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Will FDA’s Voluntary Plan Actually Reduce Antibiotics in Animal Feed?

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.

© Food Safety News
  • SteveKDC

    Ms. Zuraw’s bias is showing when it comes to why farmers and ranchers use low-levels of antibiotics in feed and water. First, weight gain or feed efficiency is NOT the only reason they’re used. Herd and flock animals will get sick, and that illness can spread rapidly. The majority of the antimicrobials used on farm are for prevention or treatment of disease, and this will continue but with oversight from a veterinarian, which is pretty much how the system operates today. This crass assumption that if all animals were allowed to run free, there would be no reason to use these products is not only naive, it just shows how little the critics know about how farming and ranching operate. Resistance is found among organically produced animals, wild animals and in parts of the country where no farming or ranching operates. Also, I’d like to point out that law professors, even in Texas, are not microbiologists or veterinarians, so their opinions are kind of pointless as to whether these products should be used. The other issue totally ignored in the broader discussion of resistance is the overuse by doctors and hospitals. No one seems to be banging on the table demanding doctors be “regulated” so they stop prescribing antibiotics just because a patient or the parent of a patient demands them. Also, when it comes to the “percentage” of antibiotics used by agriculture versus that used by the human side of the equation, here’s some numbers so you can do the math: 7-9 billion (with a “b”) farm animals; 300 million people…

    • Dr. Rob Stuart

      I agree with Steve. When in doubt, blame your food. The CDC has estimated the number of people that die each year from antibiotic-resistant bacteria to be 23,000. This number is so full of assumptions. The CDC also reported that 3000 people die each year from food-borne pathogens (See rationale for FSMA). The number of actual reported deaths due to food-borne pathogens so far in 2013 is two. A far cry from 3000. Another point is that FDA includes the ionophore-antibiotics in its total of antibiotics used in animal feeds which is misleading. Ionophores are approved for use in poultry and cattle and recently in swine as coccidiostats and fermentation modulators in ruminants. None are used in human medicine. When members of Congress make outlandish statements such as what Ms. Slaughter (D, NY) said in an interview with Food Safety News makes me sick and resistant to people like her (See interview on Food Safety website). Her statement was “Certainly one of the reasons that we believe that the American
      agribusiness uses so many antibiotics is that they keep the livestock in
      despicable, filthy, dirt-ridden conditions. And then they try to make
      up for that.” That statement from a member Congress is so sad.

      • doc raymond

        Steve and Rob, you are correct. This article is filled with quotes from activists and Congressional folks seeking publicity. One small quote from Zoetis and nothing from Merck or Elanco, other producers of antibiotics used in animals. And to add further to Rob’s statement, of that 80% number so often quoted, 30% are the ionophore class never used in medicine, and another 12% are listed as Not Individually Reported, of which all but less than 1% are not approved for human use at all. Another 42% are tetracyclines, a class important in the 50s, but the last time I prescribed a tetracycline was in the 80s. As for as Slaughter’s statement that this was the biggest move in a “generation”, I wonder how she would explain that two very important classes of antibiotics used in human medicine, the cephalosporins and fluoroquinolones, comprise less than 0.3% off all antibiotics used in animals if the FDA has not been doing their job?

        • Oginikwe

          We’d all love to hear from Elanco.

          May you could arrange that?

          • Michael Bulger

            And when was the last time you practiced medicine on a human? Last I knew, you were working for an livestock drug company.

            Really, it’s astounding that the drug company employees like Raymond and Stuart come out of the woodwork to oppose no longer using antibiotics for growth efficiency. Characters like Steve downplay thousands of serious illnesses in men, women, and children, and these two doctors applaud him. I guess in Raymond’s medical practice, human lives could be sacrificed in the name of profits.

            The medical and scientific community is in concert in calling for the reduction of antibiotic use in livestock. I guess we shouldn’t be surprised that a handful of paid pharmaceutical people with dusty degrees will stand out as contrarians. No matter how painfully out-of-touch they remain.

          • Dr. Rob Stuart

            Why do you guys get so personal with your comments if we don’t agree with your Queens, New York-approach to food animal production. I would care to quess that Mr. Bulger has probably never touched a live chicken, pig or cow. When I look at your high-rise apartments it makes me wonder “Isn’t it amazing what they put people in”. I am totally tired of far-left thinking people acting like they have all the answers and we contrarians are hay-seeds with dusty degrees. Oh, by the way, I live in Texas, one of the top cattle feeding states.

          • Michael Bulger

            As if we have no farms in New York. It’s obvious you know next to nothing about me, and that you have no valid explanation for your advocacy of one form of agriculture at the expense of human health. Your mantra of “feed the world” is a tired reductionist refrain that has been exposed as such many times over. You are not defending the only way to feed people. Rather, you are defending the only way you know how to make money feeding people.

