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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By Lynn L. Bergeson 

EPA Office of Inspector General (OIG) announced the availability of its FY 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned oversight projects concerning Ensuring the Safe Use of Chemicals include:

  • Audit of EPA’s Management of New Chemical Risk Assessments Conducted under TSCA: Determine the extent to which EPA is using and complying with applicable records-management and quality-assurance requirements and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks;
     
  • Evaluation of EPA Regions’ Oversight Responsibilities for State and Tribal Drinking Water Certification Programs: Determine whether select EPA regions are fulfilling oversight responsibilities for drinking water certification programs in states and tribal nations;
     
  • Evaluation of EPA’s Use of Pesticide Incident-Reporting Data: Determine whether EPA uses pesticide incident-reporting data to prevent unreasonable adverse effects on human health and the environment;
     
  • Evaluation of Implementation of EPA’s Federal Certification for Applicators and Dealers of Restricted-Use Pesticides within Indian Country: Determine how EPA monitors and enforces the requirements for restricted-use pesticide applicators (private and commercial) and restricted-use pesticide dealers in Indian Country;
     
  • Evaluation of EPA’s Progress toward Providing States with Clear Benchmarks to Address PFAS in Drinking Water: Determine why EPA has not established a mandatory limit for PFAS in drinking water; what challenges may prevent EPA from setting such a limit; and what EPA’s plan -- if one exists -- is for implementing such a limit; and
     
  • Evaluation of EPA’s Progress to Identify Key Regulatory Stakeholders for TSCA Existing Chemical Risk Management: Determine whether EPA identified and partnered with key regulatory stakeholders and developed a process to coordinate the regulation of occupational exposures from existing chemicals under TSCA.

OIG states that it is important to note that its planning efforts “are not static and that the projects included herein may be modified throughout the year as challenges and risks for the EPA and the CSB evolve and emerge.”

Tags: TSCA, OIG

 
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By Lynn L. Bergeson 

On December 29, 2021, the Kentucky Commissioner of Agriculture, Dr. Ryan Quarles, announced that eligible Kentucky companies can now apply to the state’s Renewable Chemical Production Program. This program provides tax credits for capital investment, job creation, and the production of more than 30 chemicals derived from biomass feedstocks. These chemicals are limited to building block chemicals with a biobased content percentage of at least 50 percent, except for chemicals sold or used for the production of food, feed, or fuel. A complete list of chemicals and company eligibility requirements can be found at https://apps.legislature.ky.gov/law/kar/302/004/010.pdf. To learn more about Kentucky’s Renewable Chemical Production Program or to request an application, contact Tim Hughes at .(JavaScript must be enabled to view this email address). Completed applications, along with a $500 compliance fee, are due by January 15, 2022.


 
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By Lynn L. Bergeson 

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to EPA’s rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking is available in our July 29, 2021, memorandum;
     
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA Fees Rule. EPA proposed to add three new fee categories: a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders. In addition, EPA proposed exemptions for entities subject to certain fee triggering activities, including: an exemption for research and development activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its processes “to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.” EPA intends to publish an NPRM in September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments. EPA intends to issue an NPRM in April 2022; and
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now in the process of reconsidering the final rule in keeping with new EOs concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022.

The Unified Agenda lists the following TSCA rulemaking at the final stage:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012 (77 Fed. Reg. 17573), that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.
Tags: TSCA

 
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Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to readers of the Biobased and Renewable Products Update, offering our best informed judgment as to the trends and key developments we expect to see in the new year. Global and national policy reforms continue to focus increasingly on a circular economy as a critical part of addressing climate change. In 2022, industry stakeholders can expect the U.S. Department of Energy (DOE) to announce funding opportunities for efforts focused on the development of novel biobased chemistry. Stakeholders in the biobased chemical industry should also plan to monitor activities on Capitol Hill, including the Sustainable Chemistry Research and Development Act, passed in July 2020 as part of the National Defense Authorization Act for fiscal year (FY) 2021. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.

