FDA Bails on Animal Antibiotics Hearings

(Article originally posted on Tablespooning.com, by Sowjanya Kudva)

On December 22, 2011 the Food and Drug Administration announced in the Federal Register that they were “withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals.” So what does this mean?

To fully understand the implications of this withdrawal, one must first look at the intricacies of the FDA’s relationship with antibiotics. Maryn McKenna, author of Superbug, recently published a fantastic timeline in Wired Magazine that revealed all the pertinent milestones of this relationship, which you can read at the bottom of this post.

In the 1950’s the FDA approved the use of antibiotics in feed for livestock. Over the years, researchers around the world have linked the emergence of “superbugs” or antibiotic-resistant bacteria with the use of antibiotics in animal agriculture. The superbug Methicillin-Resistant Staphylococus Aureus (MRSA) “kills something close to 20,000 Americans every year — more than AIDS.” In 1977, the FDA acknowledged evidence connecting drug use and antibiotic resistant bacteria, by issuing “notices of opportunity for a hearing” (NOOH) that would recall the use of penicillian and tetracyclines in animal feed. However, in 35 years, nothing’s happened. Antibiotics use is at an all time high and, now, the FDA has withdrawn its own notices for hearings.

The FDA claims it still cares about the issue, creating guidelines for “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which outlines ways to end non-theraputic antibiotic use. However they don’t establish any legally enforceable responsibilities, which allows farmers to voluntarily opt in or out of the guidelines.

In 2009 Representative Louise Slaughter took action by proposing a bill called The Preservation of Antibiotics for Medical Treatment Act (PAMTA), which would “phase out the non-therapeutic use in livestock of medically important antibiotics.” The Obama Administration backed this bill, but lobbyists for the meat industry prevented the bill from passing. Along with the meat industry’s opposition to PAMTA, the FDA showed no interest in ever phasing out non-therapeutic antibiotics. In their Federal Registar entry, they claimed it would take too many years and too much money to withdraw the use of antibiotics.

“FDA’s experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and significant amounts of Agency resources. For example, when FDA withdrew a class of animal drugs called nitrofurans in 1991, the proceedings took nearly 20 years. In another proceeding, the withdrawal of diethylstilbestrol (“DES”) in animals became final in 1979, 7 years after issuance of an NOOH. More recently, the withdrawal of enrofloxacin for use in poultry took almost 5 years and cost FDA approximately $3.3 million.”

Yet, according to PAMTA,

“Antibiotic resistant bacterial infections increase health care costs by over $20 billion each year and increase societal costs by $35 billion.”

Regardless, the FDA moved forward with their new strategy of voluntary reform, claiming that they would pursue withdrawal only if their “judicious use” guidelines didn’t produce sufficient results.

However, how will the FDA analyze the results of their “reform” if they aren’t engaged in doing substantial research into MRSA? The FDA and the USDA don’t even test for MRSA in imported and domestic meat. The first ever test of MRSA in pigs was completed independently by Tara Smith, an assistant professor at the University of Iowa’s Department of Epidemiology, along with her graduate students. “They swabbed the noses of 209 pigs from 10 farms in Iowa and Illinois and found MRSA in 70 percent of the porkers.” If that’s not enough proof, maybe the workers at Batesville Hatchery can convince them. Suffering numerous and regular outbreaks of painful MRSA related infections, the workers at Batesville miss weeks of work at a time. Calls to the USDA, the CDC and the Arkansas Dept of Health produced no response, leaving the workers at Batesville wondering who’s accountable for their health and safety.

With these studies and empirical evidence linking antibiotics to superbugs, it boggles my mind that the FDA won’t remove the use of the very antibiotics it approved. The FDA is at the forefront of food security and has no issue raiding small organic dairy farms in the name of food safety, but they refuse to delve deeply into the links between MRSA and animal antibiotics. According to the Natural Resources Defense Council, “the FDA’s paralysis isn’t just irresponsible. It’s illegal.” They filed a lawsuit against the FDA on May 25, 2011. To help make their case, they point to Denmark, the world’s largest exporter of pork. Denmark “banned antibiotics in animal feed more than a decade ago. Since then, Danish government and industry data have shown a sustained decrease in both overall antibiotic use and in the amount of drug-resistant bacteria found on livestock and meat products. At the same time, livestock production has grown and prices have remained stable.”

Denmark provides an important example of a huge industry successfully phasing out antibiotics. Yet, the FDA refuses to do anything but take baby steps. In a January 4th, 2011 press release they “issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.” Though this makes a great headline, further research shows that Cephalosporin accounts for only 0.3% of all antibiotics used in livestock, which is essentially negligible in context of the full issue.

In the face of our government’s paralysis, there is something you can do. You can boycott meat processed by big agriculture and purchase local, organic meat from farms who believe in transparency, clean meat, sanitary living conditions for animals and safe conditions for workers. However, this kind of meat is very expensive and if you can’t live a vegetarian lifestyle, you can at least voice your opinion. The FDA is taking public comment on their guidelines, which you can fill out here.

Maryn McKenna’s Timeline

  • 1951 & 1954: The FDA approves penicillin, chlortetracycline and oxytetracycline as feed additives.
  • 1969: The UK government’s “Swann Report,” formally the Joint Committee on the Use of Antibiotics in Animal Husbandry and Veterinary Medicine (headed by Dr. M. M. Swann), proposes that rising rates of multi-drug resistant bacteria are due to agricultural use.
  • 1970: The FDA becomes concerned about the human health effects of subtherapeutic use of the drugs in animals, and convenes a task force, which concludes the drugs’ use fosters the emergence of antibiotic-resistant bacteria.
  • 1973: On the basis of the task force’s findings, the FDA proposes to withdraw its 1951 and 1954 approvals, unless industry can prove they are safe.
  • 1976: In the first influential US research, Tufts University researchers establish an experimental farm, give tetracycline-laced feed to chickens on it, and recover tetracycline-resistant bacteria from the farm workers.
  • 1977: The FDA issues the “notices of opportunity for a hearing” that were withdrawn December 22, 2011.
  • 1978: The House of Representatives’ Committee on Appropriations orders the FDA to put a hold on its actions and conduct more research. The FDA asks the National Academy of Sciences to perform the research.
  • 1980: The National Academy report says it cannot prove subtherapeutic use is safe. The House Committee asks for another round of research.
  • 1981: The Senate Committee on Appropriations also asks for more research. The FDA asks the health department in Seattle and the surrounding county to perform it.
  • 1983: Pharmaceutical companies ask the FDA to withdraw the 1977 hearings notices. The FDA refuses.
  • 1984: The Seattle-King County Health Department finds that bacteria in chickens on farms using tetracycline, and the same bacteria in humans locally, have the same resistance fingerprints, and raises the possibility that the resistance DNA is moving into other bacterial species.
  • 1988: The Institute of Medicine of the National Academy issues a report that resistance from subtherapeutic use of antibiotics is a “potential human health hazard.” The FDA tells the House and Senate committees that it has all the research it needs.
  • 2001: The American Medical Association passes a resolution opposing growth-promoter drug dosing.
  • 2003: The Institute of Medicine says in a second report: “Mounting evidence suggests a relationship between antimicrobial use in animal husbandry and an increase in bacterial resistance in humans.”
  • 2004: The FDA tells feed manufacturers that it considers putting subtherapeutic doses of antibiotics into feed to be “high risk.”
  • 2010: The FDA issues its draft voluntary guidance on limiting subtherapeutic dosing.
  • 2011: After putting 34 years into pushing for removal of two of the main drug categories used for subtherapeutic dosing, the FDA backs off.

(Photo credit: Naturally Yours Blog)