          • doc raymond

            Michael, no where in my post will you find me saying I am “opposed to no longer using antibiotics for growth efficiency”. Please re-read it. Base your responses on facts. I am saying the article was written with an obvious bias, and did not even ask for comments from most pharmaceutical companies as to their intent to comply I guess that would not make a sexy headline, would it.. Instead it asked activists if “voluntary” would cut it and of course they always want more. And to answer your question, I voluntarily inactivated my license in 2008 when I moved to Colorado, not intending to practice again in Nebraska. I just tried here to present some well-known facts about what the real risk of using antibiotics in animals is, and the 80% number you people like to throw around is not what we should be discussing. And I suspect I am much more “in-touch” than you, as I spend time researching the facts vs. making personal attacks.
            I wish FSN would monitor these discussions and limit the personal attacks and name calling so we could just discuss factual information in an adult manner.

          • Michael Bulger

            You consistently ignore antimicrobial class resistance in your comments here. That alone puts you out of touch.

          • Oginikwe

            Ah, this comment is not directed towards me even though it is directed towards me in the thread. I believe it is directed at doc raymond.

          • doc raymond

            Actually, if you go to the FDA press conference transcription, you will read the Elanco statement that FDA quoted. Very open and tranparent, so you don’t need to be so cute as suggesting I could arrange it when it is already out there. “We’d all…..”. Curious as to who we all are?

          • Oginikwe

            You were complaining that there were no quotes included from Elanco in this article. Instead of complaining and pointing fingers, solve the problem and put it on here.
            “We” as in “people who visit this site.” You know, readers . . .

          • doc raymond

            My complaint, observation, is that the quote was readily available to the writer, but she chose to focus on the advocates and Congressional personnel who are unhappy unless we stop antibiotic use in animals thru laws and make it more sweeping. She had this quote. She chose to ignore it and put the industry in a bad light.

          • Oginikwe

            She doesn’t have to put the industry in a bad light–they do that all by themselves. But, my point is, instead of blaming, solve the problem and write what Elanco has to say in the comments. C’mon—be a grown-up.

        • Steven Roach

          The NIR numbers are not accurate. In 2009 in a response to a request from representative Slaughter FDA broke out further the NIR numbers. 64% are in classes used in human medicine not 1%.

    • FirstGenFarmer

      Steve,
      You’re comment reminds me of the drug company sponsored survey on WebMD that ran a few years ago in which all participants were deemed prone to serious depression and encouraged to seek treatment from their doctor. It’s as if pharmaceutical companies want us all to believe that sickness is just the natural normal condition and that we all need to be medicated for something. How said and tragic it is that out society has bought into that lie–avg. American is on 11 prescribed drugs.
      Actually, when animals are properly raised and cared for in more natural systems, such as raising cattle on well managed pasture, they remain very healthy without the routine use of antibiotics.
      I’ve been raising cattle, pigs and chickens commercially that way for over 15 years and rarely have to resort to using antibiotics and more often than not find alternative treatments work as well as antibiotics for healing.
      If a system requires antibiotics to keep animals from sickness there is something wrong with the system.

  • Oginikwe

    Dr. Arjun Srinivasan: We’ve Reached “The End of Antibiotics, Period”:
    http://www.pbs.org/wgbh/pages/frontline/health-science-technology/hunting-the-nightmare-bacteria/dr-arjun-srinivasan-weve-reached-the-end-of-antibiotics-period/

    Half of China’s Antibiotics Now Go to Livestock (Mother Jones) 9/10/2013: http://www.motherjones.com/tom-philpott/2013/09/chinas-antibiotic-meat-livestock

    Chicken Surprise: Antibiotic-Resistant E. Coli Vary with Production Method (FSN) 9/17/2013: http://www.foodsafetynews.com/2013/09/antibiotic-resistant-e-coli-levels-in-chicken-surprise-research-team/

    Results from Study of Antibiotic Resistance Threat in Food Animals (Mother Earth News) 11/30/2011:
    http://www.motherearthnews.com/sustainable-farming/antibiotic-use-in-food-animals-zwfz1111zhun.aspx

    Wendell Berry on His Hopes for Humanity: http://billmoyers.com/wp-content/themes/billmoyers/transcript-print.php?post=44158

  • BB

    I guess it’s cheap food if your definition of cheap is “pesticide- laden, unsustainable, government-subsidized, inhumane, antibiotic-resistant and super-weed promoting.” You think it’s cheap now, but our health and our environment are paying the ultimate price and will continue to do so until we wake up!