FDA Draws Criticism After U-Turn on Antibiotics in Animal Feed

Thursday, December 29, 2011 by The Guardian/UK
Environmental groups dismayed after agency drops long-held plan to regulate use of human antibiotics fed to healthy animals
by Karen McVeigh

Environmental and consumer groups have condemned the US Food and Drug Administration's move to renege on its long-held policy to regulate the use of human antibiotics in animal feed.

Last week, the agency quietly announced it was withdrawing its plan to limit the use of antibiotics fed to healthy livestock intended for human consumption.

Critics say the U-turn, which comes amid the FDA's own stated concerns over food safety, is at odds with its obligations to protect the public.

The groups also criticized the timing of the announcement, which was made during the holiday season and disclosed only in the federal register.

The use of low doses of antibiotics in agricultural animal feed contributes to drug-resistant superbugs, according to food and health experts.

One leading food policy writer described the policy reversal as "pathetic" and "dismaying."

"It's dismaying, and obviously something they felt sheepish about, otherwise it wouldn't have been released this week," Michael Pollan, author of the Onmivore's Dilemma and Food Rules: An Eater's Manual, told the Guardian.

"When Margaret Hamburg became the head of the FDA, she indicated this was a high priority for them and that she realized how much of a problem the profligate use of antibiotics was. She said she was going to treat this issue as if her hair was on fire. This isn't the way someone acts when their hair is on fire."

Pollan said there was "no question" that meat could be produced without human antibiotics, as the EU has already banned them.

The FDA first acknowledged in 1977 that the overuse of antibiotics in healthy livestock for growth promotion and disease prevention was unsafe and could promote antibiotic resistant bacteria that could infect people. An advisory committee at the time recommended that the FDA immediately withdraw approval for two drugs, penicillin and tetracycline, for subtherapeutic uses of the drugs in livestock.

Last week, in a statement in the Federal Register, the FDA says it plans instead to allow the industry to self-regulate and "focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health".

The problem, said Pollan, boils down to a lack of political will in the face of powerful industry interests. "There's a lot of corporate money in politics these days," he said. "Here you're going up against not just one powerful industry, but two. This administration has had enough trouble going after individual powerful industries. That they would prevail against two of them joined together was too much to hope for."

Livestock consume about 80% of the antibiotics sold in the US.

The FDA's decision comes after a number of high profile meat recalls. In August, 36m lbs of turkey meat were found to have been contaminated with drug-resistant salmonella that caused one death and 76 people to become ill.

When approached by the Guardian, a spokesman for the FDA could not provide anyone for comment.

A statement, taken from the Federal Register, said: "FDA continues to view antimicrobial resistance as a significant public health issue. Today's action should not be interpreted as a sign that FDA no longer has safety concerns about the use of medically important antibiotics in food-producing animals, or that FDA will not consider re-proposing withdrawal proceedings in the future if necessary."

But Avinash Kar, an attorney with the Natural Resources Defense Council (NRDC), described the move as a "step backwards" for the FDA.

Kar believes the move is an attempt to get around a lawsuit filed by the NRDC to force the FDA to withdraw approval for the practice of mixing human antibiotics into animal feed. The lawsuit, filed in May, asked the court to declare that the FDA had violated federal law by failing to withdraw approval of using penicillin and tetracycline in animal feed when animal health is not at stake.

"This action by the FDA is a response to our lawsuit" said Kar. "The findings in 1977 were included in the notice for opportunity for a hearing, and they think they can get around the lawsuit by withdrawing the notices for opportunities for a hearing. But we will not allow the FDA to ignore public health."

In response to the FDA's reliance on voluntary regulations, Kar said: "We don't believe that the industry will voluntarily regulate itself, because for the last 33 years the approach has been voluntary and the use of antibiotics in livestock has not gone down but – based on estimates – has gone up."

"The science has only gotten stronger."

Stephen Roach, of the Food Animals Concern Trust, a group also involved in the lawsuit against the FDA, said he believed the FDA was putting public health at risk.

