FDA Warns Largest Indian Drugmaker - C&EN Global Enterprise (ACS

FDA last month issued a warning to India's largest drugmaker, Sun Pharmaceutical Industries, for violating manufacturing standards at its Halol plant,...
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GOVERNMENT & POLICY CONCENTRATES

WILD BEES DECLINE IN U.S.

PRESIDENT SIGNS MICROBEAD BAN

Estimates of wild bee populations fell in 23% of the contiguous U.S. from 2008 to 2013, according to a new national assessment of the status and trends of wild bees (Proc. Natl. Acad. Sci. USA 2015, DOI: 10.1073/pnas.1517685113). The project, funded by the Department of Agriculture’s Specialty Crop Research Initiative, shows that at the same time wild bee populations are decreasing, demand for crop pollination is increasing. The mismatch appears to be getting worse as natural habitats are converted to row crops, the researchers report. Led by postdoc Insu Koh of the University of Vermont, the team estimates that regions with intense agriculture, such as the Midwest Corn Belt and California’s Central Valley, have some of the lowest levels of wild bees. Several factors are thought to be contributing to the decline of

bees and other pollinators, including habitat loss, pesticides, and climate change. The researchers suggest that farmers may need to restore habitats for wild bees around their farms or rely more on managed pollinators, such as hives tended by beekeepers.—BEE

BATTERIES LIVE TO DIE ANOTHER DAY Hundreds of thousands of used batteries from electric vehicles could find second life as energy storage devices in the coming decade, according to a report from the North American Commission for Environmental Cooperation. The nickel-metal-hydride batteries and lithium-ion batteries used in electric vehicles have about 80% of their energy storage capability left when they are no longer sufficient for vehicular use, says

U OF VERMONT

In the U.S., areas with intense agriculture have low wild bee populations.

President Barack Obama in late December signed a law that prohibits the manufacture, sale, or distribution of personal care products containing plastic microbeads. Several states have already banned the tiny plastic spheres, found in face washes, toothpastes, and other personal care products, that can pass through wastewater treatment systems and pollute waterways. Under the federal law, manufacturers must start phasing out products with plastic microbeads less than 5 mm in diameter in 2017, which is earlier than the state laws’ deadlines. “The president’s signature on this legislation is a major victory for U.S. waterways and the environment,” said Rep. Frank Pallone Jr. (D-N.J.), who introduced the bill in March 2015. The Microbead-Free Waters Act of 2015, which amends the Federal Food, Drug & Cosmetic Act, was introduced in 2015 as H.R. 1321 in the House and S. 1424 in the Senate. The United Nations Environment Programme has called for makers of personal care products to phase out microbeads.—JM

the organization, which consists of the top environmental officials from Canada, Mexico, and the U.S. Applications for these used batteries might exist for residential and commercial electric power management and power grid stabilization, the commission says, adding that “considerable research is under way in the U.S. and elsewhere to fully explore this potential.” Last year, General Motors used five first-generation Chevrolet Volt electric car batteries alongside a solar array and two wind turbines to power its data center in Milford, Mich. The commission estimates that 358,000 batteries from electric vehicles will be retired in North America by 2020, and that number is expected to grow to 1.5 million by 2030.—JM

#DITCHTHEMYTH PUTS EPA IN HOT WATER EPA broke federal laws when it used social media to promote its controversial Clean Water Rule, the Government Accountability Office concluded last month. That rule defines which waterways fall under the federal Clean Water Act, a pollution control and wetlands protection statute. The GAO investigation came at the request of Sen. James M. Inhofe (R-Okla.), who questioned EPA’s use of taxpayer dollars to raise awareness of the rule. Appropriations laws for fiscal 2014 and 2015 prohibit EPA from using its funds for unauthorized publicity, propaganda, or grassroots lobbying. During its CEN.ACS.ORG

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investigation, GAO confirmed that EPA engaged in promotional campaigns on Twitter, Facebook, and Tumblr from February 2014 through July 2015 for the rule. The agency said it used social media campaigns with hashtags #DitchtheMyth and #CleanWaterRules to clear up misinformation surrounding the rule. Inhofe, chairman of the Senate Environment & Public Works Committee, is now raising questions about how the agency publicized its Clean Power Plan. That landmark air pollution rule, issued in 2015, will limit carbon dioxide emissions from fossilfuel-fired electricity-generating plants.—JM

FDA WARNS LARGEST INDIAN DRUGMAKER FDA last month issued a warning to India’s largest drugmaker, Sun Pharmaceutical Industries, for violating manufacturing standards at its Halol plant, in the western state of Gujarat. In part, FDA says, the company “failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.” The Halol facility is among the largest and important for Sun Pharma and produces multiple formulations, including injectable products, which are mainly exported to the U.S., its largest market, which makes up about 15% of its sales. In a statement, the company says it has been implementing corrective measures since September 2014, when FDA first inspected the facility.—K.V. VENKATASUBRAMANIAN, special to C&EN