73286 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Rules and Regulations 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2012–24–08 The Boeing Company: 

Amendment 39–17278; Docket No. 

FAA–2012–0186; Directorate Identifier 

2011–NM–268–AD. 

(a) Effective Date 

This AD is effective January 14, 2013. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 737–600, –700, –700C, –800, –900, 

and –900ER series airplanes; certificated in 

any category; as identified in Boeing Alert 

Service Bulletin 737–30A1063, Revision 1, 

dated July 10, 2012. 

(d) Subject 

Joint Aircraft System Component (JASC)/ 

Air Transport Association (ATA) of America 

Code 3030, Pitot/Static Anti-Ice System. 

(e) Unsafe Condition 

This AD was prompted by reports of flight 

crew failure to activate air data probe heat. 

We are issuing this AD to prevent ice from 

forming on air data system sensors and 

consequent loss of or misleading airspeed 

indication on all airspeed indicating systems, 

which could lead to loss of control of the 

airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Modification 

Within 24 months after the effective date 

of this AD: Modify the anti-icing system for 

the angle of attack sensor, the total air 

temperature, and the pitot probes, in 

accordance with the Accomplishment 

Instructions of Boeing Alert Service Bulletin 

737–30A1063, Revision 1, dated July 10, 

2012. 

(h) Credit for Previous Actions 

This paragraph provides credit for actions 

required by paragraph (g) of this AD, if those 

actions were performed before the effective 

date of this AD using Boeing Alert Service 

Bulletin 737–30A1063, dated November 16, 

2011, which is not incorporated by reference 

in this AD. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

For more information about this AD, 

contact Frank Carreras, Aerospace Engineer, 

Systems and Equipment Branch, ANM–130S, 

FAA, Seattle Aircraft Certification Office 

(ACO), 1601 Lind Avenue SW., Renton, WA 

98057–3356; phone: 425–917–6442; fax: 425– 

917–6590; email: frank.carreras@faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Boeing Alert Service Bulletin 737– 

30A1063, Revision 1, dated July 10, 2012. 

(ii) Reserved. 

(3) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, WA 98124–2207; telephone 206– 

544–5000, extension 1; fax 206–766–5680; 

Internet https://www.myboeingfleet.com. 

(4) You may view this service information 

at FAA, Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http:// 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on 

November 23, 2012. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–29469 Filed 12–7–12; 8:45 am] 

BILLING CODE 4910–13–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: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (CPSC or Commission) 

codifies its statement of policy on 

animal testing that provides guidance 

for manufacturers of products subject to 

the Federal Hazardous Substances Act 

(FHSA) regarding replacement, 

reduction, and refinement of animal 

testing methods. 

DATES: Effective January 9, 2013. 

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 

On June 29, 2012, the Commission 

issued a notice of proposed rulemaking 

to amend regulations on the CPSC’s 

animal testing methods under 16 CPR 

part 1500 to clarify alternative test 

methods that replace, reduce, or refine 

animal testing. 77 FR 38754. The final 

rule on the Commission’s regulations on 

animal testing under 16 CFR part 1500 

is published elsewhere in this Federal 

Register. The final rule on revisions to 

the animal testing regulations is 

effective 30 days after publication of the 

rule in the Federal Register. 

In addition, on June 29, 2012, the 

Commission also proposed to codify its 

statement of policy on animal testing to 

reflect new methods accepted by the 

scientific community as replacements, 

reductions, or refinements to animal 

tests including recommendations of and 

test methods of the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM; http://iccvam.niehs.nih.gov/ 

home.htm). 77 FR 38751. Codification at 

16 CFR 1500.232 would make the 

ICCVAM recommendations and 

Commission’s animal testing policy 

more accessible and transparent to 

interested parties. Although the 

Commission proposed to make the 

animal testing policy effective on the 

date of publication in the Federal 

Register, because the animal testing 

policy references sections of the animal 

testing regulations in 16 CFR part 1500, 

we will make the statement of policy 

effective on the same date, 30 days after 

publication of the policy in the Federal 

Register. The Commission has also 

established a Web page on the CPSC’s 

Web site at http://www.cpsc.gov/library/ 

animaltesting.html regarding the 

ICCVAM recommendations and new 

developments in test methods that 

replace, reduce, or refine animal testing. 

After consideration of the comments, 

the Commission codifies its final 

statement of policy on animal testing. 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Rules and Regulations 73287 

B. Response to Comments on the 

Proposed Policy 

In the Federal Register of June 29, 

2012, we published a proposed 

statement of policy on animal testing 

(77 FR 38751). We received two 

comments on the proposed statement. 

