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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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 codify its updated animal 

testing policy at 16 CFR 1500.232, 

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, to reflect more accurately 

the ICCVAM recommendations and 

updated test methods approved by the 

Commission, this proposed rule amends 

the Commission’s regulations that 

interpret, supplement, or provide 

alternatives to definitions on animal test 

methods used to aid in the classification 

of hazardous substances under the 

FHSA. 

B. Proposed Amendments 

All of the proposed amendments to 16 

CFR part 1500 clarify or add language to 

explain that alternative test methods 

exist that avoid or reduce animal 

testing, which have been approved by 

the Commission. 

1. Definition of Highly Toxic 

Currently, the test methods in section 

1500.3(c)(1)(ii) A–C, used in the 

definitions of oral, inhalation, and 

dermal toxicity, respectively, each 

describe a method for defining a 

substance as highly toxic. The definition 

of highly toxic is: 

(i) A substance determined by the 

Commission to be highly toxic on the basis 

of human experience; and/or (ii) A substance 

that produces death within 14 days in half 

or more than half of a group of: (A) White rats 

(each weighing between 200 and 300 grams) 

when a single dose of 50 milligrams or less 

per kilogram of body weight is administered 

orally; (B) White rats (each weighing between 

200 and 300 grams) when a concentration of 

200 parts per million by volume or less of gas 

or vapor, or 2 milligrams per liter by volume 

or less of mist or dust, is inhaled 

continuously for 1 hour or less, if such 

concentration is likely to be encountered by 

man when the substance is used in any 

reasonably foreseeable manner; and/or (C) 

Rabbits (each weighing between 2.3 and 3.0 

kilograms) when a dosage of 200 milligrams 

or less per kilogram of body weight is 

administered by continuous contact with the 

bare skin for 24 hours or less by the method 

described in § 1500.40. The number of 

animals tested must be sufficient to give a 

statistically significant result and shall be in 

conformity with good pharmacological 

practices. 

The proposed amendment makes 

clear that the animal tests are not the 

only means to test or define a product’s 

toxicity under the FHSA, nor are they 

the only methods used by the CPSC to 

assess product toxicity. Because there 

are other Commission-approved test 

methods that may be used by CPSC staff 

or the public for toxicity testing and 

defining a substance as highly toxic, as 

reflected in the ICCVAM 

recommendations and outlined in the 

CPSC’statement of policy on animal 

testing published elsewhere in this 

Federal Register, the proposed rule 

adds language under new section 

1500.3(c)(1)(iii) as follows: A substance 

that produces a result of ‘highly toxic’ 

in any of the approved test methods 

described in the CPSC’s animal testing 

policy set forth in 16 CFR 1500.232. 

2. Definition of Toxic 

Currently, the test methods in section 

1500.3(c)(2)(i) A–C, used in the 

definitions of oral, inhalation, and 

dermal toxicity, respectively, each 

describe a method for defining a 

substance as toxic. The definition of 

toxic is: 

(i) Any substance that produces death 

within 14 days in half or more than half of 

a group of: (A) White rats (each weighing 

between 200 and 300 grams) when a single 

dose of 50 milligrams to 5 grams per kilogram 

of body weight is administered orally. 

Substances falling in the toxicity range 

between 500 milligrams and 5 grams per 

kilogram of body weight will be considered 

for exemption from some or all of the 

labeling requirements of the act, under 

§ 1500.82, upon a showing that such labeling 

is not needed because of the physical form 

of the substances (solid, a thick plastic, 

emulsion, etc.), the size or closure of the 

container, human experience with the article, 

or any other relevant factors; and/or (B) 

White rats (each weighing between 200 and 

300 grams) when a concentration of more 

than 200 parts per million but not more than 

20,000 parts per million by volume of gas or 

vapor, or more than 2 but not more than 200 

milligrams per liter by volume of mist or 

dust, is inhaled continuously for 1 hour or 

less, if such concentration is likely to be 

encountered by man when the substance is 

used in any reasonably foreseeable manner; 

and/or (C) Rabbits (each weighing between 

2.3 and 3.0 kilograms) when a dosage of more 

than 200 milligrams but not more than 2 

grams per kilogram of body weight is 

administered by continuous contact with the 

bare skin for 24 hours by the method 

described in § 1500.40. The number of 

animals tested must be sufficient to give a 

statistically significant result and shall be in 

conformity with good pharmacological 

practices. 

