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

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Presentation on theme: "Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care"— Presentation transcript:

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


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

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 This slide lends itself well to anecdotes.

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 The 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

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

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

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– 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 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.

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

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