“Although few Americans outside of the livestock industry have ever heard of ractopamine, the drug is controversial,” Bottemiller writes. “Fed to an estimated 60 to 80 percent of pigs in the United States, it has sickened or killed more of them than any other livestock drug on the market, Food and Drug Administration records show. Cattle and turkeys have also suffered high numbers of illnesses from the drug.”

According to the story, USDA meat inspectors have reported an increase in “downer pigs”–livestock that is unable to walk–who have been fed ractopamine. On Monday, the Supreme Court unanimously voted down a California ban on “downer” livestock being used in the food supply, on the basis of a federal preemption.

Bottemiller explains that ractopomine acts like a stress hormone, increasing heart rate and relaxing blood vessels. Its use in livestock agriculture produces up to 10 percent more meat, raising profits $2 per head. Though the drug has not been considered for human use, it is administered up until slaughter, and minute traces have been found in meat.

While these amounts have not exceeded the threshold the FDA has deemed safe, there is no allowance for the drug in the E.U. and China, where 70 percent of the world’s pork is consumed, and where the drug is currently banned. Acceptance of meat from animals raised on ractopamine in world markets has become a focus for U.S. trade officials. Bottemiller writes: “Resolving the impasse is now a top agricultural trade priority for the Obama administration, which is trying to boost exports and help revive the economy.”

At the heart of the trade dispute lies questions about the safety of the drug. Elanco, the maker of ractopamine, sold under the name Paylean, conducted the studies considered before approval of the drug in 2000, and has reported “no averse effects were observed for any treatments.” However, within a few years of the drug’s approval, the FDA received hundreds of reports from farmers, veterinarians, and USDA inspectors of sickened pigs.

Now the issue remains at an impasse at the U.N.’s Codex Alimentarius Commission, which sets global food-safety guidelines. The commission has sought to set a standard for residue levels of ractopamine in meat. With such standards in place, Washington would be in a position to challenge countries with bans on ractopamine at the World Trade Organization. China and the E.U. are the main countries blocking the residue limit at Codex. In China, organ meats, which contain the highest traces of the drug, are popular fare, and in the E.U. officials do not want to risk public outcry by importing meat raised with growth-promoting drugs, which are illegal there.

Bottemiller reported this story in conjunction with the Food & Environment Reporting Network, the first and only independent, non-profit news organization that produces investigative journalism in the critically underreported areas of food, agriculture, and environmental health. This is the second story of the Food & Environment Reporting Network, previous stories can be found here. [Full disclosure: I am the Managing Editor of that venture.]

You can read the full report here at MSNBC.com. You can also find additional reporting here on testing of ractopamine as well as more details about the process underway at Codex here on the Food & Environment Reporting Network’s Web site.

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

On Monday afternoon a coalition of 11 food safety, environmental, consumer and fisheries organizations sent a letter to the U.S. Food & Drug Administration (FDA) calling for a halt to its approval of a genetically engineered (GE) salmon after learning that the company’s–AquaBounty Technologies, Inc.–research site was contaminated with a new strain of Infectious Salmon Anaemia (ISA), the deadly fish flu that is devastating fish stocks around the world.

“This new information calls into question the reliability of AquaBounty’s data and the validity of its claims that their fish are safe for the environment” said Andrew Kimbrell, Executive Director of the Center for Food Safety. “The FDA must respond appropriately and conduct their own environmental impact statement that looks at a broad range of environmental risks from these genetically engineered salmon, including the risk of spreading diseases such as ISA and antibiotic use for other diseases.”

AquaBounty has claimed that the company’s process for raising GE fish is safer than traditional aquaculture.  However, documents that were revealed last week indicate that their production site was found by Canadian Authorities to have been contaminated in Nov. 2009.  This information was hidden from the public and potentially FDA and other Federal agencies consulting on the GE salmon application. ISA is a deadly disease and is classified as a ‘Listed’ disease by the World Organization for Animal Health (OIE)–alongside diseases such as Anthrax, Bovine spongiform encephalopathy (BSE), Foot and mouth disease, rabies, sheep pox, swine fever, avian influenza, West Nile fever, scrapie, fowl cholera, bovine tuberculosis and myxomatosis.