One commenter was an individual and 

the other comment was submitted 

jointly by the Alternatives Research and 

Development Foundation, American 

Anti-Vivisection Society, Humane 

Society of the United States, People for 

the Ethical Treatment of Animals, and 

the Physicians Committee for 

Responsible Medicine. Both 

commenters support the use of 

alternative test methods to eliminate or 

reduce the use of animals. 

1. Alternative Test Methods 

Comment: One commenter states that 

alternative test methods approved for 

testing potentially hazardous substances 

were too limited as laid out in the 

Commission’s proposal, and requests 

that the CPSC broaden its 

recommendations to in vitro and in 

silico tests beyond those already 

approved by the Commission through 

ICCVAM. Specifically, the commenter 

recommends adding methods that were 

already approved by other regulatory 

bodies, such as the Organisation for 

Economic Cooperation and 

Development (OECD) or the European 

Centre for the Validation of Alternative 

Methods (ECVAM EURL). The 

commenter further suggests that 

§ 1500.232(b) should include any 

‘‘scientifically acceptable’’ non-animal 

alternative that is ‘‘fit for the purpose,’’ 

not limited to those expressly approved 

by the Commission, nor to those that 

had undergone an official regulatory 

validation process. 

Response: The Commission agrees 

that alternatives outside of those which 

ICCVAM has approved may be 

acceptable for hazard testing. For hazard 

testing for the purpose of labeling under 

FHSA, alternative test methods beyond 

those reviewed and recommended by 

ICCVAM may be acceptable because 

ICCVAM’s purview is not exhaustive. In 

addition, data derived from 

scientifically valid testing methods can 

be used to make hazard determinations 

for substances regulated under FHSA, 

assuming tests are reliable, 

reproducible, and accurate. The 

Commission encourages hazard testing 

that supports the replacement, 

reduction, and refinement of animal test 

methods while simultaneously 

maintaining a high degree of scientific 

integrity. Therefore, if a manufacturer or 

other entity performs a hazard test for 

FHSA labeling purposes that has not 

been previously approved by the 

Commission (i.e., an ICCVAMrecommended test method or one of the 

tests described in the current version of 

the FHSA), CPSC staff will consider the 

data on a case-by-case basis and, upon 

review, determine whether to post the 

test method on the animal testing Web 

site. 

In the final statement of policy, we 

refer to in vitro and in silico methods, 

in general, as alternative test methods 

that a manufacturer may wish to 

consider in lieu of animal testing. We 

also refer generally to methods that have 

been deemed acceptable by other 

national or international organizations, 

but do not refer to them specifically in 

the regulations on animal testing under 

15 CFR 1500.3, 1500.40–42. The CPSC 

animal testing Web page at http:// 

www.cpsc.gov/library/ 

animaltesting.html is the platform on 

which the CPSC will list alternative 

methods. 

Comment: One commenter states that 

the guidance should explicitly state that 

‘‘when faced with a decision between a 

non-animal or animal-based approach, 

the non-animal approach must be 

taken.’’ 

Response: Although the Commission 

is issuing this guidance in part to 

encourage non-animal alternatives to 

testing, it cannot require manufacturers 

to adhere to its guidelines. As stated in 

the CPSC Chronic Hazard Guidelines 

(57 FR 46626, October, 9, 1992), the 

Commission does not enforce guidelines 

as mandatory requirements for 

manufacturers. A manufacturer may 

follow a different but scientifically 

supportable analysis to determine the 

potential hazard of a substance as 

reflected in the alternative test methods 

posted on the CPSC animal testing Web 

page at http://www.cpsc.gov/library/ 

animaltesting.html. 

2. In Vivo Tests 

Comment: One commenter requests 

that all details on in vivo testing 

procedures be deleted from § 1500.232, 

including the LD50/LC50 assays at 

1500.232(b)(1)(i), the method of testing 

dermally toxic substances at 

1500.232(b)(1)(ii), and the ocular 

irritation assay at 1500.232(b)(1)(iii). 

Response: The FHSA currently 

defines acute hazards based on animal 

test results and identifies irritation and 

toxicity tests that use animals. Although 

they are not superior, these in vivo test 

methods remain the baseline to which 

alternative methods are compared and 

therefore should remain in the text. 

Furthermore, the in vivo testing 

described in sections of CFR part 1500 

does remain an option to manufacturers 

performing hazard testing of substances. 

However, the Commission will 

emphasize that the use of in vitro and 

other alternative test methods, including 

a weight-of-evidence approach, and 

prior human experience are 

recommended over in vivo tests 

whenever possible throughout the 

statement of policy. Furthermore, the 

Commission reiterates its preference for 

reliable human experience over animal 

test data. These changes are reflected 

throughout the summary and statement 

of policy. 

