Biotech approvals more streamlined

APHIS catches up on backlog of biotechnology re-regulation requests.

After criticism on the amount of time it takes to approve biotech events in the United States, it seems the U.S. Department of Agriculture has upped its game.

During a House appropriations subcommittee hearing, USDA undersecretary Ed Avalos shared that the length of the petition reviews for new biotech events was reduced by more than 600 days when using the environmental assessment process.

“To strike the balance between rigorous scientific review and timely entry to the market of genetically engineered crops, USDA streamlined and improved the process for making determinations on petitions involving biotechnology,” Avalos testified.

Avalos shared that with this improvement, USDA estimates that the cumulative number of actions taken to deregulate biotechnology products based on a scientific determination will increase from a cumulative 87 actions in 2011 to an estimated 119 in 2016.

Animal and Plant Health Inspection Service Administrator Kevin Shea offered more details, and explained that, “You might recall a year ago I pledged to you we would cut the backlog of 16 by at least half, and I’m proud to say that the fantastic men and women who work in our biotechnology review program have indeed exceeded that goal, and there now only six of those 16 remain, so that means we reduced it by more than half.

“I would say this also, when we began our business process improvement just a few years ago, 2012, there were 23 re-regulation requests in the backlog. Since then 11 [more] requests to come in, so there were a total of 34 regulation requests. There are only six left. We got 28 out of 34 done. There are only six remaining. We’re going to get those done, we think, by the end of this fiscal year,” Shea testified.

Shea with the system now in “equilibrium,” the agency can not only handle the amount that comes in, but also do so more quickly. “It was taking us three to five years to do these things. We are now down to 15 to 18 months.” He noted the agency’s goal is no more than 15 months.

USDA withdrawing biotech rule

APHIS also said March 2 that it is withdrawing its 2008 proposed rule that would have amended the regulations regarding the introduction (importation, interstate movement, and environmental release) of certain genetically engineered organisms.

APHIS received over 88,300 comments on the proposed rule. Based on the scope of comments received, and in light of the experience APHIS said it gained over the past 28 years as well as continuing advances in biotechnology, APHIS has decided to withdraw the rule and begin fresh stakeholder engagement aimed at exploring alternative policy approaches. 

APHIS said it “intends to utilize an open and robust dialogue to drive the development of future regulatory or policy approaches, as well as new scientific knowledge whenever it is available.” That engagement will begin with a series of webinars that will be announced in the coming month.

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