“Infectious Salmon Anaemia threatens wild fisheries around the world and the communities whose livelihood depend on those fish” said Erich Pica, President of Friends of the Earth US. “ISA infections in Chile cost the industry around two billion dollars. A similar infection in Canada and the U.S. could be the last blow to wild Atlantic salmon populations and bring a collapse in wild salmon fisheries.”

The December 19 letter urged FDA Commissioner Margaret Hamburg to release all health data on AquaBounty’s GE salmon and to suspend any approval actions until all the data is disclosed and the public has an opportunity to review the data. Additionally, the coalition asked the FDA to conduct a full environmental impact statement that includes review of the effect of fish diseases, like ISA, on wild fish populations that might come into contact with the AquaBounty fish. Currently, the FDA has only performed a less comprehensive environmental risk assessment.

This news comes on the heels of a Senate subcommittee hearing held last Thursday on the environmental risks of GE fish, the first hearing of its kind in Congress.

Originally published on the Center for Food Safety’s blog

Today, a broadbased coalition of nearly 400 businesses and organizations dedicated to food safety and consumer rights called on the U.S. Food and Drug Administration (FDA) to require labeling of genetically engineered (GE) foods, to give consumers the right to know what is in our food. The Just Label It – We Have a Right to Know campaign submitted a petition on behalf of millions of consumers to the FDA calling for the mandatory labeling of GE foods, also referred to as genetically modified organisms, or GMOs. These are foods that are altered at the molecular level in ways that could not happen naturally.

The Federal Food, Drug, and Cosmetic Act requires the FDA to prevent consumer deception by clarifying that a food label is misleading if it omits significant, “material” information.  In 1992 however, the FDA issued a policy statement that defined “material” by the ability to be sensed by taste, smell, or other senses.  The FDA determined that GE Foods were “substantially equivalent” to conventionally produced foods, so there was no material difference and no labeling was required.  After almost 20 years, this policy is still in effect today.

For example, the FDA is currently deciding whether to deregulate GE salmon and make it commercially available. According to FDA, a salmon that is genetically engineered is not materially different from a non-GE salmon because it does not taste, smell or feel different. Without a label to tell us differently, when eating GE salmon, the public will not know if what they are consuming has been genetically altered.

“We are asking the FDA to change a decade’s old and out of touch policy,” said Andrew Kimbrell, Executive Director of the Center for Food Safety and lead author of the petition. “Today’s consumers are more informed than ever, and they have a right to know about the foods they are purchasing and consuming. We want the FDA to require labeling on foods intentionally produced using genetic engineering.”

“Polls show that consumers demand transparency in the foods they buy and overwhelmingly support labeling of GE food,” said Dr. Michael Hansen, senior scientist at Consumers Union, the public policy division of Consumer Reports. “In order to make informed decisions, the public deserves a truthful marketplace.”

Ninety-five percent of consumers believe GE foods should be labeled according to a poll [PDF] conducted by Consumers Union and 93 percent of the American public want the federal government to require mandatory labeling of GE foods. Labeling is required in other countries, including the European Union, Australia, New Zealand, Japan, Korea, Brazil, and China.

While nearly 90 percent of corn; 94 percent of soy; and 90 percent of cottonseed grown in the US are from GE seeds, the safety of GE crops for human consumption has not been adequately assured [PDF]. Several National Academy of Sciences studies have affirmed that GE crops have the potential to introduce new toxins or allergens into our food and environment.

Yet, unlike the strict safety evaluations for approval of new drugs, there are no mandatory human clinical trials of GE crops, no tests for carcinogenicity or harm to fetuses, no long term testing for human health risks, no requirement for long-term testing on animals, and limited testing for allergenicity, with some studies raising concerns that GE foods may pose an allergen risk.

“Scientists and consumers alike have many reasons for being concerned about the long-term health and environmental consequences of genetically engineered foods,” said Gary Hirshberg, CEO of Stonyfield Farm, a member of the coalition. “And the scientific debate about the benefits and risks of these crops will continue for a long time. Meanwhile an entire generation will have grown up consuming them.”

The best option to avoid GE foods is to buy USDA certified organic as the organic standards prohibit the use of GE ingredients; to look for Non-GMO Project Verified Non-GMO products; and to buy unprocessed foods such as fruits, vegetables, and avoid packaged food, much of which contains GE ingredients.

