| Biobased and Renewable Products Update |
| December 1, 2022 |
Registration Is Open For The “Articles under TSCA” Webinar On December 14, 2022
Register now to join Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C®) webinar “Articles under TSCA” from 12:00 p.m. – 1:00 p.m. (EST) on December 14, 2022. When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the regulation of chemicals in “articles,” generally meaning finished products or manufactured goods. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many in the regulated industries off guard and reflects a significant shift in U.S. chemical regulation policy. This change in policy affects all commercial entities that deal with a physical product, as they must now become familiar with the law, its requirements, and the chemical makeup of their finished goods. This webinar will cover the policy changes that led to the regulation of articles, EPA’s authority to regulate these articles, and what companies need to know to stay in compliance.
Federal
EPA’s ORD Publishes Six Strategic Research Action Plans For FYs 2023-2026, Including For Chemical Safety For Sustainability
Research in EPA’s Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS states that CSS will continue to:
- Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
- Accelerate the pace of chemical assessment to enable our partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
- Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.
Topic 1, Chemical Evaluation, includes three research areas, including emerging materials and technologies. The StRAP states that emerging materials and technologies often have unique physicochemical properties, warranting specialized approaches for evaluating hazard and exposure, and necessitating an evaluation of the environmental impacts of their use. In addition, investigation of novel products of synthetic biology, genome editing, and metabolic engineering is needed to support risk assessment of emerging biotechnology products. The emerging materials and technologies research area will develop, collate, mine, and apply information on emerging materials and technologies to support risk-based decisions, including potential impacts of disproportionately affected populations. It will address the additional data needed to characterize potential release of and exposure to these chemicals and materials, and subsequent environmental impacts of emerging materials on humans and ecological species. The research area will also address relevant cross-cutting priorities related to cumulative impacts and environmental justice potentially associated with incidental exposures.
GAO Recommends EPA And DOE Improve Decision-Making In Small Refinery Exemption Program
The U.S. Government Accountability Office (GAO) published a report on November 3, 2022, entitled Renewable Fuel Standard: Actions Needed to Improve Decision-Making in the Small Refinery Exemption Program. The Renewable Fuel Standard (RFS) requires that gasoline and diesel fuels be blended with a minimum volume of renewable fuel. Small refineries can petition EPA annually for an exemption from their RFS obligations based on disproportionate economic hardship. EPA must evaluate small refinery exemption petitions in consultation with the Department of Energy (DOE). Congressional requesters asked GAO to review issues related to EPA’s and DOE’s implementation of the small refinery exemption program. GAO examined the information, policies, and procedures EPA and DOE use to make decisions about exemptions and the extent to which exemption decisions are timely.
According to GAO, EPA does not have assurance that its decisions about small refinery exemptions under the RFS are based on valid information. In addition, EPA and DOE do not have policies and procedures specifying how they are to consult about and make exemption decisions. GAO states that EPA has routinely missed the 90-day statutory deadline for issuing exemption decisions and does not have procedures to ensure that it meets these deadlines. In five of the nine years GAO analyzed, EPA took more than 200 days to issue a decision for more than half of the petitions submitted.
GAO made seven recommendations, including that EPA reassess its conclusion that all small refineries recover their RFS compliance costs in the price of the gasoline and diesel they sell; that DOE and EPA develop documented policies and procedures for making small refinery exemption decisions; and that EPA develop procedures to ensure that it meets deadlines. DOE agreed with GAO’s recommendations. EPA disagreed with one recommendation and partially agreed with the others. GAO “maintains that the recommendations are valid.” More information is available in our November 17, 2022, blog item.
EPA Requests Nominations For Science Advisory Committee On Chemicals
EPA announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under TSCA. 87 Fed. Reg. 67898. SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022.
EPA states that it is seeking nominations from individuals who have demonstrated high levels of competence, knowledge, and expertise in scientific and other technical fields relevant to chemical safety and risk assessment. EPA seeks nominees with expertise in a variety of disciplines and focus areas, including human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure pathways to susceptible life stages and subpopulations (women, children, and other potentially exposed subpopulations). More information is available in our November 29, 2022, blog item.
EPA Adds Thousands Of Additional TSCA Risk, New Chemical Submissions To ChemView, Commits To “Near Real-Time Publication” Going Forward
On November 21, 2022, EPA announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under TSCA, including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices. More information is available in our November 22, 2022, blog item.
GAO Publishes Science & Tech Spotlight On Biorecycling Of Plastics
On November 21, 2022, GAO published a Science & Tech Spotlight on biorecycling of plastics. Biological recycling, or biorecycling, is an emerging technology that uses microbes, such as bacteria or fungi, to break down plastic into its basic components for reuse. GAO states that research suggests that biorecycling of plastics could help promote a circular economy in which plastic waste is continuously reincorporated into new products. According to GAO, entities seeking to engage in biorecycling could face a “complicated legal landscape” that may pose a challenge for the emerging technology. At the federal level, depending on the specifics of the process, aspects of biorecycling or the wastes that may result from that process might be governed by statutes such as TSCA, the Resource Conservation and Recovery Act (RCRA), and the Microbial Products of Biotechnology Rule. In addition, states, Tribal organizations, municipalities, and other stakeholders, including nonprofit organizations, businesses, and other entities, can also play important roles in regulating or supporting recycling in the United States.
