USDA Updates Dr. Carol Clarke Research Staff Officer USDA-APHIS Animal Care.
Post on 14-Dec-2015
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USDA Updates
Dr. Carol ClarkeResearch 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:– Ethologically appropriate environments for
nonhuman primates in research
WHAT HAPPENS WHEN A PETITION IS SUBMITTED TO ANIMAL CARE?
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
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 Regulations.gov– Comment period 60 days initially
• Animal Care also notifies stakeholders through the Stakeholder Registry
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
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
What Governs the Rulemaking Process?
The principal requirements for rulemaking are set by the Administrative Procedure Act (APA)
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
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
The Rulemaking Process
Step 1Step 2
Step 3Step 4
Step 5Step 6
Step 7
Proposed Rule Stage
Need Identified
Preliminary Analyses
Regulatory Workplan
Preparation of Proposed Rule
Clearance Process
Publication of Proposed Rule
Comment Period
Final Rule Stage
Step 1Step 2
Step 3Step 4
Step 5Comment Review
Regulatory Workplan
Preparation of Final Rule
Publication of Final Rule
Clearance Process
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
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
Internet Resources
• Regulations.gov• Federal Register:
http://www.gpoaccess.gov/fr/• e-CFR: http://ecfr.gpoaccess.gov/
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
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 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.
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
Your VMO or Regional Office is available to listen!
Get updates through our stakeholder registry
https://public.govdelivery.com/accounts/USDAAPHIS/ subscriber/new
Animal Care Always Available for Guidance
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