The campaign Web site, www.justlabelit.org, allows consumers an easy, one-click method to notify the FDA of their support for the petition and stay up to date on the initiative. It also offers education tools to get informed about GE foods, the benefits of labeling foods and ways to stay engaged through blogs, and social media. The campaign also launched a video that conveys the point of the initiative: Without labeling, families are being kept in the dark.

The idea is that it makes them grow faster — fast growth being the supreme goal of factory animal farming — and helps control a common intestinal disease called coccidiosis.The industry emphasizes that the arsenic is applied in organic form, which isn’t immediately toxic. “Organic” in the chemistry sense, that is, not the agricultural sense — i.e., molecules containing carbon atoms as well as arsenic. Trouble is, arsenic shifts from organic to inorganic rather easily. Indeed, “arsenic in poultry manure is rapidly converted into an inorganic form that is highly water soluble and capable of moving into surface and ground water,” write Keeve E. Nachman and Robert S. Lawrence of the Johns Hopkins Center for a Livable Future.

Inorganic arsenic is the highly poisonous stuff — see the absurd and wonderful Cary Grant classic Arsenic and Old Lace, or the EPA’s less whimsical take here and here [PDF]. The fact that the organic arsenic added to feed turns inorganic when it makes its way into manure is chilling, given the mountains of concentrated waste generated by factory poultry farms.

One way farmers add arsenic to chicken feed is through drugs such as Pfizer’s Roxarsone. And the industry has (as with most of its worst practices) strenuously defended the use of such additives. While the USDA has by and large ignored the risks (mostly in the form of an unwillingness to look for arsenic in chicken), finally–astonishingly–the Food and Drug Administration (FDA) has acted.

According to the Associated Press, the FDA has confirmed that chickens given the drug (frequently those destined for the low-cost supermarket shelf) do indeed test positive for inorganic arsenic–just as the Institute for Agriculture and Trade Policy found [PDF] back in 2006. Despite this earlier evidence, the industry had continued to steadfastly maintain that the arsenic could not and did not make it into the meat.

As part of its announcement, the FDA said the arsenic levels are low and represent no meaningful risk to those eating Roxarsone-treated chicken–a point predictably emphasized by the National Chicken Council.

Tellingly, Pfizer announced that it would withdraw Roxarsone from the market starting next month. The FDA didn’t order Pfizer to withdraw the drug–the company did so voluntarily.

Of course, this does not solve the problem of arsenic in chicken. As Michael Hansen of Consumers Union observed in a press release, “There are several other arsenic-containing drugs for animals that are on the market, and those should also be withdrawn or banned, as they have been in the European Union.”

As Food & Water Watch reported in March, “between 2000 and 2008, the USDA tested only one out of every 12 million domestically produced chickens.” So it’s not as if the government is tracking this problem in any systematic way.

It boggles my mind that the industry is so willing to risk consumer panic over this issue and wait for the media or government officials to force its hand. Instead of making smart business decisions and ending dangerous practices that might give consumers cause to avoid their product, they instead try to hold back the tide. One drug gets withdrawn while others remain. The FDA tests 100 chickens (as they did in this latest test), while millions are produced and sold every year.

It’s no wonder that the so-called “ag-gag” bills remain popular among industrial farmers and their political lackeys. They can’t seem to let go of consumer ignorance as a key business strategy. With arsenic in chicken, the FDA, the USDA, and the chicken industry seem to care far more about the perception of having acted rather than the reality of ensuring all chicken sold in the U.S. is free from this toxic substance.

Originally published on Grist

Many Americans, including a high number living in low-income communities, have come to rely on canned tomato sauces, soups, and vegetables to expedite their meal preparations. Yet a new study from the U.S. Food and Drug Administration (FDA) reveals that the canned food items on your dinner plate are over 90 percent likely to be tainted with Bisphenol-A (BPA), a primary chemical used in the lining of cans. (For more information on BPA, check out Civil Eats’ previous reporting here, here, here, and here.)

These findings are notable because they underline the fact that BPA levels in cans are variable depending on the type of food, or even within batches of the same food item. This is the FDA’s largest study to date across a wide spectrum of commonly consumed canned food items, including soups, chilis, pasta and pork and beans–foods often consumed by children, who have a heightened risk of exposure due to their body size.

