Biotechnology regulatory overhaul overdue

by Josh Sosland
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WASHINGTON — The regulatory structure guiding the introduction and production of bioengineered crops is badly out of date, discourages innovation and contributes to public uncertainty and the reluctance of emerging nations to accept the valuable technology, said a leading agricultural scientist.

Roger N. Beachy, president emeritus of the Donald Danforth Plant Science Center in St. Louis, made an impassioned case for regulatory change in testimony June 23 before the House Subcommittee on Rural Development, Research, Biotechnology and Foreign Agriculture. Dr. Beachy currently serves as director of the National Institute for Food and Agriculture.

From the perspective of safety and sustainability, the case in favor of agricultural biotechnology is overwhelming, Dr. Beachy said. He noted that in the time since regulations for biotechnology were put in place in 1987, more than 2 billion acres have been planted to bioengineered crops in 29 countries worldwide. The crops have been grown by 15.4 million farmers, more than 90% of whom are small growers in developing countries. Output from the farms have been consumed “in billions upon billions of meals by humans and livestock” around the globe.

“In all this vast experience, we have not had a single consequence of a novel or negative consequence for health or the environment,” he said. “In fact, we have seen some of the well known risks of conventional or organic agricultural dramatically reduced: (including the) the potential for contamination of food with cancer-causing compounds like aflatoxin in corn has been dramatically reduced through biotechnology.”

Dr. Beachy said the reduced use of harsh chemicals is a true measure of sustainability in agriculture.

“This is sustainability that is quantifiable, is defined by science-based criteria, not a ‘sustainability’ based on a philosophical approach that critics and the media often bandy about in criticizing conventional agriculture,” he said.

Dr. Beachy said the regulatory process in place for agricultural biotechnology was created to address concerns and risks perceived in the late 1980s.

“The regulatory process has not adapted to the experience of the past 24 years or to new knowledge generated during this period,” he said. “…It has not adapted to changes that have further enhanced the safety of the technologies. And it has not adapted to the needs of the market. The system needs attention, modification, and improvement if the U.S. and global agriculture communities and its consumers are to benefit from the investment in past and current science and technology that can impact agriculture and agriforestry.”

The burdens created by the current regulation adversely affect innovation, Dr. Beachy said. Particular pressure has been placed on smaller companies or institutions doing work in the field, he said.

“G.E. seeds for the commodity crops are produced by large companies that tend to be less constrained by cost and time,” he said. “In contrast, researchers and innovators in the academic community, including those that serve agriculture productivity, and in small companies, have considerably more difficulty in producing or delivering a genetically engineered crop to the market than do large corporations. Indeed, there are fewer than a handful of such products. Researchers in universities and small companies have since the mid-1980s made discoveries that are relevant to the less lucrative vegetable seed market, and in cutting edge areas that have potential to revolutionize the biofuels and biomaterials industry. Yet, there have been no new products released to the market from universities for more than 10 years, in part because of the time and cost necessary to bring the new product forward.”

Dr. Beachy estimated the cost of regulatory approval for products with a new genetically engineered trait at $5 million to more than $25 million with time to market of as much as 10 years.

“Some costs are, of course, related to technology development per se,” he said. “The bulk of the costs deal with the regulation process.”

Offering several examples of burdensome regulation, Dr. Beach said full biochemical characterization is required of the location of the gene in the DNA of the plant that is bioengineered.

“Scientific evidence accumulated during the past 20 years indicates that such case-by-case characterization is generally not relevant to the performance or safety of the crops themselves,” he said.

Offering four categories of proposed changes to the regulatory structure, Dr. Beach began by saying the government must return to a “firm commitment to base regulations on science.”

Other suggestions included:

1) Redefine the basis by which products of biotechnology are subjected to regulatory oversight;
2) Identify categorical exemptions that can streamline and reduce burdens for products experience has shown to be safe; and
3) Distinguish between real and perceived risks and focus on those perceived as real.
Dr. Beachy concluded by warning of further unintended consequences of overly stringent regulations.

“First, by the use of terminologies that falsely imply risk and potential lack of safety, we have created the perception that the technology itself is unsafe,” he said.

“Second, as a consequence of what many consider overly cautious regulation based on process rather than the safety of the product, many developing countries are reluctant to adopt the technologies and products developed from the technologies,” he said. “This has the effect of limiting acceptance of products of American agriculture and the development of crops that could benefit those countries.”

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