[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Proposed Rules]
[Pages 36212-36236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15202]



[[Page 36211]]

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Part III





Nuclear Regulatory Commission





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10 CFR Parts 30, 31, 32, et al.



Requirements for Distribution of Byproduct Material; Proposed Rule

  Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / 
Proposed Rules  

[[Page 36212]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 30, 31, 32, 40, and 70

RIN 3150-AH91
[NRC-2008-0338]


Requirements for Distribution of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations to make requirements for distributors of byproduct 
material clearer, less prescriptive, and more risk-informed and up to 
date. The Commission is also proposing to redefine categories of 
devices to be used under exemptions, add explicit provisions regarding 
the sealed source and device registration process, and add flexibility 
to the licensing of users of sealed sources and devices. This action is 
primarily intended to make licensing processes more efficient and 
effective. These changes would affect manufacturers and distributors of 
sources and devices containing byproduct material and future users of 
some products currently used under a general or specific license.

DATES: The comment period expires September 7, 2010. Submit comments 
specific to the information collections aspects of this rule by July 
26, 2010. Comments received after these dates will be considered if it 
is practical to do so, but the NRC is able to assure consideration only 
for comments received on or before these dates.

ADDRESSES: Please include Docket ID NRC-2008-0338 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-2008-0338 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 301-415-1966.
    Hand Deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852 between 7:30 a.m. and 4:15 p.m. during Federal workdays 
(Telephone 301-415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
301-415-1101.
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement.

FOR FURTHER INFORMATION CONTACT: Catherine R. 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
III. Proposed Actions
    A. Actions Related to Sealed Source and Device Registration
    B. Establish a New Class Exemption for Certain Industrial 
Products
    C. Remove Unnecessary Limitations From the Class Exemption for 
Gas and Aerosol Detectors
    D. Update the Regulations on Certain Static Eliminators and Ion 
Generating Tubes
    E. Remove Prescriptive Requirements for Distributors of 
Generally Licensed Devices and Exempt Products
    F. Make the Requirements for Distributors of Exempt Products 
More Risk-Informed
    G. Specific Questions for Comment
    H. Minor Clarifying or Administrative Revisions
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): 
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-2008-0338.

II. Background

A. Introduction

    The Commission has authority to issue both general and specific 
licenses for the use of byproduct material and also to exempt byproduct 
material from regulatory control under section 81 of the Atomic Energy 
Act of 1954, as amended (hereafter, ``the Act'' or the AEA). A general 
license is provided by regulation, grants authority to a person for 
particular activities involving byproduct material as described within 
the general license, and is effective without the filing of an 
application with the Commission or the issuance of a licensing document 
to a particular person. Requirements for general licensees appear in 
the regulations and are designed to be commensurate with the specific 
circumstances covered by each general license. A specific license is 
issued to a named person who has filed an application with the 
Commission.

[[Page 36213]]

    In considering its exemptions from licensing, the Commission is 
directed by the Act to make ``a finding that the exemption of such 
classes or quantities of such material or such kinds of uses or users 
will not constitute an unreasonable risk to the common defense and 
security and to the health and safety of the public.'' As beneficial 
uses of radioactive material were developed and experience grew, new 
products intended for use by the general public were invented and the 
regulations were amended to accommodate the use of new products.
    Although presenting very low risks of significant individual doses 
to members of the general public, exempt products are a source of 
routine exposure to the public. A substantial portion of the population 
uses and enjoys benefits from exempt products, such as smoke detectors, 
but also receives some radiation exposure from those products. In 
keeping with its consumer product policy, which calls for the 
Commission to evaluate the total effect of consumer products on the 
public, the Commission conducted a systematic reevaluation of the 
exemptions from licensing. A major part of the effort was an assessment 
of the potential and likely doses to workers and the public under these 
exemptions. Dose assessments for most of these exemptions can be found 
in NUREG-1717 \1\, ``Systematic Radiological Assessment of Exemptions 
for Source and Byproduct Materials,'' June 2001. Actual exposures of 
the public likely to occur are in line with Commission policy 
concerning acceptable doses from products and materials used under 
exemptions. For some exemptions, there was a significant difference 
between potential and likely doses because the use of the exemption is 
limited or nonexistent, or significantly lower quantities are used in 
products than is potentially allowed under the exemption.
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    \1\ NUREG-1717 is a historical document developed using the 
models and methodology available in the 1990s. The NUREG provides 
the estimate of the radiological impacts of the various exemptions 
from licensing based on what was known about distribution of 
material under the exemptions in the early 1990s. NUREG-1717 was 
used as the initial basis for evaluating the regulations for 
exemptions from licensing requirements and determining whether those 
regulations adequately ensured that the health and safety of the 
public were protected consistent with NRC policies related to 
radiation protection. The agency will not use the results presented 
in NUREG-1717 as a sole basis for any regulatory decisions or future 
rulemaking without additional analysis. Copies of NUREGs may be 
purchased from the Superintendent of Documents, U. S. Government 
Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies 
are also available from the National Technical Information Service, 
5285 Port Royal Road, Springfield, VA 22161. A copy is also 
available for inspection and/or copying for a fee at the NRC Public 
Document Room, One White Flint North, 11555 Rockville Pike, Public 
File Area O1-F21, Rockville, MD.
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    The NRC has reviewed the regulations governing the distribution of 
byproduct material to persons for use under the exemptions, as well as 
other regulations governing distribution of products containing 
byproduct material. The Commission decided to make these regulations 
more flexible, user-friendly, and performance-based, and to improve its 
ability to risk-inform its regulatory program. These concepts have been 
considered in developing potential revisions to the regulatory program 
in the area of distribution of byproduct material.
    In a final rule published October 16, 2007 (72 FR 58473), some of 
these revisions were made, including the removal of obsolete 
exemptions. This action is a follow-on to that effort. To make optimal 
use of rulemaking resources, both for the NRC and the States who must 
develop conforming regulations, several issues have been combined into 
this proposed rule.

B. Regulatory Framework

    The Commission's regulations in Part 30 contain the basic 
requirements for licensing of byproduct material. Part 30 includes a 
number of provisions that exempt the end user from licensing 
requirements, so-called ``exemptions.'' Some exemptions are product-
specific, intended only for specific purposes which are narrowly 
defined by regulation. More broadly defined are the general materials 
exemptions, which allow the use of many radionuclides in many chemical 
and physical forms subject to limits on activity, and which are 
specified in Sec. Sec.  30.14 and 30.18 for exempt concentrations and 
exempt quantities, respectively. The Commission's regulations also 
include two class exemptions--for self-luminous products and gas and 
aerosol detectors, in Sec. Sec.  30.19 and 30.20, respectively--which 
cover a broad class of products not limited to certain quantities or 
radionuclides. Under the class exemptions, many products can be 
approved for use through the licensing process if the applicant 
demonstrates that the specific product is within the class and meets 
certain radiation dose criteria.
    Part 31 provides general licenses for the use of certain items 
containing byproduct material and the requirements associated with 
these general licenses. The general licenses are established in 
Sec. Sec.  31.3, 31.5, 31.7, 31.8, 31.10, 31.11, and 31.12.
    Part 32 sets out requirements for the manufacture or initial 
transfer (distribution) of items containing byproduct material to 
persons exempt from licensing requirements and to persons using a 
general license. It also includes requirements applicable to certain 
manufacturers and distributors of products and materials to be used by 
specific licensees. The requirements for distributors address such 
measures as prototype testing, labeling, reporting and recordkeeping, 
quality control, and, in some cases, specific sampling procedures.

III. Proposed Actions

    This proposed rule would make a number of revisions to the 
regulations governing the use of byproduct material under exemptions 
from licensing and under general license, and to the requirements for 
those who distribute products and materials. The changes are intended 
to improve the efficiency and effectiveness of certain licensing 
actions.

A. Actions Related to Sealed Source and Device Registration

A.1 Updating Regulations To Add Registration Requirements
    Section 32.210 provides for the registration of sealed sources and 
devices containing sealed sources intended for use under a specific 
license. Manufacturers or distributors may submit a request to NRC for 
an evaluation of radiation safety information for a product and for 
registration of the product. After satisfactory completion of the 
evaluation, the NRC issues a certificate of registration to the person 
making the request. Subsequently, under Sec.  30.32(g), specific 
licensees or applicants for a specific license who wish to use the 
registered product need only identify the source or device by 
manufacturer and model number as registered with the Commission under 
Sec.  32.210 or with an Agreement State in their applications. Because 
the source or device has already been evaluated and its safety 
information is a matter of record, the users are not required to submit 
the detailed radiation safety information for the source or device in 
their license applications. This greatly simplifies the licensing 
process for the users of specifically licensed sources and devices. The 
registration system is referred to as the Sealed Source and Device (SS 
& D) Registry. Many Agreement States have similar registration 
procedures. Registration certificates for the sources and devices 
reviewed by the Agreement States are also added to the national SS & D 
Registry. However, some Agreement

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States do not include the evaluation and registration of sealed sources 
and devices in their agreements; authority for these reviews remains 
under NRC regulatory jurisdiction.
    A definition of the registry is included in Sec.  35.2 as follows: 
``Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both NRC and 
the Agreement States, that summarize the radiation safety information 
for the sealed sources and devices and describe the licensing and use 
conditions approved for the product.'' This same definition would be 
added to 10 CFR part 32 by this action, as the information requirements 
for the SS & D review and registration are in part 32. The SS & D 
Registry is maintained in a computer database, which is available to 
the Agreement States. While this process, in which the manufacturer or 
initial distributor obtains a registration certificate for the source 
or device, is generally used for most specifically licensed sources and 
devices, in some cases of custom-made sources or devices, the planned 
user will sometimes submit the detailed radiation safety information. 
As a matter of licensing practice, such a custom device, if containing 
more than certain quantities of radioactive material, is also 
registered; however, it only allows for the use of the custom-made 
source or device by the specified user. As Sec.  30.32(g) requires the 
radiation safety information to be submitted by applicants to use 
sealed sources and devices if they are not registered, manufacturers 
and distributors generally register the sources and devices that are to 
be used under a specific license. Sealed source or device review and 
registration are conducted for most sealed sources and devices to be 
used under a specific license.
    This registration process has also been extended to many generally 
licensed and some exempt products. The regulations in 10 CFR part 32 
contain requirements for submittal of radiation safety information 
concerning these products by the manufacturer or initial distributor. 
Although registration of these products by the manufacturer or initial 
distributor is not addressed by the regulations, the NRC's licensing 
practice is to issue registration certificates for certain of these 
products based on the radiation safety information submitted. Also, 
fees are assessed based on whether or not a ``sealed source and/or 
device review'' is required.
    The products in each of these categories for which the registration 
process is used as part of the licensing process are indicated in 
guidance, e.g., NUREG-1556, Vol. 3, Rev. 1, ``Consolidated Guidance 
About Materials Licenses: Applications for Sealed Source and Device 
Evaluation and Registration''; NUREG-1556, Vol. 8, ``Consolidated 
Guidance About Materials Licenses: Program-Specific Guidance About 
Exempt Distribution Licenses''; and NUREG-1556, Vol. 16, ``Consolidated 
Guidance About Materials Licenses: Program-Specific Guidance About 
Licenses Authorizing Distribution to General Licenses.'' For a number 
of categories of specifically licensed sources and devices, an explicit 
requirement for registration is included in the regulations. Existing 
specific requirements include Sec. Sec.  35.400, 35.500, 35.600, 36.21, 
and 39.41(f). These concern certain medical use products, sealed 
sources installed in irradiators after July 1, 1993, and energy 
compensation sources (a specific type of reference source used in well 
logging).
    The only products used under exemption from licensing for which the 
NRC issues registration certificates are those distributed for use 
under a ``class exemption.'' As noted earlier, a class exemption allows 
for the use under exemption of a category of products with the safety 
decision for individual products made through the licensing process. 
The safety review for these products includes evaluating the product 
against specific safety criteria contained in the regulations in 10 CFR 
part 32. The regulations currently contain two class exemptions. These 
are found in Sec.  30.19, Self-luminous products containing tritium, 
krypton-85, or promethium-147, and Sec.  30.20, Gas and aerosol 
detectors containing byproduct material, and equivalent Agreement State 
regulations. As discussed later in this document, this proposed rule 
would establish a third class exemption for certain industrial 
products.
    In the case of generally licensed products, sealed source and 
device registration certificates are issued for products distributed 
for use under Sec. Sec.  31.3, 31.5, 31.7, and 31.10, and equivalent 
Agreement State regulations. (Note that this registration is distinct 
and different in scope and purpose from the registration of devices by 
some general licensees under Sec.  31.5(c)(13).)
    Neither general licensees nor persons exempt from licensing 
requirements need to submit any safety information in order to obtain a 
product. For these products, however, the registration process also 
serves the important purpose of providing information to the regulators 
in all jurisdictions. Products are approved by NRC and, in some cases, 
by the various Agreement States for distribution to all jurisdictions. 
For those products that are registered by the manufacturer or 
distributor, the registration information is available to NRC and all 
of the Agreement States through the SS & D Registry. In this way, the 
various jurisdictions can be assured of the radiation safety of the 
products being used under their regulations that have been evaluated by 
another jurisdiction. The registration of products by model number also 
assists in the tracking of generally licensed devices by NRC and the 
Agreement States. In some cases, a secondary distributor of a generally 
licensed device may refer to the registration certificate obtained by 
the manufacturer, or more frequently a source to be installed in a 
generally licensed device may be manufactured by a different entity who 
has registered the source separately.
    For those products used under a product-specific exemption, for 
which registration certificates are not issued, the safety of the 
product has been evaluated based primarily on the constraints contained 
in the regulations, such as a quantity limit for a specific 
radionuclide, and what can be projected about the life cycle of the 
product and how it is used. Some of these evaluations are documented in 
NUREG/CR-1775, ``Environmental Assessment of Consumer Products 
Containing Radioactive Material,'' October 1980 (available at the NRC's 
electronic Reading Room, ADAMS Accession No. ML082910862), and NUREG-
1717, ``Systematic Radiological Assessment of Exemptions for Source and 
Byproduct Materials,'' June 2001. The applicable requirements in Sec.  
32.14(b) require information to be submitted to allow an evaluation of 
the potential radiation exposure and in accordance with Sec.  32.14(d), 
the NRC makes a determination that the byproduct material is ``properly 
contained in the product under the most severe conditions that are 
likely to be encountered in normal use and handling.'' But the 
information to support this evaluation of the particular product is not 
considered necessary to routinely provide to the Agreement States 
through the SS & D Registry.
    No sealed source and device review is conducted for the products 
used under the general licenses in Sec.  31.8 or Sec.  31.11. The 
general license in Sec.  31.8 is specifically for no more than 0.185 
MBq (5 [mu]Ci) of americium-241 or radium-226 in the form of 
calibration and reference sources, and applies only to specific 
licensees. The safety of these sources is also well established, with 
the

