With the impending implementation of FDA Guidance for Industry #213 and the revised Veterinary Feed Directive (VFD) Rule, the agency has expressed interest in gathering more data on antibiotic use on farm in addition to the existing sales data collected under ADUFA 105. Recently, FDA held a public meeting in conjunction with USDA and CDC, describing potential sources of on-farm antimicrobial use data. NPPC provided comments at that meeting that we will expand on in these written comments.
The importance of establishing clear objectives for data collection to the success of this surveillance program cannot be overstated. Without developing such objectives, the data collected may not be fit for purpose. NPPC believes that, at this time, the primary objective should be to demonstrate compliance with Guidance #213 by demonstrating that medically important antimicrobials are not being used for production purposes and that there is veterinary oversight of the remaining therapeutic uses of those products in feed or water. Secondary objectives that help to describe the epidemiology of antimicrobial resistance, or to develop data for use in risk assessment, are also appropriate.
It will be important for FDA, USDA and stakeholders to develop appropriate metrics to meet the stated objectives. The agency may want to consider the metrics used in some European countries and work with stakeholders to assess their value for reporting on-farm use in the United States. NPPC believes that collecting gross volume of antibiotics used on farm does not provide value for the following reasons:
Measuring and reporting volume only assumes that every antimicrobial is of the same potency.
Measuring and reporting volume only assumes that all antimicrobials are of the same importance to human, or animal, health.
The pork industry has been involved in ongoing discussions with USDA and FDA on data sources, data analysis and data reporting. The pork industry was the first industry to participate in National Animal Health Monitoring System studies, and our farmers have developed a level of trust with USDA’s Center for Epidemiology and Animal Health (CEAH) through this program. In addition, the ability of CEAH to ensure data confidentiality is essential to producer trust and participation. For these reasons, we strongly suggest that CEAH take the lead in data gathering, analysis and reporting. This data could be either data collected by CEAH or proprietary information that is shared with CEAH.
At the public meeting, longitudinal studies were discussed, and the CAHFSE project was presented as a model. The pork industry supported and participated in the CAHFSE project. That collaborative research project serves as an example of the type of research that could be expanded to provide a national representation of how on-farm antimicrobial use may be correlated to resistance found on the end product. However, that requires that data be collected not only on farm, or even early in the slaughter process, but also from product post-chill to be able to establish any potential public health risk. This type of project needs to be conducted by a research agency rather than a regulatory agency. The pork industry suggests that if CVM genuinely wishes to determine if there is an epidemiological link between on-farm antimicrobial use and the amount or types of resistant organisms found on meat, which could then be compared with the types of resistant organisms responsible for human foodborne illness, it should collaborate with trusted federal research agencies, such as USDA Agricultural Research Service and CEAH, on such an effort.
NPPC is actively reaching out to our members to help them prepare for the implementation of Guidance #213 and the VFD rule changes. We look forward to working with the agency to demonstrate the success of these efforts and to shed light on any gaps in understanding or compliance that may arise so that they can be quickly corrected.
Sincerely yours,
Dr. Ron Prestage
President, National Pork Producers Council
Source: NPPC