Policy Concentrates PHARMACEUTICALS
▸ Texas sues FDA over execution drug Texas last week filed a lawsuit seeking to force FDA to decide whether the state may legally import thiopental sodium, a drug crucial to administering lethal injections. In July 2015, U.S. Customs agents, at FDA’s request, seized 1,000 vials of thiopental sodium at a Houston airport “for further analysis,” according to the court filing. The barbiturate has not been approved by FDA for injection into humans. But the Texas Department of Criminal Justice argues that importation is lawful for the purposes of carrying out death sentences. “FDA has an obligation to fulfill its responsibilities faithfully and in a timely manner,” says Texas Attorney General Ken Paxton. “My office will not allow FDA to sit on its hands and thereby impair Texas’ responsibility to carry out its law enforcement duties.” FDA says it does not comment on pending or ongoing litigation. Texas and other states have struggled for years to obtain lethal injection drugs as U.S. manufacturers have stopped producing them, and suppliers in Europe have prohibited their export due to opposition to the death penalty.—GLENN
HESS, special to C&EN
CHEMICAL REGULATION
CREDIT: SHUTTERSTOCK
▸ EU queues up substances for possible restrictions The European Union has taken the first step toward constraining the use of four substances—bisphenol A (BPA), a perfluorinated acid, and two alkylphenols. BPA, which is estrogenic, is widely used in thermal receipt paper, linings of food cans, and some plastics. Perfluorodecanoic acid has been used as a plasticizer, lubricant, surfactant, wetting agent, and a corrosion inhibiter, according to the European Chemicals Agency (ECHA). It persists in the environment, bioaccumulates, and is toxic for reproduction, ECHA says. One alkylphenol is 4-heptylphenol, which is used in lubricants in both its branched and linear forms. The other is 4-tert-amylphenol, used as an industrial processing aid and sold for research applications. Both have endocrine disrupting properties, ECHA says. All four chemicals are being placed
Tetrachlorvinphos is used in some fleacontrol collars for pets.
PESTICIDES
EPA finds risks with flea collar chemical Tetrachlorvinphos (TCVP), an organophosphate insecticide used to control fleas and ticks on pets and livestock, may pose a health risk to people in their homes and to workers who apply it, EPA says. These conclusions are in a final human health assessment the agency released on Jan. 4. The agency has contacted pesticide makers to discuss ways to reduce exposure to the chemical. EPA plans to propose a rule requiring such reductions later this year. In the meantime, the agency is advising consumers to keep children away from TCVP pet collars, spray, and powder products, and to wash hands thoroughly with soap and water after handling TCVP products. The agency conducted the assessment in response to a 2009 petition from the Natural Resources Defense Council to ban pet products containing TCVP. The environmental group claims that the pesticide poses unacceptable risks to children’s developing brains and nervous systems. EPA initially denied the group’s petition, saying in 2014 that TCVP pet products pose no risk to human health. NRDC appealed the decision, and as part of that litigation the agency agreed to revise the human health risk assessment.—BRITT ERICKSON
on the EU’s list of substances of very high concern. Chemicals on this list become candidates for strict control under the EU’s Registration, Evaluation, Authorisation & Restriction of Chemicals program. Such controls bar the use of a chemical in the EU unless companies obtain special permission, called authorization, from ECHA.—CHERYL HOGUE
POLICY
▸ Chemical risk assessment headed in new direction Exposure science, toxicology, and epidemiology are shedding light on how disruption of biological pathways causes disease, opening the door for a new era in chemical risk assessment, says a report from the National Academies of Sciences, Engineer-
ing & Medicine. Emerging tools, such as personal monitoring devices and sensors, offer opportunities to better characterize exposures, including in vulnerable populations, the report says. Computational tools are also getting better at estimating exposures, the report finds. Cell-based assays have come a long way toward evaluating cellular processes and responses, but such technologies are not designed to evaluate the toxicity of metabolites that form when chemicals are broken down in the human body, the report notes. Many in vitro assays, computational models, and high-throughput tools were developed by the pharmaceutical industry and may not be as useful for risk assessment of chemicals or environmental pollutants. “It will most likely be necessary to adapt current assays or develop new assays specifically intended for risk-assessment purposes,” the report says. The report calls for scientists in all relevant disciplines to collaborate to ensure emerging tools and methods are used to their full potential.—BRITT ERICKSON JANUARY 9, 2017 | CEN.ACS.ORG | C&EN
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