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.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 27, 2022, that it is extending the deadline for applications from managers of standards development organizations, ecolabel programs, and other similar organizations for assessment and inclusion in the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing, a resource intended to help federal purchasers identify and procure environmentally preferable products and services. To apply to have a standard or ecolabel included in the Recommendations, applicants must submit responses to the scoping questions to .(JavaScript must be enabled to view this email address) by January 24, 2023. EPA notes that responses to the scoping questions may be high level and do not need to include detailed information or justifications. EPA will use the responses to determine the applicant's eligibility and scope of assessment. EPA states that it will review applications by product categories. In spring 2023, EPA will announce the order in which product categories will be assessed. In fall 2023, EPA will notify the first round of applicants of the results of its assessment. More information on the new process to expand the Recommendations is available in our November 7, 2022, blog item.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 20, 2022, the Federal Trade Commission (FTC) requested public comment on its Guides for the Use of Environmental Claims (Green Guides). FTC intends the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. 87 Fed. Reg. 77766. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” As noted in our December 16, 2022, memorandum, publication of the notice in the Federal Register began a 60-day comment period. Comments are due February 21, 2023.
 
FTC states that it expects “many public comments” on the following specific issues:

  • Carbon Offsets and Climate Change: The current Green Guides provide guidance on carbon offset and renewable energy claims. FTC invites comments on whether the revised Green Guides should provide additional information on related claims and issues;
     
  • The Term “Recyclable”: Among other things, FTC seeks comments on whether it should change the current threshold that guides marketers on when they can make unqualified recyclable claims, as well as whether the Green Guides should address in more detail claims for products that are collected (picked up curbside) by recycling programs but not ultimately recycled;
     
  • The Term “Recycled Content”: FTC requests comments on whether unqualified claims about recycled content -- particularly claims related to “pre-consumer” and “post industrial” content -- are widely understood by consumers, as well as whether alternative methods of substantiating recycled content claims may be appropriate; and
     
  • The Need for Additional Guidance: FTC also seeks comment on the need for additional guidance regarding claims such as “compostable,” “degradable,” ozone-friendly,” “organic,” and “sustainable,” as well as those regarding energy use and energy efficiency.

More information and an insightful commentary are available in our December 16, 2022, memorandum.


 

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.


 

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as B&C presents “Domestic Chemical Regulation and Achieving Circularity.” 

Topics Covered:

  • Achieving sustainability and the promise of the circular economy;
     
  • Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act;
     
  • Federal policy and TSCA regulatory shifts intended to support sustainability and circularity;
     
  • Transitioning chemicals from research and development (R&D) platforms into the market; and
     
  • Changes to TSCA and FIFRA that affect chemical innovation.

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.

Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University

Mathy Stanislaus was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.

Register Now


 

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.


 

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.


 

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.


 

By Lynn L. Bergeson

On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA requests public comments as it begins the process to reauthorize the BsUFA program and invites stakeholders to participate in its virtual public meeting on November 19, 2020, from 9:00 a.m. to 12:30 p.m. (EST). Registration to participate in the virtual meeting is available here. After the meeting, written comments must be submitted on or prior to December 19, 2020.


 

By Lynn L. Bergeson 

The Environmental Law Institute (ELI) recently released Environment 2021: What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead. ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a new administration.” According to ELI, the report:

  • Assesses the Trump Administration’s steps to remake federal environmental regulation and redefine the relationships among state and federal environmental decisions;
  • Identifies key categories of action affecting environmental regulation and examines some possible future outcomes; and
  • Helps environmental practitioners, policymakers, and the public at large think about what lies ahead, looking particularly at the nation’s ability to address new problems and confront as yet unsolved challenges, such as environmental justice.

 

By Lynn L. Bergeson 

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, 2021.


 
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