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CPSC RIN: 3041-AD20 Publication ID: 2012 
Title: ●Animal Testing Policy Associated With Cautionary Labeling for Hazardous Substances 
Abstract: 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 Therefore, an update is now needed to amend sections of 16 CFR part 1500 that contain outdated or incomplete information on animal testing and to incorporate these relevant new developments.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. 
Agency: Consumer Product Safety Commission(CPSC)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 16 CFR 1500   
Legal Authority: 15 USC 1261 to 1278   
Legal Deadline:  None
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Leslie Patton
Project Manager
Consumer Product Safety Commission
Directorate for Health Sciences, 4330 East West Highway,
Bethesda, MD 20814
Phone:301 504-7848

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