The cephalosporin class of drugs is used to treat a variety of serious conditions, including skin infections, urinary tract infections, pneumonia, abdominal infections, bone infections, pelvic inflammatory disease and meningitis.

Of all drugs prescribed to outpatients, 14 percent are from the cephalosporin class.

“Newer cephalosporins are used in the hospital setting to treat seriously ill patients with life-threatening disease,” according to FDA.

Mounting scientific evidence has shown that the overuse of cephalosporin in food animals is contributing to the development of drug-resistant strains of these bacteria.

“If cephalosporins are not effective in treating these diseases,” said FDA in a statement Wednesday, “doctors may have to use drugs that are not as effective or that have greater side effects.”

Two food borne illnesses–Salmonella and Shigella infections–are commonly treated with these drugs. It is via these bacteria that cephalosporin resistance is thought to be transmitted from animals to humans.

“It is likely that the extralabel use of cephalosporins in certain food-producing animal species is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria,” reads the FDA rule.

Properties of resistance can then be transmitted from one bacteria to another.

“What the science is telling us is that these bacteria all communicate and share information with each other and they pass along these resistance genes, and that’s a really troubling thing,” said Laura Rogers of Pew Charitable Trusts, a public policy watchdog. Rogers is project director for the organization’s Campaign on Human Health and Industrial Farming.

And once bacteria develop resistance to one type of cephalosporin, they can become resistant to others.

“Resistance to certain cephalosporins is of particular public health concern in light of the evidence of cross-resistance among drugs in the cephalosporin class,” FDA explains in its rule.

The agency is not forbidding the use of these drugs in animals outright, but is eliminating “extra-label” or “off-label” use, unapproved uses that may contribute to antibiotic resistance.

The newly prohibited uses include:

However, cephalosporins will still be permitted for use in the following scenarios:

These exceptions to the prohibition of extra-label uses are new to FDA’s proposed rule on cephalosporins. The agency issued an earlier version of this rule in June of 2008, but withdrew it after it met with criticism because it outlawed uses of the drug that did not lead to antimicrobial resistance.

FDA’s new order, scheduled to go into effect in April, follows a notice published in the Federal Register just before the holidays that indicated the agency was backing away from a 1977 announcement that it had decided not to withdraw penicillin and tetracyclines in animal feed.

The agency said it was planning to “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.”

In November, to the dismay of consumer and sustainable agriculture advocates, the FDA rejected two petitions to ban certain antibiotics from being used in food animal production. It said it was “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”

But in announcing the new order Wednesday, Dr. Michael Taylor, the FDA’s commissioner of foods, said, “We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals.”

The Pew Campaign praised FDA’s latest announcement, saying it targets cephalosporin use where it is most abused.

“I think this is acknowledging that there have been some misuses of the drug,” said Gale Hansen, senior officer of Pew’s Campaign on Human Health and Industrial Farming.

Each year, 9 billion broiler eggs are processed in America, and the majority of them are injected with cephalosporins. The drug is also widely administered to cattle for disease prevention. These pratices will be banned under the new rule.

However, other consumer advocates pointed out that cephalosporins make up only a small percent of all antibiotics administered to livestock for purposes such as boosting growth.

In fact, cephalosporins account for .2 percent of antibiotics administered to animals domestically each year.

Consumer groups criticized FDA for not including in its restriction other drugs that have also been shown to promote antimicrobial resistance.

“It’s high time that the FDA wakes up to the dangers of non-therapeutic uses that all antibiotics pose to our health and the safety of our food supply,” said Andrew Kimbrell, executive director of the Center for Food Safety, in a statement Wednesday.

But despite cephalosporin’s small share of the animal antibiotic pie, Rogers points out that the drug has large implications for human health.

“Cephalosporins may not be used as extensively as some other drugs, but these drugs are critically important to human health, and so we need to protect them and use them as judiciously as possible,” she said.

Other consumer advocates agree that these restrictions are indeed necessary, but say they have been too long in coming.

“The order prohibiting certain uses of cephalosporin in many food-producing animals is clearly warranted, though it may be too little, and it is definitely too late,” said Caroline Smith DeWaal, Food Safety Director of the Center for Science in the Public Interest (CSPI) in a statement Wednesday.

U.S. Rep. Louise Slaughter, D-NY, a microbiologist who has sponsored bills aimed at preserving antibiotics’ effectiveness for treating human disease, was even more critical of the FDA’s new order.

In a statement she said the rule addresses “just the tip of the iceberg” and noted that the announcement comes three years after the FDA determined that extra-label use in food animal production posed a public health threat.

“This is a modest first step by FDA,” she wrote. “We don’t have time for the FDA to ploddingly take half-measures. We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs. We need to start acting with the swiftness and decisiveness this problem deserves.”

CSPI pointed out that at least five foodborne outbreaks since 2001 have been linked to cephalosporin-resistant Salmonella. These outbreaks resulted in more than 200 illnesses and one death.

FDA noted in its question and answer document on the rule that restrictions have already been placed on 14 other drugs thought to contribute to antimicrobial resistance, and that the agency continues to promote the “judicious use” of animal antibiotics, as evidenced by its Draft Guidelines on animal antibiotic use issued in 2010.

“This action is among a number of ongoing FDA activities and initiatives intended to address concerns about the use of antimicrobial drugs in animal agriculture,” says the agency’s Q&A page.

A 60-day comment period on the new rule will run from Jan. 6 to March 6. The FDA said it will take those comments into consideration before the new order goes into effect April 5.

Originally published on Food Safety News

This is a sorry end to a process that began in 1977 (!), but McKenna created an excellent timeline that traces the history of the issue back to the 1950s. In 2009, the Obama administration breathed new life into a moribund process because the top two Obama appointees at the FDA, Commissioner Margaret Hamburg and her then-deputy Joshua Sharfstein, strongly supported restricting antibiotic use in agriculture.

But despite Hamburg and Sharfstein’s many supportive statements, the FDA has only produced a draft set of “voluntary” guidelines. And, with this latest announcement, it looks like that’s as far as they’re willing to go.

