The U.S. Food and Drug Administration has released the final version of a voluntary plan to phase out the use of certain antibiotics in food animals. Antibiotics are added to the feed or drinking water of cattle, hogs, poultry and other food-producing animals to help them gain weight faster or use less food to gain weight. About 80 percent of all antibiotics distributed in the U.S. are for food animals, and overuse can promote the prevalence of antibiotic-resistant bacteria in the food supply, ultimately resulting in resistant infections in humans. Illnesses caused by drug-resistant strains of bacteria are more likely to be potentially fatal when the medicines used to treat them are rendered less effective. “We need to be selective about the drugs we use in animals and when we use them,” said William Flynn, deputy director for science policy at FDA’s Center for Veterinary Medicine (CVM). “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.” The final guidance document explains how animal pharmaceutical companies can stop using antibiotics for growth enhancement and feed efficacy and shift from over-the-counter availability to requiring veterinary oversight. In this situation, manufacturers would still be able to use the medicines to treat, prevent or control disease under the order of, or by prescription from, a licensed veterinarian. Is ‘Voluntary’ a Dirty Word? Participation in the plan is voluntary. FDA says this is because it is “the fastest, most efficient way to make these changes.” “Based on extensive outreach to affected stakeholders, including the animal pharmaceutical industry, FDA is confident that it will see a high level of cooperation in implementing the recommended changes,” an agency spokesperson told Food Safety News. But the voluntary status of the plan has disappointed and frustrated many consumer advocates concerned with maintaining the effectiveness of antibiotics. “‘Voluntary’ regulations are merely suggestions,” said Tom McGarity, a University of Texas law professor and Center for Progressive Reform scholar. “The reason that we have regulatory agencies is because the public cannot rely on promises by industry to do better. Antibiotics have been added to animal feed for too long, and it is time to put some teeth behind regulatory requirements that limit antibiotics in animal feed.” The Keep Antibiotics Working (KAW) coalition is happy to see finalized guidance “so that we can see whether it actually works,” said Steven Roach, KAW senior analyst. “Our fear, however, is that there will be no reduction in antibiotic use as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention.” U.S. Rep. Louise Slaughter (D-NY), whose Preservation of Antibiotics for Medical Treatment Act (PAMTA) would ban non-therapeutic uses of medically important antibiotics in food animal production, said the guidance is “an inadequate response” that has “no mechanism for enforcement and no metric for success.” “Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis,” Slaughter said. “For the good of public health, FDA should step up and implement tighter restrictions on antibiotic usage,” said U.S. Rep. Rosa DeLauro (D-CT). The Natural Resources Defense Council (NRDC) has widely criticized the policy since it was first released in draft form in 2012. NRDC health attorney Avinash Kar called the finalized version “an early holiday gift to industry.” In his blog about the announcement, Kar wrote that the guidance “1) doesn’t do much, 2) pretends to do more, and 3) kicks the can significantly down the road.” Like KAW, he noted that even if drug companies stopped selling the antibiotics for enhanced growth, they could still sell them for disease prevention. “Not only is the use very similar in nature – low doses added to the feed of a large number of animals day after day – many of the antibiotics are approved for both kinds of uses,” Kar wrote. “The FDA may care whether companies call it growth promotion or disease prevention, but the bacteria do not,” said Keeve Nachman, a scientist with the Johns Hopkins Center for a Livable Future, which released a report in October highlighting the lack of government action regarding non-therapeutic uses of antibiotics. “If antibiotics are used in the same ways, they will have the same effects. The agency needs to change how antibiotics are used, but these guidelines will only change how they are labeled.” Not Everyone Is a Critic U.S. Sen. Dianne Feinstein (D-CA), who introduced a companion bill to PAMTA in the Senate, called FDA’s announcements “a significant victory for public health that take concrete steps towards … [ending] the widespread and irresponsible use of antibiotics in agriculture.” “There is more work to do, but this is a promising start — especially after decades of inaction,” said Laura Rogers, director of the Pew Charitable Trusts’ human health and industrial farming campaign. “We commend FDA for taking the first steps since 1977 to broadly reduce antibiotic overuse in livestock.” The Center for Science in the Public Interest has emphasized that although drug companies, which profit from the sales of their drugs must initiate the phase-out, FDA plans to evaluate levels of compliance and report back to the public after 90 days. Industry organizations expressed broad support for the measure. Betsy Booren, chief scientist for the American Meat Institute, said that the guidance protects “both animal and public health, ensuring the ability to medically treat animals, and maintaining the highest standard of animal welfare practices.” And the National Chicken Council’s vice president of scientific and regulatory affairs, Ashley Peterson, said her organization supports the plan because “there are strong emotions and conflicting views on the issue of antibiotic resistance – an issue that is very complex, and not black and white.” She also said that the majority of the antibiotics used in raising chickens are not a threat to creating resistance in humans. Animal drug manufacturer Zoetis even issued a statement that it supports the phase-out and plans to implement the guidance: “This reflects our continued commitment to antibiotic stewardship and represents the many ways that Zoetis promotes the responsible use of antimicrobial drugs in animals.” What Happens in Three Years? Both NRDC’s Kar and Rep. Slaughter have noted that FDA has suggested shifting to binding regulations after three years if the voluntary program is not successful. The Animal Health Institute’s statement on the guidance told consumers that “within three years, all uses of medically important antibiotics in animal agriculture will be only for therapeutic, or targeted, purposes under the supervision of a licensed veterinarian.” But it’s not a regulation yet. The official word from an FDA spokesperson is that “after three years, FDA intends to evaluate the rate of voluntary adoption by drug sponsors of the proposed changes across affected products. The agency will then consider if further action is warranted in accordance with existing provisions of the Federal Food, Drug, and Cosmetic Act for addressing matters related to the safety of approved new animal drugs.” Kar wrote that he hopes FDA will shift to binding regulations if this voluntary plan is not successful, but he noted that he doesn’t have a lot of faith in the agency after 36 years of inaction on the issue.