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USDA and the Peterkin Papers

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USDA and the Peterkin Papers

Miller Op-Ed in Tech Central Station

The U.S. Department of Agriculture's biotechnology regulations have been a shambles for more than fifteen years.  Its compulsory case-by-case review and costly field test design and other requirements have made gene-spliced plants disproportionately—and unnecessarily—expensive to develop and test.  A field trial with a gene-spliced plant may be 10-20 times more expensive than the same experiment performed with a plant that has identical traits, but that was modified with less precise genetic techniques! The USDA's approach to regulation is internally inconsistent and contradicts the official overarching federal policy (developed during the previous Bush administration), which stipulates that oversight of biotechnology products should be "risk-based," "scientifically sound," and focused on "the characteristics of the biotechnology product and the environment into which it is being introduced, not the process by which the product is created." But USDA has crafted exactly the opposite: Regulation that arguably has an inverse relationship to risk, and that is triggered by the use of gene-splicing techniques. Regulators at USDA announced recently that they plan to revise their approach to oversight of gene-spliced plants.  Good news?  Not really, because their plan ensures that they will get the scope of what they regulate wrong yet again, and that they will spend years and tens of millions of dollars on a gratuitous environmental impact statement. USDA's strategy is an example of a flawed, unnecessarily complex governmental solution to a problem that regulators created in the first place.  It is reminiscent of a classic story, "The Peterkin Papers," by Lucretia Hale, which tells the story of a well-meaning but rather dimwitted family.  One day, Mrs. Peterkin discovered that she had mistakenly put salt instead of sugar in her cup of morning coffee, making it taste awful.  She called her family around to help her decide what to do. First, they took the coffee to the local pharmacist who tried adding ammonia and various other chemicals, including a dash of arsenic, but that only made the coffee taste worse. They proceeded then to the neighborhood herbalist, who added more ingredients to the coffee, but that made it even more distasteful.  In desperation, the Peterkins turned to the famed Lady from <?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />Philadelphia, who was reputed to be very wise.  "Why don't you dump it out and make a fresh cup of coffee?" the lady asked.A fresh, scientifically sound and risk-based regulatory approach has already been proposed by academics (including this author)—which, ironically, is based on the well-established model of USDA's own plant quarantine regulations.Almost a decade ago, the Stanford University Project on Regulation of Agricultural Introductions began work on a widely applicable regulatory model for the field-testing of any organism, whatever the method or methods employed in its construction.  It is patterned after national quarantine systems, including the long-standing USDA Plant Pest Act regulations, whose approach is essentially binary: A plant that a researcher might wish to introduce into the field is either on the proscribed list of plants pests—and therefore requires a permit—or it is exempt. The more quantitative and nuanced "Stanford Model" is based on the ability of experts to stratify organisms into several risk categories.  It closely resembles the approach taken in the in the federal government's handbook, "Biosafety in Microbiological and Biomedical Laboratories," which specifies the procedures and physical containment that are appropriate for research with microorganisms, including the most dangerous pathogens known.  These microorganisms were stratified into risk categories by panels of scientists.  Interestingly, in contrast to USDA's approach to gene-spliced organisms, the handbook does not—even for the most dangerous pathogens—dictate mandatory requirements, but only offers guidance to researchers.The Stanford Model was validated in a proof-of-principle project in 1997.  (That demonstration applied only to plants, but the model can be readily applied to accommodate other kinds of organisms, as well as regional and local preferences for greater or less stringent regulation.)  The project assembled a group of approximately 20 agricultural scientists from five nations at a workshop held at the International Rice Research Institute (IRRI), in Los Baños, Philippines, in order to seek consensus on a broad, science-based approach that would evaluate all biological introductions, not just those that involved gene-spliced organisms.  The need for such a broad approach was self-evident: There was already abundant evidence that severe ecological risks can be associated with plant pests and "exotic," or non-coevolved, organisms. As part of the pilot project, the IRRI conference participants evaluated and then, based on certain risk-related characteristics, or traits, stratified a variety of crops into risk categories.  These traits included the ability to colonize, ecological relationships, effects on humans, potential for genetic change, and ease or difficulty of risk-management.  Consensus was reached without difficulty— suggesting that it would be similarly possible to categorize other organisms as well. Each of the organisms evaluated during the conference was assessed for all five factors, which enabled the group to come to a global judgment about the organism's risk category.  Most of the common crop plants addressed were found to be of negligible risk, while a few were judged to be of low but non-negligible risk.  One plant (cotton) was judged to be of negligible risk if it were field tested outside its historical center of origin, but of low but non-negligible risk if tested in the vicinity of its center of origin.In the evolution of this Stanford Model, the factors taken into account were indifferent to the genetic modification techniques employed, if any, or to the source(s) of the introduced genetic material.  The participants agreed that the use of conventional breeding techniques or gene-splicing methods to modify an organism was irrelevant to risk.  They also agreed that whether DNAs were combined from distantly related organisms—that is, organisms from different genera, families, orders, classes, phyla, or kingdoms—was irrelevant to the risk of an organism. In other words, the group's analysis supported the consensus view of the wider scientific community that the risks associated with field-testing a genetically altered organisms are independent either of the process by which it was modified or the movement of genetic material between "unrelated" organisms. The Stanford Model proves the utility and practicality of an approach in which the degree of regulatory scrutiny over field trials is commensurate with the risks—independent of whether the organisms introduced are "natural," "exotic" or have been genetically improved by conventional methods or gene-splicing techniques.What are the practical implications of an organism being assigned to a given "risk category"?  The level of oversight faced by an investigator who intends to perform a field trial with an organism in one or another of the categories could include: complete exemption, a simple "postcard notification" to a regulatory authority (without prior approval required), case-by-case review and required assent by regulators, or even prohibition (as is the case currently for experiments with Foot and Mouth Disease Virus in the United States). A key feature of the Stanford Model is that it is sufficiently flexible to accommodate differences in regulatory authorities' preferences for greater or lesser regulatory stringency.  That is, different national regulatory authorities could choose different regulatory requirements for the various risk categories, some leaning more towards exemption and notification, others towards case-by-case review. However, as long as regulatory requirements match the relative risk of each category, and do not discriminate by treating organisms of equivalent risk differently, the regulatory methodology will make scientific (and common) sense. This regulatory model makes it possible to perform accurate, scientific determinations of the risks posed by the introduction of an organism into the field and, thereby, fosters enhanced agricultural productivity and innovation, while it protects valuable ecosystems.  It offers regulatory bodies a highly adaptable, scientific paradigm for the oversight of plants, microorganisms and other organisms; whether they are "naturally occurring"; non-indigenous, "exotic" organisms; or have been genetically improved by either old or new techniques. Under such a system, some currently unregulated introductions of traditionally bred cultivars and exotic organisms considered to be of moderate or greater risk would likely become subject to regulatory review, whereas many gene-spliced organisms that now require case by case review would likely be regulated less stringently.  The introduction of such a risk-based system would make the regulation of field trials more scientific and more logical, and it would reduce the existing regulatory disincentives to the use of gene-splicing techniques. The Stanford model is ready to roll, but USDA's roadmap makes it clear that regulators intend to continue to single out gene-splicing for discriminatory regulation.  The feds who regulate plant pests are still the biggest pests of all.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />