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USDA Updates. Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care. 2 Petitions Have Been Submitted. PCRM: Develop clear and more stringent requirements for identifying and using alternatives. New England Anti-vivisectionist Society:

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USDA Updates

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    1. USDA Updates Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care

    2. 2 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


    4. STEP #1: PETITION IS RECEIVED • Petitions comes to the attention of Animal Care through APHIS’ Legislative and Public Affairs staff • A work plan is created • Summarizes the petition • Outlines possible impacts • Primary and secondary contacts are identified • Work plan is submitted to the Regulatory Analysis and Development (RAD) staff in APHIS

    5. STEP #2: POSTING FOR PUBLIC COMMENT • RAD prepares the petition for public comment • Creates questions relevant to the petition for the public to provide input • Petition is published in the Federal Register and posted for public comment on • Comment period 60 days initially • Animal Care also notifies stakeholders through the Stakeholder Registry

    6. STEP #3 Review of comments • Public responses are reviewed at the end of the comment period • A summary of the comments is made • APHIS makes a decision as to whether rulemaking is warranted

    7. Sources of Rulemaking The impetus for rulemaking can come from many sources, including: • Agency acting on its own initiative, • Statutory requirements, • Congressional hearings, • Court orders , • Emergency situations, and/or • Stakeholder requests

    8. What Governs the Rulemaking Process? The principal requirements for rulemaking are set by the Administrative Procedure Act (APA)

    9. The APA Rulemaking Process • Sometimes referred to as “notice-and-comment” rulemaking • Basic 3-step process, or procedural “floor” • Publication of proposed rule in the Federal Register • Comment period • Publication of a final rule that responds to comments and amends the regulations

    10. Publication in the Federal Register • Provides official notice of a regulation’s existence • Establishes the Federal Register text as true copy of original signed document • Gives regulations evidentiary status so they are admissible in court • Shows how and why the Code of Federal Regulations would/will be amended

    11. The Rulemaking Process

    12. Proposed Rule Stage Comment Period Publication of Proposed Rule Clearance Process Preparation of Proposed Rule Step 7 Regulatory Workplan Step 6 Step 4 Preliminary Analyses Step 5 Step 3 Need Identified Step 2 Step 1

    13. Final Rule Stage Publication of Final Rule Clearance Process Step 5 Preparation of Final Rule Step 4 Regulatory Workplan Step 3 Comment Review Step 2 Step 1

    14. Final Rule Stage • After comment period: • Agency reviews comments and prepares response • Revises text of final rule and analyses as appropriate • Final rule then submitted for review as with proposed rule • Final rule published in the Federal Register • Final rules have the force and effect of law

    15. How Long Does This Process Take? • Time depends on: • Complexity of rule • Number and nature of comments received • Priority assigned by the Agency • The designation assigned by OMB • Trade negotiations and political issues

    16. Internet Resources • • Federal Register: • e-CFR:

    17. Getting Back to the 2 Petitions… • No date yet for posting of petitions • Much too early to say whether the petitions will result in a regulatory change • APHIS prefers non-regulatory solutions to issues of concern where possible

    18. Importation of Live Dogs Final rule: Docket No. APHIS–2009–0053 Effective 11/14/2014 • Animal Welfare Act amended to ensure health and welfare of imported dogs Prohibits the importation of dogs into the US for resaleunlessthe 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.

    19. Requirements for Dogs Imported for Research Under New Rule • Importers of dogs for research must: • Complete an Animal Care import permit • Form under development • Provide a health certificate for each animal • Submit evidence to APHIS where applicable why requirements (6 mo. age, vaccination, good health) would interfere with an IACUC-approved protocol

    20. Animal Care Always Available for Guidance Your VMO or Regional Office is available to listen! Get updates through our stakeholder registry subscriber/new