3. Dermal Sensitization Test 

Comment: One commenter requests 

the addition of section 

1500.232(b)(1)(iv) on alternative test 

methods for dermal sensitization 

testing. 

Response: The Commission agrees 

and will add the following section to the 

statement of animal testing policy: 

Dermal sensitization—An acceptable in 

vitro test method (examples of valid in vitro 

tests are identified on the Commission’s 

animal testing Web site at: http:// 

www.cpsc.gov/library/animaltesting.html), or 

weight-of-evidence analysis is recommended 

before in vivo animal sensitization testing is 

considered to determine appropriate 

cautionary labeling. The weight-of-evidence 

analysis should incorporate any existing data 

on humans and animals, validated in vitro or 

in silico test results and any other relevant 

physicochemical properties that indicate the 

substance might be a dermal sensitizer. If 

there is any indication from this analysis that 

the substance is sensitizing to the skin, the 

substance should be labeled appropriately. 

4. Other Comments 

Comment: One commenter requests 

that we reorder the paragraphs in 

§ 1500.232(a) to ensure that 

manufacturers first consider the most 

human-relevant data and methods in 

determining appropriate labeling 

Response: The Commission has 

already stated a preference for human 

over animal data throughout the 

statement of policy, and will maintain 

the current order of the paragraphs in 

the animal testing policy. 

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 amends 16 CFR part 1500 

as follows: 

PART 1500—[AMENDED] 

■ 1. The authority for part 1500 

continues to read as follows: 


srobinson on DSK4SPTVN1PROD with 
73288 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Rules and Regulations 

Authority: 15 U.S.C. 1261–1278, 122 Stat. 

3016. 

■ 2. Add § 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 

hazardous 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 requires 

animal testing. The FHSA and its 

implementing regulations only require 

that a product be labeled to reflect the 

hazards associated with that product. If 

animal testing is conducted, 

Commission policy supports limiting 

such tests to a minimum number of 

animals and advocates measures that 

eliminate or reduce the pain or 

discomfort to animals that can be 

associated with such tests. The 

Commission has prepared this statement 

of policy with respect to animal testing 

to encourage the manufacturers subject 

to the FHSA to follow a similar policy. 

(4) In making the appropriate hazard 

determinations, manufacturers of 

products subject to the FHSA should 

use existing alternatives to animal 

testing whenever possible. These 

include: prior human experience (e.g., 

published case studies), in vitro or in 

silico test methods that have been 

approved by the Commission, literature 

sources containing the results of prior 

animal testing or limited human tests 

(e.g., clinical trials, dermal patch 

testing), and expert opinion (e.g., hazard 

assessment, structure-activity analysis). 

If a manufacturer or other entity 

performs a hazard test for FHSA 

labeling purposes that has not been 

previously approved by the 

Commission, CPSC staff will consider 

the data on a case-by-case basis and, 

upon review, determine whether to post 

the test method on the animal testing 

Web site. 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/library/ 

animaltesting.html. If a manufacturer or 

other entity performs a hazard test for 

FHSA labeling purposes that has not 

been previously approved by the 

Commission (e.g., an ICCVAMrecommended test method or one of the 

tests described in the current version of 

the FHSA), CPSC staff will consider the 

data on a case-by-case basis and, upon 

review, determine whether to post the 

test method on the animal testing Web 

site. 

(b) Statement of policy on animal 

testing. (1) Neither the FHSA nor the 

Commission’s regulations requires 

animal testing. Reliable human 

experience always takes precedence 

over results from animal data. In the 

cases where animal tests are conducted, 

the Commission prefers test methods 

that reduce stress and suffering in test 

animals and that use fewer animals 

while maintaining scientific integrity. 

To this end, the Commission reviews 

recommendations on alternative test 

methods developed by the scientific and 

regulatory communities. Current 

descriptions of test method 

recommendations approved by or 

known to the Commission can be 

accessed via the Internet at: http:// 

www.cpsc.gov/library/ 

animaltesting.html. The Commission 

strongly supports the use of 

scientifically sound 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 the section, should 

refer to the Commission’s animal testing 

Web page at: http://www.cpsc.gov/ 

library/animaltesting.html. 

(i) 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 Act and supplemented in 

§ 1500.3(c)(1) and (2) and the test 

method outlined in § 1500.40. The 

Commission recommends in vitro 

alternatives over in vivo LD50/LC50 

tests, or using modifications of the 

traditional LD50/LC50 test during 

toxicity testing that reduce the number 

of animals tested whenever possible. 

Data from in vitro or in silico test 

methods that have not been approved by 

the Commission may be submitted to 

the Commission for consideration of 

their acceptability. Commissionapproved testing alternatives are 

identified on the Web site at: http:// 

www.cpsc.gov/library/ 

animaltesting.html and include: 

(A) In vitro and in vivo test methods 

that have been scientifically validated 

and approved for use in toxicity testing 

by the Commission; 

(B) Valid in vitro methods to estimate 

a starting dose for an acute in vivo test; 

(C) 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; 

(D) 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. In the limit 

test, animals (10 rats) each receive a 

single dose of product at 5g per 

kilogram of body weight. If not more 

than one animal dies in 14 days, the 

product is considered to have an LD50 

of greater than 5g/kg, and thus, deemed 

to be nontoxic. Only if two or more 

animals die is a second group of 10 rats 

tested (at a lower dose). This procedure 

reduces the number of animals tested 

from the 80 to 100 animals involved in 

a full LD50 test to, typically, 10 to 20 

rats per product. This reduction in the 

number of animals tested is justified 

because an exact LD50 is not required 

by either the FHSA or the regulations. 

The FHSA requires only a categorical 

determination that the toxicity is greater 

than 5g/kg, between 50 mg/kg and 5g/ 

kg, or less than 50 mg/kg. 

(ii) Dermal irritation/corrosivity. An 

acceptable in vitro test method or 

weight-of-evidence analysis is 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Rules and Regulations 73289 

recommended before in vivo dermal 

irritation testing is considered to 

determine appropriate cautionary 

labeling. The weight-of-evidence 

analysis should incorporate any existing 

data on humans and animals, validated 

in vitro or in silico test results (valid 

tests are identified on the Commission’s 

animal testing Web site at: http:// 

www.cpsc.gov/library/ 

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, human patch 

testing is not an option, and there are 

insufficient data to determine the 

weight-of-evidence, a tiered in vivo 

animal test is recommended. 

(A) 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. 

(B) 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 semiocclusive 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. 

(iii) 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 

or in silico test data (identified on the 

Commission’s animal testing Web site 

at: http://www.cpsc.gov/library/ 

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 the substance might be a 

dermal corrosive or irritant or ocular 

irritant. 

(A) When the weight-of-evidence is 

insufficient to determine a substance’s 

ocular irritation, a Commissionapproved in vitro or in silico assay for 

ocular irritancy should be run to assess 

eye irritation potential and determine 

labeling. Examples of Commissionvalidated in vitro assays are identified 

on the Commission’s animal testing 

Web site at: http://www.cpsc.gov/ 

library/animaltesting.html). If no valid 

in vitro test exists, the test strategy for 

determining dermal corrosion/irritation 

outlined in paragraph (b)(1)(ii)(B) of this 

section can be followed to determine 

ocular irritation. 

(B) If the dermal test strategy outlined 

in section paragraph (b)(1)(ii)(B) of this 

section 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. 

(C) When any ocular irritancy testing 

on animals is conducted, including the 

method described in § 1500.42, the 

Commission recommends a threefold 

plan to reduce animal suffering: 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 (an example of 

a typical preemptive pain treatment is 

two applications of tetracaine 

ophthalmic anesthetic, 10–15 minutes 

apart, prior to instilling the test material 

to the eye); post-treatment with systemic 

analgesics for pain relief; and 

implementation of humane endpoints, 

including scheduled observations, 

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/library/ 

animaltesting.html. 

(iv) Dermal sensitization. An 

acceptable in vitro test method 

(examples of valid in vitro tests are 

identified on the Commission’s animal 

testing Web site at: http:// 

www.cpsc.gov/library/ 

animaltesting.html), or weight-ofevidence analysis is recommended 

before in vivo animal sensitization 

testing is considered to determine 

appropriate cautionary labeling. The 

weight-of-evidence analysis should 

incorporate any existing data on 

humans and animals, validated in vitro 

or in silico test results, and any relevant 

physicochemical properties that 

indicate the substance might be a 

dermal sensitizer. If there is any 

indication from this analysis that the 

substance is sensitizing to the skin, the 

substance should be labeled 

appropriately. 

(2) [Reserved]. 

Dated: November 29, 2012. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2012–29260 Filed 12–7–12; 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: Revisions to Animal 

Testing Regulations 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The U.S. Consumer Product 

Safety Commission (CPSC or 

Commission) amends regulations on the 

CPSC’s animal testing methods under 

the Federal Hazardous Substances Act 

(FHSA). 

DATES: This rule is effective on January 

9, 2013. 

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 


srobinson on DSK4SPTVN1PROD with