Henry I. Miller and Robert Wager
A Canadian company petitioned USDA regulators two years ago to “deregulate” – approve for unrestricted cultivation and marketing — a new apple variety called Arctic Apple. It contains a trait that should be appealing to consumers: It is highly resistant to the unappetizing browning that occurs when an apple is cut or bruised. The biology that made this possible is ingenious, while regulators’ treatment of this new fruit has been dilatory and just plain dumb.
Enzymatic browning is caused by the apple’s intrinsic chemical reaction to cell injury, such as when the fruit is bitten or sliced, which ruptures the cells and triggers a chemical reaction between the enzyme polyphenol oxidase (PPO) and substances in the apple that cause the apple flesh to turn brown. A family of four genes controls the majority of PPO production. By inserting low-PPO-producing genes from other apples, scientists were able to turn off more than 90 percent of PPO production, giving rise to the “Arctic Apple,” which doesn’t undergo enzymatic browning.
The same enzyme-suppression technology has been used to produce the non-browning, low-acrylamide “Innate” potato, which is expected to arrive in fast-food outlets later this year. (Acrylamide, a chemical found in small amounts in certain foods, causes cancer in some rodent models, but the significance of the levels found in humans’ diets is uncertain.)
Ordinarily, the development of a new apple variety would proceed uneventfully, but because the shutoff of the four genes was done with recombinant DNA technology (aka “genetic engineering” or “genetic modification”– i.e., “GM”), the proposed commercialization of this new variety has met with unconscionable and irresponsible regulatory delays.
USDA’s policy and execution toward new genetically engineered plant varieties have been reprehensible from the start. The Arctic Apple—and those who would benefit from growing, selling and eating it—are only the latest victims.
Since the 1980′s, there has been a broad consensus in the scientific community (which has been reflected in statements of overarching federal government policy) that the newest techniques of genetic modification are essentially an extension, or refinement, of older, less precise and less predictable ones, and that oversight should focus on the characteristics of products, not on the process used to craft them.
However, intent on building a regulatory empire, USDA heeded neither the consensus of the scientific community nor the directives from the White House. The resulting unscientific, stultifying regulation has inhibited research and development, particularly in public institutions ever since and has provided an endless source of mischief, including superfluous, obstructive government bureaucracies; wasteful spending on poorly-conceived risk-assessment research; vandalism of field trials; and bad-faith legal harassment and endless nattering by activists.
Some history is necessary to understand how misguided USDA regulators have been. USDA’s Animal and Plant Health Inspection Service (APHIS) had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are “plant pests,” defined by means of an inclusive list – that is, essentially a “thumbs up or thumbs down” approach. A plant that an investigator might wish to introduce into the field is either on the inclusive, prohibited list of plants pests — and therefore requires a permit — or it’s exempt.
This straightforward approach is risk-based, in that the organisms required to undergo case-by-case governmental review are an enhanced-risk group — organisms that can injure or damage plants — compared to organisms not considered to be plant pests. But for a quarter century, this risk-based USDA regulation has had a kind of evil twin — a regime focused exclusively on plants altered or produced with the most precise genetic engineering techniques. USDA tortured the original concept of a plant pest as something known to be harmful and crafted a new, jury-rigged category: a “regulated article,” defined in a way that captures virtually every genetically engineered plant for case by-case review, regardless of its potential risk.
In order to perform a field trial with a regulated article such as the Arctic Apple, a researcher must apply to USDA and submit extensive paperwork before, during and after the field trial. After conducting field trials for a number of years at many sites, the developer then submits a large dossier of data with a request for “deregulation” by USDA, which is equivalent to approval for unconditional cultivation. These requirements make genetically engineered plants extraordinarily expensive to develop and test–which is the reason that up to now, commercialization has been limited primarily to huge-scale commodity crops.
USDA’s discriminatory treatment of genetically engineered plants — most of which have been modified for enhanced pest-, disease-, or herbicide-resistance — makes no sense. Plants have long been selected by nature and bred by humans or irradiated to create mutants with enhanced resistance or tolerance to external threats – insects, disease organisms, herbicides and environmental stresses – to their survival and productivity.
Plants have also been modified by farmers and plant breeders for other qualities, such as yield and attractiveness to consumers. Corn has undergone gradual but drastic modification that has seen it evolve from the original grass-like plant, teosinte, with primitive, meager kernels, into modern varieties with regularly arranged kernels bulging with carbohydrates, oils, and proteins. Primitive wheat breeders crafted various varieties for different uses, often by crossing wheat varieties with remotely related species of wild grasses. As is the case for corn, modern-day wheat varieties bear little resemblance to their ancient precursors.
After years of testing, in February 2012 the creator of the Arctic Apple, British Columbia-based Okanagan Specialty Fruits, filed an application for “deregulation,” which would permit unrestricted cultivation and marketing. The company is still waiting for approval, and it is not likely to be forthcoming soon: USDA reopened the public comment period until the end of January to solicit comments “on whether these genetically engineered apples are likely to pose a plant pest risk.” (That’s about as likely as the possibility that they will harm dogs that relieve themselves on the trees.) The bureaucrats will now need to review the comments and prepare and publish responses to them. It’s doubtful that will happen this year.
There are several reasons that such a delay is unnecessary and inappropriate.
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