Health beyond the headlines
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Let Them Eat Cake (Genetically Modified)

GMO science and policy in the U.S. and the E.U.

By Lauren Weisenfluh and Dana March

Published October 11, 2012

Before harvesting genetically modified (GM) crops, tractor tires must now armor up—literally. Their defense is Kevlar, a material used by the military to line helmets and bulletproof vests and their enemy is a gnarly new breed of corn stalk, capable of weathering gale-force winds, Midwestern twisters, and other sworn enemies of run-of-the-mill crops—and most certainly capable of puncturing normal tractor tires.

Within the genomes of these corn stalks is a secret weapon—a desirable gene. Fortifying genes are stitched into the corn’s genome like a patchwork quilt, giving rise to the label “FrankenFoods”.

Genetically modified organisms (GMOs) have increased crop yield in a world where populations have skyrocketed to unprecedented levels, and where energy is getting more expensive by the day.

GMOs have the ability to withstand blistering droughts and devastating disease. Some GMOs grow insect-killing protein from Bacillus thuringiensis (Bt), while other GM crops promote resistance to viruses and Roundup herbicides. This saves the farming industry millions of dollars and encourages GMO pervasiveness—in corn, soybeans, tomatoes, papayas, potatoes, and beyond.

GMOs are in 75-80 percent of processed food available in United States (U.S.) grocery stores. But if even farming tires require Kevlar to protect them, do GMOs really belong in your gut?

Science and policy in the U.S. and abroad

The evidence regarding GMOs is hotly debated, muddled by financial interests and methodological quibbles. As a result, it has become increasingly difficult to navigate.

Politics and culture don’t make the answers any clearer. While GM crops are widely grown, harvested, and consumed in the U.S., this is not the case in the European Union (E.U.). However, E.U. member states are not united on GMO policy. In fact, the E.U. recently overturned a French ban on the cultivation of MON810 maize, a genetically modified type of corn, Zea mays.

Certainly between required GM product labeling in the E.U., recent anti-GM studies, and a whole lot of hype surrounding Proposition 37 in California, which would require labeling of GM products, one might expect the science itself to differ between the E.U. and U.S. But it doesn’t. Assessments of safety are submitted to regulatory agencies by the same source—biotechnology companies, like Monsanto. (Pharmaceutical companies go through an analogous process when seeking approvals for new drugs.) And these regulatory agencies have access to the same scientific literature.

Why the dramatic difference in policy?

A (pre)cautious approach

Whether we know enough to fully understand the risk of GMOs is controversial—and a key aspect of the debate revolves around diverging interpretations of what is known in bioethics as the precautionary principle. The precautionary principle outlines a framework for policymakers, treating technology-in-question much like a defendant in court.

Under the precautionary principle, all defendants are guilty until proven innocent. The thing is, scientific facts just depend, on who is funding the science, who is doing the science, what questions they are asking, and how they answer those questions. All this makes innocence extremely difficult to prove. Above all, it requires that reproducible results show low-to-no risk time after time.

The burden of proof falls squarely on the defendant. In simple terms, GMOs are guilty unless they can prove otherwise.

Case closed?

The transatlantic trip from lab to lunch

Before a GMO becomes part of a meal, regulators must determine its safety for the collective belly via a long chain of regulatory hurdles. (The GMO Compass has a handy guide to this process in the E.U.)

A biotechnology company, like Monsanto, provides safety information to the European Food Safety Authority (EFSA). That authority then scrutinizes and interprets the science, sometimes requesting additional evidence and testing. They ultimately pass their opinion to the European Commission, which continues the chain of scrutiny with several E.U. committees, after making a regulatory recommendation. These committees are made up of E.U. state members, including the Standing Committee on the Food Chain and Animal Health, and the Council of Ministers. The caveat is that at any point in the approval chain, any committee can side with the EFSA’s take on the science—or not.

On the other side of the pond, a different regulatory process is in place. The science comes from the same sources—biotechnology companies still provide the information pertinent to safety. However, GM products in the U.S. are innocent until proven guilty, as determined by an internal committee of experts.

The experts come from three agencies, which make decisions regarding different aspects of GMOs: the Food and Drug Administration (FDA) for food, food additives, feed, and veterinary drugs; the United States Department of Agriculture (USDA) for plants, plant pests, and veterinary biologics; and, the Environmental Protection Agency (EPA) for environmental impact.

