[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Rules and Regulations]
[Pages 43665-43696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17711]



[[Page 43665]]

Vol. 77

Wednesday,

No. 143

July 25, 2012

Part II





Nuclear Regulatory Commission





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10 CFR Parts 30, 31, 32 et al.





Requirements for Distribution of Byproduct Material; Final Rule

Federal Register / Vol. 77 , No. 143 / Wednesday, July 25, 2012 / 
Rules and Regulations

[[Page 43666]]


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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: Final rule.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) 
is amending 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 redefining categories of devices 
to be used under exemptions, adding explicit provisions regarding the 
sealed source and device registration process, and adding 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 will 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: Effective Date: This final rule is effective on October 23, 
2012.

ADDRESSES: Please refer to Docket ID NRC-2008-0338 when contacting the 
NRC about the availability of information for this final rule. You may 
access information and comment submittals related to this final 
rulemaking, which the NRC possesses and are publicly available, by any 
of the following methods:
     Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0338.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may access publicly available documents online in the NRC 
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the 
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's 
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to pdr.resource@nrc.gov.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: 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, email: Catherine.Mattsen@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background
    A. Introduction
    B. Regulatory Framework
II. Discussion
    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. Minor Clarifying or Administrative Revisions
III. Summary and Analysis of Public Comments on the Proposed Rule
    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. Remove Prescriptive Requirements for Distributors of 
Generally Licensed Devices and Exempt Products
    E. Other Issues
    F. Comments on Issues Outside of the Scope of the Rule
IV. Summary of Final Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Voluntary Consensus Standards
VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability
IX. Plain Writing
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis
XIV. Congressional Review Act

I. 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.
    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.'' (Section 81(a) 
of the Act, 42 U.S.C. 2111.) 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

[[Page 43667]]

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 or see: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1717/.
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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 were 
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 that could be more readily completed were made, 
including the removal of obsolete exemptions. This action is a follow-
on to that effort for revisions that required more detailed 
development. To make optimal use of rulemaking resources, both for the 
NRC and the Agreement States who must develop conforming regulations, 
several issues have been combined into this rule. The proposed rule 
containing these amendments was published for public comment in the 
Federal Register on June 24, 2010 (75 FR 36212). The public comment 
period closed September 7, 2010. Ten comment letters were received. The 
NRC has considered these comments in this final rule.

B. Regulatory Framework

    The Commission's regulations in part 30 of Title 10 of the Code of 
Federal Regulations (10 CFR) 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 currently 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. In the case of class exemptions, many products can be 
approved for use through the licensing process if the applicant for a 
distribution license demonstrates that the specific product is within 
the class and meets certain radiation dose criteria.
    Part 31 of 10 CFR provides general licenses for the use of certain 
items containing byproduct material and the requirements associated 
with these general licenses.
    Part 32 of 10 CFR 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 manufacturers and initial 
transferors (distributors) address such measures as prototype testing, 
labeling, reporting and recordkeeping, quality control, and, in some 
cases, specific sampling procedures.

II. Discussion

    This final rule is making 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 the 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 a similar registration 
process. Registration certificates for the sources and devices reviewed 
and approved by the Agreement States are also added to the national SS 
& D Registry. However, some Agreement States do not include the 
evaluation and registration of sealed sources and devices in their 
agreements; in these cases, 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 definition is being added 
to 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, as well as U.S. government agencies and some foreign 
regulators. 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

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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 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 was not previously addressed by the regulations, the NRC's 
licensing practice has been 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 has been used as part of the licensing process have been 
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 
Licensees.'' 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 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 rule establishes 
a third class exemption for certain industrial products.
    In the case of generally licensed products, sealed source and 
device registration certificates have been 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 the 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 the NRC and to 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 the 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 (ADAMS Accession No. 
ML082910862), and NUREG-1717. 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. Sec.  31.8 or 31.11. The 
general license in Sec.  31.8 is specifically for no more than 0.185 
MBq (5 [micro]Ci) \1\ 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 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 [micro]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.
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    \1\ The NRC's policy on units calls for new and amended 
regulations to use the International System of Units (SI) with the 
English unit equivalent following in parentheses. In this document, 
a number of references are made to existing regulations that are 
currently in English units; in referencing such values, the actual 
regulatory value is given first with the SI unit equivalent, 
sometimes a rounded approximation, following in parentheses. Also, 
when discussing comments, units used by the commenter are used.
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    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

[[Page 43669]]

under 10 CFR 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 
quantity cutoffs being established for small sources excluded from the 
requirement for registration are 0.37 MBq (10 [micro]Ci) for alpha 
emitters and 37 MBq (1 mCi) for beta and/or gamma emitters. This is a 
simplification from previous licensing practice, which used a limit of 
3.7 MBq (100 [micro]Ci) or 10 times the quantity specified in Sec.  
30.71, whichever is greater, for beta and/or gamma emitters. The limits 
using that guidance for beta/gamma emitters range from 3.7 MBq (100 
[micro]Ci) to 370 MBq (10 mCi). Thus, for any particular radionuclide, 
the new criterion is no more than 10 times higher to 10 times lower 
than previous practice. As certificates typically cover a large number 
of radionuclides for this type of sealed source, this change is not 
expected to affect the overall number of registration certificates 
issued.
    This final rule explicitly adds registration requirements to the 
regulations for byproduct material in products used under certain 
general licenses and under certain 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 provisions are in large part 
consistent with previous licensing practice and 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 sealed source and device 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 previously 
addressed only amendment of licenses, are being revised to also address 
amendment of registration certificates. The final rule is also revising 
Sec.  30.38 to remove the requirement to use Form NRC-313 for 
requesting amendments to licenses, because as a practical matter, many 
amendments are requested and obtained without use of the form.
    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 had 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 had the authority 
to revoke a registration certificate, if, for example, it determined 
that the registration was inconsistent with regulatory standards or the 
certificate had been obtained by providing falsified information. 
However, the regulations have not referenced 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 a 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 the 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 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 revised 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 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 the NRC in the 
past. This final rule also includes an explicit provision to 
specifically address such a process in Sec.  32.210(h). The Commission 
will complete such an evaluation in accordance with the criteria 
specified in Sec.  32.210. As noted under Section II. A.1, ``Updating 
Regulations to Add

[[Page 43670]]

Registration Requirements,'' of this document, this final rule adds 
specific provisions delineating which sealed sources and devices must 
be registered in the SS & D Registry, broadening the applicability of 
Sec.  32.210 to some generally licensed and exempt products. The 
Commission may use the new provision in Sec.  32.210(h) to update the 
certificate with respect to applicable current regulatory standards 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.
    Generally, the Commission has not made standards more restrictive 
with regard to products to be used under a general license or under an 
exemption from licensing, so as to restrict further distribution of a 
previously approved product. However, such a decision in the future may 
necessitate a reevaluation of a registration certificate.
    Registrations in the SS & D Registry are kept active until a 
distributor who is no longer distributing the particular sources or 
devices, 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 the 
NRC only for active registration certificates. 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 provision for inactivation (Sec.  32.211), which will 
require distributors to request inactivation of certificates normally 
within 2 years after distribution of the source(s) or device(s) covered 
by the certificate has ceased. Two years was chosen to minimize any 
impact on certificate holders. NRC certificate holders typically 
request inactivation of certificates within about a year. The 
inactivation provision has been modified in the final rule from the 
proposed wording of that section to recognize that a decision to cease 
distribution may occasionally occur more than 2 years after the last 
initial transfer of a covered source or device has been made. In this 
situation, a distributor must provide a brief explanation of the 
circumstances that led to requesting inactivation of the certificate 
after more than 2 years of no transfers. 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 revision to Sec.  32.210 for 
situations where an SS & D registration is not required, revisions to 
Sec.  30.32(g) are also being made to accommodate exceptions made in 
the SS & D registration process. In order to better accommodate the new 
provisions clearly, paragraph (g) of Sec.  30.32 has been slightly 
restructured in the final rule.
    A new Sec.  30.32(g)(3) (which appeared as Sec.  30.32(g)(4) in the 
proposed rule) provides that limited information is required for the 
smaller calibration and reference sources that are not registered. Also 
included is a 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 new Sec.  30.32(g)(4) (which appeared in 
Sec.  30.32(g)(5) in the proposed rule) allows 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 when it is 
not feasible to do so.
    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 
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 reference sources. The words, ``If it is not 
feasible to identify each sealed source and device individually,'' have 
been included in the final rule text to clarify the limited 
applicability of this provision.
    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 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

[[Page 43671]]

impossible to provide all of the categories of information identified 
in Sec.  32.210(c), as required by Sec.  30.32(g)(1)(ii), formerly 
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, formerly 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 final rule is extending that provision to 
legacy sources and devices containing any byproduct material, as 
defined in part 30; it is now designated Sec.  30.32(g)(2).

B. Establish a New Class Exemption for Certain Industrial Products

    As noted in Section I.B., ``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 
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 adding 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 Sec.  30.22, covering a broad range of 
industrial devices, will 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 will be required to demonstrate that a 
particular device meets certain safety criteria, with NRC review and 
approval. This class exemption will 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 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 new 
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 being added is an appropriate 
regulatory approach for calibration and reference sources.
    The exemption covers 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 class exemption for self-
luminous products is considered adequate and appropriate to provide for 
exempt use of products of this type.
    The new exemption for industrial products has a lower dose 
criterion for routine use than that associated with the general license 
and includes consideration of potential doses from disposal. Devices 
used under Sec.  31.5 must be returned to a specific licensee, such as 
a vendor (distributor) or waste broker, and ultimately disposed of as 
low-level radioactive waste. Under the new exemption from licensing 
requirements, there are no controls on disposal; the devices will be 
disposed without regard to their radioactivity. Thus, the potential 
impacts of uncontrolled disposal need to be evaluated in the licensing 
process for each particular device.
    The information to be submitted by an applicant to distribute a 
device for use under this new class exemption is delineated in Sec.  
32.30; these requirements are very similar to those for applications to 
distribute a product for use under the other class exemptions, for 
example, under Sec.  32.26 for gas and aerosol detectors.
    The safety criteria are similar to the 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

[[Page 43672]]

