Hazardous Substances and Articles; Administration and Enforcement Regulations: Notice of Proposed Rulemaking; Revisions to Animal Testing Regulations, 38754-38758 [2012-15882]

Download as PDF 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: https:// www.cpsc.gov/businfo/ animaltesting.html. Dated: June 25, 2012. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2012–15883 Filed 6–28–12; 8:45 am] BILLING CODE 6355–01–P CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. CPSC–2012–0036] 16 CFR Part 1500 Hazardous Substances and Articles; Administration and Enforcement Regulations: Notice of Proposed Rulemaking; Revisions to Animal Testing Regulations docket number for this proposed rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to https:// www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing. Docket: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Leslie E. Patton, Ph.D., Project Manager, Office of Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7848; lpatton@cpsc.gov. SUPPLEMENTARY INFORMATION: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (email) except through www.regulations.gov. A. Background The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261–1278, requires appropriate cautionary labeling on certain hazardous household products to alert consumers to the potential hazards that a product may present. Among the hazards addressed by the FHSA are products that are toxic, corrosive, irritants, flammable, combustible, or strong sensitizers. The FHSA and the Commission regulations at 16 CFR part 1500 provide certain test methods related to testing on animals to determine the existence of the hazards addressed by the FHSA. On May 30, 1984, the Commission adopted an animal testing policy that minimized the number of test animals required for toxicity testing and clarified when animal testing might be needed (1984 Policy) (49 FR 22522). These guidelines advised product manufacturers to use alternatives to animal testing whenever possible, including: (1) Prior human experience, (2) existing animal or limited human test results, and (3) expert opinion. The 1984 Policy stated: Written Submissions Submit written submissions in the following way: Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions), preferably in five copies, to: Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7923. Instructions: All submissions received must include the agency name and It is important to keep in mind that neither the FHSA nor the Commission’s regulations require any firm to perform animal tests. The statute and its implementing regulations only require that a product be labeled to reflect the hazards associated with that product. While animal testing may be necessary in some cases, Commission policy supports limiting such tests to the lowest feasible number and taking every feasible step to eliminate or reduce the pain or discomfort that can be associated with such tests. * * * The Commission resorts to animal testing only when the other information sources have Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. AGENCY: The U.S. Consumer Product Safety Commission (CPSC or Commission) proposes to amend and to update regulations on the CPSC’s animal testing methods under the Federal Hazardous Substances Act (FHSA). DATES: Written comments must be received by September 12, 2012. ADDRESSES: You may submit comments identified by Docket No. CPSC–2012– 0036, by any of the following methods: erowe on DSK2VPTVN1PROD with PROPOSALS-1 SUMMARY: VerDate Mar<15>2010 14:46 Jun 28, 2012 Jkt 226001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 been exhausted. Furthermore, the FHSA regulations, at 16 CFR 1500.4, clearly state that reliable human experience shall take precedence over different results from animal data. Id. at 22523. The 1984 Policy also stated that if non-animal test systems for prediction of toxicity and irritancy are accepted by the scientific community as adjuncts or alternatives to whole-animal testing, ‘‘[The CPSC Directorate for] Health Sciences will incorporate the techniques into the Commission’s compliance program to the extent feasible and will recommend any changes to the Commission’s statutes or regulations that may become appropriate as the result of advances in testing methods that are developed.’’ Id. Since the 1984 Policy, there have been new methods accepted by the scientific community as replacements or adjuncts to animal tests for predictions of toxicity and irritancy. Such developments in testing have been made in recent years, particularly since the National Institutes of Health Revitalization Act was passed in 1993 (Pub. L. 103–43, Section 1301), directing the National Institute of Environmental Health Sciences (NIEHS) to establish a method and criteria for the validation and regulatory acceptance of alternative testing methods. The NIEHS created the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; https://iccvam.niehs.nih.gov/ home.htm), which was made permanent by the ICCVAM Authorization Act of 2000, Public Law 106–545. The duties of ICCVAM are to review, optimize, and validate new, revised, or alternative test methods that encourage the reduction, refinement, or replacement of the use of animals in testing. ICCVAM has representatives from 15 federal regulatory and research agencies, including the CPSC. These agencies generate, use, or provide information from toxicity test methods for risk assessment purposes. In addition, ICCVAM provides test recommendations to federal agencies and other stakeholders to facilitate appropriate interagency and international harmonization of toxicological test protocols. ICCVAM submits recommendations for a test method to federal agencies that require or recommend acute or chronic toxicological testing. According to Public Law 106–545, these agencies should promote and encourage the development and use of alternatives to animal test methods for regulatory purposes, and ensure that any new or revised acute or chronic toxicity test method is valid for its proposed use. Federal agencies have 180 days from the E:\FR\FM\29JNP1.SGM 29JNP1 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 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 https:// www.cpsc.gov/businfo/ animaltesting.html regarding the ICCVAM recommendations and new developments in test methods that further reduce or refine animal testing. In addition, 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. erowe on DSK2VPTVN1PROD with PROPOSALS-1 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) VerDate Mar<15>2010 14:46 Jun 28, 2012 Jkt 226001 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 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 38755 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 E:\FR\FM\29JNP1.SGM 29JNP1 38756 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 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. erowe on DSK2VPTVN1PROD with PROPOSALS-1 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 VerDate Mar<15>2010 14:46 Jun 28, 2012 Jkt 226001 § 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. PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 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 https://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 1 EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400 Acute Eye Irritation. EPA 712–C– 98–195. Washington, DC: U.S. Environmental Protection Agency. (Available: https:// iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/ EPA_870_2400.pdf). 2 OECD. 2002. OECD Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-operation and Development. (Available: https:// iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/ OECDtg405.pdf). E:\FR\FM\29JNP1.SGM 29JNP1 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 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. erowe on DSK2VPTVN1PROD with PROPOSALS-1 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 VerDate Mar<15>2010 14:46 Jun 28, 2012 Jkt 226001 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 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 38757 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 E:\FR\FM\29JNP1.SGM 29JNP1 38758 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Proposed Rules 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 erowe on DSK2VPTVN1PROD with PROPOSALS-1 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 https:// 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 3 EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400 Acute Eye Irritation. EPA 712–C– 98–195. Washington, DC: U.S. Environmental Protection Agency. (Available: https:// iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/ EPA_870_2400.pdf). 4 OECD. 2002. OECD Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-operation and Development. (Available: https:// iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/ OECDtg405.pdf). 14:46 Jun 28, 2012 Jkt 226001 [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] Test for eye irritants. VerDate Mar<15>2010 Dated: June 25, 2012. Todd A. Stevenson, Secretary, U.S. Consumer Product Safety Commission. RIN 1513–AB33 Proposed Amendment to the Standards of Identity for Distilled Spirits; Comment Period Extension Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking; extension of comment period. AGENCY: 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 ‘‘Cachaca’’ as ¸ a type of rum distinctive to Brazil. DATES: Written comments on Notice No. 127 are now due on or before July 9, 2012. SUMMARY: You may send comments on Notice No. 127 to one of the following addresses: • https://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 ADDRESSES: PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 this proposal within Docket No. TTB– 2012–0002 at https:// www.regulations.gov. A link to the docket is posted on the TTB Web site at https://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. 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 ‘‘Cachaca’’ 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 Cachaca ¸ 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. SUPPLEMENTARY INFORMATION: Drafting Information Michael D. Hoover of the Regulations and Rulings Division drafted this notice. E:\FR\FM\29JNP1.SGM 29JNP1

