Policy Concentrates CLIMATE CHANGE PHARMACEUTICALS
▸ Violations of data rules on the rise More pharmaceutical companies than ever before are being warned by FDA because they allegedly falsified, altered, or failed to keep accurate data about how their drugs are made and tested, according to an analysis by the Health Research Institute (HRI). At issue are data integrity violations of FDA’s manufacturing regulations, which are meant to ensure that drugs are safe, effective, and without defects that might harm patients. From 2010 to 2012, just five drugmakers were cited for such violations, says HRI, a part of global consulting and auditing firm PricewaterhouseCoopers. But from 2013 to 2015, two dozen were cited, and nearly all were located outside the U.S. Of the 29 warning letters FDA sent to drug companies for data integrity issues over the last five years, 18 went to facilities based in India and six in China, HRI says. Although nearly 70% of FDA’s inspections were conducted domestically, only one facility in the U.S. was cited for a violation. FDA increased its focus on data integrity after Congress in 2012 gave the agency more money and increased authority to conduct inspections.—GLENN
Warm sea temperatures bleach reef off Australia The Great Barrier Reef off the east coast of Australia is in the midst of the worst bleaching event scientists have ever observed. Aerial surveys conducted by the National Coral Bleaching Taskforce, a group of more than 300 scientists from 10 research institutions across Australia, show that a 4,000 km stretch of the most pristine part of the reef is experiencing severe bleaching caused by warming sea temperatures. Increased temperatures lead to a loss of tiny photosynthetic algae called zooxanthellae, which live in coral. Without the algae, coral turn white and often die.—BRITT ERICKSON
HESS, special to C&EN
POLICY
The Commerce Department has launched an inquiry to determine whether imports of a refrigerant from China have been sold in the U.S. at prices below their fair market value, a practice called dumping. In response to a petition filed by the American Hydrofluorocarbon Coalition, the department is looking at pricing trends associated with imports of hydrofluorocarbon-134a, a coolant widely used in automobile air conditioners. According to the industry coalition, imports from China increased by more than 35% from 2013 to 2015. As a result, the group contends, U.S. manufacturers of fluorochemicals are losing market share and prices are rapidly falling. “Without relief from unfair trade, the U.S. industry will be unable to continue investing in U.S. production of refrigerants,” the coalition says. Members of the group include Arkema, Chemours, Honeywell, Hudson
Technologies, and Mexichem Fluor. Before antidumping duties are imposed, the International Trade Commission, a Commerce Department unit, will determine whether U.S. producers are being harmed by the Chinese imports. A preliminary finding is due on April 18.—GLENN HESS, special to
C&EN
POLLUTION
▸ More EPA oversight of waste disposal wells recommended EPA has not sufficiently overseen a type of underground injection well used to dispose of wastewater from oil and gas production, says a recent report from the Government
Accountability Office. These wells, which are regulated under the Safe Drinking Water Act and managed by EPA or states, include some oil and gas recovery wells, disposal wells for oil and gas wastewater, and storage wells for liquid petroleum products. According to GAO, the investigative arm of Congress, EPA has not consistently collected enough information about inspections or enforcement activities “to assess whether the programs are effectively protecting underground sources of drinking water.” In its response to the report, EPA said oversight and data management were long-term challenges and that the agency is in the process of modernizing its well inventory and compliance data collection. GAO recommends that EPA require reporting of well-specific inspection data, clarify requirements for enforcement activity reporting, and evaluate human or other resources needed to oversee the program.—JESSICA MORRISON APRIL 4, 2016 | CEN.ACS.ORG | C&EN
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ARC CENTRE OF EXCELLENCE FOR CORAL REEF STUDIES
▸ U.S. probes alleged dumping of HFC-134a
