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By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Government Accountability Office (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 the Toxic Substances Control Act (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.
 
Opportunities from biorecycling of plastics include:

  • Economic, environmental, and health gains. Biorecycling of plastics could help promote a circular economy by turning waste into more useful products while reducing dependence on fossil fuels for new plastics. Emerging recycling methods could help mitigate the negative health effects of incinerating plastic waste; and
  • Processing efficiency. Biorecycling does not require the same level of sorting for plastic waste compared with mechanical recycling, thereby saving time and money. It also consumes less energy than mechanical and some chemical recycling methods.

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.

According to GAO, policy context and questions include:

  • What aspects of biorecycling could be prioritized to help reduce the accumulation of plastic waste and its economic and environmental effects?
  • To what extent do current laws and regulations appropriately address concerns regarding the industrial use of engineered enzymes for biorecycling, while still allowing for their development?
  • What steps could the federal government, states, municipalities, and other stakeholders take if they want to support or implement effective policies for biorecycling of plastic waste?

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 21, 2022, the U.S. Environmental Protection Agency (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 the Toxic Substances Control Act (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).
 
New Chemical Submissions
 
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.
 
Notices of Substantial Risk
 
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
 
Health and Safety Data Reporting
 
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The 2022 Organization for Economic Cooperation and Development (OECD) Green Growth and Sustainable Development (GGSD) Forum will meet at their headquarters in Paris, France, November 22-23, 2022. Participants will discuss how the impact of economic shocks, such as those caused by the COVID-19 pandemic and Russia’s large-scale aggression against Ukraine, affect mission-oriented approaches for green innovation and the role that low-carbon hydrogen and the bio-economy sectors could play in a sustainable recovery. Participants will also discuss the specific challenges and opportunities faced by small- and medium-sized enterprises (SME) and the lessons learned from the international scientific cooperation that occurred in response to the COVID-19 pandemic for science, technology, and innovation (STI) efforts to address environmental degradation. Registration is open to join online or in person.

Tags: OECD, COVID-19

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 2, 2022, that it launched a new process to expand the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA is inviting managers of standards development organizations, ecolabel programs, and other similar organizations to apply for potential assessment and inclusion in the Recommendations. 87 Fed. Reg. 66176. EPA is also hosting a webinar on November 15, 2022, from 1:00 p.m.-2:30 p.m. (EST) to answer questions from stakeholders about the expansion of the Recommendations and the process for applying. The EPP program’s Recommendations help federal government purchasers use private sector standards and ecolabels to meet sustainable acquisition goals and mandates. According to EPA, they currently include more than 40 private sector environmental performance standards and ecolabels in over 30 purchase categories.
 
EPA states that to apply to have a standard or ecolabel included in the Recommendations, interested applicants should first familiarize themselves with the Framework for the Assessment of Environmental Performance Standards and Ecolabels (Framework), which will be used to assess all eligible applicants. Then, submit responses to the scoping questions to .(JavaScript must be enabled to view this email address) by January 1, 2023. EPA will use the scoping questions to determine eligibility and scope of the assessment. After the application deadline closes, EPA will issue an estimated timeline for full assessments against the Framework by product/service category within 120 days. For each category being assessed, EPA will provide further notice and instruction to applicable applicants.
 
EPA seeks to assess multi-attribute standards and ecolabels that recognize environmental performance leadership and support federal goals and mandates regarding climate, safer chemicals, or other sustainable acquisition priorities of the Biden Administration (e.g., net-zero emissions, low embodied carbon construction materials, and the restriction or elimination of per- or polyfluoroalkyl substances (PFAS) in certified products). EPA is particularly interested in assessing standards and ecolabels in the following sectors: building/construction; infrastructure; landscaping; food and cafeteria services; uniforms/clothing; professional services; and laboratories and healthcare. EPA states that standards and ecolabels that address other sectors already included in the Recommendations are welcome to apply.


