Blogs

On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV).  Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019.  It is co-sponsored by Representative John Moolenaar (R-MI).  The bill is intended to...

By Lynn L. Bergeson In response to EPA supplemental proposal outlined above, on October 15, 2019, U.S. Senator James Lankford (R-OK) issued a statement expressing his disappointment with EPA’s RFS mandates. Senator Lankford’s statement reads in part: The RFS has been a problem since day one, and the proposed increase to the mandate only further complicates a broken federal requirement to blend biofuels into gasoline. This proposal continues allowing exemptions for small refineries...

By Lynn L. Bergeson On October 15, 2019, EPA Administrator, Andrew Wheeler, signed a supplemental notice of the proposed rule on the Renewable Fuel Standard (RFS) that proposes to establish the cellulosic biofuel, advanced biofuel, and total renewable fuel volumes for 2020 and the biomass-based diesel volume for 2021. Although the rule does not change the volumes for 2020 and 2021 proposed in July 2019, it proposes and seeks comment on adjustments to the way...

By Lynn L. Bergeson On October 15, 2019, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service (RBCS) announced via the Federal Register the solicitation of applications for funds under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program). Under the Program, USDA provides guaranteed loans to fund the development, construction, and retrofitting of commercial scale biorefineries using eligible technology. The loans are also...

The European Union (EU) Observatory for Nanomaterials (EUON) announced on October 15, 2019, that it seeks topics that could be addressed in upcoming studies.  EUON conducts up to three studies annually that are intended to address knowledge gaps on nanomaterials that are of interest to the general public and the research community.  EUON states that it is looking for studies that address: According to EUON, the scope of the study can be on nanomaterials in general, a...

The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours].  According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear...

On October 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled...

On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program.  According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process.  OIG states that Safer Choice “is a voluntary labeling...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Governor of Minnesota, Tim Walz, announced that applications are now open for all 15 seats on the Governor’s Biofuels Council.  Established in September 2019 by Governor Walz, the Governor’s Biofuels Council advises the Governor and cabinet on how best to support Minnesota’s biofuels industry. Council members will include representatives of agriculture, biofuels, and transportation industries and...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On October 2, 2019, the Green Party of Canada commented, via a press release, on its Green Climate Action Plan called “Mission:  Possible.” Aiming to exceed the U.S. Green New Deal, under this plan, the Green Party outlines a 20-step action plan to achieve the goal of zero emissions by 2050.  Part of the strategy outlined emphasizes the idea that heavy-duty industrial machinery will need to...

By Lynn L. Bergeson On October 2, 2019, the government of Quebec, Canada, published in its Official Gazette a notice of a draft regulation setting standards for the integration of renewable fuels into gasoline and diesel fuel.  Under the draft regulation, the standards will apply on July 1, 2021, and will then increase. As of July 1, 2025, the integration of a minimum volume of ethanol of 15 percent into gasoline and a minimum volume...

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...

By Lynn L. Bergeson On October 4, 2019, U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, and U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced President Trump’s negotiated agreement on the Renewable Fuel Standard (RFS).  Under the agreement, EPA and USDA will undertake the following actions: In a forthcoming supplemental notice building off the recently proposed 2020 Renewable Volume Standards and the Biomass-Based Diesel Volume for...

On October 7, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion by Lise Bitsch, Governing Nanotechnologies through Societal Engagement (GoNano), entitled “Strengthening societal engagement with nanotechnologies.”  Bitsch presents several arguments for why actors in the research and innovation world of nanotechnologies and other key enabling technologies should care about societal engagement.  Bitsch also explains what societal engagement is...

On September 30, 2019, the U.S. Environmental Protection Agency (EPA) released an updated Aquatic Life Benchmarks Table for registered pesticides.  The update includes four newly registered pesticides and their degradants as well as new values for more than 30 previously registered pesticides. The benchmarks inform state and local regulators in their interpretation of water quality monitoring data. Waterbodies where benchmarks are exceeded may be prioritized for further investigation.  EPA...

The European Chemicals Agency (ECHA) issued a press release on October 8, 2019, reminding companies that by January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The new information requirements concern companies that manufacture or import nanoforms of substances that are subject to registration under REACH.  As...

On September 17, 2019, the European Food Safety Authority (EFSA) opened a consultation period on two pilot assessments of the risks posed to humans by residues of multiple pesticides in food.  EFSA is seeking comments from interested parties on the assessments.  The first assessment considers the chronic effects of multiple pesticides on the thyroid system.  The second looks at acute effects on the nervous system. EFSA produced the assessments in collaboration with the...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...

By Lynn L. Bergeson On September 30, 2019, DOE’s Smart Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced the opening of applications for Cohort of Innovators through October 31, 2019. Three DOE National Laboratories are accepting such applications: (1) Argonne National Laboratory (ANL) Chain Reaction Innovation; (2) Oak Ridge National Laboratory (ORNL) Innovation Crossroads; and (3) Lawrence Berkeley National Laboratory (LBL)...