The proposed amendment makes 

clear that the animal tests are not the 

only means to test or define a product’s 

toxicity under the FHSA, nor are they 

the only methods used by the CPSC to 

assess product toxicity. Because there 

are other Commission-approved test 

methods that may be used by CPSC staff 

or the public for toxicity testing and 

defining a substance as toxic, as 

reflected in the ICCVAM 

recommendations, and outlined in the 

CPSC’s statement of policy on animal 

testing published elsewhere in this 

Federal Register, the proposed rule 

adds language under new section 

1500.3(c)(2)(iii) as follows: Toxic also 

applies to any substance that can be 

labeled as such, based on the outcome 

of any of the approved test methods 

described in the CPSC’s animal testing 

policy set forth in 16 CFR 1500.232. 

3. Definition of Corrosive 

16 CFR 1500.3(c)(3) currently states 

that: Corrosive means a substance that 

causes visible destruction or irreversible 

alterations in the tissue at the site of 

contact. A test for a corrosive substance 

is whether, by human experience, such 

tissue destruction occurs at the site of 

application. A substance would be 

considered corrosive to the skin if, 

when tested on the intact skin of the 

albino rabbit by the technique described 

in § 1500.41, the structure of the tissue 

at the site of contact is destroyed or 

changed irreversibly in 24 hours or less. 

Other appropriate tests should be 

applied when contact of the substance 

with other than skin tissue is being 

considered. 

The method of testing described in 

§ 1500.41 is a test for acute dermal 

toxicity. The proposed rule amends this 

definition to make explicit that the 

animal testing is not the only testing 

method used or accepted by the CPSC, 

or the preferred method. Accordingly, 

the proposed rule adds the following 

text (in underline) to section 16 CFR 

1500.3(c)(3): 

Corrosive means a substance that causes 

visible destruction or irreversible alterations 

in the tissue at the site of contact. A test for 

a corrosive substance is whether, by human 

experience, such tissue destruction occurs at 

the site of application. A substance would be 

considered corrosive to the skin if a weightof-evidence analysis suggests that it is 

corrosive or if, when tested by the in vivo 

technique described in § 1500.41, the 

structure of the tissue at the site of contact 

is destroyed or changed irreversibly in 24 


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1EPA. 1998. Health Effects Test Guidelines, 

OPPTS 870.2400 Acute Eye Irritation. EPA 712–C– 

98–195. Washington, DC: U.S. Environmental 

Protection Agency. (Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/ 

EPA_870_2400.pdf). 

2OECD. 2002. OECD Guideline for the Testing of 

Chemicals 405: Acute Eye Irritation/Corrosion. 

Paris: Organisation for Economic Co-operation and 

Development. (Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/ 

OECDtg405.pdf). 

hours or less. Other appropriate tests should 

be applied when contact of the substance 

with other than skin tissue is being 

considered. A substance could also be 

labeled corrosive based on the outcome of 

any of the approved test methods described 

in the CPSC’s animal testing policy set forth 

in 16 CFR 1500.232. 

4. Definition of Irritant, Primary Irritant, 

and Eye Irritant 

Currently, 16 CFR 1500.3(c)(4) 

provides that the test methods for 

irritant, primary irritant, and eye irritant 

reference 16 CFR 1500.41 and 1500.42, 

which each describe a specific animal 

test method and outcome. For example, 

16 CFR 1500.41 states that primary 

irritation to the skin is measured by a 

patch-test technique on the abraded and 

intact skin of the albino rabbit, clipped 

free of hair. A minimum of six subjects 

are used in the skin tests. To test for eye 

irritants, 16 CFR 1500.42 requires the 

use of six albino rabbits. Such tests 

require the test material be placed in 

one eye of each animal, while the other 

eye remains untreated, to serve as a 

control to assess the grade of ocular 

reaction. 

