Memoranda

This analysis reviews the changes made to the original version of the Chemical Safety Improvement Act (CSIA) (identified as CSIA1 in this memorandum) based on Senator Barbara Boxer’s (D-CA) version of the Toxic Substances Control Act (TSCA) reform legislation released on September 18, 2014 (Boxer TSCA). This analysis attempts to analyze both the interim changes made to the bill and the changes that appear as underlined text in Boxer TSCA. Boxer TSCA was reportedly created...

Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues. How potential for spray drift and for...

On September 12, 2014, the California Department of Toxic Substances Control (DTSC) released its much anticipated draft Initial Priority Product Work Plan under the Safer Consumer Products Regulations. The Regulations require that DTSC, by October 2014, develop an Initial Priority Product Work Plan that describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. The Work Plan is available online and more detailed...

On August 9, 2014, the Government of Canada published in Gazette I (Vol. 148, no. 32) a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). The regulatory proposal seeks to align current systems for classification, material safety data sheets (MSDS), and labels with the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard published on May 26, 2012 (HCS 2012) and the approaches used in other...

The U.S. Environmental Protection Agency (EPA) released on August 28, 2014, final risk assessments for three Toxic Substances Control Act (TSCA) Work Plan chemicals — methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The much anticipated release of these assessments marks a real milestone for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), and EPA is to be...

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...

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...

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...

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,...

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...