WEBINAR
What to Expect in Chemicals in 2022
January 26, 2022, 12:00 p.m. EST
Register Now

B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
 
On December 7, 2021, the U.S. Department of Agriculture (USDA) Secretary Tom Vilsack announced that USDA is making $800 million available to support biofuel producers and improve infrastructure affected negatively by the COVID-19 pandemic. Funds will become available through USDA’s new Biofuel Producer Program authorized by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). USDA hopes that $100 million of the total amount available will increase significantly the sales and use of higher bioethanol and biodiesel blends through the expansion of the infrastructure for renewable fuels derived from U.S. agricultural products. Secretary Vilsack stated that [‌u]nder the leadership of President Biden and Vice President Harris, USDA is providing direct relief to the people of rural America who are still reeling from the economic impacts of the pandemic.” He also reported that USDA is targeting resources and investments to improve the strength and resiliency of America’s sustainable fuel markets.

Tags: USDA, Biofuel

 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
 
On December 7, 2021, the Organization for Economic Cooperation and Development (OECD) published a study titled: “A Chemicals Perspective on Designing with Sustainable Plastics: Goals, Considerations and Trade-offs.” The study builds on considerations from a similar OECD report from 2018 by analyzing four sector-specific case studies on insulation, flooring, biscuit wrappers, and detergent bottles. To produce this study, OECD conducted literature reviews, interviews, and workshops with chemists and suppliers, examining the chemicals perspective on the material selection process informing designers and engineering in finding sustainable plastics for their products. OECD concludes the study by identifying limitations and recommending the following next steps:

  • Identify and address knowledge gaps within scientific insights on chemicals;
  • Continue to promote chemical innovation for improved outcomes for products and their operating environment;
  • Integrate sustainability design goals earlier in the design process;
  • Broaden the scope to include other materials families; and
  • Involve more stakeholders.

The full study and a webinar hosted by OECD on December 7, 2021, are available here.


 
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By Lynn L. Bergeson
 
On December 13, 2021, the U.S. Department of Energy (DOE) announced the availability of $54 million in seed funding for U.S. small businesses to research, develop, and create commercialization action plans for new technologies that accelerate the national transition to a clean energy economy. Led by DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, the opportunity provides that applicants may receive up to $250,000 and become eligible for up to $1.6 million in follow-on funding. To receive funding, applicants must have projects that can help:

  • Diversify sustainable sources of minerals and materials needed to manufacture clean energy technologies;
  • Enhance thermal energy storage technologies for buildings;
  • Improve recyclability and reuse of retired solar panels and components;
  • Increase hydropower and marine energy generation;
  • Convert biomass and other waste into cost-effective, carbon-free fuels; and
  • Develop technologies for affordable, efficient hydrogen production, delivery, and storage.

DOE will also award funding to proposals to license technologies developed by a DOE national lab. Small businesses interested in applying for an SBIR or STTR award must submit a letter of intent by January 3, 2022, 5:00 p.m. (EST). Full applications are due on February 22, 2022. A full list of topics and additional details about this opportunity are available here.


 
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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
 
On December 10, 2021, the U.S. Environmental Protection Agency (EPA) announced that it will hold a virtual public hearing on its proposal for the “Renewable Fuel Standard (RFS) Program: RFS Annual Rules” signed on December 7, 2021. The virtual public hearing is scheduled for January 4, 2022, from 9:00 a.m. to 5:00 p.m. (EST). If necessary, EPA will hold an additional virtual session on January 5, 2022, to accommodate the number of testifiers.
 
EPA is proposing the 2020, 2021, and 2022 renewable fuel standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel. It is also proposing to:

  • Address the remand of the 2016 standard-setting rulemaking;
  • Extend certain RFS compliance and attest engagement reporting deadlines for the 2019, 2020, and 2021 compliance years; and
  • Implement several regulatory changes to the RFS program.

