Biotech firms seek speedier reviews of seeds
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Scott Kilman, April 28, 2010
The crop-biotechnology industry, growing frustrated as it watches the approval time for new seeds almost double under the Obama administration, is pressuring Washington to clear inventions more quickly.
The logjam at the U.S. Department of Agriculture, which must clear genetically modified seeds, is slowing the launch of products that could give farmers more alternatives to seeds from crop biotech giant Monsanto Co.
Also, some biotech-industry executives worry the delays signal that the Obama administration, which has painted itself as pro-biotech, is gearing up for a far tougher analysis of the potential environmental impact of these crops, which could make it harder for inventions to reach the marketplace.
On average, a genetically modified seed takes 1,188 days to pass federal scrutiny, almost twice as long as in 2008, the last year of the Bush administration, according to the Biotechnology Industry Organization, a Washington, D.C., trade group.
"There is concern we might see other countries move ahead of the U.S.," said Sharon Bomer Lauritsen, executive vice president of food and agriculture at BIO, who added that the delays "might stifle investment in what has been a very dynamic part of the U.S. economy." BIO's members include hundreds of companies such as DuPont Co., Syngenta AG and Monsanto, as well as academic institutions.
Members of BIO and industry leaders are meeting with Obama officials and supporters in Congress to press their issue, hoping to speed the process.
Officials at the USDA said its biotechnology-regulation office is coping with a soaring number of comments from the public and a flood of new seed inventions, some of which will likely require more-rigorous environmental reviews than past plants because they would grow in new places, such as drought-tolerant corn, or use food crops to make industrial products.
Companies submitted nine genetically modified crops for review last year to the USDA, which has typically received three or four petitions annually. The USDA signed off on three genetically modified crops last year compared with the five-a-year rate it had averaged since the 1990s.
The agency, long a cheerleader for U.S. crop biotechnology, has never turned down a genetically modified crop, although inventors have withdrawn some candidates.
Caleb Weaver, USDA press secretary, said the department is "looking into both immediate and long-term solutions to increase the efficiency and effectiveness of the review process."
Among other things, the USDA is asking Congress to increase its annual biotechnology oversight budget by 46% to $19 million.
The slowdown comes as regulators in rising agricultural powers such as Brazil, Argentina and China are showing more enthusiasm for genetically modified crops. Brazil approved nine genetically modified crops in 2009 compared with five in 2008, while Argentina approved two crops for commercialization.
The crop-biotechnology market has grown rapidly since Monsanto's weed killer-immune soybean was introduced in 1996. Nearly 90% of the corn, soybeans and cotton grown in the U.S. is produced from plants that have been given foreign traits through gene splicing, such as the ability to make a natural insecticide. Farmers world-wide are paying roughly $9 billion annually for genetically modified seed.
The vast majority of genetically modified crops grown in the U.S. are equipped with Monsanto genes, which has put the St. Louis company in the sights of the Justice Department's antitrust enforcers. Monsanto has said its practices are legal and promote competition.
The federal government must review a genetically modified crop before it can be commercialized. The Food and Drug Administration must sign off on food safety, the Environmental Protection Agency looks at any pesticides that crops have been given the genetic blueprints to make and the USDA is charged with making sure that any genetically modified crop couldn't morph into a plant pest.
Despite the regulatory back-up, industry executives are leery of criticizing the USDA, partly because they count Agriculture Secretary Tom Vilsack as a crucial supporter. Mr. Vilsack received BIO's Governor of the Year award in 2001 for his support of the industry while he was Iowa's top elected official.
The USDA has cleared 80 genetically modified crops for commercialization since the 1990s, a process that involves a federally mandated environmental analysis.
So far, only three genetically modified crops have been targeted for an "environmental impact statement," the most thorough form of the environmental review required by law. In two of the cases federal judges concluded the USDA was obligated to conduct the time-consuming studies.
Meantime, a variety of corn genetically modified by Syngenta has been in regulatory limbo since 2005. The seed makes an enzyme used in the production of ethanol fuel. Syngenta, which has invested a few hundred million dollars to develop the corn, figures ethanol producers would pay U.S. farmers a premium to grow it.
The USDA is wading through public comments on Syngenta's petition this spring, which means that the seed has missed another Midwest planting season.
"We see no reason why deregulation of this important product should be delayed any further," said Paul Minehart, a Syngenta spokesman.
