1. The Antimicrobial Resistance Issue A briefing for the Secretaries Advisory Committee on Animal Health June 19, 2014

2. Antimicrobial Resistance Scale and Scope Global issue Spans human, animal and environmental health Growing urgency to address the issue in a coordinated way – Increased number of resistant organisms – Some organisms with few treatment options – Global interconnectedness of populations

3. Action Areas Human health care Agriculture – Animal Health and Wellbeing – Interface with Public Health Foodborne pathogens and commensals Direct contact Environmental exposure Other animal care

4. Agriculture Engagement Research to understand the issue Stewardship efforts – Judicious use principles – Outreach and education Surveillance – NARMS – NAHMS

5. FDA Policy Actions Guidance for Industry (GFI) #152 – Approvals of new antimicrobial products – Consideration for antimicrobial resistance – Priority ranking for antimicrobial classes GFI #209 – Agency view on judicious antimicrobial use Use of medically important antimicrobials for growth promotion is not judicious use There is a need for greater veterinary oversight

6. FDA Policy Actions GFI #213 – Seeks voluntary removal of the growth promotion as a label claim for medically important antimicrobials (those listed in GFI #152) – Sets a 3 year timeline to accomplish label changes – Outlines process for bringing new label claims – Adds requirement for a Veterinary Feed Directive for all medically important antimicrobials in feed for therapeutic uses (prevention, control, treatment)

7. FDA Policy Actions Revision of the VFD Rule – Information required – Records retention – Format for submission – Addresses oversight definition

8. Stakeholder Input AMR Stakeholder Workshop, May 2012* – Need for antibiotic use and resistance monitoring – Need for information on management practices to reduce antibiotic resistance – Need for information on alternative medical interventions Regional Listening Sessions – Questions about how the policy would work – Questions about metrics for the impacts of the policy * http://www.fsis.usda.gov/wps/wcm/connect/9ddc0b9c-af04-4ed4-b959-b7799ddbfe11/USDA-Antibiotic-Resistance-Workshop- Summary.pdf?MOD=AJPERES

9. USDA Actions Development of a draft USDA AMR Action Plan – Responsive to stakeholder input – Coordinated among agencies (and with other departments) – Leverages resources/expertise across agencies APHIS FSIS ARS NIFA NASS ERS

10. Components of the Draft Action Plan Enhanced and expanded surveillance Biological sampling at various points in production continuum New initiatives aimed at funding multi- institutional/multiagency projects that integrate research, education, and extension Research on alternatives to conventional antibiotics Education and outreach

11. Questions for the Committee Provide feedback on the current and proposed USDA activities that address AMR Identify how USDA could best collaborate with their constituent industries to supplement and sustain these activities Recommend actions USDA could take to promote acceptance and support among State and industry stakeholders for USDA activities related to the AMR issue