How Unwitting Kiwis Punched through U.S Biotech Regs

A few years back, several New Zealand scientists began tinkering with petunias. Playing with pigment genes, they developed biotech varieties with lush dark leaves, their flowers popping against a midnight backdrop. The Kiwis wondered if they could sell their flowers. They wrote to regulators in the United States, the country most open to genetic engineering. The Agriculture Department responded, saying the petunias, because of the technology used, did not require its oversight -- a promising decision.

They had no idea they'd blown open a huge loophole in U.S. biotech regulations.

The USDA's petunia decision is set to revolutionize the way GM crops from trees to fruit are regulated. The precedent has created a route for developers to get their products to market with less oversight and at a far more rapid, and cheaper, pace.

The petunia pathway does not end government oversight of all biotech plants or animals, especially those intended for human consumption, but it shakes the foundation of the long-standing framework used to oversee these products.

It may allow new products to skirt extensive environmental review.

The precedent's vast potential became clear earlier this month, when USDA announced that it wouldn't consider a biotech lawn grass developed by Scotts Miracle-Gro Co. Scotts got wind that the USDA had approved the Kiwi petunias. Many of the company's newer biotech grasses followed the same developmental pattern as the flowers. It was an intriguing precedent, and when Scotts wrote USDA last fall asking if its bluegrass would be regulated, it cited the agency's petunia letter as its supporting evidence.

Given the ratification provided by Scotts, anyone working in plant biotech would be foolish to not follow the de facto guidelines USDA has now established, said Drew Kershen, an agricultural law professor at the University of Oklahoma who has in the past consulted for the biotech industry.

Longtime biotech opponents are outraged by USDA's decision to exclude certain categories of biotech crops from its oversight. It is a "blatant end-run around regulatory oversight," said George Kimbrell, a senior attorney at the Center for Food Safety, which has scored a spate of legal victories against biotech companies, including Scotts, in the past few years. "This illustrates that the agency is concerned only with getting these crops to market as quickly as possible, and not doing its job in regulating potential harmful impacts," Kimbrell said. "It's a microcosm of a larger regulatory failing."

During the 1980s, the government suffered from a split personality when it came to biotech rules.

The government accepted arguments that no new laws were needed to regulate biotech creations, instead adapting existing rules to modified plants, animals and microbes, a system called the Coordinated Framework for its shared responsibility between USDA, U.S. EPA and the FDA.

Since it had no new laws to empower it, USDA "captured" all the biotech plants made in the US under its authority over potential pests from the Plant Protection Act. In its early days, all biotech products involved either tools or DNA stemming from pests like bacteria and viruses, and so all plants fell under the department's sway. Since then, technology has shifted rapidly, in ways not anticipated by 1980s regulators. Scientists now understand the function of a wide variety of plant genes, not just microbial genes, and they can insert this DNA with tools like the gene gun, which shoots DNA into a plant with high-velocity metals. .

Given these advances, the New Zealand developers and Scotts, among others, could develop their plants without any technologies that could be considered plant pests, prompting USDA's ruling that they fell outside its legal control.
It was an almost inevitable loophole.

"The result of trying to treat biotech products just like any other plant pest or potential plant pest is precisely the kind of unintended consequences we see in the Kentucky bluegrass case," said Alison Peck, a law professor at West Virginia University. "No conscious decision was ever made by anyone to exempt this technology from oversight. Now we have a technology that is unregulated."

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