Expert says federal regulatory reform needed to advance agbiotech

If genetic engineering applied to agriculture or to environmental applications is to reach anything approaching its potential, then there must be “drastic regulatory reform,” Henry Miller, the Robert Wesson fellow in scientific philosophy and public policy at Stanford University’s Hoover Institution, said.

“We need to reject the self-serving demands of anti-technology activists, educate the public, and make regulation by USDA, FDA and EPA more scientific and less ideological,” Miller, a physician and molecular biologist, told Crop Protection News.

Specifically, Miller said, reform must reduce the “redundant, prolonged case-by-case reviews that are the rule for organisms modified with molecular genetic engineering techniques.”

Ironically, according to Miller, the more that anti-tech activists lobby the government for stricter regulations and get them, “the more they further the interests of those they demonize – namely the big agribusiness companies.”

That’s because regulatory disincentives are potent, he said, “and they discriminate most against the little guy.”

He said on average it costs about $136 million to bring a genetically engineered crop plant to market, far more than other new plant varieties. Therefore, over-regulation, he said, favors big agribusiness, like "the Monsantos and Duponts."

Over-regulation takes the biggest toll on public entities such as universities and research institutions. In fact, Miller said, “the outrageous and unwarranted regulatory costs relegate academia, commercial startups and public institutions to the sidelines while the agribusiness companies with deep pockets dominate the game.”

Over-regulation is a particular problem at “gatekeeper” agencies such as the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), Miller told Crop Protection News.

For instance, the APHIS must grant an affirmative approval before virtually all genetically engineered crops can be legally sold, he said. According to data gathered by the U.S. government from January 2010 through June 2013, Miller said it takes many years for a new genetically engineered crop variety “to jump through regulatory hoops” and into consumers’ pantries.

“Yet crops created with far less precise, less predictable genetic techniques like chemical and irradiation mutagenesis, and wide-cross hybridization, slip through with nary a glance from either government regulators or a whimper from activists,” Miller said.

The object of regulation is supposed to be to regulate only those activities and products that may pose an unreasonable risk, but federal agencies have chosen regulatory triggers that are arbitrary and that lack a scientific basis, he said.

So can anyone expect these needed reforms in the foreseeable future? “When genetically engineered pigs can fly,” Miller responded.

“In spite of the scientific community’s best efforts to educate them over almost 30 years, the feds have failed to appreciate that the particular genetic technique employed to construct new strains and varieties is irrelevant to risk, as is the source of a snippet of DNA that may be moved from one organism to another,” he said.

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