Agencies

Consumer Product Safety Commission

[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Proposed Rules]
[Pages 38754-38758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15882]

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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.

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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: https://www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of comments, the Commission is no
longer accepting comments submitted by electronic mail (email) except
through www.regulations.gov.

Written Submissions

Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
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 https://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leslie E. Patton, Ph.D., Project
Manager, Office of Hazard Identification and Reduction, U.S. Consumer
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814;
telephone (301) 504-7848; lpatton@cpsc.gov.

SUPPLEMENTARY INFORMATION:

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; https://iccvam.niehs.nih.gov/home.htm), which was made permanent by the ICCVAM
Authorization Act of 2000, Public Law 106-545. The duties of ICCVAM are
to review, optimize, and validate new, revised, or alternative test
methods that encourage the reduction, refinement, or replacement of the
use of animals in testing. ICCVAM has representatives from 15 federal
regulatory and research agencies, including the CPSC. These agencies
generate, use, or provide information from toxicity test methods for
risk assessment purposes. In addition, ICCVAM provides test
recommendations to federal agencies and other stakeholders to
facilitate appropriate interagency and international harmonization of
toxicological test protocols.
ICCVAM submits recommendations for a test method to federal
agencies that require or recommend acute or chronic toxicological
testing. According to Public Law 106-545, these agencies should promote
and encourage the development and use of alternatives to animal test
methods for regulatory purposes, and ensure that any new or revised
acute or chronic toxicity test method is valid for its proposed use.
Federal agencies have 180 days from the

[[Page 38755]]

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 https://www.cpsc.gov/businfo/animaltesting.html regarding the ICCVAM recommendations and new
developments in test methods that further reduce or refine animal
testing.
In addition, 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 weight-of-evidence
analysis suggests that it is corrosive or if, when tested by the in
vivo technique described in Sec. 1500.41, the structure of the
tissue at the site of contact is destroyed or changed irreversibly
in 24

[[Page 38756]]

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 Sec. 1500.3(c)(1)(ii)(C) and
Sec. 1500.3(c)(2)(C). Although the method described in Sec. 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 Sec. 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 Sec. Sec.
1500.3(c)(3) and 1500.3(c)(4). Although the method described in Sec.
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 Sec. 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 Sec. Sec. 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 Sec. 1500.3(c)(4), which
defines irritation. Although the method described in Sec. 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 Sec. 1500.42 immediately after the heading titled, ``Test for eye
irritants'':

8. Editorial Changes

The proposed rule eliminates the reference in Sec. 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
Sec. 1500.42(c) to reference guidelines from the U.S. Environmental
Protection Agency (EPA) and the Organisation for Economic Co-operation
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 https://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\
---------------------------------------------------------------------------

\1\ EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400
Acute Eye Irritation. EPA 712-C-98-195. Washington, DC: U.S.
Environmental Protection Agency. (Available: https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf).
\2\ OECD. 2002. OECD Guideline for the Testing of Chemicals 405:
Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-
operation and Development. (Available: https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf).

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[[Page 38757]]

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, Sec. 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:

Sec. 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 Sec. 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 Sec. 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
Sec. 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:

Sec. 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 Sec. 1500.3(c)(1)(ii)(C) and (2)(iii) is as
follows:
* * * * *
4. In Sec. 1500.41, add five sentences at the start of the
introductory text to read as follows:

Sec. 1500.41 Method of testing primary irritant substances.

[[Page 38758]]

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 Sec. Sec. 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:

Sec. 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 Sec. 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 https://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\
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\3\ EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400
Acute Eye Irritation. EPA 712-C-98-195. Washington, DC: U.S.
Environmental Protection Agency. (Available: https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf).
\4\ OECD. 2002. OECD Guideline for the Testing of Chemicals 405:
Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-
operation and Development. (Available: https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf).

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

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