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individual product being reviewed and approved in the licensing 
process. The general license in Sec.  31.11 pertains to in-vitro 
clinical or laboratory testing using prepackaged units containing 
certain limited quantities of byproduct material, e.g., iodine-125 in 
units not exceeding 10 [mu]Ci (0.37 MBq). These in vitro kits are not 
sealed sources or devices. They can be used only by physicians, 
clinical laboratories, hospitals, and practitioners of veterinary 
medicine who preregister with the Commission and by part 35 licensees. 
There is also no SS & D registration for the recently added general 
license in Sec.  31.12, which covers only items produced prior to the 
NRC gaining jurisdiction over radium-226. Because there is no allowance 
for future production of items to be used under this general license, 
there are no associated distributor requirements and thus, no 
requirement for a product to be registered in the SS & D Registry. 
These products are mostly antiquities produced before States had 
regulations similar to NRC's.
    Registration certificates are issued for most specifically licensed 
sealed sources and devices. The exceptions are for small calibration 
and reference sources and for sources and devices to be used by (1) 
Broad scope licensees under part 33 and equivalent Agreement State 
regulations, (2) research and development licensees, and (3) licensees 
for whom the source or device was built to their unique specifications 
and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 
mCi) of any other radionuclide. These three categories of licensees 
must be qualified by training and experience and have sufficient 
facilities and equipment to safely use and handle the requested 
quantity of radioactive material in any form as indicated in their 
license(s). Under these circumstances, licensing these three types of 
users does not rely on the inherent safety features of the source or 
device; users will be evaluated under the criteria in Sec.  30.33(a)(2) 
and (3) and licensed to handle equivalent quantities of the materials 
in any form. If the source is registered but not the device, the users 
must be licensed to handle equivalent quantities of the materials in 
unshielded form.
    For specifically licensed calibration and reference sources, the 
proposed quantity cutoffs for small sources excluded from the 
requirement for registration are 0.37 MBq (10 [mu]Ci) for alpha 
emitters and 37 MBq (1 mCi) for beta and/or gamma emitters. This is a 
simplification from current licensing practice, which uses a limit of 
3.7 MBq (100 [mu]Ci) or ten times the quantity specified in Sec.  
30.71, whichever is greater, for beta and/or gamma emitters. The limits 
using current guidance for beta/gamma emitters range from 3.7 MBq (100 
[mu]Ci) to 370 MBq (10 mCi). Thus, for any particular radionuclide, the 
proposed criterion is no more than ten times higher to ten times lower 
than current practice. As certificates typically cover a large number 
of radionuclides for this type of sealed source, this change from 
current practice is not expected to affect the overall number of 
registration certificates issued.
    The proposed rule would explicitly add registration requirements to 
the regulations for byproduct material in products used under general 
licenses and under exemptions from licensing requirements, as well as 
for additional specifically licensed sources and devices for which this 
is not currently addressed by the regulations. This will make it easier 
for potential applicants for a license to distribute these products to 
determine the applicable requirements and associated fees. These 
proposed provisions are in large part consistent with present licensing 
practice. They would appear in Sec. Sec.  32.22(a)(3)(ii), 32.26(c)(2), 
32.30(c)(3), 32.51(a)(6), 32.53(f), 32.61(g), 32.74(a)(4), and 32.210.
A.2 Adding Provisions for Amendment, Modification and Revocation, 
Review, and Inactivation of Registration Certificates
    The Commission is adding a number of other explicit provisions to 
the regulations concerning registration certificates. Many certificates 
are revised and updated from time to time as a result of amendment 
requests made by manufacturers or distributors to accommodate desired 
changes in a product or associated procedures or to add new products to 
a registration certificate covering a series of models. Sections 30.38 
and 30.39, which currently address only amendment of licenses, would be 
revised to also address amendment of registration certificates.
    Unlike specific licenses, registration certificates are not issued 
with expiration dates. If a significant safety issue arises with a 
product, regulatory means are available to address it, such as an order 
issued to a distributor to cease distribution until the safety issue is 
resolved. The Commission has authority to request additional 
information or to modify requirements under the general provisions in 
Sec. Sec.  2.204, 30.34(e), and 30.61. In addition, since the 
Commission has authority to revoke a license, and registration is used 
as part of the licensing process, the Commission has the authority to 
revoke a registration certificate, if for example, it determines that 
the registration is inconsistent with current regulatory standards. 
However, the current regulations do not reference this authority. 
Therefore, Sec.  30.61 is being revised to explicitly implement the 
Commission's authority to modify or revoke registration certificates.
    As a registration certificate, in conjunction with the license, 
authorizes distribution of a product, a certificate may be reevaluated 
at the time of license renewal. Generally, this has not been the 
practice of NRC, but may be the case for some Agreement States. In the 
case of licenses authorizing distribution to exempt persons, a limited 
review of the certificate(s), when applicable, has typically been 
conducted to ensure that the information is complete and accurate with 
respect to any changes that may have occurred since issuance of the 
certificate. For all types of certificates, it is important that there 
be consistency between the license and the certificate(s).
    The Commission does not believe that it is necessary to conduct a 
complete reevaluation of sealed sources and devices at the time that 
distribution licenses are renewed, usually every 10 years, since 
generally, there are fewer safety significant aspects that are likely 
to change reflected in the registration certificate than those 
addressed in the license. The Commission does recognize a need to 
update registration certificates and currently relies, for the most 
part, on certificate holders to request amendments of certificates, as 
appropriate. One factor is that the NRC is required to consider the 
application of industry standards, for example, as reflected in Sec.  
32.210(d). These industry standards may be updated to provide improved 
safety. Also, licensees are required by Sec.  20.1101 to implement 
radiation protection programs and to use, to the extent practical, 
procedures and engineering controls based upon sound radiation 
protection principles to achieve occupational doses and doses to 
members of the public that are as low as is reasonably achievable 
(ALARA). Thus, it is appropriate for licensees to consider new 
developments in technology and standards as they may impact ALARA in 
the design of products. However, because Sec.  32.210(f) requires the 
certificate holder to manufacture and distribute products in accordance 
with the provisions of the registration certificate and any statements 
made in the request for registration, and no reevaluation of a source 
or device, once approved, is normally required, the current

[[Page 36216]]

regulatory structure may limit rather than encourage industry 
improvement.
    There may be reasons to reevaluate a sealed source or device in 
some circumstances with regard to either the actual design of a source 
or device, or such other aspects as quality assurance or information 
provided to the user on safe use. While the current regulations provide 
adequate authority to do so, recalling a registration certificate for 
review and reissuance in the absence of a significant safety problem 
with the product is an activity very rarely conducted by NRC in the 
past. This proposed rule also includes an explicit provision to 
specifically address such a process in Sec.  32.210(h). The Commission 
would complete its evaluation in accordance with the criteria specified 
in Sec.  32.210. As noted under Section III. A.1, ``Updating 
Regulations to Add Registration Requirements,'' of this document, this 
proposed rule would add specific provisions delineating which sealed 
sources and devices must be registered in the SS & D, broadening the 
applicability of Sec.  32.210 to some generally licensed and exempt 
products. The Commission may use the proposed provision in Sec.  
32.210(h) to update the certificate with respect to applicable industry 
standards or current security concerns or to ensure the quality of the 
summary of safety information and the information on conditions of use 
contained in the registration certificate that is available to the 
various jurisdictions. The Commission specifically seeks comment on the 
circumstances under which such a reevaluation should be made and also 
on how such a reevaluation may be conducted with minimum impact to 
industry.
    The Commission requests comment on how it might best provide for 
the update of registration certificates so as not to discourage 
improvement in the design of sources or devices, more readily allow for 
the application of updated industry standards, and ensure that 
information in the certificates is fully consistent with current 
practices. In addition to the proposed provision in Sec.  32.210(h), 
other options could include reviewing certificates at the time of 
license renewal, in part or in whole; adding separate expiration dates 
to certificates with typically longer terms than licenses, e.g., 10 to 
20 years; and explicitly allowing licensees to make changes without NRC 
approval, if these changes do not reduce safety margins.
    Generally, the Commission has not previously made standards more 
restrictive with regard to products to be used under a general license 
or under an exemption from licensing, such as to restrict further 
distribution of a previously approved product. However, in a separate 
action, the Commission has proposed to revise Sec.  31.5 to restrict 
quantities of certain radionuclides that are authorized under the 
general license (August 3, 2009; 74 FR 38372). That action would impact 
the authority to distribute certain devices. The Commission therefore 
seeks comment on how certificates for devices previously approved for 
use under the general license in Sec.  31.5 (and equivalent Agreement 
State provisions) should be reevaluated and required to meet such new 
limits. In addition, the Commission seeks comments on how the NRC might 
use the proposed provision for review in Sec.  32.210(h) in relation to 
any changes in standards for products or applicable limits with respect 
to continued distribution, such as under what circumstances 
distribution of a product should be stopped by a certain date, or under 
what circumstances changes to individual certificates might be 
considered on a case-by-case basis.
    Currently, registrations in the SS & D Registry are kept active 
until a distributor who is no longer distributing a particular source 
or device, requests to change the status. At this point, the 
registration is changed to inactive status, meaning that the covered 
products are no longer authorized to be distributed. Annual fees are 
assessed by NRC only for active registrations. The SS & D registrations 
are kept indefinitely in inactive status after authorization to 
distribute has ceased, so that the registration information is 
available for sources and devices previously distributed and possibly 
still in use.
    Because some States do not have annual fees for maintaining active 
SS & D certificates, distributors do not consistently request 
inactivation of certificates, leaving active certificates in the 
database that do not reflect any continued distribution. This somewhat 
limits the information available to other jurisdictions as to what 
sources and devices are authorized for continued distribution. This 
rule includes a proposed provision for inactivation (Sec.  32.211), 
which would require distributors to request inactivation of 
certificates within 2 years following the last initial transfer of a 
source or device covered by the certificate. Two years was chosen to 
minimize any impact on certificate holders. NRC certificate holders 
typically request inactivation of certificates within about a year. 
This provision is expected to improve the consistency of this approach 
across jurisdictions through the addition of equivalent provisions to 
Agreement State regulations, and thus, the quality of the information 
concerning current distribution available to regulators.
A.3 Adding Flexibility for Licensing Users of Sealed Sources and 
Devices
    As noted, the safety information for every sealed source and device 
to be used under a specific license is not included in the SS & D 
Registry. However, the wording of Sec.  30.32(g) has not allowed as 
much flexibility as was expected when this provision was added to the 
regulations. In some circumstances, it has been impractical or 
impossible for users to provide all of the information required by 
Sec.  30.32(g). This has caused some applicants and licensees renewing 
their licenses to seek exemptions from Sec.  30.32(g) for the use of 
products for which the manufacturer or distributor has not obtained an 
SS & D registration.
    In addition to providing criteria in a proposed revision to Sec.  
32.210 for situations where an SS & D registration would not be 
required, revisions to Sec.  30.32(g) are also being proposed which 
would accommodate exceptions made in the SS & D registration process. 
In particular, a proposed Sec.  30.32(g)(4) would provide that limited 
information would be required for the smaller calibration and reference 
sources that are not registered. Also included is a proposed provision 
to allow for licenses to be issued without the need for every 
individual sealed source or device to be used to be identified by the 
applicant. A proposed Sec.  30.32(g)(5) would allow an applicant to 
propose constraints on the number and type of sealed sources and 
devices to be used and the conditions under which they will be used as 
an alternative to identifying each sealed source and device 
individually.
    This latter provision is not intended as a broadly applied change 
in the approach to licensing the use of sealed sources and devices. 
This change is intended to accommodate certain expected situations in 
which having to identify each sealed source or device presents an undue 
burden. For example, military applicants are sometimes unable to 
identify exactly which product they may be procuring. This provision 
could also be used by the types of applicants/licensees identified in 
proposed Sec.  32.210(g)(2), namely those licensed for research and 
development (R & D), those licensed under part 33, and certain custom 
users who have adequate training and experience and facilities and 
equipment to handle comparable quantities of material in other forms. 
It may also be reasonable to use such an approach to provide some 
flexibility in the case of calibration and

[[Page 36217]]

reference sources. It is anticipated that except for the R & D 
licensees, part 33 licensees, and certain custom users, one of the 
constraints would be that the sealed sources and devices are 
registered, as it is generally not practical for an applicant to supply 
adequate information to demonstrate that the radiation safety 
properties of unspecified sources or devices are inherently adequate to 
protect health and minimize danger to life and property.
    The use of the SS & D registration process as a tool for licensing 
was intended to provide a more efficient and effective licensing 
process than to have all users provide detailed information about the 
sources and devices to be used, and for license reviewers to evaluate 
the safety of the sources and devices in conjunction with the 
evaluation of the applicant's training and experience and facilities 
and equipment. The changes proposed to Sec. Sec.  30.32(g) and 
32.210(g) are intended to further improve the efficiency and 
effectiveness of the licensing process by eliminating the need for 
unnecessary exemptions for recognized situations that are not unique to 
a particular applicant.
A.4 Extending Requirements Concerning Legacy Sources and Devices to All 
Byproduct Material Covered by Part 30
    In the final rule published October 1, 2007 (72 FR 55863), which 
amended the Commission's regulations to incorporate the new categories 
of byproduct material added by the Energy Policy Act of 2005 (EPAct), a 
revision was made to Sec.  30.32(g) to facilitate licensing the use of 
legacy sealed sources and devices. These are older sources and devices 
for which the manufacturer is no longer in existence and for which it 
may be impossible to provide all of the categories of information 
identified in Sec.  32.210(c), as required by Sec.  30.32(g)(2). 
Generally, that amendment was intended to cover sources and devices 
manufactured before the promulgation of Sec.  32.210. This provision, 
in Sec.  30.32(g)(3), delineates additional information that is 
required to license the use of a sealed source or device for which all 
of the information previously required is not available. The 
information must include a description of the source or device, a 
description of radiation safety features, intended use and associated 
operating experience, and results of a recent leak test. The NRC 
licensing staff will review the submitted information to make a 
licensing decision regarding possession and use of the source or 
device. However, that amendment limited the provision to sealed sources 
and devices containing naturally occurring and accelerator-produced 
radioactive material (NARM), because the scope of that rule was limited 
to such materials. There are, however, a number of legacy sealed 
sources and devices containing pre-EPAct byproduct material, i.e., 
byproduct material as defined in section 11e.(1) of the AEA, for which 
it may also be impossible to provide all of the information required 
under Sec.  32.210(c). This rule proposes to extend that provision to 
legacy sources and devices containing any byproduct material, as 
defined in Part 30.

B. Establish a New Class Exemption for Certain Industrial Products

    As noted in the introduction on regulatory framework, class 
exemptions allow the Commission to exempt categories of products or 
devices with similar characteristics and purposes, rather than 
requiring individual exemptions for each product. For example, the 
existing class exemption in Sec.  30.20 for gas and aerosol detectors 
was established in April 1969. Since that time, new products possessing 
similar attributes were allowed to be licensed for distribution under 
Sec.  30.20 as they were developed. This regulatory structure allowed 
the new detectors to be used without product-specific exemptions, which 
would have required additional rulemaking. The health and safety of the 
public is ensured by evaluating each specific product against safety 
criteria contained in the regulations that apply to all products in a 
class.
    There are a number of products used under the general license in 
Sec.  31.5 that could meet similar safety criteria but do not come 
under either of the existing classes, i.e., Sec. Sec.  30.19 and 30.20. 
Certain industrial devices were identified by the NRC staff for 
possible use under an exemption from licensing requirements because of 
their low risk; i.e., static eliminators and ion generators containing 
polonium-210, beta backscatter and transmission devices, electron 
capture detectors for gas chromatographs, x-ray fluorescence analyzers, 
and calibration and reference sources. Dose assessments were conducted 
for these categories of products assuming use under an exemption from 
licensing and included in NUREG-1717. For each of the types of licensed 
products suggested for possible use under an exemption and included in 
the dose evaluations of NUREG-1717, some of the products clearly result 
in doses so low that requiring use under a license could be considered 
an unnecessary regulatory burden and an unnecessary expenditure of user 
and NRC resources. However, it is not clear that each type of device 
would necessarily qualify for exemption for all of the radionuclides 
and quantities used. Therefore, the NRC is proposing a new class 
exemption, rather than attempting to create a number of additional 
product-specific exemptions with appropriate limitations, such as 
radionuclide-specific quantity limits.
    The new class exemption in proposed Sec.  30.22, covering a broad 
range of industrial devices, would maintain protection of public health 
and safety and, at the same time, relieve regulatory burden. Presently, 
most of these products are licensed under the general license in Sec.  
31.5 and equivalent Agreement State regulations. In order for a product 
to be distributed for use under the new class exemption, the 
manufacturer or importer would be required to demonstrate that a 
particular device meets certain safety criteria, with NRC review and 
approval. Such a class exemption would also allow for the development 
of new products within the class or category of industrial devices that 
could be approved for use under exemption without the need for 
additional rulemaking to add product-specific exemptions.
    This approach allows for a broader number of devices to be exempted 
and for variations on a product or new products in the class to be 
approved for use under exemption from licensing without further need 
for rulemaking. The exemption may lead to more devices being developed 
with appropriately low risk that could meet the criteria for the 
exemption. Thus, additional benefit to society may accrue if more 
people make use of the types of products in this class.
    Although some calibration and reference sources are currently 
licensed under Sec.  31.5, a clarification is included in the proposed 
exemption that such sources are not covered, since it is more difficult 
to assess likely scenarios of handling and use for sources not 
incorporated into a specific device with a specific purpose; in 
particular, the number of sources that might be used or stored in close 
proximity is apt to be greater and more uncertain. Also, calibration 
and reference sources are frequently used by persons using other 
radioactive materials under a license, minimizing the benefit of an 
exemption in this case. Many of these are already used under the 
exemption in Sec.  30.18. Some containing americium-241 and radium-226 
are also covered by the general license in Sec.  31.8. Therefore, it is 
not believed that the type of exemption

