|May 21, 2020|
Final SECURE Rule Will Update And Modernize USDA’s Biotechnology Regulations
On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Hvealth Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum here.
USDA Issues Biobased Manufacturing Program Rule In Final
On May 18, 2020, USDA issued its final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (9003 Program), which incorporates the statutory definition changes as required in the Agricultural Act of 2018 (Farm Bill) and adopts the interim rule published on June 14, 2015. The 9003 Program replaces the Biorefinery Assistance Program (BAP), which guaranteed loans to fund the development, construction, and retrofitting of commercial-scale biorefineries using eligible technology. The final rule makes several specific changes to BAP, including:
- Renames the program as the 9003 Program;
- Revises the purpose statement for the program to include renewable chemicals and biobased product manufacturing;
- Expands the program to include biobased product manufacturing facilities;
- Adds definitions for “renewable chemicals” and “biobased product manufacturing”; and
- Ensures diversity in the types of projects approved by the program.
The final rule became effective on May 18, 2020.
U.S. Senators Introduce Bipartisan Bioeconomy Act
On May 15, 2020, U.S. Senators Cory Gardner (R-CO), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Marco Rubio (R-FL) introduced the Bioeconomy Research and Development Act of 2020, creating a federal research initiative to ensure continued United States leadership in engineering biology. The National Engineering Biology Research and Development Initiative would focus on the advancement of societal well-being, national security, sustainability, and economic productivity and competitiveness. It would accomplish these goals through:
- Advancement of areas of research at the intersection of biological, physical, chemical, data, and computational sciences;
- Advancement of areas in biomanufacturing research;
- Support of social and behavioral sciences and economics research that advances the field of engineering biology;
- Improvement of the understanding of the engineering biology;
- Support of risk research;
- Development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology;
- Expansion of the number of researchers, educators, and students with engineering biology training;
- Acceleration of the translation and commercialization of engineering biology research and development by the private sector; and
- Improvement of the interagency planning and coordination of federal government activities related to engineering biology.
According to Senator Rubio, the Bioeconomy Research and Development Act of 2020 has been endorsed by a number of leading research institutes, including the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member.
U.S. Air Force Synthetic Biology Challenge Deadline Approaches
The U.S. Air Force (USAF) Research Laboratory is sponsoring a $1 million challenge for synthetic biology solutions to reduce the cost and improve the quality for aerospace thermosets. This scientific challenge is focused on the use of biotechnology to create products or product precursors required by USAF. Interested parties must submit white papers on the viability of the approach to bio-synthesize two molecules A and B needed for aerospace thermosets. This is the first of three challenges and consists of three phases. Phase One is the white paper submission as previously described. Phase Two is when submitted white papers will be down-selected from the viable entrees. Potential awardees selected will then have two weeks to enter into a subsequent agreement with a company that can scale up their production concept and demonstrate capability to manufacture testable amounts with a United States company (if the awardees cannot manufacture the product themselves). In the third and final phase, semi-finalist teams will have one hour to pitch their concept and scale up strategy with their manufacturing partner (if needed) to the evaluation team.
The winner of the third phase will be awarded half of the prize ($500,000) based on their total cost estimate to complete the challenge. The team will then have to demonstrate that they can biosynthesize molecules A and B. Upon completion of this demonstration, the team will be given one-third of the prize award to demonstrate the viability of the concept to manufacture one gram each of A and B to test for purity. Interested parties must submit applications here on or prior to June 15, 2020.
EPA Approves Addition Of New Cleaning Ingredients Submitted By ACI
On May 14, 2020, the American Cleaning Institute (ACI), a BRAG member, announced that the U.S. Environmental Protection Agency (EPA) approved eight cleaning product ingredients submitted by ACI for inclusion in EPA’s Safer Chemical Ingredients List (SCIL). EPA’s Safer Choice Program focuses on assisting consumers, businesses, and purchasers to find products that perform and contain ingredients that are safer for human health and the environment. SCIL is a list of chemical ingredients that have been evaluated and determined by the Safer Choice Program to be safer than traditional chemical ingredients. This is the first time that the Safer Choice Program has approved a SCIL submission by a non-manufacturer. Kathleen Stanton, ACI Associate Vice President of Technical and International Affairs and BRAG company representative, commented on ACI’s achievement stating that “[a]dding chemicals to the SCIL encourages innovation and growth in safer products, increases markets for manufacturers and helps protect people and the environment.” The following chemical surfactants were added to SCIL:
- Octadecanoic acid, 2-ethylhexyl ester;
- Alcohols, C12-15;
- Octadecanoic acid, 12-hydroxy-;
- Fatty acids, C8-18 and C18-unsaturated, sodium salts;
- Fatty acids, C14-18 and C16-18-unsaturated, sodium salts;
- Potassium oleate;
- Fatty acids, palm-oil; and
- Sulfuric acid, mono-C14-18-alkyl esters, sodium salts.
