[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Proposed Rules]
[Pages 15660-15664]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05577]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2013-0010]

16 CFR Part 1500


Hazardous Substances and Articles; Supplemental Definition of 
``Strong Sensitizer''

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The U.S. Consumer Product Safety Commission (CPSC or 
Commission) proposes to update the supplemental definition of ``strong 
sensitizer'' under the Federal Hazardous Substances Act (FHSA). The 
proposed amendment clarifies or adds language to eliminate redundancy, 
remove certain subjective factors, incorporate new and anticipated 
technology, rank the criteria for classification of strong sensitizers 
in order of importance, define criteria for ``severity of reaction,'' 
and indicate that a weight-of-evidence approach will be used to 
determine the strength of the sensitizer.

DATES: Written comments must be received by May 28, 2013.

ADDRESSES: You may submit comments identified by Docket No. CPSC-2013-
0010, by any of the following methods:
     Electronic Submissions
    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    To ensure timely processing of comments, the Commission is no 
longer accepting comments submitted by electronic mail (email) except 
through www.regulations.gov.
     Written Submissions
    Submit written submissions in the following way:
    Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, to: Office of the Secretary, 
U.S. Consumer Product Safety Commission, Room 820, 4330 East West 
Highway, Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this proposed rulemaking. All comments received 
may be posted without change, including any personal identifiers, 
contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
electronically.

[[Page 15661]]

Such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Joanna Matheson, Ph.D., Project 
Manager, Office of Hazard Identification and Reduction, U.S. Consumer 
Product Safety Commission, 5 Research Place, Rockville, MD 20850; 
telephone (301) 987-2564; jmatheson@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Background

    The FHSA, 15 U.S.C. 1261-1278, requires appropriate cautionary 
labeling on certain hazardous household products to alert consumers to 
the potential hazards that a product may present. Among the hazards 
addressed by the FHSA are products that are toxic, corrosive, 
irritants, flammable, combustible, or strong sensitizers.
    Included within the FHSA's definition of ``hazardous substance'' is 
``any substance or mixture of substances'' that ``is a strong 
sensitizer,'' 15 U.S.C. 1261(f)(1)(iv). Section 2(k) of the FHSA, 15 
U.S.C. 1261(k), defines ``strong sensitizer'' as:

    A substance which will cause on normal living tissue through an 
allergic or photodynamic process a hypersensitivity which becomes 
evident on reapplication of the same substance and which is 
designated as such by the Commission. Before designating any 
substance a strong sensitizer, the Commission, upon consideration of 
the frequency of occurrence and severity of the reaction, shall find 
that the substance has a significant potential for causing 
hypersensitivity.

