[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Notices]
[Pages 2907-2912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00730]
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NUCLEAR REGULATORY COMMISSION
[NRC-2010-0292]
Consumer Product Policy Statement
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement; revision.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is updating its
policy statement on products intended for use by the general public
(consumer products). The update reflects our current approach to
radiation protection, legislation that has been enacted since the
policy was published in 1965, and subsequent approaches taken in the
NRC's regulatory framework for exemptions.
DATES: This revised policy statement becomes effective on January 16,
2014.
ADDRESSES: Please refer to Docket ID NRC-2010-0292 when contacting the
NRC about the availability of information for this policy statement
revision. You may access publicly-
[[Page 2908]]
available information and comment submissions related to this policy
statement revision by any of the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2010-0292. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-287-
3422; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library at http://www.nrc.gov/reading-rm/adams.html. To begin the
search, select ``ADAMS Public Documents'' and then select ``Begin Web-
based ADAMS Search.'' For problems with ADAMS, please contact the NRC's
Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-
4737, or by email to [email protected]. The ADAMS accession number
for each document referenced in this document (if that document is
available in ADAMS) is provided the first time that a document is
referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: 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; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On March 16, 1965, 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) (30 FR 3462). Under
this policy, the AEC and subsequently, the NRC have periodically
reevaluated the overall public safety 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 and from all associated
regulatory requirements. The NRC staff has reevaluated the policy
periodically and found that it has served the agency well and withstood
the passage of time. The policy was written in general terms, which
contributed to its continuance of use. However, the NRC is updating the
policy to include approaches and terminology more consistent with the
agency's current approach to radiation protection and to recognize
relevant legislative and regulatory actions taken since the policy was
originally issued.
II. 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 (ICRP). These
include ``permissible dose to the gonads'' and ``permissible body
burden.'' Newer approaches to radiation protection do not apply such
standards. 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). Since that time, the ICRP has
updated its recommendations, which no longer include separate limits
for doses to the gonads, because genetic risks are much lower than
estimated at the time the policy was written. 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
radiation protection is achieved by summing the dose from external
radiation and the doses from inhaled and ingested radioactive material.
Additional updating is needed due to Federal 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 the NRC's
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 Commission has
not issued any exemptions from licensing for products containing
special nuclear material, but the revised policy recognizes 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 generally the
primary environmental impact to be considered when evaluating a
potential exemption from licensing. Specific procedures for complying
with NEPA have been developed and are addressed in part 51 of Title 10
of the Code of Federal Regulations (10 CFR), ``Environmental Protection
Regulations for Domestic Licensing and Related Regulatory Functions.''
Therefore, any rulemaking to add an exemption from licensing
requirements requires NRC documentation of environmental considerations
in accordance with these procedures. In addition, the responsibilities
of the former Federal Radiation Council are now performed within the
U.S. Environmental Protection Agency (EPA).
Since the issuance of the 1965 policy, the Commission 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 proposing to manufacture or distribute a
product demonstrates that the product is within the class and meets
certain safety criteria. This approach to exemptions from licensing is
also being recognized in the policy.
Also, the safety criteria for the class exemptions include more
specific criteria for accidents than were reflected in the 1965 policy.
The revised policy better addresses the level of risk that is
acceptable for accident and misuse scenarios. However, the guidance
remains relatively general.
The policy directly applies to any potential rulemaking to add or
modify exemptions from licensing that cover consumer products and
usually does not apply to individual licensing actions involving such
products. However, when there is need for interpretation or judgment in
the ultimate decision to approve a product, the licensing staff may
look to the policy for additional direction. The policy has been
reflected in the applicable provisions in the regulations, including
specifically the class exemptions, so that the approval of specific
products in licensing actions will be consistent with the policy.
In accordance with the policy, the NRC staff has occasionally
reevaluated the relevant exemptions. Three of the NRC's recent
rulemaking actions included changes that reflected findings of the
latest reevaluation (see October 16, 2007, 72 FR 58473; July 25, 2012,
77 FR 43666; and May 29, 2013, 78 FR 32310).
Finally, the example products noted in paragraphs 5 and 6 of the
policy statement are revised to be more relevant and up to date. For
example, thoriated tungsten welding rods, while available to the public
as off-the-shelf items, are not intended for widespread personal or
household use. Likewise, shipping containers constructed with uranium
as shielding are not used by the public in the form of consumer
[[Page 2909]]
products. Instead, such examples as electron tubes and smoke detectors
were added.
