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POLICY & REGULATION: U.S. EPA biotech regulation bucks the scientific consensus





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TITLE:   EPA BIOTECH REGULATION BUCKS THE SCIENTIFIC CONSENSUS

SOURCE:  Forbes, USA

AUTHOR:  Henry Miller & Drew Kershen

URL:     http://blogs.forbes.com/henrymiller/2011/07/06/epa-biotech-regulation-bucks-the-scientific-consensus/

DATE:    06.07.2011

SUMMARY: "Officials at the Environmental Protection Agency profess an unwavering commitment to science. In their dreams. The bureaucrats? latest blunder is a flawed fix to a regulatory mess that they created in the first place ? namely, the regulation of field trials and commercialization of genetically engineered plants. [...] by exempting cisgenic constructions, the EPA would imply that other constructions, particularly transgenic ones (in which genes are moved across ?natural breeding boundaries?), are somehow fundamentally different and pose greater risk than cisgenic breeding."

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EPA BIOTECH REGULATION BUCKS THE SCIENTIFIC CONSENSUS

This post was co-written with Drew Kershen, a professor at the University of Oklahoma College of Law.

Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University?s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA.

Drew L. Kershen is the Earl Sneed Centennial Professor of Law, University of Oklahoma College of Law, in Norman, Okla.

Officials at the Environmental Protection Agency profess an unwavering commitment to science. In their dreams.

The bureaucrats? latest blunder is a flawed fix to a regulatory mess that they created in the first place ? namely, the regulation of field trials and commercialization of genetically engineered plants.

Some background is necessary. The EPA has long regulated field tests and the commercial use of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In 2001, the EPA issued final rules for the regulation of genetically engineered plants and concocted a new concept ? ?plant-incorporated protectants,? or PIPs, defined as ?pesticidal substances produced and used by living plants.?

But the EPA regulatory net captures pest-resistant plants only if the ?protectant? has been introduced or enhanced by the most precise and predictable techniques of genetic engineering. The registration process is excessive. The submission required for regulatory review includes copious data on the parental plant, the genetic construction, the behavior of the test plant and so on. (These requirements could not be met for any plant modified with older, cruder techniques, which are exempt from the FIFRA rules.)

The agency then conducts repeated, redundant case-by-case reviews before the initial trial; when trials are scaled up or tested on additional sites; and again if even minor changes have been made in the genetic construct. It then repeats those reviews at commercial scale.

This approach, which has been repeatedly condemned by the scientific community, has discouraged the development of new pest-resistant crops, encouraged greater use of synthetic chemical pesticides, and limited the use of the newest genetic engineering technology mainly to larger developers who can pay the inflated regulatory costs. It has also handicapped public institutions in the U.S. in the development of plants that can handle the challenges facing present-day agriculture and forests.

That brings us to the EPA?s 2011 proposal, which would exempt cisgenic PIPs from the pesticide registration requirements if they resulted from the movement of DNA ?between plants that could transfer the genetic material naturally.? Once again, we have the EPA clinging to non-risk-based criteria ? namely, ?natural? genetic combinations crafted with genetic engineering technology ? to carve out exemptions from case by case regulatory review.

The concept is not without precedent: The early NIH guidelines for research with recombinant DNA-modified organisms promulgated in the 1970s imposed less stringent regulatory requirements for organisms that resulted from cisgenic constructions ? but those guidelines long ago were relegated to the dustbin of history as NIH recognized the irrationality of focusing regulation on the most precise genetic engineering technologies.

Considered narrowly, the EPA proposal appears to have some merits. First, the exemption of cisgenic PIPs would constitute recognition, at least implicitly (if belatedly), that the insertion of DNA through ?bioengineering? techniques does not necessarily create risks that require sui generis regulation.

Second, the exemption of cisgenic PIPs would reduce the regulatory burden on this category. Excessive, unnecessary and scientifically unjustified regulatory burdens significantly hinder innovative research and development with cisgenic and transgenic (genetic constructions in which genes are moved across so-called natural breeding boundaries) genetically engineered plants. The exemption would enable some researchers and plant breeders to expend more of their resources on actual work rather than on jumping through gratuitous regulatory hoops.

In spite of these potentially worthwhile impacts, the exemption is fundamentally flawed. The proposal to exempt cisgenic PIPs poses the wrong question, so in this case even a narrowly ?correct? answer will do more harm than good to advances in plant breeding.

How can this be? First, the EPA?s basic assumptions about what constitutes risk and what requires regulation are flawed. The ?category? proposed for exemption has nothing to do with risk, which, according to scientific consensus and overarching government policy (in theory, at least), should dictate the degree of governmental scrutiny.

Second, by exempting cisgenic constructions, the EPA would imply that other constructions, particularly transgenic ones (in which genes are moved across ?natural breeding boundaries?), are somehow fundamentally different and pose greater risk than cisgenic breeding. If genuinely risk-related characteristics, rather than the use of a certain technology or the concept of ?natural,? were accepted by regulators as the proper basis for the degree and kind of regulation (as do the scientific and risk-analysis communities), the EPA would implement regulatory approaches that treat transgenic breeding no differently than cisgenic breeding.

Genetic engineering, or recombinant DNA, methods can be and are used to create both cisgenic and transgenic constructions. In both, the DNA that is inserted is highly characterized and usually completely sequenced. The degree of regulation should be proportionate to the perceived risk of the new organism, which is a function of certain characteristics of the host plant, such as weediness, toxicity, ability to outcross, etc., and the nature of the introduced or deleted gene(s).

Some additional context is essential to an understanding of EPA?s policy failures. Scientists and farmers engaged in the domestication of plants, animals and microorganisms have for millennia ?promoted? genetic recombination; they selected for ?phenotype,? or visible characteristics, with modifications in the genome following along unseen and unknown. But the potential impact and importance of these genetic changes must be viewed against the background of what occurs continuously in nature. Innumerable recombinations among related and unrelated organisms occur constantly by several mechanisms and then are tested by evolutionary pressures. Putting it another way, both cisgenic and transgenic genetic combinations occur constantly in nature.

Evolutionary studies provide perspective on the ?novelty? vs. the ?naturalness? of transgenic organisms created by genetic engineering. The sequencing of various genomes during the past quarter century reveals that nature has been remarkably conservative about using and maintaining efficient molecules as they evolved. Nearly identical DNA sequences and biochemical pathways are found in different species, across genera, and even across phylogenetic kingdoms. With such broad conservation and ?sharing? of genes in nature, debates over whether certain genes are ?human,? ?plant? or ?bacterial? become moot, as do discussions of which manmade genetic constructions are ?natural.? What is critical is the function of genes and their effects on the new host, not their origin or the techniques used to shuttle them around.

EPA continues blithely to ignore all of this. The current proposal is an affront to sound science and responsible policymaking. Its adoption would leave intact unnecessary, costly constraints on the use of the most precise and predictable technology to develop products that are critical to progress and especially to sustainability in agriculture.

Finally, as a policy issue, by exempting cisgenic breeding, EPA would enable the creators of cisgenic plants to tout their plants for marketing purposes as ?non-transgenic,? which would be irrelevant at best and misleading at worst.

Instead of continuing to deny the scientific consensus, regulators should incorporate it into policy and educate the public about its rationale.