Antibiotic Update - Dr. Dave Pyburn, National Pork Board, from the 2016 Missouri Pork Expo, February 9-10, 2016, Columbia, Missouri, USA. More presentations at http://www.swinecast.com/2016-missouri-pork-expo

1. Pork Industry Antibiotics Update
Dave Pyburn, DVM
Senior Vice President, Science and Technology

2. Building Trust – Responsible Antibiotic Use
• FDA regulated
• Involves food safety and human health
• Not pork-specific (crosses all species)
• No real, strong advocates
• For customers, changes are a brand differentiator
On-farm antibiotic use is on the minds of customers and consumers
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3. Since antibiotic resistance is a global concern, the worldwide
“One Health” approach to combat antibiotic resistance is critical to
human and animal health.
•Collaborative effort of multiple stakeholders to attain optimal
health for people, animals and the environment.
•Medical doctors and patients, veterinarians and farmers, along
with government, academia and industry stakeholders, are
cooperating.
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Antibiotic Resistance is Not a New Issue

4. Pork producers play an
important role in the
shared effort
to use antibiotics
responsibly to help
minimize the potential
emergence of antibiotic
resistant bacteria.
4
Antibiotic Resistance is Not a New Issue

5. Changes in Antibiotic Regulation –
What Will It Mean On the Farm?

6. Antibiotic Regulation
• US Food and Drug Administration (FDA) regulates
animal and human antibiotics
• State pharmacy boards have authority over
veterinary prescribing

7. 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

8. 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 exceptions:
• Swine: bacitracin, mecadox, narasin, bambermycin, and
tiamulin

9. Regulatory Action

11. FDA Regulatory Action
• On Jan. 1, 2017, the U.S. Food and Drug
Administration’s (FDA) new regulations
addressing on-farm antibiotic use in food-animal
production will take effect.

12. FDA Regulatory Action

13. FDA Regulatory Action
Removal of growth promotion/nutritional efficiency use
of medically important (to human illness) antibiotics
Bringing therapeutic use (treatment, control
prevention) under increased veterinary oversight

14. 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

15. Guidance for Industry #209
• FDA intent and recommendations regarding:
– Removal of growth promotion uses of medically
important antibiotics in food animal production
– Increased veterinary oversight of the remaining
remaining therapeutic applications (prevention,
treatment and control) of medically important
antibiotics
• This action applies to both feed-grade and water-
based antibiotics.

16. Guidance for Industry #213
• FDA request to animal-health companies to
outline intentions to voluntarily remove any
production/growth-promotion uses from product
labels of medically important antibiotics.
• All animal health companies have agreed.
• Jan. 1, 2017, is when implementation must be
completed.

17. Veterinary Feed Directive
• The final rule outlines specific requirements of the
VFD process for medically important (to treat
human infections) feed-grade antibiotics.

18. What Does This Really Mean?
• Most growth promotion uses (all medically
important antibiotics) will end by Dec 2016.
• Most feed-grade antibiotics will no longer be
available over-the-counter but will require a
veterinary feed directive (VFD).
• Antibiotics in water will require a prescription.

19. What Does This Really Mean?
• This is a significant regulatory step that will
change how antimicrobials are used in food
animal production on farms of all sizes.
• Once those labels are changed, it will be illegal to
utilize the medically important antibiotics to
promote growth.
• Producers will need a VFD or prescription to use
these products for therapeutic uses in feed and
water.

20. How Will This Affect Pork Producers?
• Producers are going to lose some antibiotics or
uses of antibiotics.
• The new FDA rule will require additional time and
effort on the part of producers, their
veterinarians, and feed mills.
• Producers will need a close relationship with their
veterinarian
– Access to veterinarians in some locations?

21. Helping Producers Prepare

22. Antibiotic Factsheet

23. Basics of On-Farm VFD Compliance
• Key Steps:
– The issuing veterinarian is required to keep the original
VFD; the feed mill/distributor and producer (client)
must each keep a copy of the VFD. Hardcopy or
electronic versions are allowed.
– The VFD and records of the related feed distribution
must be kept for a period of two years.

24. VFD Final Rule
Previous Rule
• 2 year record retention
• Original document to mill
• No extra-label use
• Order for tons of feed
• No refills, unless on label
• Written for one group of animals
on a premise
• VCPR required
Revised Rule
• 2 year record retention
• May email or fax document
• No extra-label use
• Order for number of days
• No refills, unless on label
– None at this time
• Attached list of premises
– For each mill
• State VCPR required
• Max of 6 mo. expiration

25. Basics of On-Farm VFD Compliance
• Key Steps Cont.
– Each VFD includes a specific expiration date. Any VFD
feed remaining after its related VFD has expired may
not be fed to animals without obtaining a new VFD.
This would include any remaining feed in a bin or
feeder.
Take Home Message for Producers: Talk with
your veterinarian about using any antibiotics
that fall under the new VFD requirement.

