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Agrimarketing : Crop Life America
process for new active ingredients under the data requirements of FIFRA '72. Driven by the new law's expanded data requirements and the fact that a new regulatory entity, the EPA, was now reviewing and approving pesticide licenses, the reg- ulatory process started to consume 14 or more years of the then 17-year patent life. Meanwhile, NACA was also lob- bying for data protection to ensure that companies which paid for the cost of data necessary to obtain EPA registrations for new pesticides, and new uses of previously registered pesticides, were compensated for the use of that data by follow-on regis- trants. In 1978, Congress amended FIFRA to provide those protections, but NACA was unsuccessful in its efforts to obtain patent restoration for new molecules. Congress granted patent restora- tion to the pharmaceutical industry, but not to the pesticide industry. But the pesticide industry did not, in the process, yield to certain other con- cessions that the pharmaceutical industry agreed to in order to get their patent restoration legislation. In the end, some products benefited from this outcome while others may have had a better result had the pes- ticide patent extension passed. THE DATA FOCUS Because FIFRA '72 increased the data requirements necessary to obtain registrations, NACA sharp- ened its focus on the science under- lying pesticide regulation. Under 1978 amendments to FIFRA, more- over, the law required companies to provide EPA with all reports, anec- dotal or otherwise, of adverse effects from their products. This prompted one company "to back up a truck at the EPA office at Waterside Mall and dump a huge pile of documents at the Agency's door," recalls one industry veteran, adding, "EPA charged them with 'malicious compliance!' " FIFRA '78 also required EPA to expeditiously re-register all pesti- cides, but the agency was going very slowly. EPA was re-registering only one or two pesticides a year, and so, Congress in 1988 amended FIFRA to speed up the process. Congress kept churning out additional regulatory burdens, and there were some com- panies which, by the late 1980s, were finding the burden of complying with the new regulatory burdens impossible --- and that's when sig- nificant consolidation in the industry began. THE 1990s Ray McAllister, who joined NACA in 1988 as Dir, Regulatory Affairs, says the re-registration overhaul once again changed the regulatory landscape for EPA and industry. "The re-registration process mandated by FIFRA '88 was new for everyone," McAllister recalls. "EPA had to develop entirely new proce- dures, which created a healthy ten- sion between industry and the agency. We didn't always agree with their re-registration decisions, but they were open to our input." In 1994, NACA was renamed the American Crop Protection Association (ACPA) to reflect a new focus on biotechnology and the desire to rebrand the industry for what it does --- protect crops. How- ever, while ACPA played a key role in the development of EPA registra- tion procedures for biotech "plant incorporated protectants," the domi- nant, regulatory event of the 1990's continued to revolve around tradi- tional chemical crop protection products. In 1996, a compromise agreement among environmentalists, ACPA and key lawmakers led to the aboli- tion of the aforementioned Delaney Clause and enactment of the Food Quality Protection Act (FQPA). No one involved in the negotiations to package this major change to the pesticide laws fully understood the implications of the magnitude of the work EPA would need to complete--- hard deadlines which directed EPA to review nearly 10,000 pesticide tol- erances with a level of scrutiny that actually required EPA to invent new science. Although the use of some major products has been severely restricted, and a few products have been withdrawn from the market- place, the participation of ACPA in the scientific evaluations of FQPA implementation helped save innu- merable crop protection products from cancellation. While the tolerance reassess- ments mandated by the FQPA are largely finished, the impacts of the FQPA are far from over. Its mandate for endocrine disruptor screening remains a work-in-progress, but the program promises to raise enormous scientific controversy once it is launched. Litigation has become an increas- ingly valuable tool for the associa- tion. "During our most challenging days of FQPA implementation, we brought legal action against EPA to challenge certain stages of the agency's process --- we ultimately resolved these issues out of court, but we got the correct end-policy result," says CLA Exec VP and General Counsel Doug Nelson. "Since then, we've turned to the courts to seek proactive solutions on a number of issues, and, of course, take strong defensive positions when our industry and/or the EPA are under attack." LOOKING AHEAD Political action and activity are also strong suits of the association. Beau Greenwood, CLA Exec VP, Government Affairs says, "CLA's political action committee enables our association to support candi- dates for Congress who commit to the concept of hard science based regulations, and oppose politically motivated pesticide product deci- sion making." CLA and its members have come a long way in 75 years --- but they all see that 75 years young is just the beginning. The real production demands on farmers to meet the food needs of 8 to 10 billion people, plus their fiber needs from cotton and renewable fuel needs, mean the needs for crop protection only soar into the future. "Our members are ready, and CropLife America and our global net- work must be there to bring common industry positions together to deal with the health and safety issues and public communications outreach which will be even more critical to our industry's future than it has been in the past," Vroom concludes. AM A BRIEF HISTORY/continued from page 5 6 AgriMarketing CropLife America Supplement
January February 2008