FDA’s Center for Veterinary Medicine (CVM) recently rolled out Phases 3 and 4 of its antimicrobial stewardship action plans covering fiscal years 2024-2028, but the impact on poultry is expected to be minimal due to the industry’s ongoing stewardship efforts.
“Many of the new FDA initiatives address antimicrobial issues that do not impact poultry directly or are program expansions targeted to non-poultry animals,” says Randall Singer, DVM, PhD, professor of epidemiology at the University of Minnesota and founder of Mindwalk Consulting Group.
For example, the medically important antimicrobials (MIAs) used in poultry feed in the US already have labels with defined durations.
Antimicrobial-use monitoring
One area that will involve the poultry industry is FDA’s commitment to developing long-term strategies for collecting on-farm antimicrobial-use data through public/private partnerships with animal industries. The US poultry industry has had a head start in this area.
“At this point in time, poultry is the only commodity group that has an organized, national program for collecting antimicrobial-use data at the farm level,” Singer points out.
In fact, since 2012, he has been involved with efforts by the US Poultry & Egg Association to collect such data. This initiative then became part of an official FDA/CVM pilot study in 2016 in partnership with the association. This voluntary data-collection program included approximately 70% of turkey, 85% of broiler and nearly 50% of egg production in the US during the most recent data collection effort.
“That’s an incredible success,” Singer says. “I’m really proud of what we’ve accomplished on the poultry side.”
While working with a largely integrated industry has its advantages for data collection, it still requires a level of trust to succeed on a national basis, he adds.
The data are aggregated across the industry and reported annually each December to align with FDA’s report of antibiotic sales and distribution. FDA’s 2021 report is the most current one available.
Syncing the data
“The FDA report on antimicrobial sales and distribution lacks context because it only includes total amounts. The data do not give information regarding the reason for use, for example,” Singer says. “Our goal is to synchronize the release of the on-farm usage data with the FDA report. Our data show how, where and why different classifications of antimicrobials were used.”
Not only has FDA accepted poultry’s data-collection protocols, the agency sees it as a model that other animal industries could follow. One lingering challenge is funding, which was expected to be addressed in Phases 1 and 2 of the FDA/CVM plan.
“FDA has not figured out how or if they will fund this effort long-term,” Singer adds. “So, the poultry industry decided they were going to continue the data collection, and currently it is funded solely by the US Poultry & Egg Association.”
New initiatives by FDA
Key activities in FDA’s new phases include:
- Setting defined durations of use for medically important antimicrobials used in the feed of agricultural animals;
- Updating Guide for Industry (GFI) #152, which includes a list of medically important antimicrobials in the US;
- Enhancing antimicrobial stewardship in companion animals;
- Enhancing antimicrobial-resistance monitoring, including in US surface waters.
The extended 5-year plan — Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2024-2028 — advances many key activities in FDA’s initial 5-year plan, Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for FY 2019 – FY 2023.
Other actions planned
As reported earlier, a key action outlined in Phases 3 and 4 is that FDA will work to revise drug labels to eliminate unlimited duration of MIAs when used in animal feed.
“It’s an important issue that FDA is addressing, but this doesn’t really affect poultry health in the US because there aren’t any MIAs used in poultry feed that have an unlimited duration,” Singer says.
The new plan places significant attention on the need for antibiotic stewardship in companion animals, as well as new product development. Stewardship education strategies for animal agriculture also remain a priority.
But again, because the poultry industry has been working on stewardship for numerous years and the antimicrobial options in US poultry production are extremely limited, the emphasis is primarily on the other animal sectors.
As noted, FDA will revise GFI #152, which has been drafted but not yet finalized. First released in 2003, GFI #152 specifies which antimicrobials are considered medically important and which ones are not. This list is meant to link antimicrobials approved for use in US animal production with their human medical importance.
For poultry companies that export product, this can get tricky because they may use the World Health Organization’s antimicrobial-importance list, which does not necessarily align with FDA’s. For example, based on the data it has collected, FDA does not consider bacitracin — an antibiotic commonly used in US poultry flocks to prevent, control and treat necrotic enteritis — to be medically important to humans.
Phases 1 and 2 of the FDA/CVM plan addressed feed and water-soluble antibiotics, but there is a need to address injectables, as well as review over-the-counter availability of antibiotics. Neither should impact the US poultry industry, Singer says.
Welfare needs to take priority
Over the past decade, the poultry industry’s attitude toward antibiotic use has evolved.
“What I’ve seen in the data that I collect and in my conversation with veterinarians is they have worked incredibly hard to minimize the use of antimicrobials,” Singer reports.
“But even more importantly, they have achieved much of this reduction by minimizing the need for antimicrobials.” Improvements to flock management are key in disease prevention.
“If you can prevent disease, you can reduce the need for antimicrobial use,” he adds. “But we shouldn’t have arbitrary antimicrobial-reduction targets. If you see animal-health and -welfare issues that would benefit from the use of antimicrobials, then we should treat these animals and do what we can to keep the birds healthy.”
