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:
– 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-andcomment” 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
Proposed Rule Stage
Publication
of Proposed
Rule
Preparation
of Proposed
Rule
Comment
Period
Clearance
Process
Regulatory
Workplan
Preliminary
Analyses
Step 7
Step 6
Need
Identified
Step 5
Step 4
Step 3
Step 1
Step 2
Final Rule Stage
Publication of
Final Rule
Clearance
Process
Preparation of
Final Rule
Regulatory
Workplan
Comment
Review
Step 5
Step 4
Step 1
Step 2
Step 3
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
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/
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