Requirements for Distribution of Byproduct Material, 36212-36236 [2010-15202]

Agencies

• NUCLEAR REGULATORY COMMISSION

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



[[Page 36211]]

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Part III





Nuclear Regulatory Commission





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



Requirements for Distribution of Byproduct Material; Proposed Rule

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

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NUCLEAR REGULATORY COMMISSION

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

RIN 3150-AH91
[NRC-2008-0338]


Requirements for Distribution of Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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

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

ADDRESSES: Please include Docket ID NRC-2008-0338 in the subject line 
of your comments. For instructions on submitting comments and accessing 
documents related to this action, see Section I, ``Submitting Comments 
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of 
this document. You may submit comments by any one of the following 
methods.
    Federal Rulemaking Web Site: Go to https://www.regulations.gov and 
search for documents filed under Docket ID NRC-2008-0338 Address 
questions about NRC dockets to Carol Gallagher, telephone 301-492-3668; 
e-mail Carol.Gallagher@nrc.gov.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not 
receive a reply e-mail confirming that we have received your comments, 
contact us directly at 301-415-1966.
    Hand Deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852 between 7:30 a.m. and 4:15 p.m. during Federal workdays 
(Telephone 301-415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
301-415-1101.
    You may submit comments on the information collections by the 
methods indicated in the Paperwork Reduction Act Statement.

FOR FURTHER INFORMATION CONTACT: Catherine R. Mattsen, Office of 
Federal and State Materials and Environmental Management Programs, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 
301-415-6264, e-mail, Catherine.Mattsen@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information
II. Background
    A. Introduction
    B. Regulatory Framework
III. Proposed Actions
    A. Actions Related to Sealed Source and Device Registration
    B. Establish a New Class Exemption for Certain Industrial 
Products
    C. Remove Unnecessary Limitations From the Class Exemption for 
Gas and Aerosol Detectors
    D. Update the Regulations on Certain Static Eliminators and Ion 
Generating Tubes
    E. Remove Prescriptive Requirements for Distributors of 
Generally Licensed Devices and Exempt Products
    F. Make the Requirements for Distributors of Exempt Products 
More Risk-Informed
    G. Specific Questions for Comment
    H. Minor Clarifying or Administrative Revisions
IV. Summary of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Language
VIII. Voluntary Consensus Standards
IX. Finding of No Significant Environmental Impact: Availability
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site https://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed. The NRC requests that any party soliciting or 
aggregating comments received from other persons for submission to the 
NRC inform those persons that the NRC will not edit their comments to 
remove any identifying or contact information, and therefore, they 
should not include any information in their comments that they do not 
want publicly disclosed.
    You can access publicly available documents related to this 
document using the following methods:
    NRC's Public Document Room (PDR): The public may examine and have 
copied for a fee, publicly available documents at the NRC's PDR, Room 
O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland.
    NRC's Agencywide Documents Access and Management System (ADAMS): 
Publicly available documents created or received at the NRC are 
available electronically at the NRC's Electronic Reading Room at https://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain 
entry into ADAMS, which provides text and image files of NRC's public 
documents. If you do not have access to ADAMS or if there are problems 
in accessing the documents located in ADAMS, contact the NRC's PDR 
reference staff at 1-800-397-4209, or 301-415-4737, or by e-mail to 
PDR.Resource@nrc.gov.
    Federal Rulemaking Web site: Public comments and supporting 
materials related to this proposed rule can be found at https://www.regulations.gov by searching on Docket ID NRC-2008-0338.

II. Background

A. Introduction

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

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

B. Regulatory Framework

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

III. Proposed Actions

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

A. Actions Related to Sealed Source and Device Registration

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

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

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

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

[[Page 36217]]

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

B. Establish a New Class Exemption for Certain Industrial Products

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

[[Page 36218]]

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

[[Page 36219]]

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

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

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

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

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

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

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

[[Page 36220]]

provide general standards by which performance may be judged, rather 
than specifying detailed procedures that must be followed, except for 
products for which oversight of these activities would no longer be 
required as discussed under Section III.F., ``Make the Requirements for 
Distributors of Exempt Products More Risk-Informed.'' The NUREG-1556 
series of documents provides guidance to licensees and applicants on 
acceptable approaches to meeting these requirements.
    The procedures included in the current regulatory requirements are 
generally acceptable to meet the proposed performance-based 
requirements. Safety benefits of the proposed changes in this area 
would primarily be gained indirectly by removing overly burdensome and 
possibly counterproductive procedures--and more importantly, by 
accommodating the use of new technologies. The intent is for the 
proposed regulatory requirements to be equivalent to the current 
practices (except as noted), so that existing licensees would not have 
to change their procedures as a result of this rulemaking. However, the 
provisions are written so that applicants and licensees would have 
flexibility in the methods that they use to determine the design 
quality (prototype tests) and manufacturing quality (acceptance 
sampling/QC) of these products. In keeping with international best 
manufacturing standards, manufacturers and the distributors that 
represent them are expected to maintain a quality management system 
that stresses continual improvement. Examples of such system 
requirements can be found in ISO 9001:2000, ``Quality Management 
Systems--Requirements,'' and, unique to the nuclear safety field, IAEA 
Safety Series No. 50-C/SG-Q, ``Quality Assurance for Safety in Nuclear 
Power Plants and Other Nuclear Installations, Code and Safety Guides 
Q1-Q14.'' While the focus of ISO 9001:2000 is on customer satisfaction, 
and the primary focus of the IAEA series is on nuclear facility safety, 
these documents contain some quality management concepts that are 
appropriate to the distribution of generally licensed and exempt 
products containing byproduct material.
Prototype Test Procedures
    This rule proposes to simplify current prescriptive regulations for 
prototype testing for new products proposed for use under general 
license. The proposed provisions include only those aspects that are 
results-oriented, rather than specifying detailed procedures that must 
be followed. An applicant may choose to follow current prototype test 
procedures, as they would satisfy the outcomes required by this 
proposed rule in every situation. The specific procedures would be 
removed from the regulations and included as example acceptable 
procedures in g