All Knowledge & Insights By Date

The U.S. Environmental Protection Agency (EPA) continues to implement reporting requirements pertinent to the supply, use and trade of mercury in the United States. This column provides more information and a closer look into the EPA’s October 2017 proposed rule.

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal,...

Proposition 65 (Prop 65) is very much a part of the “right-to-know” landscape in California and, as we all know, Prop 65 warnings are especially visible in that state. This much is clear. What may be less clear are the sweeping changes in the “clear and reasonable warning” requirements now scheduled to take effect from August 30, 2018. This date may seem like a long way off, but it is right around the corner in terms of coming into compliance with these dramatic changes. This Washington...

On 23 June 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 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry. Between then and now, there have been significant developments in...

On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year.  A Cmty. Voice v. EPA, No. 16-72816.  The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint...

The Acta Group (Acta®) was featured in the Winter 2017 Elements Magazine, published quarterly by Chemicals Northwest as a “one-stop solution” for global or local chemical regulatory compliance, especially for companies preparing for the May 13, 2018 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) deadline. Acta has frequently received recognition from clients and industry globally for our previous and ongoing demonstrations of excellence, most...

In early December 2017, the United Nations Environment Program (UNEP) published Frontiers 2017:  Emerging Issues of Environmental Concern.  The report covers six key emerging issues:  the environmental dimension of antimicrobial resistance; nanomaterials; marine protected areas and sustainable development; sand and dust storms; off-grid solar solutions; and environmental displacement.  The section on nanomaterials addresses nanodimensions — new discoveries about familiar materials;...

On December 22, 2017, the U.S. Environmental Protection Agency (EPA) sent to the Office of Management and Budget (OMB) a proposed rule establishing fees on certain submissions under amended Toxic Substances Control Act (TSCA) Sections 4, 5, and 6.  EPA has indicated that it expects to propose the rule in the early part of the New Year:  EPA’s regulatory agenda lists February 2018 for the proposed rule and September 2018 for the final rule. More...

On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans.  Food & Water Watch, Inc. v....

By Kathleen M. Roberts On December 13, 2017, the U.S. Department of Energy (DOE) announced the availability of up to $100 million in funding to support innovators through early-stage research and development (R&D) projects focused on technologies to transform the nation’s energy system.  The funding will be provided through the Advanced Research Projects Agency-Energy (ARPA-E) OPEN funding opportunity.  OPEN funding opportunity announcements (FOA), which are typically...

On December 19, 2017,  Bloomberg BNA Daily Environment Report included comments by Michael S. Wenk, M.S., Senior Regulatory Consultant with Bergeson & Campbell, P.C. (B&C®), regarding future chemical regulations in Brazil. Big questions remain, among them: Will Brazil recognize industrial chemicals registered through other systems like the Toxic Substances Control Act in the U.S., or REACH in the European Union? Or will companies have to reproduce testing results?...

On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018.  The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders...

On December 15, 2017, the U.S. Environmental Protection Agency (EPA) announced its release of preliminary ecological and human health risk assessments for three neonicotinoid insecticides:  clothianidin, thiamethoxam, and dinotefuran, as well as a preliminary ecological risk assessment for imidacloprid, assessing risks to birds, mammals, non-target insects, and plants.  The assessments are available in the dockets linked below: Imidacloprid Registration Review Docket ID...

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present...

The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials.  The...

By Lauren M. Graham, Ph.D. On December 8, 2017, the U.S. Department of Commerce (DOC) issued in the Federal Register a notice on the postponement of final determinations of sales in less than fair value (LTFV) investigations into biodiesel from Argentina and Indonesia and the extension of provisional measures.  As reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “DOC Initiates Biodiesel Antidumping, Countervailing...

By Kathleen M. Roberts On December 8, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register regarding its plans to submit an information collection request (ICR) to the Office of Management and Budget (OMB) on recordkeeping and reporting for the Renewable Fuel Standard (RFS) program.  The notices states that the ICR aims to streamline and update estimates related to the RFS program and consolidate all RFS estimates into one, consistent, and...

On November 30, 2017, the European Chemicals Agency (ECHA) held a webinar to explain the support documentation available for registrants that cover nanoforms in their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration dossier.  The main focus was on the registration and read-across of nanoforms, but the webinar also covered updates for information requirements for human health and the environment.  ECHA has posted the following...

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s...

On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit.  This was not entirely unexpected, as the U.S. Court of Appeals for...