    On August 12, 1961, the Food and Drug Administration (FDA) (which 
at that time administered the FHSA), issued regulations under the FHSA 
that supplemented the statutory definition of ``strong sensitizer.'' 
The regulations also provided a list of substances that the FDA had 
determined met the statutory definition for ``strong sensitizer.'' The 
five substances identified were: (1) Paraphenylenediamine and products 
containing it; (2) powdered orris root and products containing it; (3) 
epoxy resins systems containing in any concentration ethylenediamine, 
diethylenetriamine, and diglycidyl ethers of molecular weight less than 
200; (4) formaldehyde and products containing 1 percent or more of 
formaldehyde; and (5) oil of bergamot and products containing 2 percent 
or more of oil of bergamot. No additional substances have been 
determined to be ``strong sensitizers'' by the FDA or the Commission 
since promulgation of this regulation.
    In 1973, the responsibility for the administration of the FHSA was 
transferred to the Commission, and the supplemental definition of 
``strong sensitizer'' was published in title 16 of the Code of Federal 
Regulations. On May 30, 1984, the Commission revoked the above 
supplemental definition of ``strong sensitizer.'' 49 FR 22464. The 
Commission concluded at that time that the statutory definition of 
``strong sensitizer'' was adequate for any future regulatory 
determination that a substance is a strong sensitizer.
    On August 14, 1986, the Commission issued a rule supplementing the 
definition of ``strong sensitizer'' in the FHSA, 51 FR 29094, which 
currently is in effect. 16 CFR 1500.3(c)(5). As recommended by a 
Technical Advisory Panel on Allergic Sensitization (TAPAS), the 
supplemental definition clarifies how the statutory definition should 
be interpreted and explains the factors the Commission will consider in 
determining whether a substance is a ``strong sensitizer.'' The 
supplemental definition states that an ``allergic'' response is one 
that is directed by the immune system, such that a sensitization 
reaction could not be caused by an irritant or other nonallergenic 
qualities of the substance. The supplemental definition also clarifies 
that active sensitizers--substances that produce a sensitivity reaction 
solely as the result of a person's first exposure to the substance as 
opposed to after reapplication of the same substance--are included 
within the class of substances that can be determined to be strong 
sensitizers. The supplemental definition did not address strong 
sensitizers that cause hypersensitivity by a photodynamic process, 
principally because Commission staff was unaware of any household 
product subject to the FHSA that would cause significant exposure of 
consumers to a photodynamic chemical.
    The current supplemental definition makes clear that a sensitivity 
reaction could occur after the sensitizer is applied to the body's 
tissues by contact, ingestion, or inhalation; that relevant exposure is 
not limited to skin contact; and that targets for hypersensitivity 
reactions include the skin and other organ systems, such as the 
respiratory or gastrointestinal tracts, either alone or in combination. 
The supplemental definition states that the minimal severity of the 
reaction caused by the substance for purposes of determining whether 
the substance is a strong sensitizer is a clinically important allergic 
reaction and provides examples of such clinically important reactions. 
Whether a substance has a significant potential for causing 
hypersensitivity is a relative determination that must be made 
separately for each substance under consideration by the Commission. 
The supplemental definition sets forth the criteria to be considered in 
making this determination. Finally, the supplemental definition 
provides the quantitative and qualitative factors that the Commission 
should consider in determining that a substance is a ``strong'' 
sensitizer, such as the frequency of occurrence and range of severity 
in normal and susceptible populations and the results of experimental 
assays in humans and animals.
    Recognizing that the science on sensitization has changed since 
promulgation of the supplemental definition in 1986, the CPSC convened 
a panel of scientific experts from academia, industry, and the federal 
government to examine the available scientific and medical information 
concerning sensitizers, and if appropriate, propose revisions to the 
supplemental definition of strong sensitizer.

B. Effect of Strong Sensitizer Determination

    The Commission is proposing to revise its supplemental definition 
of strong sensitizer. Additional Commission action would be needed for 
any substance to be designated a strong sensitizer. In order for the 
Commission to issue a rule declaring any particular substance (or 
product containing that substance) to be a strong sensitizer, it must 
engage in notice and comment rulemaking, separate from this rulemaking, 
and make the findings specified in 15 U.S.C. 1261(k), i.e., that based 
upon consideration of the frequency of occurrence and the severity of 
the reaction, the substance has a significant potential for causing 
hypersensitivity. However, a determination that a substance is a strong 
sensitizer does not automatically trigger a labeling requirement for 
products containing that substance. Under the FHSA a substance (or 
product containing that substance) that is a hazardous substance 
requires appropriate labeling. 15 U.S.C. 1261(p). If manufacturers of 
products containing a designated strong sensitizer determine that the 
strong sensitizer in their products may cause substantial injury or 
illness as a result of reasonably foreseeable handling or use, that 
product would be a ``hazardous substance'' as defined under the FHSA, 
and therefore would warrant

[[Page 15662]]

appropriate labeling. Alternatively, where there is uncertainty, the 
Commission has the option under section 3(a)(1) of the FHSA to 
determine through notice and comment rulemaking that a product 
containing a strong sensitizer is a ``hazardous substance.'' Hazardous 
substances intended or packaged in a form suitable for use in the 
household that do not bear the appropriate cautionary labeling would be 
considered ``misbranded'' in violation of the FHSA. 15 U.S.C. 1261(p).
    Such cautionary labeling would be insufficient, however, if a toy 
or other article intended for the use of children is, bears, or 
contains a hazardous substance (as that term is defined in section 2(f) 
of the FHSA), and the hazardous substance is accessible to a child to 
whom the article is entrusted. Under that scenario, the toy or 
children's article would be considered a ``banned hazardous substance'' 
under section 2(q)(1)(A) of the FHSA unless a particular exemption 
applies. 15 U.S.C. 1261(q)(1)(A).