 
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By Lynn L. Bergeson
 
On December 8, 2021, President Joseph Biden signed an Executive Order (EO) on Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability. The EO calls for the federal government to achieve a carbon pollution-free electricity sector by 2035 and net-zero emissions economy-wide by no later than 2050. Using a whole-of-government approach, the federal government “will demonstrate how innovation and environmental stewardship can protect our planet, safeguard Federal investments against the effects of climate change, respond to the needs of all of America’s communities, and expand American technologies, industries, and jobs.” The EO directs agencies to “incentivize markets for sustainable products and services by prioritizing products that can be reused, refurbished, or recycled; maximizing environmental benefits and cost savings through use of full lifecycle cost methodologies; purchasing products that contain recycled content, are biobased, or are energy and water efficient, in accordance with relevant statutory requirements; and, to the maximum extent practicable, purchasing sustainable products and services identified or recommended by” the U.S. Environmental Protection Agency (EPA). According to the fact sheet, sustainable products include “products without added perfluoroalkyl or polyfluoroalkyl substances (PFAS).”


 

 
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By Lynn L. Bergeson

On November 11, 2021, the University of Iowa announced that its Department of Biology scientists discovered a new type of genetic variation in yeast that can improve the production of ethanol. According to the study conducted by the University’s biologists, yeast strains with certain alleles of gene MED15 are more efficient at fermentation. The study was led by Professor Jan Fassler, who states that these findings may assist scientists in engineering a better yeast strain to produce more efficiently bioethanol for fuel and wine.


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

On November 26, 2021, EPA issued a proposed rule to modify certain compliance dates under the Renewable Fuel Standard (RFS) program. For small refineries only, EPA is proposing to extend the RFS compliance reporting deadline and the associated attest engagement reporting deadline for compliance year 2019. EPA is also proposing to extend the RFS compliance reporting deadline and the associated attest reporting deadline for 2020 and 2021 compliance years for all obligated parties. Lastly, EPA is also proposing to change the way that it determines future RFS compliance and attest engagement reporting deadlines.

Comments on the proposed rule are due on or prior to January 3, 2022.

Tags: RFS, Biofuel

 
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By Lynn L. Bergeson 

According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.

OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”

To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
     
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
     
  • Scopes of work for any contracts related to the new chemicals review process;
     
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
     
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in Bergeson & Campbell, P.C.’s (B&C®) October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.
 


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

On November 23, 2021, ACS announced that it is accepting applications for its Heh-Won Chang, Ph.D. Fellowship in Green Chemistry. This opportunity provides $5,000 in financial support to full-time graduate students conducting research in green chemistry. This one-time payment may be used for any purpose, including conference travel, professional development, and living expenses while the recipient is in graduate school. This opportunity is open to full-time graduate students across the globe who have at least one full year of study remaining in their graduate programs. Recipients must present their research at the annual ACS GC&E, where the award will be presented formally. Applications are due by December 31, 2021. Additional information on application requirements is available here.


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

On November 23, 2021, the American Chemical Society (ACS) Green Chemistry Institute (GCI) announced that it is accepting applications for the Nina McClelland Memorial Award for postdoctoral chemists engaged in green chemistry research. Annually, two awardees will receive a $2,000 sponsorship to participate in and present their research at the annual ACS Green Chemistry & Engineering Conference (GC&E).

The 2022 GC&E will be held in Reston, Virginia, from June 6 to June 8, 2022. Both U.S. and international postdoctoral scholars are eligible to apply for this opportunity. For purposes of this award, ACS GCI characterizes green and sustainable chemistry innovation activities as:

  • Elimination and reduction of toxics and pollution;
     
  • Holistic systems design;
     
  • Maximization of resource efficiency; and
     
  • Utilization of life cycle thinking.

Applications must address at least one of these attributes, and nominees are encouraged to address as many of them as possible. The application deadline is December 31, 2021. Additional information on how to apply is available here.


 
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