Inaction has consequences: According to the vast majority of microbiologists and public health experts, restrictions on agricultural uses are key to preserving the effectiveness of antibiotics as well as to preventing the spread of antibiotic-resistant bacteria like MRSA and salmonella Heidelberg (cause of last summer’s record-breaking ground turkey recall). And it’s no small dosage: Every year 29 million pounds of antibiotics are given to animals — often via their feed. That figure represents 80 percent of all antibiotics used in the U.S.

Consumer groups like the Union of Concerned Scientists and the Pew Charitable Trusts have been calling for an end to the practice for years. But it’s not just outsiders who are fed up with the agency’s work on this issue; the administration’s own watchdog group, the Government Accountability Office, recently gave the agency a failing grade in the subject.

In many ways, this issue parallels the ongoing battle over BPA, the endocrine-disrupting chemical used in food packaging, plastics, and register receipts. When finally pushed to ban the chemical, the FDA declared that “its hands were tied” by regulatory hurdles and jurisdictional questions. Yet soon after, the industry lobbying group American Chemical Council responded to consumer anger and petitioned the agency to go ahead and ban BPA. Only then did the FDA indicate it would follow through.

In other words, the FDA is admitting that as long as the industry opposes it, the agency can’t keep antibiotics out of our meat and dairy products (nor, for that matter, can it ensure that antibiotics will remain effective). It’s also admitting it has no real power over the industries it regulates. If the agency continues to favor industry’s concerns over the public health, it begs the question: Who exactly is looking out for us?

On the brighter side, several organizations, including the Natural Resources Defense Council, the Center for Science in the Public Interest, and Public Citizen have actually filed a lawsuit against the FDA demanding the agency restrict antibiotics in animals. This is promising, because courts have shown more interest in defending science than the federal agencies (see this example from last year regarding rBST/rBGH in milk).

So it may just fall to a federal judge to determine what’s truly good for the public interest. Of course, it would be nice if the agency actually tasked with that responsibility would step up to the plate. But I guess that’s just too much to ask.

Originally published on Grist

In June, Pfizer announced it was ending arsenic-containing chicken feed which no one realized they were eating anyway, but its arsenic-containing Histostat, fed to turkeys, continues. Poultry growers use inorganic arsenic, a recognized carcinogen, for “growth promotion, feed efficiency and improved pigmentation,” says the FDA. Yum.

And in August, Cargill Value Added Meats, the nation’s third-largest turkey processor, recalled 36 million pounds of ground turkey because of a salmonella outbreak, linked to one death and 107 illnesses in 31 states. Even as it closed its Springdale, Arkansas plant, steam cleaned its machinery and added “two additional anti-bacterial washes” to its processing operations, 185,000 more pounds were recalled the next month from the same plant.

Since the mad cow and Chinese melamine scandals of the mid 2000′s, a lot more people think about the food their food ate than before. But fewer people think about the drugs their food ingested. Food animal drugs seldom rate Capitol Hill hearings which is just fine with Big Pharma animals divisions since if people knew the antibiotics, heavy metals, growth promotants, vaccines, anti-parasite drugs and feed additives used on the farm, they would lose their appetite. Besides, people aren’t Animal Pharma’s primary customers anyway and the long term safety of animals drugs isn’t an issue, since patients supposed to die.

One of the late Sen.Ted Kennedy’s last legislative fights was about the overuse of livestock antibiotics. “It seems scarcely believable that these precious medications could be fed by the ton to chickens and pigs,” he wrote in a bill called the Preservation of Antibiotics for Medical Treatment Act of 2007 (PAMTA) which has yet to pass. “These precious drugs aren’t even used to treat sick animals. They are used to fatten pigs and speed the growth of chickens. The result of this rampant overuse is clear: meat contaminated with drug-resistant bacteria sits on supermarket shelves all over America,” said Kennedy.

Because antibiotics make animals use feed more efficiently so they eat less and control disease in confinement farming’s packed conditions at the same time, they are practically the fifth food group. On a turkey farm with five million hens, antibiotics would save almost 2,000 tons of feed a year, says an article in a poultry journal.

And when the FDA tried to ban cephalosporins in 2008, one type of antibiotic crucial for treating salmonella in children, it became apparent just what Kennedy was up against. Two months after the FDA announced a hearing about a cephalosporin “Order of Prohibition” in agriculture, the regulatory action had morphed into a “Hearing to Review the Advances In Animal Health Within The Livestock Industry” thanks to lobbyists from the egg, chicken, turkey, milk, pork and cattle industries.

“Order of Prohibition”… “Hearing to Review the Advances In Animal Health Within The Livestock Industry,” same idea, right?

At the House Subcommittee on Livestock, Dairy, and Poultry hearings [PDF], the National Turkey Federation’s Michael Rybolt defended antibiotics as a cost savings to consumers. “The increased costs to raise turkeys without antibiotics is real,” he said. “Today at retail outlets here in the D.C. market, a conventionally raised turkey costs $1.29 per pound. A similar whole turkey that was produced without antibiotics costs $2.29 per pound. With the average consumer purchasing a 15 pound whole turkey, that would mean there would be $15 tacked on to their grocery bill.”

Conventionally grown turkeys are even a better deal when you consider the cost of antibiotics!

And, antibiotic-based turkey farming is downright green, said Rybolt, calling 227 acre turkey operations, “small family farms.” Without them, more land would be needed to grow crops and house the animals because of the “decrease in density.” And, with 175,550 more tons of feed needed, there would be “an increase in manure.”

When the FDA capitulated to industry and turned the cephalosporin prohibition into a salute to animal “advances,” former Kansas governor and former dairyman John Carlin, asked, “What changed in less than five months? Certainly the problem hasn’t gone away.”

