Companies seeking approval for new biotech crops can now prepare their own environmental study or hire an outside contractor to do so. The new options, announced by the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) in April, are part of a two-year voluntary pilot program designed to speed up document preparation, although critics argue such self-reporting is inevitably biased. Currently, genetically modified (GM) crops can take years to approve, as the agency faces a backlog of nearly two dozen petitions, according to APHIS deputy administrator Michael Gregoire. Before a crop can be deregulated, the law requires a preliminary environmental study, followed by a more comprehensive environmental assessment conducted by APHIS (the regulatory arm of the US Department of Agriculture (USDA). The environmental assessment costs the petitioner $75,000–$100,000, although the USDA may decide a crop warrants a more detailed environmental impact statement, which can cost over a million dollars. APHIS in most cases conducts the initial environmental reports, but in recent years it has paid contractors to handle that aspect of its growing workload, Gregoire says. The pilot program now allows petitioners to self-report or pay a contractor managed through APHIS. The drug industry follows a similar self-regulation system for managing the risks associated with drugs once they are on the market, known as Risk Evaluation and Mitigation Strategies (Nat. Biotechnol. 25, 1189–1190, 2007). Still, Bill Freese of the Center for Food Safety in Washington, DC, says there is a possibility with self-reporting of introducing errors which have, in the past, led to environmental assessments being overturned in federal courts. “The emphasis here needs to be on quality environmental assessments,” he says. “It’s not a cost-cutting measure if they end up in court.” But Greg Jaffe of the Center for Science in the Public Interest in Washington, DC, points out that “There are still enough checks and balances in the system.” As in other federal processes, falsifying or omitting information from an environmental report would be a criminal act, so “you can’t hide bad evidence” and like other agencies APHIS still must complete the environmental assessments itself, Jaffe says. “We’ll have to see in the end how well it’s done at this particular office.”
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The World Trade Organization has made a preliminary ruling that European Union restrictions on genetically engineered crops violate international trade rules. The United States, Canada, and Argentina together grow 80 percent of all biotech crops sold commercially, by which the EU regulates such crops. The countries argued that the EU’s regulatory process was far too slow and its standards were unreasonable given that the overwhelming body of scientific evidence finds the crops safe.
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