DRUG SAFETY
▸ U.S., EU drug inspectors team up Eight regulatory agencies in the European Union are capable of meeting U.S. FDA requirements for inspecting drug manufacturing facilities, FDA announced on Oct. 31. Earlier this year, U.S. and EU regulators amended a mutual recognition agreement, enabling them to use each other’s inspections of pharmaceutical manufacturing facilities. The intent is to avoid duplicating drug facility inspections and allow regulators to devote more resources to high-risk facilities in other countries. The agencies now recognized by FDA are in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the U.K. FDA is still evaluating the capabilities of agencies in other EU countries to inspect pharmaceutical manufacturing facilities, with the goal of completing all 28 assessments by July 2019. “At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck,” FDA Commissioner Scott Gottlieb says.—BRITT ERICKSON
BIOTECHNOLOGY
C R E D I T: JO N ATH A N BAC H MA N / R E UT ERS / NEWS CO M
▸ Congress urges agencies to update biotech policies A bipartisan group of 79 lawmakers in the U.S. House of Representatives is urging agricultural biotechnology regulators to work together to promote technologies to increase crop yields and reduce the cost of production. Existing biotech rules and policies are contradictory and “have sent inconsistent signals” to trading partners, many of whom are also trying to formulate a strategy to regulate new technologies, says a letter from the House members to the heads of USDA, FDA, and EPA. “We are concerned that if the Administration does not quickly develop a uniform position on biotechnology in agriculture, including gene editing, we will see an unworkable patchwork of international regulations emerge that will effectively further suppress American innovation,” the lawmakers, led by House Agriculture
ExxonMobil’s polyethylene plant in Beaumont, Texas, is one of the facilities involved in the settlement.
POLLUTION
ExxonMobil settles air emissions case ExxonMobil will spend $300 million to reduce air emissions from four olefin plants and four polyethylene facilities and pay a $2.5 million fine to settle allegations that it violated U.S. federal air pollution regulations. ExxonMobil had modified the facilities and increased their emissions without getting required air pollution permits, says Patrick Traylor, Environmental Protection Agency deputy assistant administrator for enforcement and compliance assurance. The settlement, announced on Oct. 31, requires the company to curb air pollution emitted from inefficient combustion of waste gases within flares at the plants. Traylor says that when fully implemented by 2020, the upgrades at the eight plants will prevent emissions of about 6,400 metric tons per year of volatile organic pollutants and 1,400 metric tons per year of hazardous air pollutants. The facilities are located in Texas in Baytown, Beaumont, and Mont Belvieu and in Baton Rouge, La. Under the settlement, ExxonMobil will also spend $2.5 million on supplemental environmental projects, including planting trees in Baytown.—CHERYL HOGUE
Committee members Neal Dunn (R-Fla.) and Jimmy Panetta (D-Calif.), write. The Biotechnology Innovation Organization, an industry trade group, says the letter shows there is “strong bipartisan support for managing tough societal challenges with innovative biology-based solutions.” The U.S. has been reviewing its regulatory system for biotech plants and animals for the past year.—GLENN HESS, special to
C&EN
TRADE
▸ U.S. initiates probe into PET resin imports The U.S. Department of Commerce is investigating whether imports of polyethylene terephthalate (PET) resin from Brazil, Indonesia, South Korea, Pakistan, and
Taiwan are being sold in the U.S. market at less than fair value. “The U.S. market is the most open in the world, but we must ensure U.S. businesses and workers are treated fairly,” says Commerce Secretary Wilbur Ross. The U.S. International Trade Commission is expected to decide by Nov. 13 whether imports of the material, used to make plastic beverage containers, harm or threaten to harm the U.S. industry and its workforce. If they are found to do so, the Commerce Department would continue its investigation and make a preliminary decision by March 5, 2018. Foreign companies that price their products in the U.S. market below the cost of production or below prices in their home markets must pay antidumping duties. The investigation was launched in response to petitions filed by DAK Americas, Indorama Ventures USA, M&G Polymers USA, and Nan Ya Plastics America.—GLENN HESS,
special to C&EN NOVEMBER 6, 2017 | CEN.ACS.ORG | C&EN
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