June 5, 2020

EPA Issues Pre-Publication Version Of Its Proposed Anti-Backsliding Determination For Renewable Fuel

By Lynn L. Bergeson 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...
May 29, 2020

DOE EERE Announces Funding Availability For Selected Small Businesses

By Lynn L. Bergeson On May 21, 2020, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the availability of approximately $21.3 million in funding for 106 Phase I small business innovation projects. The funds, announced by U.S. Secretary of Energy Dan Brouillette, are part of DOE’s $53 million available for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) research and development projects. The...
May 29, 2020

EPA Seeking Comments On The Registration Of A Novel Biopesticide And Product

By Lynn L. Bergeson On May 22, 2020, EPA’s Office of Pesticide Programs (OPP) announced the opening of a 15-day comment period on its proposal to register a new active ingredient and biopesticide product. The biopesticide product, PHC-91398, would contain Ea peptide 91398, the new active ingredient that was derived from naturally occurring bacterium and induces natural plant defenses. The plant’s reaction to the peptide “activates a hypersensitive response in treated plants,...
May 29, 2020

EPA Issues Small Manufacturer Definition Update Rule In Final

By Lynn L. Bergeson On May 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final rule amending the definition of small manufacturer, including a new definition for small government in accordance with the Toxic Substances Control Act (TSCA). Effective June 29, 2020, these amendments affect certain reporting and recordkeeping requirements in the Chemical Data Reporting (CDR) rule under TSCA.
May 29, 2020

U.S. Senators Join Forces In Bipartisan Bill Supporting Biofuel Producers

By Lynn L. Bergeson On May 21, 2020, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced a bill directing the U.S. Department of Agriculture (USDA) Secretary to establish a renewable feedstock reimbursement program. Aiming to support biofuel producers that have been negatively affected by the COVID-19 pandemic, this bill can be cited as the Renewable Fuel Feedstock Reimbursement Act of 2020. Under the reimbursement program, biofuel producers will be reimbursed for their...
May 22, 2020

“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...
May 22, 2020

EPA Approves Addition Of New Cleaning Ingredients Submitted By ACI

By Lynn L. Bergeson 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...
May 22, 2020

U.S. Air Force Synthetic Biology Challenge Deadline Approaches

By Lynn L. Bergeson 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...
May 22, 2020

U.S. Senators Introduce Bipartisan Bioeconomy Act

By Lynn L. Bergeson 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...
May 22, 2020

USDA Issues Biobased Manufacturing Program Rule In Final

By Lynn L. Bergeson 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...
May 18, 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 Health 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...
May 15, 2020

New Reporting Procedure For Co-Manufacturers Under TSCA CDR Rule May Catch Certain Manufacturers Off

By Lynn L. Bergeson One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its...
May 15, 2020

Purple Book Database Of Biological Products Updated By FDA

By Lynn L. Bergeson On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted...
May 15, 2020

Renewable Fuel Reimbursement Program Included In HEROES Act

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On May 12, 2020, a bill was introduced in the U.S. House of Representatives, which would make emergency supplemental appropriations for the fiscal year ending on September 30, 2020. Titled the Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES Act), this bill addresses various issues, many of which have been worsened by the COVID-19 pandemic. Some of these issues include provisions of revenue, health, retirement, government...
May 15, 2020

Mayors Submit Letter To EPA Administrator On RFS Uphold And Proposed Waivers

By Lynn L. Bergeson On May 11, 2020, a total of 70 Mayors from various cities in the United States submitted a letter to Andrew Wheeler, U.S. Environmental Protection Agency (EPA) Administrator, criticizing the decision not to uphold the Renewable Fuel Standard (RFS) and not to reject proposed waivers under Section 211(o)(7) of the Clean Air Act. The Mayors state that this decision on waivers is already causing damage to the economy and will continue to devastate farmers, workers, and families...
May 14, 2020

EPA Will Hold Webinar on CDR Requirements on May 19

The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements.  The 2020 CDR submission period is from June 1, 2020, to November 30, 2020.  The webinar will include information about the revised reporting requirements, including: New requirements for making confidential business information (CBI) claims; Reporting refinements related to...
May 13, 2020

EPA’s Updated Small Manufacturer Definition Will Apply to CDR Reporting Period Beginning June 1

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA).  According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the...
May 8, 2020

Register Now For The “TSCA Reform — Four Years Later,” Virtual Symposium, Wednesday, June 24, 2020,

By Lynn L. Bergeson B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform -- Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers include:...
May 8, 2020

Richard E. Engler, Ph.D., Presents “TSCA New Chemicals” During GlobalChem Webinar Series, May 13, 20

By Lynn L. Bergeson The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy...
May 1, 2020

EPA ORD Announces BOSC CSS-HERA Subcommittee Meeting

By Lynn L. Bergeson On April 29, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) announced a virtual meeting of the Board of Scientific Counselors (BOSC) Chemical Safety for Sustainability and Health and Environmental Risk Assessment (CSS-HERA) Subcommittee. The purpose of the meeting will be to review the draft 2019-2022 Strategic Research Action Plan (StRAP) of the HERA research program. The videoconference meeting will be held over a...