Memoranda

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...

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...

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...

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...

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...

On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the...

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.” The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting...

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain...

Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the “legacy” issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the...

This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the...

On December 16, 2015, the House Appropriations Committee released the Consolidated Appropriations Act, 2016. The 2,009-page bill includes full appropriations legislation and funding for the 12 annual appropriations bills through the end of fiscal year (FY) 2016. The bill would reauthorize the Land and Water Conservation Fund (LWCF), which expired on September 30, 2015. This reauthorization is likely what prompted Senator Richard Burr (R-NC) to inform Senate Majority Leader Mitch...

On November 23, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued a Letter of Interpretation (LOI) on labeling packages for import and export. The LOI discusses labeling scenarios and details OSHA’s interpretation of the Hazard Communication Standard (HCS 2012) requirements for those scenarios. Background On May 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations’ Globally Harmonized...

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important “clear and reasonable warnings” requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule),...

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important “clear and reasonable warnings” requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule),...

EPA Launches eDisclosure Portal: On December 9, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is modernizing implementation of its self-disclosure policies by creating a centralized web-based ”eDisclosure” portal to receive and automatically process self-disclosed civil violations of environmental law. 80 Fed. Reg. 76476. Under the automated eDisclosure system, “large and small businesses will quickly be able to get some of their more routine types...

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, the U.S. Environmental Protection Agency (EPA) filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC’s (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case...

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies’ application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it...

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term “natural” in the labeling of human food products. The notice states that it is establishing “a docket to receive information and comments on the use of the term ‘natural’ in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.” FDA states that this...