[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Proposed Rules]
[Pages 38751-38754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15883]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2012-0037]

16 CFR Part 1500


Codification of Animal Testing Policy

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed Statement of Policy on Animal Testing

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SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) 
proposes to codify its statement of policy on animal testing, as 
amended, which was previously published in the Federal Register. The 
amended statement of policy on animal testing is intended for 
manufacturers of products subject to the Federal Hazardous Substances 
Act (FHSA) to find alternatives to animal testing and reduce the number 
of animal tests under the FHSA.

DATES: Written comments and submissions in response to this notice must 
be received by September 12, 2012.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2012-
0037, 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, 
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 statement of animal testing policy. 
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; lpatton@cpsc.gov.

SUPPLEMENTARY INFORMATION: 
    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) 
published in the Federal Register on May 30, 1984 (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

[[Page 38752]]

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 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 update its regulations 
on animal testing at 16 C.F.R. part 1500, 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, the Commission proposes to update its statement on 
animal testing policy to reflect the ICCVAM recommendations that have 
been reviewed and adopted by the CPSC as being appropriate tests for 
assessing hazards under the FHSA. In order to make this statement of 
policy more accessible and transparent to interested parties, the 
Commission proposes to codify the policy at 16 CFR 1500.232.
    Since this is a statement of policy, a delayed effective date is 
not required. 5 U.S.C. 553(d)(2). A delayed effective date is not 
required for the additional reason that this policy is not a 
substantive rule. 5 U.S.C. 553(d)(3). Accordingly, this codification 
will become effective upon the publication of a final policy statement 
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.
    For the reasons given above, the Commission proposes to amend 16 
CFR part 1500 as follows:

PART 1500--[AMENDED]

    1. The authority for part 1500 continues to read 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. Add a new section 1500.232 to read as follows:


Sec.  1500.232  Statement on Animal Testing Policy.

(a) Summary

    (1) The U.S. Consumer Product Safety Commission issues this 
statement of policy on animal testing and alternatives to animal 
testing of hazardous substances regulated under the Federal Hazardous 
Substances Act (FHSA). The FHSA requires appropriate cautionary 
labeling on certain household products to alert consumers to the 
potential hazard(s) that the products may present. Among the hazards 
addressed by the FHSA are toxicity, corrosivity, sensitization, and 
irritation.
    (2) In order to determine the appropriate cautionary labeling, it 
is necessary to have objective criteria by which the existence of each 
hazard can be determined. Hazards such as toxicity, tissue 
corrosiveness, eye irritancy, and skin irritancy result from the 
biological response of living tissue and organs to the presence of the 
hazardous substance. One means of characterizing these hazards is to 
use animal testing as a proxy for the human reaction. In fact, the FHSA 
defines the hazard category of ``highly toxic'' in terms of animal 
toxicity when groups of 10 or more rats are exposed to specified 
amounts of the substance. The Commission's regulations under the FHSA 
concerning toxicity and irritancy allow the use of animal tests to 
determine the presence of the hazard when human data or existing animal 
data are not available.
    (3) Neither the FHSA nor the Commission's regulations require 
animal testing. The FHSA 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 a minimum number of 
animals, and the policy also advocates measures that eliminate or 
reduce the pain or discomfort to animals that can be associated with 
such tests. The Commission has prepared this statement of policy with 
respect to animal testing to encourage the manufacturers subject to the 
FHSA to follow a similar policy.

[[Page 38753]]

    (4) In making the appropriate hazard determinations, manufacturers 
of products subject to the FHSA should use existing alternatives to 
animal testing whenever possible. These include prior human experience, 
literature sources that record the results of prior animal testing or 
limited human tests, and expert opinion. The Commission recommends 
resorting to animal testing only when the other information sources 
have been exhausted. At this time, the Commission recommends use of the 
most humane procedures with the fewest animals possible to achieve 
reliable results. Recommended procedures are summarized in the 
following statement and can be accessed on the Commission's Web page 
at: http://www.cpsc.gov/businfo/animaltesting.html.

(b) Statement of Policy on Animal Testing.

