Better oversight needed for GMOs from US FDA – experts

EXCERPT: “To say ‘the debate’s over, these things are safe, there’s a consensus among scientists about that, stop standing in the way of science’ — in fact they are the ones standing in the way of science,” [Timothy A. Wise, director of the research and policy program at the Global Development and Environment Institute at Tufts University] said of the biotech and food industries. “We need to stop stifling science and start following the thread of findings that suggest that there may be human health effects.”
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Herbicide finding intensifies battle over GMO labelling

By Jan Ellen Spiegel
The CT Mirror, November 9, 2015
http://ctmirror.org/2015/11/09/herbicide-finding-intesifies-battle-over-gmo-labeling/

More than two years after passing the nation’s first law requiring labels on most foods containing genetically engineered components, there are still no labels for Genetically Modified Organisms – GMOs – in Connecticut or anywhere else in the United States.

The food and biotech industries are fighting Connecticut's law and two others in Vermont and Maine with federal legislation that would nullify (preempt is the official term) all three as well as any future attempts at GMO labeling. The bill would also set national standards for labelling food as non-GMO, essentially codifying the existing voluntary practice of labeling those foods.

But GMO labeling advocates now have some new ammunition for a counter-offensive. One of the key reasons for developing GMO crops in the U.S. has been to make them resistant to weed-killers – primarily Monsanto’s herbicide Roundup — which are used to kill weeds and other undesirable plants in and around fields where the food crops are grown.

In March, the International Agency for Research on Cancer (IARC), which is part of the World Health Organization, declared the active ingredient in Roundup – glyphosate – a “probable carcinogen”. Its use is being reviewed by the Environmental Protection Agency, and in September California announced it would begin labeling products with glyphosate as carcinogenic.

“We are outraged with this assessment,” Dr. Robb Fraley, Monsanto’s chief technology officer, said in a statement at the time. The statement also called the information “inconsistent” with decades of safety reviews, and the company offered multiple web pages with dozens of links to documentation and other material. “This result was reached by selective ‘cherry picking’ of data and is a clear example of agenda-driven bias,” the Fraley statement said.

Since then, Monsanto has asked Intertek Scientific and Regulatory Consultancy — an international consulting firm that, among other things, provides expertise on food science regulatory issues — to convene a panel to review IARC’s findings.

The glyphosate designation came as another worrisome piece in the GMO puzzle for those in the academic food science community, public officials and other experts who view the GMO approval and oversight process as flawed and secretive. They believe it adds to ongoing safety concerns and has chilling implications for the food supply in the age of climate change.

The food and biotech industries have long asserted otherwise, pointing out that some GMOs other than the herbicide-resistant ones lessen the need for agricultural chemicals. “GMOs are safe,” said Mike Gruber, senior vice president for federal affairs at the Grocery Manufacturers Association (GMA), which often speaks on behalf of the industries that oppose labeling. “There’s almost 2,000 studies that have reaffirmed the safety of genetically engineered food.”

Advocates see labeling as the first step toward addressing their concerns. It’s especially important given the regulatory environment, said Timothy A. Wise, director of the research and policy program at the Global Development and Environment Institute at Tufts University. “That regulatory environment is weak and doesn’t give the public the confidence that it should have that the products that are being approved are fully tested and safe,” said Wise, whose specialty is international development and sustainability, focusing on agriculture.

“There is no way we could possibly know how safe these crops are given that they’ve only been in existence for 20 years,” he said. “Twenty years is nothing for evaluating the long-term effects.”

GMOs explained

GMO crops are created by inserting, deleting, or otherwise changing genes to create particular traits. The process differs from hybridization, which is the deliberate, and sometimes accidental, crossbreeding of organisms.

The majority of GMO crops by far are designed to be herbicide resistant – able to withstand sprays like Roundup. Other crops are genetically altered to create resistance to pests or diseases — the most prominent of those being Bt corn, which is resistant to the European corn borer. Biotech companies argue such crops mean using fewer anti-pest sprays, but labeling advocates counter it just means the insecticides are inside the crop.

Genetic engineering also can create cosmetic and other properties, like a recently announced apple that doesn’t brown when it’s cut. But some earlier attempts, such as golden rice, designed to include beta-carotene, and tomatoes with delayed ripening and make them easier to ship, were commercial failures.

Crops that could better handle climate change-related growing extremes, such as drought and periodic flooding, are believed to be far off.

There are actually only about a dozen GMO crops in production in the U.S., but they include some of the most ubiquitous items in our food system: corn, soybeans and sugar beets. Nearly all non-organic varieties of these are now GMOs, one or more of which are likely to turn up in the majority of processed foods in the United States.

In the case of corn, nearly all feed corn is genetically modified. Throw in a couple of other major GMO crops – alfalfa and canola/rapeseed – and it’s a little hard to avoid GMOs unless you eat only organic products, generally far pricier than conventional ones.

“The problem with that is, it’s a really elitist attitude,” said Tara Cook-Littman, the Fairfield activist who spearheaded the fight for Connecticut’s labeling law and has since helped found the national Citizens for GMO Labeling.” I don’t think only rich people should be able to avoid GMOs.”

But the Coalition for Safe Affordable Food, an organization founded in early 2014 to push for the current federal legislation, contends that labeling food containing GMOs would push up food prices.

The anti-labeling GMO industry also points a to a Pew survey that shows a majority of scientists think GMOs are safe.

But Wise said some scientific opinion on the safety of GMOs is more nuanced than that.

“To say ‘the debate’s over, these things are safe, there’s a consensus among scientists about that, stop standing in the way of science’ — in fact they are the ones standing in the way of science,” he said of the biotech and food industries. “We need to stop stifling science and start following the thread of findings that suggest that there may be human health effects.”

Many agree with Wise that it’s impossible to know long-term effects yet. But they also draw a sharp distinction between risks from the genes themselves and secondary risks that flow from the genetic work – such as the widespread use of glyphosate.

Rounding up the research on glyphosate

Data compiled for the U.S. Geological Survey shows glyphosate use in the U.S. went from about 20 million pounds a year in the early 1990s to about 280 million pounds in 2013. Not all of it is because of the increased use of GMO seed – especially corn and soybeans — but most is thought to be.

Even if the genetic alterations in corn, soybeans and other crops glyphosate is sprayed on ultimately prove to be safe, labeling advocates and many scientists point out that the secondary environmental factors related to its use are not considered in approving the genetic engineering.

One is emergence of herbicide-resistant weeds, something that scientists warned about years ago.

“And that has in fact come to pass,” said Doug Gurian-Sherman, a plant pathologist who was a risk assessment scientist for genetic engineering at the Environmental Protection Agency (EPA) and is now director of sustainable agriculture and senior scientist at the Center for Food Safety. “What a lot of us consider to be an epidemic of glyphosate-resistant weeds is causing serious, major problems with farms across the country, especially in the Southeast, but moving into the corn belt in the Midwest.”

Gurian-Sherman noted that glyphosate is particularly good at killing milkweed, critical food and habitat for monarch butterflies, which have suffered drastic population drops in recent years. There has also been some evidence of glyphosate residue in water and soil.

“I think the glyphosate debate is interesting because my sense is that the activists have been unable to prove that genetically engineered foods are unsafe, and now they’re trying to tie glyphosate into this argument,” said the grocery manufacturer's Gruber. “It may be a good political strategy for the opponents of genetic engineering, but if their real goal is to ban glyphosate, then they should be more honest with legislators.”

Claire Parker, spokeswoman for the Coalition for Safe Affordable Food, called the glyphosate issue a “red herring”. “The discussion about glyphosate really demonstrates the desperation of anti-GMO activists,” she said. “Glyphosate is used on both non-GMO and GMO crops, so it’s very much a side issue.”

Testiness over testing

Many labeling advocates are looking most warily at the government's GMO approval system - something they see as a case of the fox guarding the henhouse.

Under the Food, Drug and Cosmetic Act – a law created long before GMOs – GMOS are not considered “materially different” from the original crop and so do not require labels or independent testing prior to FDA approval.

The chemical, seed and other biotech companies developing GMOs turn over their test results to the oversight agencies: principally the Food and Drug Administration, the U.S. Department of Agriculture’s Animal and Plant Heath Inspection Service and the EPA.

The agencies, with few exceptions, only review what they are given. The FDA would not agree to an interview request, and it is unclear if the FDA has ever turned down a GMO application.

Because GMOs are considered patented inventions, their developers have also been reluctant to reveal details or allow the scientific community to independently test them.

Several years ago the Center for Food Safety’s Gurian-Sherman, then with the Center for Science in the Public Interest, looked at about 25 percent of the FDA’s GMO reviews.

He called them “cursory”.

“FDA does very short reviews where they mostly just reiterate what the industry says. They’re not evaluating raw data or even statistically analyzed data. They’re just evaluating the summary,” he said. “So you have this voluntary process where the companies submit the data. They collect data themselves. They determine what tests are going to be done or not going to be done.

“It leaves the fox guarding the henhouse, absolutely.”