This month, the FDA also rejected petitions to ban human antibiotics like penicillins, tetracyclines and sulfonamides in livestock filed by the Center for Science in the Public Interest, Environmental Defense, the American Academy of Pediatrics, the American Public Health Association, Food Animal Concerns Trust (FACT), and the Union of Concerned scientists, some filed over 12 years ago. Why?  ”FDA cannot withdraw approval of a new animal drug until the legally-mandated process,” said an FDA spokesman. The process includes an “evidentiary hearing,” perhaps like the cephalosporin advances.

Of course germs in turkey and other meat, even antibiotic resistant germs, are neutralized by cooking–but drug residues are not. A report last year from the USDA’s inspector general accuses U.S. slaughterhouses of releasing products to the public with excessive drug levels in them and charges that, “The effects of these residues on human beings who consume such meat are a growing concern.”

Nor are the antibiotics just in the meat! Scientists at the University of Minnesotafound antibiotic residues in corn, green onions and cabbage after growing them on soil fertilized with livestock manure. The drugs siphoned right up from the soil in just six weeks.

A quick look at the Code of Federal Regulations for turkey drugs does not whet you appetite for Thanksgiving. There are several arsenic turkey drugs approved to provide an, “increased rate of weight gain and improved feed efficiency,” say the official guidelines. But they are also “dangerous for ducks, geese, and dogs,” and must be discontinued,  ”5 days before slaughtering animals for human consumption to allow elimination of the drug from edible tissues.” Whew.

Halofuginone, another drug given to turkeys to kill pathogens, “is toxic to fish and aquatic life” and “an irritant to eyes and skin,” says the Federal Code. “Avoid contact with skin, eyes, or clothing” and “Keep out of lakes, ponds, and streams.” Bon appetit.

Drug-based farming has cut the time to “grow” an animal almost in half while doubling the market size of the animal itself.  For example, chickens were once slaughtered at fourteen weeks, weighing two pounds and are now slaughtered at seven weeks, weighing four and six pounds.

But the Brave New food techniques come at a price because the animals’ organs can not always keep up with the metabolic frenzy. Birds “fed and managed in such a way that they are growing rapidly,” are at risk of sudden death from cardiac problems and aortic rupture, say poultry scientists.

Growth drugs in turkeys may also “result in leg weakness or paralysis,” says the Federal Code, a side effect that a turkey slaughterhouse worker reports firsthand. Many turkeys arrive at the House of Raeford, in Raeford, NC with legs broken or dislocated, he told me in an interview and, “When you try to remove them from their crates, their legs twist completely around, limp and offering no resistance.” The turkeys, “must have been in a lot of pain,” says the worker, but they don’t cry out. “In fact the only sound as you hang them, he says, is the “trucks being washed out to go back and get a new load.”

The undercover employee’s reports of the “live hanger” culture at the House of Raeford, in which workers pulled the heads and legs off turkeys when they were stuck in crates and worse, led to Denny’s suspending its business from Raeford, the nation’s seventh largest turkey producer. The slaughterhouse is also infamous for a chlorine spill that killed a worker in 2003, an ammonia spill that evacuated  two towns the next year and a murdered worker in 2006.

Still, the mother of all turkey drugs is the asthma-like drug ractopamine, marketed as the “Medicated Tom Turkey Feed” Topmax. Approved for turkeys only two years ago, figures for Topmax use in turkeys are not yet available but the same drug is now used in 45 percent of U.S. pigs and 30 percent of ration-fed cattle.

There are two reasons ractopamine has raised safety questions. One is that itslabel reads, “WARNING: The active ingredient in Topmax, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Topmax 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Topmax, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water. If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.”

The other reason is that ractopamine is not withdrawn at slaughter. In fact, it is begun as the animals near slaughter and started during turkeys’ last 14 days. It is actually pumping through their systems as they arrive on the killing floor.

Like antibiotics and arsenic, ractopamine is given to turkeys to make them grow faster. It is similar to clenbuterol, a performance enhancing sports drug that is banned in the US, for both humans and livestock, and elsewhere. But ractopamine is also banned in Europe, Taiwan and China, where 1,700 ractopamine “poisonings” were reported and ractopamine-produced pork was seized in 2007. (You have to worry when China calls a food unsafe.)

Ractopamine caused actual riots in Taiwan in 2007 when 3,500 Tawainese pig farmers, some carrying pigs, threw dung and rotten eggs at police and military soldiers over the rumor that a ractopamine ban would be lifted.  ”Get out, USA pork” and “We refuse to eat pork that contains poisonous ractopamine,” they chanted for hours according to Taiwan News.

Reports of ractopamine’s lack of safety are not hard to find.  In 2009, theEuropean Food Safety Authority (EFSA) termed ractopamine a cardiac stimulator. Ractopamine residues “represent a genuine risk to consumers,” wrote a medical  journal article, citing “long plasma half-lives, and relatively slow rates of elimination.” And a report from Ottawa’s Bureau of Veterinary Drugs says that rats fed ractopamine developed a constellation of birth defects like cleft palate, protruding tongue, short limbs, missing digits, open eyelids and enlarged heart.

The FDA is well aware of ractopamine’s downside. In 2003, three years after the drug was approved for use in U.S. pigs, the FDA accused its manufacturer, Elanco, of withholding information about ractopamine’s “safety and effectiveness” and “adverse animal drug experiences” in a fourteen-page warning letter.

Elanco, said the FDA, failed to report furious pig farmers phoning the company about “dying animals,” “downer pigs,” animals “down and shaking,” “hyperactivity” and “vomiting after eating feed with Paylean,” and also suppressed clinical trial information. But, thanks to same probable lobbying that reversed the cephalosporin ban, the FDA approved ractopamine for cattle the following year and for use in turkeys in 2009! Last year, the FDA enlarged the approval for cattle.

Turkey meat produced with ractopamine is not the same as normal meat byElanco’s own admission! “Alterations” in muscle were seen in turkeys fed ractopamine like an increase in “mononuclear cell infiltrate and myofiber degeneration,” says its 2008 new drug application documents. There was “an increase in the incidence of cysts,” and differences, some “significant,” in the weight of organs like hearts, kidneys and livers. (“Enlarged hearts” had been seen in test rats feed ractopamine in the Canadian studies.)

