[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Notices]
[Pages 63957-63959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26581]


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NUCLEAR REGULATORY COMMISSION

[NRC-2010-0292]


Consumer Product Policy Statement

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed revision to policy statement; request for public 
comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) is 
proposing to update its policy statement on products intended for use 
by the general public (consumer products). While the NRC is not making 
any significant changes to the policy, general updating is needed to 
reflect the approaches and terminology used in radiation protection 
that have evolved over time, as well as relevant legislation and 
regulatory actions.

DATES: Submit comments by December 28, 2011. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is able to assure consideration only for comments received on or before 
this date.

ADDRESSES: Please include Docket ID NRC-2010-0292 in the subject line 
of your comments. For instructions on submitting comments and accessing 
documents related to this action, see Section I, ``Submitting Comments 
and Accessing Information'' in the SUPPLEMENTARY INFORMATION section of 
this document. You may submit comments by any one of the following 
methods:
     Federal rulemaking Web site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2010-0292. Address questions about NRC dockets to Carol Gallagher, 
telephone: 301-492-3668, e-mail: [email protected].
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attn: Rulemakings and 
Adjudications Staff.
     E-mail comments to: [email protected]. If you do 
not receive a reply e-mail confirming that we have received your 
comments, contact us directly at 301-415-1677.
     Hand-deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays 
(Telephone 301-415-1677).
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.

FOR FURTHER INFORMATION CONTACT: Shirley Xu, Office of Federal and 
State Materials and Environmental Management Programs, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
7640; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove 
any identifying or contact information, the NRC cautions you against 
including any information in your submission that you do not want to be 
publicly disclosed. The NRC requests that any party soliciting or 
aggregating comments received from other persons for submission to the 
NRC inform those persons that the NRC will not edit their comments to 
remove any identifying or contact information, and therefore, they 
should not include any information in their comments that they do not 
want publicly disclosed.
    You can access publicly available documents related to this 
document using the following methods:
     NRC's Public Document Room (PDR): The public may examine 
and have copied, for a fee, publicly available documents at the NRC's 
PDR, Room O-1F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland.
     NRC's Agencywide Documents Access and Management System 
(ADAMS):
    Publicly available documents created or received at the NRC are 
available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which 
provides text and image files of NRC's public documents. If you do not 
have access to ADAMS or if there are problems in accessing the 
documents located in ADAMS, contact the NRC's PDR reference staff at 1-
800-397-4209, or 301-415-4737, or by e-mail to [email protected].
     Federal Rulemaking Web Site: Public comments and 
supporting materials related to this proposed policy statement revision 
can be found at http://www.regulations.gov by searching on Docket ID 
NRC-2010-0292.

II. Background

    On March 16, 1965 (30 FR 3462), the Atomic Energy Commission (AEC), 
the NRC's predecessor agency, issued its policy statement on products 
intended for use by the general public (consumer products). Under this 
policy, the AEC and then the NRC have periodically reevaluated the 
overall impact to the public of products allowed to be distributed for 
use by the general public, which are normally used under an exemption 
from licensing of the consumer-user and from all associated regulatory 
requirements. The AEC/NRC staff has reevaluated the policy at times and 
found it to serve the agency well in spite of the passage of 
considerable time. The policy is written in very general terms and, 
because of this, has not needed revision. However, the NRC is now 
proposing to update the policy to include approaches and terminology 
more consistent with the evolving approach to radiation protection, and 
to recognize relevant legislative and regulatory actions.

III. Discussion

    The 1965 policy used terms consistent with the approach to 
radiation protection represented primarily in the early documents of 
the International Commission on Radiation Protection

[[Page 63958]]