Lynn L. Bergeson Named Among Top 50 Women Super Lawyers In Washington, D.C.; Earns Band 1 Ranking From Chambers And Partners
Bergeson & Campbell, P.C. (B&C®) is pleased to announce that Managing Partner Lynn L. Bergeson has again been recognized by Thomson Reuters’ Super Lawyers as one of the “Top 50 Women” practicing law in Washington, D.C. in 2020. She was also named a Super Lawyer in Environmental Law, a distinction she has earned consistently since 2008.
B&C is also pleased to announce that Ms. Bergeson has earned the highest ranking attainable in Chambers and Partners USA Guide 2020 for Environmental Law — Band 1. In its review, Chambers states: “‘Absolute rockstar’ Lynn Bergeson is singled out by sources as ‘the chemical guru in the DC market.’ Her practice focuses predominantly on TSCA and FIFRA issues.” This marks 15 years of Ms. Bergeson appearing on the Chambers USA list as one of the best lawyers in America.
Ms. Bergeson’s articles and commentary have earned several awards in the first half of 2020. Lynn was named a Go-To Thought Leader by the National Law Review; the exclusive “Legal Influencer” by Lexology for the fifth consecutive quarter in the “US Infrastructure” category; and a Top Author in the Energy category of the 2020 JD Supra Readers’ Choice Awards.
In addition to the above rankings and awards for Ms. Bergeson, B&C is pleased to announce that the firm earned a National Tier 1 ranking in Environmental Litigation and a Metropolitan Tier 1 ranking for Environmental Law and Litigation in Washington, D.C. in U.S. News and World Report’s 2020 Best Law Firms rankings.
Lynn L. Bergeson is Managing Partner of B&C, a Washington, D.C. firm concentrating on conventional, nanoscale, and biobased chemicals and chemical products. She is President of the Product Stewardship Society; Vice Chair of the International Bar Association (IBA) Agricultural Law Section; Vice Chair of the American Bar Association (ABA) Section of Environment, Energy, and Resources Committee on Pesticides, Chemical Regulation, and Right-to-Know; and a former Chair of the ABA Section of Environment, Energy, and Resources.
Ms. Bergeson is also President of The Acta Group (Acta®), B&C’s scientific and regulatory consulting arm with offices in Washington, D.C., the United Kingdom, Belgium, and China, and President of B&C® Consortia Management, L.L.C. (BCCM), which helps the chemical industry form consortia to achieve shared research, testing, and regulatory goals.
B&C’s award-winning coverage of chemical regulatory matters can be found on All Things Chemical™, a podcast about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals; the Pesticide Law and Policy Blog®, covering Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) issues; the TSCAblog®, providing news and analysis regarding Lautenberg implementation and related legal and administrative developments; the Nano and Other Emerging Chemical Technologies Blog; and the BRAGTM Biobased Products Blog. In-depth commentary on these issues and a wide range of other subjects can be found on the Regulatory Developments page of B&C’s website.
“TSCA Reform — Four Years Later” Virtual Seminar
From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. B&C, The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform — Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Confirmed speakers include:
- Lynn L. Bergeson, Managing Partner, B&C
- Yvette T. Collazo, Director, Office of Pollution Prevention and Toxics (OPPT), EPA
- Thomas M. Connelly, Jr., Executive Director and CEO, American Chemical Society (ACS)
- Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA
- Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund (EDF);
- Scott Fulton, President, ELI
- Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
- Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, GWU
- Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC)
Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. – 4:30 p.m. (EDT),to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.
|■||The Register-Guard, “OSU: Researchers Make Key Advance toward Production of Important Biofuel”|
|■||The Guardian, “The End of Plastic? New Plant-Based Bottles Will Degrade in a Year”|
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