June 24, 2014

Lynn L. Bergeson, “FDA Issues Final and Draft Nanotechnology Guidances,” Nanotechnology Now, June 24, 2014.

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.”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FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance...
June 21, 2014

Lynn L. Bergeson, “House Releases Discussion Draft of TSCA Reform Legislation,” Environmental Quality Management, Summer 2014.

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...
June 21, 2014

Lynn L. Bergeson, Timothy D. Backstrom, “EPA Issues Stop Sales Order for Unregistered Food Containers Containing Nanosilver: What Are the Implications?,” Nanotechnology Law & Business, Volume 11, Issue 3, 2014.

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...
June 5, 2014

Lynn L. Bergeson, “Notice Concerning Nanoscale Materials Remains in EPA’s Regulatory Agenda,” Nanotechnology Now, June 5, 2014.

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....
June 2, 2014

Lynn L. Bergeson, “EPA and Corps of Engineers Propose New Rule Governing Clean Water Act Jurisdiction,” Pollution Engineering, June 2, 2014.

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,...
June 1, 2014

Lisa M. Campbell, James V. Aidala, Susan Hunter Youngren, “EPA Guidance on Pesticide Drift Will Affect Product Registrations,” CPDA Quarterly, June, 2014.

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...
May 29, 2014

Kathleen M. Roberts, “How to Make Friends and Win EPA Approvals: tips for biobased chemicals,” Biofuels Digest, May 28, 2014.

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...
May 22, 2014

Lynn L. Bergeson, “Spotlight Shines on Plant Safety,” Chemical Processing, May 22, 2014.

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....
May 20, 2014

Lynn L. Bergeson, “Chemical Safety and Drinking Water Protection Act,” Pollution Engineering, May 20, 2014.

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...