Memoranda

After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 Click here for a PDF brochure of the memorandum 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress significantly amended the Toxic Substances Control Act (TSCA). The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing,...

On January 4, 2017, the U.S. Environmental Protection Agency (EPA) published its final rule revising its regulation concerning the certification of applicators of restricted use pesticides (RUP).  EPA states that the final rule is intended to ensure federal certification program standards adequately protect applicators, the public, and the environment from risks associated with the use of RUPs.  According to EPA, the final rule will improve the competency of certified...

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...

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...

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...

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...

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...

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 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, we 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 industry expectations...

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...

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 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...

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...

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 Conservation and Recovery Act (RCRA). 81...

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...

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...

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 meetings over the past...

On April 22, 2016, California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final notice listing styrene as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA also issued a proposal to adopt a Prop 65 No Significant Risk Level (NSRL) of 27 micrograms per day for styrene. The listing of styrene has been contentious. OEHHA previously attempted to propose...

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...

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...

In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. Many believe...

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...

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...

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)...

OEHHA Proposes MADL For BPA (Dermal Exposure From Solid Materials): On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed a maximum allowable dose level (MADL) for bisphenol A (BPA) (dermal exposure from solid materials) of three micrograms per day. OEHHA states that it reviewed the transcript of the May 7, 2015, meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) and the hazard identification materials...

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...

A January 20, 2016, letter from U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy provides the Administration’s reaction to, and comments on, the Toxic Substances Control Act (TSCA) reform legislation that has passed both the House and the Senate in somewhat different forms. The differences between the bills are currently being sorted out and reconciled. The bills at issue are the TSCA Modernization Act of 2015 (H.R. 2576) and the Frank R....

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...

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. Environmental Protection Agency...