[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