Time to Clean Up Our Dirty Food System

Posted on December 19, 2014 by Peter Lehner

For decades, environmental lawyers focused on cleaning up the air and water. We made tremendous progress. Today, in most of the country, our air is safer to breathe and our waters more fit for drinking and recreation than at the dawn of the environmental movement. 

But while our air and water got cleaner, our food system got dirtier during that same time period. Vast numbers of chemicals started to be used in the production and processing of food, with little thought given to the long-term impacts on human health and the environment. 

Safeguards have failed to keep pace with the introduction of new chemicals, and the powerful industries behind these products put tremendous pressure on federal agencies to limit health protections, putting our health and our environment at risk. 

Here are three ways to start cleaning up our dirty food system:

1. Close the Giant Food Additive Loophole

Hundreds, if not a thousand or more, chemical food additives used in processed and packaged foods that make up the majority of the American diet are never publicly revealed, much less reviewed for safety by the FDA. A recent report from NRDC explored this loophole in food safety law, known as GRAS, or “generally recognized as safe,” which allows chemical manufacturers to decide for themselves if their product is safe. In many cases, the FDA isn’t even notified when chemical additives enter our food supply.

Some additives which manufacturers claimed to be “generally recognized as safe” have been linked to fetal leukemia, testicular degeneration, and other adverse effects in human cell or animal tests. NRDC found these additives listed as ingredients in at least 20 food products.

The FDA can and should move now to end the conflict of interest in this system; and when the agency does review a manufacturer’s safety claims, their concerns should be made available to the public. Ultimately, Congress needs to close the GRAS loophole and reform outdated food safety law. 

2. Stop Risky Herbicide Used on Corn and Soy

The EPA recently approved the herbicide Enlist Duo, which is toxic to many plants, but not to a new strain of genetically modified corn and soy. Enlist Duo is likely to become the replacement for the weed-killer popularly known as Roundup, which became one of the most widely used herbicides in the nation after Monsanto developed genetically modified corn engineered to resist it. According to Monsanto, Roundup and its family of glyphosate-based herbicides are registered for use in more than 130 countries.   

But after 20 years of heavy use, Roundup is no longer effective against certain weeds, which have evolved a resistance to it.  The industry’s solution is to escalate: develop a new strain of GMO crops that can withstand a new, more potent herbicide.  

Enlist Duo is a combination of glyphosate, the active ingredient in Roundup, and another herbicide, 2,4-D. The EPA signed off on Enlist Duo despite ample evidence of the harm caused by 2,4-D, and without taking into account the last two decades of research on glyphosate. 

In recent years, glyphosate has emerged as a major contributor to the alarming decline of monarch butterflies, as it has decimated milkweeds across the Midwest, the only plant on which a monarch will lay its eggs. (Milkweeds have not evolved any resistance to glyphosate.) Emerging evidence suggests glyphosate may pose a threat to human health, with possible links to kidney disease, pre-term deliveries, attention deficit hyperactivity disorder, birth defects, and miscarriages. 

2,4-D has been associated with decreased fertility, higher rates of birth defects, and other signs of endocrine disruption. It’s been found in drinking water and can drift in the air over great distances, increasing the likelihood of human exposure far from the fields where it’s sprayed. 

The approval of Enlist Duo will expand both the geographic area and the length of the season during which 2,4-D would be used, potentially increasing the risk of exposure to 20 million children and women of childbearing age here in the U. S.

NRDC is suing the EPA for its approval of Enlist Duo.  

3. Stop Antibiotic Abuse in Livestock Industry

Eighty percent of the antibiotics sold in this country are for use in livestock and poultry, not for humans. And these antibiotics are largely used on animals that aren’t sick. 

To keep antibiotics effective, we need to change the way we raise animals for their meat. NRDC has been spearheading a campaign to raise awareness of antibiotic abuse in the livestock industry and pressing the FDA to take action. Recently, a number of major food companies have announced that they have or will transition away from antibiotics, including Perdue Farms, Chik-Fil-A, Panera Bread, Chipotle and others. 

