40.54, ``Requirements for license to initially 
transfer source material for use under Sec.  40.22.'' Conditions for 
the Sec.  40.54 licenses are being proposed in a new section, Sec.  
40.55, ``Conditions of licenses issued under Sec.  40.54: Quality 
control, labeling, safety instructions, and records and reports.''
    The process for obtaining a specific license to distribute source 
material is expected to be relatively straightforward. Applications for 
these specific licenses for distribution would be made through the 
provisions of Sec.  40.31, ``Application for specific licenses,'' and 
applicants would be required to meet part or all of the provisions of 
Sec.  40.32, ``General requirements for issuance of specific 
licenses.'' Regulatory Guide 10.4, ``Guide for the Preparation of 
Applications for Licenses to Process Source Material,'' which may be 
used by non-fuel-cycle source material applicants, already addresses 
the submittal of information on types and quantities of source material 
planned to be distributed to exempt persons. Under both proposed 
paragraphs Sec.  40.13(c)(10) and Sec.  40.22(e), an initial 
distributor would be allowed to continue distribution of products or 
materials containing source material for 1 year beyond the effective 
date of this rule. However, if an application for a specific license 
(or license amendment, in the case of an existing NRC licensee) has 
been submitted, the applicant would be allowed to continue their 
distributions while issuance of the license is pending. Persons legally 
importing products for possession under an exemption for their own 
personal use or to be given as a personal gift would not be required to 
obtain a specific license for those products. Similarly, persons 
importing source material for use under a general license would not be 
required to obtain a specific license unless they subsequently transfer 
the source material to another person for use under a general license 
or exemption.
    The regulations contained in 10 CFR Part 40 currently do not 
require a person to obtain a specific license to distribute source 
material to persons exempt from licensing or to Sec.  40.22 general 
licensees (with the exception of counterweights for which this is 
included as a constraint within the exemption in Sec.  40.13(c)(5)). 
The regulations in Sec.  40.51 allow such transfers to occur without a 
distribution license and do not require any reporting of the transfers. 
This is not true for byproduct material licensees, who are required in 
10 CFR Part 32 to obtain a specific license for the initial 
distribution of byproduct material to persons exempt from licensing or 
for use under a general license. The import of exempt materials or 
products is generally licensed by 10 CFR 110.27(a)(2) and 10 CFR 
110.27(a)(3) provides a general license for the import to those persons 
authorized to receive products or materials under a license. However, 
in the case of source material distribution to exempt persons or to 
Sec.  40.22 general licensees, no other license is currently required, 
nor are there any requirements to report the transfer or receipt of the 
imported material.
    Because of the lack of reporting requirements associated with the 
possession of source material under exemption or the Sec.  40.22 
general license, the NRC does not have a clear understanding of the 
amounts, types, or uses of source material under exemption or under the 
Sec.  40.22 general license. Most information gathered by the NRC to 
date comes from a few specific licensees who have voluntarily provided 
distribution data. Because this information may not fully represent 
actual usage, it is difficult for the Commission to make risk-informed 
decisions in updating the related source material regulations. Without 
the proposed specific licenses for initial distributors, it would be 
difficult or impossible to enforce reporting requirements on 
unidentified distributors. Requiring initial distributors of source 
material to exempt persons or to certain general licensees to obtain a 
license for distribution would allow the NRC to track the amount and 
types of source material being distributed to those persons through 
proposed reporting requirements that would be associated with the new 
specific licenses.
A.2 Distribution of Products to Persons Exempt From Regulation
    A prohibition on distribution without a specific license is 
proposed in a new Sec.  40.13(c)(10), which directs persons seeking to 
distribute source material to exempt persons, to the proposed new Sec.  
40.52. The proposed Sec.  40.52 provides conditions for approval of a 
license application for initial distribution of source material to 
exempt persons. Additionally, the proposed Sec.  40.53 contains a 
number of conditions for initial distributors including requirements 
for reporting and recordkeeping, quality control, and labeling.
    The new reporting and recordkeeping requirements are proposed in 
Sec.  40.53(c). An initial distributor of products for use under the 
exemption in Sec.  40.13(c) would be required to submit a report, by 
January 31 of each year, regarding transfers made in the previous 
calendar year. The report would identify the distributor and indicate 
what products, types of source material and amounts, and number of 
units distributed.
    The regulations contained in 10 CFR Part 40 were initially based on 
the assumption that the health and safety impacts of source material 
were low and that considerations of protecting the common defense and 
security were more significant. When the AEA was initially written, one 
of the major focuses was to ensure that the United States government 
would have an adequate supply of uranium and thorium as ``source 
material'' for atomic

[[Page 43430]]

weapons and the nuclear fuel cycle. Exemptions from licensing were made 
for certain consumer products already in production, such as gas 
mantles containing thorium, and these exemptions have not been 
substantially modified since they were included in the original 
issuance of 10 CFR Part 40 in 1947. These exemptions essentially 
accommodated existing practice without much emphasis on health and 
safety. Recent studies have indicated that the manufacture and use of 
such products has decreased as alternative products, not containing 
source material, have become more readily available. Consistent with a 
policy statement on consumer products published on March 16, 1965 (30 
FR 3462), the Commission has periodically made various evaluations of 
potential doses from exempt products to ensure that exposures from any 
individual exempt practice do not exceed a small fraction of the 
overall recommended dose limit for the public and that the combined 
effect of exposures from various exempt practices does not result in a 
significant impact to public health and safety. However, because the 
Commission has little data on distributions of source material to 
exempt persons, these evaluations for source material have been 
particularly difficult to conduct, and may not necessarily represent 
real world conditions.
    The data collected by virtue of the proposed rule would provide the 
NRC with a more accurate and complete representation of material 
distributed to the public for use under exemptions in Sec.  40.13(c). 
This would allow the NRC to recognize trends in distribution which 
could alter earlier estimates of individual or collective doses and 
affect earlier findings regarding health and safety. These changes 
would provide a better basis for considering any future regulatory 
changes in this area and in allocating the NRC's resources. The 
proposed reporting requirements would also aid in ensuring that 
exposures to the public from all sources controlled by the NRC are 
monitored and are unlikely to exceed 1 mSv (100 mrem) per year.
    These proposed reporting and recordkeeping requirements are 
expected to impose a minimal burden on those persons requiring a 
specific license for initial distribution of source material, 
particularly given the current state of information technology. The 
first report may include information on transfers for which records 
have not been required; however, this information is expected to be 
available because of basic business recordkeeping practices. If exact 
numbers cannot be given for this first report, a best estimate for the 
whole calendar year would be acceptable.
    In addition to reporting and recordkeeping, there are a few 
additional requirements being proposed for initial distribution of 
products for use under exemption. The new requirements would help to 
ensure that products being distributed were within the quantity or 
concentration limits for those exemptions that include such limits and 
that the products were properly labeled as currently required by the 
existing conditions in the exemptions.
    In the NUREG-1717 assessment, it was identified that certain 
products containing source material and used under exemptions from 
licensing (e.g., welding rods and gas mantles) have the potential for 
routine exposures that are higher than is generally acceptable for use 
under exemption. However, the use of thorium in these products has 
significantly declined, being replaced by rare earth compounds, such as 
lanthanum and yttrium. As a result, routine use of thorium containing 
products of these types by individuals to the exclusion of similar 
products containing rare earths is less likely and typical exposures to 
users is likely less than previously estimated. At the same time, the 
likely exposures can be limited by the user who is properly informed 
concerning the inherent risks of exposures and methods for reducing 
exposure. Thus, rather than eliminate these exemptions, the Commission 
is proposing to include in the proposed distributor requirements the 
requirement to provide safe handling instructions. Some distributors 
have done so voluntarily in the past. Welding has other inherent risks, 
thus, welding rod manufacturers and importers are required by 
Occupational Safety and Health Administration regulations to prepare 
and distribute Material Safety Data Sheets (MSDSs) on the use of 
welding rods. While these identify the presence of thorium for thorium-
containing welding rods, they typically do not include information 
specifically about the radiological hazard.
    New fee categories and initial fee amounts for this new specific 
license type are being proposed as revisions to 10 CFR Parts 170 and 
171. There would be a category for the distribution aspect and a 
separate one for manufacturing or processing. The applicants and 
licensees under the proposed licensing provision Sec.  40.52 would come 
under a newly established fee category, 2.C. ``Licenses to distribute 
items containing source material to persons exempt from the licensing 
requirements of 10 CFR Part 40 of this chapter'' (the current 2.C. 
``All other source material licenses'' is proposed to be redesignated 
as 2.F. by this rule). This new fee category would apply to all initial 
distributors of products containing source material for use under Sec.  
40.13(c). The fee associated with this category would be the only fee 
required by the NRC of distributors whose possession and use of source 
material is licensed by an Agreement State or who only import finished 
products for distribution. There would be an additional fee category 
for those manufacturing or processing such products. This is similar to 
the breakdown of fees for manufacturers and distributors of exempt 
byproduct material. The initial fee associated with the distribution 
aspect of licensing for source material would be lower than those 
related to distribution of products containing byproduct material to 
exempt persons, because this rule would add more limited requirements 
applicable to the distribution aspect of licensing for source material. 
Proposed initial fee amounts for the proposed new category 2.C. are as 
follows: $7,000 for an application; $10,000 for the annual fee.
    The new fee category for manufacturing and processing would be 2.E, 
``Licenses for possession and use of source material for processing or 
manufacturing of products or materials containing source material for 
commercial distribution.'' It is proposed that the initial fees 
associated with manufacturing or processing be the same amount as those 
that currently apply to a manufacturer of a product containing source 
material that now comes under the current fee category 2.C, ``All other 
source material licenses.'' These fees are currently $10,100 for an 
application and $17,400 for the annual fee, but will change to $10,200 
and $21,100, respectively, on August 16, 2010, as a result of the 2010 
Fee Rule published on June 16, 2010 (75 FR 34220). It is proposed that 
the initial fee amounts applicable to the proposed new fee category 
2.E. be the same as those for the current category 2.C. at the time 
this proposed rule is finalized and the requirements are made 
effective. These amounts are subject to change prior to the 
finalization of this proposed rule.
    After the implementation of this proposed rule, the fee amounts for 
these new categories would change annually in accordance with NRC 
policy and procedures. Biennially, the NRC evaluates historical 
professional staff hours used to process a new license application for 
materials users fee categories which often results in changes to the 
flat application fees. In addition, results from the biennial

