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Not a Shining Month for the Food and Drug Administration

Apr 12, 2012

Nobody joins a government agency to boost their popularity. Some agencies take more lumps in the media and the public's eye than others, however, and it would be hard to find an agency less popular - at least this month - than the U.S. Food and Drug Administration (FDA). Two incidents involving public health are to blame: one involving antibiotics and the other a controversial chemical in many consumer plastics.

Last week, the FDA finally took a small measure of action, based on its own advice, 34 years late. The agency has issued an order prohibiting certain uses of the cephalosporin class of antibiotics in farm animals, including cattle, swine, chickens and turkeys. The new rules are in effect as of April 5, 2012, according to an announcement from the FDA.

Why? Because the meat industry has been abusing cephalosporins and other antibiotics for decades, using the drugs liberally and without good cause except to speed animal growth by killing internal bacteria, and the danger this presents to the public is great. In fact, about 80 percent of the antibiotics sold in the U.S. are used in animal feed simply to boost animal growth and profits.

If one was trying to breed antibiotic-resistant bacteria, there wouldn't be a better method than the one industrial farms have devised. By giving animals the drugs in low doses, they kill some - but not all - of the germs in animals' bodies, leaving a few alive. These bacterial left living then gain immunity against the antibiotics through mutation, breeding and then spreading throughout the farm. Some of these bacteria are capable of infecting humans, who are then unable to be treated with standard antibiotics.

Today, bacteria mutate so quickly to be resistant to current antibiotics that doctors who treat infectious disease are playing whack-a-mole: trying to treat patients in that tiny window of time after a drug is developed but before the microbes have had a chance to mutate to be resistant to the new drugs. Misuse of antibiotics for animal husbandry speeds the closure of this window.

The criticism of the FDA over this practice comes in, in part, because the agency was acting on its own advice -- issued in 1977. In that year, the FDA ruled that using penicillins, tetracyclines and other antibiotics in farm animals to induce them to grow faster - a practice that began on farms shortly after antibiotics were introduced in the 1930s and that dubious use was approved by the FDA in 1951 - was unsafe. Agency-commissioned research had drawn a definitive link between needless use of antibiotics and the creation of antibiotic-resistant bugs. As is policy, the agency then began to take steps to withdraw its approval for the use of antibiotics in animal feed simply to stimulate growth. It did so by initiating a comments periods during which it offered "notices of opportunity for a hearing." Following the initiation of this comments periods, it would have been beholden upon the companies that manufacture the antibiotics to prove that they are safe for use on farms for anything other than treating sick animals.

The agency's "comments" period lasted from 1977 until 2012. During this 34-year-period, the FDA was under pressure from Congress - bolstered by campaign money from pharmaceutical and agricultural interests - to take no action.

It wasn't until a federal judge ruled against the FDA in March of this year that the agency picked up where it has left off in 1977 to enforce a ban on certain agricultural uses of popular antibiotics. Despite a preponderance of evidence from studies conducted over the last three decades - some of it commissioned by the FDA itself - linking the misuse of antibiotics in farm animals to the rise of antibiotic-resistant microbes in the (human) public health arena, the FDA for years tried to push "voluntary reform." This involved the agency making polite requests to drug companies and farmers to forgo the drugs. Just as politely, the drug industry and farmers ignored the agency. In forcing the FDA to follow its own ruling of three-and-a-half decades before, the judge rebuked the agency for its passive approach that has caused considerable harm to human health.

Cephalosporins, the class of antibiotics that have finally been prohibited for "extra-label" uses in farm animals, are widely used in humans for the treatment of pneumonia, skin and soft tissue infections, pelvic inflammatory disease, foot infections in diabetics, and urinary tract infections. If cephalosporins fail to knock out these infections, doctors must move on to other classes of antibiotics, many of which are less effective and have more unpleasant side effects.

Under the new rules finally put in place by the FDA, pharmaceutical companies may no longer sell, and farmers may no longer administer, cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration. It's also prohibited to use cephalosporins drugs in cattle, swine, chickens or turkeys that are not approved for use in that particular animal (farms using drugs intended for dogs and cats in cows, for example). Finally, cephalosporin may be used only for disease treatment, not for disease prevention.

Researchers say the agency's long-delayed action on cephalosporin is a good first step. But a first step is all it is.

"The ban of cephalosporin is probably a good start in my opinion, but it's not nearly as far as we need to go," Murray Borrello, director of the environmental studies program at Alma College in Michigan, told the Great Lakes Echo.

Borrello has been studying the prevalence of antibiotic-resistant bacteria on large industrial farms in Michigan. What he found was that these farms today are breeding grounds for bacteria resistant to the antibiotic tetracycline: that they literally float in the air around these farms. The new FDA ruling, of course, doesn't cover tetracycline, which is far more widely used in animal feed than cephalosporin. As a result, Borrello says, the FDA's action is likely to make only the tiniest of dents in farms breeding antibiotic-resistant bacteria.

Let's hope it doesn't take the FDA another 34 years to address the overuse of tetracycline.