[[Page 36218]]

being proposed is an appropriate regulatory approach for calibration 
and reference sources.
    The proposed exemption would cover industrial devices with the same 
list of purposes as are covered by the general license in Sec.  31.5 
with the exception of that of producing light. The existing class 
exemption for self-luminous products is considered adequate and 
appropriate to provide for exempt use of products of this type.
    The proposed exemption of industrial products would have a lower 
dose criterion for routine use than that associated with the general 
license and would include consideration of potential doses from 
disposal. Devices used under Sec.  31.5 must be returned to a specific 
licensee, such as a vendor or waste broker, and ultimately disposed of 
as low-level radioactive waste. Under the proposed exemption from 
licensing requirements, there would be no controls on disposal; the 
devices would be disposed without regard to their radioactivity. Thus, 
the potential impacts of uncontrolled disposal would need to be 
evaluated in the licensing process for each particular device.
    The proposed safety criteria are similar to the current criteria 
for licensing the manufacture or distribution of gas and aerosol 
detectors (contained in Sec. Sec.  32.27 and 32.28). However, those 
criteria include more organ-specific limits, because they were based on 
the dose limitation methodology recommended by the International 
Commission on Radiation Protection (ICRP) in 1959 in ICRP-2, ``Report 
of ICRP Committee II on Permissible Dose for Internal Radiation,'' 
whereas more recently developed approaches to radiation protection rely 
less on individual organ dose limits or constraints, particularly when 
doses are low, and include weighting organ dose contributions to 
overall dose. These newer approaches involve calculating doses in total 
effective dose equivalent as in 10 CFR part 20, based on ICRP-26, 
``Recommendations of the International Commission on Radiological 
Protection,'' or effective dose, based on the subsequent 
recommendations of the ICRP. The proposed safety criteria for the new 
class exemption would not require that the exposures be estimated 
specifically in terms of total effective dose equivalent (TEDE) or 
effective dose.
    The intent is that generally the most up-to-date dose calculation 
methodology would be used, and that the approach would allow for future 
updates. However, the staff would normally accept the use of another 
method such as that now reflected in 10 CFR part 20, as long as it did 
not result in a significantly different level of safety.
    The NRC notes that the ICRP issued its latest recommendations in 
ICRP-103, ``The 2007 Recommendations of the International Commission on 
Radiological Protection.'' The specific dose conversion factors based 
on those recommendations have not yet been calculated. However, as the 
safety criteria for the class exemption are design criteria, it is 
preferable to have the flexibility to use the latest information on 
estimating risks.
    For the purposes of these provisions, a definition of a generic 
term for internal dose, ``committed dose,'' would be added to Sec.  
32.2 to encompass this approach, which includes weighting of organ 
doses, but not strictly under one system.
    The proposed dose criterion for routine use of these devices is 200 
[mu]Sv (20 mrem)/year, which is significantly higher than that for gas 
and aerosol detectors (5 mrem (50 [mu]Sv)/year). This exemption would 
cover industrial type devices, used almost exclusively on the job, 
meaning that routine doses will normally be occupational, i.e., doses 
received by individuals in the course of employment in which the 
individual's assigned duties involve exposure to radiation or to 
radioactive material. In a small proportion of cases, a user might not 
be a worker, but a student, for example. However, these instances are 
likely to involve a limited amount of time for exposure over the year, 
reducing doses to these types of users. Due to the industrial purpose 
of the devices, these products are not expected to be sold in the large 
quantities possible for consumer products, such as smoke detectors. 
Therefore, these products would contribute to the doses of many fewer 
people. Doses to members of the public would generally be smaller, 
usually much less than that to the user.
    In order to provide reasonable assurance that members of the public 
are not routinely exposed to more than a few mrem/year (few 10's of 
[mu]Sv/year), the proposal would also include a criterion that the 
device is unlikely to be routinely used by members of the general 
public in a non-occupational environment. The Commission's policy for 
consumer products is for the general public to receive no more than a 
small fraction of the public dose limit from exempt products, so that 
their exposures from all sources are not likely to routinely exceed the 
public dose limit, which is now 100 mrem (1 mSv)/year.
    The fact that industrial products are not as widely used as items 
commonly used in the home would tend to limit the contribution by these 
products to disposal doses; e.g., the exposures of landfill workers. 
Nonetheless, the proposal includes a separate criterion for disposal, 
10 [mu]Sv (1 mrem)/year. This criterion is lower than the proposed 
criterion for routine use, because the same individuals are apt to be 
exposed to all products disposed in any particular landfill or 
municipal incinerator.
    Accident criteria would be similar to those for products to be used 
under Sec. Sec.  30.19 and 30.20. The higher of these limits, that for 
the lowest probability accident, is also used in the safety criteria 
for the general license in Sec.  31.5, under which many of the devices 
potentially covered by the proposed new class exemption are currently 
used [Sec.  32.51(a)(2)(iii)]. However, the proposed safety criteria 
for the new class exemption include additional criteria to ensure that 
the radionuclide quantities allowed for use under the exemption are 
limited, such that the maximum possible dose is controlled, even if the 
circumstances leading to such a dose are extremely improbable.
    The accident criteria currently in Sec.  32.23(d), Sec.  32.24, 
Column IV, Sec.  32.27(c), Sec.  32.28, Column III, and Sec.  
32.51(a)(2)(iii) were expected to limit the total amount of radioactive 
material likely to be approved for use under the relevant exemption or 
general license, irrespective of the design to contain or shield the 
material. However, designs to contain the material even under severe 
conditions of use or accident have resulted in relatively large 
quantities of materials being approved in some cases. Although the risk 
is well controlled by these designs, possible scenarios of misuse or 
malicious use are not required to be evaluated.
    For this new exemption, a proposed criterion would require that 
specific scenarios of misuse be analyzed and shown to meet certain dose 
limits. The analysis required to meet this misuse criterion would be 
relatively simple. Evaluating actual risk from possible misuse or 
malicious use would be much more difficult, but such risks would be 
limited by this proposed criterion. The proposed criterion is 100 mSv 
(10 rem), plus an additional skin dose criterion. This criterion is 
slightly lower than the accident criterion of 15 rem (150 mSv) 
applicable to products covered by the existing class exemptions and the 
general license in Sec.  31.5. The proposed criterion is considered to 
be a more appropriate value given the high level of uncertainty in 
estimates of doses under accident conditions.

[[Page 36219]]

    Limiting the radionuclide quantities allowed for use under the 
exemption, even if well contained, has the additional benefits of: (1) 
Minimizing risks associated with devices becoming subject to scrap 
metal recycling, such as property damage due to contamination resulting 
from smelting; (2) further controlling overall impacts to waste 
disposal workers; (3) minimizing overall impacts to the environment 
from uncontrolled disposal of products used under exemptions from 
licensing; and (4) minimizing the potential problems of products 
exempted by NRC being detected at and sometimes rejected for disposal 
in landfills and municipal incinerators by State and local 
restrictions.
    In addition, a fixed limit for radionuclides of concern for 
security, in terms of a small fraction of the Category 2 threshold as 
listed in Appendix E of Part 20 (which is based on the International 
Atomic Energy Agency (IAEA) Code of Conduct on the Safety and Security 
of Radioactive Sources), is also included (in proposed Sec.  
32.30(c)(4)) to further ensure that the quantities of these 
radionuclides in exempt products are not such that they would be a 
practical source of obtaining radioactive materials in quantities 
sufficient to cause significant harm.

C. Remove Unnecessary Limitations From the Class Exemption for Gas and 
Aerosol Detectors

    The class exemption in Sec.  30.20 is for gas and aerosol detectors 
``designed to protect life or property from fires and airborne 
hazards.'' At the time that this exemption was added to the 
regulations, the applications of these types of devices under 
consideration were smoke detectors and devices to detect chemicals that 
would constitute an airborne hazard if inhaled. The words ``designed to 
protect life or property from fires and airborne hazards'' were 
included to ensure that the products provided a clear societal benefit. 
Products similar to those allowed, but not quite fitting the ``class,'' 
cannot be approved for use under this exemption. For example, drug 
detectors were rejected for distribution for use under this exemption 
because they do not specifically protect life or property from fires or 
airborne hazards. The NRC believes that there is a clear societal 
benefit from this application and allowing its use under the exemption 
would be justified, as long as a particular device meets the applicable 
safety standards. A minor modification, therefore, is proposed to allow 
for a slightly broader class of product without eliminating the 
expectation of a societal benefit. ``Designed to protect life or 
property from fires and airborne hazards'' would be replaced with, 
``designed to protect health, safety, or property.'' This would allow 
other potential applications under an existing regulatory framework, 
which has safety criteria designed to adequately protect public health 
and safety.

D. Update the Regulations on Certain Static Eliminators and Ion 
Generating Tubes

    Section 31.3 provides a general license for certain static 
eliminators and ion generating tubes. The static eliminators 
distributed for use under this provision include those intended for use 
by the general public. There are no requirements associated with this 
general license; however, the provision does not explicitly contain an 
exemption from parts 19, 20, and 21. Nonetheless, the Commission has 
generally treated products covered by this provision as if the users 
were exempt from licensing. Distribution must be authorized only by NRC 
and not by the Agreement States. There are no distribution requirements 
specified in part 32. Distributors are licensed under Part 30, with 
particular license conditions related to distribution determined on a 
case-by-case basis. Reporting requirements in licenses have been 
similar to exempt distribution reporting requirements.
    This inconsistency results from the fact that the use of the static 
eliminators covered by this general license predated the regulations in 
10 CFR parts 19, 20, 21, 30, and 32. The general license for static 
eliminators was first issued in part 30 in the 1950s shortly before the 
formalization of radiation protection requirements was completed by 
issuance of part 20. Therefore, the original general license did not 
include an exemption from part 20. Training requirements were separated 
from part 20 and issued in part 19 at a later date. The ion generating 
tubes covered by paragraph (d) of Sec.  31.3 were also covered by the 
general license in part 30 prior to the recodification of byproduct 
material regulations into 10 CFR parts 30, 31, 32, 33, 34, 35, and 36 
in 1965. The general licenses for byproduct material were moved from 
part 30 to part 31 at that time.
    In 1971 (36 FR 6015; April 1, 1971), the Commission proposed to 
change this general license to an exemption, and also to expand it into 
a class exemption under which additional static elimination devices and 
ion generating tubes with differing radionuclides and quantities could 
be approved for use under the exemption through licensing actions. As a 
result of competing priorities for staff effort at the time, that rule 
was never finalized.
    Although these products have a long history of use, there have been 
relatively few licensed distributors. Nonetheless, this situation has 
caused some confusion in the licensing process. The Commission is 
proposing to change this general license into an exemption from 
licensing in Sec.  30.15(a)(2). The current licensed distributor would 
not be required to amend its license, but any future distributors would 
come under the distributor provisions associated with Sec.  30.15; 
i.e., Sec. Sec.  32.14, 32.15, and 32.16. This change is intended to 
have no effect on any current distributor or user of these products, 
only to remove an inconsistency in the regulations and to make any 
future licensing decisions in this regard more efficient and effective.
    With respect to the issue of requirements for sealed source and 
device review, this change would remove the need for a registration 
certificate if these products are distributed under the authority of a 
license issued under Sec.  32.14. The licensing practice of using the 
sealed source and device review and registration process for products 
to be used under the general license in Sec.  31.3 primarily resulted 
from the lack of specific requirements for a distribution license in 
the regulations. Thus, Sec.  32.210 provided the types of information 
to be provided concerning the product for NRC review.

E. Remove Prescriptive Requirements for Distributors of Generally 
Licensed Devices and Exempt Products

    The Commission has determined that the requirements for 
manufacturers or initial distributors of exempt and generally licensed 
products are in some cases overly prescriptive, particularly in the 
areas of prototype testing and acceptance sampling/quality control (QC) 
procedures. The current prescriptive approach is easy to implement and 
regulate, but is relatively inflexible. When evaluating a new or 
redesigned product, the NRC requires prototype testing to validate the 
design of products and their ability to contain byproduct material. 
Acceptance sampling (a specific QC process) monitors the effectiveness 
of the manufacturing process for safety-significant parts to minimize 
the likelihood of failures and events caused by inadequate 
manufacturing quality.
    This proposed rule is intended to focus the regulations on 
performance, rather than procedures. The regulations would retain 
general requirements and

[[Page 36220]]

provide general standards by which performance may be judged, rather 
than specifying detailed procedures that must be followed, except for 
products for which oversight of these activities would no longer be 
required as discussed under Section III.F., ``Make the Requirements for 
Distributors of Exempt Products More Risk-Informed.'' The NUREG-1556 
series of documents provides guidance to licensees and applicants on 
acceptable approaches to meeting these requirements.
    The procedures included in the current regulatory requirements are 
generally acceptable to meet the proposed performance-based 
requirements. Safety benefits of the proposed changes in this area 
would primarily be gained indirectly by removing overly burdensome and 
possibly counterproductive procedures--and more importantly, by 
accommodating the use of new technologies. The intent is for the 
proposed regulatory requirements to be equivalent to the current 
practices (except as noted), so that existing licensees would not have 
to change their procedures as a result of this rulemaking. However, the 
provisions are written so that applicants and licensees would have 
flexibility in the methods that they use to determine the design 
quality (prototype tests) and manufacturing quality (acceptance 
sampling/QC) of these products. In keeping with international best 
manufacturing standards, manufacturers and the distributors that 
represent them are expected to maintain a quality management system 
that stresses continual improvement. Examples of such system 
requirements can be found in ISO 9001:2000, ``Quality Management 
Systems--Requirements,'' and, unique to the nuclear safety field, IAEA 
Safety Series No. 50-C/SG-Q, ``Quality Assurance for Safety in Nuclear 
Power Plants and Other Nuclear Installations, Code and Safety Guides 
Q1-Q14.'' While the focus of ISO 9001:2000 is on customer satisfaction, 
and the primary focus of the IAEA series is on nuclear facility safety, 
these documents contain some quality management concepts that are 
appropriate to the distribution of generally licensed and exempt 
products containing byproduct material.
Prototype Test Procedures
    This rule proposes to simplify current prescriptive regulations for 
prototype testing for new products proposed for use under general 
license. The proposed provisions include only those aspects that are 
results-oriented, rather than specifying detailed procedures that must 
be followed. An applicant may choose to follow current prototype test 
procedures, as they would satisfy the outcomes required by this 
proposed rule in every situation. The specific procedures would be 
removed from the regulations and included as example acceptable 
procedures in guidance documents.
    In the case of generally licensed products, regulations that 
contain prescriptive requirements for prototype testing are:
     Paragraph (d)(4) of Sec.  32.53, ``Luminous safety devices 
for use in aircraft: Requirements for license to manufacture, assemble, 
repair or initially transfer,'' standard to pass tests described in 
Sec.  32.101;
     Paragraph (d)(2) of Sec.  32.57, ``Calibration or 
reference sources containing americium-241 or radium-226: Requirements 
for license to manufacture or initially transfer,'' standard to pass 
tests described in Sec.  32.102;
     Paragraph (e)(4) of Sec.  32.61, ``Ice detection devices 
containing strontium-90; requirements for license to manufacture or 
initially transfer,'' standard to pass tests described in Sec.  32.103;
     Section 32.101, ``Schedule B--prototype tests for luminous 
safety devices for use in aircraft'';
     Section 32.102, ``Schedule C--prototype tests for 
calibration or reference sources containing americium-241 or radium-
226''; and
     Section 32.103, ``Schedule D--prototype tests for ice 
detection devices containing strontium-90.''
    No prescriptive prototype testing requirements pertaining to 
manufacturers of exempt products remain in the regulations, as they 
have been previously removed. Most recently, Sec. Sec.  32.14(d)(2) and 
32.40 were removed by a rule published October 16, 2007 (72 FR 58473).
Acceptance Sampling and Quality Control Procedures
    In the case of generally licensed products, regulations that 
contain prescriptive requirements for acceptance sampling/quality 
control procedures are:
     Paragraphs (a) though (d) of Sec.  32.55, ``Same: Quality 
assurance; prohibition of transfer'' (``Same'' refers to ``Luminous 
safety devices for use in aircraft'');
     Section 32.59, ``Same: Leak testing of each source'' 
(``Same'' refers to ``Calibration or reference sources containing 
americium-241 or radium-226'');
     Paragraphs (a) through (e) of Sec.  32.62, ``Same: Quality 
assurance; prohibition of transfer'' (``Same'' refers to ``Ice 
detection devices containing strontium-90''); and
     Section 32.110, ``Acceptance sampling procedures under 
certain specific licenses.''
    The prescriptive requirements for acceptance sampling/quality 
control procedures pertaining to manufacturers of exempt products are 
paragraphs (a)(2), (a)(3), and (c)(2) of Sec.  32.15, ``Same: Quality 
assurance, prohibition of transfer, and labeling.'' (``Same'' refers to 
``Certain items containing byproduct material.'')
    These all include specified procedures; Sec. Sec.  32.15(a) and 
(c), 32.55(b) and (d), and 32.62(c) and (e) specifically refer to Sec.  
32.110.
    The NRC intends to allow acceptance sampling to be performance-
based, rather than specifying procedural details. Section 32.110 
provides that a random sample shall be taken from each inspection lot 
of specified licensed devices for which testing is required in 
accordance with the appropriate sampling table in that section. If the 
number of defectives in the sample does not exceed the acceptance 
number in the appropriate sampling table, the lot shall be accepted, 
while if the number of defectives exceeds the acceptance number, the 
entire inspection lot shall be rejected. There is no longer a need for 
NRC to maintain the acceptance sampling tables in Sec.  32.110, which 
provides the number of acceptable defective units in various lot sizes 
for a variety of Lot Tolerance Percent Defective values. Note: Lot 
Tolerance Percent Defective is defined in Sec.  32.2 as the poorest 
quality in an individual inspection lot that should be accepted. The 
table in Sec.  32.110(b)(6) Lot Tolerance Percent Defective 5.0 percent 
correlates with the standard in the above cited regulations. However, 
the other seven tables in Sec.  32.110 apparently have been little used 
since their publication in 1974, as there are no specific standards in 
Part 32 requiring Lot Tolerance Percent Defectives other than 5 
percent. Licensees can now easily use widely available computer 
software to determine their own acceptance sampling procedures to best 
monitor their manufacturing processes. This rule would remove Sec.  
32.110. Acceptance sampling criteria would continue to be specified in 
Sec. Sec.  32.15, 32.55, and 32.62, specifying the values required for 
quality (Lot Tolerance Percent Defective) and confidence. Section 32.59 
requires leak testing of each source for calibration or reference 
sources containing americium-241 or radium-226 generally licensed under 
Sec.  31.8, rather than sampling of lots. This rule does not propose to 
change that