(ICRP). These include ``permissible dose to the gonads'' and 
``permissible body burden.'' Newer approaches to radiation protection 
do not include such limits. The recommendations of the ICRP originally 
included control of dose to the gonads because of concern for potential 
genetic risks, i.e., risks to future generations. It has been 
determined that genetic risks are much lower than believed at the time; 
thus, separate limits for doses to the gonads are no longer used. Also, 
early approaches to radiation protection included limits on body 
burden, i.e., the amount of a radionuclide present in a person's body. 
In newer approaches for controlling cumulative exposure from 
radionuclides retained in the body, the calculated dose for the year of 
intake includes doses that will result in the future.
    Additional updating is needed due to legislation that has been 
enacted since 1965. The Energy Reorganization Act of 1974 revised the 
Atomic Energy Act in a number of ways, primarily to separate the 
regulatory responsibilities from the AEC and to create the NRC. 
Relevant AEC policies, such as the subject policy, became NRC policies. 
Also in 1974, the Commission was given the authority to create 
exemptions from licensing for special nuclear material in addition to 
byproduct material and source material. The NRC has not issued any 
exemptions from licensing for products containing special nuclear 
material, but the revised policy would recognize the authority to do 
so.
    Another relevant legislative action was the National Environmental 
Policy Act (NEPA) of 1969. In subparagraph 9(c), the policy addresses 
the consideration of potential impacts to the environment from the 
possible dispersion of radioactive material and the uncontrolled 
disposal of products used under exemption. This is the primary 
environmental impact to be considered in most instances of evaluating a 
potential exemption from licensing. Specific procedures for complying 
with NEPA have been developed, and are addressed in Title 10 of the 
Code of Federal Regulations (10 CFR) part 51, ``Environmental 
Protection Regulations for Domestic Licensing and Related Regulatory 
Functions.'' Thus, any rulemaking to add an exemption from licensing 
requirements would require NRC documentation of environmental 
considerations in accordance with these procedures. In addition, the 
responsibilities of the Federal Radiation Council are now performed 
within the Environmental Protection Agency (EPA).
    Since the issuance of the 1965 policy, the NRC has issued class 
exemptions, under which additional products belonging to an identified 
class of products can be approved through a licensing action, if an 
applicant to manufacture or distribute a product demonstrates that the 
product meets certain safety criteria. This approach to exemptions from 
licensing should also be recognized in the policy. Also, these safety 
criteria include more specific criteria for accidents than in the 
existing policy. The revised policy would better address the level of 
risks that are acceptable for accident and misuse scenarios. However, 
the guidance remains relatively general.
    In addition, the example products noted in paragraphs 5 and 6 of 
the policy statement would be revised to be more relevant and up to 
date. For example, thoriated tungsten welding rods, while available to 
the public, are used in unique, expensive equipment and are not 
normally used by the public in the form of consumer products. Likewise, 
shipping containers constructed with uranium as shielding are not used 
by the public in the form of consumer products.

IV. Proposed Revised Statement of Policy

Products Intended for Use by General Public (Consumer Products)

    Criteria for the approval of products containing radioactive 
material and intended for use by the general public.
    This notice sets forth the essential terms of the Commission's 
policy with respect to approval of the use of byproduct material, 
source material, and special nuclear material in products intended for 
use by the general public (consumer products) without the imposition of 
regulatory controls on the consumer-user. This is accomplished by the 
exemption, on a case-by-case basis, of the possession and use of the 
approved items from the licensing requirements for byproduct, source, 
or special nuclear material of the Atomic Energy Act of 1954, as 
amended, and of the Commission's regulations in 10 CFR part 30, 
``Licensing of Byproduct Material,'' 10 CFR part 40, ``Licensing of 
Source Material,'' or 10 CFR part 70, ``Licensing of Special Nuclear 
Material.''
    1. At the present time it appears unlikely that the total 
contribution to the exposure of the general public to radiation from 
the use of radioactivity in consumer products will exceed a fraction of 
limits recommended for exposure to radiation from all sources. 
Information as to total quantities of radioactive materials being used 
in such products and the number of items being distributed will be 
obtained through recordkeeping and reporting requirements applicable to 
the manufacture and distribution of such products. Periodically, the 
NRC staff conducts an overall reevaluation of this information to 
estimate the range of likely doses to the population. If radioactive 
materials are used in sufficient quantities in products reaching the 
public so as to raise any question of the combined exposure from 
multiple consumer products becoming a significant fraction of the 
permissible dose to the public, the Commission will, at that time, 
reconsider its policy on the use of radioactive materials in consumer 
products.
    2. Approval of a proposed consumer product, and adding a new 
exemption from licensing provision to the regulations, depends upon 
both associated exposures of persons to radiation and the apparent 
usefulness of the product. In general, risks of exposure to radiation 
will be considered to be acceptable if it is shown that in handling, 
use, and disposal of the product, it is unlikely that individuals in 
the population will receive more than a small fraction, less than a few 
hundredths, of individual dose limits in NRC regulations and as 
recommended by such groups as the ICRP, the National Council on 
Radiation Protection and Measurements, and the EPA, and that the 
probability of individual doses exceeding any of the specified limits 
is low and the probability of individual doses approaching a level that 
could cause immediate effects is negligible. Otherwise, a decision will 
be more difficult and will require a careful weighing of all factors, 
including benefits that will accrue or be denied to the public as a 
result of the Commission's action. Factors that may be pertinent are 
listed in paragraphs 9 and 10, below.
    3. Products proposed for distribution will be useful to some 
degree. Normally, the Commission will not attempt an extensive 
evaluation of the degree of benefit or usefulness of a product to the 
public. However, in cases where tangible benefits to the public are 
questionable and approval of such a product may result in widespread 
use of radioactive material, such as in common household items, the 
degree of usefulness and benefit that accrues to the public may be a 
deciding factor. In particular, the Commission considers that the use 
of radioactive material in toys, novelties, and adornments may be of 
marginal benefit.
    4. Applications for approval of ``off-the-shelf'' items that are 
subject to

