Reregistration is a Long Dance

August 25, 2015 12:29 PM

Pesticide reregistration is a dance that doesn’t end. The tempo is supposed to be dictated by science, but when the clock nears midnight, regardless of a product’s importance to agriculture, in comes a compulsory mix of science, politics, environmental issues and safety factors.

Congress established a 15-year cycle as a precaution to keep crop protection science parallel to all market products. Each year, EPA reviews registration on 60 to 70 active ingredients and, at any one time, will have several hundred chemical reviews in progress. Ideally, the process for each compound takes about five years. In the course of Reregistration Eligibility Decisions (REDs), EPA evaluates on-hand data, determines if additional information is needed and calls in new data from registrants. After review, adjustments or risk assessments are made.

“If not much has changed, in theory, it’s a smooth process and data submissions may not be required,” says Ray McAllister, senior director of regulatory policy, CropLife America. “However, that’s not been my experience. There are usually many changes and new data required with ever-increasing restrictions on use.”
EPA requests specific data and studies from registrants, specifying protocols and how studies should be conducted. EPA offers the public an opportunity to comment and submit relevant information on products and active ingredients.

“We have a high degree of confidence in how EPA processes data and we’re vigilant regarding EPA data handling,” McAllister says. “There are attempts to influence the process from all sides, and EPA is under pressure to obtain correct scientific data and make sound scientific decisions.”

Panel findings ultimately form the basis for EPA decisions. Mark Surprenant, partner, Adams and Reese LLP, has been involved in 10 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) scientific advisory panel (SAP) hearings.

“Panels are composed of nationally-recognized experts from across the country,” Surprenant explains. “The process is fair, and science determines the outcome.”

At the conclusion of testimony and process, in an open session, panel members comb through EPA questions and compose a comprehensive report within roughly 60 days after the close of the hearing. The report is presented to EPA as a matter of public record.

During the past 15 years, endangered species and endocrine testing issues have come to prominence, serving as evaluation roadblocks and a significant burden during registration review. Both issues have formed a Gordian knot for EPA, with environmental activists, agriculture and the public wrapped in the tangle.
To produce studies to satisfy new requirements, registrants bear the cost. By the time a product is subject to registration review, it’s likely off-patent and less profitable. Therefore, the process is more of a strain for the registrant. EPA funds reregistration costs by requiring registrants to pay product maintenance fees—about $3,000 to $4,000 per product per year. Annually, approximately $28 million is funneled to registration review, with additional costs covered by congressional appropriations.

With constant testing and scientific monitoring, pesticide reviews present an ongoing battle for the agriculture industry. Unless Congress makes a change, the review cycle is fixed, regardless of the safety level behind a product.

“As the years accumulate, hopefully this process will become less difficult. We have to repeatedly demonstrate safety and utility,” McAllister says. “There always will be detractors trying to remove products from the market. Those people will always ignore science and believe products are never safe.”
Kurt Reeg, partner, Goldberg Segalla, is alarmed by the adjudication power of EPA during pesticide reviews and believes the rolling 15-year reviews enable activists to reload and regroup.

“Supporting science is irrelevant for the activists: If we didn’t get you this time; we can get you on the fourth or fifth go-around with a study of some kind,” he says.

The long-run costs to the agriculture industry are debilitating, Reeg adds. Once a manufacturer goes through the initial battle for approval, the process quickly begins again. He warns against taking reregistration for granted.

“Reregistration eats up the clock and burns a lot of money,” he says. “Activists know SAPs have the power to take scientifically-based herbicides off the market down the road. There would be a real, practical effect if vital products got blocked at reregistration.”

Agriculture must have the highest standard of vigilance in making certain products are safe—a burdensome task when government, industry and activists are all vying for position.

How Reregistration Came to Be

As a concept, reregistration dates to the 1970s when Congress directed the Environmental Protection Agency (EPA) to examine products already on the books and make certain they met updated scientific standards. EPA went through more than 20 years of fits and starts in setting up pesticide reregistration. In 1996, with passage of the Food Quality Protection Act, Congress gave EPA hard deadlines for completing reregistration and established a 15-year revolving schedule for repeating “registration review” but left schedules a little loose. In 2008, EPA finished reviews on pesticides registered before Nov. 1, 1984. In 2007, Congress mandated the first round of registration review be completed by 2022.

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