[[Page 43431]]

review impacts the annual fee for the small materials users since the 
NRC bases the annual fees for each fee category within this class on 
the application fees and estimated inspection costs for each fee 
category. Each year the annual fee for the materials users is 
calculated using a formula which distributes the NRC allocated budget 
amount for the small materials users to the various fee categories 
based on application fees, inspections costs, inspection frequency, and 
the number of licensees in the fee category.
A.3 Distribution of Source Material to General Licensees
    The prohibition on distribution without a specific license in the 
proposed Sec.  40.22(e) directs persons seeking to distribute source 
material to Sec.  40.22 general licensees to the proposed new Sec.  
40.54. The proposed Sec.  40.54 provides conditions for approval of a 
license application for initial distribution of source material to 
Sec.  40.22 general licensees. Additionally, the proposed Sec.  40.55 
contains a number of conditions for initial distributors including 
requirements for reporting and recordkeeping, labeling, and 
notifications.
    The proposed rule would add Sec.  40.55(d) and (e) to establish 
reporting and recordkeeping requirements for initial distributors of 
source material to persons generally licensed under Sec.  40.22 or 
equivalent Agreement State provisions. The rule would require that 
transfers be reported to the NRC and, if applicable, to the Agreement 
State where the material is transferred, annually by January 31. The 
report would cover transfers of source material completed in the 
previous calendar year. The reports would identify each general 
licensee receiving quantities of source material greater than 50 grams 
(g) (0.11 lb) within any calendar quarter by name and address, the 
responsible agent who may constitute a point of contact between the NRC 
or the Agreement State agency and the general licensee, and the type, 
physical form, and quantity of source material transferred. In 
addition, the distributor would be required to report the total 
quantity of source material distributed each calendar year, including 
those transfers of less than 50 g (0.11 lb) in a quarter to any person.
    When the small quantity general license was originally granted, it 
was intended to be used by pharmacists and physicians for medicinal 
purposes and by educational institutions and hospitals for educational 
and medical purposes (although the general license was later revised in 
1980 to prohibit use for medicinal and medical purposes). When the 
general license was expanded in 1961, both in terms of how much 
material and what it could be used for, no consideration was made to 
include reporting requirements at the time. As a result, the NRC has 
not been able to readily identify persons using source material under 
this general license nor verify its proper use.
    The proposed reporting requirements, when also applied to 
distributors in Agreement States by those States, would help the NRC 
identify Sec.  40.22 general licensees using larger quantities of 
source material. This would enable the NRC to better communicate with 
or inspect these general licensees, if necessary, to ensure that public 
and worker health and safety is adequately protected. The Commission 
would also use collected data to assess the extent of use of this 
general license in order to better evaluate alternatives for future 
revisions to this general license. Because the proposed reporting 
requirement is intended to apply only to anyone initially distributing 
source material to Sec.  40.22 general licensees, transfers of source 
material from general licensee to general licensee would still not be 
reported.
    Records of the initial transfer of source material for use under 
Sec.  40.22 would be required to be stored for 1 year after inclusion 
in a report to the Commission or to an Agreement State agency. 
Maintaining records for this length of time will facilitate the 
licensee's preparation of the report and allows for verification of the 
accuracy of the report by the NRC or the Agreement State. This is 
shorter than the recordkeeping requirements for transfers of generally 
licensed devices in byproduct material regulations. For generally 
licensed devices, longer recordkeeping is appropriate because of the 
possible need for tracing particular devices if generic defects were 
identified.
    These proposed reporting and recordkeeping requirements are 
expected to impose a minimal burden on those persons requiring a 
specific license for initial distribution of source material, 
particularly given the current state of information technology. The 
first report may include information on transfers for which records 
have not been required; however, this information is expected to be 
available because of basic business recordkeeping practices. If exact 
numbers cannot be given for this first report, a best estimate for the 
whole calendar year would be acceptable.
    In addition to reporting and recordkeeping, there are a few 
additional requirements being proposed for distribution of material for 
use under Sec.  40.22 and equivalent Agreement State provisions. The 
new requirements would primarily require the licensee to ensure the 
quantity or concentration of material is as labeled. The initial 
distributors would be required to provide to their customers copies of 
key relevant regulations and radiation safety precautions and 
instructions. Requiring initial distributors to provide copies of such 
regulations would make the recipient aware that the source material is 
possessed under a general license and what the requirements are under 
that general license.
    New fee categories and fee amounts for this new specific license 
type are being proposed as revisions to 10 CFR Parts 170 and 171. The 
applicants and licensees under the proposed licensing provision Sec.  
40.54 would come under a newly established fee category, 2.D. 
``Licenses to distribute source material to persons generally licensed 
under 10 CFR Part 40 of this chapter.'' Proposed initial fee amounts 
are as follows: $2,000 for an application; $5,000 for the annual fee. 
These applicants and licensees would also be subject to the proposed 
new category, 2.E., ``Licenses for possession and use of source 
material for processing or manufacturing of products or materials 
containing source material for commercial distribution.'' As discussed 
in section A.2 of this document, the initial fee amounts for this 
category would be equal to the fee for current fee category 2.C at the 
time this proposed rule is finalized and the requirements are made 
effective. These fee amounts would subsequently be revised in 
accordance with applicable NRC policy and procedures.
    The Commission currently has no licensees under the existing 
licensing provision of Sec.  40.34, which also authorizes distribution 
to a category of general licensees (those licensed under Sec.  40.25 
and Agreement State equivalent provisions). The proposed new fee 
categories 2.D. for persons who initially distribute source material to 
general licensees and 2.E. for manufacturing or processing of source 
material for commercial distribution would also cover future NRC 
applicants and licensees that apply for or possess a license under 
Sec.  40.34.
A.4. Possession and Use of Source Material under Sec.  40.22
    The NRC is proposing to revise Sec.  40.22, ``Small quantities of 
source material,'' in its entirety.

[[Page 43432]]

    Under the proposed Sec.  40.22(a), the general license would be 
limited to thorium and uranium in their natural isotopic concentrations 
and depleted uranium. This differs from the existing Sec.  40.22(a) 
which allows possession of any isotopic concentration of source 
material. Certain radionuclides of uranium and thorium, when 
isotopically separated, have the potential to present significantly 
higher doses, in particular, thorium-228, thorium-229, and uranium-232. 
Thorium-230 when separated from the uranium decay series is also a 
higher specific activity material. Although the NRC is not aware of 
these isotopes being separated for commercial use, if the separated 
isotopes were readily available, the current provisions of Sec.  40.22 
would allow a person to receive quantities large enough in terms of 
activity to present a security concern without obtaining a specific 
license. The proposed revised general license would limit uranium and 
thorium to their natural isotopic concentrations or as depleted uranium 
to ensure that persons could not obtain these much higher specific 
activity materials in an isotopically separated form without the 
authorization and safety controls provided by a specific license.
    Under the proposed Sec.  40.22(a)(1), the general licensee would be 
limited to possession of less than 1.5 kg (3.3 lb) of uranium and 
thorium at any one time and 7 kg (15.4 lb) per calendar year for all 
uranium and thorium that is in a dispersible form or has been processed 
by the general licensee. Under the current general license, assurance 
of safety is based primarily on two limiting conditions: (1) The amount 
of source material that may be used at any one time and (2) the amount 
that may be obtained in any calendar year. It had been assumed that the 
activities likely to be conducted under the general license would be 
unlikely to result in significant intakes of source material. These 
conditions, however, may not be totally effective in affording a proper 
level of safety as raised by PRM-40-27 and substantiated by the PNNL 
study. PRM-40-27 and the PNNL study indicate that situations can occur 
that exceed limitations under which certain requirements in 10 CFR 
Parts 19 and 20 usually would apply to specific licensees. These 
situations primarily result from the use of source material used or 
possessed in a dispersible form.
    In PRM-40-27, the petitioners stated that they had identified a 
site, where source material was likely possessed under the general 
license in Sec.  40.22, that had significant amounts of surface 
contamination from source material. The petitioners indicated that 
resultant exposures for the source material contamination were 
significantly above the dose limits (possibly as high as 1 rem (10 mSv) 
per year) allowed to members of the public in 10 CFR Part 20.
    The PNNL study confirmed that such exposures were possible under 
the existing Sec.  40.22 general license conditions and indicated that 
unprotected workers exposed to thorium and uranium powders during the 
lens manufacturing process, as licensed under a Sec.  40.22 general 
license, can potentially receive an annual internal radiation dose up 
to 5.6 mSv (560 mrem), and an annual committed effective dose 
approaching 8 mSv (800 mrem) without regard to excess contamination. 
This type of manufacturing process uses source material in a powdered 
form which allows for a greater chance of inhalation or ingestion of 
the source material. Although the Commission expects that these doses 
from manufacturing may be tremendously reduced if the process is 
performed in hot cells or if workers generally use respiratory 
protection (e.g., dust masks) in response to other regulatory 
requirements, the NRC is concerned about the potential exposures 
because a Sec.  40.22 licensee is not required to meet the health and 
safety requirements for protection against radiation in 10 CFR Part 20 
nor the training requirements in 10 CFR Part 19.
    The proposed new limits in Sec.  40.22(a)(1) are intended to reduce 
the likelihood that a person operating under a general license would be 
able to exceed dose limitations in 10 CFR Parts 19 and 20, which would 
require additional controls if the person were specifically licensed. 
Based upon the bounding dose calculations in the PNNL study, the NRC 
expects this proposed lower quantity to limit the potential for a 
worker to be exposed at levels exceeding 1 mSv (100 mrem) per year. In 
addition, by limiting the amount of such source material allowed to be 
received in a calendar year, the NRC expects that the potential for 
surface contamination buildup (similar to that identified in PRM-40-27) 
would also be reduced. By reducing the amount of source material that 
is available for inhalation and ingestion, the NRC has concluded the 
exemptions to 10 CFR Parts 19, 20, and 21 would continue to be 
acceptable.
    It is expected that a small number of persons currently possessing 
and using source material under the existing general license may be 
required to obtain a specific license for continued use of the source 
material under this proposed rulemaking. Persons currently possessing 
source material in dispersible forms, or processing source material, in 
quantities greater than 1.5 kg (3.3 lb) of uranium and thorium at any 
one time, or receiving more than 7 kg (15.4 lb) of uranium and thorium 
in 1 year, would be required to obtain a specific license if they could 
not reduce their possession and use of the source material to below the 
proposed new limits.
    Under the proposed Sec.  40.22(a)(2), the general licensee would be 
allowed to possess up to 7 kg (15.4 lb) total uranium and thorium at 
any one time as long as any source material possessed in addition to 
that possessed under the limits in Sec.  40.22(a)(1) is in a solid, 
non-dispersible form (e.g., a metal or sintered object; contained in 
protective envelope or in a foil; or plated on an inactive surface) and 
not chemically or physically altered. The licensee is limited to the 
receipt of no more than 70 kg (154 lb) of uranium and thorium per 
calendar year. If the licensee does physically or chemically alter the 
solid source material, that altered source material would be required 
to fall within the 1.5 kg (3.3 lb) at one time limit and no more than 7 
kg (15.4 lb) per calendar year limits of the proposed Sec.  
40.22(a)(1). Because the greater impact from the possession and use of 
source material results from inhalation or ingestion, allowing source 
material, in a solid, non-dispersible form, to continue to be possessed 
at a limit of 7 kg (15.4 lb) at any one time is not expected to 
significantly impact health and safety of workers handling or near such 
material because of the unlikely chance of inhalation or ingestion.
    Under the proposed Sec.  40.22(a)(3), persons treating drinking 
water by removing uranium for the primary purpose of meeting U.S. 
Environmental Protection Agency regulations, would continue to be 
allowed to possess up to 7 kg (15.4 lb) of uranium at one time and 
process no more than 70 kg (154 lb) of uranium per calendar year. The 
NRC has concluded that the types of activities used to remove uranium 
from drinking water adequately contain the uranium to protect worker 
health and safety. The NRC also is concerned that the implementation of 
reduced possession limits on such persons could significantly impact 
operating costs, if such facilities are required to obtain specific 
licenses, and thereby impact their ability to provide safe drinking 
water. Although persons operating such facilities would not be impacted 
by changes in possession limits, they would be required to meet the 
other requirements of the proposed rule.

