U.S. tries to catch up to other countries on biotech backlog
By Sara Wyant and Sarah Gonzalez
USDA’s Biotechnology Regulatory Services is using a new process to speed up product reviews for biotech traits and potentially, enable more traits to be commercialized. But for some, the improvements can’t come fast enough, as U.S. farmers look for new biotech options that are sometimes available in countries like Brazil and Canada years before they are approved by USDA and EPA.
During a meeting late last month, USDA’s Deputy Administrator for Biotechnology Regulatory Services Mike Firko won kudos from farm organizations after announcing that his team would be able to clear its backlog of biotech crop petitions—those submitted before USDA announced process improvements in November 2011—by the end of 2014.
For example, Dow AgroSciences submitted a petition to USDA in December 2009 to deregulate a 2,4-D and glufosinate-tolerant soybean, and the agency expects to make a decision in July. Still, critics point out that the decision comes almost two years after the product won approval in Canada.
BRS notes that it has reduced its backlog from 22 petitions in March 2012 to seven. Currently the agency is working on a total of 14 petitions and one petition extension.
Andrew Walmsley, director of congressional relations at the American Farm Bureau Federation, said USDA’s s performance is improving “but they’re not where they need to be yet.” He said BRS is working effectively with industry to clear the backlog, and that it expects to remain on schedule once that is accomplished.
In addition, he said farm organizations are hoping to see the Environmental Protection Agency improve its approval timeline for herbicide and pesticide reviews, and will look for a set of approvals from that agency this summer and in the fall.
“We still have concerns…farmers desperately need these traits,” he said. “It’s a competitive issue that farmers in other countries have access to traits that American farmers don’t.”
The agricultural industry has been frustrated with petition reviews that have grown lengthier and more inconsistent over the past decade. In an analysis presented to USDA in May, several industry groups indicated that rival agricultural producing countries were already using biotech products that were still in the approval process in the U.S.
Statistics confirmed by industry groups involved in the analysis show that from January 2010 through June 2013, the average time from submission to decision was 372 days for Brazil, 771 days for Canada, and 1,210 days for the U.S. The averages were measured for single-trait products from the time companies asked for commercial approval, after field trials.
Congressional appropriators also expressed concerns over BRS’s performance during budget deliberations this year.
“USDA’s data showed that it took, on average, almost 900 days for eight products to be approved in 2013, despite the agency’s recent efforts to improve the review process. In addition, the backlog of petitions still remains,” according to the fiscal year 2015 agriculture spending bill passed by the House Appropriations Committee.
The bill provides the $18 million requested by the White House in funding to BRS “to ensure regulatory decisions can be made in a more timely and predictable manner,” and asks USDA to continue to improve its review process.
Predictable timelines for USDA and EPA approval are critical as companies say they are spending, on average, an estimated $136 million to develop new products. Often those timelines are interrupted by lawsuits.
“Concerns about the prospect of future litigation have led to unnecessary delays in product approvals and escalating information requirements to gain those approvals, in spite of a well-established history of safe use,” according to the industry analysis.
For example, from 1992 to 2000, the USDA set a goal for deregulating biotech crops in 180 days. According to its own estimates, decision-making timeline grew to 897 days, on average, from 2006 to 2010.
In spite of instituting process improvements in November 2011, the average time from submission to deregulation in 2013 was only shortened to 890 days, the report noted.
Under the new process, 450 days should be the maximum for a final decision. “Therefore, the 2013 average of 890 days is still essentially 100 percent greater than the BRS target timeline,” the industry analysis notes.
Firko said he believes BRS will be hitting the new goals for all petitions by the end of 2015.
But even if that happens, EPA’s process could still add significant delays to new biotech approvals.
For example, USDA approved Bayer’s isoxaflutole-tolerant soy in August 2013 after more than three years of review. However, the EPA has yet to approve the requested label change to use the isoxaflutole herbicide on soybeans, continuing to make the product unmarketable.
The industry analysis notes that before 2007, EPA met its legally mandated timelines on decisions for the biotech crops it regulates as frequently as it met the required timelines for decisions on conventional pesticides. But from 2009 to 2012, “while it missed the deadlines for conventional pesticides for an average of 21 percent of its decisions, 64 percent of EPA’s decisions on biotech crops were delayed, on average.”
Editor’s note: Agri-Pulse Editor Sara Wyant can be reached at www.agri-pulse.com.