Memoranda

The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation (DDEF Guidance). EPA states that the DDEF Guidance "lays out methods for calculation of factors compensating for the application of animal toxicity data to humans (interspecies) and for compensating for sensitive populations...

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2014, that it has updated its Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. According to EPA, the updated TSCA Work Plan reflects updated data submitted to EPA on chemical releases and potential exposures that EPA received as part of the Chemical Data Reporting (CDR) Rule and the Toxics Release Inventory (TRI) Program. EPA removed or consolidated 16 chemicals, most of which are believed to be...

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a "significant new use," and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use." Persons subject to the SNURs would be...

Following the release last week of our Firm Clients and Friends Memorandum "Summary of Changes in the Chemical Safety Improvement Act (CSIA, S. 1009) and the Boxer TSCA Version Released September 18, 2014," Bergeson & Campbell, P.C. (B&C®) received copies of a number of documents relating to what is now described as the "Udall-Vitter Discussion Draft" (U-V DD) of the original CSIA (CSIA1). The documents obtained include: A version of the clean, revised text of U-V DD, which is...

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 by Senator Boxer by a...

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...

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 commended for...

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 decisions under...

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 Act...

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 public-private...

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, this...

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....

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...

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...