Presentation on theme: "Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care"— Presentation transcript:
1Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care USDA UpdatesDr. Carol ClarkeResearch Staff OfficerUSDA-APHIS Animal Care
22 Petitions Have Been Submitted PCRM:Develop clear and more stringent requirements for identifying and using alternatives.New England Anti-vivisectionist Society:Ethologically appropriate environments for nonhuman primates in research
3WHAT HAPPENS WHEN A PETITION IS SUBMITTED TO ANIMAL CARE?
4STEP #1: PETITION IS RECEIVED Petitions comes to the attention of Animal Care through APHIS’ Legislative and Public Affairs staffA work plan is createdSummarizes the petitionOutlines possible impactsPrimary and secondary contacts are identifiedWork plan is submitted to the Regulatory Analysis and Development (RAD) staff in APHIS
5STEP #2: POSTING FOR PUBLIC COMMENT RAD prepares the petition for public commentCreates questions relevant to the petition for the public to provide inputPetition is published in the Federal Register and posted for public comment on Regulations.govComment period 60 days initiallyAnimal Care also notifies stakeholders through the Stakeholder Registry
6STEP #3 Review of comments Public responses are reviewed at the end of the comment periodA summary of the comments is madeAPHIS makes a decision as to whether rulemaking is warranted
7Sources of RulemakingThe impetus for rulemaking can come from many sources, including:Agency acting on its own initiative,Statutory requirements,Congressional hearings,Court orders ,Emergency situations, and/orStakeholder requestsThis slide lends itself well to anecdotes.
8What Governs the Rulemaking Process? The principal requirements for rulemaking are set by the Administrative Procedure Act (APA)
9The APA Rulemaking Process Sometimes referred to as “notice-and-comment” rulemakingBasic 3-step process, or procedural “floor”Publication of proposed rule in the Federal RegisterComment periodPublication of a final rule that responds to comments and amends the regulationsThe Federal Register is a daily publication of executive agency regulations and notices and presidential documents.Mention FAA rule that didn’t allow for public comments.Why
10Publication in the Federal Register Provides official notice of a regulation’s existenceEstablishes the Federal Register text as true copy of original signed documentGives regulations evidentiary status so they are admissible in courtShows how and why the Code of Federal Regulations would/will be amended
13Final Rule Stage Publication of Final Rule Clearance Process Step 5Preparation of Final RuleStep 1Step 2Step 3Step 4Regulatory WorkplanComment Review
14Final Rule Stage After comment period: Agency reviews comments and prepares responseRevises text of final rule and analyses as appropriateFinal rule then submitted for review as with proposed ruleFinal rule published in the Federal RegisterFinal rules have the force and effect of law
15How Long Does This Process Take? Time depends on:Complexity of ruleNumber and nature of comments receivedPriority assigned by the AgencyThe designation assigned by OMBTrade negotiations and political issues
16Internet Resources Regulations.gov Federal Register:e-CFR:
17Getting Back to the 2 Petitions… No date yet for posting of petitionsMuch too early to say whether the petitions will result in a regulatory changeAPHIS prefers non-regulatory solutions to issues of concern where possible
18Importation of Live Dogs Final rule: Docket No. APHIS–2009– Effective 11/14/2014Animal Welfare Act amended to ensure health and welfare of imported dogsProhibits the importation of dogs into the US for resale unless the Secretary determines the dogs:are in good health,received all necessary vaccinations,are at least 6 months of age.Excludes importation for research and health reasons, however there is no ‘blanket pass’ for research facilities to import unvaccinated dogs in poor health and/or under 6 months of age.
19Requirements for Dogs Imported for Research Under New Rule Importers of dogs for research must:Complete an Animal Care import permitForm under developmentProvide a health certificate for each animalSubmit evidence to APHIS where applicable why requirements (6 mo. age, vaccination, good health) would interfere with an IACUC-approved protocol
20Animal Care Always Available for Guidance Your VMO or Regional Office is available to listen! Get updates through our stakeholder registry https://public.govdelivery.com/accounts/USDAAPHIS/ subscriber/new