Still, ractopamine, like antibiotics, is being hailed as “green” and for lowering the carbon footprint. It has “positive environmental benefits for livestock producers in terms of decreased nitrogen and phosphorus excretions,” extols one journal article. It results in a, “reduced amount of total animal waste,” unless, of course, you count the manure coming from Big Pharma.

 Originally published on AlterNet

But if Thanksgiving is truly about offering gratitude for what we have, it seems fitting to also be grateful to the turkey that many of us will eat for dinner. We ought to think about how that turkey lived before ending up on our tables. With that in mind, let’s first take a look at the life of a turkey in an industrial farm.

Turkeys on factory farms are hatched in incubators mostly on large farms in the Midwest or the South. A few days after hatching, turkeys have their upper beaks snipped off. Once the beak is removed, the turkey can no longer pick and choose what it wants to eat. In their natural environment, turkeys are omnivores. But in a factory farm, turkeys are fed a steady diet of corn-based grain feed laced with antibiotics.

Industrially produced turkeys spend their first three weeks of life crammed into a brooder with hundreds of other birds. In the fourth week, turkey chicks are moved from the brooder to a giant window-less room with 10,000 other turkeys where bright lights shine 24 hours a day. With the lights constantly blaring, natural sleeping, eating, and fertility patterns are completely disrupted and the turkeys are, for the most part, kept awake and eating non-stop. Turkeys have an instinct to roost, or to clutch something when they sleep, but on the floor of a crowded room there is no such opportunity. If this is starting to sound like torture to you, you’re on the mark.

As a result of these unhealthy and crowded living conditions, farmers must feed the turkeys a constant supply of antibiotics. Pesticides are also widely used to inhibit the spread of disease. Antibiotics are also known to promote weight gain in farm animals and this connection is being made in humans now as well. In an effort to maximize the more profitable white breast meat, farmers have genetically selected and bred the white broad breasted turkey, which become so top heavy that they can no longer stand or reproduce and as a result, all industrial turkeys are created by artificial insemination. Turkeys are then brought to slaughter, often in a brutal way.

If that wasn’t enough to make you reconsider your Butterball, there’s more. Thanksgiving is also a time when we honor the abundance of the harvest represented by the bounty on our tables. But supporting a Big Turkey farm (or any factory farm) contributes to the devastation of our natural environment and imperils the safety of our food supply.

According to the USDA, factory-farmed animals in the U.S. produce 61 million tons of waste each year–130 times the volume of human waste. The Environmental Protection Agency reports that hog, chicken, and cattle waste has polluted 35,000 miles of rivers in 22 states and contaminated groundwater in 17 states. Polluted runoff from factory farms and other industrial farms is the biggest water pollution problem in the U.S., according to the EPA.

Human health is impacted in other ways by factory farming. Just this past August, Cargill announced a recall of 185,000 pounds of ground turkey due to Salmonella contamination. With recalls and food-borne illnesses on the rise as a result of conditions in factory farms, it seems wise to avoid these foods for that reason alone.

Factory farmed meat is also implicated in long-term health consequences. Resistance to antibiotics is now a growing concern among many in the medical field and it is largely due to the 29 million pounds administered to factory-raised animals every year. As it stands today, one out of six cases of Campylobacter infection, the most common cause of bacterial food poisoning, is resistant to the antibiotic most used to treat it. And nearly all strains of Staphylococcal infections have become resistant to penicillin, while many are developing resistance to newer drugs as well. Indeed, 80 percent of all antibiotics used in this country are used on factory-farmed animals according to an FDA report.

And finally, there is the nitty-gritty of nutritional value in these factory-farmed foods. Studies show that pastured-based meat and dairy are far more nutritious than their conventional counterparts. They are richer in antioxidants; including vitamins E, beta-carotene, and vitamin C and contain far more Omega-3 fatty acids. Turkeys that are raised on grass and allowed to roam around and practice normal turkey behavior are healthier, safer to eat, good for the environment, and get to live a happy life. Our best option is to eat high quality meat and a lot less of it.

So in the spirit of Thanksgiving, let’s be grateful to the turkey that we’re eating and opt out of supporting a system of abuse and environmental destruction. Eat a pasture-raised turkey or make a vegetarian alternative for this year’s Thanksgiving feast.

Eat Wild is a valuable resource for pasture-raised meat and animal products. Brooklyn Based also lists pasture-raised turkeys available for sale in New York City. Slow Food USA has information and resources for heritage breed turkeys. Meatless Monday offers 10 tips for cooking a meatless Thanksgiving.

A petition has been created by Occupy Big Food to tell Butterball—the number one producer of turkeys in America—that Americans are no longer going to purchase turkeys that are inhumanely treated, or support a factory-farm system that creates dire environmental and health consequences. Please go to Occupy Big Food for more information and sign the petition here.

Recent estimates indicate around 80 percent of all antibiotics in the U.S. are given to food animals.

Senator Dianne Feinstein (D-CA), the primary sponsor of The Preservation of Antibiotics for Medical Treatment Act, otherwise known as PAMTA, reintroduced the measure to address “the rampant overuse of antibiotics in agriculture that creates drug-resistant bacteria, an increasing threat to human beings.”

“The effectiveness of antibiotics for humans is jeopardized when they are used to fatten healthy pigs or speed the growth of chickens,” said Senator Feinstein.  “This is a basic food safety initiative that would phase out the misuse of these drugs so that food in supermarkets across America will not spread strains of drug-resistant bacteria.”

Senators Susan Collins (R-ME), Jack Reed (D-RI), Barbara Boxer (D-CA), all collaborated on the legislation.

According to Feinstein’s office, in 2010, the senator was contacted by the Don family of Ramona, California.  Their son, Carlos, “a bright and athletic 12-year old,” became gravely ill with an infection while at summer camp and did not respond to antibiotics.

