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 Nestlé, 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.

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.

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.

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.

For more information visit: http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm     

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.

High Fructose Corn Syrup - 'Natural' or Not?

Dave Babcock has written an excellent article on the debate over whether high fructose corn syrup is natural:

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 FoodSafetyNews.com.

More on natural claims is here: USDA Reopens Comments on Use of "Natural"  and here: Health Canada Guidance on Food-like Natural.

I Was Dooped by the Loops of Froot

What a shock to find out that Froot is not fruit. What next, no good luck from Lucky Charms? However, I am (pretty) sure Fruity Pebbles do not contain real pebbles.

Kevin Underhill at Lowering the Bar (legal humor, seriously) shares some humor at the expense of yet another consumer alleging being duped into thinking Froot Loops contained real fruit.

“[Plaintiff] was misled by the packaging and marketing, which by design and intent convey the message that the Product contains real, nutritious fruit," alleges Werbel about a product named "Froot Loops."  The complaint continues, "[h]ad he known that 'Froot Loops' contained no fruit, he would not have purchased it."  This, of course, is pleaded as a class action, and Werbel alleges that the manufacturer's practices with regard to Froot Loops "present a threat to members of the general public . . . ."  Oh, the humanity.

By my count, these are the sixth and seventh lawsuits in California against the manufacturers of these two fictitiously named cereals.  But hey - just because you are 0-5 and your arguments have been openly mocked by judges as well as a large percentage of the nation's bloggers does not mean you shouldn't give it one or two more tries. It does mean that, presumably, PepsiCo and Kellogg's are highly unlikely to settle, and that in two or three months plaintiffs should be 0-7.

Kevin Underhill swiped at earlier plaintiffs, who alleged they were led to believe that "Crunch Berries" and/or "Froot Loops" are made with real fruit, “I still think this is like claiming emotional distress because you just learned "The Hobbit" isn't a true story.”

In light of this case, SF Weekly has issued a “corporate caveat noting that, while our offices are located at 185 Berry Street, our publication should in no way be considered a nutritious source of fruit.”

Defect Action Levels (The Maggots in Your Mushrooms)

It is economically impractical to produce food that is completely free of all naturally occurring defects. Non-hazardous defects that are unavoidable by good manufacturing practices are subject to tolerances, which the Food and Drug Administration (FDA) lists as “Defect Action Levels.” 

E. J. Levy had an interesting op-ed piece recently on this topic: 

You may be grossed out, but insects and mold in our food are not new. The F.D.A. actually condones a certain percentage of “natural contaminants” in our food supply — meaning, among other things, bugs, mold, rodent hairs and maggots.

In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A.’s Center for Food Safety and Applied Nutrition establishes acceptable levels of such “defects” for a range of foods products, from allspice to peanut butter.

Among the booklet’s list of allowable defects are “insect filth,” “rodent filth” (both hair and excreta pellets), “mold,” “insects,” “mammalian excreta,” “rot,” “insects and larvae” (which is to say, maggots), “insects and mites,” “insects and insect eggs,” “drosophila fly,” “sand and grit,” “parasites,” “mildew” and “foreign matter” (which includes “objectionable” items like “sticks, stones, burlap bagging, cigarette butts, etc.”).

Tomato juice, for example, may average “10 or more fly eggs per 100 grams [the equivalent of a small juice glass] or five or more fly eggs and one or more maggots.” Tomato paste and other pizza sauces are allowed a denser infestation — 30 or more fly eggs per 100 grams or 15 or more fly eggs and one or more maggots per 100 grams. . . .

E. J. Levy, The Maggots in Your Mushrooms, New York Times (Feb. 12, 2009).

For more fun and to amaze and gross out your friends:  FDA’s  Defect Levels Handbook: The Food Defect Action Levels — Levels of natural or unavoidable defects in foods that present no health hazards for humans.

Bon appétit!

Greg Jaffe Seminar on Genetically Engineered Food Oct 20 at Michigan State University

Larry King Blows It On Unsafe Meat

Marion Nestle’s comments about Larry King’s show on meat safety, Larry Kings Blows It On Unsafe Meat, is available in TheAlantic.com.  A clip from the show, of Bill Marler’s reaction to Larry King butchering the term, “E. coli” appeared on David Letterman Show right near the end of the monologue (three minutes in).

More Soda Tax News

The Food Law Prof Blog, Soda Tax in the News, has a compilation of articles on proposed taxes on sugar sodas:

• Food Law Prof Blog on President Obama's thoughts. 

• "A recent study by a star-studded cast of nutrition and obesity experts published in the New England Journal of Medicine this week is stirring things up. :The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages, (by Kelly D. Brownell, Ph.D., Thomas Farley, M.D., M.P.H., Walter C. Willett, M.D., Dr.P.H., Barry M. Popkin, Ph.D., Frank J. Chaloupka, Ph.D., Joseph W. Thompson, M.D., M.P.H., and David S. Ludwig, M.D., Ph.D.)"

• New York Times, Sept. 16, 2009: Proposed Tax on Sugary Beverages Debated

• ABCNews.go.com, Sept. 16, 2009: Public Health Leaders Propose Soda Tax 

The Precautionary Principle Is Not The Answer

“Better safe than sorry,” is a well known aphorism because it contains a lot of sense. The precautionary principle allures us with words that sound similar to common-sense precaution. 

Unfortunately, the principle is a both a shape shifter and a chameleon. The term can shift in meaning to support whatever side one wishes to take on an issue. Worse, the principle appears to—but does not—provide us guidance in dealing with uncertain risk. The principle appears effective only because it compares uncertain risk against implicit zero risk for the status quo. 

In the real world, difficult questions of uncertain risk are problems of benefits versus risks, risks versus risks, and benefits and risks versus alternative benefits and risks. The principle is at its worst in guiding us with risk versus risk situations. The precautionary principle advises us to avoid both risks—but how do both take action and inaction at the same time? Or as Michael Crichton said, “The precautionary principle properly applied forbids the precautionary principle. It is self-contradictory.”

Ronald L. Doering has written a pithy essay, “The Precautionary Principle Is Not The Answer,” that uses excellent examples to illustrate the fundamental flaw with the using the precautionary principle as an approach to deal with risk versus risk:

If the hazard of DDT, for example, were a possible threat to the environment, then the application of the precautionary principle would be to ban the product until the science is clearer. If the hazard is malaria causing mosquitoes and the million persons killed (and the 300 million made seriously ill) by malaria each year then wouldn’t the principle support taking action to continue to use the product until the science is more certain? A principle that is this malleable cannot be a reliable guide to decision making, but it is still often used as a justification for a decision taken for other reasons.

Or consider the fortification of enriched flour with folic acid. The risk of neural tube defects (major birth defects of the brain and spine, such as spina bifida) can be reduced by 50-70 percent if women receive folic acid supplementation starting three months before becoming pregnant. An estimated 1,000 more babies are born healthy each year because of mandatory fortification of foods with folic acid in the US. 
On the other hand, there are unknown risks of folate fortification for the majority of consumers who receive no benefit from increased folate. A recent study showed there might be a link between high intakes of folic acid and possible increased risk for colon cancer.
The precautionary principle supports mandatory fortification with folate. Rather than take the risk of inaction while the science is uncertain about the risks of fortification, it is better to be safe and prevent a thousand newborns a year from major birth defects. Accordingly, the US in 1994 and Canada in 1998 mandated fortification of certain flours and breads. “Applying the same principle, Britain and Ireland declined to require mandatory fortification.”

FTC's Revised Guides Governing Endorsements, Testimonials

The Federal Trade Commission (FTC) revised its guidance to advertisers on how to keep their endorsement and testimonial ads in line with the FTC Act.  Changes to the FTC’s Guides Concerning the Use of Endorsements and Testimonials in Advertising address endorsements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect.  Advertisers no longer can consider a disclaimer, such as “results not typical,” to be a safe harbor.

More information is available here.  The text of the Federal Register Notice is here.

GMA's 2010 Food Claims and Litigation Conference - Feb. 23-25 - Austin, TX

The Grocery Manufacturers Association's 2010 Food Claims and Litigation Conference is scheduled to take place February 23-25, and will be held at Barton Creek in Austin, Texas.  Nationally recognized authorities from the food, legal, and scientific communities will present up-to-the-minute information on:

-Recent Developments in Product Liability

-Emerging Trends in Foodborne Illness Litigation

-Micro-Contaminants in Food: Emerging Legislative, Regulatory and Litigation Trends

-A Thirty-Year Retrospective on Trial Sciences

-Food Allergens: Understanding the Science and Avoiding the Pitfalls

-Mass Tort 911: The Company's Been Sued! Now What?

-What Every Food Industry Defense Lawyer Needs to Know About Bankruptcy

-Recent Preemption Rulings May Be Opening the Floodgates of State Law Consumer Fraud in Labeling Class Litigation

-The Recall Playbook: Offense and Defense

-Flavoring Litigation: Current Status and Latest Regulations And Their Effect on Future Litigation

-Trends in Global Food Litigation:  Class Actions and Collective Redress

More information is available here.

It is Time for the Food Safety Enhancement Act

H.R. 2749 passed in the House of Representatives. Now is the time for the Senate to vote.

