[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Proposed Rules]
[Pages 38754-38758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15882]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2012-0036]

16 CFR Part 1500


Hazardous Substances and Articles; Administration and Enforcement 
Regulations: Notice of Proposed Rulemaking; Revisions to Animal Testing 
Regulations

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 amend and to update regulations on the CPSC's 
animal testing methods under the Federal Hazardous Substances Act 
(FHSA).

DATES: Written comments must be received by September 12, 2012.

ADDRESSES: You may submit comments identified by Docket No. CPSC-2012-
0036, 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, 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. 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: Leslie E. Patton, Ph.D., Project 
Manager, Office of Hazard Identification and Reduction, U.S. Consumer 
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 
telephone (301) 504-7848; [email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    The Federal Hazardous Substances Act (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. The FHSA and the Commission regulations at 16 CFR part 
1500 provide certain test methods related to testing on animals to 
determine the existence of the hazards addressed by the FHSA.
    On May 30, 1984, the Commission adopted an animal testing policy 
that minimized the number of test animals required for toxicity testing 
and clarified when animal testing might be needed (1984 Policy) (49 FR 
22522). These guidelines advised product manufacturers to use 
alternatives to animal testing whenever possible, including: (1) Prior 
human experience, (2) existing animal or limited human test results, 
and (3) expert opinion. The 1984 Policy stated:

    It is important to keep in mind that neither the FHSA nor the 
Commission's regulations require any firm to perform animal tests. 
The statute and its implementing regulations only require that a 
product be labeled to reflect the hazards associated with that 
product. While animal testing may be necessary in some cases, 
Commission policy supports limiting such tests to the lowest 
feasible number and taking every feasible step to eliminate or 
reduce the pain or discomfort that can be associated with such 
tests. * * * The Commission resorts to animal testing only when the 
other information sources have been exhausted. Furthermore, the FHSA 
regulations, at 16 CFR 1500.4, clearly state that reliable human 
experience shall take precedence over different results from animal 
data.

    Id. at 22523. The 1984 Policy also stated that if non-animal test 
systems for prediction of toxicity and irritancy are accepted by the 
scientific community as adjuncts or alternatives to whole-animal 
testing, ``[The CPSC Directorate for] Health Sciences will incorporate 
the techniques into the Commission's compliance program to the extent 
feasible and will recommend any changes to the Commission's statutes or 
regulations that may become appropriate as the result of advances in 
testing methods that are developed.'' Id.
    Since the 1984 Policy, there have been new methods accepted by the 
scientific community as replacements or adjuncts to animal tests for 
predictions of toxicity and irritancy. Such developments in testing 
have been made in recent years, particularly since the National 
Institutes of Health Revitalization Act was passed in 1993 (Pub. L. 
103-43, Section 1301), directing the National Institute of 
Environmental Health Sciences (NIEHS) to establish a method and 
criteria for the validation and regulatory acceptance of alternative 
testing methods. The NIEHS created the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM; http://iccvam.niehs.nih.gov/home.htm), which was made permanent by the ICCVAM 
Authorization Act of 2000, Public Law 106-545. The duties of ICCVAM are 
to review, optimize, and validate new, revised, or alternative test 
methods that encourage the reduction, refinement, or replacement of the 
use of animals in testing. ICCVAM has representatives from 15 federal 
regulatory and research agencies, including the CPSC. These agencies 
generate, use, or provide information from toxicity test methods for 
risk assessment purposes. In addition, ICCVAM provides test 
recommendations to federal agencies and other stakeholders to 
facilitate appropriate interagency and international harmonization of 
toxicological test protocols.
    ICCVAM submits recommendations for a test method to federal 
agencies that require or recommend acute or chronic toxicological 
testing. According to Public Law 106-545, these agencies should promote 
and encourage the development and use of alternatives to animal test 
methods for regulatory purposes, and ensure that any new or revised 
acute or chronic toxicity test method is valid for its proposed use. 
Federal agencies have 180 days from the