The Obama administration is beginning to look into the situation. In July the White House ordered the three agencies to reform their oversight and approval system — known as the coordinated framework — to ensure better policing of GMOs. But that will take time to develop and implement.

Gurian-Sherman chooses his words carefully, however, when it comes to the safety of the actual GMO crops. “Nothing that I found suggested that the products that were being looked at necessarily were harmful,” he said. “Frankly my feeling is that, in terms of human health risks, probably most of these will not be harmful, but some could be quite harmful.”

But, he continued, “Genetic engineering has been on balance more harmful than it has been good so far. I think the downsides substantially outweigh the benefits.”

He would like to see independent, pre-approval testing, something the GMA balks at. “Who’s going to be the independent testing authority?” asked Gruber. “I’d like to know what somebody’s definition of independent research is.”

But even independent research on the genetics is unlikely to address the concerns about secondary harms.

Aside from the use of glyphosate, Gurian-Sherman and Wise said GMOs reinforce the U.S. system of monoculture and industrial farming. They said that system would be unable to withstand the rigors of climate change, unlike smaller farms that use traditional soil and farming techniques to keep farms healthy and diverse through all kinds of climate and weather extremes.

A first step

For now, the focus of the battle remains on labelling.

Labeling already exists in 64 countries, including nearly all of Europe. Last month 19 European Union nations agreed to ban the growing of certain GMO crops, though in the last week the European Parliament rejected a move to allow individual nations in the EU to ban GMO imports. Only a few countries ban GMO imports.

Sen. Richard Blumenthal, D-Connecticut, an advocate of GMO labeling who has proposed his own legislation requiring it, said he knows the GMO approval process needs overhauling. “We’re beginning with labeling because that is the step that attracts the most consensus,” he said. “In the end there has to be steps to authorize and require better oversight by the FDA.”

He is also no fan of federal preemption. “The federal government may set a floor,” he said. “But it shouldn’t impose a ceiling on what states do.”

He doubts federal preemption legislation, which has passed the House and recently was the subject of a hearing in the Senate, will get through Congress as a so-called clean bill, but admitted he didn’t know whether President Obama would be inclined to veto it if it did. More worrisome to him is that it will get tacked on to a critical piece of legislation, such as a spending bill, that the president would be hard-pressed to veto.

While that gets sorted out, PR battles rage on both sides.

Multiple letter-writing campaigns opposing the federal legislation are under way by hundreds of national and state advocacy and food groups. Another is sponsored by Just Label It, which has support from dozens of food company business leaders, and a third comes from state legislators, though curiously only four in Connecticut have signed it.

On the other side of the debate, The Coalition for Safe Affordable Food said its letter supporting federal preemption has more than 400 signers, including 46 national organizations. Its argument mirrors that of the grocery manufacturers and others – that GMOs are safe, that they aren't materially different from the natural crop, and that a patchwork of state labeling laws would be unwieldy.

In the meantime, many eyes are on a court case on Vermont’s GMO labeling law. It was passed after Connecticut’s but is set to go into effect next July. It survived a challenge in federal district court in April and is now in federal appeals court.

Supporters of labeling laws in Maine and Connecticut also are now looking to eliminate or at least reduce the implementation triggers that have kept them from going into effect. The existing Connecticut law requires passage of similar measures in four other Northeastern states encompassing a population of at least 20 million. That means either New York or Pennsylvania needs to be on board. One of the states must border Connecticut. Both Massachusetts and Rhode Island are believed to be close to approving labeling legislation.

State Rep. Diana Urban, D-North Stonington, one of the original bill’s key supporters, said she’d like the triggers gone. Like Blumenthal, she’d like a full overhaul of the GMO oversight process.

“I understand policy has got to be incremental, and where do you start with an incremental policy? You start by saying – shouldn’t the consumer know that there are GMOs in this particular item?" she said. “Markets work the best when consumers have as much information as possible.”

Urban, who is an economist, has company in that belief. Wise at Tufts also looks at economics as a senior research fellow at the Political Economy Research Institute at UMass Amherst.

“As soon as there’s a label regime in place, there will be a sizeable market for non-GMO soybeans and non-GMO corn,” he said. “Farmers will then have a choice of which one they want too grow.”

It makes GMO labeling very economically sensible, he said. “It will allow a non-GMO market to express itself, to create demand, to create investment incentives, create profits and to compete.”

Urban put it a little differently.

“What the industry is saying is ‘if we label these, then people aren’t going to buy them,’” she said. “So ooookay – then maybe you guys need to get more information on why these are safe.”