"It is totally at odds with their mission to protect the public. This month we had a salmonella outbreak in the north-east that was resistant to penicillin and the drug that replaced penicillin, cephalosporin. We are going to continue to have multi-drug resistant salmonella outbreaks and E.coli drug-resistant outbreaks."

Roach said the use of low doses of antibiotics in animals over a long period of time created the ideal conditions for bacteria to develop drug resistance.

A growing number of scientific and medical institutions have urged action on antibiotic resistance. The World Health Organization devoted a WHO day to microbial resistance.

In September, several institutions, including the American Medical Association, the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society, wrote a letter to Congress, calling for them to to reiterate the link between antibiotic resistance and the overuse of antibiotics in food animals. Some of the same health groups took ads out in Politico and The Hill.

"Hundreds of scientific studies conducted over four decades have shown that feeding low doses of antibiotics to healthy food animals leads to drug-resistant infections in people," they wrote in the ad. "In fact, America's leading medical, scientific and public health organizations have been warning of the danger for years."

Politicians also expressed dismay at the FDA's move.

In a statement on her website, Democratic congresswoman Louise Slaughter, the author of the Preservation of Antibiotics for Medical Treatment Act (PAMTA), a legislative framework aimed at tackling antibiotic resistance, said: "Every year, 100,000 Americans die from bacterial infections acquired in the hospital and this is just the tip of the iceberg. Seventy percent of these infections are resistant to drugs commonly used to treat them. I wonder how many lives could have been saved if these proposals were adopted in 1977 as they should have been.

"We need to get our head out of the sand and start taking public health advice from scientists rather than industry lobbyists."

Factory Farms Produce 100 Times More Waste Than All People In the US Combined and It's Killing Our Drinking Water

"Factory farms are dangerous to the environment; they are ticking time bombs of manure just waiting to be spilled into public waters." 

By Jill Richardson, AlterNet
Posted on May 25, 2011

The Fifth Circuit Court of Appeals recently delivered a major victory to factory farms. Under a 2008 EPA rule, any confined animal feeding operation (CAFO) "designed, constructed, operated, and maintained in a manner such that the CAFO will discharge" animal waste must apply for a National Pollutant Discharge Elimination System (NPDES) permit under the Clean Water Act. The livestock industry ridiculed the notion that a farm must apply for a permit to discharge manure whether it intended to discharge it or not. And while, when phrased that way, it might sound ridiculous to you too, the details of the case betray a different story.

David Kirby, author of Animal Factory, The Looming Threat of Industrial Pig, Dairy, and Poultry Farms to Humans and the Environment, tells story after story in his book of factory farms discharging waste irresponsibly -- sometimes on purpose, and sometimes not. As Karen Hudson, whose story is told in the book, says, "Factory farms are dangerous to the environment; they are ticking time bombs of manure just waiting to be spilled into public waters."

The simple fact is that factory farms produce over 100 times more waste than all American humans produce combined. In the past, a pastured cow might disperse waste over an acre or more; how can farmers responsibly deal with the waste of 1,000, 5,000, or even 10,000 or more animals when they are crammed in tightly together? And, unfortunately for the farmers, they are often working under contract for major meat or dairy conglomerates who own the animals and leave the farmer with a tiny profit margin (or none at all) -- plus all of the liability, dead animals and manure. Therefore, in addition to simply disposing of manure responsibly, they also need to dispose of it cheaply if they are to stay in business.

In Karen's story, the CAFO in question perhaps did not intend to discharge manure. The farmer, if given the choice, may not have decided to apply for a permit. In February 2001, heavy rains coupled with melting snow and ice raised the levels of the nearby megadairy's manure lagoon to just inches below the rim. Panicking, the farmer, David Inskeep, decided not to hire tankers to haul away his cows' waste, as investigators had ordered him to do. Instead he ran hoses from the lagoon to a nearby ravine over a mile away and pumped two million gallons of "a foamy, brown-yellow stew" into it. The 10-foot-high berm that dammed the ravine gave way, and the result was "the worst livestock spill in Illinois history."

