TCS Daily

Bad Science Makes Bad Law

By Henry I. Miller - April 5, 2007 12:00 AM

In 1897 the Indiana House of Representatives unanimously passed House Bill 246, a measure that redefined the calculation of the value of pi, the ratio of the circumference of a circle to its diameter. Fortunately, the Senate scuttled it. A California legislator has produced a worthy successor, in the form of unscientific anti-biotechnology regulation.

Freshman Assemblyman Jared Huffman (D-San Rafael), formerly a lawyer for the National Resources Defense Council (NRDC), last month introduced AB 541, which creates a series of obstacles to agricultural research and practices that employ gene-splicing technology, the most precise and predictable techniques for the genetic improvement of plants.

AB541 is colossally bad - for researchers, plant breeders, farmers and consumers, as well as for seed and biotech companies. It completely ignores that: (1) gene-splicing is merely a set of tools; (2) genetic modification of plants for agriculture is a centuries-old continuum, and a broad scientific consensus holds that gene-splicing is essentially an extension, or refinement, of cruder techniques; and (3) on the basis of both theory and vast experience, gene-splicing has been shown to be at least as safe as other techniques for genetic improvement.

The bill provides that the "unintended presence" of a "genetically engineered" plant on someone's property "shall constitute an unreasonable interference with the use and enjoyment of the person's property" - in other words, a "private nuisance," which is grounds for legal liability -- if the offended party claims losses in excess of $3,500.

However, such "contamination" does not compromise the "organic" designation of growers, or otherwise damage their interests. Arguably, it is like complaining about a superior Lexus part in your Toyota. This provision would be an invitation to make baseless, nuisance claims for growers' losses that were actually caused by their own negligence or incompetence.

The legislation prohibits "the production of a pharmaceutical crop" in open fields in a plant species "commonly produced for use as food for humans or animals." This might sound plausible, but it is a perfect example of the kind of inflexible, one-size-fits-all regulation that ignores the science and can do incalculable damage to "biopharming," one of biotech's most important applications.

The concept of biopharming is not new. Many common medicines, such as codeine, morphine, and the anti-cancer drug taxol have long been purified from plants. But biopharming's great promise lies in using the techniques of gene-splicing to make old plants do radical new things.

Gene-splicing has been applied to plants for decades in order to improve their nutritional value (vitamin A and iron) and agronomic traits (yield, pest- and drought-resistance and the like). Programming them to produce high value-added substances is a logical, straightforward extension. Rice has been modified to produce two human proteins (found naturally in tears and saliva) which have been used successfully to treat diarrhea.

Biopharming offers tremendous advantages over traditional methods for producing pharmaceuticals. There is great potential for reducing the costs of production: The energy for product synthesis comes from the sun, and the primary raw materials are water and carbon dioxide. And if it becomes necessary to expand production rapidly, it is much easier to plant a few additional acres than to build a new bricks and mortar manufacturing facility. (Think Tamiflu, the anti-influenza drug, which is in short supply.)

However, even without the efforts of Assemblyman Huffman, excessive and rigid federal regulation of plants for biopharming already has had a chilling effect on innovation. And as to concerns about contamination of food plants that will lead to "drugs in your corn flakes," the sophistication of modern agriculture enables us to sequester different crop varieties when necessary and to safely cultivate the same species of crops for food and for new pharmaceuticals. This has been done for decades for two varieties of rapeseed, for example, one of which is the source of an industrial lubricant while another is what we call "canola."

But even if a few biopharmed plants were to find their way into the food supply, in order for unwanted health effects to occur, several highly improbable events would have to occur.

First, the active drug substance would have to be present in the final food product - say, corn chips or oil, if the drug were made in corn, for example - at sufficient levels to exert an adverse effect from either direct toxicity or allergy. But there is generally a huge dilution as small amounts of biopharmed material are pooled into a much larger harvest; with few exceptions (e.g., peanuts), even an allergic reaction requires the presence of more than a minuscule exposure. Second, the active agent would need to survive milling and other processing, and cooking. Third, it would need to be orally active (usually, proteins are not, because they are degraded in the gut).

The probability that all of these events would occur is extremely low.

The bill also requires growers to notify county agriculture commissioners at least 30 days before engaging in open-field "production" (whatever that means) of any gene-spliced plant.

This measure is pointless. In the production of new plant varieties using conventional - that is, pre-gene-splicing - techniques, breeders, farmers and food producers lack knowledge of the exact genetic changes that produced the useful traits. More important, they have no idea what other changes have occurred concomitantly in the plant -- including those that could alter the ability to cause allergic reactions.

Consider, for example, the manmade "species" Triticum agropyrotriticum, which resulted from the wide-cross combination of the genomes of bread wheat and a grass called quackgrass or couchgrass. Possessing all the chromosomes of wheat and one extra whole genome from the wild grass, T. agropyrotriticum was independently produced for both animal feed and human food in the former Soviet Union, Canada, the United States, France, Germany, and China.

At least in theory, several kinds of problems could arise from a genetic construction that introduces tens of thousands of "alien" genes into an established plant variety. These concerns include the potential for increased invasiveness of the plant in the field and the possibility that quackgrass-derived proteins could be toxic or allergenic. Yet dozens of new varieties produced each year with these imprecise traditional methods of genetic improvement enter the marketplace and food supply without any governmental review or special labeling (or objections from activists and legislators).

Only the molecular, gene-splicing methods allow breeders to identify and fully describe the changes that have been made in the progeny, so perhaps it isn't surprising that only the imprecise, trial-and-error techniques of conventional plant-breeding methods have led to food safety problems. Two conventionally bred varieties each of squash and potato and one of celery were found to contain dangerous levels of endogenous toxins and had to be barred from commercialization. Such mishaps are far less likely when genetic changes are wrought with the more precise and predictable gene-splicing techniques.

In other words, in defiance of science and common sense, the California bill creates a regulatory scheme in which the degree of governmental scrutiny and intrusion is inversely proportional to the likely risk.

Henry I. Miller, a physician and fellow at Stanford University's Hoover Institution, was director of the FDA's Office of Biotechnology from 1989 to 1993. His most recent book is, "The Frankenfood Myth."



Forced Secession
Can we get rid of California?

On every issue from global warming to acrylamide to biotech, California is setting ridiculously bad precedents and interfering with the ability of the rest of the nation to function effectively because of the size of the California market.

I suggest we kick them out. Nancy Pelosi and friends are not likely to be happy about this sort of thing, but who cares? How long does anybody think she (or the Democrats,) will last after their recent performance? What will they do other than gripe? Attack Nevada?

Force California to survive on its own, without tax support and the defense assets of the rest of the nation, and lets see how long it takes them to get their act together. When they decide to behave like rational human beings, we can let them back in.

as bad as europe
Maybe they want to match Europe, what with their stupid 'precautionary principal'; just as irrational. And I like the suggestion of the other commentor above who says calif. should split; they could then really name themselves the 'left coast'. I think that in the longer term the balkanization of the US is possible as the whole social fabric keeps breaking down.

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