Archive for the ‘Biotechnology’ Category

Panel suggests science-based approach to biotech product approval process

Written by Jonathan Eisenthal

The cost and time required to “deregulate” a new biotech product hurts the global competitiveness of American farmers, according to four experts drawn together for a panel discussion on the current state of ag biotechnology.

Ann Wright, undersecretary for marketing and regulatory programs at USDA, led off the biotechnology discussion at Minnesota Agricultural Leadership Conference, which took place August 16 and 17 in Brainerd, Minnesota. Minnesota Corn Growers Association organized the event.

Joining Wright on the podium were Tracy Linbo, director of Biotech Affairs for Pioneer Hi-Bred; Keith Reding, lead representative of Monsanto’s regulatory policy group; and Jack Bernens, head of technology acceptance for Syngenta.

Biotechnology proved timely topic. The ISAAA–The International Services for Acquisition of Agri-biotech–recently reported that in 2010, crops modified by molecular methods were grown in 29 countries on more than 360 million acres, showing that farmers embrace biotechnology wherever and as soon as it becomes available.

Wright described the process the USDA must undertake to allow a new biotech product to hit the market. Wright’s office develops Environmental Assessments and Environmental Impact Statements for approximately five products a year. Twenty four products are currently in the midst of this process. Many more products would likely gain approval, but for the legal wrangling brought by opponents of genetically engineered products.

Such opponents use the provisions of the National Environmental Policy Act (NEPA)–a law passed during the Nixon administration–to force USDA to create vast environmental documents for any product that a company wants to introduce. Her office generated a 2,500-page document in support of a new herbicide tolerant alfalfa product.

“A study of biotechnology approvals looked at how long and how costly it is to commercialize a product,” Pioneer’s Linbo told the audience. “The average worldwide is 13 years and approximately $135 million dollars. In US, the average time it takes is 7 to 9 years. The process of dealing with key (overseas) market approvals draws it out even further.”

“The regulatory process and conversations around biotech are going to have to change some,” said Wright, with nods of agreement from the rest of the panel. Several noted that rather than any scientific basis, opposition to products like amylase corn, genetically engineered to increase ethanol yield from corn, comes down to an emotional aversion to GMOs–genetically manipulated organisms.

Monsanto’s Reding said, “Of those 24 products (currently in the process of deregulation), we have nine that are pending, including drought tolerant corn, soybean and canola products. We have spent a lot of time on alfalfa and sugar beets. We’ve spent four years for the legal challenge to Roundup ™ alfalfa.”

Farmers who could be using these products years earlier to boost their production and add value to it, are the victims of this misuse of the legal and regulatory framework, according to Reding. All agreed it is the consumer, whose food supply needs to keep pace with rapid expansion of human population, who suffer from the delay of these innovative products. Many of these products promise more efficient use of precious resources like water, or reduction of environmental impacts–through more efficient use of fertilizer and other inputs.

Reding described the current tactic used by environmental groups. A law called “Equal Access to Justice,” allows individuals or groups to file for government payment of the legal costs incurred in civil and regulatory lawsuits against corporations. These lawsuits, which can cost corporations millions to see through a full court process, are meant to elicit a settlement on behalf of the environmental activist group. Such groups then take these funds wrung from corporations to research and undertake further challenges under the NEPA law.

“We have the gold standard in terms of our regulatory process,” said Syngenta’s Bernens, referring to the thorough and rigorous scientific testing of products prior to approval. Bernens said, “That process is being challenged through our court system. What does that mean for us as a country?”

The conclusion of this rhetorical thrust: America is losing its competitive edge.

Bernens gave this example: “Syngenta has its Dipthera product, which offers breakthrough insect protection. Other countries are getting cultivation approvals before US farmers. That’s a change from where we used to be, when US farmers always had the first look at new technology.”

Wright noted that the USDA appreciates the efforts of Syngenta in particular to bring together a stakeholder group to discuss and hopefully reform the entire process to make it less burdensome.

Voices from academia are rallying to the cause. In an opinion piece recently published in the New York Times, Nina B. Federoff, noted that exhaustive governmental analysis around the world has overwhelmingly concluded that genetic engineering poses no risks in and of itself. Federoff declared that it is time to “relieve the regulatory burden” in the field of biotechnology.

“The European Union has spent more than $425 million studying the safety of genetically modified crops over the past 25 years,” Federoff wrote, she is a biology professor at University of Pennsylvania and a former science advisor to the US Secretary of State (2007-2010). Federoff concluded, “(The European Union’s) recent, lengthy report on the matter can be summarized in one sentence: Crop modification by molecular methods is no more dangerous than crop modification by other methods. Serious scientific bodies that have analyzed the issue, including the National Academy of Sciences and the British Royal Society, have come to the same conclusion.”