III. Summary and Analysis of Public Comments
A proposed revision of the Consumer Product Policy Statement was
published for public comment on October 14, 2011 (76 FR 63957). The
comment period closed December 28, 2011, and four comment letters were
received. The comment letters came from the Health Physics Society, a
member of a State regulatory staff, an organization representing the
industry of manufacturers and distributors, and two certified health
physicists (commenting together). There was general support for the
policy and the intent to update it. There were no objections to the
policy or to the specific changes proposed.
One commenter noted the long history of use of certain products
with low dose potential to users and stated that the NRC has had a
comprehensive and successful system in place for many years for
evaluating the safety of devices in broad context of use in addition to
the radionuclide and activity in the product. Another expressed support
for the principal considerations in the policy, stating that the
changes are reasonable in light of the newer approaches to radiation
protection; this commenter also stated agreement with a number of
specific points such as that justifiable sources of radiation exposure
of the public include those that result in an overall net benefit to
society. Most comments reflected a desire for the policy to be more
clear or specific, with suggestions made for including additional
topics and certain definitions.
Comment: Two of the commenters thought that it would be helpful to
put a specific value on certain terms in paragraph 2 of the Statement
of Policy,\1\ which states in part that, in general, risks of exposure
will be considered acceptable if ``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. . . .'' Both of these
commenters believed that the use of actual numbers would be helpful and
preferred that the current public dose limit be stated.
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\1\ The phrase ``Statement of Policy'' as it is used here refers
specifically to Section IV within this notice. Otherwise, the term
``policy'' or ``policy statement'' is being used.
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One of these commenters suggested that more specificity in
paragraph 1 of the Statement of Policy would also be helpful. That
paragraph states that at the present time it appears unlikely that the
total contribution to exposure of the general public would exceed a
``fraction of limits recommended for exposure to all radiation
sources'' but if in the future radioactive materials were used in such
quantities as to raise a question of the combined exposure from
multiple products becoming a ``significant fraction'' of the
permissible dose to the public, the Commission would reconsider its
policy. This commenter indicated that it would be helpful if the
``fraction of limits recommended for exposure to all radiation
sources'' could be quantified as well as the ``significant fraction. .
. '' of the public dose limit that will be used as the basis for
reconsidering the policy. However, this commenter stated that there was
no problem with the proposed revised policy as long as those fractions
are no less restrictive than whatever is currently used.
Response: Paragraph 2 states that approval of a product depends
upon both associated exposures of persons to radiation and the apparent
usefulness of the product. The statement in that paragraph about a
small fraction of individual dose limits in the NRC's regulations and
as recommended by such groups as the ICRP is meant to provide a general
guideline on acceptable risks under routine conditions, above which an
in-depth analysis and weighing of all factors would be particularly
important. Paragraph 2 also addresses risks from accidents or other
non-routine scenarios involving exposures to the public. These general
guidelines allow for a comparison of the degree of benefit or
usefulness to risk for each product.
There is no single dose level that is acceptable for all products.
For example, there are two relevant class exemptions for which dose
criteria form the primary basis for approving a particular product in
licensing. The associated regulations present examples of specific
acceptable doses for specific classes of products. One covers self-
luminous products, which can be used for a multitude of purposes. For
these products, the primary routine dose criterion is 1 mrem (10
[micro]Sv)/year. The class exemption for gas and aerosol detectors
allows for a more limited set of purposes, which more clearly present a
benefit to society, as their purpose must be to protect health, safety,
or property. The primary routine dose criterion for the gas and aerosol
detector exemption is 5 mrem (50 [micro]Sv)/year. These limits are both
a small fraction of the current limit for doses to the public of 100
mrem (1 mSv)/year. At the time the policy was written, the recommended
limit for exposures to individual members of the public was 500 mrem (5
mSv)/year to the whole body, with additional specific organ limits. As
a result, somewhat higher doses from the use of consumer products could
have been acceptable at that time. Providing general guidelines in
terms of fractions of the recommended limits to the public from all
sources continues to be considered the best approach because it is
appropriate for the acceptable levels to be in proportion to the
overall limits and for more beneficial products to be allowed to result
in a somewhat larger fraction of the overall recommended limit than
products with limited benefit.
Paragraph 1 provides a general statement of the current level of
impact from all consumer products and a level of dose from the combined
effect of multiple products at which the NRC will reconsider this
policy. There is no way to fully quantify the total doses that
individuals in the population are likely to receive as the net effect
of products distributed for use under exemptions. The policy is
intended to minimize the possibility that members of the public will
receive a total dose from exposure to all sources (excluding natural
background and medical exposures) that exceeds the public dose limit.
