Regulations seen slowing down fast-moving plant biotech

by Laura Lloyd
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KANSAS CITY — Plant scientists have the technology to introduce a variety of traits into many plant species through bioengineering, but the main hurdle remains regulation, said Thomas E. Clemente, Eugene W. Price Professor of Biotechnology in the Department of Agronomy and Horticulture at the University of Nebraska.

Speaking at the Wheat Quality Convention’s annual meeting on Feb. 18, Dr. Clemente said genetic research in university laboratories is basic R.&D. exploring a wide variety of discoveries in biotechnology that may then be developed  by private industry into commercially viable products. Bioengineered strains of wheat remain in the offing because the complete sequencing of the very large wheat genome was first accomplished only a few years ago.

“What is fundamental today is what is applied tomorrow,” Dr. Clemente told his audience of several hundred convention participants at the two-day meeting.

In a number of plant species used in food, basic research has figured out how to add a single gene to a chromosome to make a change in a characteristic of the plant that will be inherited in the next generation like all the genes of that plant, Dr. Clemente said.

Citing Monsanto Corp.’s “Roundup ready” soybeans, on the market since 1996 and still the best-known bioengineered plant variety, Dr. Clemente boiled down the process of adding this trait of herbicide resistance to the soybeans sold by Monsanto: “At the end of the day, we have one more gene sitting on one more chromosome sitting in one position,” he said. “Soybean, 50,000 genes. Round-up ready, 50,001.”

The actual processes used to integrate new DNA into a plant are complex, time-consuming and expensive, Dr. Clemente said. He cited current research to bioengineer an increased amount of oleic acid in soybeans, which would improve soybean oil’s heating characteristics and was, in his opinion, likely to be present in the genetic makeup of all U.S. soybeans by 2022. He argued that students pursuing work in biotechnology need to be able to explain to private-sector professionals what they are learning in the laboratory and through field testing.

“When you go out into the real world … you’re reacting to a large group of other researchers, business people, lawyers who are able to make stuff happen” in the marketplace, Dr. Clemente said.

But the transition from basic research in universities to bioengineered products in the marketplace is heavy with challenges.

“How do we get to the marketplace? Contrary to anti-science deniers, this work is highly regulated,” Dr. Clemente said. “I cannot take seeds developed in my laboratory and take them across state lines without approval of the federal government.”

He said frequent inspections by the U.S. government of laboratories involved in biotechnology research were the norm.

“Last year, my laboratory got inspected 12 times within three months,” he said. “They wanted to know the source of the gene — did you get it from a bacterial source, did you get it from another plant species. Each of the pieces of DNA — they wanted it detailed. And they want to know how you are going to move it, how you are going to take it from point A to point B.”

He said government inspectors require information on how a bioengineered plant will be watered and how researchers would be able to control “volunteers’ growing in fields during the following crop year.”

“With something like wheat, you are going to have to moderate it for something like two years post-harvest,” he said.

The regulatory process involving the U.S. Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency, as well as intellectual property attorneys and the U.S. Patent Office, can be daunting, said Dr. Clemente.

“I can tell you there are a lot of technologies sitting on the shelf — and you only see these technologies for the big commodities — because of this regulatory situation,” Dr. Clemente said.

But he added that, despite many time-consuming and expensive regulatory hoops to jump through in the United States before a bioengineered product may enter the marketplace, the end of the process brings a reward not available in some other countries.

“Once you make it and that product is ‘deregulated,’ you are fine,” he said, “but the same rules don’t apply throughout the world.”

Other nations such as the European Union and South Korea require repeated recertification of safety every few years, said Dr. Clemente.
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