The crop-biotechnology industry, growing frustrated as it watches the approval time for new seeds almost double under the Obama administration, is pressuring Washington to clear inventions more quickly.
The logjam at the U.S. Department of Agriculture, which must clear genetically modified seeds, is slowing the launch of products that could give farmers more alternatives to seeds from crop biotech giant Monsanto Co.
Also, some biotech-industry executives worry the delays signal that the Obama administration, which has painted itself as pro-biotech, is gearing up for a far tougher analysis of the potential environmental impact of these crops, which could make it harder for inventions to reach the marketplace.
On average, a genetically modified seed takes 1,188 days to pass federal scrutiny, almost twice as long as in 2008, the last year of the Bush administration, according to the Biotechnology Industry Organization, a Washington, D.C., trade group.
"There is concern we might see other countries move ahead of the U.S.," said Sharon Bomer Lauritsen, executive vice president of food and agriculture at BIO, who added that the delays "might stifle investment in what has been a very dynamic part of the U.S. economy." BIO's members include hundreds of companies such as DuPont Co., Syngenta AG and Monsanto, as well as academic institutions.
Members of BIO and industry leaders are meeting with Obama officials and supporters in Congress to press their issue, hoping to speed the process.
Officials at the USDA said its biotechnology-regulation office is coping with a soaring number of comments from the public and a flood of new seed inventions, some of which will likely require more-rigorous environmental reviews than past plants because they would grow in new places, such as drought-tolerant corn, or use food crops to make industrial products.
Companies submitted nine genetically modified crops for review last year to the USDA, which has typically received three or four petitions annually. The USDA signed off on three genetically modified crops last year compared with the five-a-year rate it had averaged since the 1990s.
The agency, long a cheerleader for U.S. crop biotechnology, has never turned down a genetically modified crop, although inventors have withdrawn some candidates.
Caleb Weaver, USDA press secretary, said the department is "looking into both immediate and long-term solutions to increase the efficiency and effectiveness of the review process."
Among other things, the USDA is asking Congress to increase its annual biotechnology oversight budget by 46% to $19 million.
The slowdown comes as regulators in rising agricultural powers such as Brazil, Argentina and China are showing more enthusiasm for genetically modified crops. Brazil approved nine genetically modified crops in 2009 compared with five in 2008, while Argentina approved two crops for commercialization.
The crop-biotechnology market has grown rapidly since Monsanto's weed killer-immune soybean was introduced in 1996. Nearly 90% of the corn, soybeans and cotton grown in the U.S. is produced from plants that have been given foreign traits through gene splicing, such as the ability to make a natural insecticide. Farmers world-wide are paying roughly $9 billion annually for genetically modified seed.
The vast majority of genetically modified crops grown in the U.S. are equipped with Monsanto genes, which has put the St. Louis company in the sights of the Justice Department's antitrust enforcers. Monsanto has said its practices are legal and promote competition.
The federal government must review a genetically modified crop before it can be commercialized. The Food and Drug Administration must sign off on food safety, the Environmental Protection Agency looks at any pesticides that crops have been given the genetic blueprints to make and the USDA is charged with making sure that any genetically modified crop couldn't morph into a plant pest.
Despite the regulatory back-up, industry executives are leery of criticizing the USDA, partly because they count Agriculture Secretary Tom Vilsack as a crucial supporter. Mr. Vilsack received BIO's Governor of the Year award in 2001 for his support of the industry while he was Iowa's top elected official.
The USDA has cleared 80 genetically modified crops for commercialization since the 1990s, a process that involves a federally mandated environmental analysis.
So far, only three genetically modified crops have been targeted for an "environmental impact statement," the most thorough form of the environmental review required by law. In two of the cases federal judges concluded the USDA was obligated to conduct the time-consuming studies.
Meantime, a variety of corn genetically modified by Syngenta has been in regulatory limbo since 2005. The seed makes an enzyme used in the production of ethanol fuel. Syngenta, which has invested a few hundred million dollars to develop the corn, figures ethanol producers would pay U.S. farmers a premium to grow it.
The USDA is wading through public comments on Syngenta's petition this spring, which means that the seed has missed another Midwest planting season.
"We see no reason why deregulation of this important product should be delayed any further," said Paul Minehart, a Syngenta spokesman.
