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

3. WHAT HAPPENS WHEN A PETITION IS SUBMITTED TO ANIMAL CARE?

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 Regulations.gov
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 Regulations.gov
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