NUCLEAR ENERGY
▸ U.S. said to be falling behind in advanced reactors The U.S. nuclear industry is lagging behind China, Russia, and others on advanced nuclear reactor technology because of regulatory hurdles, witnesses said last week at a Senate hearing. The U.S. is starting to cede its global leadership on nuclear energy, Ashley E. Finan, policy director of the research and advocacy group Nuclear Innovation Alliance, told the Senate Environment & Public Works Committee. With that leadership position goes “influence on nonproliferation discussions and on best practices and safety and on environmental issues globally,” Finan said at the panel’s hearing on the proposed Nuclear Energy Innovation and Modernization Act (S. 512). The bipartisan legislation, introduced earlier this month, is aimed at modernizing the U.S. nuclear regulatory process and revitalizing the nuclear industry sector, said Sen. John Barrasso (R-Wyo.), the committee’s chair. Barrasso, who introduced the bill, is concerned that advanced nuclear reactor technology in the U.S. faces “delays and costs from regulatory red tape.” The measure would require the Nuclear Regulatory Commission to develop a series of steps for licensing non-light-water reactors.—JESSICA MORRISON
BIOTECHNOLOGY
CREDIT: SHUTTERSTOCK
▸ Prepare for flood of new products, report says The U.S. regulatory system is likely to be overwhelmed by an onslaught of biotechnology products in coming years, according to a report from the National Academies of Sciences, Engineering & Medicine. In the report, the National Academies committee of academic and industry biotechnology experts recommends strategies to help federal agencies prepare based on predicted future biotechnology products and anticipated regulatory challenges. “The rate at which biotechnology products are introduced, and the types of products, are expected to significantly increase in the next five to 10 years, and federal agencies need to prepare for this growth,” says Richard M. Murray, a Caltech bioengineering pro-
PHARMACEUTICALS
U.S., EU to share pharma inspection reports U.S. and European Union regulators have agreed to recognize each other’s inspection reports of pharmaceutical manufacturing facilities. The decision is expected to help FDA and EU drug inspectors avoid duplicating inspections. It’s also expected to lower inspection costs and help regulators focus resources in parts of the world where the risk of unsafe drugs is the greatest. The agreement comes after nearly three years of collaboration between FDA and EU inspectors to assess the risks and benefits of relying on foreign inspections of drug manufacturing facilities. Congress gave FDA the authority to use foreign drug inspection reports in 2012 with the passage of the FDA Safety & Innovation Act. The law allows FDA to recognize foreign inspections as long as those inspections meet U.S. requirements. “The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective, and high-quality drugs,” says Dara Corrigan, FDA’s associate commissioner for global regulatory policy.—BRITT ERICKSON
fessor who chaired the committee. To be prepared, federal agencies should grow inhouse expertise on the changing biotechnology landscape, coordinate cross-agency risk assessments for new products, and fund research into ethical, legal, and social implications of emerging biotechnology products, the report says. EPA, FDA, and USDA commissioned the study in 2015 as part of an effort to modernize the U.S. regulatory system for biotechnology products.—JESSICA MORRISON
TRADE
▸ Chemical sector outlines priorities for NAFTA rewrite With the Trump Administration vowing to renegotiate the North American Free Trade Agreement with Mexico and Canada, trade groups representing the North American chemical industry say
they are open to modernizing the accord. The American Chemistry Council, the Chemical Industry Association of Canada, and the Mexican Chemical Industry National Association say NAFTA has greatly benefited the industry, created jobs, and made the region more competitive globally. Trade in chemicals among the three NAFTA countries more than tripled from $20 billion in 1994 to more than $63 billion in 2014. But the groups say they are open to updating NAFTA, outlining priorities such as strengthening cross-border data protection, setting new standards for state-owned companies, and streamlining customs procedures. “Most importantly, all chemical products are traded duty-free under NAFTA, and a modernized NAFTA should maintain this policy,” the industry associations say in a joint statement. It’s unclear what changes the White House will seek in the trilateral trade agreement, but the GOP-led Congress is considering border adjustment import taxes and other measures that would upend the current tariff-free arrangement.—GLENN HESS,
special to C&EN MARCH 13, 2017 | CEN.ACS.ORG | C&EN
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