“It took doctors 48 hours to find a medication that could kill the Methicillin-resistant Staphylococcus aureus, or MRSA, that had infected his body.  By that time, Carlos’ lungs, kidneys, liver, intestine and heart had failed.  With only some brain activity left, Carlos lost his life because the antibiotics that hospitals have relied on for 80 years no longer worked,” said Feinstein’s office in a statement late last week.

“No parent should ever undergo the heartbreak and the tragedy that the Don’s went through,” said Feinstein.  “My bill makes important changes to the use of antibiotics and ensures that operations on a farm do not negatively impact the health and well being of families across the nation.”

The bill Feinstein is championing, PAMTA, mirrors a bill introduced by Congresswoman Louise Slaughter (D-NY), the only microbiologist serving in Congress. The legislation:

– Phases out the non-therapeutic use of medically important antibiotics in livestock;
– Requires new applications for animal antibiotics to demonstrate the use of the antibiotic will not endanger public health;
– Does not restrict the use of antibiotics to treat sick livestock or to treat pets.

“PAMTA will limit the agricultural use of seven types of antibiotics that have been identified by the Food and Drug Administration as critically important in human medicine to ensure that antibiotic-resistance is not inadvertently accelerated,” according to Feinstein’s office.

The Senate version of the legislation has 17 cosponsors and the House version has 60. Slaughter has been introducing a version of the bill since 2007.

The animal agriculture industry maintains that antibiotics are a critical tool for preventing disease and promoting animal health and welfare, casting doubt on the link between the sector’s use of antibiotics and human health issues.

Originally published on Food Safety News

Over the past couple of years, the FDA changed its tune and has finally begun to respond to the threat. Top officials at the FDA have testified of the dangers to Congress. The agency itself is developing “voluntary guidance” that would restrict the practice–which currently sees 80 percent of all antibiotics used in this country given to food animals.

Sadly, though, the FDA is still whistling when it should be belting its song to the rafters. In fact, the meat industry has successfully resisted, and in the case of the antibiotic Cephalosporin, turned back via “midnight regulations” by outgoing Bush administration FDA officials, specific measures meant to address this threat to public health.

As a result, a coalition of environmental groups including the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, Union of Concerned Scientists, and the Natural Resources Defense Council (NRDC) has decided to sue. According to a blog post by the NRDC’s Executive Director Peter Lehner, the goals are simple:

We want the FDA to follow its own safety findings and withdraw approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed. We also want the agency to respond to the petitions to withdraw approval of non-therapeutic uses in animal feed of other antibiotics important to human health.

This lawsuit will have no bearing on the use of antibiotics for treating sick animals. We simply want to end the practice of giving these critical disease fighters to healthy livestock when it’s not medically necessary.

While this may cause eyerolls among some who look at this as “just another lawsuit,” there’s something very important going on with the courts and contested science right now. As it happens, one of the main roles of a judge is as “finder of fact.” In practice, this means that judges determine whether scientific evidence is compelling enough to force government action.

In several recent cases, the courts have decided that environmentalists and reformers were right–and industry was wrong. It was, after all, the Supreme Court that ultimately forced the EPA to regulate carbon dioxide and other greenhouse gases (however fitfully the agency has done it). More relevant to this case, it has been the federal courts–including the Supreme Court–that have forced the USDA to consider things like gene flow and economic harm from contamination of organic crops by genetically modified seeds. Indeed, the courts are currently holding the USDA’s feet to the fire on its entire regulatory process surrounding genetically modified seed–much to the consternation of the biotech industry (not to mention senior administration officials). Oh, and the courts recently determined that, yes, milk treated with artificial growth hormones is worse than regular milk–as activists have claimed for decades.

And so, it may be that the courts hold the key to forcing the FDA to finally act on antibiotics in livestock. It’s one thing to ignore industry pressure–which is something the FDA is utterly unable to do. It is another thing to ignore a court order by a federal judge. It’s a shame that our politics and our regulatory environment are now so toxic to reform that even commonsense changes like preserving life-saving drugs for human use can be controversial. For the moment, judges, who are forced to treat peer-reviewed scientific evidence with the respect it deserves, may be the only hope.

Originally published on Grist

The editors of Scientific American recently encouraged U.S. hog farmers to “follow Denmark and stop giving farm animals low-dose antibiotics.” Sixteen years ago, in order to reduce the threat of increased development of antibiotic resistant bacteria in their food system and the environment, Denmark phased in an antibiotic growth promotant ban in food animal production. Guess what? According to Denmark’s Ministry of Food, Agriculture and Fisheries the ban is working and the industry has continued to thrive. The government agency found that Danish livestock and poultry farmers used 37 percent less antibiotics in 2009 than in 1994, leading to overall reductions of antimicrobial resistance countrywide.

Except for a few early hiccups regarding the methods used in weaning piglets, production levels of livestock and poultry have either stayed the same or increased. So how did Danish producers make this transition and why isn’t the U.S. jumping to follow suit? Like many things in industrial agriculture, the answer is not clear.

If any country knows how to intensively produce food animals, particularly pigs, it is Denmark. In 2008, farmers produced about 27 million hogs. In fact, the Scandinavian country claims to be the world’s largest exporter [PDF] of pork. Thus Scientific American editors argue that the Danish pork production system should serve as a suitable model to compare to ours. U.S. agriculture economists from Iowa State University agree. In a 2003 report, Drs. Helen Jensen and Dermot Hayes stated that Denmark’s pork industry is “… at least as sophisticated as that of the United States … and is therefore a suitable market for evaluating a ban on antibiotic growth promotants (AGPs).”

Based on Denmark’s experience, concerns that an AGP ban in the U.S. would cripple the industry appear to be overblown. A study published last year in the American Journal of Veterinary Medicine by Danish researchers suggested that Denmark’s AGP ban in food animals reduced overall antibiotic use and did not significantly impact production. In fact, recent numbers from Denmark show production levels of hogs increased by roughly 50 percent between 1992 and 2008.

