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 met in promulgating currently proposed regulations, as well...
June 10, 2016
EPA Extends Comment Period On RCRA Corrosive Dust Petition For Six Months And Other Recent RCRA Developments
EPA Extends Comment Period On RCRA Corrosive Dust Petition For Six Months: The U.S. Environmental Protection Agency (EPA) on June 10, 2016, extended until December 7, 2016, the comment period on its April 11, 2016 (81 Fed. Reg. 21295) tentative denial of a petition by Public Employees for Environmental Responsibility (PEER) to amend regulations under 40 C.F.R. § 261.22 regarding the definition of corrosive hazardous wastes under the Resource...
The Federal Trade Commission (FTC) announced on May 24, 2016, that Viatek Consumer Products Group, Inc. and Company owner and President Lou Lentine have agreed to settle FTC charges that they made deceptive claims for Viatek-brand Mosquito Shield Bands. FTC also charged Lentine and Viatek with violating a 2003 administrative order prohibiting Lentine from making product claims without "competent and reliable" evidence to support them. According to the FTC's February 2015...
In preparation for the opening of the reporting period for the U.S. Environmental Protection Agency's (EPA) 2016 Chemical Data Reporting (CDR) rule, Bergeson & Campbell, P.C. (B&C®) conducted a review of recent enforcement actions taken by EPA under the CDR rule. B&C reviewed enforcement action data from May 2007 through September 2014 and found 37 different cases involving an allegation of a violation of the CDR rule. Based on the data collected, B&C highlighted a number of...
As we are poised to witness the reauthorization of the Toxic Substances Control Act (TSCA) -- the first revision of our domestic chemical management law in 40 years -- stakeholders will need immediately to understand what the "new TSCA" means for their industrial operations and strategically adjust their global operations to the new law. Bergeson & Campbell, P.C. (B&C®) convened a summit to examine generally the anticipated changes to TSCA, the process and implementation issues that the...
Firm clients and friends with interests in perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), and other perfluorinated chemicals (PFCs) are likely aware that the U.S. Environmental Protection Agency (EPA) is expected to issue by mid-May or so new guidance on safe drinking water levels for these chemicals. As EPA and a handful of states continue to address elevated levels of lead in drinking water, EPA Administrator McCarthy has made clear in various...
On April 11, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum entitled "Coverage for ZirconizationTM Under 40 CFR Part 433 (Metal Finishing ELG)," which concludes that "wastewater generated by ZirconizationTM or a process that applies a zirconium oxide finish to a metal substrate is subject to the Metal Finishing [Effluent Limitation Guidelines (ELG)]." Zirconization is the trade name for a process that produces a zirconium oxide conversion on a metal substrate....
On April 22, 2016, the National Toxicology Program (NTP) issued a monograph concluding that cobalt and cobalt compounds that release cobalt ions in vivo are expected to cause human cancer. Specifically, NTP stated that "[t]here is sufficient evidence for the carcinogenicity of cobalt and cobalt compounds that release cobalt ions in vivo (collectively referred to as cobalt) in experimental animals based on increased incidence of malignant and/or a combination of malignant and...
On April 4, 2016, the U.S. Environmental Protection Agency (EPA) published its updated Recommended Aquatic Life Ambient Water Quality Criteria for Cadmium -- 2016 under Section 304(a) of the Clean Water Act (CWA). 81 Fed. Reg. 19176. The updated cadmium criteria recommendations replace the criteria values that EPA last issued in 2001. The CWA directs EPA to develop, publish, and periodically revise the ambient water quality criteria for aquatic life and human health that best reflect...
April 5, 2016
Proposition 65: OEHHA Proposes Revisions to Its Proposed Proposition 65 Warning Regulations
On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) modified its November 27, 2015, proposed rule that would repeal and replace the Proposition 65 (Prop 65) Article 6 regulations covering "clear and reasonable warnings" requirements. OEHHA states that the proposed changes are based on its response to the written comments it received on the proposed rule, and on oral comments provided during a January 13, 2016, public hearing. The modifications...
On March 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a final rule exempting manufacturers of six biodiesel chemicals from reporting processing and use information under the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA) Section 8(a). 81 Fed. Reg. 17392. In 2014, the Biobased and Renewable Products Advocacy Group (BRAG®), managed by Bergeson & Campbell, P.C.'s (B&C®) affiliate, B&C® Consortia Management, L.L.C. (BCCM) filed...
On March 18, 2016, the National Academies of Science, Engineering, and Medicine (NAS) announced the appointment of its provisional committee on "Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System." This study is being commissioned pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, "Modernizing the Regulatory System for Biotechnology Products," that states it would "commission an...
March 3, 2016
Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products
On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the Office of Science and...
February 29, 2016
Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9
The second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S....
February 11, 2016
House Bill Would Delete International Regulatory Provisions From Clean Air Act, And Other Recent CAA Developments
House Bill Would Delete International Regulatory Provisions From Clean Air Act: Stating that "this assault on our Constitution and states' rights must be stopped," Representative Scott Perry (R-PA) on February 11, 2016, introduced a bill that would deny the U.S. Environmental Protection Agency (EPA) "the ability to bypass Congress and take control of every states' energy program." The Energy Sovereignty Act (H.R. 4544) seeks to do so by eliminating Section 115 of...
On January 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) announced the adoption of final regulations (Regulations) related to the development and maintenance of a website to "provide information to the public regarding exposures to listed chemicals for which warnings are being provided" under Proposition 65 (Prop 65). Final Statement of Reasons (FSOR) at 11. OEHHA states that its intent with these Regulations is to "increase the availability of...
February 5, 2016
Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Organisms
According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies...
On January 21, 2016, the American National Standards Institute (ANSI) hosted a presentation on enforcement under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The topics covered included "Enforcement -- the Actors and the Activities"; "[the European Chemicals Agency (ECHA) Forum for Exchange of Information on Enforcement (ECHA Forum)]'s Role and Initiatives"; "Enforcement Targeted to Importers"; and "Enforcement of [Substances of...
On January 21, 2016, China's Ministry of Industry and Information Technology (MIIT) published its final version of the Administrative Measures for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products (China RoHS2). China RoHS2 will enter into force on July 1, 2016. An English translation of China RoHS2 provided by the EU Chamber of Commerce is available online. Since 2010, the Chinese government has endeavoured to update its RoHS...
January 27, 2016
Turkey Catching Up with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation
Turkey has been swiftly aligning its chemical regulatory system to that of the European Union (EU) since its EU membership negotiations commenced in 2005. KKDIK, described below, is Turkey's new chemical regulation, currently in draft. Widely referred to as Turkey REACH, KKDIK will further Turkey's vision of enacting EU REACH-like legislation. It is available in Turkish online. The name is taken from the first letters of Registration (Kaydı), Evaluation...