This is not the first time such findings have been made public. Consumers Union, the nonprofit publisher of Consumer Reports, found similar results (though at three times lower levels than the FDA findings) in a 2009 study, noting that the daily safety threshold set by the FDA of 50 micrograms per kilogram of body weight was based on outdated studies often funded by the American Plastics Council, an industry group.

Consumers Union went on to suggest limiting daily exposure to one-thousandth of that level. “Consumers have no idea how much BPA they may be exposed to from any given can,” said Dr. Urvashi Rangan, Director of Technical Policy at Consumers Union. “As we previously reported, just a few servings of some of these foods can expose consumers to levels of BPA that have caused harm in animal studies. We believe this is an unacceptable margin of safety and that consumers should not have to ingest BPA.”

The scientists from the FDA did not go on to interpret the data in this new study or make any new recommendations about the agency’s safety threshold for the chemical.

Our chemical body burden

The Centers for Disease Control has demonstrated that 93 percent of Americans have detectable levels of BPA in their urine. Other studies have concluded that BPA is a “gender-bending” chemical that messes with our hormones, as well as increases the risk of cancer, diabetes, heart disease, and hyperactivity in children. In addition, studies have found that it lowers sperm count in workers at the facilities where BPA is in use.

Chemicals enter our food system in many ways, including being used as additives in our food to change its flavor or color, moving into the food from its packaging, and through the use of pesticides on farm fields. In fact there are 80,000 different types of chemicals in use today, seven percent of which have been tested for safety by our government.

BPA is one of the more ubiquitous chemicals, found on cash register receipts, in dental fillings, and in certain types of plastics, in addition to aluminum cans. Given its ability to migrate, each of us is being exposed by various sources on a daily basis, and how this kind of multiple-point exposure adds up has yet to be studied.

Getting it out of our system

Eating a diet of whole foods is one of the best ways to clear BPA and other chemicals out of our system. But not everyone has access to these foods, and just handling the receipt on your next shopping trip can expose you (and not to mention the cashier).

In the U.S., chemicals must be proven to cause harm before they are removed from the market. Yet often exposure adds up over time, which could be resulting in chronic conditions that are difficult to quantify, making it particularly hard to ban a chemical. Advocates believe that stronger public policy is necessary to lower the risk and eliminate unwanted exposure to the chemical.

While Dianne Feinstein (D-CA) championed legislation to ban BPA altogether in the Senate last year, there has yet to be a bill that passes either the House or Senate on this issue. Meanwhile, BPA in children’s products has been banned in nine states, including Maine, Minnesota and Connecticut, as well as in the European Union, Canada and most recently, China is moving to ban the chemical. Similar BPA-ban legislation is pending in 12 other states, including California, which passed legislation in the State Senate on Monday.

Some companies are responding to the public’s concern over BPA by preemptively removing it from their baby bottles and other products. The grocery chain Kroger recently announced it would be removing BPA from the store’s brand of canned food items as well as cash register receipts. But as a recent Op-Ed in the New York Times reminded us, as companies react to public outcry by changing their formulas, they might be replacing it with similarly harmful chemicals without as much name recognition.

The fact that such a study was conducted by the FDA serves as part of a shifting strategy for the agency on BPA. As the Milwaukee Journal Sentinel reported in 2009, lobbyists for the chemical industry have historically played an active role in FDA policy making and managing public opinion of the chemical. Yet last year, the agency admitted that the chemical was not entirely safe in food contact applications, and that it supports stronger regulations and oversight.

In 2008, the agency drafted an updated assessment of the chemical which included some concern over its safety. A subcommittee reviewed the draft and refuted these findings. Two and a half years later, this internal disagreement has left a finalized assessment to gather dust on a desk somewhere at the FDA. Meanwhile, the general public continues to be exposed to a soup of chemicals, including BPA, in variable and uncontrolled doses.

As with genetically modified foods and now, antibiotics, perhaps there will soon be a lawsuit filed against the FDA to force it to better regulate BPA and the chemicals in line to replace it.

Photo: stevendepolo via Flickr

Chemicals and additives found in the food supply and other consumer products are making headlines regularly as more and more groups  raise concern over the safety of these substances. In a statement released yesterday, the American Academy of Pediatrics (AAP) asked for reform to the Toxic Substances Control Act of 1976. The group is particularly concerned about the effects these substances have on children and babies.