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 safety 
criteria for the new class exemption will not require that the 
exposures be estimated specifically in terms of total effective dose 
equivalent (TEDE) or effective dose.
    The intent is to provide flexibility so that the most up-to-date 
dose calculation methodology may be used. However, the staff will 
normally accept the use of the current approved methodology such as 
that now reflected in part 20.
    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 for 
considering risk during design.
    For the purposes of these provisions, a definition of a generic 
term for internal dose, ``committed dose,'' is being added to Sec.  
32.2 to encompass this approach, which includes weighting of organ and 
tissue doses, but not strictly under one system. The definition of 
``committed dose'' has been changed in the final rule to remove the 
reference to specific definitions in part 20 and of ICRP, but maintain 
the basic approach. The revised definition includes the term ``tissue 
weighting factors.'' The NRC would normally accept dose estimates based 
on the weighting factors in part 20 or the tissue weighting factors in 
ICRP-60, ``1990 Recommendations of the International Commission on 
Radiological Protection,'' or ICRP-103.
    The dose criterion for routine use of these devices is 200 
[micro]Sv (20 mrem)/year, which is significantly higher than that for 
gas and aerosol detectors (5 mrem (50 [micro]Sv)/year). This exemption 
covers 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 will contribute to the exposures 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 
[micro]Sv/year), the regulation also includes 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 will tend to limit the contribution by these 
products to disposal doses; e.g., the exposures of landfill workers. 
Nonetheless, the safety criteria include a separate criterion for 
disposal, 10 [micro]Sv (1 mrem)/year. This criterion is lower than the 
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 are 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 new class exemption are currently used 
(Sec.  32.51(a)(2)(iii)). However, the safety criteria for the new 
class exemption include an additional criterion 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 
radiological risk is well controlled by these designs, possible 
scenarios of misuse are not required to be evaluated.
    For this new exemption, a criterion is included requiring that 
specific scenarios of misuse be analyzed and shown to meet certain dose 
limits. The analysis required to meet this misuse criterion will be 
relatively simple. Evaluating actual risk from possible misuse would be 
much more difficult, but such risks will be limited by this misuse 
criterion. The basis for this criterion is to ensure public health and 
safety. The 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. This criterion 
is considered to be a more appropriate value given the high level of 
uncertainty in estimates of doses under accident conditions.
    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 the NRC being detected at and sometimes rejected for 
disposal in landfills and municipal incinerators by State and local 
restrictions.
    In the proposed rule, an additional fixed limit for radionuclides 
of concern, in terms of a small fraction of the Category 2 threshold as 
listed in Appendix E of part 20, was also included (as proposed Sec.  
32.30(c)(4)). This additional limit is not included in the final rule. 
The Commission has determined that there is no safety or security basis 
for a quantity limit, that the safety criteria will adequately protect 
public health and safety from products approved for use under the

[[Page 43673]]

new class exemption, and that the misuse criterion in particular will 
adequately control the quantities of material that will be approved for 
use in such products to obtain the additional benefits described above.
    Except for the removal of this specific quantity limit and the 
change to the definition of ``committed dose,'' the rule is essentially 
identical to the proposed regulatory text related to this new class 
exemption with one minor change made in response to public comment. 
That change involves the specific distances at which applicants will 
measure the radiation field around devices they seek to distribute for 
use under the exemption. This is discussed further under Section III, 
``Summary and Analysis of Public Comments on the Proposed Rule.''

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 
is justified, as long as a particular device meets the applicable 
safety standards. A minor modification, therefore, is being made 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'' is replaced with, ``designed 
to protect health, safety, or property.'' This will 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 provided 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 were no requirements associated with this 
general license; however, the provision did not explicitly contain an 
exemption from 10 CFR 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 had to be authorized 
only by the NRC and not by the Agreement States. There were no 
distribution requirements specified in part 32. Distributors were 
licensed under part 30, with particular license conditions related to 
distribution determined on a case-by-case basis. Reporting requirements 
in licenses were similar to exempt distribution reporting requirements.
    This inconsistency resulted from the fact that the use of the 
static eliminators covered by this general license predated the 
regulations in parts 19, 20, 21, 31, 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 
caused some confusion in the licensing process. The Commission is 
changing this general license into an exemption from licensing in Sec.  
30.15(a)(2). The current licensed distributor will not be required to 
amend its license in order to continue distribution, but any future 
distributors will 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 removes 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 determined that the requirements for manufacturers 
or initial distributors of exempt and generally licensed products were 
in some cases overly prescriptive, particularly in the areas of 
prototype testing and acceptance sampling/quality control (QC) 
procedures. Such a 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 rule is intended to focus the regulations on performance, 
rather than procedures. The regulations retain general requirements and 
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 II.F., ``Make the Requirements for 
Distributors of Exempt Products More Risk-Informed.'' The NUREG-1556 
series of documents provides

[[Page 43674]]

guidance to licensees and applicants on acceptable approaches to 
meeting these requirements.
    The procedures being removed from the regulations are generally 
acceptable to meet the new performance-based requirements. Safety 
benefits of the changes being made in this area will 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 revised regulatory 
requirements to be equivalent to previous practices (except as noted), 
so that existing licensees will not have to change their procedures as 
a result of this rulemaking. However, the revised provisions are 
written so that applicants and licensees 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 national and 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 the International Organization for Standardization standard, 
ISO 9001:2008, ``Quality Management Systems--Requirements.'' While the 
focus of ISO 9001:2008 is on customer satisfaction, it contains some 
quality management concepts that are appropriate to the distribution of 
generally licensed and exempt products containing byproduct material.
Prototype Test Procedures
    This final rule simplifies the prescriptive regulations for 
prototype testing for new products proposed for use under general 
license. The revised 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 rule in 
every situation. The specific procedures are being removed from the 
regulations and included as example acceptable procedures in guidance 
documents.
    In the case of generally licensed products, regulations that had 
contained prescriptive requirements for prototype testing were:
     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 remained in the regulations, as they 
had 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 
contained prescriptive requirements for acceptance sampling/quality 
control procedures were:
     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 were 
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 included specified procedures; Sec. Sec.  32.15(a) and 
(c), 32.55(b) and (d), and 32.62(c) and (e) specifically referred to 
Sec.  32.110.
    The NRC intends to allow acceptance sampling to be performance-
based, rather than specifying procedural details. Section 32.110 
provided that a random sample shall be taken from each inspection lot 
of specified 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 was not to be accepted, while if 
the number of defectives exceeds the acceptance number, the entire 
inspection lot was to be rejected. There is no longer a need for the 
NRC to maintain the acceptance sampling tables that were in Sec.  
32.110, which provided 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, correlated with the standard in the above cited 
regulations. However, the other seven tables in Sec.  32.110 apparently 
had been little used since their publication in 1974, as there were 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 final 
rule removes Sec.  32.110. Acceptance sampling criteria 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 final 
rule does not change that provision other than providing minor 
clarifications.
    Previously, the NRC required 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 provided 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

[[Page 43675]]

not be exceeded. The applicant's quality control procedures, including 
any alternate procedures proposed, are reviewed and approved by the 
NRC. This final rule does not change the 5 percent criterion for Lot 
Tolerance Percent Defective (i.e., 95 percent acceptance). The value of 
consumer risk of 10 percent was more relaxed than others used by the 
NRC, such as in inspections, which use standards of no more than 5 
percent defective at 5 percent risk. The final rule revises 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--such as in 
inspections--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 90 
percent standard was 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 revision is unlikely to change the 
approaches used by the limited number of current licensees under these 
provisions.
    Another 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, previously appearing in 
Sec. Sec.  32.15(c)(2), 32.55(d)(2), and 32.62(e)(2), is being revised. 
The prohibition of transfer appeared 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. These revisions 
concerning rejected lots 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 
final rule requires 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 
new requirement, but it is a recommendation of the International Atomic 
Energy Agency (IAEA), and may have been used voluntarily as an industry 
best practice. The 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 
made, 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, will 
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 guidance on quality control and 
quality assurance is NUREG-1556, Vol. 3, Rev. 1. This guidance 
indicates that the 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 that 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.
     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 final rule revises 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, Vol. 3, Rev. 1, including 
specifically Appendix G.
    Less prescriptive, more flexible, performance-based regulations 
will continue to specify performance requirements. Generally, the 
specific procedures being removed from the regulations 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, the 
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, Vol. 3, Rev. 1, 
Appendix F. Updated guidance will be provided when a new or revised 
industry standard becomes available that the NRC considers more 
appropriate. The licensee will 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 will need to make any necessary upgrades to their 
QC programs when this rule becomes effective. However, because license 
conditions are written broadly, it is not expected that any such 
changes in the QC programs will be inconsistent with an existing 
license (or registration certificate). Any changes needed in the 
license to better ensure consistency with the revised requirements will 
likely be

[[Page 43676]]

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, the NRC has applied 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 requirements are believed to be unnecessary, and 
not commensurate with the associated risk. This was 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.
    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 were 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 II. D., ``Update the Regulations on Certain Static 
Eliminators and Ion Generating Tubes,'' the Commission is adding 
another exemption to Sec.  30.15.) The requirements of this type for 
manufacturers and distributors of products used under Sec.  30.15 were 
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 contained a prohibition on 
transferring any defective lot or item to exempt persons.
    Even without the 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 will 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 final rule eliminates 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) are eliminated for products exempt under Sec.  30.15(a)(7) 
and (8), ionization chamber smoke detectors and electron tubes 
respectively. This requirement is also removed 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 is 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 revised Sec.  32.14(b)(5), which now 
requires 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 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 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 is 
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 will 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.

[[Page 43677]]

This will be a simple amendment as the regulations will be clear that 
this license condition is no longer required.

G. Minor Clarifying or Administrative Revisions

    Other minor revisions are being made 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 are being 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. 
Such revisions are noted in Section IV., ``Summary of Final Amendments 
by Section.''

III. Summary and Analysis of Public Comments on the Proposed Rule

    The NRC reviewed the public comments received on the June 24, 2010 
(75 FR 36212), proposed rule. The comment period ended on September 7, 
2010. Ten comment letters were received. The commenters included the 
Organization of Agreement States (OAS), the State of Wisconsin, the 
radiation safety officer of a university, and an individual. The 
remainder were manufacturers and distributors and organizations 
representing manufacturers and distributors. Two commenters requested 
an extension to the comment period. Although an extension was not 
granted, all comments were considered. In addition to inviting comments 
on any aspects of the proposed rule, the NRC posed specific questions 
for consideration. A discussion of the comments and the NRC's responses 
follow.

