Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 38751 

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. 

§ 235.3 Reports by air carriers on 

incidents involving animals during air 

transport. 

(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 

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] 

BILLING CODE 4910–9X–P 

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: 

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 


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38752 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 

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, 

§ 104, 122 Stat. 3016 (August 14, 2008). 

2. Add a new section 1500.232 to read 

as follows: 

§ 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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Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 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 § 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. 

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 

§ 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: 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 § 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-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: 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 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: 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 § 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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38754 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: 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 

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. 

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; 

lpatton@cpsc.gov. 

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 


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