Memoranda

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Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important "clear and reasonable warnings" requirements under Proposition 65 (Prop 65); and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...