Leadership at the U.S. Food and Drug Administration (FDA) made it abundantly clear last week that the low-dose usage of antibiotics in food animals, simply to promote growth or improve feed efficiency, needlessly contributes to the emergence of antibiotic resistant bacteria and poses a serious threat to public health. Despite the fact that the FDA is taking a hard-line stance on the issue, I find it frustrating to see that the agency appears to be hamstrung from taking the necessary steps to mandate industry to end the risky practice. Even more exasperating, is that it appears that the FDA may actually relax a current directive that already regulates antibiotic use. However, unlike many critics I don’t believe that this is an example of the Obama administration buckling under industry pressure. Rather, I view it as a loud and stern call for Congress to take action. Producers concerned more about profit than protecting public health are not going to cut their dependence on non-therapeutic antibiotic use in food animals unless lawmakers pass strict legislation.

Last week, the FDA fired a serious warning shot across the bow of industrial food animal producers stating in a new draft guidance that it expects industry to change its antibiotic use practices. The draft guidance asks for two simple things: stop using “medically important” antibiotics as growth promoters, limiting use to only treating sick animals; and ensure that producers do not administer these drugs without veterinary supervision. Unfortunately, the FDA says guidance documents, “do not establish legally enforceable responsibilities.” Why didn’t leadership go a step further and issue a proposed rule? I’ll address the possible answer in a moment. But what has me scratching my head are discussions about potentially changing a current medicated animal feed rule that’s already on the books.

The FDA recently sent out a notice warning that it might modify its veterinary feed directive (VFD), citing informal complaints that the rule is “overly burdensome.” The VFD was issued 10 years ago in response to the passage of the Animal Drug Availability Act of 1996, which required the FDA to regulate the approval and marketing of new animal drugs and medicated feeds. Any medicated feed that falls under the VFD category can only be used under the supervision of a veterinarian. According to the American Veterinary Medical Association’s website “the purpose of the added professional control is to reduce the rate of development of [antimicrobial] resistance and thereby prolong the period of effectiveness of the medication.” It is important to note that the VFD only applies to new drugs and that feeds containing approved antibiotics before 2000 can and are sold over-the-counter without a prescription or supervision of a veterinarian.

So, if the FDA Principal Deputy Commissioner Joshua Sharfstein went out on a limb to call the overuse of antibiotics in food animals, “an urgent public health issue,” why would FDA consider changing a 10-year-old rule that could relax regulation of antibiotic use even further? That’s exactly what the American Academy of Pediatrics, The Pew Charitable Trusts, Union of Concerned Scientists, Institute for Agriculture and Trade, Food and Animal Concerns Trust and Humane Society of the United States want to know. Back in May the organizations sent a list of specific questions to FDA Commissioner Margaret Hamburg regarding the Advance Notice of Proposed Rulemaking (ANPR):

·      From whom did the [overly burdensome] comments come – the industrial farming industry, veterinarians, or other stakeholders?

·      The FDA suggests that the ANPR is being undertaken to help “improve the program’s efficiency.” Since the primary requirement of the program is that veterinarians provide oversight on the use of certain drugs, does improved program efficiency simply mean less meaningful oversight from licensed veterinarians?

·      How is the ANPR consistent with Deputy Commissioner Joshua Sharfstein’s July 13, 2009, testimony that, “protecting public health requires the judicious use in animal agriculture of those antimicrobials of importance in human medicine…FDA also believes that use of medications for prevention and control should be under the supervision of a veterinarian?” (emphasis added)

Late last month the FDA decided to extend the comment period on the ANPR for an additional 60 days, after receiving complaints that the original 90-day comment period was not enough time to develop “meaningful or thoughtful response.”  That means the public now has until August 27 to speak up. If you’re interested in writing a response you may first want to read a new study published in PLoS One which links antibiotic use on veal calf farms in the Netherlands to a new strain of methicillin-resistant Staphylococcus aureus – ST398 (a.k.a. Staph superbug.) The authors say this is the first study that shows “direct association between animal and human carriage of ST398,” and that this latest revelation warrants the prudent use of antibiotics on the farm.

While I don’t want to see the VFD weakened in any way, I am more concerned about the medicated feeds that are not covered under the directive. Which is pretty much everything except the two drugs that have been placed under the VFD category. The Union of Concerned Scientists (UCS) estimated in 2001 that as much as 70 percent of all the antibiotics sold in the U.S. were used to promote growth in food animals. And yes, there are plenty of cases of irresponsible antibiotic use going on in people, but it doesn’t compare to the amount in animals. The UCS claims “nearly 13 million pounds [of antibiotics] per year – are used in animal agriculture for these non-therapeutic purposes. This amount is estimated to be more than four times the amount of drugs used to treat human illness.”