Last month, the U.S. Food & Drug Administration (FDA) held hearings on the safety of food dyes but failed to make a definitive ruling—the most recent study on Bisphenol-A (BPA) added to growing doubts about its safety but the FDA’s stance remains ambiguous. Meanwhile, in 2010, the Government Accountability Office (GAO) reported that the FDA is not ensuring the safety of many chemicals.

Yet while the FDA drags its heels and hedges on the safety of these substances, Americans are exposed to untested combinations of food additives, dyes, preservatives, and chemicals on a daily basis. Indeed, for the vast majority of Americans consuming industrial foods, a veritable chemical cocktail enters their bodies every day and according to the GAO report, “FDA is not systematically ensuring the continued safety of current GRAS substances.”

The term GRAS refers to “generally regarded as safe,” the moniker the FDA uses to regulate food additives, dyes, and preservatives. The trouble is this system is not effective. Dr. Michael Hansen, a senior scientist at Consumers Union, said in an interview that many additives in our food supply are never even tested. That’s because the GRAS designation is a voluntary process—instead of being required to register food additives, companies can notify the FDA about their product, but only if they so choose. Hansen added that even for those additives considered GRAS, he didn’t have much faith in the designation.

So just how many of these largely untested and unregulated chemicals is the average American consuming every day? As of yet, no study has determined this number nor has looked at what the effects of the various combinations might be. But according to the Body Burden Web site, there are 80,000 chemicals in commerce and the site says that, “No one is ever exposed to a single chemical, but to a chemical soup, the ingredients of which may interact to cause unpredictable health effects.”

There are only a few studies that evaluate the combined effects of food additives. One 2006 study published in Toxicology Science concludes that the combination of several common additives appears to have a neurotoxic effect: “Although the use of single food additives at their regulated concentrations is believed to be relatively safe in terms of neuronal development, their combined effects remain unclear.” Of the four additives looked at, only one is now banned in the U.S., while the rest remain in the foods on our grocery store shelves. In a 2000 study, researchers looked at the combination of four major food additives or a mixture of six typical artificial food colors and found indications of toxicity in both.

And perhaps the most alarming study dates back to 1976 from the Journal of Food Science. In this study, young rats were fed a low-fiber diet along with sodium cyclamate, FD&C Red No. 2 and polyoxyethylene (20) sorbitan monostearate individually and in combination. While the study found that any one of the three food additives given individually had little negative effect, the combination of all three additives resulted in weight loss and the death of all test animals within fourteen days. Sodium cyclamate is an artificial sweetener now banned in the U.S., but FD&C Red No. 2, a food dye, and polyoxyethylene (20) sorbitan monostearate, an emulsifier, are still in regular use in the food supply, according to the FDA’s Web site.

BPA, another regularly used chemical, has raised a number of concerns. The most recent study found that when participants switched to a diet with minimal amounts of canned foods or plastic food packaging, urinary levels of BPA decreased by more than 60 percent after just three days. According to the Centers for Disease Control (CDC), nearly all Americans have detectable levels of BPA in their bodies, which has been linked to breast and prostrate cancer, infertility, early puberty in girls, obesity, and ADHD. This study indicates how quickly the body will excrete BPA if given the opportunity, but here’s the key: The body must be given the opportunity to do so. Many Americans don’t take three-day fresh food breaks from a diet based largely on packaged and processed foods. What’s more, BPA is just one of the chemical compounds with potentially harmful effects entering into our systems.

Based on the anecdotal information I see in my client’s food journals, people eating processed and packaged foods are taking in exorbitant amounts of artificial ingredients and additives. Typically, a client will say something like, “I eat a bowl of cereal with low-fat milk, have yogurt for a snack, and a Subway sandwich for lunch.” While this sounds relatively harmless, here’s what it might actually look like based on some popular “health food” items:

• One serving of Kellogg’s Fiber Plus Antioxidants Berry Yogurt Crunch contains more than 13 different additives, preservatives, and food dyes, including Red 40 and Blue 1, which are known to cause allergic reactions in some people and mutations leading to cancer in lab animals. It also contains BHT, monoglycerides, and cellulose gum. In addition, conventional milk often contains residues of artificial bovine growth hormones, known endocrine disruptors as well as antibiotics used in industrial milk production.

