All Published Articles
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, industry, agriculture, environmental groups and the public have asked for a rulemaking to provide clarity. The proposal is already generating much controversy and should invite significant comments.
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 off-site movement matters. That question is, in turn, heavily dependent on factors specific to the pesticide application at issue, such as the nature of the specific pesticide (e.g., its volatility), the application method used (e.g., aerial or ground application), and climatic conditions. Because many such factors must be considered, the U.S. Environmental Protection Agency (EPA) has found it challenging to devise a “drift policy” or define generally what, if any, level of potential drift is acceptable. This article explores the current situation.
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 involved with biobased chemicals at a session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process.” This article highlights the top tips for gaining EPA regulatory approval shared by EPA’s Dr. Tracy Williamson and Dr. David Widawsky at the session.
Chemical plant safety is once again in the limelight due to some high profile and very public catastrophes. On January 3, 2014, a federal working group created by the Obama administration’s Executive Order (EO) 13650 issued a set of preliminary options intended to improve chemical plant safety and security. This is a priority topic commanding considerable attention and readers should be aware of and engaged in these developments. This column explains why.
The tragic spill of a chemical into the Elk River in West Virginia that occurred on Jan. 9, 2014, has spurred the development of new legislation. On Jan. 27, 2014, Senators Joe Manchin (D-W.V.), Barbara Boxer (D-Calif.), Chair of the Environment and Public Works Committee, and Jay Rockefeller (D-W.V.) introduced the Chemical Safety and Drinking Water Protection Act of 2014. The regrettable spill and the mismanagement of the spill’s consequences by federal and state regulators reads like a case summary of mistakes to avoid when managing a crisis of epic proportions. The legislation that may emerge from this tragedy could prevent similar events in the future.
The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). See http://echa.europa.eu/documents/10162/21680461/bpc_opinion_heiq_ags-20_en.pdf.
Whatever window of opportunity exists to reform the Toxic Substances Control Act is closing. This is not only because the mid-term elections are fast approaching, or that there are too few legislative days left this session, or even that Congress is polarized and achieving passage of complicated chemical legislation seems intuitively beyond reach. It is also because of the emergence of international and state chemical management frameworks. This article is from the Environmental Law Institute’s May/June 2014 issue of ELI Forum titled “TSCA Redux: Rejuvenating a Timeworn Statute.” The publication features articles from authors representing a variety of viewpoints on the issue including Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C.; Richard A. Denison, Lead Scientist, Environmental Defense Fund; Kathy Kinsey, Deputy Secretary for Regulatory Programs and Operations, Maryland Department of the Environment; Ann R. Klee, Vice President, Environment, Health & Safety, General Electric; John Shimkus, Chair, House Environment & the Economy Subcommittee; and Tom Udall, Chair, Senate Subcommittee on Superfund, Toxics, and Environmental Health. Visit www.eli.org for more information.
On March 7, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA) released a proposal for a draft regulation amending Proposition 65 regulations. The proposal seeks changes to the warning requirements to include more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their exposure to these chemicals. This column explains this proposal and its significance.
On Feb. 7, 2014, EPA issued a final rule under the Resource Conservation and Recovery Act authorizing the use of electronic hazardous waste manifests. The final rule will have immediate implications for virtually all domestic manufacturers of hazardous waste. This column explains why.