These moves are encouraging and welcome but still voluntary, and not yet backed up by any increased transparency into antibiotic practices. And Foster Farms, the biggest chicken producer in the West, whose product was linked to a widespread Salmonella outbreak in 2013 and 2014, has yet to announce any changes in its antibiotics practices. 

Meanwhile, the latest FDA statistics show that antibiotic sales to the livestock industry continue to rise. Real change will come when we have truly effective safeguards—not the voluntary measures offered by the FDA, and not the similarly weak proposal recently (and commendably) vetoed by Governor Jerry Brown of California. 

Governor Brown has called stakeholders back to the table to find a more effective way for the industry to change its risky practices. It’s possible that California could lead the way forward on antibiotic stewardship. 

The FDA Punts Again on Livestock Antibiotics

Posted on January 29, 2014 by Lisa Heinzerling

The Food and Drug Administration recently recommitted itself to its feeble policy of addressing the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics.  Peter Lehner discussed previous iterations of this policy in his ACOEL blog post of November 2012.  Two documents issued in December 2013 reveal the details of the agency’s current plans.   The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out certain uses of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight. (In a new article, I provide an in-depth analysis of the several different strands of the FDA’s plan.)

Together, the documents recently issued by the FDA promise little more than continued delay in tackling a public health risk that has bedeviled the Agency for decades.  The FDA’s decision to rely on voluntary action by drug companies and to continue to allow routine uses of antibiotics in whole herds and flocks of animals in order to prevent infections brought on by stressful conditions leaves gaping holes in the protection the Agency purports to provide.  The Agency’s meager backup plans in case this endeavor does not work out as it hopes do little to comfort the skeptical.  Moreover, the FDA’s proposal to weaken rules for veterinary oversight undermines the Agency’s plan to place veterinarians at the front line of preventing agricultural overuse of antibiotics.  In addition, after a small outburst of transparency at the start of the process, this whole undertaking will move underground for three years while the FDA works things out privately with participating drug companies.

Rather than pursuing this doomed course, the FDA should do what a federal district court has already ordered it to do: complete regulatory proceedings to withdraw approvals for the mass administration of medically important antibiotics to food-producing animals.  As I have explained in a recent article, the FDA’s refusal to do so rests on the mistaken legal premise that such withdrawals must be preceded by formal, trial-type hearings; this premise ignores decades of developments in administrative law and misreads the Agency’s own enabling statute.

Three Cheers for the FDA!!!

Posted on April 5, 2013 by Robert Falk

In the wake of salmonella, e-coli, and listeria outbreaks in the nation’s food supply, and driven by fears concerning contaminants like melanine and lead being imported in foods from developing countries like China, the U.S. Food and Drug Administration’s (“FDA’s”) food safety assurance programs have fallen under much criticism in recent years.  In a rare instance of bipartisan consensus in this day and age, in 2010, Congress overwhelmingly passed and, on January 4, 2011, President Obama signed, Public Law 111-353, the Food Safety Modernization Act (“FSMA”).  FSMA, in turn, required FDA to provide the first comprehensive update to its food safety programs in decades. 

On January 16, 2013, almost a year behind the schedule set by Congress, FDA published two significant draft rules and accompanying preambles to implement FSMA’s upgraded food safety system requirements (78 Fed. Reg. 3504 ; 78 Fed. Reg. 3646).  In these two significant rulemakings, FDA essentially proposes to:  (1) add to an updated set of its longstanding “good manufacturing practices (“GMP”) requirements (found in 21 C.F.R. Part 110), a mandate that all food processors implement hazard analysis and critical point of control (“HACCP”) programs, and (2) to require growers of food commodities that will not be subject to extensive processing to implement programs of good agricultural practices (“GAPs”).

Kudos to the FDA for proposing such a sensible approach to addressing Congress’s goal of ensuring enhanced food safety in America.  Rather than making requirements more prescriptive, FDA instead has essentially proposed to require food processors not already subject to HACCP requirements to conduct these disciplined analysis of food safety hazards “reasonably likely to occur” and then have the results of that risk-based analysis drive the processors to further identify, implement, and track the additional compliance measures necessary to address the potentially significant hazard presented.  In the GAP context, FDA has taken the additional step of itself analyzing the food safety hazards that are “reasonably likely to occur” in fresh produce and concluded (subject to public comment) that microbiological risks are the hazards at the farm level warranting the imposition of GAP requirements under the law for the first time (rather than merely as recommendations as has been the case until now).

Politicians, regulators, and environmental lawyers and activists too often dismiss or merely give lip service to risk-based analysis and regulation, but, at least here, FDA proposes to meaningfully embrace and apply the approach so as to allow food safety management and control resources to be best allocated to protecting the public’s health and safety.  Hat’s off to the FDA!!!

FDA Still Dragging Its Feet on Antibiotics in Animal Feed

Posted on November 13, 2012 by Peter Lehner

Eighty percent of all the antibiotics sold in the United States are given to farm animals – not humans. Most of these animals aren't even sick. It's standard practice on factory farms, as a substitute for better management practices, to routinely dose healthy pigs, cows, and chickens with antibiotics that are vital for treating human disease.  As a result of this non-therapeutic antibiotic use, these farms have become breeding grounds for superbugs--dangerous germs that can't be knocked out with the usual medicines. And that puts human health at risk.

The Natural Resources Defense Council, where I serve as Executive Director, has been at the forefront of this issue.  In response to an NRDC initiated lawsuit, twice this year a federal court ordered the FDA to take action. In March, the court required the FDA to withdraw approval for the use of penicillin and tetracyclines in animal feed, unless drug manufacturers can prove this practice is not a public health risk. In June, the court directed the FDA to reconsider its denial of two citizen petitions on antibiotic use in livestock, saying “The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits.”

Superbugs can travel off farms and contaminate the surrounding air and water, as well as our food supply, which puts people at risk of acquiring serious and even life-threatening infections. In 2010, almost 52 percent of retail chicken breasts tested by the FDA were contaminated with antibiotic-resistant E. coli. Drug-resistant bacteria have been detected in air and drinking water near industrial hog farms in three states. Drug-resistant infections caused by antibiotic-resistant bacteria, including those generated by factory farms, have been estimated to cost Americans up to $35 billion every year.

The FDA has known for more than 30 years that antibiotic abuse on factory farms poses a risk to human health. In its March decision, the court determined that the FDA formally found back in 1977 that penicillin and tetracyclines had not been shown to be safe. In its June decision, concerning other antibiotics, the court pointed out that “the Agency has all but made a finding that the subtherapeutic use of antibiotics in food-producing animals has not been shown to be safe.” Nonetheless, the use of penicillin, tetracyclines, and other medically important antibiotics in livestock quadrupled between 1970 and 2009. The agency has not stopped the practice of routinely feeding antibiotics to healthy livestock, relying instead on "voluntary guidance" to address the issue.

The FDA has appealed the March and June  decisions and remains focused on the failed strategy of allowing industry to use antibiotics as it chooses instead of standing up to protect public health. NRDC is fighting FDA’s appeals. Under an FOIA request, the FDA will begin releasing public health risk assessment documents on antibiotics to us. NRDC is also working with leading scientific organizations to keep public pressure on the FDA. Health groups from the CDC to the American Medical Association have spoken out against antibiotic abuse on industrial farms. Hundreds of thousands of citizens, including chefs, medical professionals, and progressive food companies, have called on the FDA to do its job and protect the health of our families.

It's time for the FDA to follow the law and do its job. The agency needs to curb antibiotic abuse on factory farms and protect antibiotics for those who need them most--sick people.

Federalism can be Messy -- BPA and Product Regulation in the States

Posted on September 27, 2012 by Kenneth Gray

Depending on how you count, advocates have led over 25 state legislatures or regulators to consider or adopt bans on certain uses of Bisphenol A (BPA), the recently publicized monomer that is (or was) present as a residual at low levels in some plastic products.  Recently, the U.S. Food and Drug Administration (FDA) accepted a petition from the American Chemistry Council banning use of BPA in baby bottles and sippy cups, because the use had been abandoned by manufacturers. 

For many, FDA’s scientific review of BPA studies and thoughtful analysis on the merits of regulation was too slow, and to those who conclude “I don’t want exposure to any substances of concern” use-by-use regulation did not (and will never) provide comfort.  What started as a concern in baby bottles and sippy cups, and was the subject of numerous state bans several years ago -- before the FDA acted this summer to acknowledge the abandonment of BPA in those bottle and sippy cups -- is more recently the subject of additional state proposals for bans from lids of food cans and containers.  Some ask: “Can you please ban it from any product that may reach my children?”