[[Page 38755]]

time of submission to identify any relevant test methods for which the 
ICCVAM test recommendations may be added or substituted, review such 
test recommendations, and notify ICCVAM if they will adopt the ICCVAM 
test recommendations. Since 2003, the Commission has approved, where 
applicable, the recommendations made by ICCVAM to reduce and refine 
animal testing applicable to test methods under the FHSA. In order to 
make the ICCVAM recommendations and Commission's animal testing policy 
more accessible and transparent to interested parties, the Commission 
proposes to codify its updated animal testing policy at 16 CFR 
1500.232, published elsewhere in this Federal Register, and establish a 
Web page on the CPSC's Web site at http://www.cpsc.gov/businfo/animaltesting.html regarding the ICCVAM recommendations and new 
developments in test methods that further reduce or refine animal 
testing.
    In addition, to reflect more accurately the ICCVAM recommendations 
and updated test methods approved by the Commission, this proposed rule 
amends the Commission's regulations that interpret, supplement, or 
provide alternatives to definitions on animal test methods used to aid 
in the classification of hazardous substances under the FHSA.

 B. Proposed Amendments

    All of the proposed amendments to 16 CFR part 1500 clarify or add 
language to explain that alternative test methods exist that avoid or 
reduce animal testing, which have been approved by the Commission.

1. Definition of Highly Toxic

    Currently, the test methods in section 1500.3(c)(1)(ii) A-C, used 
in the definitions of oral, inhalation, and dermal toxicity, 
respectively, each describe a method for defining a substance as highly 
toxic. The definition of highly toxic is:

    (i) A substance determined by the Commission to be highly toxic 
on the basis of human experience; and/or (ii) A substance that 
produces death within 14 days in half or more than half of a group 
of: (A) White rats (each weighing between 200 and 300 grams) when a 
single dose of 50 milligrams or less per kilogram of body weight is 
administered orally; (B) White rats (each weighing between 200 and 
300 grams) when a concentration of 200 parts per million by volume 
or less of gas or vapor, or 2 milligrams per liter by volume or less 
of mist or dust, is inhaled continuously for 1 hour or less, if such 
concentration is likely to be encountered by man when the substance 
is used in any reasonably foreseeable manner; and/or (C) Rabbits 
(each weighing between 2.3 and 3.0 kilograms) when a dosage of 200 
milligrams or less per kilogram of body weight is administered by 
continuous contact with the bare skin for 24 hours or less by the 
method described in Sec.  1500.40. The number of animals tested must 
be sufficient to give a statistically significant result and shall 
be in conformity with good pharmacological practices.

    The proposed amendment makes clear that the animal tests are not 
the only means to test or define a product's toxicity under the FHSA, 
nor are they the only methods used by the CPSC to assess product 
toxicity. Because there are other Commission-approved test methods that 
may be used by CPSC staff or the public for toxicity testing and 
defining a substance as highly toxic, as reflected in the ICCVAM 
recommendations and outlined in the CPSC'statement of policy on animal 
testing published elsewhere in this Federal Register, the proposed rule 
adds language under new section 1500.3(c)(1)(iii) as follows: A 
substance that produces a result of `highly toxic' in any of the 
approved test methods described in the CPSC's animal testing policy set 
forth in 16 CFR 1500.232.

2. Definition of Toxic

    Currently, the test methods in section 1500.3(c)(2)(i) A-C, used in 
the definitions of oral, inhalation, and dermal toxicity, respectively, 
each describe a method for defining a substance as toxic. The 
definition of toxic is:

    (i) Any substance that produces death within 14 days in half or 
more than half of a group of: (A) White rats (each weighing between 
200 and 300 grams) when a single dose of 50 milligrams to 5 grams 
per kilogram of body weight is administered orally. Substances 
falling in the toxicity range between 500 milligrams and 5 grams per 
kilogram of body weight will be considered for exemption from some 
or all of the labeling requirements of the act, under Sec.  1500.82, 
upon a showing that such labeling is not needed because of the 
physical form of the substances (solid, a thick plastic, emulsion, 
etc.), the size or closure of the container, human experience with 
the article, or any other relevant factors; and/or (B) White rats 
(each weighing between 200 and 300 grams) when a concentration of 
more than 200 parts per million but not more than 20,000 parts per 
million by volume of gas or vapor, or more than 2 but not more than 
200 milligrams per liter by volume of mist or dust, is inhaled 
continuously for 1 hour or less, if such concentration is likely to 
be encountered by man when the substance is used in any reasonably 
foreseeable manner; and/or (C) Rabbits (each weighing between 2.3 
and 3.0 kilograms) when a dosage of more than 200 milligrams but not 
more than 2 grams per kilogram of body weight is administered by 
continuous contact with the bare skin for 24 hours by the method 
described in Sec.  1500.40. The number of animals tested must be 
sufficient to give a statistically significant result and shall be 
in conformity with good pharmacological practices.

