Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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Register now to join B&C for “FIFRA Hot Topics,” a complimentary webinar covering key priorities of Office of Pesticide Programs (OPP) and what companies should know to avoid market delays. With year one of the Biden Administration’s term in the history books, we have a clearer sense of how EPA is proceeding on all fronts. EPA’s OPP is focusing on long-standing challenges, especially a renewed effort to meet Endangered Species Act (ESA) consultation requirements and determining how best to meet core pesticide registration review obligations in 2022. These program priorities must reflect special considerations for environmental justice and climate change, advance critical science and policy issues, develop a fifth Pesticide Registration Improvement Act (PRIA) implementation framework, and display a renewed commitment to working collaboratively with state partners and other stakeholders to implement the program.

Speakers include:

Tags: Webinar, FIFRA

 
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By Lynn L. Bergeson and Carla N. Hutton

On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:

  • Chemistry Assessment:
    • Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
    • Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
    • Complete characterization of the new chemical substance is often unavailable;
  • Environmental Fate and Transport Assessment:
    • Analysis of constituents may not represent the properties of the new chemical substance;
  • Engineering Assessment: Environmental Releases:
    • EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
    • Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
    • Release estimates have limitations -- examples:
      • Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
      • Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
  • Engineering Assessment: Occupational Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
    • Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
    • Exposure models do not account for some engineering controls (vapor capture/reduction);
  • Exposure Assessment: General Population and Consumer Exposures:
    • The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
    • The confidence of the exposure estimates are affected by:
      • Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
      • Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
  • Hazard Assessment:
    • Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
    • EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
    • There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.

For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).


 
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By Lynn L. Bergeson

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing was intended to help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Read more in Bergeson & Campbell, P.C.’s (B&C®) March 18, 2022, memorandum, “House Committee Holds Hearing on Bioenergy RD&D for the Fuels and Chemicals of Tomorrow."


 
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By Lynn L. Bergeson

As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA the posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA will hold a virtual public meeting April 20-21, 2022, to seek individual input. Written comments on the draft document are due April 26, 2022. Read more in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum, “EPA Posts Draft Document on 'Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA'.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy will hold a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing is to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing will also consider advancements in bioenergy research and the potential role of this resource in a cleaner energy transition. Lastly, the hearing will help inform future legislation to support and guide the United States’ bioenergy RD&D enterprise. Witnesses will include:

  • Dr. Jonathan Male, Chief Scientist for Energy Processes and Materials, Pacific Northwest National Laboratory (PNNL);
     
  • Dr. Andrew Leakey, Director of the Center for Advanced Bioenergy and Bioproducts Innovation at the University of Illinois Urbana-Champaign;
     
  • Dr. Laurel Harmon, Vice President of Government Affairs, LanzaTech; and
     
  • Dr. Eric Hegg, Professor, Biochemistry and Molecular Biology, Michigan State University.

The hearing charter notes that in addition to fuels, biomass can be used to create valuable chemicals and materials, known as “bioproducts.” According to the hearing charter, approximately 16 percent of U.S. crude oil consumption is used to make petrochemicals and products, such as plastics for industrial and consumer goods, fertilizers, and lubricants. Common biobased products include household cleaners, paints and stains, personal care items, plastic bottles and containers, packaging materials, soaps and detergents, lubricants, clothing, and building materials. The hearing charter states that the production of bioproducts relies on much of the same feedstocks, infrastructure, feedstock commoditization, and technologies that are central to biofuels production. Therefore, according to DOE, once technologies are proven for bioproduct applications, they could be readily transferred and greatly improve biofuel production.


 
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By Lynn L. Bergeson 

On January 31, 2022, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) and 12 of their colleagues submitted a letter to EPA Administrator, Michael Regan, regarding EPA’s RFS Annual Rules and Proposed RFS Small Refinery Exemption Decision. In the bipartisan letter, Senators Klobuchar and Grassley and their colleagues urge EPA to prioritize the RFS in support of a “homegrown energy future” by:

  1. Maintaining the blending requirements for 2022, including the 250 million gallon remand;
  2. Denying all pending SRE;
  3. Eliminating the proposed retroactive cuts to the 2020 RVO; and
  4. Setting 2021 volumes at the statutory levels.