Of course industry disputes this claim. The Animal Health Institute – an organization that lobbies for pharmaceutical companies such as Bayer, Pfizer and Novartis – told the New York Times that it estimated only “13 percent of agricultural antibiotics were used to promote growth.” As Times reporter Gardiner Harris keenly pointed out, if the FDA, “some day bans growth promotion as a use, there is a chance producers would simply relabel such uses as preventative.”

While serving as the communications director for the Pew Commission on Industrial Farm Animal Production my colleagues and I met with AHI staff in 2006 to discuss antibiotic use in food animals. They were trying to “redefine” therapeutic and non-therapeutic uses of antibiotics even back then.  They presented us with similar statistics. It wasn’t until we started discussing the use of antibiotics to prevent production diseases, such as liver abscesses in feedlot cattle (ruminants, designed to eat forage such as grass or hay, that are finished on grain can develop several metabolic and infectious diseases), that we began to realize they were lumping the use of antibiotics to make up for poor living conditions and animal husbandry in the same therapeutic category. There are some hard-liners who would argue medicating animals to prevent “production diseases” should not fall under the “therapeutic” category as well. Keep in mind, regardless of the definition, these low-dose treatments can still lead to the emergence of antibiotic resistant bacteria. And FYI, studies reveal cattle switched from grain-based diets to hay were less likely to shed the deadly antibiotic resistant bacteria E. coli O157:H7.

So, why hasn’t the FDA called for an outright ban? Industry has thwarted the agency’s attempts to end the non-therapeutic use of antibiotics for more than three decades. If history were any indicator, a call for a new ban would most likely end with the same fate. I am certain that if FDA leadership decided to release a draft directive last week, rather than a draft guidance, industry would already be preparing to take the FDA to court. At best, a court action could tie up any rule for years; at worst, it could set back future regulations by another decade or more. That’s why public health will remain at risk until Congress takes action and passes legislation designed to end the practice once and for all.

While it is not perfect, there is proposed legislation on the table right now entitled the Preservation of Antibiotics for Medical Treatment Act (PAMTA). Congresswoman Louise Slaughter introduced the latest version of PAMTA last March. The bill calls for:

·      Phase out the non-therapeutic use in livestock of medically important antibiotics;

·      Require this same tough standard of new applications for approval of animal antibiotics;

·      Does not restrict use of antibiotics to treat sick animals or to treat pets and other animals not used for food.

More than 300 organizations including the Center for a Livable Future, American Public Health Association, American Medical Association, and National Association of County and City Health Officials support the passage of the PAMTA.

The American Veterinary Medical Association (AVMA) is vehemently opposed to PAMTA. Dr. Michael Blackwell, public health veterinarian and vice chair of the Pew Commission on Industrial Farm Animal Production, says that to his knowledge, “the AVMA remains the only major medical or public health organization not recommending changes in agriculture practices to help ensure sustainability where the use of antimicrobials is concerned.”

Dr. Raymond Tarpley, AVMA member and retired Texas A&M professor, recently submitted a post for the Livable Future Blog imploring the AVMA to change its stance on antimicrobial use in food animals. The AVMA and industrial food animal producers claim that the benefits of low-dose antibiotic use to efficient production and food safety outweigh the risk of developing more antibiotic resistance. Dr. Tarpley says that view, however, is only valid in the context of the current unhealthy industrial animal production environment:

… where disease risks can be heightened and growth rate performance reduced by stressors such as poor ventilation and hygiene, inadequate temperature regulation and animal crowding interfering with natural behaviors. Elevated risks have led to a dependence on low-dose antimicrobials to compensate for these suboptimal husbandry practices made worse by large numbers of animals producing large quantities of untreated wastes that often trigger respiratory distress in a microbially rich environment.

When it comes to the FDA’s draft guidance on antibiotic use in food animals, the fact that FDA leadership is willing to take a hard-line stance on such a politically charged issue is commendable. I understand the argument that change takes time and that the agency must be methodical in its approach, especially when the powerful food animal and pharmaceutical industries will do everything they can to thwart it. However, timing is everything. If the FDA believes it cannot take a stronger stance now, then Congress must move on PAMTA. As Congress faces another potential shift in control, if PAMTA fails passage this year, I fear it could be another decade before we see an end to the irresponsible use of antibiotics in animal agriculture, and by then it might be too little too late.

It’s not often that I get to write about a positive food policy story coming out of my home state, but it turns out that Oklahoma Attorney General (and Democratic candidate for governor in 2010) Drew Edmondson is suing the more lenient Arkansas poultry industry for its waste, which is polluting the Illinois River on the states’ shared border. This case brings the spotlight to a huge, oft-ignored issue that many legislators in other states should take note of, too: agricultural pollution.