    The proposed amendment makes clear that the animal tests are not 
the only means to test or define a product's toxicity under the FHSA, 
nor are they the only methods used by the CPSC to assess product 
toxicity. Because there are other Commission-approved test methods that 
may be used by CPSC staff or the public for toxicity testing and 
defining a substance as toxic, as reflected in the ICCVAM 
recommendations, and outlined in the CPSC's statement of policy on 
animal testing published elsewhere in this Federal Register, the 
proposed rule adds language under new section 1500.3(c)(2)(iii) as 
follows: Toxic also applies to any substance that can be labeled as 
such, based on the outcome of any of the approved test methods 
described in the CPSC's animal testing policy set forth in 16 CFR 
1500.232.

3. Definition of Corrosive

    16 CFR 1500.3(c)(3) currently states that: Corrosive means a 
substance that causes visible destruction or irreversible alterations 
in the tissue at the site of contact. A test for a corrosive substance 
is whether, by human experience, such tissue destruction occurs at the 
site of application. A substance would be considered corrosive to the 
skin if, when tested on the intact skin of the albino rabbit by the 
technique described in Sec.  1500.41, the structure of the tissue at 
the site of contact is destroyed or changed irreversibly in 24 hours or 
less. Other appropriate tests should be applied when contact of the 
substance with other than skin tissue is being considered.
    The method of testing described in Sec.  1500.41 is a test for 
acute dermal toxicity. The proposed rule amends this definition to make 
explicit that the animal testing is not the only testing method used or 
accepted by the CPSC, or the preferred method. Accordingly, the 
proposed rule adds the following text (in underline) to section 16 CFR 
1500.3(c)(3):

    Corrosive means a substance that causes visible destruction or 
irreversible alterations in the tissue at the site of contact. A 
test for a corrosive substance is whether, by human experience, such 
tissue destruction occurs at the site of application. A substance 
would be considered corrosive to the skin if a weight-of-evidence 
analysis suggests that it is corrosive or if, when tested by the in 
vivo technique described in Sec.  1500.41, the structure of the 
tissue at the site of contact is destroyed or changed irreversibly 
in 24

[[Page 38756]]

hours or less. Other appropriate tests should be applied when 
contact of the substance with other than skin tissue is being 
considered. A substance could also be labeled corrosive based on the 
outcome of any of the approved test methods described in the CPSC's 
animal testing policy set forth in 16 CFR 1500.232.

4. Definition of Irritant, Primary Irritant, and Eye Irritant

    Currently, 16 CFR 1500.3(c)(4) provides that the test methods for 
irritant, primary irritant, and eye irritant reference 16 CFR 1500.41 
and 1500.42, which each describe a specific animal test method and 
outcome. For example, 16 CFR 1500.41 states that primary irritation to 
the skin is measured by a patch-test technique on the abraded and 
intact skin of the albino rabbit, clipped free of hair. A minimum of 
six subjects are used in the skin tests. To test for eye irritants, 16 
CFR 1500.42 requires the use of six albino rabbits. Such tests require 
the test material be placed in one eye of each animal, while the other 
eye remains untreated, to serve as a control to assess the grade of 
ocular reaction.
    The proposed rule clarifies that the method for testing for 
irritant substances should not be based solely on these specific animal 
tests because there are other scientifically valid ways of testing for 
irritants, including methods that do not use animals. Accordingly, the 
proposed rule adds the following text (in underline) to section 
1500.3(c)(4):

    The definition of irritant in section 2(j) of the act (restated 
in paragraph (b)(8) of this section) is supplemented by the 
following: Irritant includes primary irritant to the skin, as well 
as substances irritant to the eye or to mucous membranes. Primary 
irritant means a substance that is not corrosive and that human 
experience data indicate is a primary irritant; and/or means a 
substance that results in an empirical score of five or more when 
tested by the method described in 1500.41; and/or a substance that 
can be considered a primary irritant based on the outcome of any of 
the approved test methods described in the CPSC's animal testing 
policy set forth in 16 CFR 1500.232. Eye irritant means a substance 
that human experience data indicate is an irritant to the eye; and/
or means a substance for which a positive test is obtained when 
tested by the method described in 1500.42; and/or means a substance 
that can be considered an eye irritant based on the outcome of any 
of the approved test methods described in the CPSC's animal testing 
policy set forth in 16 CFR 1500.232.