Putting a specific value on the significant fraction of the public dose
limit that might trigger the Commission to reconsider the policy would
not be appropriate because (1) a specific value could imply a higher
degree of certainty in any estimate of the actual cumulative impact
than is possible, (2) the value may depend on how much other sources
are expected to be contributing to the exposure of the public at any
given time, and (3) the value may depend on the degree of benefit being
obtained from the products most contributing to the cumulative
exposure.
In general, the NRC does not expect the cumulative impact of
consumer products to ever reach a level triggering a concern because
the policy is designed to prevent unnecessary exposures and to keep
individual doses a fraction of the public dose limit and as low as
reasonably achievable. The balancing of impacts and benefits inherent
in the policy is intended to ensure that only products that present a
positive net benefit to society (i.e., justified products) are
approved. Although justification of practice is a concept that applies
to all practices involving the use of radioactive material, it is
particularly relevant to the approval of consumer products. This is
primarily because a large portion of, or essentially the entire,
[[Page 2910]]
population may be exposed. If large numbers of products were widely
distributed for use by the general public, many individuals in the
population would be exposed to a multitude of products and potentially
receive a significant cumulative dose. The consumer market is also
where unjustified products are most likely to be proposed and where any
reversal of a decision on a product is most difficult to implement.
Although new products have continued to be developed and approved
for use by the general public, the NRC did not need to revise the
policy to be more restrictive based on the criterion in paragraph 1 of
the policy. This is because, in addition to the application of the
justification principle limiting the total number of products approved,
some products approved and used in the past have declined in use for
various reasons. In addition, as the industry has matured, the amount
of radioactive material used in products has often been reduced.
Finally, this update of the policy does not constitute a
substantive change to the Commission's basis for decisions in this
area. There is no intent to be less restrictive as a result. For all of
these reasons, no changes to the Statement of Policy have been made in
response to these comments.
Comment: One commenter requested more detailed guidance on how the
NRC might deny applications based on potential uses; thought that there
should be definitions of ``useful,'' ``frivolous,'' ``adornment,'' and
``toy;'' and included suggestions for such definitions. This was
discussed in relation to paragraph 3 of the Statement of Policy.
Response: The NRC believes that paragraph 3 is clear. Some of the
words mentioned by the commenter are used in the policy and will be
interpreted in a manner that is consistent with their normal dictionary
definitions. Therefore, there is no need to add definitions to the
policy.
Comment: The same commenter recommended further guidance on what is
meant by ``an unusual degree of utility and safety'' with regard to the
statement in paragraph 4 of the Statement of Policy that applications
of ``off-the-shelf'' items that are subject to mishandling will be
approved only if they are found to combine an unusual degree of utility
and safety. In this context, the commenter noted that the NRC has in
the past rejected products for use under exemption based on the fact
that ``the end use of the product could not easily be foreseen.'' The
commenter interprets this criterion by stating, ``[w]hat the NRC means
by this statement is that the possible misuses of the product can be
foreseen.'' The commenter's concerns were that distributors should not
be held liable for intentional misuse of products and that products
should not be banned because of the possibility of misuse.
Response: The words ``an unusual degree of utility and safety'' in
paragraph 4 cannot be further specified so as to fit every situation.
Rather, each product must be evaluated on a case-by-case basis.
Paragraph 4 simply means that if a product appears to have a high
likelihood of being mishandled, especially by children, it would be
acceptable only if the potential doses are relatively low and the
product is unusually beneficial. The NRC notes that products are not
banned based solely on the possibility that the product can be
mishandled; instead, the probability of misuse and particularly the
magnitude of potential doses that could occur as a result of misuse are
considered. In any event, distributors are not held liable for the
intentional misuse of their products that have been properly
distributed.
The policy does not include a specific criterion of being able to
foresee the end use of a product. However, the NRC must be able to
determine whether the product warrants exemption from licensing and
being unable to foresee the end use of a product limits the ability of
the NRC to evaluate a number of considerations that are addressed in
the policy. Under the policy, the likely doses, the probability and
severity of accidents and misuse, and the benefits to be obtained from
allowing the product to be used under exemption are factors to be
considered. These factors cannot be reasonably evaluated if the
ultimate uses of the product are not known.
The Commission did, however, include a criterion in the regulations
of being able to foresee the end use of a product for approval of
specific products proposed for use under the class exemption for self-
luminous products. These regulations specifically provide that the NRC
may deny an application for a distribution license if the end uses of
the product cannot be reasonably foreseen. The commenter is incorrect,
however, in the interpretation of this criterion in the regulations
that this means that possible misuses of the product can be foreseen.