The proposed rule clarifies that the 

method for testing for irritant substances 

should not be based solely on these 

specific animal tests because there are 

other scientifically valid ways of testing 

for irritants, including methods that do 

not use animals. Accordingly, the 

proposed rule adds the following text 

(in underline) to section 1500.3(c)(4): 

The definition of irritant in section 2(j) of 

the act (restated in paragraph (b)(8) of this 

section) is supplemented by the following: 

Irritant includes primary irritant to the skin, 

as well as substances irritant to the eye or to 

mucous membranes. Primary irritant means a 

substance that is not corrosive and that 

human experience data indicate is a primary 

irritant; and/or means a substance that results 

in an empirical score of five or more when 

tested by the method described in 1500.41; 

and/or a substance that can be considered a 

primary irritant based on the outcome of any 

of the approved test methods described in the 

CPSC’s animal testing policy set forth in 16 

CFR 1500.232. Eye irritant means a substance 

that human experience data indicate is an 

irritant to the eye; and/or means a substance 

for which a positive test is obtained when 

tested by the method described in 1500.42; 

and/or means a substance that can be 

considered an eye irritant based on the 

outcome of any of the approved test methods 

described in the CPSC’s animal testing policy 

set forth in 16 CFR 1500.232. 

5. Method of Testing Toxic Substances 

The method of testing toxic 

substances is set forth under 16 CFR 

1500.40. This method details an acute 

dermal toxicity assay using rabbits. The 

method is referenced in 

§ 1500.3(c)(1)(ii)(C) and 

§ 1500.3(c)(2)(C). Although the method 

described in § 1500.40 is one way of 

assessing a substance’s acute dermal 

toxicity, this method is not mandatory, 

and it is not the only or preferred 

method for evaluating dermal toxicity. 

Accordingly, the proposed rule adds the 

following text (in underline) to 

§ 1500.40 immediately after the heading 

titled, ‘‘Method of testing toxic 

substances’’: 

Guidelines for testing the toxicity of 

substances, including testing that does not 

require animals, are presented in the CPSC’s 

animal testing policy set forth in 16 CFR 

1500.232. A weight-of-evidence analysis is 

recommended to evaluate existing 

information before in vivo tests are 

considered. This analysis, when deemed 

necessary to carry out, should include any of 

the following: existing human and animal 

data, in vitro data, structure activity 

relationships, physicochemical properties, 

and chemical reactivity. When in vivo testing 

is necessary, a sequential testing strategy is 

recommended to reduce the number of test 

animals. 

6. Method of Testing Primary Irritant 

Substances 

The method of testing primary irritant 

substances is set forth under 16 CFR 

1500.41. This method details an acute 

dermal toxicity assay using rabbits. The 

method is referenced in §§ 1500.3(c)(3) 

and 1500.3(c)(4). Although the method 

described in § 1500.41 is one way of 

assessing a substance’s dermal 

irritation/corrosivity, this method is not 

mandatory, and it is not the only or 

preferred method for evaluating a 

substance’s dermal irritation/ 

corrosivity. Accordingly, the proposed 

rule adds the following text (in 

underline) to § 1500.41 immediately 

after the heading titled, ‘‘Method of 

testing primary irritant substances’’: 

Guidelines for testing the dermal irritation 

and corrosivity properties of substances, 

including testing that does not require 

animals, are presented in the CPSC’s animal 

testing policy set forth in 16 CFR 1500.232. 