5. Method of Testing Toxic Substances

    The method of testing toxic substances is set forth under 16 CFR 
1500.40. This method details an acute dermal toxicity assay using 
rabbits. The method is referenced in Sec.  1500.3(c)(1)(ii)(C) and 
Sec.  1500.3(c)(2)(C). Although the method described in Sec.  1500.40 
is one way of assessing a substance's acute dermal toxicity, this 
method is not mandatory, and it is not the only or preferred method for 
evaluating dermal toxicity. Accordingly, the proposed rule adds the 
following text (in underline) to Sec.  1500.40 immediately after the 
heading titled, ``Method of testing toxic substances'':

    Guidelines for testing the toxicity of substances, including 
testing that does not require animals, are presented in the CPSC's 
animal testing policy set forth in 16 CFR 1500.232. A weight-of-
evidence analysis is recommended to evaluate existing information 
before in vivo tests are considered. This analysis, when deemed 
necessary to carry out, should include any of the following: 
existing human and animal data, in vitro data, structure activity 
relationships, physicochemical properties, and chemical reactivity. 
When in vivo testing is necessary, a sequential testing strategy is 
recommended to reduce the number of test animals.

6. Method of Testing Primary Irritant Substances

    The method of testing primary irritant substances is set forth 
under 16 CFR 1500.41. This method details an acute dermal toxicity 
assay using rabbits. The method is referenced in Sec. Sec.  
1500.3(c)(3) and 1500.3(c)(4). Although the method described in Sec.  
1500.41 is one way of assessing a substance's dermal irritation/
corrosivity, this method is not mandatory, and it is not the only or 
preferred method for evaluating a substance's dermal irritation/
corrosivity. Accordingly, the proposed rule adds the following text (in 
underline) to Sec.  1500.41 immediately after the heading titled, 
``Method of testing primary irritant substances'':

    Guidelines for testing the dermal irritation and corrosivity 
properties of substances, including testing that does not require 
animals, are presented in the CPSC's animal testing policy set forth 
in 16 CFR 1500.232. A weight-of-evidence analysis is recommended to 
evaluate existing information before in vivo tests are considered. 
This analysis should include all of the following that are 
available: human and animal data, structure activity relationships, 
physicochemical properties, and dermal toxicity. When in vivo 
testing is necessary, a sequential testing strategy is recommended 
to reduce the number of test animals. The method of testing the 
dermal corrosivity and primary irritation of substances referred to 
in Sec. Sec.  1500.3(c)(3) and (4), respectively, is a patch-test 
technique on the abraded and intact skin of the albino rabbit, 
clipped free of hair * * *

7. Test for Eye Irritants

    Section 1500.42 of 16 CFR provides a detailed animal test for eye 
irritation. The method is referenced in Sec.  1500.3(c)(4), which 
defines irritation. Although the method described in Sec.  1500.42 is 
one way of assessing a substance's properties of ocular irritation, 
this method is not mandatory, and it is not the only or preferred 
method of assessing a substance's properties of ocular irritation. 
Accordingly, the proposed rule adds the following text (in underline) 
to Sec.  1500.42 immediately after the heading titled, ``Test for eye 
irritants'':

    Guidelines for in vivo and in vitro testing of ocular irritation 
of substances, including testing that does not require animals, are 
presented in the CPSC's animal testing policy set forth in 16 CFR 
1500.232. A weight-of-evidence analysis is recommended to evaluate 
existing information before in vivo tests are considered. This 
analysis should include any of the following: existing human and 
animal data on ocular or dermal irritation, structure activity 
relationships, physicochemical properties, and chemical reactivity. 
When in vivo testing is necessary, a sequential testing strategy is 
recommended to reduce the number of test animals. Additionally, the 
routine use of topical anesthetics, systemic analgesics, and humane 
endpoints to avoid or minimize pain and distress in ocular safety 
testing is recommended.
    (a)(1) In the method of testing the ocular irritation of a 
substance referred to in Sec.  1500.3(c)(4), six albino rabbits are 
used for each test substance * * *