So what additional changes did Danish hog producers make in their methods of production to ensure that the AGP ban did not negatively affect their bottom line to a significant degree? Robert Martin, senior officer of the Pew Environment Group and former executive director of the Pew Commission on Industrial Farm Animal Production, visited several Danish hog farms in 2009 to see first hand what producers were doing to compensate for not being able to use antibiotics as growth promoters. Martin listed some of what he describes as the most important changes:

• Switching to lower density models of housing pigs
• The use of open pen and deep bedding systems
• Cleaning barns more frequently and systematically
• Improved ventilation systems
• Improved quality of feed
• Extending weaning period for piglets

Martin explains that many of these changes were phased in as farmers adopted a set of new best practices. Martin says immediately following the ban, Danish producers did see an increase in mortality of young pigs. “But instead of reverting to using antibiotics as a crutch,” Martin continued, “They initiated changes in their system.” For example, Martin learned that many producers extended the piglet weaning times by about 10 days, allowing maternal antibodies in milk to provide increased immunity. Martin also pointed out that reducing the crowded conditions and switching to a dry, deep bedding system, “allowed them to manage waste more effectively.” He said the changes are also “more humane for the pigs.” Moreover, Martin says, “They also paid more attention to feed mixtures instead of relying on antibiotics for weight gain.”

Dr. Jensen and Hayes’s report, published in the Iowa Ag Review, determined a ban similar to Denmark’s could cost the U.S. industry more than $700 million over 10 years and increase the price of pork by about 2 percent at the grocery store. Hayes noted, in recent email exchanges with the Center for a Livable Future, that in the long run, a ban would not keep producers from making money. He also wrote, “Hog farmers would reduce production until prices recovered, so there is no profit impact.” When it comes to the study’s findings, Hayes believes the economics are secondary:

The key take away for me from our studies was that the ban at the finishing stage worked as planned and reduced antibiotic use by a lot. However, when they extended the ban to the weaning state they ended up using more antibiotics and these were stronger human-use antibiotics. So a ban at the weaning stage did not work in terms of its original intent.

It is worth noting that recent Denmark data shows weaner mortality is significantly lower since the ISU study was published in 2003. Despite that fact, Hayes is correct. The therapeutic use of antibiotics has increased since the ban was instituted. According to the latest Danish Integrated Antimicrobial Resistance Monitoring and Research Program (DANMAP) report [PDF], therapeutic antibiotic use rose by almost 13 percent from 2008 to 2009. DANMAP also found the occurrence of resistance in Danish pork increased during that time period, “and is not significantly lower than in imported pork.” However, resistance to the antibiotic ciprofloxacin, an important antibiotic in human medicine, was very low in E. coli from Danish pork in contrast to imported pork. It is important to point out that therapeutic use poses much less antibiotic resistance risk than low-dose application. Don’t forget, Denmark’s overall antibiotic use in all food animal production remains nearly 40 percent lower then when the ban was first initiated.

If the AGP ban is, at the very least, reducing overall antibiotic use and Danish pork production levels are increasing, why wouldn’t U.S. producers follow suit? The National Pork Producers Council (NPPC) lobbyists publicly maintain they still don’t believe antibiotic use in food animals poses a risk to human health. In a presentation [PDF] prepared for the World Pork Expo 2010, Chelsea Redalen, the NPPC’s director of government relations, maintained that there is “little to no evidence that restricting or eliminating the use of antimicrobials in food-producing animals would improve human health or reduce the risk of antimicrobial resistance to humans.”

Statements like these, repeatedly made by hog industry representatives, leave many public health experts exasperated. Numerous peer reviewed research studies [PDF], including in the U.S. and the Netherlands, clearly demonstrate the transmission of antibiotic resistant bacteria from food animals to people. Studies out of the Netherlands published in the Journal of Emerging Infectious Diseases and the Annals of Clinical Microbiology and Antimicrobials, demonstrate that MRSA (Methicillin-resistant Staphylococcus aureus) was transmitted from pigs to a farmer and between pig farmers and their family.

Despite industry claims, U.S. government health officials have concluded there are direct links between antibiotic use in food animal production and the risk of antibiotic resistant infections in people. Responding to a letter from Drs. Robert Lawrence and Keeve Nachman of the Johns Hopkins Center for a Livable Future (CLF), the director of the U.S. Centers for Disease Control and Prevention (CDC), Dr. Thomas Frieden, confirmed that the CDC, “Feels there is strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans.”

CLF helped bring to light recently released FDA data showing that 80 percent of the antibiotics produced for human and animal use in the U.S. are sold for use in food animals. Even if significant portions of those antibiotics are used to treat disease, Dr. David Love, a CLF scientist, says he finds that statistic, “astounding.” Love believes, “If producers are reliant on the use of antibiotics to produce animals in a highly concentrated way, it means that the design of these farms makes them breeding grounds for diseases.” “Even more troubling to me,” Love says, “Is the unwise use of antibiotics for growth promotion in animal production, which compromises antibiotics, a precious resource used to protect the public’s health.”

Currently, there is proposed federal legislation that would greatly limit antibiotic use in U.S. food animal production. Rep. Louise Slaughter (D-N.Y.) recently reintroduced the Preservation of Antibiotics for Medical Treatment Act, better known as PAMTA. The bill would ban the routine use of antibiotics “deemed” critical in human medicine to promote growth in healthy animals.

So, should the U.S. follow Denmark’s lead and stop all food animal producers from dishing out low dose-antibiotics? Public health experts say it appears that those with a higher priority on limiting health risks are at loggerheads with those unwilling to change or corporations more concerned about the risks of increased costs. One thing is clear–most large pork producers do not plan on instituting a ban voluntarily.

Originally published on Grist

In fact, according to new data just released by the FDA, of the antibiotics sold in 2009 for both people and food animals almost 80 percent were reserved for livestock and poultry. A huge portion of those antibiotics were never intended to fight bacterial infections, rather producers most likely administered them in continuous low-dosages through feed or water to increase the speed at which their animals grew. And that has many public health experts and scientists troubled.

For years scientists concerned about the threat of antibiotic resistant bacteria in food animal production have been trying to figure out just how much antibiotics producers are using each year. The best they could do was come up with rough estimates. That is because the data were never publicly available, until now.