[[Page 36221]]

provision other than providing minor clarifications.
    Presently, the NRC requires the affected categories of licensees to 
perform acceptance sampling in accordance with Sec.  32.110 or propose 
alternative procedures (under Sec.  32.15(b), Sec.  32.55(c), or Sec.  
32.62(d)) which provide a Lot Tolerance Percent Defective of 5.0 
percent at a consumer's risk of 0.10. This ``consumer's risk'' 
criterion is equivalent to 90 percent confidence that the Lot Tolerance 
Percent Defective will not be exceeded. The applicant's quality control 
procedures, including any alternate procedures proposed, are reviewed 
and approved by NRC. The proposed rule would not change the 5 percent 
criterion for Lot Tolerance Percent Defective (i.e., 95 percent 
acceptance). The current value of consumer risk of 10 percent is more 
relaxed than others used by NRC, such as in inspections, which use 
standards of no more than 5 percent defective at 5 percent risk. The 
proposed rule would revise the acceptance sampling standard to no more 
than 5 percent risk, expressed as ``95 percent confidence,'' for those 
categories of products for which the acceptance criteria are specified 
in the regulations. The term ``confidence'' is now more commonly used 
in this context.
    Most of NRC's statistical acceptance criteria today B such as in 
inspections B are, at least, 95 percent acceptance with 95 percent 
confidence. Raising the required confidence level from 90 percent to 95 
percent may be an increase in burden, but is justified, because the 
current standard is inconsistent with other agency practices, as well 
as industry standards. However, it is expected that because of the 
nature of the products covered by these regulations, the lot sizes apt 
to be used, and other factors, the proposed revision is unlikely to 
change the approaches used by the limited number of current licensees 
under these provisions.
    Another proposed change in NRC's acceptance sampling regulations is 
a clarification of the prohibition on the transfer of any defective 
lot. The prohibition of transfer of rejected lots, currently appearing 
in Sec. Sec.  32.15(c)(2), 32.55(d)(2), and 32.62(e)(2), would be 
revised. Currently, the prohibition of transfer appears to apply only 
to individual items found to be defective, rather than addressing all 
items in a sampled lot that do not meet the acceptance standard. As 
proposed, these revisions concerning rejected lots would appear in 
Sec. Sec.  32.15(b)(2), 32.55(d)(2), and 32.62(e)(2). From a 
statistical standpoint, unless a lot is sampled and tested in such a 
way as to demonstrate compliance with the required measures of quality 
assurance, the entire lot should be rejected. The proposed rule would 
require that distribution of any part, or sub-lot, of a rejected lot 
must be in accordance with procedures spelled out in the license, and 
that testing after repairs must be performed by an independent 
reviewer. The provision for an independent reviewer is a proposed new 
requirement, but it is an IAEA recommendation, and may have been used 
voluntarily as an industry best practice. IAEA recommends that, based 
on sound statistical theory, depending on the safety significance of 
the defective item or lot, the independent reviewer may be a different 
inspector from the one that performed the original sampling, or an 
inspector from a third party. In the case of the products for which 
these changes are being proposed, the risk is low and it is sufficient 
for the independent inspector to simply be another qualified employee. 
Individual worker accountability plays an important role in an 
effective quality assurance (QA) program, and an independent reviewer, 
besides adding another layer of assurance that the sub-lot or part is 
acceptable, would add accountability to the program.
    The sampling plan will normally be detailed in the license, which 
will ensure that the quality assurance program is systematic and 
planned where justified, such as for lot sizes, sample sizes, criteria, 
and procedures. The primary source of current guidance on quality 
control and quality assurance is NUREG-1556, Volume 3, Rev. 1, 
``Consolidated Guidance About Materials Licenses, Applications for 
Sealed Source and Device Evaluation and Registration.'' This guidance 
indicates that NRC may accept a certificate of accreditation in lieu of 
a full set of QA/QC plans or procedures. The vendor providing 
certification must, however, make the commitment that the generic QA/QC 
program includes provisions which address the specific requirements in 
the regulations for the fabrication of the sealed sources or devices. 
Depending on the specific requirements of the fabrication process, such 
provisions would include:
     Verifying that the design conforms fully with the 
statements and commitments submitted in support of the application 
(including materials, dimensions within stated tolerances, 
manufacturing methods, assembly methods, labeling), using sampling 
methods that meet applicable provisions, such as Sec.  32.55.
     Leak testing all units to 185 Bq (0.005 [mu]Ci).
     Testing all units for proper operation of all safety 
features.
     Verifying that, for all units, the radiation levels do not 
exceed the maximum values stated in the application.
    The proper treatment and definition of lots is essential from a 
statistical perspective, and relevant to acceptance sampling 
procedures. For the purposes of acceptance sampling, a ``lot'' should 
consist of homogeneous products manufactured from the same or similar 
machines, interchangeable in terms of their intended use or function. 
Similarly, from a statistical perspective, a sampling plan must 
demonstrate certain characteristics to sufficiently guarantee quality: 
Manufacturer compliance with predetermined lot sizes, sample sizes, 
sampling methodology, and acceptance criteria; agreement with a one-
time decision to accept or reject a lot in its entirety; separate, 
predetermined treatment of sub-lots; and the calculation and reporting 
of separate measures for quality and for confidence. It should be 
emphasized, however, that the regulatory requirement for acceptance 
sampling is not an attempt to control overall product quality, but to 
minimize the possibility that a distributed product has inadequate or 
malfunctioning safety features.
    In summary, this proposed rule would revise the cited paragraphs 
concerning prototype testing and quality control, including specific 
sampling requirements, to make these requirements for distributors more 
flexible and performance-based rather than prescriptive. Guidance on 
quality assurance methods is included in NUREG-1556, Volume 3, Revision 
1, including specifically Appendix G.
    Less prescriptive, more flexible, performance-based regulations 
would continue to specify performance requirements. Generally, the 
specific procedures being removed from the regulations would continue 
to be considered acceptable. The NRC normally evaluates products using 
radiation safety criteria in accepted industry standards. If these 
standards and criteria do not readily apply to a particular case, NRC 
formulates reasonable standards and criteria in consultation with the 
manufacturer or distributor. References to appropriate industry and 
consensus standards are included in NUREG-1556, Volume 3, Rev. 1, 
Appendix F. Updated guidance would be provided when a new or revised 
industry standard becomes available that NRC considers more

[[Page 36222]]

appropriate. The licensee would be free to propose alternative methods 
to those presented in industry standards and guidance, provided that 
the methods provide sufficient evidence that all safety related 
components are capable of performing their intended functions.
    Current licensees would need to make any necessary upgrade to their 
QC programs when the rule becomes effective. However, because license 
conditions are written broadly, it is not expected that any such 
changes in the QC program would be inconsistent with an existing 
license (or registration certificate). Any changes needed in the 
license to better ensure consistency with the revised requirements 
would likely be made at the time of the next license renewal or related 
amendment of the license.

F. Make the Requirements for Distributors of Exempt Products More Risk-
Informed

    To a large extent, NRC applies similar requirements throughout Part 
32 on manufacturers and distributors of all categories of products, 
irrespective of the quantity of byproduct material within or the risk 
of a product. However, given the low risk of some exempt products, some 
of the existing requirements may be unnecessary, and not commensurate 
with the associated risk. This is particularly true in the areas of 
prototype testing and quality control requirements for products to be 
used under exemptions from licensing.
    The NRC considered whether some of the products used under an 
exemption from licensing present such low levels of radiation 
exposures, both routinely and in the event of accidents, that continued 
NRC oversight of the specific prototype tests and/or the quality 
control/quality assurance to be applied by the manufacturer or 
distributor would not be warranted.
    Although many products distributed under the class exemptions would 
likely meet such a low-risk standard, the Commission does not believe 
it prudent to eliminate any of these requirements for the class 
exemptions. The safety criteria for each class exemption are intended 
to ensure that the risks associated with any product approved for use 
under the associated exemption are quite low. Nonetheless, because of 
the nature of a class exemption to allow for new products to be 
approved, it is not possible to conclude that elimination of oversight 
of prototype testing or quality control procedures for an entire class 
of products is prudent. The evaluation of the safety of the individual 
product may depend on knowledge of such procedures.
    Although it may be possible to develop an explicit approach to 
allow for removal of oversight of these types of procedures for some of 
the products distributed under the class exemptions, the burden of 
these requirements is not so great that the effort to develop a 
specific procedure for this did not seem worthwhile. Applicants and 
licensees do nonetheless have the option to seek an individual specific 
exemption under Sec.  30.11 from any requirement applicable to the use 
of byproduct material.
    The NRC evaluated the inherent potential for radiation exposures 
from products containing byproduct material used under product-specific 
exemptions and the likelihood of increases in risks if oversight of the 
subject procedures were removed. The product-specific exemptions appear 
in Sec.  30.15. There are currently four types of products listed in 
that provision for which future distribution is allowed, specifically 
timepieces, ionization chamber smoke detectors, electron tubes, and 
ionizing radiation measuring instruments. (Note that in the discussion 
under Section III.D., ``Update the Regulations on Certain Static 
Eliminators and Ion Generating Tubes,'' the Commission is proposing to 
add another exemption to Sec.  30.15.) The requirements of this type 
for manufacturers and distributors of products used under Sec.  30.15 
are contained in: Sec.  32.14(b)(4), on submittal of information on 
prototype test procedures used and the results; Sec.  32.14(b)(5), on 
submittal of quality control procedures to be used; and Sec. Sec.  
32.15(a)(2) and (a)(3) and 32.110, on specific sampling procedures for 
quality control. Paragraph 32.15(c) also contains a prohibition on 
transferring any defective lot or item to exempt persons.
    Even without NRC's continuing oversight of these procedures, 
licensees would be motivated to retain them as good business practices. 
There are a number of factors that would likely cause manufacturers and 
distributors to continue to conduct prototype testing and at least some 
form of quality control/assurance. In some cases, functionality testing 
closely aligns with testing for containment of radioactive material. 
The consideration of risk for these products, however, did not rely on 
this expectation, beyond some reasonable bounding assumptions about the 
likelihood and consequences of distributing defective products. For 
example, failures that result in functional failure may happen more 
frequently, but it is not reasonable to assume that manufacturers would 
continue to distribute a large percentage of defective devices over 
long periods.
    The NRC used NUREG-1717 as a primary resource concerning estimates 
of doses that result from the distribution, use, maintenance and 
repair, disposal, and accidents involving these products. The NRC 
considered the extent to which these doses might be affected if the 
lack of oversight over prototype testing resulted in a product design 
that was less effective in containing or shielding the byproduct 
material. The NRC also considered the extent that doses or probability 
of accidents could be affected if the lack of oversight of quality 
control/quality assurance significantly reduced the effectiveness of 
licensees' programs in this area. This assessment was semi-qualitative 
as there is no data available on products used without regulatory 
control, which could support a quantitative probabilistic risk 
assessment.
    This proposed rule would eliminate NRC oversight for these types of 
activities for a few of the exempt products as not justified, based on 
risk. Requirements to submit information on prototype tests in Sec.  
32.14(b)(4) would be eliminated for products exempt under Sec.  
30.15(a)(7) and (8), ionization chamber smoke detectors and electron 
tubes respectively. This requirement would also be eliminated for 
timepieces under Sec.  30.15(a)(1) containing promethium-147 or tritium 
in the form of gaseous tritium light sources. Oversight of quality 
control/quality assurance would be eliminated for these same products 
as well as for products to be used under the new exemption in Sec.  
30.15(a)(2), static eliminators and ion generating tubes formerly 
covered by the general license in Sec.  31.3. This is in a proposed 
revised Sec.  32.14(b)(5), which would require that quality control 
procedures be submitted for approval only for ionizing radiation 
measuring instruments and timepieces containing tritium in the form of 
paint. Other requirements in the application for a license to 
distribute these products would remain, such as the submittal (under 
Sec.  32.14(b)) and evaluation (Sec.  32.14(d)) of basic design 
features intended to contain the byproduct material.
    Based on the assessment of the inherent safety of these products, 
it is estimated that even if a lack of appropriate prototype testing 
resulted in lower quality product designs in the future or poor quality 
control resulted in degradation of production quality, the potential 
increases in individual doses would be less than 10[mu]Sv (1 mrem)/year 
in any situation where significant numbers of products could be 
affected. Also, in the extreme case of a significant

[[Page 36223]]

change in future distributor behavior, some individual doses could be 
increased by somewhat higher amounts in non-routine situations. 
Overall, considering both potential increases in doses and the 
probability of circumstances resulting in those increases, the 
potential incremental risk is estimated to be insignificant.
    Unnecessary regulatory burden on distributors of these products 
would be reduced. Because, as noted above, licensees are not likely to 
eliminate such procedures as a result of discontinued NRC oversight, 
the benefits assumed are only those associated with eliminating the 
submittal of testing/sampling procedures for review and approval, 
eliminating the submittal of prototype testing results, and allowing 
added flexibility to change procedures in response to other factors, 
including competitive demands for continuous quality improvement, 
without NRC permission.
    Current licensees authorized to distribute products affected by 
this change would need to amend their license in order to not be held 
accountable for continuing to follow the QC/QA program as delineated in 
their license. This would be a simple amendment as the regulations 
would be clear that this license condition is no longer required.
    The NRC does not currently believe that any similar requirements 
for submitting information on such procedures for generally licensed 
devices are candidates for revocation based on risk, as the safety of 
these devices generally relies on the design and manufacturing process 
quality to a greater degree than for these exempt products. This is 
less so in the case of calibration and reference sources used under 
Sec.  31.8 and the risk directly associated with these sources may be 
sufficiently low to consider removing oversight of prototype testing or 
quality control, particularly given the general license's applicability 
only to specifically licensed persons. However, problems with leakage 
or significant variation of quantities would affect the use of these 
sources so as to indirectly affect health and safety of other 
activities.