 C. Proposed Amendment

    The proposed amendment to 16 CFR part 1500 clarifies or adds 
language to the supplemental definition of ``strong sensitizer'' to 
eliminate redundancy, remove certain subjective factors, incorporate 
new and anticipated technology, rank the criteria for classification of 
strong sensitizers in order of importance, define criteria for 
``severity of reaction,'' and indicate that a weight-of-evidence 
approach will be used to determine the strength of the sensitizer.
    1. Definition of sensitizer. The current definition of sensitizer 
in Sec.  1500.3(c)(5) is, ``a substance that will induce an 
immunologically-mediated (allergic) response, including allergic 
photosensitivity. The allergic reaction will become evident upon 
reexposure to the same substance. Occasionally, a sensitizer will 
induce and elicit an allergic response on first exposure by virtue of 
active sensitization.''
    The proposed amendment reflects the traditional definition for 
sensitization; sensitization is a multi-stage immune mediated process 
which occurs over a period of time. Under the proposed amendment, those 
substances that sensitize through atypical mechanisms, rather than by 
inducing an obvious ``immunologically-mediated response'' will be 
captured by the assessment process. The proposed amendment also 
eliminates the last sentence of the current definition based on 
concerns that it may be misinterpreted such that substances that cause 
an irritant response only \1\ (the response that is noted after the 
first exposure to a substance is more frequently an irritant response 
and not an allergic response) could be erroneously included in the 
category of ``strong sensitizers.'' Typically, allergic responses are 
the result of a two-step process: (1) Induction (sensitization) which 
requires sufficient or cumulative exposure to induce an immune response 
with few or no symptoms and (2) elicitation when an individual who has 
been sensitized demonstrates symptoms upon subsequent exposures. The 
phrase ``variable period of exposure'' is included in the proposed 
amendment to reflect the latency period which is a characteristic in 
the development of sensitization.
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    \1\ An ``irritant response'' is a nonimmune mediated response 
and one that results from direct injury to the tissue. An irritant 
is any agent that is capable of producing cell damage in any 
individual if applied for sufficient time and concentration.
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    2. Definition of significant potential for causing hypersentivity. 
Currently, 16 CFR 1500.3(c)(5)(iv) provides that '' `significant 
potential for causing hypersensitivity' is a relative determination 
that must be made separately for each substance. It may be based upon 
the chemical or functional properties of the substance, documented 
medical evidence of allergic reactions obtained from epidemiological 
studies surveys or individual case reports, controlled in vitro or in 
vivo experimental assays, or susceptibility profiles in normal or 
allergic subjects.''
    The proposed revision to this section reiterates the statutory 
requirement that before designating any substance a ``strong'' 
sensitizer, the Commission must find that the substance has significant 
potential for causing hypersensitivity. The proposed revision adds 
qualifiers for susceptibility profiles--genetics, age, gender, and 
atopic status-- to the list of information or data that may be 
considered in determining whether a substance has a significant 
potential for causing hypersensitivity; and the proposed revision also 
replaces the term ``normal'' with ``non-sensitized.'' These 
characteristics are well-known modifiers in the development and 
exacerbation of allergic responses to chemical sensitizers; and 
replacing the term ``normal'' with ``non-sensitized'' reflects more 
accurately what would be considered the general control population.
    The proposed revision of this section also incorporates a 
discussion of the factors to be considered in determining whether a 
substance is a ``strong'' sensitizer. The current supplemental 
definition of ``strong sensitizer'' contains a separate subsection that 
sets forth factors that should be considered in determining the 
strength of a sensitizer. (16 CFR 1500.3(c)(5)(ii)). The current 
section includes several factors that are subjective rather than 
quantitative (i.e., physical discomfort, distress, hardship) and allows 
for risk assessment considerations in connection with an analysis that 
should only be a hazard characterization step.
    The current definition of strong reads:

    In determining that a substance is a ``strong'' sensitizer, the 
Commission shall consider the available data for a number of 
factors. These factors include any and or all of the following (if 
available): Quantitative or qualitative risk assessment, frequency 
of occurrence and range of severity of reactions in healthy or 
susceptible populations, the result of experimental assays in 
animals or humans (considering dose-response factors), with human 
data taking precedence over animal data, other data on potency or 
bioavailability of sensitizers, data on reactions to a cross-
reacting substance or to a chemical that metabolizes or degrades to 
form the same or a cross-reacting substance, the threshold of human 
sensitivity, epidemiological studies, and other appropriate in vivo 
or in vitro test studies.

    The proposed amendment eliminates the ``quantitative or qualitative 
risk assessment factor'' because the Commission believes this 
terminology is a source of confusion in that it places a risk 
assessment step within the hazard identification step of the overall 
process of determining whether a product containing a strong sensitizer 
requires labeling. The proposed amendment makes clear that a weight-of-
the-evidence approach is to be used in determining the strength of a 
sensitizer because of the imprecise nature of some of the current 
factors and the potential lack of information or data available to 
permit useful consideration of certain factors. Rather than allowing an 
``any or all'' approach to what factors would be considered by the 
Commission in determining whether a sensitizer is strong, the amendment 
ranks data sources in order of importance, following the FHSA 
preference for human data over animal data; and the amendment takes 
into consideration the value and relevance that certain data would 
provide in evaluating the potential of a substance to cause 
hypersensitivity. For example, the proposed amendment expresses a 
preference for general population epidemiological studies over 
occupational studies because the degree of sensitization in the 
workplace is likely to be greater than that of the general population, 
due to greater

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exposure (both in time and concentration) to the sensitizing agent.
    The proposed amendment provides that for a substance to be 
considered a ``strong'' sensitizer the substance must be found to 
produce a ``clinically important reaction,'' which is defined as a 
reaction with a significant impact on the quality of life. Examples of 
such reactions included in the proposed revision to this section are 
substantial physical discomfort or distress, substantial hardship, 
functional or structural impairment, or chronic morbidity. The proposed 
revision to this section also directs the Commission to consider the 
location of the hypersensitivity response, such as the face, hands, and 
feet, and the persistence of clinical manifestations in determining 
whether the substance produces a ``clinically important reaction.''
    The proposed revision to this section adds several factors the 
Commission can consider in determining a substance's sensitizing 
potential, for which validated methods currently do not exist but are 
in development, such as: Quantitative Structure-Activity Relationships 
(QSARs), and in silico \2\ data, along with the caveat that using these 
techniques would be in addition to consideration of human and animal 
data. We expect that in vitro and in silico validated methods will be 
available as part of an integrated testing strategy within the next 5 
years, and including these components in the amendment ensures that the 
definition is compatible with current science. The proposed revision 
also includes a definition of ``bioavailability'' (i.e., the dose of 
the substance available to interact with a tissue and that tissue's 
ability to absorb the substance and the actual penetrating ability of 
the substance).
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    \2\ QSARs are mathematical models that relate a quantitative 
measure of chemical structure to biological activity. In silico data 
is a computational approach using sophisticated computer models for 
the determination of a sensitizing potential. Both of these 
approaches are evolving methodologies that have not yet been 
validated, but are being pursued as testing options that would 
reduce the numbers of expensive laboratory and animal experiments 
being carried out.
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    3. Definition of Normal Living Tissue. Currently, 16 CFR 
1500.3(c)(5)(v) defines normal living tissue as:

the skin and other organ systems, such as the respiratory or 
gastrointestinal tract, either singularly or in combination, 
following sensitization by contact ingestion or inhalation.