    (1) The Commission reviews staff recommendations on alternative 
test methods developed by the scientific and regulatory communities. 
Current descriptions of test method recommendations approved by the 
Commission can be accessed via the Internet at: http://www.cpsc.gov/businfo/animaltesting.html. Overall, the Commission prefers test 
methods that reduce stress and suffering in test animals and that use 
none or fewer animals while maintaining scientific integrity. The 
Commission strongly supports the use of validated alternatives to 
animal testing. The following parts of this section outline some of 
these alternatives. Testing laboratories and other interested persons 
requiring assistance interpreting the results obtained when a substance 
is tested in accordance with the methods described here, or in 
following the testing strategies outlined in this statement of policy 
and the regulations under 16 CFR part 1500, should refer to the 
Commission's animal testing Web page at http://www.cpsc.gov/businfo/animaltesting.html.
    (a) Acute toxicity--The traditional FHSA animal test for acute 
toxicity determines the median lethal dose (LD50) or lethal 
concentration (LC50), the dose or concentration that is 
expected to kill half the test animals. Procedures for determining the 
median LD50/LC50 are described in section 2(h)(1) 
of the FHSA and supplemented in Sec.  1500.3(c)(1) and (2) and the test 
method outlined in Sec.  1500.40. The Commission recommends using 
modifications of the traditional LD50/LC50 test 
during toxicity testing that reduce the number of animals tested, 
whenever possible. Approved modifications are identified on the Web 
site at: http://www.cpsc.gov/businfo/animaltesting.html and include:
    (i) In vitro and in vivo test methods that have been scientifically 
validated and approved for use in toxicity testing by the Commission;
    (ii) Valid in vitro methods to estimate a starting dose for an 
acute in vivo test;
    (iii) A sequential version of the traditional LD50/
LC50 tests described in Sec.  1500.3(c)(1) and (2) and the 
test method described in Sec.  1500.40, in which dose groups are run 
successively rather than simultaneously;
    (iv) A limit-dose test, where the LD50/LC50 
is determined as a point estimate, which can still be used to 
categorize a hazard, although it gives no information on hazard dose 
response.
    (b) Dermal irritation/corrosivity--A weight-of-evidence analysis is 
recommended to evaluate existing information before in vivo dermal 
irritation testing is considered to determine appropriate cautionary 
labeling. This analysis should incorporate any existing data on humans 
and animals, validated in vitro test results (valid tests are 
identified on the Commission's animal testing Web site at: http://www.cpsc.gov/businfo/animaltesting.html), the substance's dermal 
toxicity, evidence of corrosivity/irritation of one or more 
structurally related substances or mixtures of such substances, data 
demonstrating low or high pH (<= 2 or >= 11.5) of the substance, and 
any other relevant physicochemical properties that indicate the 
substance might be a dermal corrosive or irritant. If there is any 
indication from this analysis that the substance is either corrosive or 
irritating to the skin, the substance should be labeled appropriately. 
If the substance is not corrosive in vitro, but no data exist regarding 
its irritation potential, human patch testing should be considered. If 
in vitro data are unavailable, and human patch testing is not an 
option, a tiered in vivo animal test is recommended.
    (i) In a tiered in vivo dermal study, a single rabbit is tested 
initially. If the outcome is positive for corrosivity, testing is 
stopped, and the substance is labeled appropriately. If the substance 
is not corrosive, two more rabbits should be patch-tested to complete 
the assessment of skin irritation potential.
    (ii) If a tiered test is not feasible, the Commission recommends 
the test method described in Sec.  1500.41. Note that in any in vivo 
dermal irritation test method, the Commission recommends using a semi-
occlusive patch to cover the animal's test site, and eliminating the 
use of stocks for restraint during the exposure period, thereby 
allowing the animal free mobility and access to food and water.
    (c) Ocular irritation--A weight-of-evidence analysis is recommended 
to evaluate existing information before any in vivo ocular irritation 
testing is considered. This analysis should incorporate any existing 
data on humans and animals, validated in vitro test data (identified on 
the Commission's animal testing Web site at: http://www.cpsc.gov/businfo/animaltesting.html), the substance's dermal corrosivity/
irritation (primary skin irritants and corrosives are also usually eye 
irritants, and therefore, do not need to be tested in the eye), 
evidence of ocular irritation of one or more structurally related 
substances or mixtures of such substances, data demonstrating high 
acidity or alkalinity of the substance, and any other relevant 
physicochemical properties that indicate that the substance might be a 
dermal corrosive or irritant or ocular irritant.
    (i) When the weight-of-evidence is insufficient to determine a 
substance's ocular irritation, a Commission-approved in vitro assay for 
ocular irritancy should be run to assess eye irritation potential and 
determine labeling. Valid in vitro assays are identified at: http://www.cpsc.gov/businfo/animaltesting.html. If no valid in vitro test 
exists, the test strategy for determining dermal corrosion/irritation 
outlined in section (b)(ii) above can be followed to determine ocular 
irritation.
    (ii) If the dermal test strategy outlined in section (b)(ii) leads 
to a conclusion of not corrosive, a tiered in vivo ocular irritation 
test should be performed, in which a single rabbit is exposed to the 
substance initially. If the outcome of this initial test is positive, 
testing is stopped, and the substance is labeled an eye irritant. If 
the outcome of this initial test is negative, one to two more rabbits 
are tested for ocular irritation, and the outcome of this test will 
determine the label. If a tiered test is not feasible, the Commission 
recommends the test method described in Sec.  1500.42.
    (iii) When any ocular irritancy testing on animals is considered 
necessary, including the method described in Sec.  1500.42, the 
Commission recommends a threefold plan to reduce animal suffering: (1) 
The use of preemptive pain management, including topical anesthetics 
and systemic analgesics that eliminate or reduce suffering that may 
occur as a result of the application process or from the test substance 
itself; (2) post-treatment with systemic analgesics for pain relief; 
and (3) implementation of humane endpoints, including scheduled 
observations,

[[Page 38754]]

monitoring, and recording of clinical signs of distress and pain, and 
recording the nature, severity, and progression of eye injuries. The 
specific techniques that have been approved by the Commission can be 
found at: http://www.cpsc.gov/businfo/animaltesting.html.

    Dated: June 25, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-15883 Filed 6-28-12; 8:45 am]
BILLING CODE 6355-01-P