U.S. Department of Agriculture Proposed Activities to Address Antibiotic Resistance Secretary’s Advisory Council on Animal Health April 29, 2015 L.M. Granger, D.V.M.

National Strategy on Combating Antibiotic-Resistant Bacteria Slow the emergence and prevent the spread of resistant bacteria. Strengthen National efforts to identify and report cases of antibiotic resistance. Advance the development and use of rapid diagnostic tests for the identification and characterization of antibiotic-resistant bacteria. Accelerate basic and applied research and development for new antibiotics as well as other therapeutics and vaccines. Improve international collaboration, capacities for antibiotic- resistance prevention, surveillance, control, and antibiotic research and development.

Overview Gaps identified by Stakeholders Goals and objectives of USDA activities to address antibiotic resistance SACAH recommendations for USDA FY2016 budget 3

Stakeholders Recommendations to USDA in 2012 Workshop Holistic approach considering entire microbiome Strengthen National Antimicrobial Resistance Monitoring System (NARMS) Strengthen National Animal Health Monitoring System (NAHMS) Conduct research via a long-term plan Conduct outreach and education 4

USDA Goals to Address Antibiotic Resistance Obtain and disseminate science-based, quantitative antibiotic drug use information coupled with the development of resistance in food-producing animals and relate this to livestock management practices. Address recognized knowledge gaps and develop effective, practical mitigation strategies that will help to prolong the effectiveness of antibiotics to treat both people and animals. Identify novel strategic approaches (immunological, genetic, nutritional, etc.) that could be exploited to control/mitigate infectious disease and thus reduce the need to use traditional antibiotics. 5

USDA National Action Plan Objectives December, 2014 Objective 1: Determine and/or model patterns, purposes, and impacts of antibiotic use in food-producing animals. Objective 2: Monitor antibiotic drug susceptibilities of selected bacterial organisms in food-producing animals, production environments, and meat and poultry. Objective 3: Identify feasible management practices, alternatives to traditional antibiotics, and other mitigations to reduce AMR associated with food-producing animals and their production environments. 6

Proposed Surveillance Passive, enhanced and expanded survey questionnaires longitudinal studies Measurement of antimicrobial drug use and resistance, and related production practices by livestock and poultry producers 7

NAHMS on-farm prospective monitoring studies Determine use Therapeutic indications Prevention Benchmark measures to inform FDA policy Estimate quantities by spp., production type, age, etc. Evaluation of resistance patterns Modeling of associations Longitudinal studies, sentinel groups Investigative follow-up Coordination with partner agencies with regulatory responsibilities Investigative studies for scientific inquiry

NVSL / NAHLN laboratory diagnostics, genomics, data NAHLN collection of data Passive surveillance Opportunistic Companion animals MED-VET-NET / Pulse NET Genetic resistance (genomics) Sample testing methodologies and standardization of techniques Identify pathogens of interest (Guidance # 152, Appendix A)

National Veterinary Accreditation Program Education and Outreach National Veterinary Accreditation Program Judicious use VFD training Data stream NAHMS reports Expand stage One Health Coordinating Center Get Smart on the Farm

Proposed Research Alternatives Vaccines Feed, nutrition, genetic resistance Ecology Management practices Multi-institutional/multiagency projects that integrate research, education, and extension. 11

Economic analysis Policy analysis Impact analysis Data sharing Data access, management, quality, analysis of metadata Research needs Identification and statements of need Communication ( Not education and outreach)

Reporting Administrative accountability OMB GHSA OIE VSDA APHIS OA OSEC GAO OIG Informational VetNET PulseNET NAHMS

SACAH Recommendations NAHMS is engaging industry representatives to develop survey questionnaire AVMA is convening a data “task force” AAVMC is active Public meeting jointly sponsored by FDA and USDA Objective is to collect and report more accurate antibiotic usage data 14

USDA does not plan to require reporting, does not plan active surveillance, or required laboratory submissions; and does not have access to this sort of data stream. (NARMS and FSIS) Private sector (“third party”) data may be protected under CIPSEA Chief Data Quality Officer to head a unit that will be primarily engaged with confidentiality, quality, validation and verification of data.

There is no regulatory authority that VS can exercise to achieve its goals. One example where that is not true is with approvals of diagnostics and vaccines as alternatives to antibiotics. Another is CIPSEA.

While USDA has much of the infrastructure in place to deliver strong support to the AMR effort, each area will require substantial augmentation of financial and human resources. USDA will need to collaborate to develop criteria for susceptibility reporting across FAO, OIE and WHO regional surveillance programs, to strengthen understanding and control of AMR transmission.

FY2016 Budget From a base of $20M in 2015, the FY2016 budget proposes $77M Increase USDA funding for antimicrobial resistance by $57M 65 M for research 12 M for surveillance 18

Details can be found in: USDA AMR Workshop: 0b9c-af04-4ed4-b959-b7799ddbfe11/USDA- Antibiotic-Resistance-Workshop- Summary.pdf?MOD=AJPERES 0b9c-af04-4ed4-b959-b7799ddbfe11/USDA- Antibiotic-Resistance-Workshop- Summary.pdf?MOD=AJPERES USDA AMR National Action Plan: USDA 2016 Budget Explanatory Notes l