A. Actions Related to Sealed Source and Device Registration

A.1 Updating Regulations To Add Registration Requirements
    Comment: While only one commenter specifically supported the 
overall change to add requirements for registration of the various 
categories of sources and devices and to add the definition of the 
sealed source and device registry to part 32, most appeared to 
generally support these changes. One commenter specifically noted the 
importance of the Compatibility Category B for SS & D related changes 
in order to ensure consistency throughout all jurisdictions.
    Response: No changes to this aspect of the rule have been made. The 
Commission agrees with the importance of national consistency in this 
regard. Compatibility Category B applies as proposed to the paragraphs 
in part 32 relevant to requirements to obtain SS & D registration 
(except for those sections that are NRC only because the NRC retains 
authority over all distribution to exempt persons). Also as proposed, 
Compatibility Category D continues to apply to Sec.  32.210 for those 
States that do not issue registration certificates.
A.2 Adding Provisions for Amendment, Modification and Revocation, 
Review, and Inactivation of Registration Certificates
    A large portion of the comments received on the proposed rule 
concerned the provisions for inactivation of certificates and for 
reevaluation of certificates. There were four specific questions raised 
in the notice of proposed rulemaking concerning the updating of 
registration certificates. The following comments relate primarily to 
these two questions:
    Q.1 Updating of registration certificates in the SS & D Registry:
    (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? Q.1 (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?
    Comment: Commenters on this subject were manufacturers and 
distributors and representatives of the industry. These commenters 
recommended that a re-evaluation of registration certificates be 
conducted: (1) Upon request by the manufacturer or initial distributor 
due to changes [that would affect regulatory compliance]; (2) to ensure 
compliance with regulations; (3) based on indications of radiological 
safety concerns or when new regulations implement more restrictive dose 
constraints; or (4) when the regulations that apply to those sealed 
sources or devices change to an extent that compliance with the 
regulation could require modification of the conditions of the 
registration. One commenter supported the recommendation that no 
reevaluation was needed except to ensure compliance with the 
regulations or if there are reports of defects that would affect 
regulatory compliance, by indicating that the fundamentals of radiation 
protection or technology are not likely to undergo any change 
significant enough to create a compelling need for reevaluation of a 
device certificate.
    Response: Generally, the NRC agrees with the circumstances 
recommended by the various commenters for reevaluation of a 
registration certificate. Another possible situation in which a review 
might be required would be in the case of an older certificate that has 
not been revised by request of the holder and that has limited 
information related to the original demonstration of safety. However, 
at this time, the NRC does not envision the routine auditing of 
certificates for adequacy of information.
    Comment: One commenter recommended that if the regulations for 
sealed sources and devices change to an extent that compliance with the 
regulation could require modification of the conditions of the 
registration, then the affected licensees should be notified of those 
requirements, and the date by which compliance is required. Likewise, 
licensees could be required to make a notification that no design 
changes are required.
    Response: The approach suggested by the commenter is a reasonable 
one for the NRC to take in such a circumstance; however, such an 
occurrence is rare and implementation details would be decided on a 
case-by-case basis.
    Comment: One commenter agreed that it is not necessary to conduct a 
complete reevaluation of sealed sources and devices at the time that 
distribution licenses are reviewed, but also stated that the NRC should 
change NUREG-1556 guidance to explicitly require a review of 
certificates at the time of license renewal to ensure that the 
information is complete, accurate, and that the source or device 
remains current considering the application of the current industry 
standards.
    Response: The NRC agrees that it is not necessary to conduct a 
complete reevaluation of sealed sources and devices at the time that 
distribution licenses are reviewed for renewal, although some review of 
certificates for consistency with the license is appropriate at that 
time. The NRC staff is currently updating the guidance in NUREG-1556 
series concerning such matters.
    Comment: One commenter suggested that the NRC conduct a 
comprehensive audit of all certificates in the registry and reconcile 
them with NRC and Agreement States Distribution License issued. This 
commenter noted problems, such as licenses being amended without 
amendment of the accompanying registration certificates and the 
existence of certificates still

[[Page 43678]]

listed for active vendors when the company's distribution license had 
been previously terminated.
    Response: This is not something to be addressed in rulemaking. The 
NRC sometimes identifies such problems as the commenter has noted and 
corrects them. The NRC could not conduct a complete audit of all 
certificates, as the Agreement States have responsibility for ensuring 
the consistency of their distributor licenses with the relevant 
certificates. The addition of the inactivation provision in Sec.  
32.211 is intended to improve the consistency in this aspect of the SS 
& D registration process.
    Comment: The NRC should monitor changes to relevant ANSI [American 
National Standards Institute] and ISO standards for reference during 
the review process.
    Response: The NRC generally keeps current with respect to such 
standards, in some cases participating on the committees making the 
revisions. This comment did not call for any particular change to the 
current rulemaking language in this final rule.
    Comment: Two commenters expressed the opinion that Sec.  32.210(h) 
was redundant and therefore not necessary, given that the NRC already 
has authority under Sec.  30.61 to request additional information or to 
modify requirements, if necessary, to revoke a license and registration 
certificate. One stated that Sec.  32.210(h) would not ensure 
consistency between licenses and certificates and that instead of 
adding this provision, Sec. Sec.  30.34(e) and 30.61 should be 
designated Compatibility Category B or A for Agreement States because 
of the transboundary implications associated with source or device 
registrations, which could be distributed in all fifty states and 
worldwide. This commenter also suggested that this would grant 
Agreement States the ability to review, revoke, inactivate, or modify 
certificates based on significant safety issues.
    Response: The NRC disagrees that Sec.  32.210(h) is duplicative of 
the general authority provided under Sec.  30.61. The intent of this 
rule concerning sealed source and device registration certificates is 
to make the regulations more explicit as to how the registration 
process is used in the licensing process. The details of this process 
should be specified in part 32. It would not be appropriate to 
designate Sec. Sec.  30.34(e) and 30.61 Compatibility Category B for 
Agreement States, which is the program element assigned when there are 
significant direct transboundary implications, in order to address the 
transboundary implications associated with source or device 
registrations. These provisions cover a broad range of licenses for 
which there are no transboundary implications. The importance of 
national consistency for sealed source and device registrations is more 
appropriately handled in the categorization of the appropriate part 32 
provisions, such as Sec. Sec.  32.210 and 32.211. However, the 
Commission has decided that the transboundary implications of Sec.  
32.210(h) are not significant enough to require identical treatment by 
each jurisdiction, so this one paragraph within Sec.  32.210 has been 
assigned Compatibility Category C (for Agreement States who perform SS 
& D evaluations); thus, those States would adopt the essential 
objectives of Sec.  32.210(h), rather than essentially the same 
language.
    Comment: One commenter suggested that Sec.  32.210(h) include a 
backfit provision, suggesting an approach where certificate holders 
would be given a certain amount of time to reevaluate their source or 
device to determine whether it meets new dose criteria. This suggested 
approach also included actions that could be taken to control user 
doses if the source or device does not meet the criteria.
    Response: Requiring previously approved products to meet new 
standards established in the regulations is not an action the NRC would 
anticipate taking very often, particularly given that overall standards 
for radiation protection are not expected to change dramatically in the 
foreseeable future. There are no new dose criteria in this rule to be 
applied to previously approved products. It is not appropriate to 
incorporate an implementation provision into this rule as suggested by 
the commenter to cover potential future changes in regulations 
concerning dose criteria. Specific implementation provisions of this 
type can only reasonably be provided in the regulations in connection 
with a specific regulatory change being implemented. The NRC deals with 
such circumstances within the rulemaking process which makes such a 
change.
    The following comments respond to this question posed:
    Q 1.(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.)
    Comment: Two of the commenters suggested that device certificates 
should expire and be renewed at intervals of 10 years or longer, and 
that at the time of renewal, the certificate be updated to meet current 
industry standards. One of these commenters thought that this could be 
done in lieu of requiring inactivation of a device certificate after 2 
years, stating that the inactivation provision would severely restrict 
business and put an undue burden on both the State and NRC programs, 
and companies with small distributions. The other stated that 
expiration dates should be specific to each device, based on its 
certificate approval date, and that the renewal should be easily 
performed requiring only a request to renew and an explanation of any 
changes needed to comply with current radiation safety standards. In 
contrast, one commenter stated that requiring reviews of certificates 
in conjunction with license renewal or placing expiration dates on 
certificates is unnecessary.
    Response: The option of adding expiration dates and then conducting 
a renewal process would not appropriately replace the inactivation 
process. If a distributor is no longer distributing products covered by 
a certificate, there would be no reason to renew the certificate. The 
inactivation provision is discussed further later in this section.
    If the NRC were to institute a policy of adding expiration dates to 
registration certificates, the expiration date would be specific to the 
certificate and the sources or devices covered by the certificate based 
on the issuance date as suggested by the commenter. Although the 
Commission agrees there is value in using an expiration/renewal process 
for registration certificates, instituting such a system nationally 
would be a significant change from the process in place for some time 
and would put additional burdens on the Agreement States that issue 
certificates at a time when resources are limited. There are other 
means to deal with changes that should be made to certificates, such as 
the use of the new provision in Sec.  32.210(h).
    Comment: One commenter suggested that the NRC should explicitly 
list which criteria constitute an amendment such as change in product 
name, company name, or any component directly related to radiation 
safety. Another commenter suggested that if

[[Page 43679]]

