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. Continue reading New self-reporting for GM crops
Tag Archives: Policy
Overwhelmed drug regulators seek cure in cooperation
Regulatory authorities such as the US Food and Drug Administration and European Medicines Agency face continual criticism for their plodding pace of drug approval decisions. In 2009, the last year for which complete data are available, the median time for a standard review of a drug application in the US was 13 months—30% longer than the agency’s target for such reviews. But even with this situation, it’s undeniable that both agencies devote far more human and financial resources to the process than most other countries can afford to spend on their own.
To keep up, many other medical regulatory authorities are banding together with one another to share the expertise and clinical results needed to make faster decisions. Continue reading Overwhelmed drug regulators seek cure in cooperation
Australian Government Silent on Synchrotron Budget While Scientists Plan Expansion
One might think that the managers of the Australian Synchrotron would be panicking given the news that neither the federal government nor the Victoria state government has addressed in their just-released budget proposals how the facility will be funded beyond June 2012, when its original 5-year financial plan ends. After all, the two governments currently provide most of the synchrotron’s annual funding. Yet, at least publicly, those running the synchrotron are thinking not about how to save the young facility but how to grow it. “We are now in the process of wanting to expand,” says Andrew Peele, a physicist at La Trobe University in Victoria who has been head of science at the synchrotron since late last year. Continue reading Australian Government Silent on Synchrotron Budget While Scientists Plan Expansion
Facing budget cuts, Spain launches funding foundation
MADRID — In Spain, the government’s overall spending on research is set to wither by about 8% this year, according to an analysis released last fall by the Confederation of Spanish Scientific Societies. Given the climate of budget cuts, it’s perhaps no surprise that scientists there are turning to the public for funding. Continue reading Facing budget cuts, Spain launches funding foundation