[[Page 43433]]

However, these persons continue to have multiple options for operating 
within the NRC's regulations, including operation under a specific 
license or applying for enforcement discretion as discussed in the 2006 
Regulatory Information Summary (RIS-2006-020), ``Guidance for Receiving 
Enforcement Discretion When Concentrating Uranium at Community Water 
Systems,'' dated September 14, 2006.
    The proposed Sec.  40.22(b) primarily provides clarification of how 
existing regulations apply to Sec.  40.22 general licensees. Paragraph 
40.22(b)(1) restates an existing requirement prohibiting the 
administration of source material to humans, unless authorized by a 
specific license.
    Under the proposed Sec.  40.22(b)(2), the NRC is clarifying 
disposal requirements for source material possessed under Sec.  40.22. 
Because Sec.  40.22 currently exempts the general licensee from the 
requirements in 10 CFR Part 20, one can infer that disposal of source 
material may be exempt from regulation because 10 CFR Part 20 includes 
disposal requirements. However, there is no exemption from Sec.  40.51 
which includes transfer provisions for licensees (including general 
licensees) which, depending upon how the general licensee disposes of 
the material, may be applicable and therefore limit disposal 
opportunities. The NRC is proposing in Sec.  40.22(b)(2) to 
specifically prohibit abandonment of source material but allow up to 
0.5 kg (1.1 lb) of source material per calendar year to be permanently 
disposed of without further NRC restrictions as long as the source 
material is in a solid, non-dispersible form (e.g., a metal brick, 
encapsulated in cement, etc.). The person receiving the source material 
to be permanently disposed would still be required to meet the 
applicable regulations of other agencies regarding such disposals. The 
NRC concludes that such small quantities would allow small general 
licensees (e.g., educational institutions) to economically dispose of 
the source material and would result in minimal impact to public health 
and safety because its form would limit ingestion and inhalation of the 
source material. The person receiving source material transferred under 
the provisions of Sec.  40.22(b)(2)(i) would not be subject to further 
regulation by the NRC to the extent that the source material received 
under this provision was promptly and permanently disposed of by the 
recipient. Larger quantities of source material would be required to be 
disposed of as radioactive material through the provisions of Sec.  
20.2001 (e.g., at an appropriately licensed disposal facility, or below 
the effluent release concentrations in 10 CFR Part 20, etc.) or 
transferred to another person otherwise authorized to receive the 
source material.
    Because Sec.  40.22 does not currently exempt the general licensee 
from other requirements in 10 CFR Part 40, the NRC is proposing in 
Sec.  40.22(b)(3) to direct the general licensee's attention to other 
applicable sections of 10 CFR Part 40. Similarly, Sec.  40.22(b)(5) 
directs the general licensee's attention to regulations regarding 
export of source material.
    As part of its attempt to evaluate the current use of source 
material under the general license, the NRC found it difficult to 
obtain significant information voluntarily from general licensees. The 
proposed new condition in Sec.  40.22(b)(4) would clearly obligate 
general licensees to respond to the NRC's written requests within 30 
days.
    As identified in PRM-40-27, contamination may become problematic 
for some persons using source material under the general license. The 
NRC is concerned that not only might a licensee not attribute what 
could be significant amounts of source material contamination to its 
possession limits but also, such as in the case identified in PRM-40-
27, might abandon significant amounts of source material in place. This 
abandonment could result in other persons that later inhabit the 
facility from unknowingly exposing their workers or others to the 
source material contamination. As a result, in proposed Sec.  40.22(c), 
the NRC is proposing to require the general licensee to minimize 
contamination at the site and ensure that the site is cleaned up to be 
protective of future worker and public health and safety. If the 
general licensee identifies evidence that there may be significant 
contamination, the license would be required to notify the NRC and may 
consult with the NRC as to the appropriateness of sampling and 
restoration activities. The goal of this requirement is to reduce the 
likelihood that any remaining contamination would have the potential to 
result in the 25 mrem (0.25 mSv) limits in Sec.  20.1402 being 
exceeded. The NRC would expect a licensee to identify a concern about 
significant contamination based on both visual inspection (i.e., 
particulates remaining from operations) and operational and historical 
data (e.g., operations often resulted in airborne or dispersed 
particulates or there were history of spills, etc.). If there is any 
doubt as to whether remaining contamination may be considered 
significant, the licensee should consult with the NRC or a health 
physics consultant.
    In the proposed Sec.  40.22(d), the NRC is proposing to continue to 
exempt persons generally licensed under Sec.  40.22 from 10 CFR Parts 
19, 20, and 21, with the exceptions concerning disposal and 
decommissioning in proposed Sec.  40.22(b)(2) and (c). In addition, the 
NRC is proposing that this exemption would not extend to any NRC 
specific licensee; in the current regulation only 10 CFR Part 40 
licensees are excluded. This modification is expected to provide 
minimal impact to those other specific licensees who possess source 
material under the general license, because they would already be 
subject to 10 CFR Parts 19, 20, and 21 for other licensed materials.
A.5 Revision of Exemption for Thorium Lenses
    Paragraph 40.13(c)(7) exempts thorium contained in finished optical 
lenses, provided that each lens does not contain more than 30 percent 
by weight of thorium and meets certain use limitations, including that 
the thorium not be contained in contact lenses, spectacles, or 
eyepieces in binoculars or other optical instruments. Thorium is used 
in or on lenses to modify optical properties of the lens. The 
exemption, when originally established, was intended for uses where the 
thorium was homogonously spread throughout the lens. However, more 
recently, manufacturers are more likely to apply a thin coating of 
thorium to the lens; this has brought up concerns of the applicability 
of the existing exemption for such coated lenses. Also, NRC has 
identified that source material may also be used as a coating on 
mirrors.
    To clarify the regulatory status of these coated lenses and to 
address coatings on mirrors, the rule proposes three changes to the 
existing exemption: (1) Expand the exemption to include source material 
in or on finished coated lenses and mirrors; (2) reduce the source 
material limit from 30 percent by weight to 10 percent by weight for 
products distributed in the future; and (3) expand the exemption to 
include uranium. The remaining limitations on use would continue to 
apply.
    Although historical information indicates that lenses containing up 
to 28 percent by weight of thorium oxide were manufactured in the past, 
most lenses that have been possessed under this exemption have 
contained concentrations closer to 10 percent by weight of thorium. The 
NRC has not been able to identify any manufacturers or distributors of 
lenses containing homogeneous amounts of thorium since

[[Page 43434]]

1980, because the industry appears to have moved to using thorium as a 
thin-film coating on the surface of lenses. The NRC's evaluation found 
that thin-film coated lenses contain a significantly lower total mass 
of thorium than that generally found in the same size homogeneous 
lenses. In addition, the NRC has learned that certain lens 
manufacturers also use thorium in combination with uranium to achieve 
desired properties. Although a coated lens does not contain the source 
material homogeneously within the lens (as is the case with lenses that 
may currently be possessed under the exemption), the PNNL study 
indicated that doses from both normal and accident conditions from 
lenses coated with either or both uranium and thorium were estimated to 
be well below 10 microsievert ([mu]Sv) per year (1 mrem per year). As a 
result, the NRC is proposing to expand the exemption to include these 
thin-film coatings and to also apply the exemption to lenses and 
mirrors containing uranium. The NRC's expectation is that the source 
material would be fixed onto the lens or mirror and not readily able to 
be removed from the surface. The exemption prohibits and would continue 
to prohibit shaping, grinding, polishing, and any other manufacturing 
process other than assembling the finished lens into an optical system 
or device.
    The NRC is also proposing to revise Sec.  40.13(c)(7) to limit the 
source material contained on or in the lens to no more than 10 percent 
by weight of source material across the volume of the lens, although 
lenses containing up to 30 percent by weight of thorium that were 
produced prior to the effective date of this rule would continue to be 
covered by this exemption from licensing. Based on information that the 
manufacture of lenses containing homogeneous thorium is no longer 
occurring and that the majority of lenses currently being manufactured, 
contain concentrations less than 10 percent by weight of thorium, this 
reduction in the limit is expected to have minimal impact on industry. 
The actual percent by weight of source material on a thin-coated lens 
is expected to be well below this limit as averaged over the entire 
lens.
A.6 Revision of Exemption for Glassware
    Paragraph 40.13(c)(2)(iii) exempts glassware containing up to 10 
percent source material by weight. Although the estimated doses 
associated with this exemption are acceptable, the benefit from this 
use of source material is limited to achieving a unique color and glow 
in the glassware. Such glassware has been used in products such as 
dinnerware and toys. This use of source material might be considered 
frivolous, which is not in keeping with the policy of the Commission 
with regard to consumer products. However, this use predates the AEA, 
has been ongoing for decades, and continues today. Current 
manufacturing is relatively limited and the concentration in any 
recently produced items appears to be less than 2 percent source 
material (uranium). The one NRC-licensed manufacturer maintains 
concentration in products to within 1 percent by weight uranium. This 
rule proposes to limit products manufactured in the future to no more 
than 2 percent by weight source material. This would have minimal 
impact on the industry, limited to any costs associated with ensuring 
and documenting that products do not exceed this limit. It would ensure 
that doses to members of the public exposed to products distributed for 
use under this exemption in the future would be unlikely to exceed 10 
[mu]Sv (1 mrem) per year. This is more appropriate for products with 
minimal societal benefit and is consistent with the concept of ALARA 
(as low as reasonably achievable).
A.7. Obsolete Exemptions
    Some exemptions from licensing are considered obsolete in that no 
products are being distributed for use under the exemption. In at least 
one case, no products covered by the exemption remain in use. 
Generally, this has occurred because new technologies have made the use 
of radioactive material unnecessary or less cost-effective.
    The NRC is proposing to delete exemptions for products that are no 
longer being used or manufactured, or to restrict further distribution 
while allowing for the continued possession and use of previously 
distributed items. NUREG-1717 describes the various products covered by 
the individual exemptions. Two of the conclusions in that report 
concerning distribution are:
     For Sec.  40.13(d): It is believed that fire detection 
units containing source material have not been manufactured for 
commercial use; and
     For Sec.  40.13(c)(2)(i): The exemption for ceramic 
tableware containing source material could result in significant doses, 
which might be of concern, if used as one's everyday dinnerware.
    The exemption in Sec.  40.13(d) would be removed; however, in the 
unlikely event that persons possess products covered by this provision, 
this action would not change the regulatory status of any products 
previously manufactured in conformance with the provisions of the 
regulations applicable at the time. In the case of ceramic tableware, 
the proposed rule would limit the exemption to previously manufactured 
products. This action would provide assurance that health and safety 
are adequately protected from possible future distribution. Preliminary 
estimates indicated a potential for exposures higher than is 
appropriate for materials being used under an exemption. However, these 
were estimated using particularly conservative assumptions for routine 
use, rather than the more typical use as a collectable.
    Deleting the provision in Sec.  40.13(d) would simplify the 
regulations by eliminating extraneous text. Also, the Commission 
periodically reevaluates the exposure of the general public from all 
products and materials distributed for use under exemption, to ensure 
that the total contribution of these products to the exposure of the 
public will not exceed small fractions of the allowable limits. 
Eliminating obsolete exemptions would add to the assurance that future 
use of products in these categories would not contribute to exposures 
of the public and would also eliminate the need to reassess the 
potential exposure of the public from possible future distributions of 
these products.
    There are other products covered by the exemptions in Sec.  
40.13(c) for which distribution is very limited and may have ceased, 
however, without the types of distributor requirements now being 
proposed, it is difficult to be certain concerning whether any 
distribution continues.
    This risk-based approach to exemptions is in line with the 
strategic plan of the NRC.

B. Whom would this action affect?

    This proposed rule would affect manufacturers and distributors of 
certain products and materials containing source material, and persons 
using source material under the general license in Sec.  40.22. Certain 
persons initially transferring source material to exempt persons or 
general licensees would be required to obtain a specific license for 
such distribution. Certain persons currently possessing a general 
license under Sec.  40.22 may be required to obtain a specific license 
for the continued possession and use of source material if they cannot 
adapt their operations to the newly proposed possession limits or if 
they initially transfer products containing source material. The 
proposed rule would exempt persons who possess thorium or uranium 
coated lenses or mirrors from licensing requirements for those lenses

[[Page 43435]]

and mirrors through a proposed revision to Sec.  40.13(c)(7).

