[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15883]
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
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:
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
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; [email protected].
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
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
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:
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.
(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
(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.
(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
(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
(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
(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
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