[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Rules and Regulations]
[Pages 43666-43696]
From the Federal Register Online via the Government Publishing 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 [email protected].
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: [email protected].
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
[[Page 43668]]
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 [email protected]; 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 [email protected].
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