    The proposed revision adds a specific reference to mucous 
membranes, such as ocular and oral systems, as types of normal living 
tissue upon which a substance can cause a hypersensitivity that 
warrants a determination that a substance is a ``strong sensitizer.''
    4. Definition of Severity of Reaction. The current definition for 
severity of reaction at 16 CFR 1500.3(c)(5)(iii)) states that the 
minimal severity of a reaction for the purpose of designating a 
material as a ``strong sensitizer'' is a clinically important reaction, 
and provides examples of the types of illnesses that could satisfy this 
criteria, such as physical discomfort, distress, hardship, or 
functional or structural impairment.
    The proposed amendment eliminates this subsection and incorporates 
the factors to be considered in determining whether a substance is a 
``strong'' sensitizer into the proposed revised section Significant 
potential for causing hypersensitivity.

D. Staff Guidance and Notice of Availability

    Commission staff has developed a guidance document that is intended 
to clarify the ``strong sensitizer'' definition and assist 
manufacturers in understanding how CPSC staff would assess whether a 
substance and/or product containing that substance should be considered 
a ``strong sensitizer.'' A Notice of Availability is published 
elsewhere in this issue of the Federal Register, which provides a link 
to the location on the Commission's Web site where the staff guidance 
document can be found.

E. Impact on Small Businesses

    Under the Regulatory Flexibility Act (RFA), when an agency issues a 
proposed rule, it generally must prepare an initial regulatory 
flexibility analysis describing the impact the proposed rule is 
expected to have on small entities. 5 U.S.C. 603. The RFA does not 
require a regulatory flexibility analysis if the head of the agency 
certifies that the rule will not have a significant effect on a 
substantial number of small entities. Id. 605(b).
    The Commission's Directorate for Economic Analysis prepared a 
preliminary assessment of the impact of revising the supplemental 
definition of ``strong sensitizer.'' That assessment found that there 
would be little or no effect on small businesses and other entities 
because the proposed amendment, which simply modifies the existing 
supplemental definition of ``strong sensitizer,'' will not result in 
product modifications to comply; nor will the revised supplemental 
definition impose any additional testing or recordkeeping burdens. The 
obligation to label a product as a ``strong sensitizer'' and any costs 
associated with that obligation will not arise until the Commission has 
designated a substance contained in the product as a ``strong 
sensitizer,'' which would occur only in connection with a separate 
notice and comment rulemaking proceeding. Thereafter, we would assess 
the potential small business impact of designating the particular 
substance as a strong sensitizer. Moreover, the proposed amendment is 
not expected to impose any indirect burden on small businesses or other 
entities because it is not expected to lead to any additional 
substances being designated as strong sensitizers that would not be so 
designated in the absence of the amendment. Based upon the foregoing 
assessment, the Commission finds preliminarily that the proposed rule 
would not have a significant impact on a substantial number of small 
entities.

F. Environmental Considerations

    Generally, CPSC rules are considered to ``have little or no 
potential for affecting the human environment,'' and environmental 
assessments and environmental impact statements are not usually 
prepared for these rules (see 16 CFR 1021.5(c)(1)). The Commission does 
not expect the proposed rule to have any adverse impact on the 
environment under this categorical exclusion.

G. Executive Orders

    According to Executive Order 12988 (February 5, 1996), agencies 
must state in clear language the preemptive effect, if any, of new 
regulations. Section 18 of the FHSA addresses the preemptive effect of 
certain rules issued under the FHSA. 15 U.S.C. 1261n. Because this 
rulemaking would revise a regulatory definition rather than issue a 
labeling or banning requirement, section 18 of the FHSA does not 
provide for the proposed rule to have preemptive effect.

H. Paperwork Reduction Act

    This rule would not impose any information collection requirements. 
Accordingly, this rule is not subject to the Paperwork Reduction Act, 
44 U.S.C. 3501-3520.

I. Effective Date

    The Administrative Procedure Act generally requires that a 
substantive rule be published not less than 30 days before its 
effective date, unless the agency finds, for good cause shown, that a 
lesser time period is required. 5 U.S.C. 553(d)(3). We propose that the 
rule would take effect 30 days after

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publication of a final rule in the Federal Register.