The next FDA blunder comes courtesy of Bisphenol-A, also called BPA, an organic compound and widely used industrial chemical, particularly as an additive to plastics. It hardens clear plastic, rendering it less prone to breakage, which is why it was considered ideal for use in baby bottles and children's sippy cups. It's also widely used in food packaging, including in the lining of cans destined to hold soup, beverages, canned vegetables and fruits and other foods.

BPA is also what's commonly known as an "endocrine disruptor," because it mimics the effects of hormones, particularly estrogen, in the human body. The effects of the compound are well known in animal studies, and there is some emerging research in humans linking BPA exposure and altered behavior in toddlers, increased risk of miscarriage, diabetes, cardiovascular disease and erectile dysfunction.

But according to the FDA, it's just fine to stay in the food chain for now, despite considerable evidence to the contrary.

In early April, the FDA denied a petition from the environmental group the Natural Resources Defense Council (NRDC), which asked the agency to ban BPA from food and food packaging. The agency said that studies of BPA are not yet complete and that petitioners did not present compelling enough scientific evidence to justify a ban. Though BPA has been shown to be harmful in animal studies, there is no irrefutable evidence yet, the FDA said, that it causes harm to humans. The agency added that it thought the studies indicating harm to humans presented by the NRDC were too small to be thoroughly conclusive.

"While evidence from some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans," said the agency said in its response to the NRDC petition. The agency did promise, however, that federal scientists would "continue to study the issue."

In other words, it might be harmful to humans, particularly children, but until we know exactly how harmful it is, the plastics and packaging materials industry can keep using it.

Just getting to this point - the FDA rejection of the requested ban - required a push from a federal judge, as with the action against agricultural use of cephalosporin. The NRDC first filed its petition asking the FDA to ban BPA in 2008. When the FDA failed to respond within the required time frame to the NRDC petition - not to mention a number of other legal actions filed by different parties - the NRDC sued the agency. In December, a federal judge ruled that the FDA had until the end of March to respond.

The agency's ruling is particularly troubling considering that it revised its own opinion on BPA in 2010, officially noting that there is "some concern" about the chemical's impact on the brain and reproductive system of infants and young children. While adults and older kids flush the chemical out their kidneys in relatively short order, babies and toddlers can retain it - a fact proven by testing that has found BPA in the bodies of most American children. As an endocrine disruptor that mimics the effects of estrogen, the chemical can then interfere with the growth of young children. Despite this acknowledgment of possible negative health consequences to kids, the agency still took no steps to stop the use of BPA in children's products.

Opponents and activists fighting for the elimination of BPA from food packaging products don't deny that research is still emerging on the substance's precise effects on humans. But the view is that while harm is suspected - even if not conclusively proven - it's the FDA's responsibility to err on the side of caution and force the manufacturers of BPA and the companies who use it to prove that it's safe, rather than taking decades and millions of taxpayer dollars to try and prove that it's not safe.

Beyond baby bottles, BPA is widely used in the linings of food and beverage cans. In many cases, particularly where the can's contents are acidic or corrosive, as with tomato sauce or soda, researchers have found that the BPA leaches out of the can lining and into the food...and into the bodies of people who consume the products. In fact, BPA can be found in the bodies of some 90 percent of Americans. A 2010 study by the Environmental Working Group found that cash register receipts are chock-full of the stuff, and the group raised questions about health problems in individuals who handle receipts regularly, such as supermarket checkout workers.

So why the foot-dragging by the agency and the companies that manufacture BPA or use it in their products? It's big, big business.

Bloomberg News has reported that the global BPA market is worth about $8 billion. About a quarter of the BPA manufactured goes into can linings, and the rest finds its way into polycarbonate plastics, primarily food containers and beverage bottles. Also according to Bloomberg, the three biggest suppliers of BPA to the U.S. marketplace are German chemical giant Bayer, the U.S.'s Dow Chemical and Saudi Basic Industries Corporation, a company that is 70 percent owned by the government of Saudi Arabia.

With entities like that come lots of money, lots of lobbying power and lots of Washington favors, which may go a long way toward explaining the challenges of getting BPA out of the food supply (something other nations, including Canada, have already managed to do).

Consumer pressure - the only kind that seems to get any action lately - has forced several canned food companies to go on the defensive. Thanks to rather loud customer and environmental group demand, the Campbell's Soup company, the largest canned soup maker in the world, recently vowed to phase out BPA from its cans by finding alternatives. Though the company maintains that it thinks BPA is safe, it recognizes a losing PR fight when it sees one. ("Retaining customer trust" was the way the company phrased its announcement.)

Other companies are folding to pressure from consumers, as well, and removing BPA from their products. At the end of 2009, the six biggest makers of baby bottles in the U.S. all vowed to remove BPA from their products, and Heinz, which makes baby formula in addition to its other products, switched to a BPA-free coating for its formula cans. The companies had been under intense pressure from consumers and parents' groups. In 2008, both Wal-Mart Stores and Toys "R" Us began phasing out bottles, sippy cups and other children's items containing BPA, due to customer demand. Food giants ConAgra and General Mills have also switched to BPA-free alternatives as sealants for some of their canned tomatoes.

In the meantime, the FDA will keep "examining the issue." Americans can feel safer already.