Articles

On June 19, 2014, the U.S. Environmental Protection Agency (EPA) issued a direct final rule exempting manufacturers of three chemical substances from certain reporting-process-and-use information requirements under the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule for those compounds. This column discusses the rule and the potential value of public petitioning....

The growing number of rail mishaps involving oil is attracting much press attention and now regulatory attention as well. On May 7, 2014, the U.S. Department of Transportation (DOT) issued an emergency order requiring all railroads operating trains containing bulk quantities of UN 1267, petroleum crude oil, Class 3 that either originates or is sourced from the Bakken formation in the Williston Basin (Bakken crude oil) to notify State Emergency Response Commissions (SERC) about the...

On June 2, 2014, the U.S. Environmental Protection Agency (EPA) issued an ambitious and likely contentious rule to diminish significantly the United States’ contribution to greenhouse gases (GHG). The rule is proposed under the authority of the Clean Air Act (CAA) and takes direct aim at the coal industry by requiring a 30 percent reduction in carbon dioxide (CO2) emissions from existing fossil fuel-fired power plants by 2030, using 2005 as the baseline year. This...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance...

Reform of the Toxic Substances Control Act (TSCA) may be a little closer to reality since Rep. John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released on February 27, 2014, a much anticipated discussion draft that would update TSCA. The Chemicals in Commerce Act (CICA) keys off of Senate Bill (S.) 1009, the Chemical Safety Improvement Act (CSIA), which was introduced on May 22, 2013, by late...

On March 19, 2014, the U.S. Environmental Protection Agency (EPA) issued an administrative order to Pathway Investment Corp. (Pathway) of Englewood, New Jersey, to stop the sale of plastic food storage containers that are not registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to a press release issued on March 31, 2014, by EPA concerning the stop sale order, the Company’s Kinetic Go Green Premium Food Storage Containers...

On May 23, 2014, the U.S. Environmental Protection Agency (EPA) posted its 2014 Regulatory Agenda, which still includes RIN 2070-AJ54, “Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule.” See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=2070-AJ54....

In late March, EPA and Army Corps of Engineers (Corps) proposed a rule that would dramatically revise and expand the reach of the Clean Water Act’s (CWA) jurisdiction. Unquestionably, determining the scope of the CWA’s jurisdiction, particularly over streams and tributaries, has become confusing and complex following several Supreme Court decisions and various EPA interpretations issued in response to these decisions over the years. For nearly a decade, Congress, state and local officials,...

How to address and manage potential risks posed by pesticide “drift” — the unintentional movement of some level of pesticide outside of the intended area of application — has long been a challenging, complex regulatory policy issue. It is difficult to dispute that when applying a pesticide product some small amount may, in some circumstances, move off-site. In other words: “drift happens.” The issue quickly becomes whether, from a risk management perspective, the amount of...

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive...