Codification of Animal Testing Policy, 38751-38754 [2012-15883]
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Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules
transportation, is being kept as a pet in
a family household in the United States
and any dog or cat which, at the time
of transportation, is shipped as part of
a commercial shipment on a scheduled
passenger flight, including shipments by
trainers and breeders.
§ 235.2
Applicability.
This part applies to the scheduled
domestic and international passenger
service of any U.S. air carrier that
operates such service with at least one
aircraft having a designed seating
capacity of more than 60 passenger
seats.
loss, injury, and death of animals.
Report ‘‘0’’ for any category for which
there were no such incidents. If the
carrier had no reportable incidents for
that calendar year, it shall report ‘‘0’’ in
each category.
(2) The December report must contain
the following certification signed by
your authorized representative: ‘‘I, the
undersigned, do certify that this report
has been prepared under my direction
in accordance with the regulations in 14
CFR Part 235. I affirm that, to the best
of my knowledge and belief, this is a
true, correct and complete report.’’
[FR Doc. 2012–16024 Filed 6–28–12; 8:45 am]
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§ 235.3 Reports by air carriers on
incidents involving animals during air
transport.
BILLING CODE 4910–9X–P
(a) Each covered carrier shall, within
15 days after the end of the month to
which the information applies, submit
to the United States Department of
Transportation’s Aviation Consumer
Protection Division a report on any
incidents involving the loss, injury, or
death of an animal during air transport
provided by the air carrier, including
incidents on flights by that carrier that
are operated with aircraft having 60 or
fewer seats. The report shall be made in
the form and manner set forth in
reporting directives issued by the
Deputy General Counsel for the U.S.
Department of Transportation and shall
contain the following information:
(1) Carrier and flight number;
(2) Date and time of the incident;
(3) Description of the animal,
including name, if applicable;
(4) Name and contact information of
the owner(s), guardian and/or shipper of
the animal;
(5) Narrative description of the
incident;
(6) Narrative description of the cause
of the incident;
(7) Narrative description of any
corrective action taken in response to
the incident; and
(8) Name, title, address, and
telephone number of the individual
filing the report on behalf of the air
carrier.
(b) Within 15 days after the end of
December of each year, each covered
carrier shall submit the following
information (this information may be
included in any report that the carrier
may file for the loss, injury, or death of
animals during the month of December):
(1) The total number of incidents
involving an animal during air transport
provided by the air carrier for the entire
calendar year, including incidents on
flights by that carrier that are operated
with aircraft having 60 or fewer seats.
The report shall include subtotals for
CONSUMER PRODUCT SAFETY
COMMISSION
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[Docket No. CPSC–2012–0037]
16 CFR Part 1500
Codification of Animal Testing Policy
Consumer Product Safety
Commission.
ACTION: Proposed Statement of Policy on
Animal Testing
AGENCY:
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.
SUMMARY:
Written comments and
submissions in response to this notice
must be received by September 12,
2012.
DATES:
You may submit comments,
identified by Docket No. CPSC–2012–
0037, by any of the following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
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:
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38751
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
https://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 https://
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
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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; https://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
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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 https://
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:
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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,
§ 104, 122 Stat. 3016 (August 14, 2008).
2. Add a new section 1500.232 to read
as follows:
§ 1500.232
Policy.
Statement on Animal Testing
(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.
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(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: https://
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: https://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 https://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 § 1500.3(c)(1) and
(2) and the test method outlined in
§ 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.
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Approved modifications are identified
on the Web site at: https://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
§ 1500.3(c)(1) and (2) and the test
method described in § 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: https://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 § 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
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38753
animal free mobility and access to food
and water.
(c) Ocular irritation—A weight-ofevidence 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: https://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 Commissionapproved in vitro assay for ocular
irritancy should be run to assess eye
irritation potential and determine
labeling. Valid in vitro assays are
identified at: https://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 § 1500.42.
(iii) When any ocular irritancy testing
on animals is considered necessary,
including the method described in
§ 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,
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Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules
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: https://
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
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
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 https://
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 https://
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:
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
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.
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:
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
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
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
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:
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SUMMARY:
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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; https://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
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Agencies
[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: https://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 https://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 https://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
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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; https://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
https://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.
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(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: https://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: https://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 https://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: https://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: https://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: https://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: https://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,
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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: https://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