Saturday, November 21, 2009

Time to Put Aside Biotech Biases

The World Summit on Food Security in Rome just finished a few days ago. A few words of Peter Brabeck-Letmathe, the chairman of NestlĂ©, talking about how hostility to new food technologies exacerbated the global food crisis by holding back agricultural productivity, “It is disheartening to see how easily a group of well-intentioned and well-fed activists can decide about new technologies at the expense of those who are starving.”

Some have dismissed these remarks. Harder to dismiss are the thoughts of Paul Collier, a professor of economics at Oxford University and author of “The Bottom Billion: Why the Poorest Countries Are Failing and What Can Be Done About It,” in the New York Times,
The debate over genetically modified crops and food has been contaminated by political and aesthetic prejudices: hostility to U.S. corporations, fear of big science and romanticism about local, organic production.
Food supply is too important to be the plaything of these prejudices. If there is not enough food we know who will go hungry.
Genetic modification is analogous to nuclear power: nobody loves it, but climate change has made its adoption imperative. As Africa’s climate deteriorates, it will need to accelerate crop adaptation. As population grows it will need to raise yields. Genetic modification offers both faster crop adaptation and a biological, rather than chemical, approach to yield increases.
Opponents talk darkly of risks but provide no scientific basis for their amorphous expressions of concern. Meanwhile the true risks are mounting. Over the past decade global food demand has risen more rapidly than expected. Supply may not keep pace with demand, inducing rising prices and periodic spikes. If this happens there is a risk that the children of the urban poor will suffer prolonged bouts of malnutrition.
African governments are now recognizing that by imitating the European ban on genetic modification they have not reduced the risks facing their societies but increased them. Thirteen years, during which there could have been research on African crops, have been wasted. Africa has been in thrall to Europe, and Europe has been in thrall to populism.
Genetic modification alone will not solve the food problem: like climate change, there is no single solution. But continuing refusal to use it is making a difficult problem yet more daunting.
I have written on a related aspect of this issue, In Lean Times, Biotech Grains Are Less Taboo. When there is no direct burden to people, they tend to take “better safe than sorry” as their overarching risk-management principle. Sometimes this approach works, but it also can magnify risk grossly out of proportion to reality.

Wednesday, November 18, 2009

Google legal research is free!

Google launched a free online case law search system available through Google Scholar (select scholar as search option, then legal cases). Of course, it's not LEXIS or Westlaw, but it is surprisingly comprehensive and robust. Every citation is hyperlinked to the full text of the opinion cited. It looks like a great tool for preliminary research. One announcement is here.

Tuesday, November 17, 2009

Ensuring Global Food Safety

Ensuring Global Food Safety: Exploring Global Harmonization, edited by Christine E. Boisrobert et al., is now published. I wrote a very small part of this large book. You can find out more here.

Friday, November 13, 2009

FDA To Look Into Safety of Caffeinated Alcoholic Beverages

The Food and Drug Administration (FDA) notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.  To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.  It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned.  FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace. 

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use. In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Friday, November 06, 2009

Courts force U.S. reckoning with dominance of GM crops

Paul Voosen, New York Times (Oct. 8, 2009), writes that 90% of U.S. soy and cotton crops are genetically engineered (GM crops).  In addition, 85% of the corn crop is also genetically engineered, and it is found throughout the food system. 
     “These crops are safe to eat. The science on that is unequivocal, even in Europe, where a moratorium on new GM crops has existed for a decade. And by most accounts, GM crops have been an economic benefit to farmers, simplifying field maintenance and reducing the number of hands needed for weeding.
     “But as these crops have come to dominate the agricultural landscape, farmers who eschew their growing -- for ethical, organic or trade reasons -- have found themselves at a loss, frustrated by regulators and the majority of fellow farmers who have accepted GM crops as the new normal. . . . For the past two decades, the government has argued "essentially that there's no difference between a GM crop and its nonmodified sibling," said Alison Peck, a law professor at West Virginia University.
     "’Their arguments all sort of flowed from this presumption -- that these two kinds of crops are fungible,’ Peck said.
     “Two recent decisions out of the Northern District of California are the first-time acknowledgement by any federal entity of a difference between GM and non-GM crops, Peck said. The latest ruling, on the GM sugar beets of Willamette Valley, came down late last month and will move into the remedy phase at the end of this month. Both rulings -- the first, upheld several times on appeal, came down in 2007 -- found the regulatory apparatus used by the Department of Agriculture severely lacking. USDA, along with the Food and Drug Administration and U.S. EPA, oversees GM crops, using jury-rigged laws written well before the invention of biotechnology. Unlike Japan, Europe or even Russia, the United States has never passed legislation on GM crops.”
     USDA came to view GE and non-GE crops as identical, fungible. If the farmer wanted to keep GE-genes out of their field, it was that farmer’s burden to provide for buffer zones and other measures to keep out pollen drift. This could have serious economic consequences for organic and other non-GE farmers.
     To make the point about keeping out pollen, Voosen makes a interesting comparison to cattle ranching. “In the eastern part of the United States, traditionally, farmers have been obliged to fence in cattle. In the West, meanwhile, landowners are required to fence out roaming herds. The same distinctions apply to crops. Europe has been busy erecting a complex regulatory apparatus requiring farmers to ‘fence in’ their GM crops with isolation distances and liability funds. With no regulations, the United States has in effect required non-GM farmers to ‘fence out’ GM crops, placing the economic burden on conventional farming.”
  A copy of Judge Jeffrey S. White order in Center for Food Safety, et al. v. Thomas J. Vilsack, et al., is available here.

Tuesday, November 03, 2009

High Fructose Corn Syrup - 'Natural' or Not?

So, let's say I was making you dinner, and in preparing one of the ingredients was "fixed to a column by the use of a synthetic fixing agent, glutaraldehyde."  Even if I told you that I washed off all the "unreacted glutaraldehyde," would you be willing to call the dinner I made you "natural?"

If you wouldn't, don't eat with the decision makers from the FDA. 
Kudos to Marler Clark for presenting us with