[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

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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