GAO identified the following challenges:
- Implementation costs. Recycling plastics is generally more expensive than creating new plastics. Further, companies may face high start-up costs to develop a biorecycling facility;
- Limited applicability. The enzymes researchers have identified are currently limited to degrading only a few types of plastic; and
- Knowledge gaps. Research is needed to address the unintended consequences of biorecycling. For example, researchers have not assessed the risks engineered enzymes might pose if released into the environment.
GAO states that it meets Congressional information needs in several ways, including by providing oversight, insight, and foresight on science and technology issues. GAO notes that it also provides targeted assistance on specific science and technology topics to support Congressional oversight activities and provide advice on legislative proposals. More information is available in our November 28, 2022, blog item.
EPA’s FY 2023 Top Management Challenges Include Providing For The Safe Use Of Chemicals
Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, the EPA Office of Inspector General (OIG) released its report regarding EPA’s FY 2023 top management challenges. According to the report, the eight top management challenges for EPA in FY 2023 include:
- Providing for the Safe Use of Chemicals: The public must be able to depend on the EPA’s ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemicals.
OIG states in its full report that an audit of TSCA’s New Chemicals Review Process is currently ongoing as part of its FY 2022 Oversight Plan. According to OIG, the objective of that review is to 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.
OIG concludes that many of the Biden Administration’s top priorities rely on the work of the OCSPP. Both EPA OIG and EPA have noted that key OCSPP programs face a steep staffing shortage and a lack of planning that could negatively impact critical chemical work, however. Absent the resources OCSPP needs for its TSCA programs, EPA “will remain challenged with meeting its statutory deadlines.” OIG states that if OCSPP is unable to balance the workload with its resource needs, EPA “will continue to face the key challenge of ensuring the safety of chemicals.”
USDA Scientists Produce Nanobodies In Plant Cells That Block Emerging Pathogens
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order (EO) on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy. More information on the EO is available in our September 13, 2022, blog item.
International
EuropaBio Announces Biomanufacturing Platform
EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure that it is visible and recognized within the industrial strategy and Europe’s green and digital transitions. The Platform will address the policy and wider frameworks through which biomanufacturing is delivered. EuropaBio states that together with members and stakeholders, the Platform will address how economic growth, employment, and resilience are achieved through policy, legal frameworks, and regulation at the European Union (EU) and national levels. Platform activities will build an economic evidence base for biomanufacture across sectors; reflect policy priorities from EuropaBio’s Healthcare, Industrial Biotechnology, and National Association Councils; and build case studies to demonstrate diversity and impact of biomanufacture.
Events
“EPA Webinar On Supplemental Proposed Rule To Modify TSCA Fees” On December 6, 2022
EPA will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the TSCA fees rule. EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs consistent with direction in the FY 2022 appropriations bill to consider the “full” implementation costs of the law. The webinar will provide stakeholders an opportunity to provide comment to EPA on the supplemental proposed rule. Registration for the webinar is open. More information on the supplemental proposed rule is available in our November 18, 2022, memorandum.
“SAF Grand Challenge Roadmap: Soaring Towards Sustainable Fuel Production Goals” On December 13, 2022
DOE’s Bioenergy Technologies Office (BETO) will hold a webinar on December 13, 2022, on the “SAF Grand Challenge Roadmap: Soaring Towards Sustainable Fuel Production Goals.” Attendees will learn about the six action areas that support the Grand Challenge’s goals of:
- Reducing life cycle greenhouse gas emissions (GHG) by 50 percent compared to conventional fuel;
- Producing enough sustainable aviation fuels (SAF) to meet 100 percent of aviation fuel demand by 2050; and
- Enhancing fuel sustainability.
The webinar will feature the director of BETO and speakers from DOE and the National Renewable Energy Laboratory, who will discuss engaging with industry to achieve these goals. Speakers will include:
- Valerie Reed: Director, BETO;
- Zia Haq: Senior Analyst, BETO;
- Craig Brown: Bioenergy Systems Technical Integration Lead, National Renewable Energy Laboratory; and
- Mark Shmorhun: Technology Manager, Systems, Development, and Integration, BETO.
Registration is now open.
“EuropaBio Biomanufacturing Platform — Policy Summit 2023” On March 15, 2023 The EuropaBio Biomanufacturing Platform will host its first policy summit on March 15, 2023, in Brussels. The summit will set the vision for Europe’s global innovation, competitiveness, and sustainability through the lens of biomanufacturing and set a baseline for its understanding and recognition within policy. The summit will be open to EuropaBio members and invited stakeholders. Contact c.skentelbery@europabio.org for further information.
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