certificates are not written in an overly specific manner, most minor 
product changes or improvements could be handled by submittals 
regarding the change which show that the device meets the original 
requirements. Additionally, the NRC could amend the certificate's tie-
down condition to reference the registrant's revised submissions by 
date.
    Response: Paragraph (f) of Sec.  32.210 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. It would be complicated and not feasible 
for this provision to be revised to indicate exactly which aspects must 
be followed. Such an approach could increase risks that a distributor 
may make changes with unintended impacts on safety. The NRC has 
modified administrative practices concerning the content of 
registration certificates so as to minimize the inclusion of details 
not important to safety on the certificate. The NRC does amend 
certificates to reference new submissions as appropriate.
    Comment: Another commenter also recommended that the NRC add 
amendment criteria to Sec.  32.210 providing suggested regulatory text 
which is similar to the approach in 10 CFR 50.59. This suggested 
approach would allow distributors to make changes based on their own 
evaluation as to the potential impact on safety and require them to 
keep records of the changes and report them to the NRC within 24 
months.
    Response: The NRC staff did consider recommending such a provision 
in part 30 in particular when conducting the systematic assessment of 
exemptions. However, because of the difficulties expected developing 
such a provision for the broad range of products and facilities 
involved in the use of byproduct material, the staff did not recommend 
such a provision for parts 30 and/or 32. The approach suggested by the 
commenter included the need for complex analyses by the distributor 
concerning safety that would not be reported to the NRC for up to 24 
months. The NRC believes that this may lead to compromises in safety. 
Also, at one time, fees charged for amendment of licenses and 
registration certificates were a deterrent to licensees proposing 
changes; however, changes were made to the fee structure, so that this 
is no longer the case.
    The following comments respond to this question posed:
    Q.1(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.)
    Comment: A few commenters recommended that previously approved 
devices be grandfathered when standards are changed, one recommending 
this for devices in use, others for future distributions under existing 
active certificates as well. One of those supporting allowing continued 
distribution of previously approved devices recommended that the 
grandfathering of previously approved devices should be a Compatibility 
Category B for Agreement States. Generally, these commenters did not 
believe it justified to change the status of previously approved 
devices unless there was a significant impact on health, safety, 
security, or the environment. One of these commenters stated that such 
actions should only be taken if well justified in terms of benefit 
versus cost and that revised standards should only apply to devices 
distributed after a certain date. Related to the referenced proposed 
rule, which would have added an activity limit to the general license 
in Sec.  31.5, two of the commenters indicated that the registration 
certificates would have to be revised to address distribution to both 
general and specific licensees. One commenter stated that it disagrees 
with the content of the proposed rule on limiting the amount of 
byproduct material in generally licensed devices.
    Response: The Commission has decided against adopting a final rule 
based on the referenced proposed rule. That proposed rule would not 
have grandfathered devices already in use under the general license. 
The impact that the rule would have had on current users played a role 
in the decision not to adopt a final rule on that subject.
    Generally, the NRC agrees with the comment that it would not be 
justified to change the status of previously approved devices unless 
there was a significant impact on health, safety, security, or the 
environment. The NRC recognizes that the appropriate regulatory action 
may be different when considering a change for (1) products to be 
approved in the future, (2) the continued distribution of products 
previously approved, and (3) products previously manufactured and 
already in use.
    Comment: A few commenters recommended that new and re-distributed 
devices, devices manufactured after a certain date, or devices with 
significant changes, should require a new or updated certificate that 
complies with current or revised standards.
    Response: Because of existing requirements in Sec.  32.210(f), a 
certificate would have to be amended before devices with significant 
changes could be distributed. As to changes made to regulatory 
requirements that may necessitate a change to an existing certificate, 
the NRC makes decisions on implementation of a revised regulation on a 
case-by-case basis considering the risks involved and benefits 
associated with the particular change.
    Comment: One commenter proposed that an independent screening 
review be performed to identify the set of devices likely to result in 
occupational dose in excess of 500 mrem TEDE and a public dose of 50 
mrem in 1 year, and then establish notification or review criteria for 
the certificate holders accordingly. This commenter suggested that the 
NRC notify each certificate holder with devices exceeding the dose 
criteria and request a factual accuracy review, comments regarding the 
calculations, and the cost to recall and make changes to ensure 
compliance with the dose values. This recommendation went on to suggest 
that, if occupational doses could exceed 500 mrem/year, the distributor 
should be required to notify users that they should comply with part 20 
(or the Agreement State regulations), and that if public doses could 
exceed 50 mrem, but not 100 mrem, the NRC should require an ALARA 
review similar to that required by 10 CFR 20.1101(d).
    Response: This proposal did not suggest revising the regulations. 
However, in looking at a possible screening process, it should be noted 
that acceptable potential doses that workers and the general public may 
receive from a device depends on whether it is to be used under an 
exemption from licensing, a general license, or a specific license. 
Devices to be used under certain exemptions and the general license in 
Sec.  31.5 are evaluated against specific safety criteria in part 32. 
There are no specific criteria for devices used under specific license; 
the safety of workers and the public being primarily protected by part 
20, which applies to all specific licensees. Applying such a process as 
suggested by the commenter across the board would be inappropriate. In 
particular, the

[[Page 43680]]

recommended criteria would be inappropriate for evaluating products 
used under exemptions from licensing. Also, in the absence of an 
indication of a problem or adverse operational experience, the NRC does 
not believe it necessary to conduct a screening for all previously 
approved devices.
The Inactivation Provision in Sec.  32.211
    The only issue that received a significant number of objections was 
the proposed inactivation requirement. However, much of this reaction 
resulted from apparent misinterpretation of the intent of the provision 
and because of unforeseen impacts that could result if devices are 
transferred only occasionally with two years passing without a transfer 
of a device for which some continued distribution is anticipated.
    Comment: A few commenters indicated that it was not uncommon for 2 
years to pass between transfers of particular devices and that the 
requirement to inactivate in this instance would be burdensome to 
business. Comments were that compliance with this proposed rule would 
not be practical, that licensees may not know in advance when their 
last manufacture or transfer of a sealed source or device will take 
place, and that the certificate holders should decide when to 
inactivate certificates based on their business needs and intentions. 
Commenters specifically suggested that one may anticipate new 
applications for a product, development of new markets, etc., and that 
it might force inactivation of a certificate for a device which may be 
required again in another few months. Two commenters noted that the 
costs of maintaining the certificate, including the fees, provide 
incentive to inactivate a certificate when there are no prospects of 
future sales; one of these commenters recognized the rationale for 
desiring registrations to be inactivated if there is no intent to 
manufacture and/or distribute within a reasonable period. One commenter 
stated that the existing certificates already must be renewed 
periodically. This commenter suggested a 5-year time limit to apply for 
inactivation.
    Response: The primary intent of the amendments concerning the 
sealed source and device registry, including the inactivation 
provision, is to make the regulations more explicit and transparent 
with respect to the use of registration certificates as part of the 
licensing process and also to improve national consistency in the 
processes used, thus improving the quality of the information in the 
registration database. This provision was not intended to interfere 
with business decisions or processes, but rather was proposed to 
alleviate any confusion as to which sources and devices are authorized 
for continued distribution, as well as providing a mechanism for 
regulators to help ensure the continued availability of qualified 
device service providers. The NRC would not want distributors to 
unnecessarily inactivate a certificate as a result of this provision 
and then need to apply for an active certificate again in the case of 
product with a limited market.
    The intent of the language of the proposed rule text was that the 
request would be made when two conditions are met: (1) There is no 
ongoing intent to distribute and (2) 2 years have passed since 
distribution has ceased. However, the Statement of Considerations for 
the proposed rule did not address the condition in the regulation that 
the distributor must have no intention to make further transfers. As 
the commenters have noted, an unintended consequence of the rule as 
proposed might have been that if a distributor does not make the 
decision to make no further transfers more than 2 years after the last 
transfer, it could be in noncompliance with the regulations.
    The text in this final rule has therefore been revised to clarify 
that no action need be taken after 2 years without a transfer until it 
is determined that there will be no future transfers. However, within 
90 days of such a determination, inactivation must be requested and 
some brief explanation must be provided if more than 2 years has 
elapsed since distribution of any source or device covered by the 
certificate has ceased.
    If a licensee is concerned that an inspection could identify a 
certificate that it is being kept active in anticipation of future 
sales, even though no sale has been made in 2 years, it may document 
its intent to continue sales; however, this would not be required. 
There may be existing evidence available of an expectation to continue 
to distribute. In some cases, there are capabilities that must be 
maintained in order to continue to be able to and/or be authorized to 
distribute, particularly for a manufacturer. There may be such 
documents as marketing materials, including catalogues of available 
products, or internal memos, which indicate either an ongoing intent to 
sell or a decision to cease distribution.
    In addition, the situation of not transferring any source or device 
for more than 2 years with the intent to continue sales is expected to 
be relatively rare, particularly because individual certificates 
frequently include numerous models that have been approved for 
distribution. While distributors should update certificates to indicate 
which models are no longer being sold, the NRC did not make doing so a 
requirement or set a deadline for this type of amendment of 
certificates. The text of Sec.  32.211 has also been revised to clarify 
that inactivation is necessary when all sources or devices covered by a 
certificate are no longer being distributed and to clarify that 
certificates must be inactivated before the associated distribution 
license is terminated. The specific address for submitting inactivation 
requests is also added.
    Comment: Some commenters expressed concern that the proposed 
language of Sec.  32.211 did not appear to allow redistributions or 
other transfers of sources or devices after inactivation of a 
certificate. Two commenters specifically suggested that the proposed 
wording of the fourth sentence in proposed Sec.  32.211 should be 
changed to include the word ``initially'' so that it reads: ``A 
specific license to manufacture or initially transfer a source or 
device covered only by an inactivated certificate no longer authorizes 
the licensee to initially transfer such sources or devices for use.'' 
Another commenter was also concerned about redistribution, stating that 
it should be authorized even if the certificate is inactive. This 
commenter believed that an inactive certificate does not allow for the 
transfer or redistribution of registered sources or devices by specific 
licensees and noted that a source or device no longer being initially 
distributed is nonetheless safe for use by persons authorized to use 
the source in accordance with the conditions of the registration 
certificate.
    Response: The intent of proposed Sec.  32.211 in this regard is 
that only the unique authority provided to the distributor by the 
registration certificate (along with the associated license) to 
initially transfer a source or device ceases, without any effect on any 
other transfers of the covered source(s) or device(s). The suggested 
addition of the word, ``initially,'' has been made for clarification. 
The inactivation of a certificate does not limit the use or transfer of 
previously manufactured sources and devices. The Commission agrees that 
a source or device that is no longer being distributed is nonetheless 
safe for use by persons authorized to use it in accordance with the 
conditions of the certificate. The only concern after the inactivation 
of a certificate is that proper servicing continues to be available. 
The inactivation provision clarifies that a device shall be serviced

[[Page 43681]]

as provided in the certificate and the inactivation process alerts the 
regulator that servicing may not be available from the original 
distributor.
A.3 Adding Flexibility for Licensing Users of Sealed Sources and 
Devices
    Two specific questions were posed in the proposed rule concerning 
this issue:
    Q.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:
    (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?
    Comment: In response to this question, two commenters requested 
that the NRC be as clear and detailed or practical as possible when 
imposing new requirements. Additionally, one commenter suggested that 
the NRC add an example of an exemption in NUREG-1556.
    Response: The text of the final rule has been revised to clarify 
that this approach may be used if it is not feasible to identify each 
sealed source and device individually. Examples of situations where use 
of this approach is acceptable were discussed in the proposed rule as 
well as in the discussion of this issue in Section II. A.3., ``Adding 
Flexibility for Licensing Users of Sealed Sources and Devices.'' Such 
examples and additional guidance are being provided in the interim 
guidance [Docket ID NRC-2012-0074] developed for this rulemaking, and 
will ultimately be included in the revisions to applicable volumes of 
NUREG-1556. A notice concerning the availability of the interim 
guidance for comment was published in the Proposed Rules section of 
this issue of the Federal Register. However, one situation that is not 
considered appropriate for this approach is in applying for the renewal 
of a license that had been previously issued without identification of 
individual sources and devices where it is simply inconvenient to 
provide an inventory of currently held sources and devices.
    Q.5(b) Are there other situations besides those discussed, when 
identifying all of the sealed sources and devices to be licensed is 
particularly impractical?
    Comment: Two commenters responded to this question. One comment 
concerned not applying any limits on the quantities distributed to 
generally licensed or exempt devices. The other commenter suggested 
that the definition of ``sealed source'' in Sec.  30.4 (and part 70) 
lacks specificity and should be revised to focus on only those sources 
manufactured and distributed pursuant to an SS & D registration. This 
commenter indicated that this would address confusion as to the 
applicability of certain requirements, in particular, leak testing 
requirements, to sources that are contained in ways that could be 
construed to constitute a sealed source, under the current definition. 
The suggested revision would have limited sealed sources to those that 
are registered in the SS & D Registry.
    Response: The provision proposed in Sec.  30.32(g)(5) and in the 
final rule as Sec.  30.32(g)(4) is not applicable to generally licensed 
or exempt devices, which do not have to be listed on a specific 
license. Addressing concerns related to the applicability of leak 
testing requirements for specifically licensed sources is outside of 
the scope of this rule. Limiting the definition of ``sealed source'' to 
registered sources would be inconsistent with aspects of this rule (in 
particular Sec.  32.210(g)) and other provisions in NRC regulations.

