On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." 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FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively. FDA...
June 25, 2014
EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance
Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(e), a registrant may distribute or sell its registered product under another person's name and address instead of (or in addition to) its own without a separate FIFRA Section 3 registration. Such distribution and sale is termed "supplemental distribution" (sometimes referred to as a sub-registration) and the product is referred to as a "distributor product." FIFRA § 3(e), 7 U.S.C. § 136a(e); 40 C.F.R. § 152.132. The...
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On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products."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FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific...
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 Sen. Frank R. Lautenberg (D-NJ) and Sen. David...
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 and Kinetic...
Far from slowing down as the dog days of summer approach, BRAG and its growing membership have been highly visible and actively working to smooth the regulatory path for, and advance the commercialization of, biobased chemicals. And the pace is only going to pick-up as the temperature rises. BRAG is: Shaping Biobased Policy BRAG is engaged with U.S. Environmental Protection Agency (EPA) staff concerning BRAG's petition for reduced reporting requirements for certain biobased chemical substances...
June 13, 2014
Lynn L. Bergeson Joins Editorial Board of Industrial Biotechnology, the Journal of Biobased Innovation
Co-Editor-in-Chief Larry P. Walker, Ph.D., announced that Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and President of B&C Consortia Management, L.L.C. (BCCM), has been appointed to the editorial board of Industrial Biotechnology, the journal of biobased innovation driving the global bioeconomy published bimonthly by Mary Ann Liebert, Inc. Publishers. In making the announcement, Dr. Walker commented that "Ms. Bergeson's membership on the...
The U.S. Environmental Protection Agency (EPA) announced on June 12, 2014, safer alternatives to flame retardants currently used in consumer and commercial products, including building insulation and products with flexible polyurethane foam. According to EPA, flame retardant chemicals such as hexabromocyclododecane (HBCD) and pentabromodiphenyl ether (pentaBDE) "raise concerns for human health and the environment including potential reproductive, developmental, and neurological effects and can...
June 12, 2014
Next-Phase GHS 2015 Deadlines Loom: Time to Re-Author, Re-Label, and Refocus on Mixtures
Within the next 12-18 months, companies are facing multiple deadlines for various country adaptations of the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). These include major re-evaluations of how chemical mixtures and substances are classified, re-authoring of Safety Data Sheets (SDS), and re-labeling requirements for the U.S., the European Region, Brazil, Serbia, Malaysia, Australia, and South Africa. Each country or region has adopted...
June 10, 2014
EPA Extols Pesticide Civil Penalty, but the Decision Could Be Problematic for Registrants and EPA
On June 6, 2014, the U.S. Environmental Protection Agency (EPA) announced that Liphatech, Inc. (Liphatech), a pesticide manufacturer based in Milwaukee, WI, paid a $738,000 civil penalty for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations. The vast majority of the penalty was based on violations of FIFRA Section 12(a)(2)(E), because, EPA alleged, Liphatech failed to identify Rozol, a rodenticide used to control prairie dogs, as a Restricted Use Pesticide (RUP) in its...