And the U.S. experts don’t care what transpires abroad.

GMO, s’il vous plaît? Maybe not

MON810, Monsanto’s genetically modified corn, known commercially as YieldGard, is armed with Cry1Ab, a protein known as a delta-endotoxin, particularly toxic to the European corn borer, causing its paralysis and death. Recently, it made headlines for killing baby Monarch butterflies as well.

MON810 was deemed safe for the environment and food and animal feed in the U.S. in 1995 and 1996, respectively. It received regulatory approvals across the board in the E.U. in 1998.

This past March, the French temporarily, albeit illegally, banned cultivation of MON810 maize, despite the fact that the World Trade Organization ended a six-year E.U. GMO moratorium, permitting the cultivation of MON810 in the E.U. in 2004. Eyeing the E.U.’s largely untapped GM market, the U.S., along with other countries, including Argentina and Canada, pushed strongly for an end to the moratorium. And they got it.

The ban is the most recent in a scientific and political wrestling match between E.U. member states and authorities permitting the cultivation of the genetically engineered corn. In 2008, France joined Austria, Hungary, Italy, Greece, and Poland in banning MON810. All opposed the labeling of MON810 as safe.

Recently, the French waved what it called additional scientific evidence at the EFSA. These studies highlighted questions about the potentially harmful presence of the Cry1Ab protein in soil and water, and negative impacts on other, non-target organisms both in water and on land, such as bees and butterflies.

However, the EFSA dismissed the additional evidence, claiming that most of the studies had been addressed in previous EFSA assessments. About scientific evidence that had not been covered in previous EFSA assessments, the EFSA concluded that ecosystem risks were either minimal or could be avoided with proper management.

So, why did the EFSA give the French the regulatory finger?

The EFSA compared MON810 to its non-GMO counterpart in terms of toxicity, allergenicity, nutrition, and environmental effects. To sum up simply—necessary, given the complex regulatory jargon—no significant adverse effects were found, according to the EFSA.

The toxicological testing of MON810 in a 90-day feeding study of rats indicated no cause for alarm, the EFSA contended. However, it seems that another GMO, MON863—not MON810—was actually tested, leading Greenpeace to deem the assessment invalid. Moreover, even if MON810 had been tested in 90 adult rat-days, this time period is equivalent to about 7.5 human years. Considering that we are likely exposed to these crops on a regular basis, 90 rat-days says little about the potential effects of chronic—even lifetime—exposure in humans.

Precedence leaves no reason to expect allergenicity to either the plant or the Cry1Ab protein might be a problem, according to the EFSA. “Maize is not considered a common allergenic food,” claims the EFSA’s rebuttal to French arguments, which cites studies in children and Japanese populations. Nutritionally, the story is the same. Trials of MON810 in broiler chickens found no adverse effects in terms of nutrition or mortality.

Regarding the environment, the EFSA conceded that risks may exist, but that appropriate strategies can be taken to mitigate them. For instance, Lepidoptera, the broad order of moths and butterflies, have largely developed resistance to Cry1Ab proteins, with the exception of a species found in the European ecosystem.

Food for thought

The French are still not convinced. Their attitudes, like those of many other E.U. countries, are more precautionary than the EFSA. The French ban on MON810, spurred by vehement GMO protests, was politically well-timed: the presidential election was just around the corner in France.

Despite the EFSA’s ruling and the science that suggest its safety, France still wants to send MON810 to the GMO guillotine.

As people try to make sense of their food and the science behind it, debate and political and economic maneuvering will surely continue. The U.S. will likely remain more permissive of GMOs than the E.U., given the complex interrelations among the government, agribusiness, and farmers. And while that’s good news for the manufacturers of Kevlar, it’s still unclear whether it’s good news for population health.

In the context of contested scientific evidence regarding GMOs, we can only hope that such a ubiquitous exposure is, in fact, relatively safe. In the end, we may just have to go with our guts. Regulatory agencies seem to be saying, “Let them eat cake,” with a soupçon of genetic engineering. The icing could be sickly sweet, indeed.

Edited by Abdul El-Sayed.

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The views and opinions expressed on this website are solely those of the authors and do not represent those of the Department of Epidemiology, the Mailman School of Public Health, or Columbia University.