Troy Bigelow from the USDA presented a new approach to regulating pseudorabies virus (PRV) and swine brucellosis (SB) that combines the two programs. The current regulations are prescriptive and difficult to update, while the proposed performance-based approach in state health plans would streamline regulations. States would get a risk-based status and national surveillance would be enhanced. The new approach aims to reduce regulatory burden while continuing to prevent disease spread and assure low-risk animal movement. Public comments are requested to help develop the new regulations.

1. Safeguarding Animal Health
National Institute of Animal Agriculture
Swine Committee Meeting
Troy Bigelow, DVM
National Center for Animal Health Programs
U.S. Department of Agriculture
Animal and Plant Health Inspection Service
Veterinary Services
April 16, 2013
1
A New Approach to PRV and SB: A Concept

2. Safeguarding Animal Health
Overview
• Background- The need for change
• The concept paper- VS’ current thinking
• Next steps
• Discussion
2

3. Safeguarding Animal Health
Need for Change:
• The eradication programs worked
 Approaching 10 years PRV free
 All states swine brucellosis free
• Risks
 Feral swine reservoir
 Movement of swine exposed to feral
• Interstate movement
 Movement protocols developed before PRV and SB
eradiated from commercial herds
 Most swine, including swine with unknown possible
exposure to feral swine, are considered free for
movement
3

4. Safeguarding Animal Health
The Need for Change: Current
Regulations
• Regulatory Inflexibility
Prescriptive
Difficult to update in timely manner to reflect
changes in: Science, surveillance and industry
practices
• Inconstancies:
Current regulations differ between PRV and SB
Indemnification process different
• Commercial Terminology
4

5. Safeguarding Animal Health 5
Need for Change: Traditional
Regulatory Approach
• Disease-based programs
• Highly prescriptive and detailed
regulations
• Difficult and time-consuming to amend
regulations
• Does not take advantage of program
similarities

6. Safeguarding Animal Health
The Need for Change: Concepts
• Performance-based, outcome focused
• Combines disease regulation when
appropriate
• Details provided in guidance documents
• Amendments can be made more efficiently
• Stakeholder involvement prior to rulemaking
6

7. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking
• A New Approach for Managing
Swine Brucellosis and Swine
Pseudorabies Virus: Veterinary
Services’ Proposed Action Plan
• Federal Register:
• Request for extension
• New closing date: July 7th.
7

8. Safeguarding Animal Health
VS’ Current Thinking- A New
Approach
• Combines swine brucellosis and
pseudorabies regulatory programs
• Creates performance-based regulations for
the combined program
• State classification system based on disease
mitigation and prevention of disease spread
• Streamlines and creates a national science-
based surveillance plan.
8

9. Safeguarding Animal Health
VS’ Current Thinking- A New
Approach: The Details
• Swine Health Plans
State and Tribes
Contains description of industry
Identifies potential sources of PRV/SB infection of
swine
Surveillance and recordkeeping methods
Control measures
9

10. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking:
The Details
• Swine Health Plan Process
 Submitted to VS
 Reviewed
 Notice for public comment (open and transparent)
 Approved
• Changes need to be resubmitted
• States receive a performance based status
 Consistent
 Provisionally consistent
 Inconsistent
• Reviewable
10

11. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking:
The Details
• VS could rescind approval of a plan
when:
Diseased non-slaughter animals are
allowed to move interstate
Activities in the plan aren’t implemented
or maintained
Epidemiological investigations aren’t
conducted
Requested amendments to the plan
aren’t made
11

12. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking:
The Details
• Enhanced surveillance
National surveillance plan
National surveillance reports
All states have to participate in the national plan
States can perform additional surveillance to
address specific risks
Yearly surveillance reporting
Reporting burden lessened
12

13. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking:
The Details
Interstate Movement
• Intend to continue many existing CFR
requirements
Infected swine
Move to slaughter
 Exposed Swine
 Directly to slaughter
 Quarantined feedlots
– States discretion
– Test prior to move
13

14. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking:
The Details
• Interstate Movement (continued)
Not infected, not exposed
Swine with status from States with approved plans, move
freely
Swine from provisionally consistent States could be
subject to certain movement restrictions
Swine from inconsistent states restrictions but individual
producers can obtain movement eligibility
14

15. Safeguarding Animal Health
Concept Paper-VS’ Current Thinking
• Laboratory Requirements
Defines Official Tests
Official tests identified in supplemental documents
Allows flexibility.
Intend to continue many existing regulations
• Streamlines Indemnity
Removes inconsistencies
15

16. Safeguarding Animal Health
Summary: Swine Health and the
New Approach
• Flexible, performance-based framework
• Combines similar disease programs
• Reduces burden on States
• Updates our regulatory programs
16

17. Safeguarding Animal Health
Summary: Swine Health and the
New Approach
• Allows each state to address its own unique
risks
• Assurance that animals in interstate
commerce are low risk
• Creates national surveillance plan
• Commercial terminology
17

18. Safeguarding Animal Health
Next Steps
• Please visit www.regulations.gov to comment
on the proposed action plan
• Gathering stakeholder input prior to
rulemaking
18

19. Safeguarding Animal Health
Discussion
19