• Dannon Light & Fit Peach yogurt contains more than 11 different additives including Red 40, aspartame, potassium sorbate, sucralose, and acesulfame potassium.

• A Subway sandwich of turkey and cheese on nine-grain bread with fat-free honey mustard, peppers, and pickles contains more than 40 different additives, preservatives, and dyes. The pickles and peppers have yellow 5 and polysorbate 80, the bread has ten different additives including dough conditioners, DATEM, and sodium stearoyl lactylate, and the turkey contains ten additives as well.

The person in this example has consumed more 60 food additives eating breakfast, a small snack, and lunch alone, to say nothing of dinner, dessert, further snacking and drinks. Consumers Union’s Dr. Hansen told me, “I wouldn’t be surprised if it were up to 100 additives or more that people are taking in on a daily basis.”

And it’s not just food. A number of additional toxins also enter our systems from other industrial sources and often come in the form of phthalate plasticizers and parabens—both of which are used in personal care products, some medications, and even foods and food preservation. Most Americans use some form of shampoo, soap, lotion, and antiperspirant every day, and these toxins, applied to the skin, are absorbed dermally.

According to a 2010 study, like BPA, parabens and phthalates can clear our bodies relatively quickly but only if we aren’t exposed to them on a regular basis. The study states, “For serious health problems to arise, exposure to these rapidly-clearing compounds must occur on a daily basis.” Phthalates are associated with infertility, obesity, asthma, and allergies, as well as breast cancer; parabens are a cause for concern regarding breast cancer.

So what if it’s not the dyes alone, the preservatives alone, or the BPA alone, but some haphazard combination thereof that has yet to be studied or evaluated properly? Jason August, with the FDA’s Office of Food Additive Safety, admitted as much in his defense of food dyes in relation to ADHD recently when he said, “There were other factors in most of these studies that could have been the reason or could have gone hand in hand with the dyes to create these problems in these particular children, including preservatives.”

This is precisely why the FDA needs to be more rigorous with its testing of individual additives and start evaluating the combined effects or “other factors” that August so blithely refers to here.

Chemicals used in all of these industrial products are big business—food corporations own some of the largest personal care companies and they’re profiting on multiple fronts with cheap, industrial ingredients. For example, Nestlé owns 30 percent of the world’s largest cosmetic and beauty company L’Oreal—tightly regulating these substances and evaluating potential harm would be a financial hardship for these corporations.

But the real hardship is placed on the American people who trust that the foods they eat are properly regulated by the government and safe for themselves and their families. How long will the FDA continue to put the health of the American people at risk with its antiquated policy? Let’s hope with pressure from groups like the AAP, changing consumer demand, and continued headlines, the FDA will finally do its job.

Photo: 1970s Monsanto advertisement, via Christian Montone on Flickr

Consumer Reports’ latest tests of 42 samples from cans and pouches of tuna bought primarily in the New York metropolitan area and online confirm that white (albacore) tuna usually contains far more mercury than light tuna. According to Consumers Union, pregnant women should avoid tuna and younger women and kids should limit their consumption.

“Canned tuna, especially white, tends to be high in mercury, and younger women and children should limit how much they eat. As a precaution, pregnant women should avoid tuna entirely,” said Dr. Urvashi Rangan, Director of Technical Policy, at Consumers Union, nonprofit publisher of Consumer Reports.

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) advise that women of childbearing age and young children may eat up to 12 ounces a week of light tuna or other “low in mercury” seafood, including, within that limit, up to 6 ounces per week of white tuna.

Consumers Union’s fish-safety experts continue to suggest a more cautious approach, advising pregnant women, as a precaution, to avoid eating tuna because of its potential effects on fetal development. Consumers Union further advises that children who weigh more than 45 pounds limit their weekly intake from 4 to 12.5 ounces of light tuna or from 1.5 to 4 ounces of white tuna, depending on their weight; and children who weigh less than 45 pounds limit their weekly intake from 0 to 4 ounces of light tuna or from 0 to 1.5 ounces of white tuna, depending on their weight.

