Memoranda

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...

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...

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...

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....

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...

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...

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...

EPA Issues Final RMP Rule: On January 13, 2017, EPA published in the Federal Register its final rule amending the Accidental Release Prevention Requirements for Risk Management Programs (RMP) under Clean Air Act (CAA) Section 112(r)(7). 82 Fed. Reg. 4594. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to...

On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union. The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a...

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 short list of notable achievements that will have some remaining work to...

What the implementation of new TSCA will look like, along with the general environmental program and emphasis of the new Trump Administration, is very unclear this early in the New Year (the new President will not arrive until January 20). What is more predictable is that the operating environment of OCSPP will change significantly, with uncertain impacts on both the U.S. Environmental Protection Agency’s (EPA) pesticide and toxic chemical regulatory programs. EPA institutionally may never be...

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 House of Representatives on...

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), posted with an...

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...

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 "thoroughly...

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...

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 action is a result of three...

The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the...

As most recently reported in The Acta Group's (ACTA®) October 28, 2015, Global Regulatory Update, the Australian government is implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). According to an item in the October 6, 2015, issue of The NICNAS Bulletin, the September 2015 implementation plan outlines opportunities for community and industry consultation; timing of legislative and information technology (IT)...

On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA's role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled...

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims that its additives for plastics (ECM Plastics) would make treated plastics biodegrade in a landfill. The FTC Final Order and Opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law...

n October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson...

On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...

On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard.  EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective...

The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, "FTC Sends Warning Letters about Green Certification Seals," that it sent warning letters to five providers of environmental certification seals and 32 businesses using those seals, "alerting them to the agency's concerns that the seals could be considered deceptive and may not comply with the FTC's environmental marketing guidelines." FTC states that environmental certification seals are intended to help...

The U.S. Environmental Protection Agency (EPA) released on September 17, 2015, a signed final significant new use rule (SNUR) for hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). Under the final rule, persons who intend to manufacture (including import) or process HBCD for use in consumer textiles (other than for use in motor vehicles) must notify EPA at least 90 days before commencing that activity. EPA notes that in this SNUR, the exemption for persons importing or...

On September 2, 2015, the U.S. Department of Health and Human Services' (HHS) Agency for Toxic Substances and Disease Registry (ATSDR), in accordance with guidelines developed by ATSDR and the U.S. Environmental Protection Agency (EPA), issued a proposed Toxicological Profile for Perfluoroalkyls for review and comment that included updated toxicological profiles for 13 perfluorinated chemicals, including two well-studied perfluorinated chemicals, perfluorooctane sulfonic acid (PFOS)...

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the...

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae...

On July 20, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish "policies and procedures to ensure uniform enforcement of the Hazard Communication standard" (HCS 2012). The Directive repeals previous instructions CPL 02-02-038 and CPL 02-02-039. It also cancels both enforcement memorandums effective February 9, 2015, and May 29, 2015, respectively. For more...

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential...

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this bill as it works to improve the protection of human health and...

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of...

After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a...

On June 11, 2015, the U.S. Environmental Protection Agency (EPA) held a meeting on its Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT Chemical Control Division, provided further insight into EPA's goals, directives, and...

The House is scheduled to vote late today, June 23, 2015 (around 6:30 p.m. or 7:00 p.m.), on the TSCA Modernization Act of 2015 (H.R. 2576). The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this...