In accordance with a 2008 amendment to the Animal Drug User Fee Act, for the first time the FDA released last week an annual amount of antimicrobial drugs sold and distributed for use in food animals. The grand total for 2009 is 13.1 million kilograms or 28.8 million pounds. I found the stories covering this revelation interesting, but they did not convey the whole picture. It is important to understand how this amount compares to the total available for people. So, I contacted the FDA for an estimate of the volume of antibiotics sold for human use in 2009. This is what a spokesperson told me:

“Our Office of Surveillance and Epidemiology just finished an analysis based on IMS Health data. Sales data in kilograms sold for selected antibacterial drugs were obtained as a surrogate of human antibacterial drug use in the U.S. market. Approximately 3.3 million kilograms of antibacterial drugs were sold in year 2009. OSE states that all data in this analysis have been cleared for public use by IMS Health, IMS National Sales Perspectives™.”

3.3 million kilograms is a little over 7 million pounds. As far as I can determine, this is the first time the FDA has made data on estimates of human usage public. Below is a breakdown of the FDA numbers prepared by my colleague, Dr. David Love, also from the Johns Hopkins Center for a Livable Future, which compares the estimated amounts of human usage with food animal usage.

Take a look at the data for tetracycline. More than 10 million pounds of the antibiotic were sold for use in food animals. That’s more than all of the antibiotics combined set aside for humans in 2009. Many studies suggest the high use of tetracycline in food animals, particularly in pigs, has lead to the increased rates of bacterial resistance to the antibiotic, such as Methicillin-resistant Staphylococcus aureus or MRSA.

Despite this new information, the hog industry denies the suggestion that it is overusing antibiotics. In response to the FDA’s report, the National Pork Producers Council also pointed out to Food Safety News’ Helena Bottemiller that, “ionophores… are not used in human medicine, they don’t have anything to do with the effectiveness of antibiotics in people.”  That statement is inaccurate. All uses of antibiotics have the potential to decrease the effectiveness of antibiotics in people. Ionophores are no exception. While several industry funded studies determined that ionophore use in animals is “not likely” to transfer resistance from animals to people, researchers couldn’t come to a definitive conclusion because ionophores can lead to bacterial resistance to the antibiotic bacitracin, which is commonly used to treat skin and eye infections.

Every time an antibiotic is used there is a risk of adding to the growing pool of antibiotic resistance. LivableFutureBlog readers might recall an October blog post in which Dr. Ellen Silbergeld, professor of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health, warned that, “Bacteria respond to chemical structures, not brand names, and resistance to one member of a pharmaceutical class results in cross resistance to all other members of the same class.”  Silbergeld says when bacteria develop resistance to one member of that class of antibiotics it can be resistant to all.

So, what is the government doing to ensure we don’t squander the effectiveness of antibiotics for human use on the production of food animals? Since President Barack Obama took office, the FDA says it has taken several steps. Dr. Joshua Sharfstein, Principal Deputy Commissioner of the FDA, took a stand last year by stating that the Administration, “supports ending the use of antibiotics for growth and feed efficiency” in food animals. However, instead of requiring industry take action, the FDA released a draft-guidance last June that essentially asks industry to voluntarily end the use of antibiotics as growth promoters in food animals and include veterinary oversight or consultation on all antibiotic use.

Lawmakers such as Congresswoman Louise Slaughter and Senator Barbara Boxer have been introducing versions of the Preservation of Antibiotics for Medical Treatment Act (PAMTA) for more than a decade that would mandate antibiotic use changes in food animals. Earlier this year it looked like the bill had a good chance of passing, but the bill failed to make it to the floor of the House or Senate. While not perfect, PAMTA would ban the use of medically important antibiotics as growth promoters. Passage of PAMTA would be an important step in saving the potency of antibiotics for human use. However, the current version of the bill could be stronger if it followed more closely the recommendations from the Pew Commission on Industrial Farm Animal Production final report, which calls for a ban on the non-therapeutic use of all antibiotics, not just those considered medically important, in food animals.

Now that we officially know that food animals use an overwhelming majority of our antibiotics, I hope it is more clear to everyone that legislation limiting the overuse and misuse of antibiotics in livestock and poultry must be passed. The next battle, which industry has already begun, is defining what non-therapeutic use will constitute. Producers are already claiming that the use of antibiotics for growth promotion has decreased, maintaining current low-dose usage is aimed at disease prevention. Regardless, all low-dose usage of antibiotics can lead to a significant increase in antibiotic resistance. As Dr. Alexander Fleming, the discoverer of penicillin warned, “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.”

Originally published on Center For A Livable Future

Knowing this, I continue to be frustrated with the fact that Agriculture Secretary Tom Vilsack does not publicly recognize that the industrial food animal production system is a leading contributor to the increase of antibiotic resistance in pathogens that infect people and animals. Earlier this month at a National Cattlemen’s Beef Association meeting, Vilsack responded to a question about the Preservation of Antibiotics for Medical Treatment Act (PAMTA) by saying the, “USDA’s public position is, and always has been, that antibiotics need to be used judiciously, and we believe they already are.”

That quote had me scratching my head when I read it in a New York Times Op-Ed a couple of weeks ago. The Times’ editors interpreted the statement as saying Vilsack believes there is no need to change antibiotic use policy among food animal producers. That contradicts the positions of both the FDA and CDC. The Times pointed out that while neither regulatory agency is doing enough to address the problem both, at least, recognize that current antibiotic use should change.

Congresswoman Louise Slaughter (D-NY) and Senator Dianne Feinstein (D-CA), the primary sponsors of PAMTA, which calls for limits on the non-therapeutic use of certain antibiotics in livestock production, were perplexed with Secretary Vilsack’s comment too.  They recently requested that Vilsack clarify his stance on the issue. In a letter, Slaughter and Feinstein wrote:

Media reports suggest that you may have mischaracterized our legislation and made statements that run contrary to previous positions taken by Department officials. We hope that you can provide us with reassurance that your off-the-cuff remarks were taken out of context, and that you remain committed to protecting human and animal health.