A weight-of-evidence analysis is 

recommended to evaluate existing 

information before in vivo tests are 

considered. This analysis should include all 

of the following that are available: human 

and animal data, structure activity 

relationships, physicochemical properties, 

and dermal toxicity. When in vivo testing is 

necessary, a sequential testing strategy is 

recommended to reduce the number of test 

animals. The method of testing the dermal 

corrosivity and primary irritation of 

substances referred to in §§ 1500.3(c)(3) and 

(4), respectively, is a patch-test technique on 

the abraded and intact skin of the albino 

rabbit, clipped free of hair * * * 

7. Test for Eye Irritants 

Section 1500.42 of 16 CFR provides a 

detailed animal test for eye irritation. 

The method is referenced in 

§ 1500.3(c)(4), which defines irritation. 

Although the method described in 

§ 1500.42 is one way of assessing a 

substance’s properties of ocular 

irritation, this method is not mandatory, 

and it is not the only or preferred 

method of assessing a substance’s 

properties of ocular irritation. 

Accordingly, the proposed rule adds the 

following text (in underline) to 

§ 1500.42 immediately after the heading 

titled, ‘‘Test for eye irritants’’: 

Guidelines for in vivo and in vitro testing 

of ocular irritation of substances, including 

testing that does not require animals, are 

presented in the CPSC’s animal testing policy 

set forth in 16 CFR 1500.232. A weight-ofevidence analysis is recommended to 

evaluate existing information before in vivo 

tests are considered. This analysis should 

include any of the following: existing human 

and animal data on ocular or dermal 

irritation, structure activity relationships, 

physicochemical properties, and chemical 

reactivity. When in vivo testing is necessary, 

a sequential testing strategy is recommended 

to reduce the number of test animals. 

Additionally, the routine use of topical 

anesthetics, systemic analgesics, and 

humane endpoints to avoid or minimize pain 

and distress in ocular safety testing is 

recommended. 

(a)(1) In the method of testing the ocular 

irritation of a substance referred to in 

§ 1500.3(c)(4), six albino rabbits are used for 

each test substance * * * 

8. Editorial Changes 

The proposed rule eliminates the 

reference in § 1500.42(c) to the 

‘‘Illustrated Guide for Grading Eye 

Irritation by Hazardous Substances,’’ 

and the accompanying note. The 

referenced guide is out of print, and 

photocopies are rare. Instead, the 

proposed rule amends § 1500.42(c) to 

reference guidelines from the U.S. 

Environmental Protection Agency (EPA) 

and the Organisation for Economic Cooperation and Development (OECD) as 

follows: 

To assist testing laboratories and others 

interested in interpreting ocular irritation test 

results, the CPSC animal testing policy Web 

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

animaltesting.html will contain the scoring 

system defined in the U.S. EPA’s Test 

Guideline, OPPTS 870.2400: Acute Eye 

Irritation 1 or the OECD Test Guideline 405: 

Acute Eye Irritation/Corrosion.2


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C. Impact on Small Businesses 

Under the Regulatory Flexibility Act 

(RFA), when an agency issues a 

proposed rule, it generally must prepare 

an initial regulatory flexibility analysis 

describing the impact the proposed rule 

is expected to have on small entities. 5 

U.S.C. 603. The RFA does not require a 

regulatory flexibility analysis if the head 

of the agency certifies that the rule will 

not have a significant effect on a 

substantial number of small entities. 

The Commission’s Directorate for 

Economic Analysis prepared a 

preliminary assessment of the impact of 

amending the regulations on animal 

testing. That assessment found that 

there would be little or no effect on 

small businesses and other entities 

because the proposed amendments will 

not result in product modifications in 

order to comply, and they will not result 

in additional testing or recordkeeping 

burdens. Based on the foregoing 

assessment, the Commission 

preliminarily finds that the proposed 

rule would not have a significant impact 

on a substantial number of small 

entities. 

D. Environmental Considerations 

Generally, CPSC rules are considered 

to ‘‘have little or no potential for 

affecting the human environment,’’ and 

environmental assessments and 

environmental impact statements are 

not usually prepared for these rules (see 

16 CFR 1021.5(c)(1)). The Commission 

does not expect the proposed rule to 

have any adverse impact on the 

environment under this categorical 

exclusion. 