Bill Marler predicted that food safety legislation would pass Congress by Thanksgiving and be signed by the President before Christmas. Predicting the movement of Congress is difficult. Sometimes only a shocking event can prod Congress to action. Tainted cookie dough may have been the last straw for the House passage of H.R. 2749.

Senators, what are you waiting for?

The Congressional Research Service (CRS) a nonpartisan arm of the Library of Congress prepared the following summary of H.R. 2749:

As of 6/8/2009--Introduced. Food Safety Enhancement Act of 2009 - 

 ·    Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing food safety.

 ·    Requires each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan.

 ·    Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from foodborne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export.

 ·    Authorizes the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States.

 ·    Defines the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood.

 ·    Requires country of origin labeling on food and annual registration of importers.

 ·    Provides for unique identifiers for food facilities and food importers.

 ·    Deems a food to be adulterated if an inspection is delayed or refused.

 ·    Requires the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities.

 ·    Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices.

 ·    Gives the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding.

 ·    Establishes whistleblower protections.

For further thoughts:

•      Bill Marler’s summary
•      New York Times Editorial, Vote for Safer Food 
•            Hearings of the Subcommittee on Health

Dannon Settles False Ad Suit for $35 Million

Noreen O'Leary reports that the law firm, Coughlin, Stoia, Geller, Rudman & Robbins, secured a $35 million settlement with Dannon over allegedly misleading ads and labeling of  Activia and DanActive yogurt products. Under the stipulation of settlement, Dannon also agreed to change the way it markets and labels these products.

Now CSGR&R is pursuing a similar complaint against General Mills and its Yoplait Yo-Plus yogurt. The complaint against Yo-Plus alleges, "General Mills has no support for these claims, even though it states that it does, going so far as to claim it has clinical proof. General Mills' representations are false, misleading and reasonably likely to deceive the public."

A rep for General Mills, which began to market Yo-Plus in August 2007, said: "As a standing practice, we don't comment on pending litigation."

Noreen O’Leary also wrote, “Junk Science: 'Functional' foods promise good health -- but can they deliver?"

That Model of Poor Legal Drafting

My morning distraction was reading the Hatch-Waxman 25^th Anniversary Trivia by Kurt Karst. My favorite part is the exchange between Judge Roger W. Titus, U.S. District Court for the District of Maryland, and Gerald C. Kell from the Department of Justice (December 21, 2006) in Biovail Corporation. v. FDA:

THE COURT:  [After asking detailed questions about the Federal Food, Drug, and Cosmetic Act.]  All right.  There’s a special place in Hell where they torture people who write things like this.  For 14 years I was on the Rules Committee of Maryland’s Court of Appeals that didn’t have as many subsections as this, so I would flunk the person who gave me this as a draft rule.  I would say this is 50 rules.

Anyway, I wanted to wander into the right place of this endless section.  When I first went to Westlaw and said, just give me section 355, it had to tell me it was going to be 85 pages.  I said, no, no, no, no.  Let’s try (j), and I get this huge thing here.

ATTORNEY:  Well I hope that our brief lays out the precise subsections, Your Honor.  I believe it does.  But that is the sum of my argument, unless the court has any further questions.

THE COURT:  No.  You’ve been very helpful.  I’m glad to have somebody here who knows what they’re talking about.

ATTORNEY:  So am I, Your Honor.  It’s just not me.  Thank you.

THE COURT:  Thank you.  

To protect the public and to put a trial lawyer out of business

A clever blog post by Bill Marler, "New Food Safety Legislation is needed - to protect the public and to put a trial lawyer out of business."

USDA Reopens Comments on Use of "Natural"

The U.S. Dept. of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued an Advance Notice of Proposed Rulemaking (ANPRM) to seek additional comments from the public on the conditions under which FSIS should permit the claim “natural” in the labeling of meat and poultry products. After considering the more than 12,000 comments on “natural” submitted in response to a Federal Register notice that the Agency issued on Dec. 5, 2006, and the comments presented at a public meeting held by the FSIS on Dec. 12, 2006, FSIS has decided to solicit additional public input.

FSIS is soliciting further comments on numerous issues. More information is available in 74 Federal Register 46951-46957 (Sept. 14, 2009). Comments are due by Nov. 13, 2009.

Additional reading: Ricardo Carvajal, FSIS Has Second Thoughts On Issuing a Proposed Rule to Define “Natural”.

Fish Detective Busts Restaurant Switcharoos

The NPR Health Blog’s Scott Hensley has an interesting short piece concerning economic adulteration. Restaurants sometimes substitute cheaper fish for more expensive species, like grouper and red snapper. You can read the blog post here. Particularly interesting are the precocious New York high school students who used genetic testing to detect adulteration in the Big Apple’s restaurants and markets. Half the restaurants and six of ten grocery stores had mislabeled fish.