G. Specific Questions for Comment

    The NRC invites comments on any aspect of this proposed rule, but 
has these specific questions for consideration:
    1. Updating of registration certificates in the SS & D Registry 
(Discussed in Section III. A.2):
    (a) Under what circumstances should proposed Sec.  32.210(h) be 
used to require a reevaluation? How should such a reevaluation be 
conducted with minimum impact to industry?
    (b) How might registration certificates best be updated so as not 
to discourage improvement in the design of sources or devices, more 
readily allow for the application of updated industry standards, and 
ensure that information in the certificates is fully consistent with 
current practices? (For example, in addition to the proposed provision 
in Sec.  32.210(h), other options could include reviewing certificates 
at the time of license renewal, in part or in whole; adding separate 
expiration dates to certificates with typically longer terms than 
licenses, e.g., 10 to 20 years; and explicitly allowing licensees to 
make changes without NRC approval, if these changes do not reduce 
safety margins.)
    (c) How should certificates for previously approved devices be 
handled if the device does not meet current standards, such as in the 
case of the separately proposed (August 3, 2009; 74 FR 38372) quantity 
limit in the general license in Sec.  31.5 (and comparable Agreement 
State provisions)? How should registration certificates be handled in 
this situation? (For example, in some cases, the distributor may be 
able to limit the quantity of affected radionuclides, rather than 
change its certificate to one for specifically licensed devices.)
    (d) In general, how might the NRC use the proposed provision for 
review in Sec.  32.210(h) in relation to changes in standards for 
products or limits in addressing continued distribution and the timing 
for changes to the authority to distribute tied to the registration 
certificate?
    2. New class exemption for industrial products in Sec.  30.20 
(Discussed in Section III. B.):
    (a) Is the 20 mrem/year routine dose criterion appropriate, given 
that users are workers, but there is no control of conditions of use 
once a product is distributed for use under an exemption from license?
    (b) Would it be appropriate to apply certain aspects of the 
proposed standards for this class exemption to the safety criteria 
(Sec. Sec.  32.23 and 32.27) for the existing class exemptions 
(Sec. Sec.  30.19 and 30.20), namely, the use of more up-to-date 
methodology for dose assessment as reflected in the proposed definition 
of the term ``committed dose,'' the inclusion of a misuse scenario and/
or a specific quantity limit to control quantities that may meet the 
safety criteria when a source is well contained and shielded, and the 
consideration of the number of products likely to accumulate in one 
place in the dose assessments for all scenarios?
    3. Expanding the class exemption for gas and aerosol detectors in 
Sec.  30.20 by revising the requirement of ``designed to protect life 
or property from fires and airborne hazards'' to instead be ``designed 
to protect health, safety, or property'' (Discussed in Section III. 
C.):
    (a) Are there additional products that may be exempted under this 
expanded definition of the class not specifically considered by the 
NRC?
    (b) Are these words adequate to ensure that products present a 
clear societal benefit?
    (c) Are there any potential problems with approving additional 
products for use under this exemption and later reevaluating the safety 
criteria associated with this exemption for potential alignment with 
newer recommendations of the ICRP?
    4. Changes to certain quality control requirements in Sec. Sec.  
32.15, 32.55, and 32.62 to (i) raise the statistical acceptance 
criteria; i.e., increasing the required confidence that the Lot 
Tolerance Percent Defective will not be exceeded from the current 90 
percent (consumer risk of 0.10) to 95 percent; and (ii) require that 
distribution of any part, or sub-lot, of a rejected lot must be in 
accordance with procedures spelled out in the license and that testing 
after repairs must be performed by an independent reviewer (Discussed 
in Section III. E.). These proposed revisions are in Sec.  32.15(a) and 
(b) for certain exempt items, Sec.  32.55(b) and (d) for luminous 
safety devices used in aircraft, and Sec.  32.62(c) and (e) for ice 
detection devices.:
    (a) Would any actual changes in practice need to be made by 
affected licensees? The NRC would welcome information that would aid in 
evaluating any impact.
    (b) Would there be any impact on manufacturers or distributors of 
products for which oversight of quality control practices are proposed 
to be removed, if the new provisions were applied to these products 
instead, i.e., if all of the exceptions in Sec.  32.14(b)(5) were not 
made effective as proposed? (As discussed under Section III. F. ``Make 
the Requirements for Distributors of Exempt Products More Risk-
Informed,'' products for which quality control oversight may be removed 
are: Ionization chamber smoke detectors, electron tubes, and timepieces 
containing promethium-147 or tritium in the form of gaseous tritium 
light sources, covered by exemptions in Sec.  30.15, and for products 
to be used under the proposed new exemption in

[[Page 36224]]

Sec.  30.15(a)(2), static eliminators and ion generating tubes formerly 
covered by the general license in Sec.  31.3.)
    5. Proposal in Sec.  30.32(g)(5) to allow some licenses to specify 
only constraints on the number and type of sealed sources and devices 
to be used and the conditions under which they are to be used 
(Discussed in Section III. A.3):
    (a) In view of the expectation that this authorization would only 
be granted in limited situations and due to special circumstances, how 
can NRC make it clear that approval of this approach would be at the 
NRC's discretion, rather than this being an open-ended option for 
anyone, or should the regulation specify when this approach is 
acceptable?
    (b) Are there other situations besides those discussed, when 
identifying all of the sealed sources and devices to be licensed is 
particularly impractical?

H. Minor Clarifying or Administrative Revisions

    Other minor revisions are proposed to better organize, clarify, or 
update the regulations in these parts, such as the renaming of subparts 
C and D and the movement of Sec. Sec.  32.72 and 32.74 from subpart B 
to subpart C. These two sections would be moved because they do not 
cover generally licensed items. Minor conforming amendments are 
included in Parts 40 and 70 because the delineation of the delegation 
of licensing programs to the Regions is written broadly in these parts. 
All such revisions are noted in the following section.

IV. Summary of Proposed Amendments by Section

    10 CFR 30.6(b)(1)(iv)--Would add a reference to new 10 CFR 32.30 as 
a licensing category not delegated to the NRC Regions.
    10 CFR 30.15(a)(2)--Would add an exemption for certain static 
eliminators and ion generators in place of the general license in 10 
CFR 31.3.
    10 CFR 30.19(b)--Would clarify that applicants under 10 CFR 32.22 
should also apply for a registration certificate.
    10 CFR 30.20--Would slightly expand the class of products covered 
under this exemption from licensing; would clarify that applicants 
under 10 CFR 32.26 should also apply for a registration certificate; 
would update parts of the regulations from which persons are exempt to 
include 10 CFR Part 19.
    10 CFR 30.22--Would establish a new class exemption for industrial 
devices initially transferred from 10 CFR 32.30 licensees.
    10 CFR 30.32(g)(3)--Would extend the provision for providing 
alternative information on NARM legacy sealed sources and devices to 
all legacy sealed sources and devices.
    10 CFR 30.32(g)(4)--Would add a provision for providing limited 
information for certain calibration and reference sources.
    10 CFR 30.32(g)(5)--Would add a provision to allow for constraints 
on the number and type of sealed sources and devices to be used and the 
conditions under which they are to be used rather than requiring 
complete identification of all sealed sources and devices to be 
licensed.
    10 CFR 30.38--Would add an explicit provision for amendment of 
registration certificates.
    10 CFR 30.39--Would add registration certificates to clarify that 
the same requirements are applicable to amendment of a registration 
certificate as for issuance of a new certificate.
    10 CFR 30.61--Would add registration certificates to provisions for 
modification and revocation of licenses and update reference to Parts 
under which licenses are issued.
    10 CFR 31.3--General license would be removed, section reserved, 
and replaced by a new exemption in 10 CFR 30.15(a)(2).
    10 CFR 31.23--Would remove reference to 10 CFR 31.3 and make other 
minor corrections.
    10 CFR 32.1--Would expand the description of the scope of 10 CFR 
Part 32 to cover additional requirements and make clarifications.
    10 CFR 32.2--Would add definitions of ``committed dose'' and 
``sealed source and device registry.''
    10 CFR 32.8--Would add to the list of information collection 
requirements: 10 CFR 32.30 on application requirements for distributors 
of exempt industrial devices, 10 CFR 32.31 on safety criteria to be 
addressed in the application for license under 10 CFR 32.30, 10 CFR 
32.32 on reporting and recordkeeping requirements for distributors of 
exempt industrial devices, and 10 CFR 32.211 on requesting inactivation 
of registration certificates.
    10 CFR 32.14(b)(4)--Would make exceptions to prototype testing 
requirements.
    10 CFR 32.14(b)(5)--Would make exceptions to quality control 
requirements.
    10 CFR 32.15(a), (b), and (c)--Would remove the specific procedural 
requirements for quality assurance, revise the acceptance criterion, 
and limit these requirements to products for which such procedures 
would be required under 10 CFR 32.14.
    10 CFR 32.22--Would add an explicit requirement for sealed source 
and device registration.
    10 CFR 32.26--Would revise the introductory text to expand the 
limitation of ``from fires or airborne hazards,'' for the purpose of 
the detectors, thus, expanding the class of products covered; and would 
add an explicit requirement for sealed source and device registration.
    10 CFR 32.30--Would establish requirements for an application to 
manufacture, process, produce, or initially transfer for sale or 
distribution exempt industrial devices.
    10 CFR 32.31--Would establish safety criteria for approving 
industrial devices to be distributed for use under 10 CFR 30.22 and 
equivalent Agreement State regulations.
    10 CFR 32.32--Would establish specific conditions of license for 
distribution of exempt industrial devices, including quality control, 
labeling, and reporting and recordkeeping requirements.
    10 CFR 32.51(a)(6)--Would add an explicit requirement for sealed 
source and device registration for devices to be transferred for use 
under 10 CFR 31.5 and equivalent Agreement State regulations.
    10 CFR 32.53--Would remove the reference to 10 CFR 32.101 and add 
requirements for prototype testing without details of procedures to be 
followed; would revise the requirement for information to be submitted 
on quality control/quality assurance to be consistent with less 
prescriptive approach in 10 CFR 32.55; would add an explicit 
requirement for sealed source and device registration.
    10 CFR 32.55--Would revise the requirement to conduct quality 
assurance to be clearer and less prescriptive and revise the acceptance 
criterion.
    10 CFR 32.56--Would add ATTN: GLTS to address for reporting, 
explicitly require reports to Agreement States, and clarify the need 
for reporting even if no transfers were made during the reporting 
period.
    10 CFR 32.57(d)(2) and (e)--Would remove reference to 10 CFR 32.102 
and add less prescriptive requirement for prototype testing in 
paragraph (e).
    10 CFR 32.59--Would make minor clarifying amendments to testing 
requirements for calibration and reference sources to be used under 10 
CFR 31.8 and equivalent Agreement State regulations.
    10 CFR 32.61(e)(4) and (f)--Would revise the prototype test 
requirement by removing reference to 10 CFR 32.103 and adding less 
prescriptive

[[Page 36225]]

requirement for prototype testing in paragraph (f).
    10 CFR 32.61(g)--Would add an explicit requirement for sealed 
source and device registration.
    10 CFR 32.62(c), (d), and (e)--Would revise and clarify quality 
assurance requirements, acceptance criterion, and associated 
prohibition of transfer.
    Heading of Subpart C would be changed to ``Specifically Licensed 
Items.''
    10 CFR 32.72 and 10 CFR 32.74 would be moved from Subpart B to 
renamed Subpart C.
    10 CFR 32.74(a)(4)--Would add an explicit requirement for sealed 
source and device registration for sealed sources and devices for 
medical use.
    10 CFR 32.101--Specific prototype test procedures for luminous 
safety devices for use in aircraft would be removed.
    10 CFR 32.102--Specific prototype test procedures for calibration 
and reference sources containing americium-241 or radium-226 would be 
removed.
    10 CFR 32.103--Specific prototype test procedures for ice detection 
devices containing strontium-90 would be removed.
    10 CFR 32.110--Specific acceptance sampling procedures would be 
removed.
    Heading of Subpart D would be changed to ``Sealed Source and Device 
Registration.''
    10 CFR 32.201--Would be moved from Subpart D to renamed Subpart C.
    10 CFR 32.210(a) and (e)--Would remove restriction of applicability 
to specifically licensed items.
    10 CFR 32.210(b)--Would add ATTN: SSDR to address for requests.
    10 CFR 32.210(d)--Would add reference to other criteria which apply 
to various categories of sealed sources and devices.
    10 CFR 32.210(g)--Would add criteria for sources and devices not 
requiring SS & D registration.
    10 CFR 32.210(h)--Would add an explicit provision for additional 
review of registration certificates.
    10 CFR 32.211--Would add an explicit provision for inactivation of 
sealed source and device registration certificates.
    10 CFR 32.303(b)--Would add reference to new requirements not 
issued under section 223 of the AEA, as well as correct previous 
omissions.
    10 CFR 40.5(b)(1)(iv)--Would add reference to new 10 CFR 32.30 as a 
licensing category not delegated to the NRC Regions.
    10 CFR 70.5(b)(1)(iv)--Would add reference to new 10 CFR 32.30 as a 
licensing category not delegated to the NRC Regions.

V. Criminal Penalties

    For the purpose of Section 223 of the Atomic Energy Act (AEA), the 
Commission is proposing to amend 10 CFR parts 30 and 32 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 on September 3, 1997 (62 FR 
46517), NRC program elements (including regulations) are placed into 
compatibility categories A, B, C, D, NRC or adequacy category Health 
and Safety (H&S). Compatibility Category A are those program elements 
that are basic radiation protection standards and scientific terms and 
definitions that are necessary to understand radiation protection 
concepts. An Agreement State should adopt Category A program elements 
in an essentially identical manner in order to provide uniformity in 
the regulation of agreement material on a nationwide basis. 
Compatibility Category B are those program elements that apply to 
activities that have direct and significant effects in multiple 
jurisdictions. An Agreement State should adopt Category B program 
elements in an essentially identical manner. Compatibility Category C 
are those program elements that do not meet the criteria of Category A 
or B, but the essential objectives of which an Agreement State should 
adopt to avoid conflict, duplication, gaps, or other conditions that 
would jeopardize an orderly pattern in the regulation of agreement 
material on a national basis. An Agreement State should adopt the 
essential objectives of the Category C program elements. Compatibility 
Category D are those program elements that do not meet any of the 
criteria of Category A, B, or C, above, and, thus, do not need to be 
adopted by Agreement States for purposes of compatibility. 
Compatibility Category NRC are those program elements that address 
areas of regulation that cannot be relinquished to the Agreement States 
under the Atomic Energy Act of 1954, as amended, or provisions of Title 
10 of the Code of Federal Regulations (CFR). These program elements 
should not be adopted by the Agreement States. H&S are program elements 
that are required because of a particular health and safety role in the 
regulation of agreement material within the State and should be adopted 
in a manner that embodies the essential objectives of the NRC program.
    The proposed rule would be a matter of compatibility between the 
NRC and the Agreement States, thereby providing consistency among 
Agreement State and NRC requirements. The proposed compatibility 
categories are designated in the following table:

                                               Compatibility Table
----------------------------------------------------------------------------------------------------------------
                                                                                           Compatibility
             Section                      Change                 Subject         -------------------------------
                                                                                     Existing           New
----------------------------------------------------------------------------------------------------------------
30.6(b)(1)(iv)...................  Amend..............  Communications..........  D.............  D
30.15(a)(2)......................  Add................  Certain items containing  ..............  B
                                                         byproduct material.
30.19(b).........................  Amend..............  Self-luminous products    B.............  B
                                                         containing tritium,
                                                         krypton[dash]85, or
                                                         promethium[dash]147.
30.20............................  Amend..............  Gas and aerosol           B.............  B
                                                         detectors containing
                                                         byproduct material.
30.22............................  New................  Certain industrial        ..............  B
                                                         devices.
30.32(g)(3)......................  Amend..............  Application for specific  C.............  C
                                                         licenses.
30.32(g)(4)......................  Add................  Application for specific  ..............  C
                                                         licenses.
30.32(g)(5)......................  Add................  Application for specific  ..............  C
                                                         licenses.
30.38............................  Amend..............  Application for           D.............  D
                                                         amendment of licenses
                                                         and registration
                                                         certificates.
30.39............................  Amend..............  Commission action on      D.............  D
                                                         applications to renew
                                                         or amend.
30.61............................  Amend..............  Modification and          D.............  D
                                                         revocation of licenses
                                                         and registration
                                                         certificates.