C. Specific Requests for Comment

    The NRC has identified specific questions related to this proposed 
rulemaking as well as some questions for consideration in potential 
future rulemakings.
    The NRC seeks comments, in particular, on the following specific 
questions presented in the proposed rulemaking:
    (1) In the proposed expansion to Sec.  40.13(c)(7), the exemption 
is limited by a concentration limit. It is expected that coatings on 
lenses are always very thin in practice such that it is unlikely that 
coated lenses would be near the concentration limit. However, a 
concentration limit may not be the most appropriate control, as it is 
generally not appropriate for surface contamination or hot spots to be 
averaged with other material for comparison to a concentration limit. 
Should other controls (e.g., mass or activity limit) be used and if so, 
what limits should be considered?
    (2) On the proposed revision to the general license for small 
quantities of source material in Sec.  40.22, is the limitation to 
natural or depleted uranium and natural thorium the most appropriate 
way to prevent persons from obtaining source material radionuclides 
with high specific activities without applying for a specific license? 
Does this adequately protect public health and safety from, for 
example, thorium-230 extracted from ore high in uranium content? Should 
an activity limit(s) be added to the weight limit? If so, what activity 
limit would adequately protect health and safety without adding 
significant implementation burden for ensuring the activity limit(s) 
are not exceeded?
    (3) In Sec.  40.22(c), the NRC proposes to require persons to 
contact the NRC if they identify significant contamination but does not 
specifically identify what is considered to be significant 
contamination. Is this a reasonable approach or are there other 
approaches the NRC should consider? Should the NRC prescribe what is 
considered significant contamination, and if so, what should be defined 
as significant contamination? Should the NRC instead specifically 
require general licensees to complete surveys in accordance with the 
provisions of Sec.  20.1501 to ensure that the limits in Sec.  20.1402 
are not exceeded, in particular for those licensees possessing source 
material under the proposed Sec.  40.22(a)(1)? Would a requirement for 
such surveys result in unnecessary expenses, particularly for general 
licensees possessing very small quantities, or should such a 
requirement be limited and if so, how?
    (4) In assessing proposed changes to Sec.  40.22, has the NRC 
properly identified and assessed the range of activities undertaken 
under the existing general license? Has the NRC overestimated or 
underestimated the potential for impacts from such operations and if 
so, how (e.g., is there exposure data available that the NRC did not 
have available during development of the proposed rule, but should be 
considering)? Similarly, are the assumptions discussed in the proposed 
revisions to exemptions in Sec.  40.13 correct (i.e., are some products 
still being manufactured at concentration levels above the proposed 
concentration limits)?
    (5) In Sec.  170.31, the NRC is proposing to add new categories 
2.C., 2.D., and 2.E. and associated fees for applications for those 
categories. Similarly, in Sec.  171.16, the NRC is proposing to add new 
categories 2.C., 2.D., and 2.E and associated annual fees to the table 
in paragraph (d). In both situations, the proposed new fees are based 
upon similar existing activities, although in future years these fees 
would be based upon actual NRC effort on these activities as data is 
accumulated. Are these new fee categories appropriate and are the 
initial fees reasonable?
    (6) In Sec.  40.22(b)(2)(ii), quantities of source material greater 
than 0.5 kg (1 lb) per year would be required to be disposed of as 
radioactive material through the provisions of Sec.  20.2001 or 
transferred to another person otherwise authorized to receive the 
source material. Should the NRC consider other disposal alternatives 
for these larger quantities, such as in U.S. Environmental Protection 
Agency's Resource Conservation and Recovery Act (RCRA) Subtitle C 
hazardous waste disposal facilities or RCRA Subtitle D municipal Solid 
waste landfills?
    The NRC would also welcome preliminary input on the following 
issues for potential future rulemaking:
    (1) Should the general license in Sec.  40.22 be expanded to cover 
11(e)2 byproduct material, i.e., mill tailings and wastes, to allow for 
small quantities, such as samples, to be more readily transferred for 
testing, for example? Given that the entire material is 11(e)2 
byproduct material, and not just the uranium or thorium contained in 
the material, would higher weight limits be appropriate? If allowed, 
should any other conditions be changed (e.g., waste disposal, etc.) or 
added?
    (2) Should explicit provisions be added to 10 CFR Part 40 and 10 
CFR Part 70 to cover the inclusion of source material and special 
nuclear material in items in the sealed source and device registry, 
similar to 10 CFR 32.210?
    (3) There has been little use of the provisions in Sec. Sec.  40.25 
and 40.34 for the use of depleted uranium under a general license. How 
could these provisions be revised to expand the likely use of these 
provisions and make the general license more useful to the regulatory 
program? Is the subjective nature of the findings in Sec.  40.34(a)(3) 
and (b) concerning the usefulness of a product or device and the 
benefits from the use of the depleted uranium a deterrent to 
applicants/potential distributors? Also, should the exposure limits in 
Sec.  40.34(a)(2) be reduced to 1 mSv (100 mrem) per year?
    (4) Are there product exemptions in Sec.  40.13(c) that should be 
considered obsolete and revised to allow only those products that were 
previously distributed? Are there other changes to the exemptions in 
Sec.  40.13(c) that should be considered?

D. What should I consider as I prepare my comments to the NRC?

    Recommendations for preparing your comments:
    i. Identify the rulemaking: RIN 3150-AH15; docket ID NRC-2009-0084.
    ii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iii. Describe any assumptions and provide any technical information 
and/or data that you used.
    iv. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    v. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vi. Explain your views as clearly as possible.
    vii. Make sure to submit your comments by the comment period 
deadline identified.
    viii. Section VI of this document contains a request for comment on 
the compatibility designations for the proposed rule; Section VII 
contains a request for comments on the use of plain language; Section 
IX contains a request for comments on the environmental assessment; 
Section X contains a request for comments on the information collection 
requirements; Section XI contains a request for comments on the draft 
regulatory analysis; and Section XII contains a request for comments on 
the impact of the proposed rule on small businesses.

[[Page 43436]]

IV. Summary of Proposed Amendments by Section

Section 30.6 Communications

    10 CFR 30.6(b)(1)(iv)--Would add a reference to new Sec.  40.52 as 
a licensing category not delegated to the NRC Regions.

Section 40.5 Communications

    10 CFR 40.5(b)(1)(iv)--Would add a reference to new Sec.  40.52 as 
a licensing category not delegated to the NRC Regions.

Section 40.8 Information Collection Requirements: OMB Approval

    10 CFR 40.8(b)--Would add sections to the list of information 
collection requirements.

Section 40.13 Unimportant Quantities of Source Material

    10 CFR 40.13(c)--Would clarify that persons exempt from licensing 
requirements are also exempt from 10 CFR Parts 19, 20, and 21.
    10 CFR 40.13(c)(2)(i)--Would restrict the exemption for use of 
source material in certain ceramic tableware to that previously 
manufactured.
    10 CFR 40.13(c)(2)(iii)--Would revise the exemption for use of 
source material in glassware to reduce the limit of 10 percent by 
weight source material to 2 percent by weight source material for 
glassware manufactured in the future.
    10 CFR 40.13(c)(5)--Would remove paragraph (c)(5)(i), as it is 
redundant with the new paragraph (c)(10), and renumber the subsequent 
paragraphs within (c)(5).
    10 CFR 40.13(c)(7)--Would revise the exemption for use of source 
material in optical lenses to: (1) Reduce the limit of 30 percent by 
weight thorium to 10 percent by weight thorium for glassware 
manufactured in the future; (2) accommodate lenses with coatings; (3) 
add uranium to the material that may be combined with or on the lenses; 
and (4) add mirrors.
    10 CFR 40.13(c)(10)--Would add paragraph (c)(10) to restrict 
initial distribution under the exemption and direct one to requirements 
for authorization under an NRC specific license to initially transfer 
or distribute source material.
    10 CFR 40.13(d)--Would remove an obsolete exemption for use of 
source material in fire detection units.

Section 40.22 Small Quantities of Source Material

    10 CFR 40.22(a)(1)--Would apply a limit of 1.5 kg (3.3 lb) at any 
one time to certain forms of uranium and thorium that may be inhaled or 
ingested during normal working conditions and would restrict receipt to 
less than 7 kg (15.4 lb) per year.
    10 CFR 40.22 (a)(2)--Would allow additional possession of certain 
forms of uranium and thorium that are not expected to be normally 
inhaled or ingested. However, the total amount of uranium and thorium 
possessed under the general license would still be limited to 7 kg 
(15.4 lb) at any one time and the receipt of no more than 70 kg (154 
lb) of uranium and thorium per year.
    10 CFR 40.22(a)(3)--Would allow persons removing uranium from 
drinking water to continue to possess up to 7 kg (15.4 lb) of uranium 
at any one time and to remove up to 70 kg (154 lb) of uranium from 
drinking water per calendar year.
    10 CFR 40.22(b)(1)--Would continue to prohibit persons from 
administering source material, or the resulting radiation, either 
externally or internally, to human beings except as authorized by the 
NRC in a specific license.
    10 CFR 40.22(b)(2)--Would clarify that any person who receives, 
possesses, uses, or transfers source material under Sec.  40.22 may not 
abandon source material. The source material may be transferred under 
Sec.  40.51 or permanently disposed. The general licensee would be 
allowed to dispose of up to a total of 0.5 kg (1.1 lb) per calendar 
year of source material through transfer to any person for permanent 
disposal as long as the source material is in a solid, non-dispersible 
form (e.g., metal brick, encapsulated in cement, etc.). The recipient 
of the source material would not be required to obtain a license from 
the NRC as long as it was permanently disposed. Permanent disposal of 
quantities of source material exceeding 0.5 kg (1.1 lb) of source 
material per calendar year or in non-solid forms (e.g., is readily 
ingested or inhaled) would be required to be in accordance with Sec.  
20.2001.
    10 CFR 40.22(b)(3)--Would clarify which provisions in 10 CFR Part 
40 apply under the general license.
    10 CFR 40.22(b)(4)--Would add a provision to explicitly require 
that licensees must respond to written requests by the NRC.
    10 CFR 40.22(b)(5)--Would clarify that export of source material is 
subject to 10 CFR Part 110.
    10 CFR 40.22(c)--Would require that any person who receives, 
possesses, uses, or transfers source material in accordance with 
paragraph (a) of Sec.  40.22 must conduct activities so as to minimize 
contamination of the facility and the environment.
    10 CFR 40.22(d)--Would revise and move the requirements currently 
under paragraph (b) of this section to paragraph (d) of this section.
    10 CFR 40.22(e)--Would restrict initial distribution for use under 
the general license to a specific license issued under Sec.  40.54 or 
equivalent provisions of an Agreement State.

Section 40.32 General Requirements for Issuance of a Specific License

    10 CFR 40.32(f)--Would add Sec. Sec.  40.52 and 40.54 to the list 
of sections that have special requirements that need to be satisfied 
for the issuance of certain specific licenses.

Section 40.52 Certain Items Containing Source Material; Requirements 
for License To Apply or Initially Transfer

    10 CFR 40.52--Would establish requirements for a license 
authorizing distribution for use under the exemptions from licensing in 
Sec.  40.13(c) and equivalent provisions of Agreement States.

Section 40.53 Conditions of Licenses Issued Under Sec.  40.52: Quality 
Control, Labeling, and Records and Reports

    10 CFR 40.53--Would establish requirements for licenses issued 
under Sec.  40.52, including reporting and recordkeeping requirements 
for distributions of products for use under Sec.  40.13(c) and 
equivalent provisions of Agreement States.

Section 40.54 Requirements for License To Initially Transfer Source 
Material for Use Under Sec.  40.22

    10 CFR 40.54--Would establish requirements for a license 
authorizing initial transfer or distribution for use under Sec.  40.22 
and equivalent provisions of Agreement States.

Section 40.55 Conditions of Licenses Issued Under Sec.  40.54: Quality 
Control, Labeling, Safety Instructions, Records and Reports

    10 CFR 40.55--Would establish requirements for licenses issued 
under Sec.  40.54, including reporting and recordkeeping requirements 
for distributions of source material for use under the general license 
in Sec.  40.22 and equivalent provisions of Agreement States.

Section 40.82 Criminal Penalties

    10 CFR 40.82(b)--Would add sections to the list of provisions that 
are not subject to criminal sanctions.

Section 70.5 Communications

    10 CFR 70.5(b)(1)(iv)--Would add a reference to the proposed Sec.  
40.52 as a

[[Page 43437]]

licensing category not delegated to the NRC Regions.

Section 170.31 Schedule of Fees for Materials Licenses and Other 
Regulatory Services, Including Inspections, and Import and Export 
Licenses

    10 CFR 170.31--Would add to the schedule of fees three new 
categories for distributors of source material.

Section 171.16 Annual Fees: Materials Licensees, Holders of 
Certificates of Compliance, Holders of Sealed Source and Device 
Registrations, Holders of Quality Assurance Program Approvals, and 
Government Agencies Licensed By NRC

    10 CFR 171.16--Would add three fee categories for distributors of 
source material to the annual fees.

V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is proposing to amend Sec.  40.22 and add Sec. Sec.  40.53 
and 40.55 under one or more of Sections 161b, 161i, or 161o of the AEA. 
Willful violations of the rule would be subject to criminal 
enforcement.

VI. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs''approved by the Commission on June 30, 1997, 
and published in the Federal Register (62 FR 46517; September 3, 1997), 
this proposed rule would be a matter of compatibility between the NRC 
and the Agreement States, thereby providing consistency among the 
Agreement States and the NRC requirements. The NRC staff analyzed the 
proposed rule in accordance with the procedure established within Part 
III, ``Categorization Process for NRC Program Elements,''of Handbook 
5.9 to Management Directive 5.9, ``Adequacy and Compatibility of 
Agreement State Programs'' (a copy of which may be viewed at http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
    NRC program elements (including regulations) are placed into four 
compatibility categories (see the Draft Compatibility Table in this 
section). In addition, the NRC program elements can also be identified 
as having particular health and safety significance or as being 
reserved solely to the NRC. Compatibility Category A are those program 
elements that are basic radiation protection standards and scientific 
terms and definitions that are necessary to understand radiation 
protection concepts. An Agreement State should adopt Category A program 
elements in an essentially identical manner to provide uniformity in 
the regulation of agreement material on a nationwide basis. 
Compatibility Category B are those program elements that apply to 
activities that have direct and significant effects in multiple 
jurisdictions. An Agreement State should adopt Category B program 
elements in an essentially identical manner. Compatibility Category C 
are those program elements that do not meet the criteria of Category A 
or B, but the essential objectives of which an Agreement State should 
adopt to avoid conflict, duplication, gaps, or other conditions that 
would jeopardize an orderly pattern in the regulation of agreement 
material on a nationwide basis. An Agreement State should adopt the 
essential objectives of the Category C program elements. Compatibility 
Category D are those program elements that do not meet any of the 
criteria of Category A, B, or C, above and, thus, do not need to be 
adopted by Agreement States for purposes of compatibility.
    Health and Safety (H&S) are program elements that are not required 
for compatibility but are identified as having a particular health and 
safety role (i.e., adequacy) in the regulation of agreement material 
within the State. Although not required for compatibility, the State 
should adopt program elements in this H&S category based on those of 
the NRC that embody the essential objectives of the NRC program 
elements, because of particular health and safety considerations. 
Compatibility Category NRC are those program elements that address 
areas of regulation that cannot be relinquished to Agreement States 
under the Atomic Energy Act, as amended, or provisions of Title 10 of 
the Code of Federal Regulations. These program elements are not adopted 
by Agreement States. The following table lists the Parts and Sections 
that would be revised and their corresponding categorization under the 
``Policy Statement on Adequacy and Compatibility of Agreement State 
Programs.''

 Draft Compatibility Table for Proposed Rule Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License
                                                                     and Exemptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Compatibility
               Section                           Change                      Subject           ---------------------------------------------------------
                                                                                                          Existing                       New
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Part 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
30.6................................  Amend......................  Communications.............  D..........................  D
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Part 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
40.5................................  Amend......................  Communications.............  D..........................  D
40.8................................  Amend......................  Information collection       D..........................  D
                                                                    requirements: OMB approval.
40.13(c)............................  Amend......................  Unimportant quantities of    B..........................  B
                                                                    source material.
40.13(c)(2)(i)......................  Amend......................  Unimportant quantities of    B..........................  B
                                                                    source material.
40.13(c)(2)(iii)....................  Amend......................  Unimportant quantities of    B..........................  B
                                                                    source material.
40.13(c)(7).........................  Amend......................  Unimportant quantities of    B..........................  B
                                                                    source material.
40.13(c)(10)........................  New........................  Unimportant quantities of    ...........................  B
                                                                    source material.
40.13(d)............................  Remove.....................  Unimportant quantities of    B..........................  *
                                                                    source material.
40.22(a)............................  Amend......................  Small quantities of source   B..........................  B
                                                                    material.
40.22(a)(1).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(a)(2).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(a)(3).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(b)............................  Amend......................  Small quantities of source   B..........................  B
                                                                    material (Previously
                                                                    40.22(c)).
40.22(b)(1).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(b)(2).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(b)(3).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.

[[Page 43438]]

 
40.22(b)(4).........................  New........................  Small quantities of source   ...........................  D
                                                                    material.
40.22(b)(5).........................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.22(c)............................  New........................  Small quantities of source   ...........................  C
                                                                    material.
40.22(d)............................  Amend......................  Small quantities of source   B..........................  B
                                                                    material (Previously
                                                                    40.22(b)).
40.22(e)............................  New........................  Small quantities of source   ...........................  B
                                                                    material.
40.52...............................  New........................  Certain items containing     ...........................  NRC
                                                                    source material;
                                                                    requirements for license
                                                                    to apply or initially
                                                                    transfer.
40.53...............................  New........................  Conditions of licenses       ...........................  NRC
                                                                    issued under Sec.   40.52:
                                                                    Quality control, labeling,
                                                                    and records and reports.
40.54...............................  New........................  Requirements for license to  ...........................  B
                                                                    initially transfer source
                                                                    material for use under
                                                                    Sec.   40.22.
40.55(a)............................  New........................  Conditions of licenses       ...........................  B
                                                                    issued under Sec.   40.54:
                                                                    Quality control, labeling,
                                                                    safety instructions, and
                                                                    records and reports.
40.55(b)............................  New........................  Conditions of licenses       ...........................  B
                                                                    issued under Sec.   40.54:
                                                                    Quality control, labeling,
                                                                    safety instructions, and
                                                                    records and reports.
40.55(c)............................  New........................  Conditions of licenses       ...........................  B
                                                                    issued under Sec.   40.54:
                                                                    Quality control, labeling,
                                                                    safety instructions, and
                                                                    records and reports.
40.55(d)............................  New........................  Conditions of licenses       ...........................  B
                                                                    issued under Sec.   40.54:
                                                                    Quality control, labeling,
                                                                    safety instructions, and
                                                                    records and reports.
40.55(e)............................  New........................  Conditions of licenses       ...........................  C
                                                                    issued under Sec.   40.54:
                                                                    Quality control, labeling,
                                                                    safety instructions, and
                                                                    records and reports.
40.82...............................  Amend......................  Criminal penalties.........  D..........................  D
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Part 70
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.5................................  Amend......................  Communications.............  D..........................  D
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Part 170
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.31..............................  Amend......................  Schedules of fees for        D..........................  D
                                                                    materials licenses and
                                                                    other regulatory services,
                                                                    including inspections, and
                                                                    import and export licenses.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Part 171
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.16..............................  Amend......................  Annual fees for materials    D..........................  D
                                                                    licenses and other
                                                                    regulatory services.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Denotes an existing provision that is currently designated Compatibility Category B which would be removed from the regulations as a result of these
  proposed amendments. Agreement States should remove this provision from their regulations when the amendment becomes final.

    The NRC invites comment on the compatibility category designations 
in the proposed rule and suggests that commenters refer to Handbook 5.9 
of Management Directive 5.9 for more information. The NRC notes that, 
like the rule text, the compatibility category designations can change 
between the proposed rule and final rule, based on comments received 
and Commission decisions regarding the final rule. The NRC encourages 
anyone interested in commenting on the compatibility category 
designations in any manner to do so during the comment period.

VII. Plain Language

    The Presidential Memorandum ``Plain Language in Government 
Writing'' published June 10, 1998 (63 FR 31883), directed that the 
Government's documents be in clear and accessible language. The NRC 
requests comments on this proposed rule specifically with respect to 
the clarity and effectiveness of the language used. Comments should be 
sent to the address listed under the ADDRESSES heading in this 
document.

VIII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113) requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
the use of such a standard is inconsistent with applicable law or 
otherwise impractical. In this proposed rule, the NRC would establish 
requirements for distributors of source material to persons exempt from 
regulation and to general licensees. In addition, the proposed 
amendments would modify the existing possession and use requirements 
for the general license for small quantities of source material to 
better align the requirements with current health and safety standards. 
The Commission is also proposing to revise, clarify, or delete certain 
exemptions from licensing to make the requirements for the use of 
source material under the exemptions more risk informed. The NRC is not 
aware of any voluntary consensus standards that address the proposed 
subject matter of this proposed rule. The NRC will consider using a 
voluntary consensus standard if an appropriate standard is identified. 
If

[[Page 43439]]

a voluntary consensus standard is identified for consideration, the 
submittal should explain why the standard should be used.

IX. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the Commission's regulations in 
Subpart A of 10 CFR Part 51, not to prepare an environmental impact 
statement for this proposed rule because the Commission has concluded 
on the basis of an environmental assessment that this proposed rule, if 
adopted, would not be a major Federal action significantly affecting 
the quality of the human environment.
    The majority of the provisions in the proposed rule come within the 
scope of categorical exclusion in Sec.  51.22, and as such, an 
environmental review is not necessary. The implementation of the 
remaining provisions of the proposed rule would not result in any 
significant negative impact to the environment. Proposed revisions to 
Sec.  40.22 primarily provide additional limitations on, and clarify 
the requirements of, the Sec.  40.22 general licensee, thus, 
potentially reducing the impact on environmental resources from the 
status quo. Similarly, certain exemptions are being revised or deleted 
to limit the future use of certain products containing source material. 
Although the NRC is proposing to expand the exemption from licensing in 
Sec.  40.13(c)(7) to allow coated lenses, the NRC's evaluation 
indicated that these products contain significantly less source 
material than those currently authorized under the exemption. The 
Commission has determined that the implementation of this proposed rule 
would be procedural and administrative in nature.
    The determination of this environmental assessment is that there 
would be no significant impact to the public from this action. However, 
the general public should note that the NRC welcomes public 
participation. Comments on any aspect of the Environmental Assessment 
may be submitted to the NRC as indicated under the ADDRESSES heading in 
this document.
    The NRC has sent a copy of the Environmental Assessment and this 
proposed rule to every State Liaison Officer and requested their 
comments on the Environmental Assessment. The Environmental Assessment 
may be examined at the NRC Public Document Room, O-1F21, 11555 
Rockville Pike, Rockville, MD 20852, or online at http://www.regulations.gov under Docket ID NRC-2009-0084.