List of Subjects in 16 CFR Part 1500

    Consumer protection, Hazardous substances, Imports, Infants and 
children, Labeling, Law enforcement, Reporting and recordkeeping 
requirements, and Toys.

    Accordingly, 16 CFR part 1500 is proposed to be amended as follows:

PART 1500--[AMENDED]

0
1. The authority citation for part 1500 continues to reads as follows:

    Authority: 15 U.S.C. 1261-1278.

0
2. In Sec.  1500.3, revise paragraph (c)(5) to read as follows:


Sec.  1500.3  Definitions.

* * * * *
    (c) * * *
    (5) The definition of strong sensitizer in section 2(k) of the 
Federal Hazardous Substances Act (restated in 16 CFR 1500.3(b)(9)) is 
supplemented by the following definitions:
    (i) Sensitizer. A sensitizer is a substance that is capable of 
inducing a state of immunologically mediated hypersensitivity 
(including allergic photosensitivity) following a variable period of 
exposure to that substance. Hypersensitivity to a substance will become 
evident by an allergic reaction elicited upon reexposure to the same 
substance.
    (ii) Significant potential for causing hypersensitivity. Before 
designating any substance a ``strong sensitizer,'' the Commission shall 
find that the substance has significant potential for causing 
hypersensitivity. Significant potential for causing hypersensitivity is 
a relative determination that must be made separately for each 
substance. It may be based on chemical or functional properties of the 
substance; documented medical evidence of allergic reactions upon 
subsequent exposure to the same substance obtained from epidemiological 
surveys or individual case reports; controlled in vitro or in vivo 
experimental studies; and susceptibility profiles (e.g., genetics, age, 
gender, atopic status) in non-sensitized or allergic subjects.
    (A) In determining whether a substance is a ``strong'' sensitizer, 
the Commission shall consider the available data for a number of 
factors, following a weight-of-evidence approach. The following factors 
(if available), ranked in descending order of importance, should be 
considered: well-conducted clinical and diagnostic studies, 
epidemiological studies, with a preference for general population 
studies over occupational studies, well-conducted animal studies, well-
conducted in vitro test studies, cross-reactivity data, and case 
histories. Criteria for a ``well-conducted'' study would include 
validated outcomes, relevant dosing and route of administration, and 
use of appropriate controls. Studies should be carried out according to 
national and/or international test guidelines and according to good 
laboratory practice (GLP), compliance with good clinical practice 
(GCP), and good epidemiological practice (GEP).
    (B) Before the Commission designates any substance a ``strong'' 
sensitizer, frequency of occurrence and range of severity of reactions 
in exposed subpopulations having average or high susceptibility will be 
considered. The minimal severity of a reaction for the purpose of 
designating a material a ``strong sensitizer'' is a clinically 
important reaction. A clinically important reaction would be considered 
one with loss of function and significant impact on quality of life. 
Consideration should be given to the location of the hypersensitivity 
response, such as the face, hands, and feet and persistence of clinical 
manifestations. For example, strong sensitizers may produce substantial 
illness, including any or all of the following: substantial physical 
discomfort and distress, substantial hardship, functional or structural 
impairment, chronic morbidity.
    (C) Additional consideration may be given to Quantitative 
Structure-Activity Relationships (QSARs), in silico data, specific 
human sensitization threshold values, and other data on potency and 
sensitizer bioavailability, if data are available and methods are 
validated. Bioavailability is the dose of the allergen available to 
interact with a tissue. It is a reflection of how well the skin or 
another organ can absorb the allergen and the actual penetrating 
ability of the allergen, including factors such as size and composition 
of the chemical.
    (iii) Normal living tissue. The allergic hypersensitivity reaction 
occurs in normal living tissues, including the skin, mucous membranes 
(e.g., ocular, oral), and other organ systems, such as the respiratory 
tract, gastrointestinal tract, or either singularly or in combination, 
following sensitization by contact, ingestion, or inhalation.
* * * * *

    Dated: March 7, 2013.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2013-05577 Filed 3-11-13; 8:45 am]
BILLING CODE 6355-01-P