This criterion is not related primarily to misuse but rather to the
ability to project how people are likely to be exposed to the
radioactive material within or the radiation produced by a product, as
well as the conditions under which the product would be used. Self-
luminous products in particular have a wide range of potential
applications and might easily be widely used for purposes other than
those originally intended if not clearly designed for a specific use.
This criterion also ensures that the uses (not the occasional misuse)
of radioactive material in products are justified. The NRC considers
the potential for unintended end uses that may occur on a widespread
basis differently from misuse or ``mishandling'' as used in paragraph 4
of the policy, although the NRC recognizes that, in some cases, a
product with relatively wide open end uses might also be more likely to
be misused.
Comment: With regard to paragraph 8 of the Statement of Policy,
which discusses the use of other limitations, such as quality control
and testing, considered important to health and safety, one commenter
suggested that the phrase ``radiation doses to users'' be used in place
of ``health and safety.''
Response: The commenter did not provide a basis for this suggested
change. In addition, the suggested replacement words would not be
appropriate, as it is not only doses to users that are relevant but
also doses to others who may be exposed at any time throughout the
lifecycle of the product.
Comment: With regard to subparagraph 9(b), which states that a
principal consideration in evaluating proposals for the use of
radioactive materials in consumer products is the potential total
cumulative radiation dose to individuals in the population who may be
exposed to radiation from a number of products, one commenter asked the
following questions: What method is used to determine the type and
number of products? How are the number and type of products a person is
exposed to controlled? Is this possibly misinterpreted to be ``from a
number of pathways'' available from the product?
Response: The phrase ``from a number of products'' in subparagraph
9(b) is not misinterpreted to be from a number of pathways from the
same product but rather concerns exposures from many products.
Subparagraph 9(b) covers an overall intent to reduce the likelihood
that large segments of the population would receive a significant
cumulative radiation dose from being exposed to many exempt products.
Because products approved for use under exemptions from licensing are
no longer under regulatory control, the number and type of products a
person is exposed to cannot be controlled nor determined. Instead, the
NRC collects information on the total number of the various types of
products distributed and looks broadly at the overall impact
[[Page 2911]]
of all products being distributed. A complete reevaluation of the
number and type of products a person may be exposed to is not conducted
each time a petition is received for an exemption for a new product.
New products expected to be widely distributed and to expose much
of the population warrant a more careful weighing of impacts and
benefits, and more attention to ensuring that doses will be as low as
is reasonably achieveable (ALARA), if the product is approved, than
those that are likely to have limited distribution. This helps ensure
minimization of the likelihood that large segments of the population
would receive a significant cumulative radiation dose from being
exposed to many exempt products.
Comment: One commenter asked for further information on the
criteria used to evaluate public benefit mentioned as a principal
consideration in evaluating a product in subparagraph 9(d) of the
Statement of Policy.
Response: Benefits come in a wide variety of ways and some are not
quantifiable. The benefits that may accrue to society from a particular
product must be evaluated on a case-by- case basis; this often involves
an exercise in judgment. International guidance recognizes that
government authorities must make value judgments in determining whether
a practice is justified (i.e., the benefit outweighs the harm). Due to
the low doses that normally result from products used under exemptions
from licensing, it would not be necessary for the benefit of a product
to accrue to the individuals exposed; rather, any benefits to society
as a whole can be considered.
Comment: One commenter asked what criteria are used to determine if
children can access a product.
Response: Aspects such as product size and likely storage or use
locations might be factors affecting accessibility to children. Again,
consideration of such matters requires judgment and evaluation on a
case-by-case basis. It would not be possible for the NRC to establish
generic criteria that could be applied to every situation.
Comment: One commenter suggested that subparagraph 10(d) of the
Statement of Policy, which concerns the potential of a radionuclide to
cause internal doses, be reworded to replace the term ``exposures''
with the term ``doses'' to be consistent with ICRP and National Council
on Radiation Protection and Measurements (NCRP) terminology.
Response: The NRC agrees that the word ``dose'' is more appropriate
than ``exposure'' in some instances in the policy, including in
subparagraph 10(d), and has made such changes.
Comment: This commenter also recommended that the NRC consider
quantification of both external doses and internal doses (from
inhalation, ingestion, and dermal absorption) when evaluating new
consumer products.
Response: The NRC does quantify both external and internal doses
when evaluating new consumer products. Much of the policy, however, is
intentionally general with respect to the use of the terms
``exposures'' and ``doses.'' These terms cover both external or
internal exposures. In subparagraph 9(a), the policy specifies
consideration of both external and internal exposures.
