3041-AD20 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 3041 Consumer Product Safety Commission CPSC Animal Testing Policy Associated With Cautionary Labeling for Hazardous Substances CPSC staff is proposing rulemaking to amend the animal testing policy associated with the determination of cautionary labeling for hazardous substances under the Federal Hazardous Substances Act (FHSA). The last update to the animal testing policy was an uncodified policy in 1984 that called for a reduction in the number of animals required for toxicity testing and clarified when animal testing might be needed. The policy also states that "Health Sciences will incorporate the techniques into the Commission's compliance program 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." Such developments in testing have been produced in recent years, particularly since the National Institutes of Health Revitalization Act was passed in 1993 directing the National Institute of Environmental Health Science (NIEHS) to establish a method and criteria for the validation and regulatory acceptance of alternative testing methods (Pub. L. 103-43, section 1301). Therefore, an update is now needed to amend sections of 16 CFR part 1500 that contain outdated or incomplete information on animal testing and to incorporate these relevant new developments. Changes to 16 CFR part 1500 will emphasize the fact that animal testing is not a requirement of the FHSA, but rather, one of several options for toxicity testing. Specifically, CPSC staff recommends substantive amendments to 16 CFR 1500.3(c)(1), (2)(i), (3), and (4), which provide definitions of FHSA hazard terms "highly toxic," "toxic," "corrosive," "irritant," "primary irritant," and "eye irritant," each of which relates to the outcome of a specific animal test. CPSC staff also recommends substantive amendments to the acute dermal toxicity assay (sec. 1500.40), the primary irritant assay (sec. 1500.41), and eye irritant assay (sec. 1500.42), all of which use rabbits. In addition, CPSC staff prepared for Commission consideration a briefing package describing the new policy and its proposed codification. On June 13, 2012 staff submitted for Commission consideration a briefing package on the proposed rule and proposed codification of the animal testing policy. On June 22, 2012, the Commission voted unanimously to approve publication of the proposed rule to amend the testing regulations, and to codify the proposed statement of policy on animal testing in the Federal Register. Both were published on June 29, 2012. Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage No No 16 CFR 1500 15 USC 1261 to 1278 No Staff Sends Briefing Package to Commission 06/13/2012 Commission Decision 06/22/2012 NPRM for Revisions to Animal Testing Regulations Published in Federal Register 06/29/2012 77 FR 38754 Proposed Statement of Policy on Animal Testing 06/29/2012 77 FR 38751 NPRM Comment Period End 09/12/2012 Staff Sends Briefing Package to Commission 12/00/2012 Undetermined Undetermined No No Leslie Patton 3041 Consumer Product Safety Commission CPSC 301 504-7848 lpatton@cpsc.gov Directorate for Health Sciences, 4330 East West Highway, Bethesda MD 20814