USDA Updates

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

2 Petitions Have Been Submitted

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PCRM:

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Develop clear and more stringent requirements for identifying and using alternatives.

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New England Anti-vivisectionist Society:

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Ethologically appropriate environments for nonhuman primates in research

WHAT HAPPENS WHEN A PETITION IS SUBMITTED TO ANIMAL CARE?

STEP #1: PETITION IS RECEIVED

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Petitions comes to the attention of Animal Care through APHIS’ Legislative and Public Affairs staff A work plan is created

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Summarizes the petition Outlines possible impacts

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Primary and secondary contacts are identified Work plan is submitted to the Regulatory Analysis and Development (RAD) staff in APHIS

STEP #2: POSTING FOR PUBLIC COMMENT

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RAD prepares the petition for public comment

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Creates questions relevant to the petition for the public to provide input

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Petition is published in the Federal Register and posted for public comment on Regulations.gov

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Comment period 60 days initially Animal Care also notifies stakeholders through the Stakeholder Registry

STEP #3 REVIEW OF COMMENTS

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Public responses are reviewed at the end of the comment period

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A summary of the comments is made

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APHIS makes a decision as to whether rulemaking is warranted

Sources of Rulemaking

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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

What Governs the Rulemaking Process?

The principal requirements for rulemaking are set by the Administrative Procedure Act (APA)

The APA Rulemaking Process

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Sometimes referred to as “notice-and comment” rulemaking Basic 3-step process, or procedural “floor”

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Publication of proposed rule in the Federal

Register

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Comment period

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Publication of a final rule that responds to comments and amends the regulations

Publication in the Federal Register

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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

The Rulemaking Process

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

Final Rule Stage Comment Review

Step 1

Regulatory Workplan Preparation of Final Rule Clearance Process

Step 4 Step 3 Step 2

Publication of Final Rule

Step 5

Final Rule Stage

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After comment period:

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Agency reviews comments and prepares response

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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

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Final rules have the force and effect of law

How Long Does This Process Take?

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Time depends on:

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Complexity of rule

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Number and nature of comments received

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Priority assigned by the Agency

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The designation assigned by OMB

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Trade negotiations and political issues

Internet Resources

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Regulations.gov

Federal Register: http://www.gpoaccess.gov/fr/ e-CFR: http://ecfr.gpoaccess.gov/

Getting Back to the 2 Petitions…

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No date yet for posting of petitions

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Much too early to say whether the petitions will result in a regulatory change

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APHIS prefers non-regulatory solutions to issues of concern where possible

Importation of Live Dogs

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Final rule: Docket No. APHIS–2009–0053 Effective 11/14/2014 Animal Welfare Act amended to ensure health and welfare of imported dogs

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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.

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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.

Requirements for Dogs Imported for Research Under New Rule

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Importers of dogs for research must:

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Complete an Animal Care import permit

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Form under development

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Provide a health certificate for each animal

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Submit evidence to APHIS where applicable why requirements ( 6 mo. age, vaccination, good health) would interfere with an IACUC-approved protocol

Animal 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