Consumer Reports’ tests, conducted at an outside lab, found:

• Every sample contained measurable levels of mercury, ranging from 0.018 to 0.774 parts per million (ppm). The FDA can take legal action to pull products containing 1 ppm or more from the market. (It never has, according to an FDA spokesman.)
• Samples of white tuna had 0.217 to 0.774 ppm of mercury and averaged 0.427 ppm. By eating 2.5 ounces (about half a can) of any of the tested samples, a woman of childbearing age would exceed the daily mercury intake that EPA considers safe.
• Samples of light tuna had 0.018 to 0.176 ppm and averaged 0.071 ppm. At that average, a woman of childbearing age eating 2.5 ounces would get less than the EPA’s limit, but for about half the tested samples, eating 5 ounces (about one can) would exceed the limit.

In 2006, Consumer Reports scrutinized [PDF] the results of the FDA’s tests in 2002 to 2004 of mercury levels in hundreds of samples of canned tuna. The agency’s white-tuna samples averaged 0.353 ppm; light tuna, 0.118 ppm. But Consumer Reports found that as much as six percent of the FDA’s light-tuna samples had at least as much mercury as the average in white tuna—in some cases more than twice as much.

Given the uncertainties about the impact of occasional fetal exposure to such high levels, Consumer Reports urged the FDA to warn consumers about occasional spikes in mercury levels in canned light tuna. More than four years later, the FDA still hasn’t issued such a warning. When asked why by Consumers Union, an FDA spokesman indicated to the group that the agency had already taken the spikes into account when formulating its mercury advice.

“The FDA should strengthen its current guidance and advise pregnant women to avoid tuna altogether, especially given the uncertainties about the impact of occasional fetal exposure to high mercury levels,” said Jean Halloran, Director of Food Policy Initiatives at Consumers Union. “The FDA should also continue to test for mercury across the spectrum of fish and seafood in the marketplace in order to provide consumers with adequate information on the mercury levels of all fish.”

Halloran noted that there may well be other species that vulnerable groups like pregnant women should avoid, but the FDA needs to conduct more testing to draw conclusions. “The last set of FDA data gathered from 2002-2004 and published in 2006 needs to be updated and the sample size of many species should be increased,” she said.

Heavy metal accumulates in tuna and other fish in an especially toxic form, methylmercury, which comes from mercury released by coal-fired power plants and other industrial or natural sources. According to Consumers Union, some studies have linked even low-level mercury exposure in pregnant women and young children to subtle impairments in hearing, hand-eye coordination, and learning ability. Other evidence [PDF] suggests that frequent consumption of high-mercury fish might affect adults’ neurologic, cardiovascular, and immune systems. The body is slow to eliminate mercury so it can accumulate in people over time.

Fish are rich in protein, vitamin D, and omega-3 fatty acids. Studies have shown that omega-3s reduce the risk of heart attack and stroke and might also elevate mood and help prevent certain cancers, cognitive decline, and certain eye diseases. During pregnancy, omega-3s might help in developing the fetus’s brain and visual system.

“Fortunately, it’s easy to choose lower-mercury fish that are also rich in healthful omega-3 fatty acids,” Dr. Rangan said. “That’s especially important for women who are pregnant or might become pregnant, nursing mothers, and young children, because fetuses and youngsters are still developing their nervous systems and are therefore at particular risk from methylmercury’s neurotoxic effects.”

Federal agencies advise children and women of childbearing age to avoid four high-mercury fish: king mackerel, shark, swordfish, and tilefish.

So what kind of seafood is safe to eat? According to Rangan, popular seafood, including clams, Alaskan salmon, shrimp, and tilapia, contain relatively little mercury and are better choices. Other lower-mercury choices include: oysters, pollock, sardines, Pacific flounder and sole, herring, mullet, and scallops (with some limitations for women of child-bearing age and children).

The story appears in the January 2011 issue of Consumer Reports and is also available free online.

Photo: Kiruh via Flickr

The genetically modified salmon called AquAdvantage was discussed on Monday in front of the Veterinary Medicine Advisory Committee, which will help the Food and Drug Administration (FDA) decide whether or not to approve the fish for commercial production. The meeting comes after an unusually short 14-day period of public comment on the “new animal drug.”

That’s right: the first potentially approved genetically engineered animal is being considered just like a pharmaceutical, instead of as a precedent with significant implications for the environment, other species, and human health, which would usually require a 60-90-day comment period to enable the public to go over the 255-pages of recently released technical information from the FDA.

