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: Business
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
Monsanto dips into algae
Monsanto acquired a stake in Sapphire Energy, a San Diego–based algae fuel company known for its prominent backers, including Bill Gates’s firm Cascade Investment, in Kirkland, Washington, and the Wellcome Trust, in London. Through the deal (figures were not disclosed), the St. Louis agriculture giant gains access to Sapphire’s expertise and technology for isolating algal traits that could be applied to agricultural genetic research. Continue reading Monsanto dips into algae
EV Battery Swapping’s First Real Test
Smartphone owners know all about battery anxiety: Spend too long playing games and the battery icon flashes ”empty” the next time you need to make a call. For drivers of electric cars, the problem is more serious: They can’t just walk over with a 20-liter jug of electricity from the nearest charging station, and even if they do manage to glide into a station on their last electrons, it could take hours to top off a car battery. Continue reading EV Battery Swapping’s First Real Test