Memoranda

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On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.”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FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...

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...

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...

The Democratic Minority has circulated a redline version of the April 22, 2014, discussion draft of the Chemicals in Commerce Act (CICA2). A copy of the redline version of CICA2 is available online. The redline version is an interesting mix of substantial rewrites, deletions, and additions. The redline version, which we will refer to as CICA2-D to distinguish it from CICA2 and the original discussion draft, CICA1, proposes changes that favorably respond to numerous non-governmental...