B. Establish a New Class Exemption for Certain Industrial Products

    Only about half of the commenters made any statements about the 
proposed new class exemption. The comments received were mostly 
supportive, although some concerns were noted. Support for the proposed 
exemption came primarily from a major manufacturer and from the OAS. 
The manufacturer indicated that research and development of new devices 
is expensive and time-consuming, that the uncertainty in the regulatory 
outcome and the lengthy rulemaking process to obtain a product-specific 
exemption made exempt product development risky, and that creating a 
class exemption for industrial devices with risk-informed, performance-
based criteria would reduce uncertainty, speed approvals, and lower 
barriers to innovation, and would provide a nationwide standard. This 
manufacturer also pointed out the difficulties of general licensing for 
low-risk devices with inconsistencies in Agreement State licensing of 
portable devices even though the SS & D Registry authorizes 
distribution to general licensees. This commenter noted the 
complications of marketing and distribution of such products on a 
nationwide basis as well as those for users who may be authorized to 
use a device under a general license in State A, but if they transport 
the device to State B, a specific license is required. Both this 
manufacturer and the OAS suggested that manufacturers would be more 
inclined to develop products using lower quantities of radioactive 
materials in order to meet the criteria for exemption, with one 
commenter suggesting that this would result in a reduction in some 
hazards to workers, members of the public, and the environment.
    Comment: One manufacturer/distributor expressed concern that the 
health and safety of the public or the environment might not be 
adequately protected, noting the possibility that the increased number 
of devices allowed to be disposed of in landfills and scrap metal 
reprocessing streams would potentially increase the number of alarms at 
landfills, scrap metal facilities, and metal recycling facilities and 
ultimately create a burden on State regulatory authorities as a result. 
However, this commenter also said that the number of devices exempted 
by this provision would be very small and that this could be handled on 
an individual source or device basis and that the exception could be 
included in the NUREG-1556 guidance.
    Response: Granting an exemption from licensing and all of the 
associated requirements is not appropriately handled through guidance. 
Although an individual can request specific exemptions under Sec.  
30.11, it is not practical for a manufacturer to distribute a product 
to be used by persons who individually have to request an exemption 
from licensing. The NRC normally does not issue exemptions from all of 
the licensing requirements of part 30 except through rulemaking to 
establish a broadly applicable exemption from licensing.
    Although the NRC cannot ensure that exempt products do not 
occasionally cause alarms at such places as landfills, scrap metal 
facilities, and metal recycling facilities, the NRC does not believe 
that this possibility alone would justify not exempting products for 
which the safety of the public is adequately protected. This would 
unnecessarily limit the benefits society may derive from the uses of 
radioactive material.
    This new exemption has been designed to ensure that quantities of 
byproduct materials approved for use in products are well controlled. 
This includes the misuse scenario in Sec.  32.31(b), which ensures that 
relatively high quantities are not approved based

[[Page 43682]]

on the material being well contained and well shielded. One of the 
benefits of such criteria is limiting the possibility that quantities 
of material in any products approved for use under the new class 
exemption are sufficient to cause such problems during disposal as 
raised by the commenter.
    In addition, labeling requirements help to minimize the efforts 
that are ultimately spent toward resolving what to do in these cases. 
When a product is identified in the waste that caused the alarm, the 
label should be intact in most cases and this provides the information 
necessary to determine if the product can be accepted or what the 
disposal options are for it. Most products covered by an exemption do 
not contain quantities of byproduct material large enough to set off 
alarms, particularly when shielded within a quantity of waste. How much 
byproduct material can result in an alarm depends on the practices at 
the site for handling and sorting waste and when the waste passes any 
alarm system.
    Comment: A few commenters discussed the values in the safety 
criteria in Sec.  32.31, particularly the 20 mrem/year routine use 
criterion, although not all specifically in response to the following 
question related to this issue:
    Q.2 New class exemption for industrial products in Sec.  30.20:
    (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?
    A manufacturer and an organization representing manufacturers and 
distributors suggested that the 20 mrem/year criterion was 
unnecessarily low. These commenters suggested that the criterion should 
be 50 mrem/year or 100 mrem/year. The commenter suggesting 50 mrem/year 
argued that 20 mrem/year would be overly burdensome, that the median 
dose would be lower than the criterion, because of the requirement to 
estimate the likely number of devices likely to be in one place, and 
that the most likely scenario of exposure to the public was disposal 
and that has a separate limit of 1 mrem/year. The commenter supporting 
100 mrem/year did not see any reason for the criterion to be lower than 
the public dose criterion, but also asked how the NRC would monitor 
compliance with the new criterion given that members of the public are 
not typically issued dosimetry.
    Another commenter suggested that the 20 mrem/year criterion should 
be lower, also stating that the discussion of a 10 rem misuse scenario 
is inconsistent with the 25 mrem/year value in 10 CFR 20.1402 and the 
10 mrem/year constraint imposed by 10 CFR 20.1101(d), since misuse 
could result in an airborne intake of radioactive material. This 
commenter suggested that a more consistent argument might be made for a 
criterion of 10 mrem/year TEDE for all scenarios.
    Response: The safety criteria for a class exemption such as the new 
industrial product exemption are design criteria. Demonstrating that a 
product meets these criteria depends on projections of future events. 
There is no monitoring of actual user exposures. As products used under 
exemption are used without any further regulatory control, the agency 
cannot ensure that users will not be exposed to a number of different 
products. They may also be exposed to other sources of radiation. Given 
the uncertainty in the ultimate exposures and the fact that individuals 
may be exposed to multiple sources, using the public dose limit of 1 
mSv (100 mrem)/year is not adequate or appropriate.
    Using the same dose criterion for all scenarios would be 
inconsistent on a risk basis as the various scenarios have different 
probabilities of occurrence, particularly in the case of accident 
scenarios. In addition, the lower criterion for disposal is used 
because individuals who are impacted by the uncontrolled disposal of 
exempt products are exposed to all radioactive material going to the 
same disposal facility, such as a landfill.
    With regard to the commenter's comparisons to other existing 
regulations, ``practice-specific'' limits such as the criteria for 
unrestricted release in Sec.  20.1402, constraints on air emissions in 
Sec.  20.1101(d), and the safety criterion for routine use of 
``exempt'' industrial products do not need to be numerically 
consistent. The two cited provisions in part 20 are essentially the 
fraction of the overall public dose limit considered appropriate for 
that particular source of exposure to the public. Such practice-
specific limits are chosen based on cost/benefit considerations and 
other factors related to each specific practice.
    Given the cost/benefit considerations and the likelihood of the 
same workers being exposed to a number of different types of devices 
falling under this and other exemptions, the Commission believes that 
200 [micro]Sv (20 mrem)/year is an appropriate criterion for worker 
exposures from a device used under exemption, particularly given that 
the applicant must estimate the number of the same device likely to be 
present in the location of use and show that the total exposure from 
that number of devices is unlikely to exceed this criterion.
    The argument for raising the routine use criterion to 50 mrem (500 
[micro]Sv)/year is also not compelling. Although some individuals using 
a single or small number of devices would incur a lower than 20 mrem 
(200 [micro]Sv)/year dose, the NRC does not agree that the median dose 
would be significantly below the criterion. Also, estimating the median 
dose and regulating on that basis is not the appropriate way to control 
exposures, as it would not control well the maximum likely dose.
    Comment: One commenter noted that the requirement in Sec.  
32.30(b)(6) to submit information including the maximum radiation 
levels at 5 and 25 centimeters (cm) was inconsistent with other 
sections of the regulations, regulatory guidance documents, and 
consensus standards and recommended that the latter distance be changed 
to 30 centimeters. Regulations and guidance documents referenced 
included: (1) The definition of radiation areas and high radiation 
areas in 10 CFR 20.1003; (2) the exception to posting requirements in 
10 CFR 20.1903(c); (3) the ANSI/Health Physics Society standard, ANSI/
HPS N43.8-2008, ``Classification of Industrial Ionizing Radiation 
Gauging Devices'' (which uses the distances 5 cm, 30 cm, and 100 cm for 
developing the classification of devices); and 4) NUREG-1556, Vol. 3, 
Rev. 1 (which provides for making radiation measurements at 5 cm, 30 
cm, and 100 cm from the product). This commenter also recommended that 
similar changes be made to Sec. Sec.  32.22 and 32.26.
    Response: The NRC agrees that consistency with ANSI/HPS N43.8-2008 
and NUREG-1556, Vol. 3, Rev. 1 is appropriate for this situation, 
although the other references are not particularly relevant, as they 
deal with different types of requirements. The final rule has been 
changed to require that measurements be taken at 5 and 30 cm. Note this 
change in distances for measurements does not affect the safety 
criteria for devices. The measurements are designed to characterize the 
radiation profile around the device for use in evaluating the safety of 
the device. However, the measurements are not used directly in 
determining acceptability. For a particular device, the applicant must 
describe how it would be used and the scenarios in which people are 
exposed during the entire life cycle of the device. This includes 
estimating distances at which one would typically be exposed. The 
radiation profile can be used to estimate

[[Page 43683]]

the radiation field at various distances for use in the analysis.
    Changes to Sec. Sec.  32.22 and 32.26 are outside the scope of this 
rulemaking.
    While not applicable to the new class exemption itself, the 
proposed rule also posed this question in connection with the new class 
exemption:
    Q.2(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?
    Comment: One commenter specifically supported making such changes 
to the safety criteria for the two class exemptions established in 1969 
provided they are also changed to reflect the Federal Radiation Council 
(FRC)/Environmental Protection Agency (EPA) guidance on use of ICRP-26 
in the setting of radiation safety regulations. Another commenter 
indicated that manufacturers in any industry cannot typically be held 
responsible for the intentional misuse of any product, but gave 
examples of safety features that can be incorporated in the products to 
help prevent improper use.
    Response: The Commission posed this question in order to obtain 
input for any future rulemaking in this area. The NRC plans to consider 
such changes in the future to the other two class exemptions; however, 
the approach may not be specifically tied to ICRP-26 methodology. The 
NRC is currently evaluating what changes to its regulatory program 
should be considered in connection with achieving better alignment with 
ICRP-103 recommendations. The basic recommended limit for exposures of 
the public is consistent in the various versions of the basic safety 
standards in ICRP-26, ICRP-60, and ICRP-103. The details of calculating 
doses have been evolving. In the case of design standards such as the 
subject regulations, it is appropriate to allow for the use of the 
latest methodology.
    The misuse scenario as used in the safety criteria for the new 
class exemption has been developed to limit the quantity of byproduct 
material in products used under the exemption so as to limit the 
potential harm that can be created with the product in any situation, 
not to attribute responsibility (for example, to a manufacturer) in 
actual cases of intentional misuse.

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

    The only comments on this issue were in response to the three 
specific questions posed:
    Q.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'':
    (a) Are there additional products that may be exempted under this 
expanded definition of the class not specifically considered by the 
NRC?
    Comment: One commenter suggested that the revision could inspire 
new products alleged to protect property from all sorts of airborne 
hazards, such as, detectors to detect chemical contaminates in air at 
ultra clean nano fabrication facilities as well as to sniff airline 
passengers for drugs.
    Response: Detectors for maintaining ultra clean nano fabrication 
facilities would appear to be a type of product with a reasonable 
benefit to society. The NRC considers it reasonable to allow such a 
product to be used under exemption, if it is adequately shown to meet 
the safety criteria in part 32 for evaluation of such products. As the 
change in scope of the class of products covered by this exemption is 
relatively limited, the NRC does not expect to see the development of a 
large number of new products as a result of this change and most are 
likely to be products used in moderate numbers.
    Q.3(b) Are these words adequate to ensure that products present a 
clear societal benefit?
    Comment: One commenter simply agreed. Another disagreed, indicating 
that using detectors to sniff for drugs might not be considered ``a 
clear societal benefit'' by many and that use in nano technology to 
manufacture ``cool but frivolous products,'' might not be considered a 
clear societal benefit.
    Response: If detectors were developed that could be approved for 
use under this exemption for use in nano technology, they would not be 
exclusively used for the production of frivolous products, but might 
also be used for more important applications. Overall some reasonable 
societal benefit would be expected to balance the limited impact from 
exempting the detectors. Similarly, the detection of drugs is generally 
accepted as presenting an overall benefit to society, but NRC 
recognizes that there could be situations in which the determination of 
societal benefit is a matter of judgment. Under the final regulations, 
the NRC will look to see whether the product provides a benefit in 
protecting health, safety, or property, and if it does, the NRC will 
find there is a societal benefit.
    Q.3(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?
    Comment: One commenter expressed general agreement with expanding 
the scope of exempt device approvals, and also stated that it endorsed 
the position taken by the Canadian Nuclear Safety Commission, certain 
European countries, and Japanese regulators to allow the complete 
exemption without device registration or distribution license of 
products with activities below IAEA exemption ``clearance'' levels. The 
commenter who questioned whether the revised words for the purpose of 
the devices ensured products with a clear societal benefit in response 
to Question 3(b) also stated that creating exemptions consistent with 
world markets is good for U.S. consumers and manufacturers.
    Response: With regard to the suggestion to allow complete exemption 
of products with activities below IAEA exemption ``clearance'' levels, 
this comment is not specifically responsive to the question posed. 
However, the NRC does not agree that there should be a ``complete 
exemption'' such as the commenter suggested. The NRC notes that, 
related to this issue, the NRC's regulations in Sec. Sec.  30.14 and 
30.70 exempt materials based on the concentration of the byproduct 
material contained within it. Although this is not considered a 
``clearance'' provision, distribution licenses are only required by 
Sec.  32.11 for products and materials into which byproduct material is 
introduced by an intentional action. The regulations in Sec. Sec.  
30.18 and 30.71 exempt materials based on the quantity of the byproduct 
material. In this case, distribution licenses are required in the case 
of commercial distribution. These are the circumstances for which the 
NRC considers it appropriate to exercise oversight of the processes to 
ensure that the materials transferred for use under these general 
material exemptions in fact meet the constraints of the exemption.

[[Page 43684]]

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

    Comments received responded to the questions posed related to this 
issue:
    Q.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. 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.
    Comment: One commenter stated that licensees would be required to 
change their procedures, retrain their work force and incur additional 
cost.
    Response: The commenter provided no support for this statement. The 
commenter was contacted and did not provide any additional supporting 
information on this comment. Most licensees authorized under the 
distribution provisions for which the sampling/quality control 
standards are being revised in fact test all products rather than using 
a sampling procedure. The NRC does not believe that these changes will 
result in such a significant burden as the commenter is suggesting.
    Q.4(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 Sec.  
30.15(a)(2), static eliminators and ion generating tubes formerly 
covered by the general license in Sec.  31.3.)
    Comment: One commenter stated that many manufacturers are ISO 9001 
certified and their current procedures are adequate to address any 
quality control issues.
    Response: Although this statement is not responsive to the 
particular question posed, the NRC agrees with the comment.

E. Other Issues

    There were no specific comments received on the issues of updating 
the regulations on certain static eliminators and ion generating tubes 
or making the requirements for distributors of exempt products more 
risk-informed, or on the proposed minor clarifying and administrative 
revisions. Some additional minor clarifying changes have been made to 
the final amendments.

F. Comments on Issues Outside of the Scope of the Rule

    In addition to those comments noted above, there were a few other 
comments made that are outside of the scope of the rule.
    Comment: One commenter stated that the NRC should require 
manufacturers to take back exempt products after their useful life has 
expired, without charge to the user of the device, to reduce the amount 
of material disposed in landfills and released to the environment.
    Response: The impacts from disposal of products used under the 
exemptions from licensing have been fully evaluated and determined to 
be acceptable. Requiring manufacturers to take back exempt products 
would unnecessarily increase costs to consumers and create problems 
when distributors have gone out of business and terminated their 
license. Also, the collection of large numbers of products in one place 
results in larger exposures to those handling the products than when 
they are disposed in numerous municipal disposal facilities across the 
country.
    Comment: One commenter requested that the NRC make clear the 
requirements for inventory, leak testing, and reporting in parts 30, 
40, and 70.
    Response: Besides being outside the scope of this rule, the 
resolution of this issue would be complicated and the commenter did not 
provide an adequate approach for doing so.
    Comment: The OAS restated its concerns about the quantities of 
material used in generally licensed devices being too high and the 
current general license program not providing adequate accountability 
for registered material.
    Response: These concerns were presented in a petition for 
rulemaking (PRM-31-5), which has been handled separately from this 
action. The Commission considered the issues raised in a separate 
rulemaking, but decided against issuing a final rule. Final action on 
that petition was published January 25, 2012 (77 FR 3640).

IV. Summary of Final Amendments by Section

    10 CFR 30.6(b)(1)(iv)--Adds a reference to new 10 CFR 32.30 as a 
licensing category not delegated to the NRC Regions.
    10 CFR 30.8(c)(1)--Removes reference to 10 CFR 30.38 as a section 
that contains NRC Form 313.
    10 CFR 30.15(a)(2)--Adds an exemption for certain static 
eliminators and ion generators in place of the general license formerly 
in 10 CFR 31.3.
    10 CFR 30.19(b)--Clarifies that applicants under 10 CFR 32.22 
should also apply for a registration certificate.
    10 CFR 30.20--Slightly expands the class of products covered under 
this exemption from licensing; clarifies that applicants under 10 CFR 
32.26 should also apply for a registration certificate; updates the 
parts of the regulations from which persons are exempt to include 10 
CFR part 19.
    10 CFR 30.22--Establishes a new class exemption for industrial 
devices initially transferred from 10 CFR 32.30 licensees.
    10 CFR 30.32(g)--Restructured for clarity.
    10 CFR 30.32(g)(2)--Extends and redesignates 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)(3)--Adds a provision for providing limited 
information for certain calibration and reference sources.
    10 CFR 30.32(g)(4)--Adds 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 in certain cases.
    10 CFR 30.38--Revises the heading and adds an explicit provision 
for amendment of registration certificates and removes reference to NRC 
Form 313.
    10 CFR 30.39--Adds registration certificates to clarify that the 
same requirements are applicable to amendment of a registration 
certificate as for issuance of a new certificate.

[[Page 43685]]

    10 CFR 30.61--Revises the heading and adds registration 
certificates to provisions for modification and revocation of licenses 
and updates reference to parts under which licenses are issued.
    10 CFR 31.3--General license is removed, section reserved, and 
replaced by a new exemption in 10 CFR 30.15(a)(2).
    10 CFR 31.23(b)--Removes reference to 10 CFR 31.3 and makes other 
minor corrections.
    10 CFR 32.1(a)--Expands the description of the scope of 10 CFR part 
32 to cover additional requirements and makes clarifications.
    10 CFR 32.2--Adds definitions of ``committed dose'' and ``sealed 
source and device registry.'' The definition of ``committed dose'' was 
modified from the proposed rule to remove an improper incorporation by 
reference.
    10 CFR 32.8(b)--Adds 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)--Makes exceptions to prototype testing 
requirements.
    10 CFR 32.14(b)(5)--Makes exceptions to quality control 
requirements.
    10 CFR 32.15(a), (b), and (c)--Removes the specific procedural 
requirements for quality assurance, revises the acceptance criterion, 
and limits these requirements to products for which such procedures 
will be required under 10 CFR 32.14.
    10 CFR 32.22(a)(3)--Adds an explicit requirement for sealed source 
and device registration.
    10 CFR 32.26--Revises 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 adds 
an explicit requirement for sealed source and device registration.
    10 CFR 32.30--Establishes requirements for an application to 
manufacture, process, produce, or initially transfer for sale or 
distribution exempt industrial devices.
    10 CFR 32.31--Establishes 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--Establishes 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)--Adds 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--Removes the reference to 10 CFR 32.101 and adds 
requirements for prototype testing without details of procedures to be 
followed; revises the requirement for information to be submitted on 
quality control/quality assurance to be consistent with less 
prescriptive approach in 10 CFR 32.55; and adds an explicit requirement 
for sealed source and device registration.
    10 CFR 32.55--Revises the requirement to conduct quality assurance 
to be clearer and less prescriptive and revises the acceptance 
criterion.
    10 CFR 32.56--Adds ATTN: GLTS to address for reporting, explicitly 
requires reports to Agreement States, and clarifies the need for 
reporting even if no transfers were made during the reporting period.
    10 CFR 32.57(d)(2) and (e)--Removes reference to 10 CFR 32.102 and 
adds less prescriptive requirement for prototype testing in paragraph 
(e).
    10 CFR 32.59--Makes 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)--Revises the prototype test requirement 
by removing reference to 10 CFR 32.103 and adding less prescriptive 
requirement for prototype testing in paragraph (f).
    10 CFR 32.61(g)--Adds an explicit requirement for sealed source and 
device registration.
    10 CFR 32.62(c), (d), and (e)--Revises and clarifies quality 
assurance requirements, acceptance criterion, and associated 
prohibition of transfer.
    Heading of subpart C is changed to ``Specifically Licensed Items.''
    10 CFR 32.72 and 10 CFR 32.74 are moved from subpart B to renamed 
subpart C.
    10 CFR 32.74(a)(4)--Adds 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 are removed.
    10 CFR 32.102--Specific prototype test procedures for calibration 
and reference sources containing americium-241 or radium-226 are 
removed.
    10 CFR 32.103--Specific prototype test procedures for ice detection 
devices containing strontium-90 are removed.
    10 CFR 32.110--Specific acceptance sampling procedures are removed.
    Heading of subpart D is changed to ``Sealed Source and Device 
Registration.''
    10 CFR 32.201 is moved from subpart D to renamed subpart C.
    10 CFR 32.210(a) and (e)--Remove restriction of applicability to 
specifically licensed items.
    10 CFR 32.210(b)--Adds ATTN: SSDR to address for requests.
    10 CFR 32.210(d)--Adds reference to other criteria that apply to 
various categories of sealed sources and devices.
    10 CFR 32.210(g)--Adds criteria for sources and devices not 
requiring SS & D registration.
    10 CFR 32.210(h)--Adds an explicit provision for additional review 
of registration certificates.
    10 CFR 32.211--Adds an explicit provision for inactivation of 
sealed source and device registration certificates.
    10 CFR 32.303(b)--Adds reference to new requirements not issued 
under section 223 of the AEA, as well as correcting previous omissions.
    10 CFR 40.5(b)(1)(iv)--Adds reference to new 10 CFR 32.30 as a 
licensing category not delegated to the NRC Regions.
    10 CFR 70.5(b)(1)(iv)--Adds 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 amending 10 CFR parts 30 and 32 under one or more of 
Sections 161b, 161i, or 161o of the AEA. Willful violations of the rule 
will be subject to criminal enforcement.