[[Page 63959]]

mishandling, especially by children, will be approved only if they are 
found to combine an unusual degree of utility and safety.
    5. The Commission has approved certain long-standing uses of source 
material, many of which antedate the atomic energy program. These 
include:
    (a) Use of uranium to color glass for certain decorative purposes; 
and
    (b) Thorium in various alloys and products (e.g., gas mantles, 
optical lenses, tungsten wire in such things as electric lamps and 
vacuum tubes) to impart desirable physical properties.
    6. The Commission also approved the use of tritium as a substitute 
luminous material for the long-standing use of radium for this purpose 
on watch and clock dials and hands.
    7. The Commission has approved additional uses of byproduct and 
source material in consumer products. These include the following:
    (a) Tritium and other radionuclides in electron tubes;
    (b) Americium-241 in smoke detectors; and
    (c) Thorium and uranium in piezoelectric ceramic, which is used in 
many electronic products and other consumer products.
    8. In approving uses of byproduct, source, or special nuclear 
material in consumer products, the Commission establishes limits on 
quantities or concentrations of radioactive materials and, if 
appropriate, on radiation emitted. In some cases, other limitations, 
such as quality control and testing, considered important to health and 
safety are also specified. In the case of class exemptions, specific 
safety criteria are included in the regulations, which require the 
applicant to evaluate many pathways of exposure of the public.

Principal Considerations With Respect to Evaluation of Products

    9. In evaluating proposals for the use of radioactive materials in 
consumer products the principal considerations are:
    (a) The potential external and internal exposure of individuals in 
the population to radiation from the handling, use and disposal of 
individual products;
    (b) The potential total cumulative radiation dose to individuals in 
the population who may be exposed to radiation from a number of 
products;
    (c) The long-term potential external and internal exposure of the 
general population from the uncontrolled disposal and dispersal into 
the environment of radioactive materials from products authorized by 
the Commission; and
    (d) The benefit that will accrue to or be denied the public because 
of the utility of the product by approval or disapproval of a specific 
product.
    10. The general criteria for approval of individual products are 
set forth in paragraph 2, above. Detailed evaluation of potential 
exposures would take into consideration the following factors, together 
with other considerations, which may appear pertinent in the particular 
case:
    (a) The external radiation levels from the product.
    (b) The proximity of the product to human tissue during use.
    (c) The area of tissue exposed. A dose to the skin of the whole 
body would be considered more significant than a similar dose to a 
small portion of the skin of the body.
    (d) Potential of the radionuclides to cause exposures from intakes. 
Materials that result in lower cumulative exposures when taken into the 
body would be considered more favorably than materials that result in 
higher exposures from intakes.
    (e) The quantity of radioactive material per individual product. 
The smaller the quantity the more favorably would the product be 
considered.
    (f) Form of material. Materials with a low solubility in body 
fluids and the environment will be considered more favorably than those 
with a high solubility.
    (g) Containment of the material. Products which contain the 
material under very severe environmental conditions will be considered 
more favorably than those that will not contain the material under such 
conditions.
    (h) Degree of access to product during normal handling and use. 
Products which are inaccessible to children and other persons during 
use will be considered more favorably than those that are accessible.

    Dated at Rockville, Maryland, this 7th day of October, 2011.

    For the Nuclear Regulatory Commission.
Robert J. Lewis,
Acting Deputy Director, Office of Federal and State Materials and 
Environmental Management Programs.
[FR Doc. 2011-26581 Filed 10-13-11; 8:45 am]
BILLING CODE 7590-01-P