1. Changes in antibiotic regulation – what will it mean on the farm? Jennifer Koeman, National Pork Board Harry Snelson, American Association of Swine Veterinarians

2. Topics Background Current Antibiotic Regulations – Label Claims – VFD New Antibiotic Regulations What this means on the farm What you can do to prepare

3. Background

4. Antibiotic Regulation US Food and Drug Administration regulates animal and human antibiotics State pharmacy boards have authority over veterinary prescribing

5. Antibiotic Label Claims Disease Treatment Disease Control Disease Prevention – Treatment, Control and Prevention are considered therapeutic – FDA has said they are necessary for animal health and welfare Growth Promotion or Improvement of Nutritional Efficiency

6. Antibiotic Classes Medically important (as defined by FDA) – Same, or in same classes, as antibiotics used to treat humans – Most antibiotics approved for use in animal feed are medically important with possible exceptions: Swine: bacitracin, mecadox, narasin, bambermycin, and tiamulin

7. Antibiotics in Feed Must be used according to label directions – No extra-label use for veterinarians Veterinary Feed Directive (VFD) – Veterinary order, similar to a prescription – FDA oversight, not state pharmacy boards

8. Veterinary Feed Directive Current requirements – Written for amount of feed to be consumed in a time period – Original copy required to the feed mill within 5 days – VCPR – Refills not straightforward – Keep records (mill, veterinarian, farmer) for two years

9. Regulatory Action

13. Regulatory Activity Removal of growth promotion/nutritional efficiency use Increased veterinary oversight

14. Guidance for Industry #209 Guidance is how the regulatory agency will conduct their business – Does not have the force of law, but provides the agency’s position on regulatory matters – Voluntary is relative

15. Guidance for Industry #209 “Production uses” (growth promotion and nutritional efficiency) of antibiotics in classes used in human medicine are injudicious – Does not call them unsafe Requires other uses of these same classes of antibiotics be under “veterinary oversight”

16. FDA medically important All swine antibiotics will be affected under Guidance 209 except – Bacitracin – Carbadox – Bambermycin – Ionophores – Tiamulin These antibiotics will remain available for growth promotion and/or over-the-counter (OTC) in feed and water

17. Guidance for Industry #209 “Voluntarily” working with sponsors to discontinue claims or migrate production claims to disease prevention – Guidance #213 gives roadmap on implementation

18. Guidance for Industry #213 Animal Health sponsors have all agreed to voluntarily surrender their approvals for growth promotion, and move remaining therapeutic uses under VFD or prescription for affected products – Implementation to be completed by end of 2016

19. FDA Guidance 213/VFD Guidance #213 and VFD finalized Growth Promotion and Nutritional Efficiency labels will be removed by Dec. 2016 – “Medically Important” Disease Prevention, Control and Treatment will be VFD in feed, Rx in water

20. Guidance for Industry What does it really mean? – Most growth promotion uses will end within 3 years – Most feed grade antibiotics will no longer be available over-the-counter but will require a veterinary “order” – Antibiotics in water will require a prescription

21. What does this really mean? Significant regulatory step that will result in changes on how antibiotics are used on the farm Once those labels are changed, it will be illegal to utilize these antibiotics to promote growth Producers will need a VFD or prescription to use these products in feed and water

22. How will this affect pork producers? Producers are going to lose some antibiotics or uses of antibiotics Increased costs and increased time Producers will need a close relationship with their veterinarian – access to rural veterinarians?

23. What can you do to prepare?

24. Swine veterinarians and producers are familiar with the VFD process However, there will be changes to the number of products requiring a VFD and the frequency with which VFDs will need to be written Veterinarians will continue to work closely with their clients to ensure the ongoing judicious use of antibiotics

25. Work with your veterinarian Secure a good working relationship with your herd veterinarian and build familiarity with your production system. Critical as drugs transition to VFD – Currently two VFD drugs – pulmotil and nuflor – All medically important feed grade abtics will require a VFD on January, 2017

26. VFD proposed final rule 2 year record maintenance – – vet, distributor, client – Records maintained as paper or electronic Expiration date – As per approved label or, if no labelled date, – Vet assigned not to exceed 6 months – VFD feed cannot be fed beyond the expiration date VCPR – Comply with state requirements – FDA codified VCPR (21CFR530) if no or inadequate state regs

27. VFD proposed final rule VCPR – minimum requirements: – the veterinarian engage with the client to assume responsibility for making clinical judgments about patient health – have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed, and – provide for any necessary follow-up evaluation or care.

28. VFD proposed final rule Refills – authorization to obtain and feed additional VFD feed in the same total quantity and under the same conditions of the existing VFD by the expiration date of the VFD – vet can assign refills IF refills are allowed on the product label – Currently, no products have a label approval for refills VFD estimates the number of animals receiving the feed not the amount of feed VFD cannot be used to estimate on-farm abtic use

29. Evaluate herd health protocols Sit down with your veterinarian to evaluate all animal-health management protocols and herd vaccination programs – Veterinarians can work with producers to develop strategies to minimize disease risk through facility design, pig flows, vaccination protocols, herd health monitoring, disease surveillance and appropriate diagnostics

30. Understand product changes Review all swine medications currently being used within the operation Discuss which products are affected by veterinary feed directives and prescriptions and how the process will work on the farm – Veterinarians can provide guidance on judicious antibiotic use and help ensure compliance with the new guidelines and regulations

31. Be vigilant with record-keeping Walk through the record-keeping requirements and strategies – Record keeping is, and will continue to be, a key aspect of on-farm antibiotic use – VFD final rule requires veterinarians, distributors and producers to retain the VFD for 2 years

32. Continue best practices Follow VFD label instructions Ensure proper withdrawal intervals Employ PQA Plus Responsible Antibiotic Use Practices

33. Next Steps

34. Industry Efforts Outreach and education to producers and veterinarians – State meetings – Numerous industry communications planned – AASV outreach – PQA Plus® to reflect changes Working with other organizations to assure consistent understanding of VFD rule Honing research priorities

35. This message funded by America’s Pork Producers and the Pork Checkoff Questions?

36. White House interest spawns new initiatives Executive Order 13676: Combating Antibiotic- Resistant Bacteria—issued by President Barack Obama on September 18, 2014

37. White House interest spawns new initiatives

38. National Strategy “Directs Federal agencies to accelerate response to this growing threat to the nation’s health and security.”

39. PCAST Surveillance – Want White House coordination Stewardship – Development of alternatives for animal use – Supportive of FDA process, for now Continued Development of Antibiotics – Calling for public private partnerships

40. National Action Plan “roadmap to guide the Nation in rising to this challenge” “guide activities by the U.S. Government…is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug- resistant threats that affect people in the U.S. and around the world.”

41. National Security Priority Defense, Agriculture, Health and Human Services to lead interagency task force – State, Justice, Homeland Security, USAID, Veterans Affairs, Environmental Protection, National Security Council CARB Advisory Panel – Stakeholders and experts to advise the agencies on the implementation of the CARB action plan

42. National Security Priority White House Forum on Antibiotic Stewardship – Key human and animal health constituencies to improve antibiotic use (antibiotic stewardship) nationwide