Seed companies including Monsanto Co., the world’s largest, will get speedier regulatory reviews of their genetically modified crops under forthcoming rule changes, the U.S. Department of Agriculture said.
The goal is to cut by half the time needed to approve biotech crops from the current average of three years, Michael Gregoire, a USDA deputy administrator, said today in a telephone interview. The changes will take effect when they’re published in the Federal Register, probably in March, he said.
Approvals that took six months in the 1990s have lengthened because of increased public interest, more legal challenges and the advent of national organic food standards, Gregoire said. U.S. farmers worry they may be disadvantaged as countries such as Brazil approve new technologies faster, said Steve Censky, chief executive officer of the American Soybean Association.
"It is a concern from a competition standpoint,” Censky said in a telephone interview.
Faster approvals also benefit seed developers by allowing them to profit from new products sooner, Jeff Windau, a St. Louis-based analyst at Edward Jones & Co., said in a telephone interview. The financial benefit is difficult to estimate until the new rules are in place, he said.
"If you can reduce the approval time, you get sales that much faster,” said Windau, who rates Monsanto “hold” and DuPont Co. “buy.” “It could be significant for the companies like Monsanto and DuPont.”
One way the USDA plans to speed up approvals is by inviting public comments as soon as seed developers such as Monsanto file a complete petition for deregulation of a biotech crop, rather than waiting until the end of the review, Gregoire said.
That will allow regulators at the USDA’s Animal and Plant Health Inspection Service, or APHIS, to address any concerns as they conduct their environmental analysis and risk assessment, he said.
"We can improve the quality of decisions by providing for this earlier public input in the process,” Gregoire said. “We are not sacrificing quality at all.”
Congress is helping to speed crop reviews by increasing APHIS’s budget for biotech regulation to a record $18 million this year, from $13 million in 2011, Gregoire said.
The Center for Food Safety, a Washington-based non-profit group that has successfully challenged approvals of Monsanto’s Roundup Ready sugar-beet and alfalfa crops, said the rule change is aimed at preventing opponents of modified crops from voicing criticism of the agency’s methods.
Working the System
"They are trying to work the system so they can dismiss public comments more quickly and easily in order to speed things up,” Bill Freese, a policy analyst at the group, said in a telephone interview. “It’s a rubber-stamp system. A real regulatory system will occasionally reject something.”
Under the rule changes, new versions of existing crop technologies, such as corn that produces a naturally occurring pesticide, would undergo a review lasting about 13 months, Gregoire said. That would be accomplished by making the agency’s determination final after a 30-day public review period, he said.
For new technologies, such as a crops engineered to tolerate a new herbicide, there will be a second comment period after the agency makes its preliminary decision, extending the duration of the review to about 16 months, he said.
Which of these two regulatory routes is taken for each of the 22 biotech crops currently under review will be announced along with the publication of the rule change, Gregoire said.