The permits in question in the recently decided case would require farmers like Inskeep to make a plan for how to handle animal waste, and to follow that plan or face penalties. A version of this law has been in place for decades, but the details of the law have changed several times in the last few years. The major question of the case is: Can a CAFO be held liable for failing to apply for a permit?

Under a 1976 rule, all large CAFOs (those with more than 1,000 cattle or equivalent amounts of other species) and some medium-sized CAFOs were required to have permits to discharge waste. If a CAFO discharged waste without a permit, it faced civil or criminal penalties. The only permissible, unregulated pollution was "agricultural stormwater discharges," when a storm carried animal waste into navigable rivers.

This changed in 2003, when a new rule required all CAFOs to apply for permits or to ask the EPA for a "no potential to discharge" determination to become exempt from needing a permit. Additionally, the 2003 rule required all CAFOs to design and implement a "Nutrient Management Plan" (i.e. a plan to responsibly deal with animal waste). So long as the farmer followed his or her Nutrient Management Plan, any pollution of waterways was to be included in the "agricultural stormwater discharges" exemption.

After some legal wrangling, both by industrial farming interests and by environmental groups, the rules were changed again in 2008. The 2008 rule only requires CAFOs to apply for a permit if they are "designed, constructed, operated, and maintained in a manner such that the CAFO will discharge." Unless a CAFO can prove it does not meet that criteria (and thus does not need a permit), a discharge of manure would result in penalties both for the discharge itself and for failure to have a permit.

The recent court decision ruled that the EPA has no right to require CAFOs to apply for permits unless they actually discharge waste. Once a CAFO discharges waste, however, the court decided that the EPA can then require it to apply for a permit.

The industrial farming groups -- the National Pork Producers Council, the American Farm Bureau Federation, the Oklahoma Pork Council, United Egg Producers, the North Carolina Pork Council, the National Chicken Council, the U.S. Poultry & Egg Association, Dairy Business Association Inc., and the National Milk Producers Federation -- also challenged the EPA's right to force CAFOs to design and implement Nutrient Management Plans and to penalize them if the plans are not followed and waste is discharged into waterways. On this issue, the court sided with the EPA.

What is the impact of this decision? Could it perhaps have no impact at all, as the CAFOs exempted from applying for permits are those that are not polluting? Sadly, this is likely not the case. By forcing CAFOs to apply for a permit, the EPA was forcing them to create a plan to manage the large amounts of waste their animals would inevitably generate. Without planning ahead for responsibly disposing of manure, how many CAFOs will wait until the last minute, like Inskeep, and then dump millions of gallons of manure into the environment? Even though the EPA will still be able to penalize them once they do, the damage to the environment will already be done.

These are not hypothetical scenarios. Just ask Rick Dove, an ex-Marine who serves as a Riverkeeper on his beloved Neuse River in North Carolina. After retiring from the Marines, he lived his dream of becoming a small-scale commercial fisherman on the river briefly -- until enormous hog operations moved in, each producing as much waste as a town of 20,000 people, and their waste killed the fish.

Dove has seen hog farmers oversaturating their "sprayfields" -- cropland intended to absorb the unfathomable amount of manure generated by the hogs -- resulting in contamination of local waterways, but he has also seen the farmers illegally dumping the manure directly into the rivers. And then he's seen the Neuse turn red, green, yellow, orange, and black with various types of algae blooms that precede fish kills that kill millions or even a billion fish at a time.

In addition to irresponsible spraying or dumping of manure, there are the many lagoon spills that occur. In these cases, farmers likely have no intention of dumping manure into the environment, but it happens all the same. Kirby says that when writing his book, "there were so many lagoon spills that my editor had me take some out." And because such spills are accidents, farmers won't necessarily apply for permits ahead of time, since they don't intend to discharge manure.

The losers in this story are not just "tree-hugging" environmentalists or even fishermen. In far too many cases, the losers are drinkers of water -- which is all of us.