The letter commends EPA’s efforts to better the RFS program and highlights areas with room for improvement. Of particular concern to the letter signatories is EPA’s proposal to waive retroactively 2.96 billion gallons of renewable fuel from the 2020 RVOs. The letter states that adjusting these biofuel volumes more than two years after they were finalized would set a troubling precedent and impact negatively the entire agriculture and fuel supply chain. Therefore, Klobuchar and her colleagues urge EPA to eliminate the proposed retroactive cuts to the 2020 volumes and require obligated parties to comply with the 2020 standards that were issued in final in 2019. The signatories express similar concerns with the proposal to reset retroactively authority to establish 2021 RVOs and state that EPA cannot meet its ambitious climate goals without providing for growth and certainty in the RFS.

Senators Klobuchar and Grassley and their colleagues request that EPA finalize these actions as quickly as possible to restore integrity, stability, and growth to the RFS program and the U.S. biofuel sector.


 
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By Lynn L. Bergeson 

On February 16, 2022, EPW held a hearing to examine EPA’s RFS program. U.S. Senator and EPW Chairman, Tom Carper (D-DE), made the opening statement, highlighting that EPW had not held an oversight hearing on the RFS since 2016. While Senator Carper demonstrated continued support for the RFS program, he also noted that “[f]or example, the amount of advanced renewable fuel used today in this country is far less than the 36 billion gallons that Congress mandated in 2007 be used by 2022. That shortfall is partly due to unforeseen market challenges and partly due to EPA’s delay in approving new fuels to enter the marketplace.” Senator Carper criticized the CAA for prohibiting some advanced biofuels that qualify for state programs from qualifying as renewable fuels under the RFS. He highlighted that volatility in compliance costs for refiners also presents challenges to implementing the RFS. The hearing included further discussions on other management and implementation challenges that EPA is facing and addressed opportunities to encourage increased deployment of more sustainable fuels.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. 

On February 22, 2022, U.S. Senator and Chairwoman of the U.S. Senate Committee on Agriculture, Nutrition, and Forestry, Debbie Stabenow (D-MI), and U.S. Senator and Committee member, Amy Klobuchar (D-MN), sent a letter to the U.S. Secretary of Agriculture, Tom Vilsack, requesting improvements to the United States’ biobased economy. Senators Stabenow and Klobuchar’s request focuses particularly on the U.S. Department of Agriculture (USDA) BioPreferred® Program (Program), urging that USDA leverage its long-standing expertise in biobased products to strengthen the Program.

Managed by USDA, the Program aims to increase the purchase and use of biobased products, spur economic development, create new jobs, and provide new markets for farm commodities. The Program has two major parts:

  • Mandatory purchasing requirements for federal agencies and their contractors; and
  • A voluntary labeling initiative for biobased products.

According to Senators Stabenow and Klobuchar, federal procurement for BioPreferred® products has failed to increase, despite significant product innovations in recent years. The two U.S. Senators encourage the U.S. Office of Management and Budget (OMB) and USDA to educate procurement officers on the benefits of BioPreferred® products and routinely to measure progress of the Program. They also request that Secretary Vilsack and the U.S. Secretary of Commerce complete swiftly creation of North American Product Classification System (NAPCS) codes, correlating them to North American Industry Classification System (NAICS) codes to capture the multiple industries into which each product is sold.
 


 
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By Lynn L. Bergeson 

On January 27, 2022, U.S. Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Environment and Public Works (EPW) Committee, and 14 of her colleagues submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Michael Regan, requesting that EPA reconsider its proposed actions under the Renewable Fuel Standard (RFS) program through the RFS Annual Rules and the Proposed RFS Small Refinery Exemption Decision. Senator Capito and her colleagues request specifically that EPA reassess its proposed denial of all pending small refinery exemption (SRE) petitions under the RFS program, because EPA’s decision breaches congressional intent under the Clean Air Act (CAA). According to the letter, Congress’ intent in amending the CAA to allow for SREs was to alleviate disproportionate economic hardship associated with RFS compliance for small refiners. Therefore, the denial of all pending SRE petitions contravenes Congress’ intent and, according to Senator Capito and her colleagues, will lead to increased litigation and uncertainty under the RFS program.

The letter also states that EPA’s “proposal for all-time high Renewable Volume Obligations (RVO) for 2022 does not reflect market realities and is likely to further raise costs for refiners – especially small and independent refiners – and therefore American consumers and the economy.” Senator Capito and her colleagues urge EPA to reconsider these actions to:

  • Provide relief and certainty for companies, employees, and communities across the United States;
  • Bolster access to affordable and domestically produced fuels for U.S. consumers; and
  • Remove obstacles for an economy that is challenged currently by inflation and supply chain difficulties.