E. Executive Orders 

According to Executive Order 12988 

(February 5, 1996), agencies must state 

in clear language the preemptive effect, 

if any, of new regulations. The 

preemptive effect of regulations such as 

this proposed rule is stated in section 18 

of the FHSA. 15 U.S.C. 1261n. 

F. Paperwork Reduction Act 

This rule would not impose any 

information collection requirements. 

Accordingly, this rule is not subject to 

the Paperwork Reduction Act, 44 U.S.C. 

3501–3520. 

G. Effective Date 

The Administrative Procedure Act 

generally requires that a substantive rule 

be published not less than 30 days 

before its effective date, unless the 

agency finds, for good cause shown, that 

a lesser time period is required. 5 U.S.C. 

553(d)(3). We propose that the rule 

would take effect 30 days after 

publication of a final rule 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. 

Accordingly, 16 CFR part 1500 is 

proposed to be amended as follows: 

PART 1500—[AMENDED] 

1. The authority citation for part 1500 

continues to reads 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. Amend section 1500.3 by adding 

new paragraphs (c)(1)(iii) and (c)(2)(iii) 

and revise paragraphs (c)(3) and (c)(4), 

to read as follows: 

§ 1500.3 Definitions. 

* * * * * 

(c) * * * 

(1) * * * 

(iii) A substance that produces a 

result of ‘highly toxic’ in any of the 

approved test methods described in the 

CPSC’s animal testing policy set forth in 

16 CFR 1500.232. 

(2) * * * 

(iii) Toxic also applies to any 

substance that can be labeled as such, 

based on the outcome of any of the 

approved test methods described in the 

CPSC’s animal testing policy set forth in 

16 CFR 1500.232. 

(3) Corrosive means a substance that 

causes visible destruction or irreversible 

alterations in the tissue at the site of 

contact. A test for a corrosive substance 

is whether, by human experience, such 

tissue destruction occurs at the site of 

application. A substance would be 

considered corrosive to the skin if a 

weight-of-evidence analysis suggests 

that it is corrosive or if, when tested by 

the in vivo technique described in 

§ 1500.41, the structure of the tissue at 

the site of contact is destroyed or 

changed irreversibly in 24 hours or less. 

Other appropriate tests should be 

applied when contact of the substance 

with other than skin tissue is being 

considered. A substance could also be 

labeled corrosive based on the outcome 

of any of the approved test methods 

described in the CPSC’s animal testing 

policy set forth in 16 CFR 1500.232. 

(4) The definition of irritant in section 

2(j) of the act (restated in paragraph 

(b)(8) of this section) is supplemented 

by the following: Irritant includes 

primary irritant to the skin, as well as 

substances irritant to the eye or to the 

mucous membranes. Primary irritant 

means a substance that is not corrosive 

and that human experience data 

indicate is a primary irritant; and/or 

means a substance that results in an 

empirical score of five or more when 

tested by the method described in 

§ 1500.41; and/or a substance that can 

be considered a primary irritant based 

on the outcome of any of the approved 

test methods described in the CPSC’s 

animal testing policy set forth in 16 CFR 

1500.232. Eye irritant means a substance 

that human experience data indicate is 

an irritant to the eye; and/or means a 

substance for which a positive test is 

obtained when tested by the method 

described in § 1500.42; and/or means a 

substance that can be considered an eye 

irritant based on the outcome of any of 

the approved test methods described in 

the CPSC’s animal testing policy set 

forth in 16 CFR 1500.232. 

* * * * * 

3. Amend section 1500.40 by revising 

the introductory text to read as follows: 

§ 1500.40 Method of testing toxic 

substances. 