From AP:

In the lawsuit, Edmondson claims runoff from land that has been spread with chicken waste for decades has contaminated the watershed. He is suing a dozen Arkansas poultry companies that buy birds from the 1,800 poultry houses that dot the watershed in Oklahoma and Arkansas. The defendants include Tyson Foods Inc., the world’s largest meat producer.

Here’s hoping that Edmondson gets heard on this issue. I needn’t remind you that not a single Oklahoma county went for Barack Obama in the 2008 election, and that it is a stronghold for climate change deniers like Republican Senator Jim Inhofe. So, not surprisingly, Edmondson faces an uphill battle in this fight, where poultry groups are pitting workers, who they’ve told will lose their jobs, against him.

But Oklahoma could be poised to redeem itself, taking on the unsustainablity of industrial agriculture.

Unfortunately runoff is not just a problem in this one river on the border of Oklahoma and Arkansas. It is a huge issue that we’ve seen increase worldwide since the industrialization of agriculture and the proliferation of animal confinement operations, which took off at an unprecedented rate in the 1970s. Factory farms raising animals had to answer the question of what to do with all that excess waste (photo: liquid manure being applied to fields), which was being produced in quantities that rival the waste of small cities without a sewage system.

These are medieval conditions that could also be stoking disease outbreaks like the resistant bacteria MRSA, the salmonella and e coli that has been contaminating meat so often these days, and even possibly a cause of the swine flu. This potential for disease originating in concentrated animal feeding operations (CAFOs) is precisely why these animals are currently given up to 70% of the antibiotics taken in the United States, and by extension, why antibiotic resistance is a topic of such great importance for Congress.

Manure makes for good fertility in reasonable quantities (and hopefully without the antibiotics, which plants have proven able to take up)  — but when spread in the massive quantities operations like these are forced to distribute, excess waste washes away from fields and goes down river, where it assists, along with over-used chemical-based fertilizers, in creating dead zones: water over-enriched with nutrients, creating an oxygen-free environment where only algae can survive. In 2003, there were 146 dead zones worldwide in our oceans (the clearinghouse for all the world’s rivers and streams) and the largest measured 70,000 square kilometers. A new study in 2008 found 405 dead zones.

Algae is not just gross to look at or swim in, either. The French have recently taken increased notice of the problem of agricultural runoff, after decomposing sea lettuce, which creates a noxious gas, killed a horse on a beach on the coast of Brittany. Here at home, the Environmental Protection Agency (EPA) might consider regulating chemical fertilizer application. The woman in charge of the dead zone issue at the EPA is Suzanne Schwartz, and you can get in touch with her to let her know how you feel about industrial agriculture runoff at: Schwartz.Suzanne@epamail.epa.gov

Here is what I had to say to her in a recent email:

I am very concerned with the effects large amounts of runoff from industrial agriculture are having on our rivers and streams, and by extension, our health as a nation. As you know, a report in 2008 revealed that we now have 405 dead zones worldwide, and life in those parts of the oceans cannot be supported. These areas are near the coasts, so they also affect the air we breathe, the water we drink, tourist and recreational usage, our food supply and more. Industrial agriculture is taking a huge toll on our collective landscape, and the corporations that cause the pollution are profiting handsomely on its demise. Please support Oklahoma Attorney General Drew Edmondson’s attempt to take on this issue in the Illinois River on the Oklahoma border with Arkansas, where pollution is at its worst in that river’s history. And please take a serious stand against synthetic fertilizer and confined animal feeding operation waste runoff — these have proven in the last decades to be an unsustainable way to produce food. With your help, we can begin to shift to a new paradigm of food production.

In the United States, our largest dead zone forms every year in the Gulf of Mexico. If you’d like to better understand the process of dead zone formation, check out this excellent visualization by the National Environmental Satellite, Data and Information Service of the National Oceanic and Atmospheric Administration:

Photo #2: The Socially Responsible Agriculture Project

For public health advocates, the fact that the FDA is officially linking antimicrobial resistance to animal agriculture is worthy of celebration, considering industry lobbyists successfully bullied the FDA under the Bush Administration to look the other way and tried to sweep the unsavory facts under the rug for years. Not surprisingly, Dave Warner a spokesperson for the National Pork Producers Council told the New York Times:

“there are no good studies that show that some of these antibiotic-resistant diseases… have any link to antibiotic use in food-animal production.”

The NYT obviously didn’t do any digging on this, because they could have called Warner out on his claim. Maybe both the NYT and Warner could learn a great deal from Dr. Frederick Angulo over at the Center for Disease Control and Prevention. Dr. Angulo knows a little bit about infectious diseases. He’s a medical epidemiologist trained in veterinary medicine and human public health. Angulo serves as the CDC’s Deputy Chief of the Enteric Diseases Epidemiology Branch in Atlanta. He’s considered to be a world-renowned expert in foodborne and waterborne diseases. Just recently the Journal of the American Veterinary Medical Association quoted him as saying:

“There is scientific consensus that antibiotic use in food animals contributes to resistance in humans,” Dr. Angulo said. “And there’s increasing evidence that such resistance results in adverse human health consequences at the population level. Antibiotics are a finite and precious resource, and we need to promote prudent and judicious antibiotic use.”

Antibiotic resistance may sound like a new issue to many Americans, but believe it or not it’s been a concern almost since Dr. Alexander Fleming discovered penicillin in 1928. During his 1945 Nobel Prize lecture, Fleming warned about the dangers of resistance:

“It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionally happened in the body.”

The Union of Concerned Scientists estimates that as much as 70% of all the antimicrobials produced in the U.S. are given to food animals. Millions of pounds of antimicrobials are administered each year at low doses to these animals, usually in their feed. So it’s not surprising that we’re finding antimicrobial resistant bugs like MRSA, better known as the flesh-eating bacteria, or resistant forms of Campylobacter, E. coli and Salmonella on the meats that we buy in the grocery store and floating around in the environment. Big Ag advocates claim that the proposed ban is going to backfire and we’ll end up with even more sick food animals and force farmers to treat them with antibiotics anyway. Many, like Congressman Leonard Boswell (D-IA) point to examples in Denmark, where a ban enacted more than a decade ago initially increased the mortality of piglets and the need to treat them with antibiotics. But as Robert Martin, former executive director for the Pew Commission on Industrial Farm Animal Production, testified, what the industry seems to ignore (or doesn’t want the public to know) is that once Danish hog farmers improved their production practices, “including better ventilation in the barns, more space provided for the animals, and more frequent cleaning of the barns,” the mortality rates quickly declined to pre-ban numbers.

Two Danish scientists, Dr. Frank Møller Aarestrup and Dr. Henrik Wegener, from the National Food Institute at the Technical University of Denmark submitted written testimony to the Rules Committee in effort to “set the record straight.” Drs. Aarstrup and Henrick said “representatives of organizations funded by U.S. agri-business have criticized and mis-represented the facts on the Danish ban of antibiotics since its inception.” In fact, according to their soon to be published study on the “Danish experience,” over the long-term, significantly reducing the use of antimicrobials actually increased swine productivity.

Lawmakers, like Senator Ted Kennedy (D-MA) and Congresswoman Slaughter have been introducing forms of PAMTA for almost a decade now. From the beginning, organizations like the American Public Health Association, American Medical Association, Consumers Union and the Center for Science in the Public Interest recognized the need to restrict the constant low dosage use of antibiotics in agriculture. Each year, provisions in the legislation varied, but each version proposed banning the use of antibiotics important to human health from being used in food animals and to restrict the use of other antibiotics.

While many health advocates applaud lawmakers for introducing PAMTA, there are some who believe the legislation should be stronger. Martin was invited to Monday’s hearing to present the Pew Commission’s findings and recommendations on how to tackle the antibiotic resistance threat posed by animal agriculture. The Commission goes a few steps further than PAMTA. Rather than limiting the ban to the 7 classes of antibiotics important to human health, the Commission recommended a ban on the non-therapeutic use of all antibiotics and other antimicrobials, like ionophores, that have the potential to lead to the increase of antimicrobial resistant bacteria in the environment. Ionophores are made up of organic compounds that have antibiotic properties. Instead of using fungus based antibiotics ionophores are commonly added to feed to kill single-cell parasites that infest the intestinal tracts of animals. You might remember Tyson Foods got into a little hot water a few years ago for labeling its chicken antibiotic-free despite the fact it was still treating its birds with ionophores. While the use of ionophores continues to add to the ever-increasing “reservoir of antimicrobial resistance,” the USDA says the use of the compounds, “…does not necessarily lead to other types of antibiotic resistance.” What led scientists to couch their conclusion was that they did find that the use could lead to resistance in bacitracin, which is commonly found in antibiotic ointments, like Neosporin, used to treat skin and eye infections.

Robert Martin says, “PAMTA is a good first step, but as it’s currently written, I think it’s only a beginning in reducing the threat of antibiotic resistance in animal agriculture.” The proposed legislation could even be less effective if industry lobbyists are successful in redefining what the proposed law should consider therapeutic uses of antibiotics. Martin warns that the industry is trying to argue that producers no longer use antibiotics as growth promoters; rather they’re primarily using the drugs to keep the animals from getting sick. Martin quipped, “it’s the crowded, unhealthy, putrid conditions these animals are forced to live in that’s making them sick, and that is not a reasonable excuse to threaten the effectiveness of antibiotics in human medicine.”