Memoranda

On September 16, 2016, the White House posted a blog item, “Building on 30 Years of Experience to Prepare for the Future of Biotechnology,” releasing two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for...

On September 16, 2016, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA is proposing the action under the authoritative bodies’ listing mechanism. Comments are due October...

On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016. According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain aspects of the electronic reporting system that...

On August 16, 2016, the U.S. Environmental Protection Agency (EPA) reached a settlement in Clean Water Act (CWA) lawsuits filed over its 2015 Multi-Sector General Permit (MSGP) for Stormwater Discharges from Industrial Activities. 80 Fed. Reg. 34403 (June 16, 2015). The MSGP is the collective term for the CWA National Pollutant Discharge Elimination System (NPDES) program’s general permits for stormwater discharges from industrial facilities spanning 29 sectors, including, but...

The Ministry of the Environment (MOE) published an amended version of the Act for the Registration and Evaluation of Chemicals (K-REACH) enforcement decree and enforcement rules, which have both entered into force. The amendments include some exemptions from reporting for new chemicals, and an extended 14-day grace period for substances used only for research and development (R&D) purposes. The final amendments do not include a proposal to remove a provision that states...

China Implements Requirements For Shipments From Zika-Infected Countries, Including The U.S.: In March 2016, the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) began requiring all countries on its Zika-infected list to comply with disinsection requirements. The United States Department of Agriculture (USDA) Foreign Agricultural Service’s (FAS) August 19, 2016, “Update on China’s Requirements for Shipments from Zika-Infected...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and...

Scientists Issue Letter Criticizing EDC Criteria: On July 6, 2016, a group of 15 European and U.S. researchers wrote to the European Union’s (EU) Health and Food Safety Directorate, criticizing recent proposals for the identification of endocrine disrupting chemicals (EDC) under the Plant Protection Products (PPP) Regulation and the Biocidal Products Regulation (BPR). The scientists addressed two major concerns relating to the proposed criteria: The...

On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the “not likely to present an unreasonable risk” determination at Section 5(a)(3)(C). It is...

On July 15, 2016, the California Department of Toxic Substances Control (DTSC) announced the release of its proposed regulation on children’s foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product (PP) under the Safer Consumer Products Regulations (SCPR). DTSC first released information about this PP on March 13, 2014, so this proposed regulation is a major step in the SCPR process and...

On July 15, 2016, the California Department of Toxic Substances Control (DTSC) announced the release of its proposed regulation on children’s foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product (PP) under the Safer Consumer Products Regulations (SCPR). DTSC first released information about this PP on March 13, 2014, so this proposed regulation is a major step in the SCPR process and...

On July 13, 2016, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA), in coordination with the Federal Railroad Administration (FRA), announced proposed regulations for Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains (HHFTs). The rule would expand the comprehensive oil spill response plan requirements under the Clean Water Act (CWA) to certain HHFT trains based on the amount of crude oil being...

In our June 29, 2016, Clients and Friends memorandum, Brazil Moves Closer to National Chemical Inventory, The Acta Group (Acta®) discussed Brazil’s pending Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação) predicting its imminent publication in the Brazilian Official Gazette, the Diário Oficial. On June 30, 2016, the Regulação was released for an approximately 45-day comment period. While generally adhering to both...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182, and copies are expected to be available from the U.S. Government...

On October 15, 2015, the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MME) announced plans to develop a national chemical Inventory (Inventory), with initial legislation expected by December 31, 2015. Due to a sometimes contentious debate between industry and the MME (Authority), the Inventory process had been considerably delayed. In a Brazilian chemical industry forum on June 23, 2016, it was announced that significant progress has been made toward implementing...

EPA Makes Final Revisions To EPCRA Hazard Categories: On June 13, 2016, the U.S. Environmental Protection Agency (EPA) issued final revisions to EPCRA Sections 311 and 312 occasioned by changes to the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS). 81 Fed. Reg. 38104. Under the revised HCS, chemical manufacturers and importers are required to evaluate their chemicals according to the new criteria adopted from the United Nations (UN) Globally...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the new law, landmark legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). EPA’s web page includes links for users to access: According to the FAQs, EPA’s plans for meeting the deadlines under...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to the Toxic Substances Control Act (TSCA). Lautenberg results in fundamental shifts in the requirements and approach under TSCA, while introducing important new concepts and approaches. It is our view that the body of changes, including the careful balancing of competing needs and interests and the deft and assiduous drafting,...

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our memorandum, “An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA,” the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be...