 
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By Lynn L. Bergeson 

On February 24, 2022, EPA announced the selection of 11 organizations to receive a total of approximately $2 million in funding to divert food waste from landfills by expanding anaerobic digester capacity nationwide. Anaerobic digestion (AD) produces biogas that can be captured and used for energy production and digestate (a fertilizer product) by using microorganisms to break down organic materials, such as food scraps and manure, in the absence of oxygen. By reducing the amount of wasted food in landfills and consequently methane emissions, AD may reduce significantly the impacts of climate change. EPA’s food recovery hierarchy includes AD as a strategy that is preferable to landfilling and incineration, because it contributes to building a circular economy. Each of the selected organizations will receive between $150,000 and $200,000 over two years. A list of the selected projects is available here.


 
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By Lynn L. Bergeson and Carla N. Hutton

On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. According to EPA, it has received more than 30 biofuel PMNs “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the [Renewable Fuel Standard (RFS)] program and help support the goals of energy security through increasing domestic production” within the United States. Future webinars will cover the TSCA Inventory, nomenclature, and Bona Fide process; new chemicals risk assessments, including applications of the tools, models, and databases; and new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).

More information on webinar is available in our March 1, 2022, memorandum.

Tags: TSCA, EPA, Biofuel, PMN

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will hold a virtual public meeting April 20-21, 2022, to seek individual input on the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. In addition, EPA announced the availability of and is soliciting public comment on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” EPA states that the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. According to EPA, the effort will be performed in partnership with its Office of Research and Development (ORD) and other federal entities to leverage their expertise and resources. Written comments are due April 26, 2022. Registration for the meeting is now open.

According to EPA, the research program will refine existing approaches and develop and implement new approach methodologies (NAM) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach to using data from structurally similar chemicals to determine potential risks from new chemicals, also known as read-across. According to EPA, this will increase the efficiency of new chemical reviews, promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently exist only in hard copy or in various disparate TSCA databases. EPA will combine the information with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information (CBI) will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. EPA states that as this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA, as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will integrate more efficiently all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA states that additional information on each of these areas will be provided in the draft collaborative research plan that will be available in the docket by March 14, 2022. Later in 2022, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA also intends to issue a Federal Register notice announcing the BOSC meeting and to open a docket for public comments.

Although the notice states that EPA’s background documents and the related supporting materials to the draft are available in the docket established for this meeting, Docket ID Number EPA-HQ-OPPT-2022-0218, nothing is available at this time. EPA states that it will provide additional background documents as the materials become available. After the virtual public meeting, EPA will prepare meeting minutes summarizing the individual comments received at the meeting. EPA will post the meeting minutes on its website and in the relevant docket.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing TSCA requirements, outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals PMN process. Future webinars will include:

Registration is required for the February 23, 2022, webinar.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.


 
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By Lynn L. Bergeson 

On February 1, 2022, DOE EERE BETO issued two new requests for information (RFI) on biomass conversion R&D and community organic waste programs. The RFI titled “Biomass Conversion Research, Development, and Analysis Programs” focuses on biomass conversion R&D and seeks to address improved robustness of microbial cells, catalytic processes, and state-of-technology analyses in the BETO research portfolio. Through this program, BETO is interested in receiving feedback on barriers, capabilities, tools, and other general information needed to prioritize future R&D programs in the areas of organism and catalyst development. BETO also seeks input on which analyses are most useful to the broader bioenergy research and industrial community. Responses to this RFI must be submitted by March 11, 2022, and are required to be provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address).

DOE EERE BETO’s RFI titled “Community-scale Resource and Energy Recovery from Waste Solutions” requests feedback from industry, academia, research laboratories, government agencies, and other stakeholders on issues related to community programs for organic waste. DOE EERE wishes to understand better which wastes related to economic, environmental, and social impacts are of highest priority to communities and how DOE can make its Conversion R&D program more effective in addressing these types of challenges. BETO is particularly interested in input on five different waste streams: dairy manure, swine manure, food waste, municipal wastewater residuals, and fats/oils/greases. Responses to this RFI must also be submitted by March 11, 2022, and provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address). In lieu of providing written responses to this RFI, BETO is also accepting requests for a 30-minute individual discussion via e-mail. Additional information on both RFIs is available here.


 
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