VI. Agreement State Compatibility

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997, 
and published in the Federal Register (62 FR 46517; September 3, 1997), 
this final rule would be a matter of compatibility between the NRC and 
the Agreement States, thereby providing consistency among the Agreement 
States and the NRC requirements. The NRC staff analyzed the final rule 
in accordance with the procedure established within Part III, 
``Categorization Process for NRC Program Elements,'' of Handbook 5.9 to 
Management Directive 5.9, ``Adequacy

[[Page 43686]]

and Compatibility of Agreement State Programs'' (a copy of which may be 
viewed at http://www.nrc.gov/reading-rm/doc-collections/management-directives/).
    NRC program elements (including regulations) are placed into four 
compatibility categories (See the Compatibility Table in this section). 
In addition, the NRC program elements can also be identified as having 
particular health and safety significance or as being reserved solely 
to the NRC. Compatibility Category A are those program elements that 
are basic radiation protection standards and scientific terms and 
definitions that are necessary to understand radiation protection 
concepts. An Agreement State should adopt Category A program elements 
in an essentially identical manner to provide uniformity in the 
regulation of agreement material on a nationwide basis. Compatibility 
Category B are those program elements that apply to activities that 
have direct and significant effects in multiple jurisdictions. An 
Agreement State should adopt Category B program elements in an 
essentially identical manner. Compatibility Category C are those 
program elements that do not meet the criteria of Category A or B, but 
the essential objectives of which an Agreement State should adopt to 
avoid conflict, duplication, gaps, or other conditions that would 
jeopardize an orderly pattern in the regulation of agreement material 
on a nationwide basis. An Agreement State should adopt the essential 
objectives of the Category C program elements. Compatibility Category D 
are those program elements that do not meet any of the criteria of 
Category A, B, or C, and, thus, do not need to be adopted by Agreement 
States for purposes of compatibility.
    Health and Safety (H&S) are program elements that are not required 
for compatibility but are identified as having a particular health and 
safety role (i.e., adequacy) in the regulation of agreement material 
within the State. Although not required for compatibility, the State 
should adopt program elements in this H&S category based on those of 
the NRC that embody the essential objectives of the NRC program 
elements because of particular health and safety considerations. 
Compatibility Category NRC are those program elements that address 
areas of regulation that cannot be relinquished to Agreement States 
under the Atomic Energy Act, as amended, or provisions of 10 CFR. These 
program elements are not adopted by Agreement States. The following 
table lists the parts and sections that would be revised and their 
corresponding categorization under the ``Policy Statement on Adequacy 
and Compatibility of Agreement State Programs.''
    The final rule is a matter of compatibility between the NRC and the 
Agreement States, thereby providing consistency among Agreement State 
and NRC requirements. The compatibility categories are designated in 
the following table:

                                       Compatibility Table for Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                             Compatibility
         Section/paragraph                  Change                  Subject          ---------------------------
                                                                                        Existing         New
----------------------------------------------------------------------------------------------------------------
30.6(b)(1)(iv)....................  Amend................  Communications...........            D             D
30.8(c)(1)........................  Amend................  Information collection               D             D
                                                            requirements: OMB
                                                            approval.
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 detectors            B             B
                                                            containing byproduct
                                                            material.
30.22.............................  New..................  Certain industrial         ............            B
                                                            devices.
30.32(g)..........................  Amend................  Application for specific              C             C
                                                            licenses.
30.38.............................  Amend................  Application for amendment            D             D
                                                            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.
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      ............            D
                                                            dose.
32.2..............................  Add..................  Definition: Sealed source  ............            D
                                                            and device registry.
32.8(b)...........................  Amend................  Information collection               D             D
                                                            requirements: OMB
                                                            approval.
32.14(b)(4) & (b)(5)..............  Amend................  Certain items containing            NRC           NRC
                                                            byproduct material;
                                                            requirements for license
                                                            to apply or initially
                                                            transfer.
32.15(a), (b), & (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[dash]85 or
                                                            promethium[dash]147:
                                                            Requirements for license
                                                            to manufacture, process,
                                                            produce, or initially
                                                            transfer.
32.26.............................  Amend................  Gas and aerosol detectors           NRC           NRC
                                                            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.

[[Page 43687]]

 
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) & (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) & (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[dash]241 or
                                                            radium[dash]226:
                                                            Requirements for license
                                                            to manufacture or
                                                            initially transfer.
32.57(e)..........................  Add..................  Calibration or reference             B             B
                                                            sources containing
                                                            americium[dash]241 or
                                                            radium[dash]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[dash]90;
                                                            requirements for license
                                                            to manufacture or
                                                            initially transfer.
32.61(f) & (g)....................  Add..................  Ice detection devices      ............            B
                                                            containing
                                                            strontium[dash]90;
                                                            requirements for license
                                                            to manufacture or
                                                            initially transfer.
32.62(c), (d), & (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--Schedule            B       [starf]
                                                            B--prototype tests for
                                                            luminous safety devices
                                                            for use in aircraft].
32.102............................  Remove...............  [Existing title--Schedule            B       [starf]
                                                            C--prototype tests for
                                                            calibration or reference
                                                            sources containing
                                                            americium[dash]241 or
                                                            radium[dash]226].
32.103............................  Remove...............  [Existing title--Schedule            B       [starf]
                                                            D--prototype tests for
                                                            ice detection devices
                                                            containing
                                                            strontium[dash]90].
32.110............................  Remove...............  [Existing title--                    B       [starf]
                                                            Acceptance sampling
                                                            procedures under certain
                                                            specific licenses].
32.210(a), (b), (d), & (e)........  Amend................  Registration of product              B             B
                                                            information.              [starf][star  [starf][star
                                                                                               f]            f]
32.210(g).........................  Add..................  Registration of product    ............            B
                                                            information.                            [starf][star
                                                                                                             f]
32.210(h).........................  Add..................  Registration of product    ............             C
                                                            information.                            [starf][star
                                                                                                             f]
32.211............................  New..................  Inactivation of            ............            B
                                                            certificates of                         [starf][star
                                                            registration of sealed                           f]
                                                            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.

VII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995 (Pub. 
L. 104-113) requires that Federal agencies use technical standards that 
are developed or adopted by voluntary consensus standards bodies unless 
the use of such a standard is inconsistent with applicable law or 
otherwise impractical. In this final rule, the NRC is making the 
requirements for distributors of byproduct material clearer, less 
prescriptive, and more risk-informed and up to date. The Commission is 
also redefining categories of devices to be used under exemptions, 
adding explicit provisions regarding the sealed source and device 
registration process, and adding 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), will continue 
to indicate that the NRC uses accepted industry standards, if 
applicable, in its evaluations.

VIII. Environmental Assessment and Finding of No Significant 
Environmental Impact: Availability

    The Commission has determined under the National Environmental 
Policy Act (NEPA) of 1969, as amended, and the Commission's regulations 
in subpart A of 10 CFR part 51, not to prepare an environmental impact 
statement for this final rule because the Commission has concluded on 
the basis of an environmental assessment that this final rule, if 
adopted, would not be a major Federal action significantly affecting 
the quality of the human

[[Page 43688]]

environment. The following is a summary of the Environmental 
Assessment: Many of the individual actions being taken 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 rule will 
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 the environmental assessment is that there 
will be no significant impact to the public from this action.
    This conclusion was published in the environmental assessment that 
was posted to the Federal rulemaking Web site, http://www.regulations.gov, for 75 days after publication of the proposed 
rule. There were no comments received on the content of the 
environmental assessment.

IX. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31883).

X. Paperwork Reduction Act Statement

    This final rule contains new or amended information collection 
requirements that are subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). These requirements were approved by the 
Office of Management and Budget, control numbers 3150-0017; 3150-0001; 
and 3150-0120.
    The burden to the public for these information collections is 
estimated to average 16.39 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
information collection. Send comments on any aspect of these 
information collections, including suggestions for reducing the burden, 
to the Information Services Branch (T-5 F53), U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, or by Internet electronic mail 
to INFOCOLLECTS.Resource@nrc.gov; and to the Desk Officer, Office of 
Information and Regulatory Affairs, NEOB-10202, (3150-0017; -0001; -
0120), Office of Management and Budget, Washington, DC 20503, or by 
Internet electronic mail to Chad_S_Whiteman@omb.eop.gov.

Public Protection Notification

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

XI. Regulatory Analysis

    The Commission has prepared a regulatory analysis on this 
regulation. The analysis examines the costs and benefits of the 
alternatives considered by the Commission. The analysis is available 
for inspection on http://www.regulations.gov by searching on Docket ID 
NRC-2008-0338 and in the NRC's PDR, 11555 Rockville Pike, Rockville, MD 
20852.

XII. Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
605(b)), the Commission certifies that this rule will not 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 revisions to the regulatory program will 
result in a significant economic impact on the affected entities.