Because it is difficult to get the federal machine to act quickly, why not seek an audience in your state capital?  It is easier to file legislation in many states than in Congress, easier to get exercised citizens to the state capital, easier to involve local media looking for a controversy, and cheaper for citizens to play at the state level than in Washington.  However, state toxicologists and regulators often don’t have the resources of the FDA, they are often not as well equipped (and certainly not as experienced) in making the necessary risk evaluations and product regulations.  And putting environmental police in the grocery aisles seems to squander limited state environmental resources.  As Maine DEP Commissioner Patricia Aho recently put it: “We’re environmental regulators.  You’re asking us to be the FDA in some regards here.”

Even assuming states are equipped to address those issues, how can national manufacturers (or national or regional retailers) deal with state-by-state regulation of different products using the same materials?  Not very well!  And how are consumers to understand why chemicals in a product present acceptable risks in one state, but unacceptable risks in another?  They don’t.  Why is state-by-state regulation of chemicals in products in the national interest when FDA has jurisdiction?  Maybe it isn’t. 

Congressman Markey has petitioned the FDA for a federal ban on coatings in infant formula packages (arguing abandonment), and the federal agency has sought comment.  But that petition was made after extensive state efforts against use in baby bottles and sippy cups.  The FDA will consider the matter, so it may be some time before the FDA acts.  In the interim, states are still being encouraged to adopt their own bans on certain uses of BPA.

FDA is even more broadly considering BPA safety and its uses under FDA jurisdiction, but in the meantime, keep your eye on your local legislature if you want to watch a messy process that is frustrating for everyone.

MANDATORY LABELING OF FOODS PRODUCED USING GENETIC ENGINEERING IS ON THE HORIZON

Posted on May 29, 2012 by Robert Uram

Labeling of food produced using genetic engineering is on the horizon either as a result of a petition that is pending before the Food and Drug Administration or as a result of a ballot initiative in California.  Labeling of genetically engineered food appears to have widespread popular support.

The presence of foods produced with the assistance of genetically modified organisms, or GMOs, is widespread in the United States, especially for crops like corn and soybeans.  The most common genetic modification to date is an introduced trait to make a plant resistant to a specific herbicide, allowing farmers to use the herbicide without killing the crop.  Today, most of the crops produced using GMOs can used without having to comply with any significant regulatory requirements. 

Concern over use of genetically modified organisms covers a broad range of issues, including increased use of pesticides, the presence of genetically engineered foods in products that are not intended to be produced with such methodologies, and health concerns that may arise from consuming genetically engineered foods.  One way to address those concerns is to ensure that consumers know which products are produced using genetic modification so that those with concerns can avoid them.  However, unlike many other developed countries, the United States has no laws requiring labeling of food produced with genetically modified organisms.

Recently, more than one million individuals, more than 500 partner organizations representing the healthcare community, consumer advocates, farmers, concerned parents, environmentalists, food and farming organizations, businesses, and 55 members of Congress joined in support of a petition to the Food and Drug Administration for mandatory labeling of genetically engineered foods.  The petition, among other things, calls for the FDA to issue regulations requiring labeling of all foods produced using genetic engineering.

In addition to the FDA petition, an initiative has been filed in California seeking to require the labeling of genetically modified foods in California. On May 2, 2012, more than 970,000 signatures were filed supporting a referendum to impose a California right-to-know requirement for GMOs.  The California law is known as the California Right-To-Know Genetically Engineered Food Act.  If adopted by the voters this November, commencing on July 1, 2014, retail sale of food offered in California would be banned if it is or may have been entirely or partially produced with genetic engineering, unless the production method is disclosed in clear and conspicuous words.  The labeling requirements would not apply to foods which inadvertently contain genetically engineered food products and has other limited exceptions.

These labeling requirements, if adopted, will give consumers a greater opportunity to decide whether or a not to purchase genetically engineered food and may have a far reaching effect on the markets for genetically engineered food.