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Bloomberg BNA Daily Environment Report reported on Lynn L. Bergeson’s comments regarding final nanotechnology guidances released by the Food and Drug Administration. “The guidances reaffirm the FDA’s position that it has sufficient statutory authorities and policies to oversee the safety of products it regulates, Bergeson said. She expanded on that perspective in a memo her law firm issued. The FDA also restated its view that nanotechnology isn’t inherently safe or harmful,...

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products."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FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively.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...

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...

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...

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...

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...

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...

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...

In April 2013, an explosion destroyed a fertilizer plant in West, Texas, killing 15. In response to this and other recent catastrophic and fatal incidents at chemical facilities, President Obama on August 1, 2013, issued Executive Order (EO) 13650 -- Improving Chemical Facility Safety and Security. The purpose of the EO is to enhance the safety and security of chemical facilities and reduce risks associated with hazardous chemicals to facility workers and operators, communities, and...

Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson and B&C affiliate Charles Auer in a Special Report on TSCA Reform published today. “Charles Auer, a consultant who led TSCA implementation throughout most of his 32-year career at the EPA, agreed it will be challenging to resolve the many valid questions that would arise on user fees. It would be unwise, however, to continue to ignore the question of funding in TSCA reform discussions, he...