X. Paperwork Reduction Act Statement

    This proposed rule contains new or amended information collection 
requirements contained in 10 CFR Part 40 that are subject to the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). These 
information requirements have been submitted to the Office of 
Management and Budget for review and approval of the information 
collection requirements. The proposed rule changes to 10 CFR Parts 30, 
70, 170, and 171 do not contain new or amended information collection 
requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR Parts 30, 40, 70, 
170, and 171; Distribution of Source Material to Exempt Persons and to 
General Licensees and Revision of General License and Exemptions.
    The form number: NRC Form 313.
    How often the collection is required: One time for licensing 
applications and amendments for new initial distribution licenses or 
for certain general licensees ceasing activities; annual for reports on 
initial distribution of source material; occasional for responses to 
direct NRC requests for information.
    Who will be required or asked to report: Applicants and licensees 
who manufacture or initially distribute products or materials 
containing source material to persons exempt from the regulations or 
for use under a general license, and some users of source material 
possessed under a general license.
    An estimate of the number of annual responses: 164.3 (10 CFR Part 
19 = 1 response; 10 CFR Part 20 = 7 responses; 10 CFR Part 40 = 95 
responses; NRC Form-313 = 12.3 responses, plus 49 recordkeepers).
    The estimated number of annual respondents: 75 (10 CFR Part 19 = 1 
respondent; 10 CFR Part 20 = 2.33 respondents; 10 CFR Part 40 = 75 
respondents; NRC Form-313 = 11.3 respondents). Because some licensees 
may report under multiple parts, the total number of respondents for 
the proposed rule is 75 (40 NRC licensees plus 35 Agreement State 
licensees).
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 753.3 (10 CFR Part 19 = 45.3 
hours; 10 CFR Part 20 = 255 hours; 10 CFR Part 40 = 361.4 hours, NRC 
Form-313 = 91.6 hours).
    Abstract: The NRC is proposing to amend its regulations in 10 CFR 
Part 40 to establish new requirements for distributors of source 
material to persons exempt from the regulations or for use under a 
general license in Sec.  40.22. In addition, the Commission is also 
proposing to modify the existing possession and use requirements for 
Sec.  40.22 general licensees to align the requirements with current 
health and safety standards. Finally, the Commission is proposing to 
revise, clarify, or delete certain exemptions in Sec.  40.13(c) to make 
the exemptions more risk informed. Conforming changes would be made to 
10 CFR Parts 30, 70, 170 and 171. These changes would affect 
manufacturers and distributors of products and materials containing 
source material and future users of some products used under exemptions 
from licensing and under the Sec.  40.22 general license.
    Information collections would result from new requirements for 
certain persons initially distributing source material to obtain a 
specific license. These new specific licensees would be required to 
provide reports regarding their initial distributions of source 
material to the NRC and the Agreement States on an annual basis and 
maintain records of such reports, as well as meet existing information 
collection requirements in 10 CFR Parts 19 and 20. In addition, 
labeling requirements and notifications to recipients would be required 
for certain initial distributions of source material. Proposed 
revisions to the general license provisions in Sec.  40.22 would 
specifically require the general licensee to respond to NRC requests 
for information in a timely manner and notify the NRC when ceasing 
activities if significant contamination is identified.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in the proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the proper 
performance of the functions of the NRC, including whether the 
information will have practical utility?
    2. Is the estimate of burden accurate?
    3. Is there a way to enhance the quality, utility, and clarity of 
the information to be collected?
    4. How can the burden of the information collection be minimized, 
including the use of automated collection techniques?
    A copy of the OMB clearance package may be viewed free of charge at 
the NRC Public Document Room, One White Flint North, 11555 Rockville 
Pike, Room O-1 F21, Rockville, MD 20852. The OMB clearance package and 
rule are available at the NRC worldwide Web site: http://www.nrc.gov/
public-involve/

[[Page 43440]]

doc-comment/omb/index.html for 60 days after the signature date of this 
notice.
    Send comments on any aspect of these proposed information 
collections, including suggestions for reducing the burden and on the 
above issues, by October 25, 2010 to the Information Services Branch 
(T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, or Internet electronic mail to NEOB-10202 (3150-AH15), Office of 
Management and Budget, Washington, DC 20503. Comments on the proposed 
information collections may also be submitted via the Federal 
Rulemaking Web site http://www.regulations.gov, docket ID NRC-2009-
0084. Comments received after this date will be considered if it is 
practical to do so, but assurance of consideration cannot be given to 
comments received after this date.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information or an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

XI. Regulatory Analysis

    The Commission has prepared a draft regulatory analysis on this 
proposed regulation. The analysis examines the costs and benefits of 
the alternatives considered by the Commission.
    The Commission requests public comment on the draft regulatory 
analysis. Comments on the draft analysis may be submitted to the NRC as 
indicated under the ADDRESSES heading in this document. The analysis is 
available for inspection in the NRC Public Document Room, 11555 
Rockville Pike, Rockville, MD 20852, or online at www.regulations.gov 
under Docket Number ID NRC-2009-0084. Single copies of the draft 
regulatory analysis are available from Gary Comfort, telephone: (301) 
415-8106, e-mail: [email protected], or Catherine Mattsen, 
telephone: (301) 415-6264, e-mail: [email protected], of the 
Office of Federal and State Materials and Environmental Management 
Programs.

XII. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule would not, if 
promulgated, have a significant economic impact on a substantial number 
of small entities. A significant number of the licensees affected by 
this action would meet the definition of ``small entities'' set forth 
in the Regulatory Flexibility Act or the Small Business Size Standards 
set out in regulations issued by the Small Business Administration at 
13 CFR Part 121. However, none of the proposed revisions to the 
regulatory program would result in a significant economic impact on the 
affected entities.

XIII. Backfit Analysis

    The NRC's backfit provisions are found in the regulations at 
Sec. Sec.  50.109, 52.39, 52.63, 52.83, 52.98, 52.145, 52.171, 70.76, 
72.62, and 76.76. The requirements contained in this proposed rule do 
not involve any provisions that would impose backfits on nuclear power 
plant licensees as defined in 10 CFR Parts 50 or 52, or on licensees 
for gaseous diffusion plants, independent spent fuel storage 
installations or special nuclear material as defined in 10 CFR Parts 
70, 72 and 76, respectively, and as such a backfit analysis is not 
required. Therefore, a backfit analysis need not be prepared for this 
proposed rule to address these classes of entities. With respect to 10 
CFR Part 40 licensees, the NRC has determined that there are no 
provisions for backfit in 10 CFR Part 40. Therefore, a backfit analysis 
need not be prepared for this proposed rule to address part 40 
licensees.

List of Subjects

10 CFR Part 30

    Byproduct material, Criminal penalties, Government contracts, 
Intergovernmental relations, Isotopes, Nuclear materials, Radiation 
protection, Reporting and recordkeeping requirements.

10 CFR Part 40

    Criminal penalties, Government contracts, Hazardous materials 
transportation, Nuclear materials, Reporting and recordkeeping 
requirements, Source material, Uranium.

10 CFR Part 70

    Criminal penalties, Hazardous materials transportation, Material 
control and accounting, Nuclear materials, Packaging and containers, 
Radiation protection, Reporting and recordkeeping requirements, 
Scientific equipment, Security measures, Special nuclear material.

10 CFR Part 170

    Byproduct material, Import and export licenses, Intergovernmental 
relations, Nonpayment penalties, Nuclear materials, Nuclear power 
plants and reactors, Source material, Special nuclear material.

10 CFR Part 171

    Annual charges, Byproduct material, Holders of certificates, 
registrations, approvals, Intergovernmental relations, Nonpayment 
penalties, Nuclear materials, Nuclear power plants and reactors, Source 
material, Special nuclear material.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to 
adopt the following amendments to 10 CFR parts 30, 40, and 70 and the 
following amendments to 10 CFR parts 170 and 171, as amended on June 
16, 2010, at 75 FR 34220, effective August 16, 2010.

PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF 
BYPRODUCT MATERIAL

    1. The authority citation for Part 30 continues to read as follows:

    Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 549 (2005).
    Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under 
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

    2. In Sec.  30.6, paragraph (b)(1)(iv) is revised to read as 
follows:


Sec.  30.6  Communications.

* * * * *
    (b) * * *
    (1) * * *
    (iv) Distribution of products containing radioactive material to 
persons exempt under Sec. Sec.  32.11 through 32.30 and Sec.  40.52 of 
this chapter.
* * * * *

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

    3. The authority citation for Part 40 continues to read as follows:

     Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 
Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 
83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 
83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093,

[[Page 43441]]

2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 
274, Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L. 
97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as 
amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 
2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy 
Policy Act of 2005, Pub. L. No. 109-59, 119 Stat. 594 (2005).
    Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 
U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 Stat. 
939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68 
Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued 
under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

    4. In Sec.  40.5, paragraph (b)(1)(iv) is revised to read as 
follows:


Sec.  40.5  Communications.

* * * * *
    (b) * * *
    (1) * * *
    (iv) Distribution of products containing radioactive material to 
persons exempt under Sec. Sec.  32.11 through 32.30 and Sec.  40.52 of 
this chapter.
* * * * *
    5. In Sec.  40.8, paragraph (b) is revised to read as follows:


Sec.  40.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.  40.9, 40.22, 40.23, 40.25, 40.26, 40.27, 
40.31, 40.34, 40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.52, 
40.53, 40.54, 40.55, 40.60, 40.61, 40.64, 40.65, 40.66, 40.67, and 
appendix A to this part.
* * * * *
    6. In Sec.  40.13, the introductory text to paragraph (c), and 
paragraphs (c)(2)(i), (c)(2)(iii), (c)(5) and (c)(7) are revised, 
paragraph (c)(10) is added, and paragraph (d) is removed.
    The revisions and addition read as follows:


Sec.  40.13  Unimportant quantities of source material.

* * * * *
    (c) Any person is exempt from the requirements for a license set 
forth in section 62 of the Act and from the regulations in this part 
and parts 19, 20, and 21 of this chapter to the extent that such person 
receives, possesses, uses, or transfers:
* * * * *
    (2) * * *
    (i) Glazed ceramic tableware manufactured before [effective date of 
final rule], provided that the glaze contains not more than 20 percent 
by weight source material;
* * * * *
    (iii) Glassware containing not more than 2 percent by weight source 
material or, for glassware manufactured before [effective date of final 
rule], 10 percent by weight source material; but not including 
commercially manufactured glass brick, pane glass, ceramic tile, or 
other glass or ceramic used in construction;
* * * * *
    (5) Uranium contained in counterweights installed in aircraft, 
rockets, projectiles, and missiles, or stored or handled in connection 
with installation or removal of such counterweights: Provided, That:
    (i) Each counterweight has been impressed with the following legend 
clearly legible through any plating or other covering: ``Depleted 
Uranium''; \2\
    (ii) Each counterweight is durably and legibly labeled or marked 
with the identification of the manufacturer, and the statement: 
``Unauthorized Alterations Prohibited''; \2\
---------------------------------------------------------------------------

    \2\ The requirements specified in paragraphs (c)(5)(i) and 
(c)(5)(ii) of this section need not be met by counterweights 
manufactured prior to December 31, 1969, provided that such 
counterweights were manufactured under a specific license issued by 
the Atomic Energy Commission and were impressed with the legend 
required by Sec.  40.13(c)(5)(i) in effect on June 30, 1969.
---------------------------------------------------------------------------

    (iii) The exemption contained in this paragraph shall not be deemed 
to authorize the chemical, physical, or metallurgical treatment or 
processing of any such counterweights other than repair or restoration 
of any plating or other covering.
* * * * *
    (7) Thorium or uranium contained in or on finished optical lenses 
and mirrors, provided that each lens does not contain more than 10 
percent by weight thorium or uranium or, for lenses manufactured before 
[effective date of the final rule], 30 percent by weight of thorium; 
and that the exemption contained in this paragraph does not authorize 
either:
    (i) The shaping, grinding or polishing of such lens or mirror or 
manufacturing processes other than the assembly of such lens or mirror 
into optical systems and devices without any alteration of the lens or 
mirror; or
    (ii) The receipt, possession, use, or transfer of uranium or 
thorium contained in contact lenses, or in spectacles, or in eyepieces 
in binoculars or other optical instruments.
* * * * *
    (10) No person may initially transfer for sale or distribution a 
product containing source material to persons exempt under this 
paragraph (c), or equivalent regulations of an Agreement State, unless 
authorized by a license issued under Sec.  40.52 to initially transfer 
such products for sale or distribution.
    (i) Persons initially distributing source material in products 
covered by the exemptions in this paragraph (c) before [effective date 
of the final rule] without specific authorization may continue such 
distribution for 1 year beyond this date. Initial distribution may also 
be continued until the Commission takes final action on a pending 
application for license or license amendment to specifically authorize 
distribution submitted no later than 1 year beyond this date.
    (ii) Persons authorized to manufacture, process, or produce 
materials or products containing source material by an Agreement State 
and persons who import finished products or parts for sale or 
distribution must be authorized by a license issued under Sec.  40.52 
for distribution only and are exempt from the requirements of parts 19 
and 20 of this chapter, and Sec.  40.32(b) and (c).
* * * * *
    7. Section 40.22 is revised to read as follows:


Sec.  40.22  Small quantities of source material.