8. Editorial Changes

    The proposed rule eliminates the reference in Sec.  1500.42(c) to 
the ``Illustrated Guide for Grading Eye Irritation by Hazardous 
Substances,'' and the accompanying note. The referenced guide is out of 
print, and photocopies are rare. Instead, the proposed rule amends 
Sec.  1500.42(c) to reference guidelines from the U.S. Environmental 
Protection Agency (EPA) and the Organisation for Economic Co-operation 
and Development (OECD) as follows:

    To assist testing laboratories and others interested in 
interpreting ocular irritation test results, the CPSC animal testing 
policy Web page at http://www.cpsc.gov/businfo/animaltesting.html 
will contain the scoring system defined in the U.S. EPA's Test 
Guideline, OPPTS 870.2400: Acute Eye Irritation \1\ or the OECD Test 
Guideline 405: Acute Eye Irritation/Corrosion.\2\
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    \1\ EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400 
Acute Eye Irritation. EPA 712-C-98-195. Washington, DC: U.S. 
Environmental Protection Agency. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf).
    \2\ OECD. 2002. OECD Guideline for the Testing of Chemicals 405: 
Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-
operation and Development. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf).

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[[Page 38757]]

C. 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.
    The Commission's Directorate for Economic Analysis prepared a 
preliminary assessment of the impact of amending the regulations on 
animal testing. That assessment found that there would be little or no 
effect on small businesses and other entities because the proposed 
amendments will not result in product modifications in order to comply, 
and they will not result in additional testing or recordkeeping 
burdens. Based on the foregoing assessment, the Commission 
preliminarily finds that the proposed rule would not have a significant 
impact on a substantial number of small entities.

D. 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.

E. Executive Orders

    According to Executive Order 12988 (February 5, 1996), agencies 
must state in clear language the preemptive effect, if any, of new 
regulations. The preemptive effect of regulations such as this proposed 
rule is stated in section 18 of the FHSA. 15 U.S.C. 1261n.

F. 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.

G. 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 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]

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

    Authority:  15 U.S.C. 1261-1278, 122 Stat. 3016; the Consumer 
Product Safety Improvement Act of 2008, Pub. L. 110-314, Sec.  104, 
122 Stat. 3016 (August 14, 2008).

    2. Amend section 1500.3 by adding new paragraphs (c)(1)(iii) and 
(c)(2)(iii) and revise paragraphs (c)(3) and (c)(4), to read as 
follows:


Sec.  1500.3  Definitions.

* * * * *
    (c) * * *
    (1) * * *
    (iii) A substance that produces a result of `highly toxic' in any 
of the approved test methods described in the CPSC's animal testing 
policy set forth in 16 CFR 1500.232.
    (2) * * *
    (iii) Toxic also applies to any substance that can be labeled as 
such, based on the outcome of any of the approved test methods 
described in the CPSC's animal testing policy set forth in 16 CFR 
1500.232.
    (3) Corrosive means a substance that causes visible destruction or 
irreversible alterations in the tissue at the site of contact. A test 
for a corrosive substance is whether, by human experience, such tissue 
destruction occurs at the site of application. A substance would be 
considered corrosive to the skin if a weight-of-evidence analysis 
suggests that it is corrosive or if, when tested by the in vivo 
technique described in Sec.  1500.41, the structure of the tissue at 
the site of contact is destroyed or changed irreversibly in 24 hours or 
less. Other appropriate tests should be applied when contact of the 
substance with other than skin tissue is being considered. A substance 
could also be labeled corrosive based on the outcome of any of the 
approved test methods described in the CPSC's animal testing policy set 
forth in 16 CFR 1500.232.
    (4) The definition of irritant in section 2(j) of the act (restated 
in paragraph (b)(8) of this section) is supplemented by the following: 
Irritant includes primary irritant to the skin, as well as substances 
irritant to the eye or to the mucous membranes. Primary irritant means 
a substance that is not corrosive and that human experience data 
indicate is a primary irritant; and/or means a substance that results 
in an empirical score of five or more when tested by the method 
described in Sec.  1500.41; and/or a substance that can be considered a 
primary irritant based on the outcome of any of the approved test 
methods described in the CPSC's animal testing policy set forth in 16 
CFR 1500.232. Eye irritant means a substance that human experience data 
indicate is an irritant to the eye; and/or means a substance for which 
a positive test is obtained when tested by the method described in 
Sec.  1500.42; and/or means a substance that can be considered an eye 
irritant based on the outcome of any of the approved test methods 
described in the CPSC's animal testing policy set forth in 16 CFR 
1500.232.
* * * * *
    3. Amend section 1500.40 by revising the introductory text to read 
as follows:


