### 38751 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.

**§ 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


### 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.


### 38753 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules

(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.htm l.

(a) Acute toxicity —The traditional FHSA animal test for acute toxicity
determines the median lethal dose (LD 50 ) or lethal concentration (LC 50 ), the dose or concentration that is expected to
kill half the test animals. Procedures for determining the median LD 50/LC 50 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 LD 50/LC 50 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 LD 50/LC 50 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 LD 50/

LC 50 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’socular 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,


### 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