    (a) A general license is hereby issued authorizing commercial and 
industrial firms; research, educational, and medical institutions; and 
Federal, State, and local government agencies to receive, possess, use, 
and transfer uranium and thorium, in their natural isotopic 
concentrations and in the form of depleted uranium, for research, 
development, educational, commercial, or operational purposes in the 
following forms and quantities:
    (1) Not more than 1.5 kg (3.3 lb) of uranium and thorium in any 
form at any one time. A person authorized to possess, use, and transfer 
source material under this paragraph may not receive more than a total 
of 7 kg (15.4 lb) of uranium and thorium in any one calendar year. 
Source material possessed under paragraph (a)(2) of this section does 
not apply toward these limits; and
    (2) Not more than 7 kg (15.4 lb) of uranium and thorium at any one 
time so long as the form is solid and non-dispersible. A person 
authorized to possess, use, and transfer source material under this 
paragraph may not receive more than a total of 70 kg (154 lb) of 
uranium and thorium in any one calendar year and may not alter the 
chemical or physical form of the source

[[Page 43442]]

material possessed under this paragraph. The total quantity of source 
material possessed under this paragraph must include source material 
possessed under paragraph (a)(1) of this section; or
    (3) Not more than 7 kg (15.4 lb) of uranium, removed during the 
treatment of drinking water, at any one time. A person may not remove 
more than 70 kg (154 lb) of uranium from drinking water during a 
calendar year under this paragraph.
    (b) Any person who receives, possesses, uses, or transfers source 
material in accordance with the general license in paragraph (a) of 
this section:
    (1) Is prohibited from administering source material, or the 
radiation therefrom, either externally or internally, to human beings 
except as may be authorized by the NRC in a specific license.
    (2) Shall not abandon such source material. Source material may be 
disposed of as follows:
    (i) A cumulative total of 0.5 kg (1.1 lb) of source material in a 
solid, non-dispersible form may be transferred each calendar year, by a 
person authorized to receive, possess, use, and transfer source 
material under this general license to persons receiving the material 
for permanent disposal. The recipient of source material transferred 
under the provisions of this paragraph is exempt from the requirements 
to obtain a license under this part to the extent the source material 
is permanently disposed. This provision does not apply to any person 
who is in possession of source material under a specific license issued 
under this chapter; or
    (ii) In accordance with Sec.  20.2001 of this chapter.
    (3) Is subject to the provisions in Sec. Sec.  40.1 through 40.10, 
40.41(a) through (e), 40.46, 40.51, 40.60 through 40.63, 40.71, and 
40.81.
    (4) Shall respond to written requests from the NRC to provide 
information relating to the general license within 30 calendar days of 
the date of the request, or other time specified in the request. If the 
person cannot provide the requested information within the allotted 
time, the person shall, within that same time period, request a longer 
period to supply the information by providing the Director of the 
Office of Federal and State Materials and Environmental Management 
Programs, using an appropriate method listed in Sec.  40.5(a), a 
written justification for the request;
    (5) Shall not export such source material except in accordance with 
part 110 of this chapter.
    (c) Any person who receives, possesses, uses, or transfers source 
material in accordance with paragraph (a) of this section shall conduct 
activities so as to minimize contamination of the facility and the 
environment. When activities involving such source material are 
permanently ceased at any site, if evidence of significant 
contamination is identified, the general licensee shall notify the 
Director of the Office of Federal and State Materials and Environmental 
Management Programs by an appropriate method listed in Sec.  40.5(a) 
about such contamination and may consult with the NRC as to the 
appropriateness of sampling and restoration activities to ensure that 
any contamination or residual source material remaining at the site 
where source material was used under this general license is not likely 
to result in exposures that exceed the limits in Sec.  20.1402 of this 
chapter.
    (d) Any person who receives, possesses, uses, or transfers source 
material in accordance with the general license granted in paragraph 
(a) of this section is exempt from the provisions of parts 19, 20, and 
21 of this chapter to the extent that such receipt, possession, use, 
and transfer are within the terms of this general license, except that 
such person shall comply with the provisions of Sec. Sec.  20.1402 and 
20.2001 of this chapter to the extent necessary to meet the provisions 
of paragraphs (b)(2) and (c) of this section. However, this exemption 
does apply to any person who also holds a specific license issued under 
this chapter.
    (e) No person may initially transfer or distribute source material 
to persons generally licensed under paragraph (a) of this section, or 
equivalent regulations of an Agreement State, unless authorized by a 
specific license issued in accordance with Sec.  40.54 or equivalent 
provisions of an Agreement State. Initial distribution of source 
material to persons generally licensed by paragraph (a) of this section 
before [EFFECTIVE DATE OF FINAL RULE] without specific authorization 
may continue for 1 year beyond this date. Distribution may also be 
continued until the Commission takes final action on a pending 
application for license or license amendment to specifically authorize 
distribution submitted no later than 1 year beyond this date.
    8. In Sec.  40.32, paragraph (f) is revised to read as follows:


Sec.  40.32  General requirements for issuance of a specific license.

* * * * *
    (f) The applicant satisfies any applicable special requirements 
contained in Sec. Sec.  40.34, 40.52, and 40.54.
* * * * *
    9. Sections 40.52, 40.53, 40.54, and 40.55 are added under the 
undesignated heading ``Transfer of Source Material'' to read as 
follows:


Sec.  40.52  Certain items containing source material; requirements for 
license to apply or initially transfer.

    An application for a specific license to apply source material to, 
incorporate source material into, manufacture, process, or produce the 
products specified in Sec.  40.13(c) or to initially transfer for sale 
or distribution any products containing source material for use under 
Sec.  40.13(c) or equivalent provisions of an Agreement State will be 
approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.  40.32. However, the requirements of Sec.  40.32(b) and (c) do not 
apply to an application for a license to transfer products 
manufactured, processed, or produced in accordance with a license 
issued by an Agreement State or to the import of finished products or 
parts.
    (b) The applicant submits sufficient information regarding the 
product pertinent to the evaluation of the potential radiation 
exposures, including:
    (1) Chemical and physical form and maximum quantity of source 
material in each product;
    (2) Details of construction and design of each product, if 
applicable. For coated lenses, this must include a description of 
manufacturing methods that will ensure that the coatings are unlikely 
to be removed under the conditions expected to be encountered during 
handling and use;
    (3) For products with applicable quantity or concentration limits, 
quality control procedures to be followed in the fabrication of 
production lots of the product and the quality control standards the 
product will be required to meet;
    (4) The proposed method of labeling or marking each unit, and/or 
its container with the identification of the manufacturer or initial 
transferor of the product and the source material in the product; and
    (5) The means of providing radiation safety precautions and 
instructions relating to handling, use, and storage of products to be 
used under Sec.  40.13(c)(1)(i) and (c)(1)(iii).
    (c) Each product will contain no more than the quantity or the 
concentration of source material specified for that product in Sec.  
40.13(c).

[[Page 43443]]

Sec.  40.53  Conditions of licenses issued under Sec.  40.52: Quality 
control, labeling, and records and reports.

    (a) Each person licensed under Sec.  40.52 must ensure that the 
quantities or concentrations of source material do not exceed any 
applicable limit in Sec.  40.13(c).
    (b) Each person licensed under Sec.  40.52 must ensure that each 
product is labeled as provided in the specific exemption under Sec.  
40.13(c). Those distributing products to be used under Sec.  
40.13(c)(1)(i) and (c)(1)(iii) or equivalent regulations of an 
Agreement State must provide radiation safety precautions and 
instructions relating to handling, use, and storage of these products 
as specified in the license.
    (c)(1) Each person licensed under Sec.  40.52 must file a report 
with the Director, Office of Federal and State Materials and 
Environmental Management Programs, by an appropriate method listed in 
Sec.  40.5(a), including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (2) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee and indicate that the products are transferred for use under 
Sec.  40.13(c), giving the specific paragraph designation, or 
equivalent regulations of an Agreement State.
    (3) The report must include the following information on products 
transferred to other persons for use under Sec.  40.13(c) or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each product and 
the model number(s), if applicable;
    (ii) For each type of source material in each type of product and 
each model number, if applicable, the total quantity of the source 
material; and
    (iii) The number of units of each type of product transferred 
during the reporting period by model number, if applicable.
    (4) The licensee must file the report, covering the preceding 
calendar year, on or before January 31 of each year. Licensees who 
permanently discontinue activities authorized by the license issued 
under Sec.  40.52 must file a report for the current calendar year 
within 30 days after ceasing distribution.
    (5) If no transfers of source material have been made to persons 
exempt under Sec.  40.13(c) or the equivalent regulations of an 
Agreement State, during the reporting period, the report must so 
indicate.
    (6) The licensee must maintain all information concerning transfers 
that support the reports required by this section for 1 year after each 
transfer is included in a report to the Commission.


Sec.  40.54  Requirements for license to initially transfer source 
material for use under Sec.  40.22.

    An application for a specific license to initially transfer source 
material for use under Sec.  40.22, or equivalent regulations of an 
Agreement State, will be approved if:
    (a) The applicant satisfies the general requirements specified in 
Sec.  40.32; and
    (b) The applicant submits adequate information on and the 
Commission approves the methods to be used for quality control, 
labeling, and providing safety instructions to recipients.


Sec.  40.55  Conditions of licenses issued under Sec.  40.54: Quality 
control, labeling, safety instructions, and records and reports.

    (a) Each person licensed under Sec.  40.54 must label the immediate 
container of each quantity of source material with the type of source 
material and quantity of material and the words, ``radioactive 
material.''
    (b) Each person licensed under Sec.  40.54 must ensure that the 
quantities and concentrations of source material are as labeled and 
indicated in any transfer records.
    (c) Each person licensed under Sec.  40.54 must provide the 
information specified in this paragraph to each person to whom source 
material is transferred for use under Sec.  40.22 or equivalent 
provisions in Agreement State regulations. This information must be 
transferred before the source material is transferred for the first 
time in each calendar year to the particular recipient. The required 
information includes:
    (1) A copy of Sec. Sec.  40.22 and 40.51, or relevant equivalent 
regulations of the Agreement State.
    (2) Appropriate radiation safety precautions and instructions 
relating to handling, use, storage, and disposal of the material.
    (d) Each person licensed under Sec.  40.54 must report transfers as 
follows:
    (1) File a report with the Director, Office of Federal and State 
Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555. The report shall include 
the following information:
    (i) The name, address, and license number of the person who 
transferred the source material;
    (ii) For each general licensee under Sec.  40.22 or equivalent 
Agreement State regulations to whom greater than 50 grams (0.11 lb) of 
source material has been transferred in a single calendar quarter, the 
name and address of the general licensee to whom source material is 
distributed; a responsible agent, by name and/or position and phone 
number, of the general licensee to whom the material was sent; and the 
type, physical form, and quantity of source material transferred; and
    (iii) The total quantity of each type and physical form of source 
material transferred in the reporting period to all such generally 
licensed recipients.
    (2) File a report with the responsible Agreement State agency for 
transfers of greater than 50 grams (0.11 lb) of source material 
transferred to a general licensee in an Agreement State within a 
calendar quarter. The report shall include the following information 
specific to those transfers made to the Agreement State being reported 
to:
    (i) The name, address, and license number of the person who 
transferred the source material; and
    (ii) The name and address of the general licensee to whom source 
material was distributed; a responsible agent, by name and/or position 
and phone number, of the general licensee to whom the material was 
sent; and the type, physical form, and quantity of source material 
transferred.
    (iii) The total quantity of each type and physical form of source 
material transferred in the reporting period to all such generally 
licensed recipients within the Agreement State.
    (3) Submit each report by January 31 of each year covering all 
transfers for the previous calendar year. If no transfers were made to 
persons generally licensed under Sec.  40.22 or equivalent Agreement 
State provisions during the current period, a report shall be submitted 
to the Commission indicating so. If no transfers have been made to 
general licensees in a particular Agreement State during the reporting 
period, this information must be reported to the responsible Agreement 
State agency upon request of the agency.
    (e) Each person licensed under Sec.  40.54 must maintain all 
information that supports the reports required by this section 
concerning each transfer to a general licensee for a period of 1 year 
after the event is included in a report to the Commission or to an 
Agreement State agency.
    10. In Sec.  40.82, paragraph (b) is revised to read as follows:


Sec.  40.82  Criminal penalties.