XIII. Backfit Analysis

    The NRC's backfit provisions are found in the regulations at 
Sec. Sec.  50.109, 52.39, 52.63, 52.83, 52.98, 52.145, 52.171, 70.76, 
72.62, and 76.76. The requirements contained in this final rule do not 
involve any provisions that will impose backfits on nuclear power plant 
licensees as defined in 10 CFR parts 50 or 52, or on licensees for 
gaseous diffusion plants, independent spent fuel storage installations 
or special nuclear material as defined in 10 CFR parts 70, 72 and 76, 
respectively, and as such a backfit analysis is not required. 
Therefore, a backfit analysis need not be prepared for this final rule 
to address these classes of entities. With respect to 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 rule to address parts 30, 31, or 32 licensees.

XIV. Congressional Review Act

    In accordance with the Congressional Review Act of 1996, the NRC 
has determined that this action is not a major rule and has verified 
this determination with the Office of Information and Regulatory 
Affairs of OMB.

List of Subjects

10 CFR Part 30

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

10 CFR Part 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. 552 and 553; the NRC is adopting 
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

0
1. The authority citation for part 30 continues to read as follows:


[[Page 43689]]


    Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183, 
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236, 
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42 
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec. 
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. No. 
109-58, 119 Stat. 549 (2005).
    Section 30.7 also issued under Energy Reorganization Act sec. 
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec. 
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic 
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued 
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).


0
2. In Sec.  30.6, paragraph (b)(1)(iv) is revised to read as follows:


Sec.  30.6  Communications.

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

0
3. In Sec.  30.8, paragraph (c)(1) is revised to read as follows:


Sec.  30.8  Information collection requirements: OMB approval.

* * * * *
    (c) * * *
    (1) In Sec. Sec.  30.32 and 30.37, NRC Form 313 is approved under 
control number 3150-0120.
* * * * *

0
4. 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 October 23, 2012 for use under 
the general license then provided in Sec.  31.3 and equivalent 
regulations of Agreement States and manufactured, tested, and labeled 
by the manufacturer in accordance with the specifications contained in 
a specific license issued by the Commission.
* * * * *

0
5. 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.
* * * * *

0
6. 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. This exemption also covers gas and aerosol 
detectors manufactured or distributed before November 30, 2007, in 
accordance with a specific license issued by a State under comparable 
provisions to Sec.  32.26 of this chapter authorizing distribution to 
persons exempt from regulatory requirements.
    (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.

0
7. 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.

0
8. In Sec.  30.32, paragraph (g) is revised to read as follows:


Sec.  30.32  Application for specific licenses.

* * * * *
    (g)(1) Except as provided in paragraphs (g)(2), (3), and (4) of 
this section, an application for a specific license to use byproduct 
material in the form of a sealed source or in a device that contains 
the sealed source must either--
    (i) Identify the source or device by manufacturer and model number 
as registered with the Commission under Sec.  32.210 of this chapter, 
with an Agreement State, or for a source or a device containing radium-
226 or accelerator-produced radioactive material with a State under 
provisions comparable to Sec.  32.210 of this chapter; or
    (ii) Contain the information identified in Sec.  32.210(c) of this 
chapter.
    (2) For sources or devices manufactured before October 23, 2012 
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

[[Page 43690]]

specified in Sec.  32.210(c) of this chapter, the application must 
include:
    (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.
    (3) 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.
    (4) If it is not feasible to identify each sealed source and device 
individually, the applicant may propose constraints on the number and 
type of sealed sources and devices to be used and the conditions under 
which they will be used, in lieu of identifying each sealed source and 
device.
* * * * *

0
9. 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 must be filed in accordance 
with Sec.  30.32 and must 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 must be filed in accordance with Sec.  32.210 of this 
chapter and any other applicable provisions and must specify the 
respects in which the certificate holder desires its certificate to be 
amended and the grounds for the amendment.

0
10. 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.

0
11. 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 in 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 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 or certificate holder in writing and the 
licensee or certificate holder shall have been given an opportunity to 
demonstrate or achieve compliance with all lawful requirements.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

0
12. The authority citation for part 31 continues to read as follows:

    Authority: Atomic Energy Act secs. 81, 161, 183, 223, 234 (42 
U.S.C. 2111, 2201, 2233, 2273, 2282); Energy Reorganization Act 
secs. 201, 202 (42 U.S.C. 5841, 5842); Government Paperwork 
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act 
of 2005, 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]

0
13. Section 31.3 is removed and reserved.

0
14. 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

0
15. The authority citation for part 32 continues to read as follows:

    Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223, 
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy 
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork 
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act 
of 2005, sec. 651(e), Pub. L. No. 109-58, 119 Stat. 806-810 (42 
U.S.C. 2014, 2021, 2021b, 2111).

0
16. 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.
    (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.
* * * * *

0
17. 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 for the purposes of this part means the radiation 
dose that will accumulate over time as a result of retention in the 
body of radioactive material. Committed dose is a generic term for 
internal dose and must be calculated by summing the projected dose over 
the 50 years after intake for

[[Page 43691]]

all irradiated organs or tissues multiplying the doses to individual 
organs and tissues by applicable tissue weighting factors.
* * * * *
    Sealed Source and Device Registry means the national registry that 
contains all the registration certificates, generated by both the 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.

0
18. 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.
* * * * *

0
19. In Sec.  32.14, paragraphs (b)(4) and (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;
* * * * *

0
20. 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 shall:
    (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 must 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 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]
* * * * *

0
21. 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 product meets the safety 
criteria in Sec.  32.23; and
    (ii) The product has been evaluated by the NRC and registered in 
the Sealed Source and Device Registry.
* * * * *

0
22. 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 product meets the safety 
criteria in Sec.  32.27; and
    (2) The product has been evaluated by the NRC and registered in the 
Sealed Source and Device Registry.

0
23. 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 (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;

[[Page 43692]]

    (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 30 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.

0
24. 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 radioactive material from the 
device will exceed 200 [micro]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 [micro]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 that 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).

0
25. 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

[[Page 43693]]

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.

0
26. 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.
* * * * *

0
27. 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 shall 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 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.

0
28. 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 shall visually inspect 
each device and shall 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 shall:
    (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 shall 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.

[[Page 43694]]


0
29. 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 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 must be reported to the responsible Agreement State agency 
upon request of the agency.

0
30. 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 shall 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 kilobecquerel (0.005 
microcurie) of americium-241 or radium-226 from the source or any other 
evidence of physical damage.

0
31. 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 shall 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.

0
32. 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 shall 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.

0
33. 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 shall:
    (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 shall 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

[[Page 43695]]

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

0
34. The heading of subpart C is revised to read as set forth above.


Sec. Sec.  32.72 and 32.74   [Transferred to Subpart C]

0
35. 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]

0
36. Section 32.101 is removed.


Sec.  32.102  [Removed]

0
37. Section 32.102 is removed.


Sec.  32.103  [Removed]

0
38. Section 32.103 is removed.


Sec.  32.110  [Removed]

0
39. Section 32.110 is removed.

Subpart D--Sealed Source and Device Registration

0
40. The heading of subpart D is revised to read as set forth above.


Sec.  32.201  [Transferred to Subpart C]

0
41. Section 32.201 is transferred from subpart D to subpart C.

0
42. 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 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 [micro]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 provisions of an Agreement State; 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 and the 
certificate holder shall provide the information as requested.

0
43. Section 32.211 is added to subpart D to read as follows:


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

    (a) A certificate holder who no longer manufactures or initially 
transfers any of the sealed source(s) or device(s) covered by a 
particular certificate issued by the Commission shall request 
inactivation of the registration certificate. Such a request must be 
made 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 and must normally be made no 
later than two years after initial

[[Page 43696]]

distribution of all of the source(s) or device(s) covered by the 
certificate has ceased. However, if the certificate holder determines 
that an initial transfer was in fact the last initial transfer more 
than two years after that transfer, the certificate holder shall 
request inactivation of the certificate within 90 days of this 
determination and briefly describe the circumstances of the delay.
    (b) If a distribution license is to be terminated in accordance 
with Sec.  30.36 of this chapter, the licensee shall request 
inactivation of its registration certificates associated with that 
distribution license before the Commission will terminate the license. 
Such a request for inactivation of certificate(s) must indicate that 
the license is being terminated and include the associated specific 
license number.
    (c) A specific license to manufacture or initially transfer a 
source or device covered only by an inactivated certificate no longer 
authorizes the licensee to initially 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.

0
44. 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

0
45. The authority citation for part 40 continues to read as follows:

    Authority: Atomic Energy Act secs. 11(e)(2), 62, 63, 64, 65, 81, 
161, 181, 182, 183, 186, 193, 223, 234, 274, 275 (42 U.S.C. 
2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2231, 
2232, 2233, 2236, 2243, 2273, 2282, 2021, 2022); Energy 
Reorganization Act secs. 201, 202, 206 (42 U.S.C. 5841, 5842, 5846); 
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504 
note); Energy Policy Act of 2005, Pub. L. No. 109-59, 119 Stat. 594 
(2005).
    Section 40.7 also issued under Energy Reorganization Act sec. 
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec. 
2902 (42 U.S.C. 5851). Section 40.31(g) also issued under Atomic 
Energy Act sec. 122 (42 U.S.C. 2152). Section 40.46 also issued 
under Atomic Energy Act sec. 184 (42 U.S.C. 2234). Section 40.71 
also issued under Atomic Energy Act sec. 187 (42 U.S.C. 2237).

0
46. In Sec.  40.5, paragraph (b)(1)(iv) is revised to read as follows:


Sec.  40.5  Communications.

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

PART 70--DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

0
47. The authority citation for part 70 continues to read as follows:

    Authority: Atomic Energy Act secs. 51, 53, 161, 182, 183, 193, 
223, 234 (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2243, 2273, 2282, 
2297f); secs. 201, 202, 204, 206, 211 (42 U.S.C. 5841, 5842, 5845, 
5846, 5851); Government Paperwork Elimination Act sec. 1704 (44 
U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. No. 109-58, 
119 Stat. 194 (2005).
    Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, 
Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
    Section 70.21(g) also issued under Atomic Energy Act sec. 122 
(42 U.S.C. 2152). Section 70.31 also issued under Atomic Energy Act 
sec. 57(d) (42 U.S.C. 2077(d)). Sections 70.36 and 70.44 also issued 
under Atomic Energy Act sec. 184 (42 U.S.C. 2234). Section 70.81 
also issued under Atomic Energy Act secs. 186, 187 (42 U.S.C. 2236, 
2237). Section 70.82 also issued under Atomic Energy Act sec. 108 
(42 U.S.C. 2138).

0
48. In Sec.  70.5, paragraph (b)(1)(iv) is revised to read as follows:


Sec.  70.5  Communications.

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

    Dated at Rockville, Maryland, this 13th day of July, 2012.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2012-17711 Filed 7-24-12; 8:45 am]
BILLING CODE 7590-01-P