[[Page 36226]]

 
31.3.............................  Remove.............  [Existing title--Certain  B.............  [starf]
                                                         devices and equipment].
31.23(b).........................  Amend..............  Criminal penalties......  D.............  D
32.1(a)..........................  Amend..............  Purpose and scope.......  D.............  D
32.2.............................  Add................  Definition: Committed     ..............  NRC
                                                         dose.
32.2.............................  Add................  Definition: Sealed        ..............  D
                                                         source and device
                                                         registry.
32.8(b)..........................  Amend..............  Information collection    D.............  D
                                                         requirements: OMB
                                                         approval.
32.14(b)(4) and (b)(5)...........  Amend..............  Certain items containing  NRC...........  NRC
                                                         byproduct material;
                                                         requirements for
                                                         license to apply or
                                                         initially transfer.
32.15(a), (b), and (c)...........  Amend..............  Same: Quality assurance,  NRC...........  NRC
                                                         prohibition of
                                                         transfer, and labeling.
32.22(a)(3)......................  Add................  Self-luminous products    NRC...........  NRC
                                                         containing tritium,
                                                         krypton-85 or
                                                         promethium-147:
                                                         Requirements for
                                                         license to manufacture,
                                                         process, produce, or
                                                         initially transfer.
32.26............................  Amend..............  Gas and aerosol           NRC...........  NRC
                                                         detectors containing
                                                         byproduct material:
                                                         Requirements for
                                                         license to manufacture,
                                                         process, produce, or
                                                         initially transfer.
32.30............................  New................  Certain industrial        ..............  NRC
                                                         devices containing
                                                         byproduct material:
                                                         Requirements for
                                                         license to manufacture,
                                                         process, produce, or
                                                         initially transfer.
32.31............................  New................  Certain industrial        ..............  NRC
                                                         devices containing
                                                         byproduct material:
                                                         Safety criteria.
32.32............................  New................  Conditions of licenses    ..............  NRC
                                                         issued under Sec.
                                                         32.30: Quality control,
                                                         labeling, and reports
                                                         of transfer.
32.51(a)(6)......................  Add................  Byproduct material        ..............  B
                                                         contained in devices
                                                         for use under Sec.
                                                         31.5; requirements for
                                                         license to manufacture,
                                                         or initially transfer.
32.53(b)(5) and (d)(4)...........  Amend..............  Luminous safety devices   B.............  B
                                                         for use in aircraft:
                                                         Requirements for
                                                         license to manufacture,
                                                         assemble, repair or
                                                         initially transfer.
32.53(e) and (f).................  Add................  Luminous safety devices   B.............  B
                                                         for use in aircraft:
                                                         Requirements for
                                                         license to manufacture,
                                                         assemble, repair or
                                                         initially transfer.
32.55............................  Amend..............  Same: Quality assurance,  B.............  B
                                                         prohibition of transfer.
32.56............................  Amend..............  Same: Material transfer   B.............  B
                                                         reports.
32.57(d)(2)......................  Amend..............  Calibration or reference  B.............  B
                                                         sources containing
                                                         americium-241 or radium-
                                                         226: Requirements for
                                                         license to manufacture
                                                         or initially transfer.
32.57(e).........................  Add................  Calibration or reference  B.............  B
                                                         sources containing
                                                         americium-241 or radium-
                                                         226: Requirements for
                                                         license to manufacture
                                                         or initially transfer.
32.59............................  Amend..............  Same: Leak testing of     B.............  B
                                                         each source.
32.61(e)(4)......................  Amend..............  Ice detection devices     B.............  B
                                                         containing strontium-
                                                         90; requirements for
                                                         license to manufacture
                                                         or initially transfer.
32.61(f) and (g).................  Add................  Ice detection devices     ..............  B
                                                         containing
                                                         strontium[dash]90;
                                                         requirements for
                                                         license to manufacture
                                                         or initially transfer.
32.62(c), (d), and (e)...........  Amend..............  Same: Quality assurance;  B.............  B
                                                         prohibition of transfer.
32.74(a)(4)......................  Add................  Manufacture and           ..............  B
                                                         distribution of sources
                                                         or devices containing
                                                         byproduct material for
                                                         medical use.
32.101...........................  Remove.............  [Existing title--         B.............  [starf]
                                                         Schedule B--prototype
                                                         tests for luminous
                                                         safety devices for use
                                                         in aircraft].
32.102...........................  Remove.............  [Existing title--         B.............  [starf]
                                                         Schedule C--prototype
                                                         tests for calibration
                                                         or reference sources
                                                         containing americium-
                                                         241 or radium-226].
32.103...........................  Remove.............  [Existing title--         B.............  [starf]
                                                         Schedule D--prototype
                                                         tests for ice detection
                                                         devices containing
                                                         strontium-90].
32.110...........................  Remove.............  [Existing title--         B.............  [starf]
                                                         Acceptance sampling
                                                         procedures under
                                                         certain specific
                                                         licenses].
32.210(a), (b), (d), and (e).....  Amend..............  Registration of product   B.............  B
                                                         information.             [starf][starf]  [starf][starf]
32.210(g) and (h)................  Add................  Registration of product   ..............  B
                                                         information.                             [starf][starf]
32.211...........................  New................  Inactivation of           ..............  B
                                                         certificates of                          [starf][starf]
                                                         registration of sealed
                                                         sources and devices.
32.303(b)........................  Amend..............  Criminal penalties......  D.............  D
40.5(b)(1)(iv)...................  Amend..............  Communications..........  D.............  D
70.5(b)(1)(iv)...................  Amend..............  Communications..........  D.............  D
----------------------------------------------------------------------------------------------------------------
[starf] Denotes regulations that are designated Compatibility Category B but which will be removed from the
  regulations as a result of these proposed amendments. Agreement States should remove these provisions from
  their regulations when the regulations become final.
[starf][starf] D--for States that do not perform SS & D evaluations.


[[Page 36227]]

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.

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 make the 
requirements for distributors of byproduct material clearer, less 
prescriptive, and more risk-informed and up to date. The Commission is 
also proposing to redefine categories of devices to be used under 
exemptions, add explicit provisions regarding the sealed source and 
device registration process, and add flexibility to the licensing of 
users of sealed sources and devices. This action does not constitute 
the establishment of a standard that establishes generally applicable 
requirements. However, the regulations being amended concerning sealed 
source and device reviews, in particular Sec.  32.210(d), would 
continue to indicate that the NRC uses accepted industry standards, if 
applicable, in its evaluations.

IX. Finding of No Significant Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended (NEPA), 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 following is a summary of the 
Environmental Assessment: Many of the individual actions being proposed 
are the type of actions described in the categorical exclusions of 
Sec. Sec.  51.22(c)(2) and 51.22(c)(3)(i) and (iii). In addition, the 
proposed rule would remove prescriptive procedural provisions, add a 
new class exemption and a new product-specific exemption, broaden an 
existing class exemption, add flexibility to the basis for licensing 
the use of sealed sources and devices, and remove some requirements for 
the distributors of low risk exempt products. The Commission has 
concluded that none of these actions would have significant impacts to 
the environment or otherwise include any condition requiring 
consultation under section 102(2)(C) of NEPA.
    The determination of this Environmental Assessment is that there 
will 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.
    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 on http://www.regulations.gov and at the NRC Public 
Document Room, O-1F21, 11555 Rockville Pike, Rockville, MD 20852. 
Single copies of the Environmental Assessment may be obtained from 
Catherine R. 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].

X. Paperwork Reduction Act Statement

    This proposed rule would contain new or amended information 
collection requirements that are subject to the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501, et seq.). This proposed rule has been 
submitted to the Office of Management and Budget for review and 
approval of the information collection requirements.
    Type of submission, new or revision: Revision.
    The title of the information collection: 10 CFR Parts 30, 31, 32, 
40, and 70, Requirements for Distribution of Byproduct Material, 
Proposed Rule
    The form number if applicable: NRC Form 313
    How often the collection is required: One time; annual; and 
occasional.
    Who will be required or asked to report: Applicants and licensees 
who manufacture or initially distribute sealed sources and devices, and 
some users of those sources and devices.
    An estimate of the number of annual responses: 58 [(10 CFR part 
32--37 responses + 6 recordkeepers) + (NRC Form 313--15 responses)]
    The estimated number of annual respondents: 44 (25 NRC licensees + 
19 Agreement State licensees)
    An estimate of the total number of hours needed annually to 
complete the requirement or request: 951 hours [10 CFR Part 32--957 
(351 reporting + 606 recordkeeping) + (NRC Form 313--decrease of 6 
hours reporting)]
    Abstract: The NRC is proposing to amend its regulations to make 
requirements for distributors of byproduct material clearer, less 
prescriptive, and more risk-informed and up to date. The Commission is 
also proposing to redefine categories of devices to be used under 
exemptions, add explicit provisions regarding the sealed source and 
device registration process, and add flexibility to the licensing of 
users of sealed sources and devices. This action is primarily intended 
to make licensing processes more efficient and effective. These changes 
would affect manufacturers and distributors of sources and devices 
containing byproduct material and future users of some products 
currently used under general or specific license.
    The NRC is seeking public comment on the potential impact of the 
information collections contained in this proposed rule and on the 
following issues:
    1. Is the proposed information collection necessary for the NRC to 
properly perform its functions? Does the information have practical 
utility?
    2. Is the burden estimate 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 or other forms of 
information technology?
    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-1F21, Rockville, MD 20852. The OMB clearance package and 
rule are available at the NRC World Wide Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the 
signature date of this notice.
    Send comments on any aspect of these proposed regulations related 
to information collections, including suggestions for reducing the 
burden and on the above issues, by July 26, 2010, to Information 
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, or by Internet electronic mail to

[[Page 36228]]

[email protected], and to Christine J. Kymn, Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202 (3150-0017, 
3150-0001, and 3150-0120), Office of Management and Budget, Washington, 
DC 20503. Comments on the proposed information collections may also be 
submitted via the Federal eRulemaking Portal https://www.regulations.gov, Docket No. NRC-2008-0338. 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. 
You may also e-mail comments to [email protected] or 
comment by telephone at (202) 395-4638.

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. The analysis is available for 
inspection on http://www.regulations.gov and in the NRC Public Document 
Room, 11555 Rockville Pike, Rockville, MD 20852. Single copies of the 
Regulatory Analysis may be obtained from Catherine R. 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].

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 
licenses issued under parts 30, 31, and 32, the NRC has determined that 
there are no applicable provisions for backfit. Therefore, a backfit 
analysis need not be prepared for this proposed rule to address parts 
30, 31, or 32 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 31

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Packaging and containers, Radiation protection, Reporting 
and recordkeeping requirements, Scientific equipment.

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

10 CFR Part 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.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended; the Energy Reorganization 
Act of 1974, as amended; and 5 U.S.C. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR parts 30, 31, 32, 40, and 70.

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); 
sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C. 2014, 
2021, 2021b, 2111).
    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.
* * * * *
    3. In Sec.  30.15, paragraph (a)(2) is added to read as follows:


Sec.  30.15  Certain items containing byproduct material.

    (a) * * *
    (2)(i) Static elimination devices which contain, as a sealed source 
or sources, byproduct material consisting of a total of not more than 
18.5 MBq (500 [mu]Ci) of polonium-210 per device.
    (ii) Ion generating tubes designed for ionization of air that 
contain, as a sealed source or sources, byproduct material consisting 
of a total of not more than 18.5 MBq (500 [mu]Ci) of polonium-210 per 
device or of a total of not more than 1.85 GBq (50 mCi) of hydrogen-3 
(tritium) per device.
    (iii) Such devices authorized before (insert effective date of this 
rule) for use under the general license then provided in Sec.  31.3 and 
equivalent regulations of

[[Page 36229]]

Agreement States and manufactured, tested, and labeled by the 
manufacturer in accordance with the specifications contained in a 
specific license issued by the Commission.
* * * * *
    4. In Sec.  30.19, paragraph (b) is revised to read as follows:


Sec.  30.19  Self-luminous products containing tritium, krypton-85, or 
promethium-147.

* * * * *
    (b) Any person who desires to manufacture, process, or produce, or 
initially transfer for sale or distribution self-luminous products 
containing tritium, krypton-85, or promethium-147 for use under 
paragraph (a) of this section, should apply for a license under Sec.  
32.22 of this chapter and for a certificate of registration in 
accordance with Sec.  32.210 of this chapter.
* * * * *
    5. Section 30.20 is revised to read as follows:


Sec.  30.20  Gas and aerosol detectors containing byproduct material.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution gas and aerosol detectors 
containing byproduct material, any person is exempt from the 
requirements for a license set forth in section 81 of the Act and from 
the regulations in parts 19, 20, 21, and 30 through 36 and 39 of this 
chapter to the extent that such person receives, possesses, uses, 
transfers, owns, or acquires byproduct material in gas and aerosol 
detectors designed to protect health, safety, or property, and 
manufactured, processed, produced, or initially transferred in 
accordance with a specific license issued under Sec.  32.26 of this 
chapter, which license authorizes the initial transfer of the product 
for use under this section.
    (b) Any person who desires to manufacture, process, or produce gas 
and aerosol detectors containing byproduct material, or to initially 
transfer such products for use under paragraph (a) of this section, 
should apply for a license under Sec.  32.26 of this chapter and for a 
certificate of registration in accordance with Sec.  32.210 of this 
chapter.
    6. Section 30.22 is added under the undesignated heading Exemptions 
to read as follows:


Sec.  30.22   Certain industrial devices.

    (a) Except for persons who manufacture, process, produce, or 
initially transfer for sale or distribution industrial devices 
containing byproduct material designed and manufactured for the purpose 
of detecting, measuring, gauging or controlling thickness, density, 
level, interface location, radiation, leakage, or qualitative or 
quantitative chemical composition, or for producing an ionized 
atmosphere, any person is exempt from the requirements for a license 
set forth in section 81 of the Act and from the regulations in parts 
19, 20, 21, 30 through 36, and 39 of this chapter to the extent that 
such person receives, possesses, uses, transfers, owns, or acquires 
byproduct material, in these certain detecting, measuring, gauging, or 
controlling devices and certain devices for producing an ionized 
atmosphere, and manufactured, processed, produced, or initially 
transferred in accordance with a specific license issued under Sec.  
32.30 of this chapter, which license authorizes the initial transfer of 
the device for use under this section. This exemption does not cover 
sources not incorporated into a device, such as calibration and 
reference sources.
    (b) Any person who desires to manufacture, process, produce, or 
initially transfer for sale or distribution industrial devices 
containing byproduct material for use under paragraph (a) of this 
section, should apply for a license under Sec.  32.30 of this chapter 
and for a certificate of registration in accordance with Sec.  32.210 
of this chapter.
    7. In Sec.  30.32, paragraph (g)(3) is revised and paragraphs 
(g)(4) and (g)(5) are added to read as follows:


Sec.  30.32   Application for specific licenses.

* * * * *
    (g) * * *
    (3) For sources or devices manufactured before (insert effective 
date of this rule) that are not registered with the Commission under 
Sec.  32.210 of this chapter or with an Agreement State, and for which 
the applicant is unable to provide all categories of information 
specified in Sec.  32.210(c) of this chapter, the applicant must 
provide:
    (i) All available information identified in Sec.  32.210(c) of this 
chapter concerning the source, and, if applicable, the device; and
    (ii) Sufficient additional information to demonstrate that there is 
reasonable assurance that the radiation safety properties of the source 
or device are adequate to protect health and minimize danger to life 
and property. Such information must include a description of the source 
or device, a description of radiation safety features, the intended use 
and associated operating experience, and the results of a recent leak 
test; or
    (4) For sealed sources and devices allowed to be distributed 
without registration of safety information in accordance with Sec.  
32.210(g)(1) of this chapter, the applicant may supply only the 
manufacturer, model number, and radionuclide and quantity; or
    (5) Propose constraints on the number and type of sealed sources 
and devices to be used and the conditions under which they will be 
used, as an alternative to identifying each sealed source and device 
individually.
* * * * *
    8. Section 30.38 is revised to read as follows:


Sec.  30.38   Application for amendment of licenses and registration 
certificates.

    Applications for amendment of a license shall be filed on Form NRC-
313 in accordance with Sec.  30.32 and shall specify the respects in 
which the licensee desires its license to be amended and the grounds 
for the amendment. Applications for amendment of sealed source and 
device registration certificates shall be filed in accordance with 
Sec.  32.210 of this chapter and any other applicable provisions and 
shall specify the respects in which the licensee desires its 
certificate to be amended and the grounds for the amendment.
    9. Section 30.39 is revised to read as follows:


Sec.  30.39  Commission action on applications to renew or amend.

    In considering an application to renew or amend a license or to 
amend a sealed source or device registration certificate, the 
Commission will apply the applicable criteria set forth in Sec.  30.33 
and parts 32 through 36 and 39 of this chapter.
    10. Section 30.61 is revised to read as follows:


Sec.  30.61  Modification and revocation of licenses and registration 
certificates.