Sec.  1500.40  Method of testing toxic substances.

    Guidelines for testing the toxicity of substances, including 
testing that does not require animals, are presented in the CPSC's 
animal testing policy set forth in 16 CFR 1500.232. A weight-of-
evidence analysis is recommended to evaluate existing information 
before in vivo tests are considered. This analysis, when deemed 
necessary to carry out, should include any of the following: existing 
human and animal data, in vitro data, structure activity relationships, 
physicochemical properties, and chemical reactivity. When in vivo 
testing is necessary, a sequential testing strategy is recommended to 
reduce the number of test animals. The method of testing the toxic 
substances referred to in Sec.  1500.3(c)(1)(ii)(C) and (2)(iii) is as 
follows:
* * * * *
    4. In Sec.  1500.41, add five sentences at the start of the 
introductory text to read as follows:


Sec.  1500.41  Method of testing primary irritant substances.

    Guidelines for testing the dermal irritation and corrosivity 
properties of substances, including testing that does not require 
animals, are presented in the CPSC's animal testing policy set forth in 
16 CFR 1500.232. A weight-of-evidence analysis is recommended to 
evaluate existing information before in vivo tests are considered. This 
analysis should include all of the following that are available: Human 
and animal data, structure activity relationships, physicochemical 
properties, and dermal

[[Page 38758]]

toxicity. When in vivo testing is necessary, a sequential testing 
strategy is recommended to reduce the number of test animals. The 
method of testing the dermal corrosivity and primary irritation of 
substances referred to in Sec. Sec.  1500.3(c)(3) and (4), 
respectively, is a patch-test technique on the abraded and intact skin 
of the albino rabbit, clipped free of hair. * * *
    5. Amend section 1500.42 by adding introductory text, adding a 
sentence at the beginning of paragraph (a)(1), and revising paragraph 
(c) to read as follows:


Sec.  1500.42  Test for eye irritants.

    Guidelines for in vivo and in vitro testing of ocular irritation of 
substances, including testing that does not require animals, are 
presented in the CPSC's animal testing policy set forth in 16 CFR 
1500.232. A weight-of-evidence analysis is recommended to evaluate 
existing information before in vivo tests are considered. This analysis 
should include any of the following: Existing human and animal data on 
ocular or dermal irritation, structure activity relationships, 
physicochemical properties, and chemical reactivity. When in vivo 
testing is necessary, a sequential testing strategy is recommended to 
reduce the number of test animals. Additionally, the routine use of 
topical anesthetics, systemic analgesics, and humane endpoints to avoid 
or minimize pain and distress in ocular safety testing is recommended.
    (a)(1) In the method of testing the ocular irritation of a 
substance referred to in Sec.  1500.3(c)(4), six albino rabbits are 
used for each test substance * * *
* * * * *
    (c) To assist testing laboratories and others interested in 
interpreting ocular irritation test results, the CPSC animal testing 
policy Web page at http://www.cpsc.gov/businfo/animaltesting.html will 
contain the scoring system defined in the U.S. EPA's Test Guideline, 
OPPTS 870.2400: Acute Eye Irritation \3\ or the OECD Test Guideline 
405: Acute Eye Irritation/Corrosion.\4\
---------------------------------------------------------------------------

    \3\ EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400 
Acute Eye Irritation. EPA 712-C-98-195. Washington, DC: U.S. 
Environmental Protection Agency. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf).
    \4\ OECD. 2002. OECD Guideline for the Testing of Chemicals 405: 
Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-
operation and Development. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf).

    Dated: June 25, 2012.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2012-15882 Filed 6-28-12; 8:45 am]
BILLING CODE 6355-01-P