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The OSPAR Commission's (OSPAR) Harmonized Offshore Chemical Notification Format (HOCNF) is of paramount importance for a wide range of personnel, including chemical manufacturers and product manufacturers whose products are used on an offshore oil platform. Despite its significance, many in the U.S. are largely unaware of its role in the petrochemical community. We describe the program generally below focusing on the interrelations with other chemical programs, including the Registration,...
July 2, 2014
China in Talks to Join the OECD System for the Mutual Acceptance of Data in Assessment of Chemicals
It has recently been reported that China is in discussions with the Organization for Economic Cooperation and Development (OECD) to become a provisional adherent to the Mutual Acceptance of Data (MAD) system. This would require China to accept data from safety testing of chemicals from participating countries generated under the MAD conditions and to establish a Good Laboratory Practice (GLP) compliance monitoring program. If China were to become a provisional adherent to the MAD system, this...
July 2, 2014
EPA’s Supplemental Distribution Enforcement Actions Are Buzzing: How to Avoid Getting Stung
Wednesday, July 23, 20141:00 p.m. - 2:00 p.m. (EDT) The U.S. Environmental Protection Agency (EPA) has made good on its intent to focus enforcement efforts on Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) supplemental distribution, resulting in several settlements with significant penalty assessments. Bergeson & Campbell, P.C. (B&C®) recently issued a memorandum discussing the enforcement actions, the regulatory requirements for supplemental...
July 1, 2014
Learn How to Pre-Screen New Chemicals Using EPA’s Models and Methods at Sustainable Futures Training
Co-hosted by the Biobased and Renewable Products Advocacy Group (BRAG™), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU) August 5-7, 2014, at the GWU Campus in Washington, D.C. ABOUT THE WORKSHOP: During this hands-on three-day workshop, you will learn about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals. Methods addressed will include hazard and risk screening for human...
On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington, D.C. and via webcast. The Acting U.S. Surgeon General, Rear Admiral Boris D. Lushniak, M.D., M.P.H., gave the opening remarks stating the importance of these changes in relation to the Surgeon General's national prevention strategy started in June 2011. FDA has posted...
The Federal Trade Commission (FTC) has stepped-up its enforcement initiatives and recently settled two cases with companies that market plastic lumber and related products. FTC alleged that these companies misled consumers in violation of Section 5 of the Federal Trade Commission Act (FTC Act) in their marketing materials regarding the environmental attributes of their products. Specifically, these cases hinge on claims related to the recycled content and post-consumer content of their products....
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...
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...
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...