Policy Concentrates CHEMICAL REGULATION
EPA moves to ban uses of trichloroethylene Proposal would prohibit some uses of common solvent to protect workers, consumers those risks. The chemical industry is strongly opposed to restricting that particular use. TCE is one of the first 10 chemicals that EPA will evaluate for risk under the revised TSCA, which was enacted in June. The agency plans to use its new authorities to assess all remaining uses of the chemical. “For the first time in a generation, we are able to restrict chemicals already in commerce that pose risks to public health and the environment,” says Jim Jones, EPA assistant administrator for chemical safety and pollution prevention. “I am confident that the new authority Congress has given us is exactly what we need to finally address these important issues,” he says. The last time EPA tried to restrict the use of a toxic chemical under TSCA was in 1989 when it banned asbestos. A federal appeals court, however, overturned that ban two years later.
Dry cleaners will no longer be allowed to use trichloroethylene to remove stains under a proposed EPA regulation. EPA expects to have an easier time under the revised law because it no longer has to show that restriction of each use is the least burdensome way to reduce the risk. The new law allows EPA to restrict a chemical “to the extent necessary” to reduce the risk.—BRITT ERICKSON
HEALTH
Medical innovation bill sails through Congress Legislation authorizes increases in funding for NIH, FDA with caveats In one of their last moves of the year, U.S. lawmakers cleared legislation designed to boost medical innovation and stem the growing opioid abuse crisis. President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. The bipartisan legislation authorizes $6.3 billion over 10 years to be funneled to the National Institutes of Health, the Food & Drug Administration, and states. But the money is not guaranteed. Congress would still need to approve the funding each year. About $4.8 billion of the money is authorized for NIH to fund a cancer initiative, a genomics-based precision medicine effort, and research on the human brain. Another $1 billion would go to states to help deal with opioid addiction. The remaining funds are slated for FDA to accelerate the approval of new drugs and devices and to hire new scientists, doctors, and engineers. Spearheaded by Reps. Fred Upton
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C&EN | CEN.ACS.ORG | DECEMBER 12/19, 2016
(R-Mich.) and Diana DeGette (D-Colo.), the law aims to include patient experiences in the drug approval process and bring cures to patients faster. To do so, it reduces the amount of data pharmaceutical companies need to provide to FDA to support the approval of Proponents of certain new drugs. the 21st Century For example, the Cures Act sported legislation allows buttons this year FDA to accelerate to promote the bill the approval of on Capitol Hill. regenerative thera-
pies, and in some cases use data summaries in lieu of full clinical trial data. It also allows drug companies to market their products “off label” for uses that have not been approved by FDA. Opponents of the legislation are calling such provisions a huge giveaway to the pharmaceutical industry. “The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices,” says Michael Carome, Director of the Public Citizen’s Health Research Group, a consumer advocacy organization. The pharmaceutical industry is welcoming the new law. “The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development,” says Pharmaceutical Research & Manufacturers of America CEO Stephen J. Ubl. “It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”—BRITT ERICKSON
CREDIT: SHUTTERSTOCK (CLERK); HOUSE OF REPRESENTATIVES, ENERGY & COMMERCE COMMITTEE (BUTTONS)
Trichloroethylene (TCE) would no longer be permitted in aerosol degreasers and stain removers, which are used by dry-cleaning facilities, under a regulation proposed Dec. 7 by EPA. The action marks the first time in more than 20 years that EPA has tried to use its authority under the Toxic Substances Control Act (TSCA) to restrict the use of a hazardous chemical. EPA concluded in 2014 that TCE in spot cleaning agents and aerosol spray degreasers could pose health risks to workers and consumers. TCE is a known human carcinogen, and studies have associated the chemical with neurological, developmental, and immunological toxicity. The agency’s 2014 assessment also found risks associated with the use of TCE in commercial vapor degreasing, but EPA is working on a separate regulation to address