Comment: One of the comment letters recommended recognition of an
AEC/NRC practice that has evolved subsequent to 1965 to require, when
practical, labeling or marking of the product, stating that this
practice is consistent with the ALARA principle and recognizes the
consumers' and others' interest in radiation. This comment letter made
the point that labeling of the product and its point-of-sale package
enables consumers and others to make informed decisions about
acquisition, use, and disposal of the product and also noted an
assumption that omission of the recognition of current NRC labeling and
marking requirements in the published policy update was an oversight
and not a change in policy about informing the public.
Response: Labeling was not mentioned in the policy because it is
not a factor in considering the initial approval of a product for use
under an exemption. Labeling is, however, a consideration in
determining requirements for manufacturers and distributors when they
subsequently distribute an approved product. Impacts to health and
safety are controlled through both constraints in an exemption and the
requirements placed on the manufacturers and distributors. Examples of
typical distributor requirements are among the topics in paragraph 8 of
the Statement of Policy. The NRC agrees that labeling may be an
important matter and has added mention of labeling to that paragraph.
The NRC notes that, while labeling was considered an important
issue for some products, the agency has not had a uniform policy of
always requiring labeling of consumer or other products for the purpose
of informing purchasers and others of the presence of radioactive
material. In the past, the Commission was more inclined to require
labeling when it was a matter of safety (i.e., when a user may
reasonably minimize one's exposure with proper handling). This practice
is indeed consistent with the ALARA principle. The description in the
comment letter of the evolving practice of requiring labeling, when
practical, is correct, at least as new exemptions were added. With the
recent revisions made to 10 CFR part 40 (May 29, 2013; 78 FR 32310),
this practice has been more uniformly applied by adding labeling
requirements for some older exemptions from licensing.
The draft Statement of Policy published for public comment has been
further revised to clarify points not addressed by the comments. Most
importantly, in the area of accident risks in paragraph 2 of the draft
Statement of Policy, the upper limit of potential doses to individuals
was characterized as approaching a level that could cause immediate
effects being negligible. This has been revised to state that the
probability of individual doses exceeding a level that could cause
effects for which there is a threshold dose must be negligible.
IV. Statement of Policy
Products Intended for Use by the General Public (Consumer Products)
Criteria for the approval of products containing radioactive
material and intended for use by the general public.
The U.S. Nuclear Regulatory Commission (NRC) issues this Policy
Statement to set forth its 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, ``Rules of General Applicability to
Domestic Licensing of Byproduct Material,'' 10 CFR part 40, ``Domestic
Licensing of Source Material,'' or 10 CFR part 70, ``Domestic 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
[[Page 2912]]
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 dose from multiple consumer products becoming a significant
fraction of the permissible dose to members of 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
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 the NRC's regulations and as
recommended by such groups as the International Commission on
Radiological Protection, the National Council on Radiation Protection
and Measurements, and the U.S. Environmental Protection Agency, and
that the probability of individual doses exceeding the limits is low.
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. However, in
any case, the probability of individual doses exceeding a level that
could cause effects for which there is a threshold dose must be
negligible, even in the event of severe accidents involving the numbers
of a product that may be present during distribution.
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 a product may result in widespread use of
radioactive material, such as in common household items, the degree of
usefulness and benefit 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 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 predate 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, and tungsten wire in such things as electric lamps and
vacuum tubes) to impart desirable physical properties.
6. The Commission has 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 the case of class exemptions
covering a class of products, specific safety criteria are included in
the regulations, which require the applicant to evaluate many pathways
of exposure of the public. In some cases, other limitations considered
important to health and safety, such as quality control and testing,
are also specified. In most cases, labeling of the product, when
practical, or the point-of-sale packaging is required to inform
purchasers and others of the presence of radioactive material.
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, storage, 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 dose to the
general population from the uncontrolled disposal and dispersal into
the environment of radioactive materials from products authorized by
the Commission; and
(d) The societal benefit that will accrue to or be denied because
of the usefulness 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. Detailed evaluation of potential doses will
take into consideration the following factors, together with other
considerations that 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 doses from intakes.
Materials that result in lower dose when taken into the body would be
considered more favorably than materials that result in higher doses
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 that 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 that are inaccessible to children and other persons during use
will be considered more favorably than those that are accessible.
Dated at Rockville, Maryland, this 9th day of January, 2014.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2014-00730 Filed 1-15-14; 8:45 am]
BILLING CODE 7950-01-P