    (a) The terms and conditions of each license and registration 
certificate issued under the regulations in this part and parts 31 
through 36 and 39 of this chapter shall be subject to amendment, 
revision, or modification by reason of amendments to the Act, or by 
reason of rules, regulations, and orders issued in accordance with the 
terms of the Act.
    (b) Any license or registration certificate may be revoked, 
suspended, or modified, in whole or in part, for any material false 
statement in the application or any statement of fact required under 
section 182 of the Act, or because of conditions revealed by such 
application or statement of fact or any report, record, or inspection 
or other means that would warrant the Commission to refuse to grant a 
license

[[Page 36230]]

or registration certificate on an original application, or for 
violation of, or failure to observe any of the terms and provisions of 
the Act or of any rule, regulation, or order of the Commission.
    (c) Except in cases of willfulness or those in which the public 
health, interest, or safety requires otherwise, no license or 
registration certificate shall be modified, suspended, or revoked 
unless, before the institution of proceedings therefor, facts or 
conduct that may warrant such action shall have been called to the 
attention of the licensee in writing and the licensee shall have been 
given an opportunity to demonstrate or achieve compliance with all 
lawful requirements.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

    11. The authority citation for Part 31 continues to read as 
follows:

    Authority:  Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 2201, 2233); secs. 201, as amended, 202, 88 
Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 
Stat. 2750 (44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 
Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).


Sec.  31.3  [Removed and Reserved]

    12. Section 31.3 is removed and reserved.
    13. In Sec.  31.23, paragraph (b) is revised to read as follows:


Sec.  31.23  Criminal penalties.

* * * * *
    (b) The regulations in part 31 that are not issued under sections 
161b, 161i, or 161o for the purposes of section 223 are as follows: 
Sec. Sec.  31.1, 31.2, 31.4, 31.9, 31.22, and 31.23.

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

    14. The authority citation for Part 32 continues to read as 
follows:

    Authority:  Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 
954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 
Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 
(44 U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-
810 (42 U.S.C. 2014, 2021, 2021b, 2111).

    15. In Sec.  32.1, paragraph (a) is revised to read as follows:


Sec.  32.1  Purpose and scope.

    (a)(1) This part prescribes requirements for the issuance of 
specific licenses to persons who manufacture or initially transfer 
items containing byproduct material for sale or distribution to:
    (i) Persons exempted from the licensing requirements of part 30 of 
this chapter, or equivalent regulations of an Agreement State; or
    (ii) Persons generally licensed under part 31 of this chapter or 
equivalent regulations of an Agreement State; or
    (iii) Persons licensed under part 35 of this chapter.
    (2) This part prescribes requirements for the issuance of specific 
licenses to persons who introduce byproduct material into a product or 
material owned by or in the possession of a licensee or another, and 
regulations governing holders of such licenses.
    (3) This part prescribes certain requirements governing holders of 
licenses to manufacture or distribute items containing byproduct 
material.
    (4) This part describes procedures and prescribes requirements for 
the issuance of certificates of registration (covering radiation safety 
information about a product) to manufacturers or initial transferors of 
sealed sources or devices containing sealed sources.
* * * * *
    16. In Sec.  32.2, the definitions of Committed dose and Sealed 
Source and Device Registry are added in alphabetical order to read as 
follows:


Sec.  32.2  Definitions.

* * * * *
    Committed dose means the radiation dose that will accumulate over 
time as a result of retention in the body of radioactive material. For 
the purposes of this part, committed dose is a generic term for 
internal dose and means committed effective dose equivalent, as defined 
in part 20 of this chapter, or committed effective dose as defined by 
the International Commission on Radiation Protection.
* * * * *
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both NRC and 
the Agreement States, that summarize the radiation safety information 
for the sealed sources and devices and describe the licensing and use 
conditions approved for the product.
    17. In Sec.  32.8, paragraph (b) is revised to read as follows:


Sec.  32.8  Information collection requirements: OMB approval.

* * * * *
    (b) The approved information collection requirements contained in 
this part appear in Sec. Sec.  32.11, 32.12, 32.14, 32.15, 32.16, 
32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 
32.29, 32.30, 32.31, 32.32, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 
32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, 32.210, 
and 32.211.
* * * * *
    18. In Sec.  32.14, paragraphs (b)(4) and (b)(5) are revised to 
read as follows:


Sec.  32.14  Certain items containing byproduct material; requirements 
for license to apply or initially transfer.

* * * * *
    (b) * * *
    (4) Except for electron tubes and ionization chamber smoke 
detectors and timepieces containing promethium-147 or tritium in the 
form of gaseous tritium light sources, procedures for and results of 
prototype testing to demonstrate that the byproduct material will not 
become detached from the product and that the byproduct material will 
not be released to the environment under the most severe conditions 
likely to be encountered in normal use of the product;
    (5) In the case of ionizing radiation measuring instruments and 
timepieces containing tritium in the form of paint, 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;
* * * * *
    19. In Sec.  32.15, paragraph (c) is removed and reserved and 
paragraphs (a) and (b) are revised to read as follows:


Sec.  32.15  Same: Quality assurance, prohibition of transfer, and 
labeling.

    (a) Each person licensed under Sec.  32.14 for products for which 
quality control procedures are required must:
    (1) Maintain quality assurance systems in the manufacture of the 
part or product, or the installation of the part into the product, in a 
manner sufficient to provide reasonable assurance that the safety-
related components of the distributed products are capable of 
performing their intended functions;
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in the license issued under Sec.  32.14, to 
provide at least 95 percent confidence that the Lot Tolerance Percent 
Defective of 5.0 percent will not be exceeded; and
    (3) Visually inspect each unit in inspection lots. Any unit which 
has an observable physical defect that could adversely affect 
containment of the byproduct material shall be considered a defective 
unit.
    (b) No person licensed under Sec.  32.14 shall transfer to other 
persons for use under Sec.  30.15 of this chapter or

[[Page 36231]]

equivalent regulations of an Agreement State:
    (1) Any part or product tested and found defective under the 
criteria and procedures specified in the license issued under Sec.  
32.14, unless the defective part or product has been repaired or 
reworked, retested, and found by an independent inspector to meet the 
applicable acceptance criteria; or
    (2) Any part or product contained within any lot that has been 
sampled and rejected as a result of the procedures in paragraph (a)(2) 
of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.  32.14; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with the procedures specified in paragraphs (a)(2) and 
(b)(2)(i) of this section and any other criteria that may be required 
as a condition of the license issued under Sec.  32.14.
    (c) [Reserved]
* * * * *
    20. In Sec.  32.22, paragraph (a)(3) is added to read as follows:


Sec.  32.22  Self-luminous products containing tritium, krypton-85 or 
promethium-147: Requirements for license to manufacture, process, 
produce, or initially transfer.

    (a) * * *
    (3)(i) The Commission determines that the device meets the safety 
criteria in Sec.  32.23; and
    (ii) The device has been evaluated by NRC and registered in the 
Sealed Source and Device Registry.
* * * * *
    21. In Sec.  32.26, the introductory text is revised and paragraph 
(c) is added to read as follows:


Sec.  32.26  Gas and aerosol detectors containing byproduct material: 
Requirements for license to manufacture, process, produce, or initially 
transfer.

    An application for a specific license to manufacture, process, or 
produce gas and aerosol detectors containing byproduct material and 
designed to protect health, safety, or property, or to initially 
transfer such products for use under Sec.  30.20 of this chapter or 
equivalent regulations of an Agreement State, will be approved if:
* * * * *
    (c)(1) The Commission determines that the device meets the safety 
criteria in Sec.  32.27; and
    (2) The device has been evaluated by NRC and registered in the 
Sealed Source and Device Registry.
    22. Section 32.30 is added under Subpart A to read as follows:


Sec.  32.30  Certain industrial devices containing byproduct material: 
Requirements for license to manufacture, process, produce, or initially 
transfer.

    An application for a specific license to manufacture, process, 
produce, or initially transfer for sale or distribution devices 
containing byproduct material for use under Sec.  30.22 of this chapter 
or equivalent regulations of an Agreement State will be approved if:
    (a) The applicant satisfies the general requirements of Sec.  30.33 
of this chapter: However, the requirements of Sec.  30.33(a)(2) and 
(a)(3) do not apply to an application for a license to transfer 
byproduct material in such industrial devices manufactured, processed, 
or produced under a license issued by an Agreement State;
    (b) The applicant submits sufficient information relating to the 
design, manufacture, prototype testing, quality control procedures, 
labeling or marking, and conditions of handling, storage, use, and 
disposal of the industrial devices to demonstrate that the device will 
meet the safety criteria set forth in Sec.  32.31. The information 
should include:
    (1) A description of the device and its intended use or uses;
    (2) The type and quantity of byproduct material in each unit;
    (3) Chemical and physical form of the byproduct material in the 
device and changes in chemical and physical form that may occur during 
the useful life of the device;
    (4) Solubility in water and body fluids of the forms of the 
byproduct material identified in paragraphs (b)(3) and (b)(12) of this 
section;
    (5) Details of construction and design of the device as related to 
containment and shielding of the byproduct material and other safety 
features under normal and severe conditions of handling, storage, use, 
and disposal of the device;
    (6) Maximum external radiation levels at 5 and 25 centimeters from 
any external surface of the device, averaged over an area not to exceed 
10 square centimeters, and the method of measurement;
    (7) Degree of access of human beings to the device during normal 
handling and use;
    (8) Total quantity of byproduct material expected to be distributed 
in the devices annually;
    (9) The expected useful life of the device;
    (10) The proposed methods of labeling or marking the device and its 
point-of-sale package to satisfy the requirements of Sec.  32.32(b);
    (11) Procedures for prototype testing of the device to demonstrate 
the effectiveness of the containment, shielding, and other safety 
features under both normal and severe conditions of handling, storage, 
use, and disposal of the device;
    (12) Results of the prototype testing of the device, including any 
change in the form of the byproduct material contained in the device, 
the extent to which the byproduct material may be released to the 
environment, any increase in external radiation levels, and any other 
changes in safety features;
    (13) The estimated external radiation doses and committed doses 
resulting from the intake of byproduct material in any one year 
relevant to the safety criteria in Sec.  32.31 and the basis for these 
estimates;
    (14) A determination that the probabilities with respect to the 
doses referred to in Sec.  32.31(a)(4) meet the criteria of that 
paragraph;
    (15) Quality control procedures to be followed in the fabrication 
of production lots of the devices and the quality control standards the 
devices will be required to meet; and
    (16) Any additional information, including experimental studies and 
tests, required by the Commission.
    (c)(1) The Commission determines that the device meets the safety 
criteria in Sec.  32.31.
    (2) The device is unlikely to be routinely used by members of the 
general public in a non-occupational environment.
    (3) The device has been registered in the Sealed Source and Device 
Registry.
    (4) The quantity of byproduct material in the device does not 
exceed 10-4 times the value listed in Appendix E to part 20 
of this chapter as a Category 2 quantity.
    23. Section 32.31 is added under Subpart A to read as follows:


Sec.  32.31  Certain industrial devices containing byproduct material: 
Safety criteria.

    (a) An applicant for a license under Sec.  32.30 shall demonstrate 
that the device is designed and will be manufactured so that:
    (1) In normal use, handling, and storage of the quantities of 
exempt units likely to accumulate in one location, including during 
marketing, distribution, installation, and servicing of the device, it 
is unlikely that the external radiation dose in any one year, or the 
committed dose resulting from the intake of radioactive material in any 
one year, to a suitable sample of the group of individuals expected to 
be most highly exposed to radiation or

[[Page 36232]]

radioactive material from the device will exceed 200 [mu]Sv (20 mrem).
    (2) It is unlikely that the external radiation dose in any one 
year, or the committed dose resulting from the intake of radioactive 
material in any one year, to a suitable sample of the group of 
individuals expected to be most highly exposed to radiation or 
radioactive material from disposal of the quantities of units likely to 
accumulate in the same disposal site will exceed 10 [mu]Sv (1 mrem).
    (3) It is unlikely that there will be a significant reduction in 
the effectiveness of the containment, shielding, or other safety 
features of the device from wear and abuse likely to occur in normal 
handling and use of the device during its useful life.
    (4) In use, handling, storage, and disposal of the quantities of 
exempt units likely to accumulate in one location, including during 
marketing, distribution, installation, and servicing of the device, the 
probability is low that the containment, shielding, or other safety 
features of the device would fail under such circumstances that a 
person would receive an external radiation dose or committed dose in 
excess of 5 mSv (500 mrem), and the probability is negligible that a 
person would receive an external radiation dose or committed dose of 
100 mSv (10 rem) or greater.\1\
---------------------------------------------------------------------------

    \1\ It is the intent of this paragraph that as the magnitude of 
the potential dose increases above that permitted under normal 
conditions, the probability that any individual will receive such a 
dose must decrease. The probabilities have been expressed in general 
terms to emphasize the approximate nature of the estimates which are 
to be made. The following values may be used as guides in estimating 
compliance with the criteria: Low--not more than one such failure/
incident per year for each 10,000 exempt units distributed. 
Negligible--not more than one such failure/incident per year for 
each one million exempt units distributed.
---------------------------------------------------------------------------

    (b) An applicant for a license under Sec.  32.30 shall demonstrate 
that, even in unlikely scenarios of misuse, including those resulting 
in direct exposure to the unshielded source removed from the device for 
1,000 hours at an average distance of 1 meter and those resulting in 
dispersal and subsequent intake of 10-4 of the quantity of 
byproduct material (or in the case of tritium, an intake of 10 
percent), a person will not receive an external radiation dose or 
committed dose in excess of 100 mSv (10 rem), and, if the unshielded 
source is small enough to fit in a pocket, that the dose to localized 
areas of skin averaged over areas no larger than 1 square centimeter 
from carrying the unshielded source in a pocket for 80 hours will not 
exceed 2 Sv (200 rem).
    24. Section 32.32 is added under Subpart A to read as follows:


Sec.  32.32  Conditions of licenses issued under Sec.  32.30: Quality 
control, labeling, and reports of transfer.

    Each person licensed under Sec.  32.30 shall:
    (a) Carry out adequate control procedures in the manufacture of the 
device to ensure that each production lot meets the quality control 
standards approved by the Commission;
    (b) Label or mark each device and its point-of-sale package so 
that:
    (1) Each item has a durable, legible, readily visible label or 
marking on the external surface of the device containing:
    (i) The following statement: ``CONTAINS RADIOACTIVE MATERIAL'';
    (ii) The name of the radionuclide(s) and quantity(ies) of activity;
    (iii) An identification of the person licensed under Sec.  32.30 to 
transfer the device for use under Sec.  30.22 of this chapter or 
equivalent regulations of an Agreement State; and
    (iv) Instructions and precautions necessary to assure safe 
installation, operation, and servicing of the device (documents such as 
operating and service manuals may be identified in the label and used 
to provide this information).
    (2) The external surface of the point-of-sale package has a 
legible, readily visible label or marking containing:
    (i) The name of the radionuclide and quantity of activity;
    (ii) An identification of the person licensed under Sec.  32.30 to 
transfer the device for use under Sec.  30.22 of this chapter or 
equivalent regulations of an Agreement State; and
    (iii) The following or a substantially similar statement: ``THIS 
DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN 
COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 
10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY 
REQUIREMENTS.''
    (3) Each device and point-of-sale package contains such other 
information as may be required by the Commission; and
    (c) Maintain records of all transfers and file a report with the 
Director of the Office of Federal and State Materials and Environmental 
Management Programs by an appropriate method listed in Sec.  30.6(a) of 
this chapter, including in the address: ATTN: Document Control Desk/
Exempt Distribution.
    (1) The report must clearly identify the specific licensee 
submitting the report and include the license number of the specific 
licensee.
    (2) The report must indicate that the devices are transferred for 
use under Sec.  30.22 of this chapter or equivalent regulations of an 
Agreement State.
    (3) The report must include the following information on devices 
transferred to other persons for use under Sec.  30.22 or equivalent 
regulations of an Agreement State:
    (i) A description or identification of the type of each device and 
the model number(s);
    (ii) For each radionuclide in each type of device and each model 
number, the total quantity of the radionuclide; and
    (iii) The number of units of each type of device transferred during 
the reporting period by model number.
    (4)(i) The licensee shall file the report, covering the preceding 
calendar year, on or before January 31 of each year.
    (ii) Licensees who permanently discontinue activities authorized by 
the license issued under Sec.  32.30 shall file a report for the 
current calendar year within 30 days after ceasing distribution.
    (5) If no transfers of byproduct material have been made under 
Sec.  32.30 during the reporting period, the report must so indicate.
    (6) The licensee shall maintain the record of a transfer for a 
period of one year after the transfer is included in a report to the 
Commission.
    25. In Sec.  32.51, paragraph(a)(6) is added to read as follows:


Sec.  32.51  Byproduct material contained in devices for use under 
Sec.  31.5; requirements for license to manufacture, or initially 
transfer.