Guidelines for testing the toxicity of 

substances, including testing that does 

not require animals, are presented in the 

CPSC’s animal testing policy set forth in 

16 CFR 1500.232. A weight-of-evidence 

analysis is recommended to evaluate 

existing information before in vivo tests 

are considered. This analysis, when 

deemed necessary to carry out, should 

include any of the following: existing 

human and animal data, in vitro data, 

structure activity relationships, 

physicochemical properties, and 

chemical reactivity. When in vivo 

testing is necessary, a sequential testing 

strategy is recommended to reduce the 

number of test animals. The method of 

testing the toxic substances referred to 

in § 1500.3(c)(1)(ii)(C) and (2)(iii) is as 

follows: 

* * * * * 

4. In § 1500.41, add five sentences at 

the start of the introductory text to read 

as follows: 

§ 1500.41 Method of testing primary 

irritant substances. 

Guidelines for testing the dermal 

irritation and corrosivity properties of 

substances, including testing that does 

not require animals, are presented in the 

CPSC’s animal testing policy set forth in 

16 CFR 1500.232. A weight-of-evidence 

analysis is recommended to evaluate 

existing information before in vivo tests 

are considered. This analysis should 

include all of the following that are 

available: Human and animal data, 

structure activity relationships, 

physicochemical properties, and dermal 


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38758 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 

3EPA. 1998. Health Effects Test Guidelines, 

OPPTS 870.2400 Acute Eye Irritation. EPA 712–C– 

98–195. Washington, DC: U.S. Environmental 

Protection Agency. (Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/ 

EPA_870_2400.pdf). 

4OECD. 2002. OECD Guideline for the Testing of 

Chemicals 405: Acute Eye Irritation/Corrosion. 

Paris: Organisation for Economic Co-operation and 

Development. (Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/ 

OECDtg405.pdf). 

toxicity. When in vivo testing is 

necessary, a sequential testing strategy 

is recommended to reduce the number 

of test animals. The method of testing 

the dermal corrosivity and primary 

irritation of substances referred to in 

§§ 1500.3(c)(3) and (4), respectively, is a 

patch-test technique on the abraded and 

intact skin of the albino rabbit, clipped 

free of hair. * * * 

5. Amend section 1500.42 by adding 

introductory text, adding a sentence at 

the beginning of paragraph (a)(1), and 

revising paragraph (c) to read as follows: 

§ 1500.42 Test for eye irritants. 

Guidelines for in vivo and in vitro 

testing of ocular irritation of substances, 

including testing that does not require 

animals, are presented in the CPSC’s 

animal testing policy set forth in 16 CFR 

1500.232. A weight-of-evidence analysis 

is recommended to evaluate existing 

information before in vivo tests are 

considered. This analysis should 

include any of the following: Existing 

human and animal data on ocular or 

dermal irritation, structure activity 

relationships, physicochemical 

properties, and chemical reactivity. 

When in vivo testing is necessary, a 

sequential testing strategy is 

recommended to reduce the number of 

test animals. Additionally, the routine 

use of topical anesthetics, systemic 

analgesics, and humane endpoints to 

avoid or minimize pain and distress in 

ocular safety testing is recommended. 

(a)(1) In the method of testing the 

ocular irritation of a substance referred 

to in § 1500.3(c)(4), six albino rabbits are 

used for each test substance * * * 

* * * * * 

(c) To assist testing laboratories and 

others interested in interpreting ocular 

irritation test results, the CPSC animal 

testing policy Web page at http:// 

www.cpsc.gov/businfo/ 

animaltesting.html will contain the 

scoring system defined in the U.S. 

EPA’s Test Guideline, OPPTS 870.2400: 

Acute Eye Irritation 3 or the OECD Test 

Guideline 405: Acute Eye Irritation/ 

Corrosion.4

Dated: June 25, 2012. 

Todd A. Stevenson, 

Secretary, U.S. Consumer Product Safety 

Commission. 

[FR Doc. 2012–15882 Filed 6–28–12; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 5 

[Docket No. TTB–2012–0002; Notice No. 

127A; Re: Notice No. 127] 

RIN 1513–AB33 

Proposed Amendment to the 

Standards of Identity for Distilled 

Spirits; Comment Period Extension 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking; 

extension of comment period. 