26. Veterinary-Client-Patient Relationship
• The new FDA antibiotics regulations will require
pig farmers to have a valid veterinary-client-
patient relationship (VCPR).
• This means a pig farmer will need to have a good
relationship with their veterinarian and expect to
spend more time in developing a plan that
satisfies all VFD requirements.
• Your veterinarian should be familiar with the state
and/or federal VCPR requirements.

27. Record-keeping Priorities
• Producers with Pork Quality Assurance® Plus (PQA
Plus®) certification should be well familiar with
requirements for accurate and complete record-
keeping.
• The record-keeping commitment will involve
keeping hard copies or electronic versions of all
VFDs for two years and one year for all
prescriptions.

28. Your Checklist for Success (USCARE)
• Understand the new feed (Veterinary Feed Directive)
and water (prescription) rules.
• Strengthen your veterinary-client-patient relationship
(VCPR).
• Communicate with your feed mill.
• Assess your herd health and welfare strategies.
• Renew your commitment to responsible antibiotic
use.
• Ensure your record-keeping compliance.

29. Producer Antibiotic Resource Center
• Antibiotic Resource Center located at:
www.pork.org/antibiotics
– All resources
– FAQs
– VCPR definitions
– Additional clarifications from FDA

30. Other Checkoff Antibiotics Efforts

31. New Antibiotics Policy and Position

32. NPB Policy on Antibiotics
On behalf of America’s pig farmers, the National Pork Board
has created the following values that reflect farmers’
commitment to using antibiotics responsibly on the farm. We
affirm that:
•Using antibiotics responsibly in animals and humans is
essential to protect the health and wellbeing of both.
•Preventing disease, rather than treating disease, by using
disease-prevention strategies, that may include antibiotics, is
essential for animal health and well-being and can prevent
unnecessary illness, suffering and mortality.
•Protecting the efficacy of antibiotics is important today
because it can help ensure the overall health and well-being of
future generations of people and animals.
•Reducing the need to use medically important antibiotics by
using best management practices is a worthy objective.

33. NPB Policy on Antibiotics (cont.)
We agree to implement the following guidelines to
demonstrate our values. They include:
•Advocating objective, scientifically rigorous studies and risk
assessments to make informed decisions regarding on-farm
use of antibiotics in food-animal production.
•Supporting veterinarian oversight and best practices as the
basis of antimicrobial use decision-making on the farm.
– Continual evaluation of treatment programs, appropriate diagnostics
and timely interventions are important components of veterinary best
practices.
•Promoting stakeholder education to continually enhance on-
farm knowledge to improve antibiotic best practices.
– Antibiotic stewardship guidance for veterinarians and pork producers
includes Pork Quality Assurance® Plus,

34. NPB Policy on Antibiotics (cont.)
• American Association of Swine Veterinarians’ Basic
Guidelines of Judicious Therapeutic Use of
Antimicrobials in Pork Production and continuing
education for veterinarians.
• Demonstrating compliance with all regulatory
requirements to underscore antibiotic stewardship, e.g.,
treatment records as described in PQA Plus®.
• Encouraging transparency and providing assurances
regarding farmers’ commitment to raising healthy animals
to help ensure a safe food supply.

35. NPB Antibiotic Use Policy
• Using antibiotics responsibly
• Preventing disease, rather than treating disease
• Protecting the efficacy of antibiotics
• Reducing the need to use medically important
antibiotics

36. Checkoff Stewardship Plan

37. Checkoff Research - 2016
• NPB to allocate up to $1.4 million in Checkoff
funding for scientific research, producer
education and consumer awareness programs

38. Priority Research Areas for 2016
1. Analysis and assessment of preventive uses of
antibiotics at therapeutic doses in pork
production to optimize swine health and public
health.
2. Analysis and assessment of specific animal
population antibiotic treatment versus individual
animal treatment in pork production to optimize
swine health and public health.

39. Priority Research Areas for 2016 cont.
3. Evaluation of on-farm challenges to antibiotic
record keeping and identification of strategies to
improve antibiotic record keeping practice for
continuous improvement of responsible
antibiotic use on the farm.
4. Characterization and assessment of the
environmental fate of antibiotics, antibiotic
metabolites, antibiotic resistant bacteria and
antibiotic resistant genes on swine farms.

40. Priority Research Areas for 2016 cont.
5. Exploration of strategies to protect herd health
and minimize the need for antibiotics.
Other:
• Full-time subject matter expert (Dr. Peter Davies)
in 2016 who will evaluate models and metrics to
assess antibiotic stewardship and use in the U.S.
swine industry.

41. Ongoing Expert Input
• Director, Producer and Public Health
• Producer, Public Health and Workplace
Safety Committee
• Topical working groups (PQA, Antibiotics, Food
Attribution, others)
• Blue Ribbon Panel of third-party animal and
human health experts, along with consumer
marketing experts

42. Summary
• “Be Ready” for the new antibiotic changes.
• To stay informed on the VFD and related
regulations, bookmark pork.org/antibiotics.
– Where you will find the latest information and
resources about this important issue throughout 2016.

44. This message funded by America’s Pork Producers
Questions?