Consumers Union, publisher of Consumer Reports, criticized the decision in a letter to the agency dated September 15th. “Since GE salmon is not in any way a lifesaving product such as certain pharmaceuticals or medical devices,” the group wrote, “we must question why the agency believes it is necessary to move forward so quickly, in a way that does not allow for the standard 60 to 90 days of public review.”

Consumers Union also criticized the make-up of the committee, which they suggested should have included “three fish ecologists, four food safety experts (including specialists in food allergies and in the effects of hormones on human health), and scientists from the consumer and environmental community.” Sourcewatch gives details on the committee members, while Jill Richardson provides bios for the temporary voting members on the committee, which includes a former employee of Monsanto and one non-scientist consumer representative.

Unlike clones, which are copies of an animal and which the FDA has already ruled safe to eat, genetically modified animals are those which have had their genetic code altered. The AquAdvantage salmon, for example, mixes a gene for producing a growth hormone from the Chinook salmon and a gene that encourages over-production of that hormone from an eel-like fish called the ocean pout.

After presentations by witnesses supporting the fish’s approval, consumer groups, scientists and others were given the chance to speak on the record. A re-occurring theme included discussion of the fact that AquaBounty Technologies, the company behind the petition, had control over the studies the FDA was now looking over instead of conducting studies based on the FDA’s established guidelines. Second, that the scope of the plans for the AquAdvantage salmon’s production would by necessity be bigger than the small tank facility in Panama that was presented in the documents. Many groups asked that the FDA request and Environmental Impact Statement  with consideration of the effects on larger-scale ecosystems, the fear being that the salmon could escape and compete with already-endangered wild salmon populations.

The FDA has already ruled that the genetically modified AquAdvantage salmon is safe to eat, and yet during the public comment period, many speakers focused on the shoddy science, small sample size, and the potential for allergic reactions. Another topic brought up during the hour of public comment was the lack of sufficient data on health concerns about modifying the fish to produce four times more of the growth hormone iGF-1, which has been tied to increased risks of cancer.

The committee had very few questions for the speakers during the public comment period, aside from taking interest in a poll by Food and Water Watch, which found that 78 percent of consumers do not approve of genetically engineered salmon. This coincides with the findings the Washington Post received when it asked its readers, “If genetically engineered salmon wins FDA approval, will you buy it?” to which 78 percent responded “No. I’m too concerned about potential health and environmental risks.”

The committee didn’t vote on anything yesterday. According to Andrew Pollack at the New York Times:

Approval, if it comes, is likely to take at least several months. The F.D.A. said it would prepare an environmental assessment that would be open to comment for 30 days. If the agency decides that there could be a significant environmental impact—something that does not appear likely—it will have to do a full environmental impact statement, which could take months or years.

Today’s VMAC meeting on genetically engineered salmon will deal specifically with whether or not the GE salmon should be labeled. (You can give public comment on this issue until November 22, 2010, details at the previous link and below.) Consumers Union conducted a nationwide poll [PDF] in 2008 which revealed that 95 percent of consumers want genetically modified food labeled.

But as Lyndsey Layton reported in the Washington Post on Sunday, if the AquAdvantage salmon is approved it will most likely not be labeled as genetically modified, and thus will remain indistinguishable from other salmon at the supermarket. “The FDA says it cannot require a label on the genetically modified food once it determines that the altered fish is not “materially” different from other salmon–something agency scientists have said is true,” Layton writes.

And the opposite is also true–wild salmon will have trouble using packaging that claims the product to be “GE-free,” because the agency feels these types of labels imply a quality difference.

But the exact opposite is true abroad. Layton writes:

In the European Union and Japan, it is nearly impossible to find genetically modified foods, largely because laws require labeling, said William K. Hallman, director of the Food Policy Institute at Rutgers University. “No one wants to carry products with such a label,” he said. “The food companies figure that consumers won’t buy it.”

If you feel empowered to speak out on this issue, Food and Water Watch suggests calling the White House. And you can still give your thoughts on the labeling question (and more, why not?) for AquAdvantage Salmon by identifying Docket No: FDA-2010 -N-0385 via http://www.regulations.gov or by writing:

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852