The Antimicrobial Resistance Issue

A briefing for the Secretaries Advisory Committee on Animal Health

June 19, 2014

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

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

Agriculture Engagement

• Research to understand the issue• Stewardship efforts– Judicious use principles– Outreach and education

• Surveillance– NARMS– NAHMS

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

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)

FDA Policy Actions

• Revision of the VFD Rule– Information required– Records retention– Format for submission– Addresses oversight definition

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

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

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

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