* * * * *
    (b) The regulations in part 40 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.  40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12, 
40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34,

[[Page 43444]]

40.43, 40.44, 40.45, 40.52, 40.54, 40.71, 40.81, and 40.82.

PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

    11. The authority citation for part 70 continues to read as 
follows:

    Authority:  Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 
953, 954, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 
2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 
202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 
U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended 
by Pub.L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 
1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 
2005, Pub. L. 109-58, 119 Stat. 194 (2005).
    Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, 
Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
    Section 70.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 
U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 
939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. 
L. 93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44 
also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 
2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955 
(42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68 
Stat. 939, as amended (42 U.S.C. 2138).
    12. In Sec.  70.5, paragraph (b)(1)(iv) is revised to read as 
follows:


Sec.  70.5  Communications.

* * * * *
    (b) * * *
    (1) * * *
    (iv) Distribution of products containing radioactive material to 
persons exempt under Sec. Sec.  32.11 through 32.30 and 40.52 of this 
chapter.
* * * * *

PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT 
LICENSES AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT 
OF 1954, AS AMENDED

    13. The authority citation for part 170 continues to read as 
follows:

    Authority:  Sec. 9701, Pub. L. 97-258, 96 Stat. 1051 (31 U.S.C. 
9701); sec. 301, Pub. L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w); 
sec. 201, Pub. L. 93-438, 88 Stat. 1242, as amended (42 U.S.C. 
5841); sec. 205a, Pub. L. 101-576, 104 Stat. 2842, as amended (31 
U.S. C. 901, 902); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); 
sec. 623, Pub. L. 109-58, 119 Stat. 783 (42 U.S.C. 2201(w)); sec. 
651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 2021, 
2021b, 2111).

    14. Section 170.31 is amended by redesignating materials license 
category 2.C. as category 2.F. and revising it, and by adding new 
categories 2.C., 2.D., and 2.E. to read as follows:


Sec.  170.31  Schedules of fees for materials licenses and other 
regulatory services, including inspections, and import and export 
licenses.

* * * * *

                       Schedules of Materials Fees
                     [See footnotes at end of table]
------------------------------------------------------------------------
   Categories of materials licenses and types of fees \1\      Fee 1 2
------------------------------------------------------------------------
 
                              * * * * * * *
2. Source material.........................................
 
                              * * * * * * *
    C. Licenses to distribute items containing source
     material to persons exempt from the licensing
     requirements of part 40 of this chapter.
        Application [Program Code(s): 11240]...............       $7,000
    D. Licenses to distribute source material to persons
     generally licensed under part 40 of this chapter.
        Application [Program Code(s): 11230 and 11231].....        2,000
    E. Licenses for possession and use of source material
     for processing or manufacturing of products or
     materials containing source material for commercial
     distribution.
        Application [Program Code(s): 11710]...............       10,200
    F. All other specific source material licenses.
        Application [Program Code(s): 11200, 11220, 11221,        10,200
         11300, 11800, 11810]..............................
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ Types of fees--Separate charges, as shown in the schedule, will be
  assessed for pre-application consultations and reviews; applications
  for new licenses, approvals, or license terminations; possession only
  licenses; issuances of new licenses and approvals; certain amendments
  and renewals to existing licenses and approvals; safety evaluations of
  sealed sources and devices; generally licensed device registrations;
  and certain inspections. The following guidelines apply to these
  charges:
(a) Application and registration fees. Applications for new materials
  licenses and export and import licenses; applications to reinstate
  expired, terminated, or inactive licenses except those subject to fees
  assessed at full costs; applications filed by Agreement State
  licensees to register under the general license provisions of 10 CFR
  150.20; and applications for amendments to materials licenses that
  would place the license in a higher fee category or add a new fee
  category must be accompanied by the prescribed application fee for
  each category.
(1) Applications for licenses covering more than one fee category of
  special nuclear material or source material must be accompanied by the
  prescribed application fee for the highest fee category.
(2) Applications for new licenses that cover both byproduct material and
  special nuclear material in sealed sources for use in gauging devices
  will pay the appropriate application fee for fee Category 1.C. only.
(b) Licensing fees. Fees for reviews of applications for new licenses,
  renewals, and amendments to existing licenses, pre-application
  consultations and other documents submitted to the NRC for review, and
  project manager time for fee categories subject to full cost fees are
  due upon notification by the Commission in accordance with Sec.
  170.12(b).
(c) Amendment fees. Applications for amendments to export and import
  licenses must be accompanied by the prescribed amendment fee for each
  license affected. An application for an amendment to an export or
  import license or approval classified in more than one fee category
  must be accompanied by the prescribed amendment fee for the category
  affected by the amendment, unless the amendment is applicable to two
  or more fee categories, in which case the amendment fee for the
  highest fee category would apply.
(d) Inspection fees. Inspections resulting from investigations conducted
  by the Office of Investigations and non-routine inspections that
  result from third-party allegations are not subject to fees.
  Inspection fees are due upon notification by the Commission in
  accordance with Sec.   170.12(c).
(e) Generally licensed device registrations under 10 CFR 31.5.
  Submittals of registration information must be accompanied by the
  prescribed fee.

[[Page 43445]]

 
\2\ Fees will not be charged for orders related to civil penalties or
  other civil sanctions issued by the Commission under 10 CFR 2.202 or
  for amendments resulting specifically from the requirements of these
  orders. For orders unrelated to civil penalties or other civil
  sanctions, fees will be charged for any resulting licensee-specific
  activities not otherwise exempted from fees under this chapter. Fees
  will be charged for approvals issued under a specific exemption
  provision of the Commission's regulations under Title 10 of the Code
  of Federal Regulations (e.g., 10 CFR 30.11, 40.14, 70.14, 73.5, and
  any other sections in effect now or in the future), regardless of
  whether the approval is in the form of a license amendment, letter of
  approval, safety evaluation report, or other form. In addition to the
  fee shown, an applicant may be assessed an additional fee for sealed
  source and device evaluations as shown in Categories 9.A. through 9.D.
\3\ Full cost fees will be determined based on the professional staff
  time multiplied by the appropriate professional hourly rate
  established in Sec.   170.20 in effect when the service is provided,
  and the appropriate contractual support services expended. For
  applications currently on file for which review costs have reached an
  applicable fee ceiling established by the June 20, 1984 and July 2,
  1990 rules, but are still pending completion of the review, the cost
  incurred after any applicable ceiling was reached through January 29,
  1989 will not be billed to the applicant. Any professional staff-hours
  expended above those ceilings on or after January 30, 1989 will be
  assessed at the applicable rates established by Sec.   170.20, as
  appropriate, except for topical reports for which costs exceed
  $50,000. Costs which exceed $50,000 for each topical report,
  amendment, revision, or supplement to a topical report completed or
  under review from January 30, 1989 through August 8, 1991 will not be
  billed to the applicant. Any professional hours expended on or after
  August 9, 1991 will be assessed at the applicable rate established in
  Sec.   170.20.

PART 171--ANNUAL FEES FOR REACTOR LICENSES AND FUEL CYCLE LICENSES 
AND MATERIALS LICENSES, INCLUDING HOLDERS OF CERTIFICATES OF 
COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE PROGRAM APPROVALS, 
AND GOVERNMENT AGENCIES LICENSED BY NRC

    15. The authority citation for part 171 continues to read as 
follows:

    Authority:  Sec. 7601, Pub. L. 99-272, 100 Stat. 146, as amended 
by sec. 5601, Pub. L. 100-203, 101 Stat. 1330 as amended by sec. 
3201, Pub. L. 101-239, 103 Stat. 2132, as amended by sec. 6101, Pub. 
L. 101-508, 104 Stat. 1388, as amended by sec. 2903a, Pub. L. 102-
486, 106 Stat. 3125 (42 U.S.C. 2213, 2214), and as amended by Title 
IV, Pub. L. 109-103, 119 Stat. 2283 (42 U.S.C. 2214); sec. 301, Pub. 
L. 92-314, 86 Stat. 227 (42 U.S.C. 2201w); sec. 201, Pub. L. 93-438, 
88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 
2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 
806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).

    16. In Sec.  171.16, the table in paragraph (d) is amended by 
redesignating materials license category 2.C. as category 2.F. and 
revising it, and by adding new categories 2.C., 2.D., and 2.E. to read 
as follows:


Sec.  171.16  Annual fees: Materials licensees, holders of certificates 
of compliance, holders of sealed source and device registrations, 
holders of quality assurance program approvals and government agencies 
licensed by the NRC.

* * * * *
    (d) * * *

   Schedule of Materials Annual Fees and Fees for Government Agencies
                             Licensed by NRC
                     [See footnotes at end of table]
------------------------------------------------------------------------
                                                             Annual fees
               Category of materials licenses                   1 2 3
------------------------------------------------------------------------
 
                              * * * * * * *
2. Source Material.........................................
 
                              * * * * * * *
    C. Licenses to distribute items containing source            $10,000
     material to persons exempt from the licensing
     requirements of part 40 of this chapter [Program
     Code(s): 11240].......................................
    D. Licenses to distribute source material to persons           5,000
     generally licensed under part 40 of this chapter
     [Program Code(s): 11230 and 11231]....................
    E. Licenses for possession and use of source material         21,100
     for processing or manufacturing of products or
     materials containing source material for commercial
     distribution. [Program Code(s): 11710]................
    F. All other specific source material licenses.               21,100
     [Program Code(s): 11200, 11220, 11221, 11300, 11800,
     11810]................................................
 
                              * * * * * * *
------------------------------------------------------------------------
\1\Annual fees will be assessed based on whether a licensee held a valid
  license with the NRC authorizing possession and use of radioactive
  material during the current FY. The annual fee is waived for those
  materials licenses and holders of certificates, registrations, and
  approvals who either filed for termination of their licenses or
  approvals or filed for possession only/storage licenses before October
  1, 2009, and permanently ceased licensed activities entirely before
  this date. Annual fees for licensees who filed for termination of a
  license, downgrade of a license, or for a possession-only license
  during the FY and for new licenses issued during the FY will be
  prorated in accordance with the provisions of Sec.   171.17. If a
  person holds more than one license, certificate, registration, or
  approval, the annual fee(s) will be assessed for each license,
  certificate, registration, or approval held by that person. For
  licenses that authorize more than one activity on a single license
  (e.g., human use and irradiator activities), annual fees will be
  assessed for each category applicable to the license. Licensees paying
  annual fees under Category 1.A. (1) are not subject to the annual fees
  for Categories 1.C. and 1.D. for sealed sources authorized in the
  license.
\2\ Payment of the prescribed annual fee does not automatically renew
  the license, certificate, registration, or approval for which the fee
  is paid. Renewal applications must be filed in accordance with the
  requirements of parts 30, 40, 70, 71, 72, or 76 of this chapter.
\3\Each FY, fees for these materials licenses will be calculated and
  assessed in accordance with Sec.   171.13 and will be published in the
  Federal Register for notice and comment.


[[Page 43446]]

* * * * *

    Dated at Rockville, Maryland, this 20th day of July 2010.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2010-18223 Filed 7-23-10; 8:45 am]
BILLING CODE 7590-01-P