Biobased Products News and Policy Report – Update from Bergeson & Campbell, P.C.

Biobased Products News and Policy Report

June 4, 2020

Federal

EPA Issues Pre-Publication Version Of Its Proposed Anti-Backsliding Determination For Renewable Fuels And Air Quality

On May 29, 2020, the U.S. Environmental Protection Agency (EPA) issued a pre-publication version of a proposed anti-backsliding determination that no additional measures are necessary pursuant to the Clean Air Act (CAA) Section 211(v) to mitigate the adverse air quality impacts of renewable fuel volumes required under CAA Section 211(o). The proposed determination will be published in the Federal Register for a 30-day comment period. CAA Section 211 requires EPA to take two actions. The first action is for EPA to complete a study to determine whether renewable fuel volumes required under CAA Section 211(o) will adversely impact air quality given changes of vehicle and engine emissions of air pollutants. This study is often referred to as the anti-backsliding study and must include consideration of various blend levels, types of renewable fuels, and available vehicle technologies. The study must also include appropriate national, regional, and local air quality control measures. EPA has completed the study, which is available here.

The second action requires EPA to make a decision on whether it should proceed down one of the following paths:

  • Promulgation of fuel regulations to implement appropriate measures to mitigate any adverse impacts on air quality as a result of the renewable volumes required by Section 211; or
     
  • Determination that no such measures are required.
     

In this case, EPA is proposing a determination “that no additional appropriate fuel control measures are necessary to mitigate adverse air quality impacts of required renewable fuel volumes.”

EPA Releases Biannual Update To Public TSCA Inventory

EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).

DOE EERE Announces Workshop On Tools To Accelerate Scaling-Up Of Biobased Fuels

On June 3, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced that it will be hosting a public virtual workshop titled “Workshop on Predictive Models and High Performance Computing as Tools to Accelerate the Scaling-up of New Bio-Based Fuels.” The goal is to determine if predictive models and high performance computing can and should be used to reduce biotechnology uncertainty and accelerate scaling-up of biorefinery/chemical production equipment and optimize operations. The virtual workshop will be held from June 9 to June 11, 2020, from 10:30 a.m. to 4:30 p.m. (EDT) each day. Registration is required by 4:00 p.m. (EDT) June 5, 2020.

Workshop On Bioanalysis To Be Held By FDA

On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:

  • Bioanalytical method validation: history, process, and regulatory perspectives;
     
  • Biosimilars;
     
  • Regulated bioanalysis for large molecules;
     
  • Regulated bioanalysis for small molecules;
     
  • Drugs and biologics;
     
  • Bioanalysis of unstable analysis;
     
  • Repeat analysis; and
     
  • A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.

Registration is required.

Events

ELI Webinar: “Innovative Solutions To Fast Fashion Challenges”

On June 10, 2020, from 12:00 p.m. to 1:30 p.m. (EDT),the Environmental Law Institute (ELI) will host a free webinar titled “Innovative Solutions to Fast Fashion Challenges.” Co-sponsored by the Plant Based Products Council (PBPC), the webinar will explore the future of fast sustainable fashion. Panelists’ discussions will include fashion industry challenges, consumer trends, policy obstacles and opportunities, and the potential for circular economies, including best practices to manage supply chains. Interested parties should register here by June 8, 2020.

Other News
 

Fresh Plaza, “Biodegradable PATI Bags to Protect Bunches of Bananas on Trial in South Africa
 
Energy.agwired.com, “Ethanol Interests Challenge EPA Study Results
 
New Atlas, “Shrimp Shells to Serve as the Basis for New Multi-Protective Coatings
 
The Times of India, “Punjab: LPU Researchers Developed New Algae-Based Respirator to Help Mask Wearers Breathe Easy
 
Horizon Magazine, “Biodegradable Glitter and Pollution Eating Microalgae: the New Materials Inspired by Nature
 

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