    (a) * * *
    (6) The device has been registered in the Sealed Source and Device 
Registry.
* * * * *
    26. In Sec.  32.53, paragraphs (b)(5) and (d)(4) are revised and 
paragraphs (e) and (f) are added to read as follows:


Sec.  32.53  Luminous safety devices for use in aircraft: Requirements 
for license to manufacture, assemble, repair or initially transfer.

* * * * *
    (b) * * *
    (5) Quality assurance procedures to be followed that are sufficient 
to ensure compliance with Sec.  32.55;
* * * * *
    (d) * * *
    (4) Prototypes of the device have been subjected to and have 
satisfactorily passed the tests required by paragraph (e) of this 
section.
    (e) The applicant must subject at least five prototypes of the 
device to tests as follows:
    (1) The devices are subjected to tests that adequately take into 
account the

[[Page 36233]]

individual, aggregate, and cumulative effects of environmental 
conditions expected in service that could adversely affect the 
effective containment of tritium or promethium-147, such as 
temperature, moisture, absolute pressure, water immersion, vibration, 
shock, and weathering.
    (2) The devices are inspected for evidence of physical damage and 
for loss of tritium or promethium-147, after each stage of testing, 
using methods of inspection adequate for determining compliance with 
the criteria in paragraph (e)(3) of this section.
    (3) Device designs are rejected for which the following has been 
detected for any unit:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of tritium or promethium-147 from the device; or
    (ii) Surface contamination of tritium or promethium-147 on the 
device of more than 2,200 disintegrations per minute per 100 square 
centimeters of surface area; or
    (iii) Any other evidence of physical damage.
    (f) The device has been registered in the Sealed Source and Device 
Registry.
    27. Section 32.55 is revised to read as follows:


Sec.  32.55  Same: Quality assurance, prohibition of transfer.

    (a) Each person licensed under Sec.  32.53 must visually inspect 
each device and must reject any that has an observable physical defect 
that could adversely affect containment of the tritium or promethium-
147.
    (b) Each person licensed under Sec.  32.53 must:
    (1) Maintain quality assurance systems in the manufacture of the 
luminous safety device in a manner sufficient to provide reasonable 
assurance that the safety-related components of the distributed devices 
are capable of performing their intended functions; and
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in paragraph (c) of this section and in the 
license issued under Sec.  32.53, to provide at least 95 percent 
confidence that the Lot Tolerance Percent Defective of 5.0 percent will 
not be exceeded.
    (c) The licensee must subject each inspection lot to:
    (1) Tests that adequately take into account the individual, 
aggregate, and cumulative effects of environmental conditions expected 
in service that could adversely affect the effective containment of 
tritium or promethium-147, such as absolute pressure and water 
immersion.
    (2) Inspection for evidence of physical damage, containment 
failure, or for loss of tritium or promethium-147 after each stage of 
testing, using methods of inspection adequate for applying the 
following criteria for defective:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of tritium or promethium-147 from the device;
    (ii) Levels of radiation in excess of 5 microgray (0.5 millirad) 
per hour at 10 centimeters from any surface when measured through 50 
milligrams per square centimeter of absorber, if the device contains 
promethium-147; and
    (iii) Any other criteria specified in the license issued under 
Sec.  32.53.
    (d) No person licensed under Sec.  32.53 shall transfer to persons 
generally licensed under Sec.  31.7 of this chapter, or under an 
equivalent general license of an Agreement State:
    (1) Any luminous safety device tested and found defective under any 
condition of a license issued under Sec.  32.53, or paragraph (b) of 
this section, unless the defective luminous safety device has been 
repaired or reworked, retested, and determined by an independent 
inspector to meet the applicable acceptance criteria; or
    (2) Any luminous safety device contained within any lot that has 
been sampled and rejected as a result of the procedures in paragraph 
(b)(2) of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.  32.53; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any 
other criteria that may be required as a condition of the license 
issued under Sec.  32.53.
    28. Section 32.56 is revised to read as follows:


Sec.  32.56  Same: Material transfer reports.

    (a) Each person licensed under Sec.  32.53 shall file an annual 
report with the Director, Office of Federal and State Materials and 
Environmental Management Programs, ATTN: Document Control Desk/GLTS, by 
an appropriate method listed in Sec.  30.6(a) of this chapter, which 
must state the total quantity of tritium or promethium-147 transferred 
to persons generally licensed under Sec.  31.7 of this chapter. The 
report must identify each general licensee by name, state the kinds and 
numbers of luminous devices transferred, and specify the quantity of 
tritium or promethium-147 in each kind of device. Each report must 
cover the year ending June 30 and must be filed within thirty (30) days 
thereafter. If no transfers have been made to or from persons generally 
licensed under Sec.  31.7 of this chapter during the reporting period, 
the report must so indicate.
    (b) Each person licensed under Sec.  32.53 shall report annually 
all transfers of devices to persons for use under a general license in 
an Agreement State's regulations that are equivalent to Sec.  31.7 of 
this chapter to the responsible Agreement State agency. The report must 
state the total quantity of tritium or promethium-147 transferred, 
identify each general licensee by name, state the kinds and numbers of 
luminous devices transferred, and specify the quantity of tritium or 
promethium-147 in each kind of device. If no transfers have been made 
to a particular Agreement State during the reporting period, this 
information shall be reported to the responsible Agreement State agency 
upon request of the agency.
    29. In Sec.  32.57, paragraph (d)(2) is revised and paragraph (e) 
is added to read as follows:


Sec.  32.57  Calibration or reference sources containing americium-241 
or radium-226: Requirements for license to manufacture or initially 
transfer.

* * * * *
    (d) * * *
    (2) The source has been subjected to and has satisfactorily passed 
appropriate tests required by paragraph (e) of this section.
    (e) The applicant must subject at least five prototypes of each 
source that is designed to contain more than 0.185 kilobecquerel (0.005 
microcurie) of americium-241 or radium-226 to tests as follows:
    (1) The initial quantity of radioactive material deposited on each 
source is measured by direct counting of the source.
    (2) The sources are subjected to tests that adequately take into 
account the individual, aggregate, and cumulative effects of 
environmental conditions expected in service that could adversely 
affect the effective containment or binding of americium-241 or radium-
226, such as physical handling, moisture, and water immersion.
    (3) The sources are inspected for evidence of physical damage and 
for loss of americium-241 or radium-226, after each stage of testing, 
using methods of inspection adequate for determining compliance with 
the criteria in paragraph (e)(4) of this section.
    (4) Source designs are rejected for which the following has been 
detected for any unit: removal of more than 0.185

[[Page 36234]]

kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from 
the source or any other evidence of physical damage.
    30. Section 32.59 is revised to read as follows:


Sec.  32.59  Same: Leak testing of each source.

    Each person licensed under Sec.  32.57 must perform a dry wipe test 
upon each source containing more than 3.7 kilobecquerels (0.1 
microcurie) of americium-241 or radium-226 before transferring the 
source to a general licensee under Sec.  31.8 of this chapter or under 
equivalent regulations of an Agreement State. This test must be 
performed by wiping the entire radioactive surface of the source with a 
filter paper with the application of moderate finger pressure. The 
radioactivity on the filter paper must be measured using methods 
capable of detecting 0.185 kilobecquerel (0.005 microcurie) of 
americium-241 or radium-226. If a source has been shown to be leaking 
or losing more than 0.185 kilobecquerel (0.005 microcurie) of 
americium-241 or radium-226 by the methods described in this section, 
the source must be rejected and must not be transferred to a general 
licensee under Sec.  31.8 of this chapter, or equivalent regulations of 
an Agreement State.
    31. In Sec.  32.61, paragraph (e)(4) is revised and paragraphs (f) 
and (g) are added to read as follows:


Sec.  32.61  Ice detection devices containing strontium-90; 
requirements for license to manufacture or initially transfer.

* * * * *
    (e) * * *
    (4) Prototypes of the device have been subjected to and have 
satisfactorily passed the tests required by paragraph (f) of this 
section.
* * * * *
    (f) The applicant must subject at least five prototypes of the 
device to tests as follows:
    (1) The devices are subjected to tests that adequately take into 
account the individual, aggregate, and cumulative effects of 
environmental conditions expected in service that could adversely 
affect the effective containment of strontium-90, such as temperature, 
moisture, absolute pressure, water immersion, vibration, shock, and 
weathering.
    (2) The devices are inspected for evidence of physical damage and 
for loss of strontium-90 after each stage of testing, using methods of 
inspection adequate for determining compliance with the criteria in 
paragraph (f)(3) of this section.
    (3) Device designs are rejected for which the following has been 
detected for any unit:
    (i) A leak resulting in a loss of 0.1 percent or more of the 
original amount of strontium-90 from the device; or
    (ii) Surface contamination of strontium-90 on the device of more 
than 2,200 disintegrations per minute per 100 square centimeters of 
surface area; or
    (iii) Any other evidence of physical damage.
    (g) The device has been registered in the Sealed Source and Device 
Registry.
    32. In Sec.  32.62, paragraphs (c), (d), and (e) are revised to 
read as follows:


Sec.  32.62  Same: Quality assurance; prohibition of transfer.

* * * * *
    (c) Each person licensed under Sec.  32.61 must:
    (1) Maintain quality assurance systems in the manufacture of the 
ice detection device containing strontium-90 in a manner sufficient to 
provide reasonable assurance that the safety-related components of the 
distributed devices are capable of performing their intended functions; 
and
    (2) Subject inspection lots to acceptance sampling procedures, by 
procedures specified in paragraph (d) of this section and in the 
license issued under Sec.  32.61, to provide at least 95 percent 
confidence that the Lot Tolerance Percent Defective of 5.0 percent will 
not be exceeded.
    (d) Each person licensed under Sec.  32.61 must subject each 
inspection lot to:
    (1) Tests that adequately take into account the individual, 
aggregate, and cumulative effects of environmental conditions expected 
in service that could possibly affect the effective containment of 
strontium-90, such as absolute pressure and water immersion.
    (2) Inspection for evidence of physical damage, containment 
failure, or for loss of strontium-90 after each stage of testing, using 
methods of inspection adequate to determine compliance with the 
following criteria for defective: a leak resulting in a loss of 0.1 
percent or more of the original amount of strontium-90 from the device 
and any other criteria specified in the license issued under Sec.  
32.61.
    (e) No person licensed under Sec.  32.61 shall transfer to persons 
generally licensed under Sec.  31.10 of this chapter, or under an 
equivalent general license of an Agreement State:
    (1) Any ice detection device containing strontium-90 tested and 
found defective under the criteria specified in a license issued under 
Sec.  32.61, unless the defective ice detection device has been 
repaired or reworked, retested, and determined by an independent 
inspector to meet the applicable acceptance criteria; or
    (2) Any ice detection device containing strontium-90 contained 
within any lot that has been sampled and rejected as a result of the 
procedures in paragraph (c)(2) of this section, unless:
    (i) A procedure for defining sub-lot size, independence, and 
additional testing procedures is contained in the license issued under 
Sec.  32.61; and
    (ii) Each individual sub-lot is sampled, tested, and accepted in 
accordance with paragraphs (c)(2) and (e)(2)(i) of this section and any 
other criteria as may be required as a condition of the license issued 
under Sec.  32.61.

Subpart C--Specifically Licensed Items

    33. The heading of Subpart C is revised to read as previously set 
out.
    34. Sections 32.72 and 32.74 are transferred from Subpart B to 
Subpart C; Sec.  32.74 is amended by adding paragraph (a)(4) to read as 
follows:


Sec.  32.74  Manufacture and distribution of sources or devices 
containing byproduct material for medical use.

    (a) * * *
    (4) The source or device has been registered in the Sealed Source 
and Device Registry.
* * * * *


Sec.  32.101  [Removed]

    35. Section 32.101 is removed.


Sec.  32.102  [Removed]

    36. Section 32.102 is removed.


Sec.  32.103  [Removed]

    37. Section 32.103 is removed.


Sec.  32.110  [Removed]

    38. Section 32.110 is removed.

Subpart D--Sealed Source and Device Registration

    39. The heading of Subpart D is revised to read as previously set 
out.


Sec.  32.201  [Amended]

    40. Section 32.201 is transferred from Subpart D to Subpart C.
    41. In Sec.  32.210, paragraphs (a), (b), (d), and (e) are revised, 
and paragraphs (g) and (h) are added to read as follows:


Sec.  32.210  Registration of product information.

    (a) Any manufacturer or initial distributor of a sealed source or 
device containing a sealed source may submit

[[Page 36235]]

a request to the NRC for evaluation of radiation safety information 
about its product and for its registration.
    (b) The request for review must be sent to the NRC's Office of 
Federal and State Materials and Environmental Management Programs, 
ATTN: SSDR by an appropriate method listed in Sec.  30.6(a) of this 
chapter.
* * * * *
    (d) The NRC normally evaluates a sealed source or a device using 
radiation safety criteria in accepted industry standards. If these 
standards and criteria do not readily apply to a particular case, the 
NRC formulates reasonable standards and criteria with the help of the 
manufacturer or distributor. The NRC shall use criteria and standards 
sufficient to ensure that the radiation safety properties of the device 
or sealed source are adequate to protect health and minimize danger to 
life and property. Subpart A of this part includes specific criteria 
that apply to certain exempt products and Subpart B includes specific 
criteria applicable to certain generally licensed devices. Subpart C 
includes specific provisions that apply to certain specifically 
licensed items.
    (e) After completion of the evaluation, the Commission issues a 
certificate of registration to the person making the request. The 
certificate of registration acknowledges the availability of the 
submitted information for inclusion in an application for a specific 
license proposing use of the product, or concerning use under an 
exemption from licensing or general license as applicable for the 
category of certificate.
* * * * *
    (g) Authority to manufacture or initially distribute a sealed 
source or device to specific licensees may be provided in the license 
without the issuance of a certificate of registration in the following 
cases:
    (1) Calibration and reference sources containing no more than:
    (i) 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; 
or
    (ii) 0.37 MBq (10 [mu]Ci), for alpha emitting radionuclides; or
    (2) The intended recipients are qualified by training and 
experience and have sufficient facilities and equipment to safely use 
and handle the requested quantity of radioactive material in any form 
in the case of unregistered sources or, for registered sealed sources 
contained in unregistered devices, are qualified by training and 
experience and have sufficient facilities and equipment to safely use 
and handle the requested quantity of radioactive material in unshielded 
form, as specified in their licenses; and
    (i) The intended recipients are licensed under part 33 of this 
chapter or comparable Agreement State provisions; or
    (ii) The recipients are authorized for research and development; or
    (iii) The sources and devices are to be built to the unique 
specifications of the particular recipient and contain no more than 740 
GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide.
    (h) After the certificate is issued, the Commission may conduct an 
additional review as it determines is necessary to ensure compliance 
with current regulatory standards. In conducting its review, the 
Commission will complete its evaluation in accordance with criteria 
specified in this section. The Commission may request such additional 
information as it considers necessary to conduct its review.
    42. Section 32.211 is added under Subpart D to read as follows:


Sec.  32.211  Inactivation of certificates of registration of sealed 
sources and devices.

    A specific licensee who no longer intends to manufacture or 
initially transfer a sealed source or device registered with the 
Commission shall request inactivation of the registration certificate. 
Such a request shall be made no later than two years after the last 
initial transfer of a source or device covered by the certificate. If 
this cessation of activity is associated with the termination of a 
specific license, the request for inactivation of registration should 
state the intent to terminate a license giving the specific license 
number. A specific license to manufacture or initially transfer a 
source or device covered only by an inactivated certificate no longer 
authorizes the licensee to transfer such sources or devices for use. 
Servicing of devices must be in accordance with any conditions in the 
certificate, including in the case of an inactive certificate.
    43. In Sec.  32.303, paragraph (b) is revised to read as follows:


Sec.  32.303  Criminal penalties.

* * * * *
    (b) The regulations in part 32 that are not issued under 
subsections 161b, 161i, or 161o for the purposes of section 223 are as 
follows: Sec. Sec.  32.1, 32.2, 32.8, 32.11, 32.14, 32.18, 32.21, 
32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, 32.53, 
32.57, 32.61, 32.71, 32.72, 32.74, 32.301, and 32.303.

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

    44. 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, 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). Section 40.7 
also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (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).

    45. 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 of this chapter.
* * * * *

PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

    46. 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).
    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 is 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).

    47. In Sec.  70.5, paragraph (b)(1)(iv) is revised to read as 
follows:


Sec.  70.5  Communications.

* * * * *

[[Page 36236]]

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

    Dated at Rockville, Maryland, this 17th day of June 2010.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2010-15202 Filed 6-23-10; 8:45 am]
BILLING CODE 7590-01-P