Memoranda

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...