 

This week’s All Things Chemical® podcast will be of interest to readers of the B&C® Biobased and Sustainable Chemicals Blog. This episode features a conversation between Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) and Dr. Claire Skentelbery, Director General, EuropaBio -- The European Association for Bioindustries. Many know Claire from her prior role as Director General of the Nanotechnology Industries Association, where she energized that Brussels-based trade association to new and exciting heights. Claire has brought her considerable scientific, science policy, and trade association management skills to EuropaBio at an exciting time, as biotechnology is widely recognized to be a pivotal component of the European Union’s (EU) commitment to sustainability. Lynn and Claire cover a lot of territory in this conversation and discuss evolving perceptions of biotechnology in the EU, how biotechnology is advancing the EU’s commitment to sustainability and circularity, and what’s next for biotech advocacy in the EU.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The California Department of Toxic Substances Control (CDTSC) invites stakeholders to two external engagement sessions, on November 1 and November 3, 2022, to share their perspectives on an actionable definition of sustainable chemistry. CDTSC states that stakeholders’ participation and expertise can help refine a draft, consensus definition and set of criteria for sustainable chemistry. According to CDTSC, the draft definition and criteria were developed over the past six months by a 20-person Expert Committee on Sustainable Chemistry (ECOSChem) that includes representatives from industry, academia, and governmental and non-governmental organizations, including a representative from the Safer Consumer Products Program (SCP). The charge of ECOSChem is to establish “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.” More  information about the project is available in a background document.
 
The ECOSChem process is facilitated and supported by Beyond Benign and the Lowell Center for Sustainable Production (LCSP), who will host two external engagement meetings. CDTSC asks participants to register in advance for the November 1, 2022, meeting or the November 3, 2022, meeting. During the meetings, the Project Team will introduce the project and the draft definition and criteria (15 minutes). Participants will then move into small groups organized by sector that will be moderated by ECOSChem members (45 minutes), followed by a wrap-up session where key input will be shared with the large group with time for discussion (30 minutes). Discussion materials for these meetings will be sent out on October 31, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R. Part 340. According to APHIS, the corn plant, from Infinite Enzymes, Inc., was modified to produce the enzyme manganese peroxidase in corn seed and to make it resistant to the herbicide glufosinate. The potato plant, from J.R. Simplot Company, was modified to make it resistant to potato late blight and potato virus Y and to alter the potato tuber’s sugar profile and quality.
 
According to APHIS, in both cases, it “found these plants unlikely to pose an increased plant pest risk compared to other cultivated corn and potato plants.” As a result, they are not subject to regulation under 7 C.F.R. Part 340. From a plant pest risk perspective, these plants may be safely grown and used in breeding in the United States. APHIS notes that its responses are based on information from the developers and its own:

  • Familiarity with plant varieties;
  • Knowledge of the traits; and
  • Understanding of the modifications.

Under 7 C.F.R. Part 340, developers may request an RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS issues a response indicating the plant is not subject to the regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by USDA’s National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS), and discuss details included in the fiscal year (FY) 2023 Request for Applications (RFA). NIFA plans to invest $5.5 million in this funding opportunity, which supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the federal regulatory process. Applications may be submitted by any U.S. public or private research or educational institution or organization. The closing date for grant applications is January 19, 2023. Registration for the webinar is required.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments.
 
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe to stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemical submissions and common issues that cause EPA to have to reconduct risk assessments (“rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
 
This will be the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. As reported in our July 28, 2022, memorandum, in July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. Meeting materials are available for those who missed the first webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations, including the new Regulatory Status Review and Confirmation Request processes, and other 2022 activities.
 
BRS seeks feedback on discussion topics for the meeting. Comments or suggestions on potential topics of interest are due October 14, 2022, to .(JavaScript must be enabled to view this email address). BRS will send out further meeting details and registration information. BRS states that stakeholders should check the BRS website for future meeting updates.


 
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