On December 20, 2016, EPA announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.” For...
The U.S. Environmental Protection Agency (EPA) is scheduled to publish in the December 21, 2016, Federal Register a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA). Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow. As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain...
December 15, 2016
EPA Proposes To Add Nonylphenol Ethoxylates To Section 313 And Other Recent EPCRA Developments
EPA Proposes To Add Nonylphenol Ethoxylates To Section 313: On November 16, 2016, the U.S. Environmental Protection Agency (EPA) proposed to add nonylphenol ethoxylates (NPE) as a category for which reporting is needed under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 81 Fed. Reg. 80624. EPA is proposing to add this chemical category to the EPCRA Section 313 list because EPA believes NPEs meet the EPCRA Section 313(d)(2)(C) toxicity criteria. Specifically,...
On December 8, 2016, President-Elect Donald Trump confirmed his intention to nominate Oklahoma Attorney General (AG) E. Scott Pruitt to head the U.S. Environmental Protection Agency (EPA). Rumors about Mr. Pruitt’s nomination have been circulating for some time, but his nomination was confirmed via a Facebook post. Mr. Pruitt has been the Oklahoma AG since November 2010. Mr. Pruitt received a B.A. from Georgetown College in Georgetown, Kentucky, in Political Science and...
December 1, 2016
Brexit — An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws
On June 23, 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should “Leave” or “Remain” in the European Union (EU). The referendum turnout was 71.8 percent and the Leave Campaign won by 52 percent to 48 percent, making “Brexit” an important and imminent probability with potentially significant implications for a range of stakeholders, including the chemicals industry. The following statement from current UK Prime Minister...
On November 15, 2016, the California Department of Toxic Substances Control (DTSC) held a webinar to provide an update on its progress and seek input from stakeholders regarding the selection of the next set of Priority Products under the Safer Consumer Products Regulations (SCPR). A recording of the webinar will be uploaded by DTSC to its workshops web page when available. The webinar is the first step in implementing DTSC’s 2015-2017 Priority Product Work...
November 18, 2016
Deadline Approaches to Nominate Chemicals to Thailand’s Inventory of Existing Chemicals
As reported in The Acta Group EU, Ltd’s (Acta EU®) August 26, 2016, Global Regulatory Update, this summer, Thailand’s Department of Industrial Works (DIW) published a preliminary inventory of existing chemicals (Preliminary of Thailand Existing Chemicals Inventory). The preliminary inventory can be searched by Chemical Abstracts Service (CAS) number or trade name. DIW created the preliminary inventory by combining the hazardous substance list; the most recent hazardous chemical...
November 4, 2016
California DPR Proposes Far-Reaching Regulation Giving Further Protections to Children
The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3) increase...
In our June 29, 2016, Clients and Friends memorandum, “Brazil Moves Closer to National Chemical Inventory,” Bergeson & Campbell, P.C. (B&C®) 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 July 5, 2016, B&C released a memorandum entitled “A Critical Review of Brazil’s Just-Published...
On August 28, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements. Bergeson & Campbell, P.C. (B&C®) prepared a memorandum discussing OEHHA’s November 27, 2015, proposed rule, Proposition 65: OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations, and the March 25, 2016, revisions to those...
September 21, 2016
Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products
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...
September 15, 2016
CWA: EPA Settlement Telegraphs Changes to General Permit Coverage for Facilities with Coal Tar Sealed Pavement
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...
August 19, 2016
China Implements Requirements For Shipments From Zika-Infected Countries, Including The U.S., And Other Recent Chinese Regulatory Developments
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...
July 29, 2016
TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards
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...