#15-186

Progress

Date Full Report Received

10/31/2017

Date Abstract Report Received

10/31/2017

Investigation

Institution:
Primary Investigator:

Societal concerns about antibiotic use (ABU) and antibiotic resistance are a major vulnerability for the US swine industry. National and international events have led to increasing pressures for accountability regarding ABU in food animals. These include calls for better measurement of ABU in all sectors (including human medicine and food animal production) and for more responsibility and accountability for antibiotic use by all parties involved in provision and administration of antibiotics.

This project was undertaken to help the US swine industry to remain at the forefront on this issue, and focused specifically on measurement of antibiotic use. The objectives were to 1) Research and identify metrics of value to the pork industry for continual improvement of antibiotic use practices; 2) Assess sources of data and record keeping systems to support ABU measurement; and 3) Develop a framework to protect confidentiality of cooperating producers that provide data on ABU. Projected outcomes of the project were 1) A white paper providing a detailed assessment of options for measuring ABU in the US swine industry; 2) Design of a pilot program based on the white paper; and 3) Initial implementation of the pilot study of ABU.

The white paper was submitted to NPB as part of an interim report in April 2016, just after the FDA had issued a Funding Opportunity Announcement directed at measurement of ABU in major food animal species. The NPB and NPPC encouraged the PI to submit a proposal to that FDA call, which was submitted in May 2016. The FDA proposal, a combined proposal for the avian and swine industries (PI. Dr. Randall Singer, Co-PI. Dr. Peter Davies) was funded by FDA commencing in September 2016 with a projected 5 year duration (2016 – 2021). From that time, the FDA funded project has driven the ongoing evolution of the work initiated in project #15-186. However, this represents an expansion of the original scope of #15-186 rather than a fundamental change in direction. The goals specified in the FDA call were:
• Provide detailed antimicrobial drug use data that accurately reflects actual on-farm use;
• Provide “baseline” data on antimicrobial use (i.e., data prior to the implementation of Guidance For Industry (GFI) #213
• Pilot methodologies for collecting, summarizing, and reporting antimicrobial use data;
• Foster public-private partnerships/collaboration;
• Leverage existing data systems and minimize burden and disruption to animal producers;
• Incorporate strategies for protecting farm/producer identity and other confidential information.

The April 2016 white paper included several recommendations to advance the overall effort including:
• Formation of a technical committee on ABU surveillance to direct industry leadership on ABU initiatives. Priority issues identified for the group were to discuss the feasibility of data collection options, industry communication and collaboration, confidentiality issues, and metrics
• Implementation of a pilot project as a ‘proof of concept’ based on data that are currently collected in industry to define the feasibility, scope and barriers to ABU surveillance based on voluntary sharing of data.

The initial scope of activities has been to collect data on ABU in growing pigs (weaning to market) for the 2016 calendar year from a convenience sample of production systems willing to voluntarily share data. Retrospective data isare being obtained at a system level by product (both medically important and not medically important) and stratified by route (feed, water, injection) and where feasible by phase (e.g., nursery, finishing, wean-to-finish). These data will provide relatively basic estimates of ABU, but will still yield substantially more information than is currently available about ABU use in US swine. Seventeen systems have been contacted and or/visited and 11 (representing over 20% of national pig production) have agreed to provide the data requested. A process for managing data confidentially has been established, 4 systems have submitted data, and the remaining systems are expected to submit data over the next month. Initial reporting of summary data will occur among participants as soon as the data have been aggregated and analyzed. The next phase of the project will be to repeat the data collection for the 2017 year, and report the aggregate data for both 2016 and 2017 for the FDA is project in the fall of 2018. It is hoped that release of summary data to other industry stakeholders will occur prior to the FDA report but will be contingent on agreement of the participants. For all participants to date, no retrospective data are available on the purpose or details of administration (route, dose, duration). Obtaining data on these important aspects is a priority for the next phase of the work.