I called the Secretary’s office for a clarification myself. A USDA spokesperson sent me the following statement:

USDA believes that antibiotic use should be used judiciously to slow the development of resistance in animals. USDA believes livestock producers are good stewards, use antibiotics judiciously, but there are some bad actors, and continued use can develop resistance. USDA wants to be a partner with Congress, producers and other federal partners to address this important issue.

This statement does little to address the issue at hand. The problem does not lie with a few rogue producers. Rather, there is a currently FDA-approved industry standard of feeding livestock and poultry low concentrations of antibiotics and other antimicrobials–including arsenic-based treatments–in their feed to promote growth. Considering industry produces more than 10 billion food animals a year (the majority chicken and hogs) the amount of antibiotics used in food animals is astronomical. Case in point, researchers at Johns Hopkins Bloomberg School of Public Health estimate that the amount of antibiotics North Carolina hog producers use in their swine feed every year exceeds the total amount of antibiotics used to treat infections in people nationwide. It is estimated that as much as 70 percent of the antimicrobial drugs used in the US are administered to animals not to treat disease, but to purportedly promote growth or prevent the spread of pathogens among livestock and poultry living in intensive confinement.

All uses of antibiotics contribute to drug resistance.  While human medicine plays a large role in the antibiotic drug resistance problem, new research is clearly showing that resistant bugs from food animals are starting to show up in people more and more.  Johns Hopkins Bloomberg School of Public Health and Hershey Medical Center researchers recently published a study that confirms other research indicating that hospitals are no longer the main source of exposure for methicillin resistant Staphylococcus aureus or MRSA.  And researchers in Europe have published evidence that livestock production is increasingly becoming a major source for the Super Staph bug.

The reason why PAMTA is focusing on the non-therapeutic use of antibiotics in animals is that it is contrary to everything we have known for 70 years about preserving these drugs.  The amounts of antibiotics used in animal feeds are low and are not intended to kill bacteria.  That creates a problem first recognized by the inventor of penicillin, Alexander Fleming, who warned in 1945 that, “the greatest possibility of evil in self-medication is the use of too small doses so that instead of clearing up infection, the microbes are educated to resist penicillin.” Many infectious disease experts believe that we may very well be close to a post-antibiotic era, which could mean a return to a time when a simple bacterial infection could cause your child, your parents or you serious health problems or even death.

In their letter to Secretary Vilsack, Senator Feinstein and Congresswoman Slaughter tried to clear up what they call common misconceptions about their legislation:

The Preservation of Antibiotics for Medical Treatment Act does not ban the use of antibiotics. And in fact we share your belief banning all uses of antibiotics would be counterproductive. Instead, the Preservation of Antibiotics for Medical Treatment Act addresses usage of seven antibiotics that are critical in human medicine, phasing them out for non-therapeutic uses in livestock production.

While I support the proposed legislation to limit antibiotic use in food animals, I have continually made it clear that the current language in PAMTA should be stronger.  I believe the concession to only focus on the so-called “seven antibiotics that are critical in human medicine” weakens the bill. If we are going to be up front with the public, we must make it clear that bacteria don’t differentiate between types of antibiotics, whether they are approved for human medicine or not.

Dr. Ellen Silbergeld, professor of environmental health sciences at the Johns Hopkins Bloomberg School of Public Health, recently testified before Pennsylvania’s state legislature regarding its own proposed legislation to limit antibiotic use in food animals. She warned that, “bacteria respond to chemical structures, not brand names, and resistance to one member of a pharmaceutical class results in cross resistance to all other members of the same class.” For example, she noted that resistance in campylobacter (a nasty bug that the USDA says is the second most frequently reported cause for foodborne illness) to the antibiotic enrofloxicin (an antibiotic approved for pets and other domestic animals, commonly called Baytril) results in resistance to the very important human therapeutic antibiotic ciprofloxacin. Both antibiotics are two of more than 30 variations of the fluroquinolone class of antibiotics. As Silbergeld explains when bacteria develop resistance to one member of that class of antibiotics it can be resistant to all.

Authors made certain that language in PAMTA would ensure that any, “derivative of a drug that is used in humans or intended for use in humans to treat or prevent disease or infection caused by microorganisms,” would be banned from being used as a growth promoter in food animals. But–and this is a big “but”–the bill does not address the fact that the use of any antibiotic can lead to a pool of resistance that can affect every antibiotic class–important to both human and animal medicine.

Silbergeld has long warned that antibiotic resistant bacteria can share the genes (bits of DNA) that code for resistance with other bacteria in the environment and therefore readily transfer antibiotic resistance.  Sharing genes between bacteria is almost as easy for these organisms as forwarding an email to a friend; only bacteria are exchanging genetic code information. Resistance genes for multiple classes of antibiotics can be shared in the same “email,” or what scientists call plasmid “cassettes.”  For instance, some isolates of Salmonella and Campylobacter have been found to have taken up a “cassette” of resistance genes that protect them from as many as 17 different antibiotic drugs.

What this means is that not only can bacteria share resistance genes within the same class of antibiotics such as the fluoroquinolines class antibiotics containing enrofloxicin (restricted for veterinary use) and ciprofloxacin (critical to human medicine), but also bacteria have the capability of exchanging resistance genes between different classes of antibiotics like we’ve seen in Salmonella and Campylobacter. Allowing the non-therapeutic use of any antibiotic in food animals, regardless of whether it is defined as important to human medicine or not, could still lead to the development of bacteria that are resistant to an antibiotic that you and I may one day depend on.

The concept behind PAMTA is an important one. We must stop wasting one of medicine’s most important lifesaving discoveries simply as a way to increase the growth of food animals and subsequently profit for the food industry. If PAMTA is not passed this year I hope that the next version would follow more closely the recommendations from the Pew Commission on Industrial Farm Animal Production’s final report, which calls for “the phasing out and then banning the non-therapeutic use of [ALL] antimicrobials in food animal production.”

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.