The European Chemicals Agency (ECHA) recently released 25 decisions on data sharing disputes under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and two decisions on data sharing disputes under the Biocides Product Regulation (BPR). Compensation for data sharing is to be determined under REACH and BPR by the same standard, that is, in a “fair, transparent and non-discriminatory manner,” and as such there are similar issues in the ECHA...
August 18, 2014
New Decision in Mega ESA Case Dismisses Most Consultation Claims with Prejudice, Although Certain Claims Survive Pending Further Submissions
In a wide-ranging decision issued on August 13, 2014, in Center for Biological Diversity v. EPA (N.D. Cal.) (often referred to as the “Mega ESA” case), Magistrate Judge Spero has dismissed most of the claims by the Plaintiffs that the U.S. Environmental Protection Agency (EPA) failed to consult or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) in connection with EPA’s registration under the Federal Insecticide, Fungicide, and Rodenticide...
On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may...
July 14, 2014
Presidential Memorandum Creates Federal Strategy to Promote Health of Honey Bees and Other Pollinators
On June 20, 2014, President Obama issued a Presidential memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The memorandum creates a Pollinator Health Task Force, which will be co-chaired by the U.S. Department Agriculture (USDA) and U.S. Environmental Protection Agency (EPA). The Task Force will develop a National Pollinator Health Strategy, which includes a Pollinator Research Action Plan, Public Education Plan, and...
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,...
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...
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....
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,...
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. §...
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...