SUMMARY: The Alcohol and Tobacco Tax 

and Trade Bureau (TTB) is extending 

the comment period for Notice No. 127, 

Proposed Amendment to the Standards 

of Identity for Distilled Spirits, for an 

additional 10 days. In Notice No. 127, 

a notice of proposed rulemaking 

published in the Federal Register on 

April 30, 2012, TTB proposes to amend 

the standards of identity regulations for 

distilled spirits to include ‘‘Cachac ̧a’’ as 

a type of rum distinctive to Brazil. 

DATES: Written comments on Notice No. 

127 are now due on or before July 9, 

2012. 

ADDRESSES: You may send comments on 

Notice No. 127 to one of the following 

addresses: 

• http://www.regulations.gov: To 

submit comments via the Internet, use 

the comment form for Notice No. 127 as 

posted within Docket No. TTB–2012– 

0002 on ‘‘Regulations.gov,’’ the Federal 

e-rulemaking portal; 

• U.S. Mail: Director, Regulations and 

Rulings Division, Alcohol and Tobacco 

Tax and Trade Bureau, P.O. Box 14412, 

Washington, DC 20044–4412. 

• Hand Delivery/Courier in Lieu of 

Mail: Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street NW., Suite 

200–E, Washington, DC 20005. 

See the Public Participation section of 

this notice for specific instructions and 

requirements for submitting comments, 

and for information on how to request 

a public hearing. 

You may view copies of all 

rulemaking documents, supporting 

materials, and any comments related to 

this proposal within Docket No. TTB– 

2012–0002 at http:// 

www.regulations.gov. A link to the 

docket is posted on the TTB Web site at 

http://www.ttb.gov/regulations_laws/ 

all_rulemaking.shtml under Notice No. 

127. You also may view copies of all 

related rulemaking documents, 

supporting materials, and any 

comments related to this proposal by 

appointment at the TTB Information 

Resource Center, 1310 G Street NW., 

Washington, DC 20005. Please call 202– 

453–2270 to make an appointment. 

FOR FURTHER INFORMATION CONTACT: 

Christopher M. Thiemann, Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau, 1310 G 

Street NW., Suite 200E, Washington, DC 

20005; telephone 202–453–1039, ext. 

138. 

SUPPLEMENTARY INFORMATION: In Notice 

No. 127, published in the Federal 

Register on April 30, 2012, at 77 FR 

25382, the Alcohol and Tobacco Tax 

and Trade Bureau (TTB) proposes to 

amend its regulations concerning the 

standards of identity for distilled spirits 

at 27 CFR 5.22 to include ‘‘Cachac ̧a’’ as 

a type of rum and as a distinctive 

product of Brazil. TTB undertook this 

rulemaking action in response to a 

petition from the Government of Brazil, 

and in response to an agreement 

between the United States and Brazil 

setting out a procedure that could lead 

each party to recognize certain 

distinctive distilled spirits produced in 

the other party’s territory. The 

agreement provides in part that if, 

following the publication of a notice of 

proposed rulemaking, the United States 

publishes a final rule that lists Cachac ̧a 

as a type of rum distinctive to Brazil, 

then Brazil, within 30 days thereafter, 

will recognize Bourbon Whiskey and 

Tennessee Whiskey as distinctive 

products of the United States. 

The 60-day comment period for 

Notice No. 127 originally was set to 

close on June 29, 2012. On June 15, 

2012, TTB received a comment from the 

European Union requesting an 

extension of the comment period ‘‘in 

order to have time to analyze and 

prepare comments’’ on the proposal (see 

Comment 4 within Docket No. TTB– 

2012–0002). In response to this request, 

TTB is extending the comment period 

for an additional 10 days, and, therefore, 

comments on Notice No. 127 are now 

due on or before July 9, 2012. 

Drafting Information 

Michael D. Hoover of the Regulations 

and Rulings Division drafted this notice. 


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