What's behind the delay in biotech approvals?

By Sarah Gonzalez

© Copyright Agri-Pulse Communications, Inc.



WASHINGTON, April 9, 2014 - The USDA's Animal and Plant Health Inspection Service (APHIS) launched a process three years ago to cut the time it takes to approve biotechnology crop products, but industry stakeholders are still scratching their heads over what's taking so long.

In the meantime, other countries are jumping ahead. This will be the first year farmers in Argentina, Brazil and Canada have access to new seed traits enhanced through biotechnology that are not yet approved for planting in the U.S., noted Cathleen Enright, Ph.D., BIO executive vice president for food and agricultural policy, during a presentation to farmers this spring.

According to an APHIS Biotechnology Regulatory Services (BRS) presentation to stakeholders in November, APHIS completed one petition from start to finish in 658 days, “reducing the average time from the old process by 364 days.” The petition had been submitted by Genective for glyphosate-tolerant corn in December 2011, shortly after the agency announced its new approval process, according to an APHIS spokesperson.

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While USDA did significantly improve the approval timelines for some products, the most recent data show the complete deregulation process ranges between 400 to 1,500 days, according to another presentation from APHIS's stakeholder meeting. Most recently, in March, USDA deregulated a herbicide resistant soybean product from BASF, which the company first submitted in 2009. 

The biotechnology industry, understandably, has been pushing USDA to speed up the approval process, especially as agricultural rivals such as Brazil ramp up biotech crop plantings.  

During the Senate Appropriations hearing, Sen. Roy Blunt, R-Mo., asked Ag Secretary Vilsack about Brazil's regulatory process, noting “they have what neither of us would consider a backlog” of biotechnology petitions.

Vilsack said Brazil's approval system begins at a different point in the process than APHIS's. “If it started where we do, their timelines would be similar to ours,” he said.

APHIS's analysis of its deregulation decisions indicate that from 1992 to 1999 the approval process took 178 days, but the timeline increased significantly in the past decade. By late 2011, the average time to complete petition determinations was around three years. In November 2011, APHIS announced it would reduce the timeline by standardizing and streamlining the process, with the goal of cutting it by more than half.

During a hearing last week, Rep. Robert Aderholt, R-Ala., chairman of the House Appropriations agriculture subcommittee, asked USDA officials about the review process involving eight products that took, on average, about 900 days.

“Many in Congress are concerned that the politics of biotech may be interfering with the scientific review process,” Aderholt said. Of 22 backlogged petitions from 2013, the department has approved six, he said.

Ed Avalos, USDA undersecretary for marketing and regulatory programs, told the lawmakers the department is committed to reducing the petition timeline, “but in a way that does not impact the integrity of our work.”

“I acknowledge that our averages were really slow and if you look at the point we'd gotten to by late 2011, it was taking too long,” Deputy Administrator for Biotechnology Regulatory Services (BRS) Mike Firko told Agri-Pulse in an interview. Unfortunately, he said several petitions remained stuck in the old system even after the new process launched.

Firko clarified that the 360-day reduction Vilsack referred to applied to just one petition which was handled after the agency began implementing its new system. APHIS was able to provide nonregulated status within about 650 days, instead of the old average of almost 1,000 days.

When APHIS announced its new approval process in late 2011, the agency had 23 pending petitions and has received eight additional petitions since then for a total of 31. Fourteen petitions have received non-regulated status under the new system, Firko said, and the backlog now sits at 15. 

“That backlog went from 23 to 15,” Firko said. “We knew from day one that this wasn't going to be like flipping a switch and all of sudden we'd go from three years to 14 months.”

Within the updated process, petitions can take two different paths. If the product is similar to what APHIS has already deregulated, the goal is to approve it within 13 months. If the product is new, it should take 15 months. Firko hopes the department will be meeting those goals by the end of 2015.

“The biggest challenge is the backlog,” Firko said. “We're making big progress. Once we're at a steady state, and we're getting in as many as pushing out, the 13-15 months is going to be possible.”

The agency approved nine products for deregulation in 2013. ”Not only do we have a large number of petitions coming in, we've cut the time down on those,” he said. “We're very anxious to meet the deadlines we've established,” he said. “We're conscious of the fact that we've raised expectations.”

During last week's hearing, Avalos and Aphis Administrator Kevin Shea, said the USDA needs the time to get a petition decision right in hopes of avoiding litigation.

“We don't want to deregulate a product and then face litigation, which we have faced on every major product we have deregulated,” Shea said. “We have to be careful that we don't make a decision that can be overturned in court.”

Aderholt asked Shea how much money USDA has had to pay to settle lawsuits related to approval of the use of genetically-modified organisms. Shea said that in 2012, USDA paid out about $3 million.

“We end up paying plaintiffs' legal fees because they prevail on grounds that we have not done sufficient environmental impact statements,” Shea said. “We are trying so hard to do all the required environmental work up front.”

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